chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Persistent R shoulder/delt pain, 4/10 pain, only with overhead activity of his R arm, sharp, localized to the delt/shoulder area, and does not radiate down his arm. Did not remember anything unusual about the vaccination -- no excessive bleeding, no post-injection swelling/redness, no excessive pain at time of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Dizziness, Feeling cold, Gait inability
Clinical narrative: Monday 2/4 - received SHINGRIX - Arm sore/ turned red/inflamed. Tuesday  0300 shaking/trembling (cold) body aching/ Light headed/ dizzy/ Ached all over, weak and nauseous." (Could not walk yesterday 2/5/19)bones in feet hurt." Feeling better today.  Still having some weakness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Nausea, Pain, Pain in extremity, Skin reaction
Clinical narrative: Monday 2/4 - received SHINGRIX - Arm sore/ turned red/inflamed. Tuesday  0300 shaking/trembling (cold) body aching/ Light headed/ dizzy/ Ached all over, weak and nauseous." (Could not walk yesterday 2/5/19)bones in feet hurt." Feeling better today.  Still having some weakness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Monday 2/4 - received SHINGRIX - Arm sore/ turned red/inflamed. Tuesday  0300 shaking/trembling (cold) body aching/ Light headed/ dizzy/ Ached all over, weak and nauseous." (Could not walk yesterday 2/5/19)bones in feet hurt." Feeling better today.  Still having some weakness.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: 2/6/19 patient reports cannot move arm behind her back, pain with lifting over her head, pain radiates down her left arm.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient came back to the pharmacy about an hour after receiving the shot, complaining of hives and itching. Patient was given diphenhydramine 50mg capsule and after 15 minutes patient stated they felt better.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Ecchymosis, Induration, Peripheral swelling, Tenderness
Clinical narrative: Three days after vaccine, upper arm became swollen and tender to touch and bruising present. Symptoms got worse over the next 4 days and bruising and swelling have slowly been getting better. Now (2/1/19) - 14 days after vaccine (patient represented to clinic), arm is swollen 7 x 4 cm induration in center, ecchymosis 6 x 4 cm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported hives 2 days after receiving 2nd dose of SHINGRIX. OTC topical steroids ineffective. Gave prednisone today and advised to use topical BENADRYL for itching.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Hypersomnia, Injection site pain
Clinical narrative: Within 4 hours injection site very sore including entire left shoulder, right shoulder aching, extremely tired for almost 2 days causing constant sleeping with upset stomach.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Infection, Swelling
Clinical narrative: Pt got an "infection" that she was given a Z-pack for. As far as I could tell, it just looked bruised, a little swollen and red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Insomnia, Nausea
Clinical narrative: Nausea, weakness, insomnia.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Intermittent fever up to 105 for at least 5 days.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Large red area around injection site reported 2 hrs after administration. Followed up with patient 6 hours post administration and reaction had not worsened. Patient reported no tightness of chest or breathing difficulties.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Pain on right arm, checked with MD, found no muscle damage.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Fall, Middle insomnia
Clinical narrative: Patient had 2 dose of SHINGRIX at 11pm, stated feeling dizzy wake up at night. She fell down and got bruise.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Urgent diarrhea 3 1/2 hours after shot was administered. Next morning (day 2, 15 hrs after vaccine was administered) woke up feeling fatigued. Remained fatigued all day. So much so that I had to lie down for a few hours. 24 hrs after shot injection, I feel nauseous with a strong headache.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Eyelid rash, Influenza like illness, Rash vesicular
Clinical narrative: Flu like symptoms. Patient then reported vesicular rash on her eyelid on 2/6/19, area of previous shingles outbreak. Patient was sent to ophthalmology for evaluation.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in left arm, described as throbbing pain that began night of injection and has continued since that day. Patient has been taking TYLENOL for pain and called her physician for an appointment.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Injection site nodule, Injection site swelling
Clinical narrative: Legs began to swell with large knots on both legs at the injection site, lasting a few weeks. She began running a fever which lasted about a week. She would no longer speak, hold eye contact, clap, wave, give hugs and kisses, play with her siblings, etc. She would just sit and stare or play alone. She would no longer respond to her name or any sounds to get her attention.  She was tested on August 2017 and in less than 10 minutes they were able to diagnose her with autism spectrum disorder. She has been in therapy over a year now and is still non verbal.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Laboratory test abnormal, Pyrexia, Regressive behaviour, Social avoidant behaviour, Staring
Clinical narrative: Legs began to swell with large knots on both legs at the injection site, lasting a few weeks. She began running a fever which lasted about a week. She would no longer speak, hold eye contact, clap, wave, give hugs and kisses, play with her siblings, etc. She would just sit and stare or play alone. She would no longer respond to her name or any sounds to get her attention.  She was tested on August 2017 and in less than 10 minutes they were able to diagnose her with autism spectrum disorder. She has been in therapy over a year now and is still non verbal.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Legs began to swell with large knots on both legs at the injection site, lasting a few weeks. She began running a fever which lasted about a week. She would no longer speak, hold eye contact, clap, wave, give hugs and kisses, play with her siblings, etc. She would just sit and stare or play alone. She would no longer respond to her name or any sounds to get her attention.  She was tested on August 2017 and in less than 10 minutes they were able to diagnose her with autism spectrum disorder. She has been in therapy over a year now and is still non verbal.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Bilateral rash on face started day 3 and is worsening still on day 7.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: Child started to develop flu like symptoms (headache, excessive throw up, runny nose, seemed overly tired and upset, stomach ache including diarrhea. Temperature maintained 97.8 degrees so no fever. Two days post vaccine, symptoms have relieved and child is back to normal self.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Influenza like illness, Rhinorrhoea, Vomiting
Clinical narrative: Child started to develop flu like symptoms (headache, excessive throw up, runny nose, seemed overly tired and upset, stomach ache including diarrhea. Temperature maintained 97.8 degrees so no fever. Two days post vaccine, symptoms have relieved and child is back to normal self.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Eye disorder, Fatigue, Gait inability
Clinical narrative: THE NEXT DAY THAT HE RECEIVE THOSE VACCINES, HE COULD NOT WALK FOR 2 DAYS, HE WAS TIRED AND HIS EYES LOOK DIFFERENT AFTER THAT IN SEPTEMBER 2018 HE COULD NOT WALK AGAIN AND NOW I'M TAKING HIM TO THE CHIROPRACTIC AND THAT IS HELPING. I TALK WITH HIS DOCTOR AND SHE SAYS WAS A NORMAL REACTION, SHE DIDN'T LISTEN TO ME.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema multiforme, Fatigue, Injection site rash, Nausea
Clinical narrative: 1/31/19 Started with chills, fatigue, aches and nausea. Patient states she did nothing and symptoms improved by 02/02/2019. 02/05/2019 Patient has rash left upper arm getting worse. Saw MD today. Has Erythema Multiforme. Advised BENADRYL. May need steroids.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 1/31/19 Started with chills, fatigue, aches and nausea. Patient states she did nothing and symptoms improved by 02/02/2019. 02/05/2019 Patient has rash left upper arm getting worse. Saw MD today. Has Erythema Multiforme. Advised BENADRYL. May need steroids.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site inflammation, Injection site pain
Clinical narrative: Pt reports having intense pain and inflammation at injection site. This has resolved, however there is a dime sized discoloration at injection site. Looks like and 'age spot'.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Crying, Injection site mass, Injection site swelling
Clinical narrative: Uncontrollable crying per mom report. About 2 cm swelling/lump to (R) upper lateral thigh. Ice pack and OTC Ibuprofen with instructions to return to clinic in AM if not better.
Age: 39.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient passed out and convulsed for approx. 30 seconds. patient regained consciousness; EMS arrived; patient's vitals were WNL.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt said arm pain that traveled down to elbow, then the other arm started to hurt at same spot. Lasted for over a week.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: Fever, chills, body aches, arm soreness, headache less than 24 hours after injection lasted 3 days. The rash presented 3 days after injection. Warm to touch. Red, lumpy itches slightly, arm is still somewhat sore.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: Fever, chills, body aches, arm soreness, headache less than 24 hours after injection lasted 3 days. The rash presented 3 days after injection. Warm to touch. Red, lumpy itches slightly, arm is still somewhat sore.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Fever, chills, body aches, arm soreness, headache less than 24 hours after injection lasted 3 days. The rash presented 3 days after injection. Warm to touch. Red, lumpy itches slightly, arm is still somewhat sore.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, arm soreness, headache less than 24 hours after injection lasted 3 days. The rash presented 3 days after injection. Warm to touch. Red, lumpy itches slightly, arm is still somewhat sore.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Fluid intake reduced, Irritability, Pyrexia
Clinical narrative: Patient had his WCE and immunizations 2 days ago, has been running fever since Temp 103-103.5 degrees, only goes down to about 101 degrees. Patient has been fussy, not drinking much had low grade fever with first set of shots.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Lymphoedema, Pain in extremity, Peripheral swelling
Clinical narrative: Tuesday (1-29-19) started with swelling and pain in Right arm inner arm, and back of arm. No fever or redness. Patient diagnosed with Lymphedema of Right upper extremities due to vaccine. Patient has been put on AUGMENTIN and Prednisone. Patient is to call in 1 week for update.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Feeling abnormal, Headache, Malaise
Clinical narrative: Pt called 7 days later and was still shaking, tremoring, had pain in the vaccinated arm and felt anxious. She had unbearable head aches for 3 days and just felt foggy and sick. She was weak and feverish for the first 48 hrs. No treatment given.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Pt called 7 days later and was still shaking, tremoring, had pain in the vaccinated arm and felt anxious. She had unbearable head aches for 3 days and just felt foggy and sick. She was weak and feverish for the first 48 hrs. No treatment given.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration
Clinical narrative: SHINGRIX injection was given Sub-Q instead of IM. Patient had redness in left elbow 2 days later-No issue at injection site.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Malaise, Urticaria
Clinical narrative: Headache, malaise, urticaria within 24h of BEXSERO and second MENVEO. Denies previous MENVEO reaction.
Age: 1.25
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None. Extra dose of PCV-13 was given.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Trouble breathing/wheezing 1 to 2 days after vaccine administration. Taken to ER. Prescribed Prednisone and albuterol.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Emotional distress, Headache
Clinical narrative: Patient experienced 45 minutes of inconsolable behavior. Frequency in headaches.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal dreams, Asthenia, Bone pain, Crying, Erythema
Clinical narrative: 1-25 Left was cold and Body started hurting 1-26 arm swelled up 27-28 could not lift arm. Red swollen bigger than my hand including fingers body hurt in the bones, cried dreamed I was dying. 29 arm started going down but as it went down I was getting sick hurting again. Took 3 months for the knot to go away. While I was sick stomach starting feeling swollen, now I just seem like I can't get my energy back. Really took a toll on me I am just sending this because one thing or another keeps happening to me. I just want to get well.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Malaise, Mobility decreased, Nausea, Nodule
Clinical narrative: 1-25 Left was cold and Body started hurting 1-26 arm swelled up 27-28 could not lift arm. Red swollen bigger than my hand including fingers body hurt in the bones, cried dreamed I was dying. 29 arm started going down but as it went down I was getting sick hurting again. Took 3 months for the knot to go away. While I was sick stomach starting feeling swollen, now I just seem like I can't get my energy back. Really took a toll on me I am just sending this because one thing or another keeps happening to me. I just want to get well.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: 1-25 Left was cold and Body started hurting 1-26 arm swelled up 27-28 could not lift arm. Red swollen bigger than my hand including fingers body hurt in the bones, cried dreamed I was dying. 29 arm started going down but as it went down I was getting sick hurting again. Took 3 months for the knot to go away. While I was sick stomach starting feeling swollen, now I just seem like I can't get my energy back. Really took a toll on me I am just sending this because one thing or another keeps happening to me. I just want to get well.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bundle branch block right, Disorientation, Dizziness, Electrocardiogram abnormal, Fatigue
Clinical narrative: This case was reported by a nurse and described the occurrence of faint in a 61-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis.  The patient's past medical history included hypertension, meniere's disease, tinnitus and vertigo. Concurrent medical conditions included ex-smoker and drug allergy (Unknown drug allergy).  On 17th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st January 2019, 4 days after receiving SHINGRIX, the patient experienced faint (serious criteria GSK medically significant), dizziness, nausea, disorientation, tiredness and tremor of hands. On 21st January 2019, the outcome of the tremor of hands was recovered/resolved. On 22nd January 2019, the outcome of the faint, dizziness and nausea were recovered/resolved. On an unknown date, the outcome of the disorientation and tiredness were unknown. It was unknown if the reporter considered the faint, dizziness, nausea, disorientation, tiredness and tremor of hands to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 year's old. The patient played tennis at 9 AM. The patient tried some bread minutes later, felt dizziness (3 episode of severe dizziness), felt better, and played tennis. At 11.30 ate bread and again felt dizzy sat down then felt disoriented, felt tired, unsure if passed out, went upstairs and showered went out and ran onwards 6.30 PM, felt dizziness, called husband and found to be seated on chair and hand shaking for 5 seconds. The patient experienced 1 episode of nausea and faint. The patient was informed to cardiology and neurology. This case has been linked with US2019GSK015430, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Poor quality sleep, Syncope, Tremor
Clinical narrative: This case was reported by a nurse and described the occurrence of faint in a 61-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis.  The patient's past medical history included hypertension, meniere's disease, tinnitus and vertigo. Concurrent medical conditions included ex-smoker and drug allergy (Unknown drug allergy).  On 17th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st January 2019, 4 days after receiving SHINGRIX, the patient experienced faint (serious criteria GSK medically significant), dizziness, nausea, disorientation, tiredness and tremor of hands. On 21st January 2019, the outcome of the tremor of hands was recovered/resolved. On 22nd January 2019, the outcome of the faint, dizziness and nausea were recovered/resolved. On an unknown date, the outcome of the disorientation and tiredness were unknown. It was unknown if the reporter considered the faint, dizziness, nausea, disorientation, tiredness and tremor of hands to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 year's old. The patient played tennis at 9 AM. The patient tried some bread minutes later, felt dizziness (3 episode of severe dizziness), felt better, and played tennis. At 11.30 ate bread and again felt dizzy sat down then felt disoriented, felt tired, unsure if passed out, went upstairs and showered went out and ran onwards 6.30 PM, felt dizziness, called husband and found to be seated on chair and hand shaking for 5 seconds. The patient experienced 1 episode of nausea and faint. The patient was informed to cardiology and neurology. This case has been linked with US2019GSK015430, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Disorientation, Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: This case was reported by a nurse and described the occurrence of faint in a 61-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis.  The patient's past medical history included hypertension, meniere's disease, tinnitus and vertigo. Concurrent medical conditions included ex-smoker and drug allergy (Unknown drug allergy).  On 17th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st January 2019, 4 days after receiving SHINGRIX, the patient experienced faint (serious criteria GSK medically significant), dizziness, nausea, disorientation, tiredness and tremor of hands. On 21st January 2019, the outcome of the tremor of hands was recovered/resolved. On 22nd January 2019, the outcome of the faint, dizziness and nausea were recovered/resolved. On an unknown date, the outcome of the disorientation and tiredness were unknown. It was unknown if the reporter considered the faint, dizziness, nausea, disorientation, tiredness and tremor of hands to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 year's old. The patient played tennis at 9 AM. The patient tried some bread minutes later, felt dizziness (3 episode of severe dizziness), felt better, and played tennis. At 11.30 ate bread and again felt dizzy sat down then felt disoriented, felt tired, unsure if passed out, went upstairs and showered went out and ran onwards 6.30 PM, felt dizziness, called husband and found to be seated on chair and hand shaking for 5 seconds. The patient experienced 1 episode of nausea and faint. The patient was informed to cardiology and neurology. This case has been linked with US2019GSK015430, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a nurse and described the occurrence of faint in a 61-year-old female patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis.  The patient's past medical history included hypertension, meniere's disease, tinnitus and vertigo. Concurrent medical conditions included ex-smoker and drug allergy (Unknown drug allergy).  On 17th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st January 2019, 4 days after receiving SHINGRIX, the patient experienced faint (serious criteria GSK medically significant), dizziness, nausea, disorientation, tiredness and tremor of hands. On 21st January 2019, the outcome of the tremor of hands was recovered/resolved. On 22nd January 2019, the outcome of the faint, dizziness and nausea were recovered/resolved. On an unknown date, the outcome of the disorientation and tiredness were unknown. It was unknown if the reporter considered the faint, dizziness, nausea, disorientation, tiredness and tremor of hands to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 year's old. The patient played tennis at 9 AM. The patient tried some bread minutes later, felt dizziness (3 episode of severe dizziness), felt better, and played tennis. At 11.30 ate bread and again felt dizzy sat down then felt disoriented, felt tired, unsure if passed out, went upstairs and showered went out and ran onwards 6.30 PM, felt dizziness, called husband and found to be seated on chair and hand shaking for 5 seconds. The patient experienced 1 episode of nausea and faint. The patient was informed to cardiology and neurology. This case has been linked with US2019GSK015430, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia, Vaccination site infection
Clinical narrative: The patient experienced swelling at the injection site accompanied by severe pain and high temperature ( 101). She had to see a doctor on 02/05/2019 as her symptoms were getting worse and her doctor gave her an antibiotic as he diagnosed it as a skin infection in the vaccination site of administration. The patient refused to release the antibiotic name.
Age: 1.08
Sex: F
Vaccine: DTAP, DTOX, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Gait inability, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: SHE HAVE FEVER THE DAY OF THE VACCINES AND THAT AFTERNOON SHE HAVE HER RIGHT TIGHT RED, HOT TO TOUCH AND INFLAMMATION. SHE COULD NOT WALK BECAUSE THE THIGHT WAS SO BIG.
Age: 1.08
Sex: F
Vaccine: DTAP, DTOX, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: SHE HAVE FEVER THE DAY OF THE VACCINES AND THAT AFTERNOON SHE HAVE HER RIGHT TIGHT RED, HOT TO TOUCH AND INFLAMMATION. SHE COULD NOT WALK BECAUSE THE THIGHT WAS SO BIG.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Headache, Oxygen saturation decreased
Clinical narrative: I STARTED NOTICE THAT EVERY YEAR AFTER SHE GOT THE FLU SHOT SHE ENDED UP IN EMERGENCY ROOM. WITH LOW OXIGEN, SHE CANT BREATH, HEADACHE. EVERY TIME SHE HAS STEROIDES, ALBUTEROL AND TYLENOL IN THE EMERGENCY ROOM.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site inflammation, Nausea, Pain, Pyrexia
Clinical narrative: Very soon after vaccine, I developed severe headache, nausea, inflammed arm at injection site, fever, aching all over.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: Arm soreness, fever (100.6), muscle aches and pains, fatigue, chills, nausea.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Arm soreness, fever (100.6), muscle aches and pains, fatigue, chills, nausea.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Soreness and swelling at the injection site that lasted 4 days. Muscle and joint pain, headache, shivering, fever, fatigue, dizziness. These symptoms lasted 24 hours.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Soreness and swelling at the injection site that lasted 4 days. Muscle and joint pain, headache, shivering, fever, fatigue, dizziness. These symptoms lasted 24 hours.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-AUG-2018, the patients were inadvertently vaccinated with ROTATEQ, orally (dose, lot# and expiration date were not reported) after the product was stored in the shipping container longer than the carton allowed for. No adverse effects were reported. No product quality complaint (PQC) was reported. This is a non-valid case due to lack of patients' identifiers.
Sex: U
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with an unknown number of improperly stored doses of VAQTA, lot # R002086 and expiration date 22-APR-2019, lot # R006210 and expiration date 22-APR-2019, lot # N026997 and expiration date 10-NOV-2018 (route, exact dose and dose number were not reported) and LIQUID PEDVAXHIB, lot # R000877 and expiration date 24-SEP-2020 (route, exact dose and dose number were not reported) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion at or above 0 degrees Celsius up to 1 degrees Celsius for 1 hour. The previous excursion was 2 degrees Celsius to 8 degrees Celsius for 12 hours. The call was because of a data logger. Follow up information received on 04-FEB-2019. All telephone attempts to obtain follow-up information have been unsuccessful.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 26-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot# and expiration date were not provided) for prophylaxis. Later on 08-NOV-2018, and 12-JAN-2019 the patient was administered with the subsequent doses of GARDASIL 9. No adverse effects reported.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test negative, Complex regional pain syndrome, Fatigue, Headache, Laboratory test normal
Clinical narrative: This spontaneous report was received from the mother of the consumer, referring to her daughter, an approximately 16 year-old female patient. The patient's had not  historical conditions, concurrent conditions and not concomitant medications ; however, it was reported that the patient is possibly allergic to morphine. On an unspecified date, the patient started the vaccination series with GARDASIL for routine vaccine (dosage, route of administration anatomical location, lot number and expiration date were not reported) which was completed in February 2009. On approximately 2009, within one week of completing the series, the patient had a high fever, headaches, light sensitivity and fatigue. It was reported that tests for Lyme and meningitis were negative and within "to three to four days these symptoms were resolved. In approximately 2010, reported as "one year later", the patient began experiencing pain through her body and spread to all four limbs in 2011. She was diagnosed with Complex Regional Pain Syndrome (although she never had an injury), and needed assistance with crutches for mobility, and at the reporting time, she was confined to a wheelchair for many years (disability). On an unspecified date, the patient sought for medical attention. It was reported that the patient has been to many rehabilitation facilities, on an unspecified dates. At the time of this report, the outcome of high fever, headaches, light sensitivity and fatigue was resolved and for the Complex Regional Pain Syndrome and mobility decreased was ongoing. The reporter did not provide the causality assessment for the events. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1902USA002071:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain, Pain in extremity, Photophobia, Pyrexia
Clinical narrative: This spontaneous report was received from the mother of the consumer, referring to her daughter, an approximately 16 year-old female patient. The patient's had not  historical conditions, concurrent conditions and not concomitant medications ; however, it was reported that the patient is possibly allergic to morphine. On an unspecified date, the patient started the vaccination series with GARDASIL for routine vaccine (dosage, route of administration anatomical location, lot number and expiration date were not reported) which was completed in February 2009. On approximately 2009, within one week of completing the series, the patient had a high fever, headaches, light sensitivity and fatigue. It was reported that tests for Lyme and meningitis were negative and within "to three to four days these symptoms were resolved. In approximately 2010, reported as "one year later", the patient began experiencing pain through her body and spread to all four limbs in 2011. She was diagnosed with Complex Regional Pain Syndrome (although she never had an injury), and needed assistance with crutches for mobility, and at the reporting time, she was confined to a wheelchair for many years (disability). On an unspecified date, the patient sought for medical attention. It was reported that the patient has been to many rehabilitation facilities, on an unspecified dates. At the time of this report, the outcome of high fever, headaches, light sensitivity and fatigue was resolved and for the Complex Regional Pain Syndrome and mobility decreased was ongoing. The reporter did not provide the causality assessment for the events. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1902USA002071:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: This spontaneous report was received from the mother of the consumer, referring to her daughter, an approximately 16 year-old female patient. The patient's had not  historical conditions, concurrent conditions and not concomitant medications ; however, it was reported that the patient is possibly allergic to morphine. On an unspecified date, the patient started the vaccination series with GARDASIL for routine vaccine (dosage, route of administration anatomical location, lot number and expiration date were not reported) which was completed in February 2009. On approximately 2009, within one week of completing the series, the patient had a high fever, headaches, light sensitivity and fatigue. It was reported that tests for Lyme and meningitis were negative and within "to three to four days these symptoms were resolved. In approximately 2010, reported as "one year later", the patient began experiencing pain through her body and spread to all four limbs in 2011. She was diagnosed with Complex Regional Pain Syndrome (although she never had an injury), and needed assistance with crutches for mobility, and at the reporting time, she was confined to a wheelchair for many years (disability). On an unspecified date, the patient sought for medical attention. It was reported that the patient has been to many rehabilitation facilities, on an unspecified dates. At the time of this report, the outcome of high fever, headaches, light sensitivity and fatigue was resolved and for the Complex Regional Pain Syndrome and mobility decreased was ongoing. The reporter did not provide the causality assessment for the events. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1902USA002071:
Sex: U
Vaccine: HEP, HPV9
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an unspecified reporter via an article about significant mortality decrease after vaccine shortage, referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB or GARDASIL 9, both for prophylaxis (strength, dose, frequency, route, lot #, expiration date and indication were not reported). It was reported that from 2003 to 2017, there was a yearly basis an average of 29 deaths after the use of the RECOMBIVAX HB. In 2018 there were only 6 of 2 which were linked to RECOMBIVAX HB. It was also reported that the recipient of the Merck vaccines, which contained aluminum, could lead to neurological and auto-immunological disorders. The outcome of the events was unknown. The causality assessment was not provided. Upon internal review, auto-immunological disorder was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 07-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On 16-JUN-2016 (reported as 9 days after receiving the vaccine), the patient was diagnosed with shingles near frontal area and back of her head. On an unknown date, the patient suffered and was diagnosed with pneumonia requiring hospitalization. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. ; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, pneumonia was determined to be medically significant. ZOSTAVAX, persistent strain of herpes zoster/shingles and pneumonia  were considered to be disabling. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: This spontaneous report as received from a physician concerning a 12 year old (actually 28 year old) female patient. The patient had no relevant medical history, drug reactions or allergies or concomitant medications. In approximately 2003, when the patient was 12 year old, she was vaccinated with one dose of ENGERIX-B, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) followed with in the appropriate schedule by one dose of RECOMBIVAX HB for prophylaxis and routine vaccination (dose, route of administration, lot number and expiration date were not reported). In approximately 2003, with in the same day of each of the doses, the patient experienced a febrile reaction, the fever reach 103 F (39.44 C)that lasted two or three days each time. No laboratory tests were performed. The patient was treated with an unspecified antipyretic therapy and the fever resolved. The physician also mentioned that the patient did not experienced any anaphylaxis, stridor, wheezing, urticaria or arthralgia. At the time of the report, the patient had recovered.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's concurrent conditions, concomitant medications or medical history. On 23-JAN-2019, the patient was vaccinated inadvertently with an expired dose of ROTATEQ lot # N005078 with expiration date on 22-NOV-2018, per oral for prophylaxis (dose was not reported). However, no adverse effects were reported.
Sex: M
Vaccine: HPV4
Symptoms: Complex regional pain syndrome
Clinical narrative: This spontaneous report was received from a consumer, referring to several  "an influx of boys" of unknown ages. The patients had not historical conditions, concurrent conditions and concomitant medications reported. On an unspecified date, once the vaccine was approved for males, the patients received the vaccination series with GARDASIL for prophylaxis (dosage, route of administration anatomical location, lot number and expiration date were not reported). On an unknown date, the patients were diagnosed with Complex Regional Pain Syndrome after vaccination and were treated in a rehabilitation facility. At the time of this report, the outcome of Complex Regional Pain Syndrome was ongoing. The reporter did not provide the causality assessment for the events. The reporter considered the event of, Complex Regional Pain Syndrome, to be disabling. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1901USA012217:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) in July 2015, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated at an emergency room for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Malaise, Mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult female patient who received SHINGRIX for prophylaxis. On 26th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a day after receiving SHINGRIX, the patient experienced itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass. On an unknown date, the outcome of the itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass were unknown. It was unknown if the reporter considered the itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be 62 or 63 years. The patient preferred not to give any more personal information. The patient received SHINGRIX on Saturday and had been ill ever since (2nd day) chills, diarrhea, aches (even in joints in my back) and woke up with a large lump on her face. It looks like a rash and itches terribly. The patient was surprised to wake up am to this lump on her cheek. The patient planned to call her dermatologist this am on the date of reporting. The patient might receive a letter from safety department.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult female patient who received SHINGRIX for prophylaxis. On 26th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a day after receiving SHINGRIX, the patient experienced itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass. On an unknown date, the outcome of the itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass were unknown. It was unknown if the reporter considered the itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be 62 or 63 years. The patient preferred not to give any more personal information. The patient received SHINGRIX on Saturday and had been ill ever since (2nd day) chills, diarrhea, aches (even in joints in my back) and woke up with a large lump on her face. It looks like a rash and itches terribly. The patient was surprised to wake up am to this lump on her cheek. The patient planned to call her dermatologist this am on the date of reporting. The patient might receive a letter from safety department.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a nurse and described the occurrence of itchy rash in a 57-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 7th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced itchy rash and papular rash. The patient was treated with Triamcinolone Cream and CERAVE Moisturizer. On an unknown date, the outcome of the itchy rash and papular rash were recovering/resolving. It was unknown if the reporter considered the itchy rash and papular rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient never smoke had and no known allergies. The reporter stated that 2 days after receiving SHINGRIX vaccine the patient developed an itchy rash on the opposite arm on left deltoid and upper back. Symptoms persists now after 2 weeks. The patient had the picture on his phone and dermatology physician looked at the pictures. Dermatology physician advised to continue triamcinolone cream 1 percent and monitor. The patient used dove soap or body wash for now, moisturizer CERAVE. The patient was to contact dermatology if rash get worse.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On 22nd January 2019, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and had fever for about 6 hours post administration. The event onset date approximately mentioned as 22nd January 2019.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not reported. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and ended up in bed because it made him feel so lousy. The patient was unwilling to provide any further details as he wanted to get off the phone. This case has been linked to the US2019005835, reported for the dose 2 of the same patient.