chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Tension
Clinical narrative: On 10/26/2017, I received employee vaccine in clinic conference room. Right arm was sore; and became increasingly painful over next few days. On 10/31/2017, notified my manager of sharp, radiating pain in my right arm that was bringing me close to tears. Area where shot was given in arm was swollen, hot & red. Recommended to see nurse, who examined and recommended seeing provider right away. Saw Dr. late afternoon in Urgent Care, was prescribed TYLENOL and 800mg ibuprofen, and something to prevent stomach from reacting to ibuprofen (Don't have with me, not remembering name) and icing area. Next day, 11/1/2017, in morning realized my right side of face had some numb areas, (right eyebrow to cheek bone) which seemed to progress to more areas on right side of face as the morning went on. Let my manager know I was having some additional symptoms, discussed with nurse as well; went to Clinic at 1pm to see Dr. to let her know of new symptoms and persisting pain & weakness in arm. Was admitted into hospital observation that afternoon. Dr stopped in to evaluate, said most likely combination of needle too close to nerve & chemical reaction to vaccine. 11/2/2017 MRI to brain & cervical area was done, results good, was released to go home. Given pain meds to take when needed; 11/6/17 Returned to work for couple hours, but experienced numbness in shoulder/forearm while typing/using mouse. Saw Dr. for after hospital check. Lab work to check inflammation. Prescribed muscle relaxer and I went home. Physical therapy also prescribed. 11/7/17 Saw Dr. at clinic; had EMG with good results, no long term nerve damage; anticipates 4-6 weeks to recover/heal. Follow up with physical therapy. 11/13/2017 Physical therapy appt at 4:15pm. Overall improving, still have arm discomfort / tenseness / weakness in arm.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Malaise, Pallor, Unresponsive to stimuli
Clinical narrative: The patient was seated during vaccine administration- he looked and observed the injection process- as I withdrew the needle and covered the injection site with a gauze pad, the patient stated "I don't feel well" I observed his color change to pale, assisted him to supine position, +radial pulse throughout incident - did not respond to verbal stimulation for app 30 seconds, but then stated "ok" when I asked him if he was alright. Patient was monitored in the department for app 45 minutes, vital signs stable- alert oriented, ambulatory, drank water, juice, candy bar and buttered roll- as patient stated he did not have breakfast and he has fainted before when blood was taken.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: GENERALIZED PRURITIS 25 BENADRYL GIVEN PO.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Aphasia, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Communication disorder, Decreased eye contact
Clinical narrative: After his 6 months shows he was having a fever i took him to the hospital, was discharged and gave him Tylenol. He also had been with eczema red rashes on his face (which I thought was part of eczema but wasn't),  ear infections more than usual. At around 8-10 months I noticed him always sick with colds and suddenly stopped talking back, lost of emotions, no eye contact, no laughing, lost interest and communication. At 12 month for sure he was at a loss for words, completely silent. He was referred to clinic to get a diagnosis and by two years of age he was diagnosed with autism. He had high pain tolerance, lack of communication, was behind in speech and motor skills. Short attention span and too hyper. He has seen psychologists, is currently taking various  therapies and at age four now is on Meds.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Decreased interest, Disturbance in attention, Ear infection, Eczema, Emotional poverty
Clinical narrative: After his 6 months shows he was having a fever i took him to the hospital, was discharged and gave him Tylenol. He also had been with eczema red rashes on his face (which I thought was part of eczema but wasn't),  ear infections more than usual. At around 8-10 months I noticed him always sick with colds and suddenly stopped talking back, lost of emotions, no eye contact, no laughing, lost interest and communication. At 12 month for sure he was at a loss for words, completely silent. He was referred to clinic to get a diagnosis and by two years of age he was diagnosed with autism. He had high pain tolerance, lack of communication, was behind in speech and motor skills. Short attention span and too hyper. He has seen psychologists, is currently taking various  therapies and at age four now is on Meds.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Malaise, Motor developmental delay, Nasopharyngitis, Psychomotor hyperactivity, Pyrexia
Clinical narrative: After his 6 months shows he was having a fever i took him to the hospital, was discharged and gave him Tylenol. He also had been with eczema red rashes on his face (which I thought was part of eczema but wasn't),  ear infections more than usual. At around 8-10 months I noticed him always sick with colds and suddenly stopped talking back, lost of emotions, no eye contact, no laughing, lost interest and communication. At 12 month for sure he was at a loss for words, completely silent. He was referred to clinic to get a diagnosis and by two years of age he was diagnosed with autism. He had high pain tolerance, lack of communication, was behind in speech and motor skills. Short attention span and too hyper. He has seen psychologists, is currently taking various  therapies and at age four now is on Meds.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Rash, Rash erythematous, Speech disorder developmental
Clinical narrative: After his 6 months shows he was having a fever i took him to the hospital, was discharged and gave him Tylenol. He also had been with eczema red rashes on his face (which I thought was part of eczema but wasn't),  ear infections more than usual. At around 8-10 months I noticed him always sick with colds and suddenly stopped talking back, lost of emotions, no eye contact, no laughing, lost interest and communication. At 12 month for sure he was at a loss for words, completely silent. He was referred to clinic to get a diagnosis and by two years of age he was diagnosed with autism. He had high pain tolerance, lack of communication, was behind in speech and motor skills. Short attention span and too hyper. He has seen psychologists, is currently taking various  therapies and at age four now is on Meds.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: WRONG FLU GIVEN.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test, Limb discomfort, Musculoskeletal pain
Clinical narrative: Pain in left shoulder much pain at top-down arm into hand. Couldn't raise arm, can't sleep on left side, it's been over 2 years. Can't lift much still much pain. Now into 3 yrs. 11/6/17 my intent was the pain and disability of this shoulder and arm would go away. I've been to 3 doctors. Can't help. Said perhaps it would go away in 2 yrs or so. Am now in 3rd year. Am awakened at night from pain in left shoulder, arm, and hand. I should have reported it much sooner. The shot was given very high up in left arm. Perhaps in bursa sac or deltoid tissue. Whatever it certainly disabled my arm for good. Hope you can compensate me for not only disability but pain and suffering I'm still having.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Sleep disorder, Weight bearing difficulty, X-ray
Clinical narrative: Pain in left shoulder much pain at top-down arm into hand. Couldn't raise arm, can't sleep on left side, it's been over 2 years. Can't lift much still much pain. Now into 3 yrs. 11/6/17 my intent was the pain and disability of this shoulder and arm would go away. I've been to 3 doctors. Can't help. Said perhaps it would go away in 2 yrs or so. Am now in 3rd year. Am awakened at night from pain in left shoulder, arm, and hand. I should have reported it much sooner. The shot was given very high up in left arm. Perhaps in bursa sac or deltoid tissue. Whatever it certainly disabled my arm for good. Hope you can compensate me for not only disability but pain and suffering I'm still having.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Mom calls on Friday, reports left deltoid red and swollen, took to UC Thursday night given BENARDRYL. No increased swelling but c/o itchiness, not painful.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Lip swelling
Clinical narrative: Swollen top lip the day after vaccines. Mom put lip balm on and monitored. Decreased swelling today.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Nausea, Vomiting
Clinical narrative: 30-45 minutes after vaccine she developed dizziness, a feeling of warmth, nausea, and vomiting. All but the nausea resolved in 10 minutes, nausea took 4 hr to go away (on it's own). No swelling of lips or tongue or any shortness of breath. She did not seek medical attention, having already left the clinic. She called the next day to report her symptoms.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction on injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: Local reaction on injection site.
Age: 68.0
Sex: F
Vaccine: FLUR4
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Full body muscle weakness and tingling nerve sensation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: 11/10/2017 Moderate Adverse reaction to vaccine component.
Age: 1.75
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given Tdap instead of Dtap - Parents were notified right away and HD was called. Vaccine was still valid but considered a med error. This form filled out as well as incident report. More training will be provided for MA with vaccines.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient says her left shoulder hurts badly ever since vaccine administration and she has been unable to move her left arm across her body since morning after vaccine administration (2 weeks).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: Severe Left arm pain at the site to the point I could not move my arm. I required assistance to to get my arm in or out of a sleeve. Any movement at all was excruciating pain level 10 on (0-10) scale.  Chilling and fever occurred around 8pm highest temperature was 101.2F temporal. It came down after tylenol. Swelling of the injection site. Could barely see acromiom process. It is somewhat better this morning 11/14/2017 I can move the arm but still probably pain of 5 (0-10) scale. No fever today. Some swelling but improved.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Severe Left arm pain at the site to the point I could not move my arm. I required assistance to to get my arm in or out of a sleeve. Any movement at all was excruciating pain level 10 on (0-10) scale.  Chilling and fever occurred around 8pm highest temperature was 101.2F temporal. It came down after tylenol. Swelling of the injection site. Could barely see acromiom process. It is somewhat better this morning 11/14/2017 I can move the arm but still probably pain of 5 (0-10) scale. No fever today. Some swelling but improved.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Impaired driving ability, Impaired work ability, Induration, Injected limb mobility decreased, Limb discomfort
Clinical narrative: *Please note, I know it was a pneumonia and flu vaccinations. I cannot find sheet with exact formula/vaccination name/manufacturer. My left arm turned hard, scalding hot to touch, couldn't move it, wipe, or drive. Also, could not change or put clothes on, or take them off . Arm also swelled up not fitting in sleeves, I could get on. Morning of 11/9/17, after being up all night debating urgent care or ER, I Felt like I had weights and excruciating pain pulling, my arm down every time attempting to lift it. Had a horrid migraine and 102 degree fever. Couldn't work that Thursday or Friday. Finally my mom took me to urgent care and I was prescribed steroids.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Loss of personal independence in daily activities, Migraine, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: *Please note, I know it was a pneumonia and flu vaccinations. I cannot find sheet with exact formula/vaccination name/manufacturer. My left arm turned hard, scalding hot to touch, couldn't move it, wipe, or drive. Also, could not change or put clothes on, or take them off . Arm also swelled up not fitting in sleeves, I could get on. Morning of 11/9/17, after being up all night debating urgent care or ER, I Felt like I had weights and excruciating pain pulling, my arm down every time attempting to lift it. Had a horrid migraine and 102 degree fever. Couldn't work that Thursday or Friday. Finally my mom took me to urgent care and I was prescribed steroids.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination complication
Clinical narrative: *Please note, I know it was a pneumonia and flu vaccinations. I cannot find sheet with exact formula/vaccination name/manufacturer. My left arm turned hard, scalding hot to touch, couldn't move it, wipe, or drive. Also, could not change or put clothes on, or take them off . Arm also swelled up not fitting in sleeves, I could get on. Morning of 11/9/17, after being up all night debating urgent care or ER, I Felt like I had weights and excruciating pain pulling, my arm down every time attempting to lift it. Had a horrid migraine and 102 degree fever. Couldn't work that Thursday or Friday. Finally my mom took me to urgent care and I was prescribed steroids.
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Rash, Swelling
Clinical narrative: Patient came in day after having vaccine (11/08/2017) for consultation with the pharmacist about redness around and under the arm of the injection site. The patient went to the doctor on 11/09/2017 to have the swelling and redness checked out. The doctor recommended that he start an antibiotic if it did not get any better by the next day. The rash started to subside.
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient came in day after having vaccine (11/08/2017) for consultation with the pharmacist about redness around and under the arm of the injection site. The patient went to the doctor on 11/09/2017 to have the swelling and redness checked out. The doctor recommended that he start an antibiotic if it did not get any better by the next day. The rash started to subside.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse reaction, Drug administered at inappropriate site, Incorrect route of drug administration
Clinical narrative: Patient received his flu shot in his right vastus lateralis. Immediately nothing happened. When patient went home Mom noticed a reaction. Mom applied cold packs and gave Ibuprofen for pain. Resolved by Thursday 11/9. Mom took pictures and then showed them to DO on 11/6. DO stated the vaccine injection site was in the wrong location. It was given subcutaneous Mom advised to monitor patient at home. Patient showed no further symptoms.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site inflammation, Injection site reaction, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Received flu shot at work on Friday at 230 - by 3pm right arm was extremely painful and sore, by 6 am Saturday I woke up with a hot, inflamed painful rash on my right upper arm that lasted until Monday morning and had a 101 fever and nausea until this morning.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Received flu shot at work on Friday at 230 - by 3pm right arm was extremely painful and sore, by 6 am Saturday I woke up with a hot, inflamed painful rash on my right upper arm that lasted until Monday morning and had a 101 fever and nausea until this morning.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site rash, Rash erythematous
Clinical narrative: Patient's spouse came in on 11/08/2017 to consult with pharmacist about a red rash on the right arm. The rash wrapped around the arm starting at injection site. The patient also said that his wife was having a hard time breathing, but it could have been contributed to her anxiety.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Patient's spouse came in on 11/08/2017 to consult with pharmacist about a red rash on the right arm. The rash wrapped around the arm starting at injection site. The patient also said that his wife was having a hard time breathing, but it could have been contributed to her anxiety.
Age: 71.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient called and spoke with the pharmacist about redness on and around the arm where the vaccine was given.
Age: 71.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Chills, Dyspnoea, Pain, Pyrexia, Swelling
Clinical narrative: Patient called and spoke with the pharmacist about redness on and around the arm where the vaccine was given.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TD
Symptoms: Loss of consciousness, Muscle contracture, Myoclonus, Opisthotonus, Posture abnormal
Clinical narrative: After receiving the patient's last vaccine, the RN Reported that the patient started to faint and she had to catch him. It was unclear if he had a seizure or a vasovagal episode for us. The patient became awake alert and oriented after about 10-15 secs. While, the patient was describing what he felt which was a sensation of black from his eyes and fainting and then waking up. The patient had a second episode that was directly witnessed by this provider. The patient specifically started arching his back and leaned toward his left. His biceps contracted and he kept them close to his chest. His legs started having more classic tonic clonic movements. The patient was laid down. This episode lasted approximately 15 seconds and then patient was awake/alert afterwards. AAOx3. The timing between the episodes was approximately 5 minutes. Decision was made to transfer to ER downstairs. Unclear if first episode was a seizure or a vasovagal episode but second episode was more classic convulsion. Probably vasovagal as he has no prior history of seizures. Of note, two episodes is atypical. The episodes would be best described as LOC with myoclonus of lower extremities.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TD
Symptoms: Seizure, Syncope, Tonic clonic movements
Clinical narrative: After receiving the patient's last vaccine, the RN Reported that the patient started to faint and she had to catch him. It was unclear if he had a seizure or a vasovagal episode for us. The patient became awake alert and oriented after about 10-15 secs. While, the patient was describing what he felt which was a sensation of black from his eyes and fainting and then waking up. The patient had a second episode that was directly witnessed by this provider. The patient specifically started arching his back and leaned toward his left. His biceps contracted and he kept them close to his chest. His legs started having more classic tonic clonic movements. The patient was laid down. This episode lasted approximately 15 seconds and then patient was awake/alert afterwards. AAOx3. The timing between the episodes was approximately 5 minutes. Decision was made to transfer to ER downstairs. Unclear if first episode was a seizure or a vasovagal episode but second episode was more classic convulsion. Probably vasovagal as he has no prior history of seizures. Of note, two episodes is atypical. The episodes would be best described as LOC with myoclonus of lower extremities.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient c/o  of normal soreness/pain (post injection site pain of 2 on a scale of 1-10 with 0 being no pain) and pain in surrounding upper deltoid region, for three weeks. Later, the patient's spouse massaged her right upper arm at HS. When patient woke up in am, the pain in her arm  was escalated to an 8 on scale of 1-10. She c/o of difficulty moving arm away from her core, or elevating her arm. Due to this increased pain, she was unable to complete full ROM for 2 days. Afterwards, and continuing up to the present, she was able to complete full ROM, but with pain at 8 when trying to do so. Otherwise, pain level exists at a 2 for non full ROM activities throughout the day. Dr. advised client that bursitis sometimes happens after injections. Dr. suggested use of Motrin or Aleve for discomfort that may be caused by sleeping on her right side. Dr. suggested follow up with her MD for any increase in her pain. Dr. states if the pain is increased the MD may consider Physical Therapy or Ultrasound on the affected area.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called day after vaccine was given (11/11/2017) with a complaint of redness, swelling and heat on and around the whole arm of the injection site.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Patient called day after vaccine was given (11/11/2017) with a complaint of redness, swelling and heat on and around the whole arm of the injection site.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Headache, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient reports on date of vaccine given (10/3/17), she experienced fever, chills, headache-all which resolved the morning of 10/4/17. Reports 10/3/17 to present date (10/5/17) warmth and redness to left upper arm starting out the size of an orange and gradually decreasing in size and warmth/redness.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Mother called PM of 10/26/2017 to report that child's arm where he received his flu vaccine on 10/24/2017, was red and had a "knot the size of baseball" around injection site. She states that he has had no fever and the site is not draining. She first noticed the problem the morning of 10/25/2017 and marked the site to monitor size. Mother stated that she noted no significant change PM of 10/24/2017 and gave child BENADRYL. She was advised to call to report this to us by a relative who is a paramedic. I explained that this reaction is a possible side effect of any vaccine and that careful monitoring, as she has done, is important. She reported that the site had reduced slightly the
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching at injection site next day.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site pain
Clinical narrative: Tenderness (R) deltoid.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Administration site pain, Administration site swelling, Injection site erythema, Injection site pruritus
Clinical narrative: 10/29/17-Pt was given FLUZONE HD in left deltoid, and PREVNAR 13 in rt deltoid. 11/1/17-pt reported redness, soreness, itching and swelling at the administration sites. Advised TYLENOL and ice. 11/3-spoke to pt. stating to resolve w/out treatment. Reported to PCP 11/1/17.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Couldn't raise right arm above shoulder for 2 weeks. Dr. said it would go away. Very painful I can now raise my arm. But still painful and can get stiff also my right side neck and side. I use hot shower now-A.M. and a vibrator on my shoulder P.M. at first-I had nausea, hives, join pain.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Urticaria
Clinical narrative: Couldn't raise right arm above shoulder for 2 weeks. Dr. said it would go away. Very painful I can now raise my arm. But still painful and can get stiff also my right side neck and side. I use hot shower now-A.M. and a vibrator on my shoulder P.M. at first-I had nausea, hives, join pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Pyrexia, Tremor
Clinical narrative: High grade fever greater than 103 degrees F. Weakness/fatigue. Trembling.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Pt. had pain in L shoulder starting 11/7/17 between 6-7PM. Went to Emergency Room 11/7/17 and was prescribed tramadol. Went to Primary Care MD 11/13/17 was prescribed Ibuprofen and a sling.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Facial paralysis, Paralysis
Clinical narrative: Onset of Bell's Palsy following flu vaccination. Received Sanofi Pasteur FLUZONE QuadPFS2017-18 QUAD PFS2017-18 vaccine on 10/30/17. Initial onset of paralysis symptoms 11/4/17. Medicated via prednisone and valacyclovir following ER visit after symptoms worsened 11/6/17.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician assistant refers to a 27 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date, the patient became pregnant, last menstrual period; date of conception and estimate delivery date were not reported. On 18-OCT-2017, the patient was inadvertently vaccinated with a dose of VARIVAX (lot # N014366, expiration date 09-MAY-2019) (dose and route were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported. The pregnancy outcome was outcome pending.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a 64 year old (also reported as almost 65 year old) female patient. The patient's concurrent condition included multiple myeloma and allergy to statins, seafood and PERCOCET. Medical history or concomitant medications were not provided. On approximately 16-OCT-2017 (reported as about 1 week ago), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, lot number and expiration date were not provided) for prophylaxis. Approximately in October 2017, the reporter stated that patient experienced swollen and painful at the injection site, but not was red. The patient was treated with TYLENOL. The outcome of injection swollen and painful at the injection site was reported as not recovered. The causal relationship between swollen and painful at the injection site and the therapy with PNEUMOVAX 23 was not assessed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4-years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-NOV-2017, the patient was vaccinated with an expired dose of PROQUAD lot# M018638 and expiration date 11-OCT-2017 (dose and route of administration were not reported), reconstituted with sterile diluent. There were no adverse effects reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Pt reports that a week and a half after receiving her flu shot the small amount of soreness she had been experiencing became more severe. It woke her up in the night. She took a dose of aspirin which helped. She continues to experience pain today which is limiting her range of motion. Shoulder is not impacted, pain is in the L deltoid muscle.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Influenza like illness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine given Monday,11-6. Awoke 11-7 with right arm swollen, red & painful. Thursday 11-9; arm still swollen, felt achy all over "like I had the flu".  Saw Dr in clinic at 3pm. Took oral Benadryl pms, & Claritin ams, ice to swollen area. Ice relieved a lot of the pain. Better when contacted 11-12.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Within hours had redness, induration, swelling at site, increased to max 3 cm over 24 hours.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient was given flu vaccine by LPN. Nurse left the room, patient was sitting on the exam table. Patient passed out. Dad was standing near the table and caught patient before he fell. Dad yelled out to the staff that patient had passed out. Nurses ran into the room. Patient was lying on the table, alert and oriented. Patient's blood pressure was normal, he was able to keep down fluids, observed in office for 15 minutes and was able to walk to his fathers vehicle without assistance.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Rash
Clinical narrative: Patient states his throat swelled up the evening following his immunization. He reports he did not seek medical treatment for it. Also he attributes a long-standing rash on his hands to the vaccination. He went to his primary care physician about the rash who told the patient he did not believe it to be due to the immunization.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: He developed significant redness, swelling (cellulitis) on and around the injection site (about 8 x 9 cm) size, it was warm and slightly tender.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Febrile convulsion
Clinical narrative: Patient was seen in the ER for a Febrile Seizure.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm has been sore for two weeks, patient says soreness is getting worse, feels like the joint hurts even, hurts when she moves her arm, pain wakes her up at night.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Rash erythematous, Skin tightness
Clinical narrative: Round, red raised rash and hardened area below the injection site, tightness and soreness at the site.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Oropharyngeal pain, Pain in extremity
Clinical narrative: BROUGHT TO OUR ATTENTION ON 10/31/17. STATES LEFT ARM IS STILL SORE, AT FIRST COULDN'T LIFT IT, HAD PAIN RIGHT AWAY AT UNDERSIDE OF ARM AND SHOULDER.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions and allergies were not provided. On 27-OCT-2017, the patient was vaccinated with an expired dose of PROQUAD, subcutaneously, for prophylaxis (lot # M017337, expiry date: 05-OCT-2017). Concomitant therapies included sterile diluent (MERCK) (lot # M045717, expiry date: 31-MAY-2019). No adverse effects were reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 21-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 23-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 25-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, concerning an adult patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 11-SEP-2017 and on 03-NOV-2017, the patient was vaccinated with improperly stored doses of VARIVAX, lot number N000681 with expiration date in 06-JAN-2019 (strength, anatomical location, dose number and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (MRK) (lot number and expiration date were unknown); the pharmacist did not know if the sterile diluent (MRK) used had an excursion. The VARIVAX was stored at a temperature range of 6 degrees Fahrenheit (°F) to 14 °F for the time frame of 1.5 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse symptoms were reported.
Age: 0.83
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from an office manager, concerning an 11 month old male patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 (strength, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Age: 6.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Eye swelling, Headache, Pyrexia, Swelling, Swelling face
Clinical narrative: Upon arriving at home after vaccine, pt face and neck swelled, picture shows right side of face and eye swelling. Used Benedryl to calm it down for two days, then developed 101 fever and persistent headache. Patient was feeling better on visit 11/08/2017.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth and mild swelling around injection site about 21 cm x 17 cm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sepsis
Clinical narrative: Patient developed a fever (high) and had to be hospitalized, apparently there was signs of sepsis and she was in the hospital for 5 days. Dr. is quoted as saying environmental exposure is the cause.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Skin warm, Swelling, Urticaria
Clinical narrative: Large swelling at shoulder warm, painful, welting. Described as multiple golfballs size.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Vertigo
Clinical narrative: Pt states her gait is "unsteady"  Vertigo.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: It has been one month since vaccination given and patient still has shoulder pain and restriction when lifting arm.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N012488 with expiration date 20-APR-2019 , lot number reported as N19839 with expiration date 13-JUL-2019 and lot number reported as N14369 with expiration date 09-MAY-2019 and PROQUAD lot number N016113 with expiration date 21-NOV-2018, lot number N015623 with expiration date 15-NOV-2018 and lot number N012490 with expiration date 17-OCT-2018 (dose, route and anatomical location were not reported for the above described vaccines) all for prophylaxis. There was no previous temperature excursion. The vaccines were exposed to temperatures between -9 C (Celsius) to 8 C (Celsius) during 1 hour and 25 minutes. Data digital logger was filled. No adverse effects were reported. Lot number N19839 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N14369 is an invalid lot number for varicella virus vaccine live (oka/merck). This is one of several reports from the same source. Sender's Comments: US-009507513-1711USA004034: US-009507513-1711USA004033: US-009507513-1711USA004035.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N012488 with expiration date 20-APR-2019 , lot number reported as N19839 with expiration date 13-JUL-2019 and lot number reported as N14369 with expiration date 09-MAY-2019 and PROQUAD lot number N016113 with expiration date 21-NOV-2018, lot number N015623 with expiration date 15-NOV-2018 and lot number N012490 with expiration date 17-OCT-2018 (dose, route and anatomical location were not reported for the above described vaccines) all for prophylaxis. There was no previous temperature excursion. The vaccines were exposed to temperatures between -9 C (Celsius) to 8 C (Celsius) during 1 hour and 25 minutes. Data digital logger was filled. No adverse effects were reported. Lot number N19839 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N14369 is an invalid lot number for varicella virus vaccine live (oka/merck). This is one of several reports from the same source. Sender's Comments: US-009507513-1711USA004033: US-009507513-1710USA009985: US-009507513-1711USA004035.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 15 month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 13-NOV-2017, the patient was vaccinated with a dose of M-M-R II lot # M049212 with expiration date 16-DEC-2018, for prophylaxis (dose and route of administration were not reported). Other suspect therapies included sterile diluent (MERCK) lot # N006807 with expiration date 31-JUL-2019. It was stated that at the time of vaccination, "more than half of the vaccine dripped out onto the patient's leg". No adverse effects were reported.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable health care professional via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced redness and swelling of the arm in which she received the vaccination on an unspecified date with outcome of unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: "Hardening" of arm at injection site. No report of pain, rash or fever.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Injection site vesicles, Pain, Pyrexia
Clinical narrative: Patient states that she had a fever for 4 days. Felt dizzy. Had blistering at injection site. Had body aches. Had a welt on her arm from shoulder to elbow. Still had redness on arm 3 weeks later. Patient stated that she rested and is feeling better now. She did not state if she took any medications for the fever.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient states that she had a fever for 4 days. Felt dizzy. Had blistering at injection site. Had body aches. Had a welt on her arm from shoulder to elbow. Still had redness on arm 3 weeks later. Patient stated that she rested and is feeling better now. She did not state if she took any medications for the fever.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 56.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt experienced high fever, 103F, redness and swollen on the site, body chills and pain. She went to ER and was treated with 5 days of antibiotic and some Advil.
Age: 56.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Pt experienced high fever, 103F, redness and swollen on the site, body chills and pain. She went to ER and was treated with 5 days of antibiotic and some Advil.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Eczema, Rash, Urticaria
Clinical narrative: Patient developed hive like rash from scalp to chin on face. Her front part of neck was covered in rash also. 2 days later rash changed to an eczema type rash and she continues to have eczema 4 days later, on cheeks, part of forehead, chin, and neck.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Severe Arm pain within a few hours of the injection. Rated as a 10/10. 7/10 with Pain meds. No redness at site, no shoulder pain or tenderness. Treated with ice and pain medication.