chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Streptococcus test negative
Clinical narrative: Around 5-6pm patient started to get hot, sweaty, and throat started to swell up.   Patient was sweating through dinner and did not feel good at all.  Later, started to feel cold so took shower and Tylenol. On Sunday, symptoms worsen and started alternating Tylenol and Ibuprofen alternating; had diarrhea after hot/cold flashes.  On Monday patient rested, symptoms continued, and coughing started. Yesterday patient felt better but still was sweating profusely.  Patient has overall body aches and hot/cold flashes.  Patient could not get in touch in PCP so yesterday went to ER.    Patient tested for Flu A/B and strepresults were negative. Doctor specified symptoms were probably related to the vaccine.  Patient given Afrin, Tylenol, Ibuprofen, Mucinex D, throat lozenges.  Patient noted her children received the vaccine the same day with no problems. Patient feels a little better today.    Patient has only received Flu vaccine the last 7 years; has not experienced any problems.
Age: 65.0
Sex: M
Vaccine: TYP
Symptoms: Atrophy
Clinical narrative: The patient states severe atrophy in the vaccinated arm
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: patient's mom said patient had sore arm and shoulder the following day that lasted for "more than a day or two" and resolved with ice and nsaids
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Patient got home and arm was sore so took some Ibuprofen. Patient went to bed around 9.  Patient woke up today and felt completely wiped out, with no energy, nausea, loss of appetite, slight headache.  Arm still is sore but improving.  Patient has not contacted the pharmacy yet.     Patient received the Pneumonia vaccine in the same facility in mid-October; patient had no problems after the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient got home and arm was sore so took some Ibuprofen. Patient went to bed around 9.  Patient woke up today and felt completely wiped out, with no energy, nausea, loss of appetite, slight headache.  Arm still is sore but improving.  Patient has not contacted the pharmacy yet.     Patient received the Pneumonia vaccine in the same facility in mid-October; patient had no problems after the vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Nasopharyngitis, Oral herpes, Oral pain
Clinical narrative: Flu-like symptoms started 1-2 day later.  Symptoms included: cold, aches, sneezing, sore throat, and mouth was sore so couldn't brush teeth.  Developed cold sores on lips which has never happened before. Flu-like symptoms lasted about 1 week and still has some residual cough.  Patient has been using hydrogen peroxide mouthwash to help with the cold sores. Sores not improving yet and still has them now.  Patient noted that he received the Flu-HD last year with no problem.  Patient called pharmacy today to let them know the symptoms.   Yesterday patient contacted doctor and has appointment scheduled for follow-up.  Patient is concerned about the mouth sores as had not had herpes before or possible exposure.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Sneezing
Clinical narrative: Flu-like symptoms started 1-2 day later.  Symptoms included: cold, aches, sneezing, sore throat, and mouth was sore so couldn't brush teeth.  Developed cold sores on lips which has never happened before. Flu-like symptoms lasted about 1 week and still has some residual cough.  Patient has been using hydrogen peroxide mouthwash to help with the cold sores. Sores not improving yet and still has them now.  Patient noted that he received the Flu-HD last year with no problem.  Patient called pharmacy today to let them know the symptoms.   Yesterday patient contacted doctor and has appointment scheduled for follow-up.  Patient is concerned about the mouth sores as had not had herpes before or possible exposure.
Age: 61.0
Sex: F
Vaccine: FLUC4, HEPAB, PPV, VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: PATIENT PRESENTED TO MY PHARMACY ON 11/12/19 WITH HER LEFT ARM SLIGHTLY INFLAMED AND RED. SHE REPORTED IT STARTED THE NEXT DAY, SHE APPLIED ICE  THROUGH THE WEEKEND AND IT WAS GETTING MUCH BETTER THAN IT WAS PREVIOUSLY. I ADVISED HER TO CONTINUE WITH THE ICE AND CALL HER REGULAR MD IN THE MORNING IF NO IMPROVEMENT
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was asked to sit down and wait after vaccine since had a reaction on previous year. Within 10  minutes numbness/tingling on arm began--going down arm and from one finger to the other (pinky, then ring, the middle finger. Numbness on same arm as vaccine site.  Patient was still at vaccination site and did not receive any treatment/meds.  Patient told to contact VAERS to report.    Last year, symptoms started within same time and lasted about 1 week.   Numbness just on the vaccine arm. Last year patient went to ER and was prescribed Naproxen.  There was numbness but no tingling and pinky finger was the worse
Age: 86.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reported to pharmacy on 11/02/2019 stating that she was still feeling pain at the site of injection
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Lethargy, Vaccination complication
Clinical narrative: I received my flu vaccine, voluntarily, and was 12 weeks pregnant. We heard the baby's heartbeat at that appointment. I was lethargic that night and for 2 days and could barely move. At my next prenatal appointment we found out the baby had died in utero, measuring at 12 weeks. I had no risk factors and have never had a miscarriage before. Nothing in my environment caused my miscarriage. I had an extreme reaction to the flu and I miscarried all within a day or 2 of having the flu shot.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dysarthria, Facial paralysis, Transient ischaemic attack
Clinical narrative: At first there were no symptoms.  Patient had a  TIA on 4/28; faced drooping on one side, slurred speech and weakness. Patient went to ER.  Patient was released after he was normal.   Patient followed up with PCP. Faced drooping on one side, slurred speech and weakness.  The doctor did not associate TIA with the vaccine so 2nd was recommended.  Patient recovered pretty quickly.   TIA occurred after 2nd dose as well.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Swelling at the site of injection.  Dr. diagnosed it as cellulitis.   This was reported to the pharmacy by Dr.'s office.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Patient stated that her arm was very sore to the point that she didn't want to really move it the evening of getting the injection.  She stated she had trouble sleeping due to the pain and also had a fever.  She did state that she had done yardwork after receiving vaccine which may have contributed some to the soreness.   She said the injection site and surrounding area was not red or swollen.  She said today the soreness seemed to be getting a little better. She also reached out to MD regarding adverse reaction but had not scheduled MD appt as of our conversation.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient experiencing pain from immunization, no redness/inflammation reported. PCP does not note any damage in the ligament/does not suspect frozen shoulder. Patient states they increased exercise intensity after receiving immunization with hopes of helping soreness with no success. Pain is felt after strenuous exercise located in the lower arm by the bicep.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site pain, Neurological examination normal
Clinical narrative: 17 YOF pt accompanied by mother presented to clinic on 11-12-19 with c/o lightheadedness and feeling faint x 1 day (resolved). Pt denies any other symptoms. Pt presented on 11-11-19 for influenza and bexsero vaccines at 3 pm. Per pt, she started to developed "really bad pain" on the injection site on the left arm. Then that resolved and she started to feel faint and lightheaded at around 8-9 pm. She reports that the symptoms were intermittent and only when changing positions. She reports the symptoms resolved at around 1 pm today. She denies chest pain, SOB or visual changes. Pt afebrile. No distress noted. A/O x 3. CN WNL. Negative romberg. Neuro exam WNL. VAERS report made. ER precautions given. Pt and parent v/u. Parent instructed to f/u with PCP prn. She v/u.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Feeling abnormal, Headache, Influenza virus test negative
Clinical narrative: ON 10/12 PATIENT REPORTED SHE WOKE UP WITH HER NECK HURTING, SHOULDERS FELT LIKE THEY WERE ON FIRE, SCALP HURTING, LYMPH NODES SWOLLEN IN NECK, AND HAD HEADACHES. SHE TOOK CELEBREX AND 30 MINS LATER SHE FELT NO RELIEF. ON 10/13 PATIENT SAID SHE STILL FELT AWFUL SO SHE STAYED IN BED ALL DAY AND IT HURT T0 MOVE HER HEAD. ON 10/14 PATIENT WENT TO THE URGENT CARE TO BE TESTED FOR THE FLU. RESULTS WERE NEGATIVE BUT FELT IT WAS A VIRAL INFECTION NOT CAUSED BY THE SHOT ON 10/17 A RASH DEVELPED ON THE LEFT SIDE OF PATIENT'S FACE AND HER SCALP HURT ON 10/18 PATIENT SAW A DERMATOLOGIST WHO TOLD HER IT WAS PROBABLY CELLULITIS AND NOT CAUSED BY THE SHINGLES SHOT. PATIENT GIVEN HYDROCORTISON CREAM ON 10/19 THE RASH IS EXTENDING TO THE LOWER PORTION OF HER LEFT FACE AND LYMPH NODES ARE STILL SWOLLEN UNDER THE JAW ON 10/20 THE RASH COVERED THE ENTIRE LEFT SIDE OF HER FACE. DEMATOLOGIST GAVE PATIENT ANTIBIOTIC AND EVENTUALLY RASH WAS MUCH BETTER BY 10/22.  PATIENT SAYS THE ONLY THING DIFFERENT IN HER ROUTINE WAS THE SHINGLES VACCINATION
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Neck pain, Pain, Pain of skin, Rash
Clinical narrative: ON 10/12 PATIENT REPORTED SHE WOKE UP WITH HER NECK HURTING, SHOULDERS FELT LIKE THEY WERE ON FIRE, SCALP HURTING, LYMPH NODES SWOLLEN IN NECK, AND HAD HEADACHES. SHE TOOK CELEBREX AND 30 MINS LATER SHE FELT NO RELIEF. ON 10/13 PATIENT SAID SHE STILL FELT AWFUL SO SHE STAYED IN BED ALL DAY AND IT HURT T0 MOVE HER HEAD. ON 10/14 PATIENT WENT TO THE URGENT CARE TO BE TESTED FOR THE FLU. RESULTS WERE NEGATIVE BUT FELT IT WAS A VIRAL INFECTION NOT CAUSED BY THE SHOT ON 10/17 A RASH DEVELPED ON THE LEFT SIDE OF PATIENT'S FACE AND HER SCALP HURT ON 10/18 PATIENT SAW A DERMATOLOGIST WHO TOLD HER IT WAS PROBABLY CELLULITIS AND NOT CAUSED BY THE SHINGLES SHOT. PATIENT GIVEN HYDROCORTISON CREAM ON 10/19 THE RASH IS EXTENDING TO THE LOWER PORTION OF HER LEFT FACE AND LYMPH NODES ARE STILL SWOLLEN UNDER THE JAW ON 10/20 THE RASH COVERED THE ENTIRE LEFT SIDE OF HER FACE. DEMATOLOGIST GAVE PATIENT ANTIBIOTIC AND EVENTUALLY RASH WAS MUCH BETTER BY 10/22.  PATIENT SAYS THE ONLY THING DIFFERENT IN HER ROUTINE WAS THE SHINGLES VACCINATION
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Pallor
Clinical narrative: pt received shot and was normal walked to front of store and checked out then reentered and looked pale and about to faint. sat down in chair and seemed distant and still about to faint but was responding then went to hospital in ambulance prob about 10 min to 15 minutes after shot symtoms occured and continued until left with paramedics about 15 minutes later.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called pharmacy and later came into pharmacy on 11/12/19 in to show/report arm is in pain 8 out of 10 to touch, swollen, and bright red.  yesterday on 11/11 the red and swollen area was a 1/2 of current size, after advsing twice over the phone and in person to seek medical attention, Patient wanted to wait one night, Patient bought tylenol and antihistimine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient presented to pharmacy on 11/12/19 stating that she had pain and soreness in the arm she received the flu shot in and said it was hard to move for the past month. She saw her primary care MD two weeks ago who told her that her brachial nerve may be involved and is referring her to a neurologist for an EMG.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: UNDERSIDE OF RIGHT ARM HAS EXTENSIVE RED DISCOLORATION THAT HAS SPREAD & IS WARM TO THE TOUCH
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Chromaturia, Sinusitis
Clinical narrative: On the evening of November 09, 2019 Pt. began to experience symptoms of a sinus infection. Pt. treated symptoms with Tylenol at the standard dose, and with Clindamycin HCL, 300 mg. q 6 hours for three days. Symptoms improved, however pt. experienced unusually dark urine the morning of November 12, 2019. Pt. is prescribed standing order clindamycin due to frequency of UTI secondary to urinary catherization, but had not taken any drugs for several weeks prior to the vaccination. If symptoms continue, pt. will receive care via either Emergency Department or a PCP as appropriate. There is nothing further to report at this time.
Age: 46.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: redness, swelling, pain at injection site, unable to sleep
Age: 30.0
Sex: M
Vaccine: FLU4, MMR, TDAP
Symptoms: Blood pressure decreased, Electrocardiogram normal, Loss of consciousness
Clinical narrative: Patient passed out 5 minutes after all injections were completed. Regained consciousness immediately and was alert and oriented x5. Paramedics called and came to evaluate the patient.  Patient declined ambulance ride or hospital visit, and attained a ride home.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Limb mass
Clinical narrative: Lump on foot getting bigger had it for a year
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: High-pitched crying
Clinical narrative: High pitched non stop crying for > 3 hours that started after parents got home from vaccines - about  1 hour afterward to my recollection.   Recovered after this time without longer term issues now 3 weeks later.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Periarthritis, X-ray
Clinical narrative: Flu shot caused symptoms of frozen shoulder. I was unable to move my arm up and the injection site was sore + painful. I went to PT and am currently working on gaining mobility back on my left side.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Hypersensitivity, Mobility decreased, Pain in extremity
Clinical narrative: I could NOT walk, get up out of bed with Severe debilitating pain in hips, legs, arms - I had TramadoL From a surgical procedure - took it 3 days with ExTra Strength TylenoL. Very adverse Reaction; informed PCP - she said "allergic reaction" - I was informed NO Second dose! this reaction was extreme!
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Erythema, Local reaction, Pyrexia, Rash
Clinical narrative: Rash - 8 cm localized reaction, red, warm. resolved w/in 3 days. low grade fever, cough
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Rash - 8 cm localized reaction, red, warm. resolved w/in 3 days. low grade fever, cough
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Pyrexia, Stridor
Clinical narrative: Fever and worsening acute on chronic stridor requiring hospitalization
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased, Vaccination site pain
Clinical narrative: 10/28/19 Pain at the vaccine site. 11/1/19 unable to lift arm and started taking motrin. 11/7/18 unable to sleep because of the pain.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Malaise, Pain, Pyrexia
Clinical narrative: Fever, Chills & Aches night of 10/24. Lasted around 12 hours but not feeling well for 3 days. On 11/5 started a rash on right lower torso. Saw MD on 11/5. Started Valtrex 1gm TID X 7D. MD diag. as diffuse shingles rash.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Fever, Chills & Aches night of 10/24. Lasted around 12 hours but not feeling well for 3 days. On 11/5 started a rash on right lower torso. Saw MD on 11/5. Started Valtrex 1gm TID X 7D. MD diag. as diffuse shingles rash.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Impaired work ability, Malaise, Pain
Clinical narrative: Fever, Chills & Aches night of 10/24. Lasted around 12 hours but not feeling well for 3 days. On 11/5 started a rash on right lower torso. Saw MD on 11/5. Started Valtrex 1gm TID X 7D. MD diag. as diffuse shingles rash.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Skin test positive
Clinical narrative: Fever, Chills & Aches night of 10/24. Lasted around 12 hours but not feeling well for 3 days. On 11/5 started a rash on right lower torso. Saw MD on 11/5. Started Valtrex 1gm TID X 7D. MD diag. as diffuse shingles rash.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling and soreness
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dizziness, Insomnia, Mobility decreased, Pain
Clinical narrative: 17 yo with progressive scleroderma with chronic pain and depression and recent admission to clinic brought in by father for concerns for vaccine reaction to PPV-23 Received vaccine 11/7/19 at 10am and at 4pm started having significant pain in arm and by 8pm had so much pain she was unable to move arm. She developed body aches all over and is still tender this morning over her shoulder on 11/8/19 also pain in her back and arm. She also had dizziness, and had a hard time sleeping and hard time getting out of bed due to severity of symptoms. Ibuprofen helped a little. Today 11/8/19 is a bit improved but still not moving arm because she has significant pain. Able to use hand normally, no tingling or numbness. Had significant pain with previous vaccines but no systemic reaction such as this.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: 17 yo with progressive scleroderma with chronic pain and depression and recent admission to clinic brought in by father for concerns for vaccine reaction to PPV-23 Received vaccine 11/7/19 at 10am and at 4pm started having significant pain in arm and by 8pm had so much pain she was unable to move arm. She developed body aches all over and is still tender this morning over her shoulder on 11/8/19 also pain in her back and arm. She also had dizziness, and had a hard time sleeping and hard time getting out of bed due to severity of symptoms. Ibuprofen helped a little. Today 11/8/19 is a bit improved but still not moving arm because she has significant pain. Able to use hand normally, no tingling or numbness. Had significant pain with previous vaccines but no systemic reaction such as this.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complains of swollen, pain, and red of injection site. No fever. Patient did not provide how big was redness.
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Cough, Crying, Dyspnoea, Face injury, Fall
Clinical narrative: Medical Assistant Administered 1st vaccine, pt took a deep breath while crying; simultaneously, 2nd Vaccine Administered, at that point pt became limp & breathless, had episode of synchopy. Nurse came in & placed him prone, felt mucus plug in chest, & slapped his back a few times. Pt took breath & started crying almost immediately. Please see office visit Note for further clarification. DX: Syncope VS clearing mucus plus vs hyperventilation Patient is a 19 month old male. He presents with acute cough, congestion/drainage, and fainting. The history is obtained from the patient's mother and maternal great grandmother. The history appears to be reliable. 19 m m brought by his mother for vaccination for hepatitis A and influenza vaccination. MA administered his vaccines. Per MA, he began to cry after first vaccine. While crying hard, he inhaled deeply, 2nd vaccine was given and he became breathless. MA sat him up. Mom picked him up. Nurse in doorway stepped over to pick him up from mom, felt mucus move in chest, placed him prone, and slapped his back. He began to cry almost immediately. He was crying, breathing without distress, pink and well-perfused, in nurse's arms as I walked in. Patient's vitals were RR 36 bpm with HR 148. Patient was observed and reassessed every 10 minutes. Repeat vitals 20 minutes later were HR 135 bpm, RR 28 bpm, oxygen saturations 98% on room air also while crying and fighting to climb down from mom's lap. Mom reports that yesterday he developed cough, nasal congestion. Per mom, cough has progressively worsened today becoming gradually more wet and congested as the day has passed. No fever. No loss of appetite. Drinking well. No vomiting. No change in stools. No rash. Wetting diapers normally. On Sunday, 3 days ago, he was moving from mom to dad walking down steps when he fell on step, hitting right cheek and eyelid. No loss of consciousness. He cried immediately. No vomiting. No clumsiness. No unusual irritability. He has abrasions to right upper eyelid, cheek and chin that are healing well. He fell at great-grandmother's house recently and hit chin, on Friday of last week. Fall was witnessed by great-grandmother. He cried immediately, no loss of consciousness. Abrasion on chin is healing well.
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Hypotonia, Nasal congestion, Productive cough, Respiratory tract congestion, Secretion discharge
Clinical narrative: Medical Assistant Administered 1st vaccine, pt took a deep breath while crying; simultaneously, 2nd Vaccine Administered, at that point pt became limp & breathless, had episode of synchopy. Nurse came in & placed him prone, felt mucus plug in chest, & slapped his back a few times. Pt took breath & started crying almost immediately. Please see office visit Note for further clarification. DX: Syncope VS clearing mucus plus vs hyperventilation Patient is a 19 month old male. He presents with acute cough, congestion/drainage, and fainting. The history is obtained from the patient's mother and maternal great grandmother. The history appears to be reliable. 19 m m brought by his mother for vaccination for hepatitis A and influenza vaccination. MA administered his vaccines. Per MA, he began to cry after first vaccine. While crying hard, he inhaled deeply, 2nd vaccine was given and he became breathless. MA sat him up. Mom picked him up. Nurse in doorway stepped over to pick him up from mom, felt mucus move in chest, placed him prone, and slapped his back. He began to cry almost immediately. He was crying, breathing without distress, pink and well-perfused, in nurse's arms as I walked in. Patient's vitals were RR 36 bpm with HR 148. Patient was observed and reassessed every 10 minutes. Repeat vitals 20 minutes later were HR 135 bpm, RR 28 bpm, oxygen saturations 98% on room air also while crying and fighting to climb down from mom's lap. Mom reports that yesterday he developed cough, nasal congestion. Per mom, cough has progressively worsened today becoming gradually more wet and congested as the day has passed. No fever. No loss of appetite. Drinking well. No vomiting. No change in stools. No rash. Wetting diapers normally. On Sunday, 3 days ago, he was moving from mom to dad walking down steps when he fell on step, hitting right cheek and eyelid. No loss of consciousness. He cried immediately. No vomiting. No clumsiness. No unusual irritability. He has abrasions to right upper eyelid, cheek and chin that are healing well. He fell at great-grandmother's house recently and hit chin, on Friday of last week. Fall was witnessed by great-grandmother. He cried immediately, no loss of consciousness. Abrasion on chin is healing well.
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Skin abrasion, Syncope
Clinical narrative: Medical Assistant Administered 1st vaccine, pt took a deep breath while crying; simultaneously, 2nd Vaccine Administered, at that point pt became limp & breathless, had episode of synchopy. Nurse came in & placed him prone, felt mucus plug in chest, & slapped his back a few times. Pt took breath & started crying almost immediately. Please see office visit Note for further clarification. DX: Syncope VS clearing mucus plus vs hyperventilation Patient is a 19 month old male. He presents with acute cough, congestion/drainage, and fainting. The history is obtained from the patient's mother and maternal great grandmother. The history appears to be reliable. 19 m m brought by his mother for vaccination for hepatitis A and influenza vaccination. MA administered his vaccines. Per MA, he began to cry after first vaccine. While crying hard, he inhaled deeply, 2nd vaccine was given and he became breathless. MA sat him up. Mom picked him up. Nurse in doorway stepped over to pick him up from mom, felt mucus move in chest, placed him prone, and slapped his back. He began to cry almost immediately. He was crying, breathing without distress, pink and well-perfused, in nurse's arms as I walked in. Patient's vitals were RR 36 bpm with HR 148. Patient was observed and reassessed every 10 minutes. Repeat vitals 20 minutes later were HR 135 bpm, RR 28 bpm, oxygen saturations 98% on room air also while crying and fighting to climb down from mom's lap. Mom reports that yesterday he developed cough, nasal congestion. Per mom, cough has progressively worsened today becoming gradually more wet and congested as the day has passed. No fever. No loss of appetite. Drinking well. No vomiting. No change in stools. No rash. Wetting diapers normally. On Sunday, 3 days ago, he was moving from mom to dad walking down steps when he fell on step, hitting right cheek and eyelid. No loss of consciousness. He cried immediately. No vomiting. No clumsiness. No unusual irritability. He has abrasions to right upper eyelid, cheek and chin that are healing well. He fell at great-grandmother's house recently and hit chin, on Friday of last week. Fall was witnessed by great-grandmother. He cried immediately, no loss of consciousness. Abrasion on chin is healing well.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Flushing, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: Pt received vaccine at approximately 5:35 pm. A few minutes after patient received vaccine, pt stood up to leave and describes feeling a strong head pain and pressure, and nausea. pt then sat down again in a bench seat next to his brother looking pale out of it. He became very pale and was instructed to elevate his feet. His father felt his head and he was sweaty. While pt was pale in the face and lips, his hands become red and flushed. 911 was called and pt remained pale for several minutes until paramedics arrived at 5:50pm. Vitals per paramedics were: pulse 57 and sitting blood pressure of 120/80; standing blood pressure of 118/72. Patient's father declined transporting to the hospital and patient did regain color. Patient seemed to feel better and was able to get up and walk out of the store. At 7:00pm the patient's parents were called to check on how he was doing. They reported that he seemed to be feeling much better. He had regained his color and was doing his homework and was able to eat dinner.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pallor
Clinical narrative: Pt received vaccine at approximately 5:35 pm. A few minutes after patient received vaccine, pt stood up to leave and describes feeling a strong head pain and pressure, and nausea. pt then sat down again in a bench seat next to his brother looking pale out of it. He became very pale and was instructed to elevate his feet. His father felt his head and he was sweaty. While pt was pale in the face and lips, his hands become red and flushed. 911 was called and pt remained pale for several minutes until paramedics arrived at 5:50pm. Vitals per paramedics were: pulse 57 and sitting blood pressure of 120/80; standing blood pressure of 118/72. Patient's father declined transporting to the hospital and patient did regain color. Patient seemed to feel better and was able to get up and walk out of the store. At 7:00pm the patient's parents were called to check on how he was doing. They reported that he seemed to be feeling much better. He had regained his color and was doing his homework and was able to eat dinner.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Gait inability, Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: About 16hrs after receiving vaccines child woke-up with left leg red and swelling. Child was unable to walk at the time She woke-up. Went to ER Dx: Vaccine reaction Dx: Left Leg pain
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: X-ray limb normal
Clinical narrative: About 16hrs after receiving vaccines child woke-up with left leg red and swelling. Child was unable to walk at the time She woke-up. Went to ER Dx: Vaccine reaction Dx: Left Leg pain
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dysarthria, Facial paralysis, Pain in extremity, Transient ischaemic attack
Clinical narrative: After vaccine arm was a bit sore but nothing major.  Patient had a  TIA on 8/25; face drooped on one side, speech slurred and weakness. TIA occurred within similar window to first dose.    Patient went to ER.   Patient kept over night for observation.  Patient followed up with PCP. He is doing well.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Pt received Shingrix #2 on 11/8/19 @ 4:00 pm on 11/09/19 pt started running a fever of 101.9 degrees Pt also developed a red, tender, itchy, spotchy rash on her upper left forearm Fever diminished on 11/10/19 Rash still visible on 11/12/19
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pt received Shingrix #2 on 11/8/19 @ 4:00 pm on 11/09/19 pt started running a fever of 101.9 degrees Pt also developed a red, tender, itchy, spotchy rash on her upper left forearm Fever diminished on 11/10/19 Rash still visible on 11/12/19
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Urticaria
Clinical narrative: Hives across legs and torso without airway compromise. resolved with prednisone and benadryl.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Induration, Limb mass
Clinical narrative: Noticed a hard lump in left arm; This spontaneous report as received from a other health professional refers to a male patient of unknown age. The patient's medical history included substance abuse.   On 22-FEB-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1586749 dose 2, 1 dosage form, intramuscular in the right arm.  Other suspect therapies included meningococcal b rfhbp rnada rnhba omv vaccine (e. coli)(BEXSERO), influenza virus split virion 4v vaccine inactivated(FLUARIX QUADRIVALENT) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA). Concomitant therapies included bupropion(BUPROPION), fluticasone(FLUTICASONE) and cephalexin(KEFLEX).   On 25-FEB-2019, 2 days 12 hrs 30 min after onset of therapy the patient experienced limb mass.    The outcome of limb mass was reported as recovered/resolved.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Limb mass
Clinical narrative: Noticed a hard lump in left arm; This spontaneous report as received from a other health professional refers to a male patient of unknown age. The patient's medical history included substance abuse.   On 22-FEB-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1586749 dose 2, 1 dosage form, intramuscular in the right arm.  Other suspect therapies included meningococcal b rfhbp rnada rnhba omv vaccine (e. coli)(BEXSERO), influenza virus split virion 4v vaccine inactivated(FLUARIX QUADRIVALENT) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA). Concomitant therapies included bupropion(BUPROPION), fluticasone(FLUTICASONE) and cephalexin(KEFLEX).   On 25-FEB-2019, 2 days 12 hrs 30 min after onset of therapy the patient experienced limb mass.    The outcome of limb mass was reported as recovered/resolved.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB, FLUX, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Seizure, Viral test negative
Clinical narrative: Patient had 2 seizures on the day of 10/03/2019. First seizure was around 6pm and was a small and didn't last long. I had just giving him Tylenol. At 1130pm the second seizure occurred and lasted 15-20 minutes and motrin was giving before. Ambulance was called and we were taking to Hospital. I was told he was having a febrile seizure due to high fever. On 11/09/2019, patient had another seizure in the car in his car seat with NO FEVER. The seizure was about 7-10 minutes. We made it to urgent care because it was closer and they checked his temperature and it was 99.2. The staff called the ambulance and we were taking to the hospital. The medic checked his temp continously while on our ride and it never exceed 99.5. When we arrive to the hospital the CNA checked his temp and stated he had a fever of 38.2°c. The fever was treated with motrin.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Swelling, Urticaria, Wheezing
Clinical narrative: Patient got the flu shot at around 11:15 AM on 11/12/2019. After a few hours (around 4PM), she called back and reported that she experienced allergic reactions to the vaccine such as hives, wheezing and swelling. She then took Benadryl and the hives almost disappeared. Patient was told by the reporter (pharmacist) to keep monitoring it and contact to healthcare professional right away if it worsens or does not get better soon. She agreed to follow instructions.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Blood test, Burning sensation, Facial paralysis, Fatigue
Clinical narrative: 3 weeks after taking the vaccine i started to have left leg numbness and a burning feeling when showering, when the cold water would hit my left leg i had a burning sensation.  Following that i also experienced walking and balance issues, dropping on the left side of my face.  Hearing issues.  Fatigue.  Tingling or numbness feeling on the arms and legs.  Stomach issues.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Gait disturbance, Gastric disorder, Hypoacusis, Hypoaesthesia, Magnetic resonance imaging brain abnormal
Clinical narrative: 3 weeks after taking the vaccine i started to have left leg numbness and a burning feeling when showering, when the cold water would hit my left leg i had a burning sensation.  Following that i also experienced walking and balance issues, dropping on the left side of my face.  Hearing issues.  Fatigue.  Tingling or numbness feeling on the arms and legs.  Stomach issues.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: 3 weeks after taking the vaccine i started to have left leg numbness and a burning feeling when showering, when the cold water would hit my left leg i had a burning sensation.  Following that i also experienced walking and balance issues, dropping on the left side of my face.  Hearing issues.  Fatigue.  Tingling or numbness feeling on the arms and legs.  Stomach issues.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Disturbance in attention, Dizziness, Fatigue, Headache
Clinical narrative: Started to feel sick almost immediately, felt dizzy and lightheaded. Left arm painful and stinging at times. Began to have very sharp pains in joints running all the way down to feet. Very bad headache (and I never get headaches), interfering with my schoolwork, sleep, and work. Tried to work but very fatigued and tired whereas normally I am very energetic. Had to take constant breaks at work. At home couldn't concentrate, read or write very well due to extreme headache. Started to feel sick to my stomach and like I was going to vomit. As I am typing this now I feel lightheaded, have a horrible headache, and feel like I am going to throw up constantly. Before I got the flu shot I was fine, healthy, energetic, could walk for hours. I am afraid of what will happen if these symptoms do not go away or worsen as I have to work tomorrow and I am in college. I have been taking vitamins and drinking tea with antioxidants to try to help but it's not really doing much for me.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Insomnia, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: Started to feel sick almost immediately, felt dizzy and lightheaded. Left arm painful and stinging at times. Began to have very sharp pains in joints running all the way down to feet. Very bad headache (and I never get headaches), interfering with my schoolwork, sleep, and work. Tried to work but very fatigued and tired whereas normally I am very energetic. Had to take constant breaks at work. At home couldn't concentrate, read or write very well due to extreme headache. Started to feel sick to my stomach and like I was going to vomit. As I am typing this now I feel lightheaded, have a horrible headache, and feel like I am going to throw up constantly. Before I got the flu shot I was fine, healthy, energetic, could walk for hours. I am afraid of what will happen if these symptoms do not go away or worsen as I have to work tomorrow and I am in college. I have been taking vitamins and drinking tea with antioxidants to try to help but it's not really doing much for me.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Started to feel sick almost immediately, felt dizzy and lightheaded. Left arm painful and stinging at times. Began to have very sharp pains in joints running all the way down to feet. Very bad headache (and I never get headaches), interfering with my schoolwork, sleep, and work. Tried to work but very fatigued and tired whereas normally I am very energetic. Had to take constant breaks at work. At home couldn't concentrate, read or write very well due to extreme headache. Started to feel sick to my stomach and like I was going to vomit. As I am typing this now I feel lightheaded, have a horrible headache, and feel like I am going to throw up constantly. Before I got the flu shot I was fine, healthy, energetic, could walk for hours. I am afraid of what will happen if these symptoms do not go away or worsen as I have to work tomorrow and I am in college. I have been taking vitamins and drinking tea with antioxidants to try to help but it's not really doing much for me.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Arm pain moderate within 5 minutes Symptoms onset at two hours post vaccination of diffuse myalgias, moderate headache, followed by repeated vomiting. At 4 hours had a Fever of 102. Symptoms remaining intense for 24 hours of frequent vomiting, headache, fevers and myalgias. Improvement by 48 hours. Back to normal at 72 hours.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Urticaria
Clinical narrative: Very painful shoulder muscle, hives, resolved with allergy meds and aspirin
Sex: F
Vaccine: ANTH
Symptoms: Headache, Injection site pain, Neuralgia, Pyrexia
Clinical narrative: Nerve pain on injection side; Headache; Low grade fever; Site pain; Spontaneous report received on 19SEP2019.  A female consumer reported that she experienced nerve pain on injection side (PT: Neuralgia), headache (PT: Headache), low grade fever (PT: Pyrexia), and injection site pain (PT: Injection site pain), following immunization with BioThrax. On 17SEP2019 at 01:30 PM, she received a dose of BioThrax by intramuscular route in the left arm. On the same day, at 2:15 PM, she experienced low grade fever (101 degree Fahrenheit), which lasted for 18 hours, along with a headache which was also lasted for 18 hours. In addition, she also had nerve pain on injection side. She recovered from the reported events headache, low grade fever, and site pain on 18SEP2019 at 08:00 AM, while she did not recover from the event nerve pain on injection side.  Treatment medication included oral Naproxen (400 mg).  Medical history included fever/ pain post vaccination with diphtheria tetanus and pertussis (Dtap), at age 29 years and fever/ arthritis post vaccination with measles, mumps, and rubella (MMR) vaccine, at age 31 years.  Company comment: The described events "headache, low grade fever and injection site pain" are known effects of Biothrax, and therefore are considered to be causally related to the administration of Biothrax. The event nerve pain on injection side is likely due to the local reaction at injection site and causally related to the vaccine.; Sender's Comments: Company comment: The described events "headache, low grade fever and injection site pain" are known effects of Biothrax, and therefore are considered to be causally related to the administration of Biothrax. The event nerve pain on injection side is likely due to the local reaction at injection site and causally related to the vaccine.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not provided.  On 15-OCT-2019, the patient was was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail was not reported, lot # N022303, expiration date 01-MAR-2019) intramuscularly for prophylaxis (expired product administered). No temperature excursion. No adverse effects were reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; She reported that on 10/5/2016 and l l/30/2016, the 13 year old patient was administered doses of PROQUAD; Inappropriate age at vaccine administration; This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 05-OCT-2016, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # M015698, expiration date not provided but upon internal validation established as 26-SEP-2017 (strength, dose and route of administration were not provided) for prophylaxis and on 30-NOV-2016, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # M015698, expiration date not provided but upon internal validation established as 26-SEP-2017 (strength, dose and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration and product administered to patient of inappropriate age). No adverse effects were reported. The outcome of the events was unknown.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product use issue
Clinical narrative: No adverse effects reported; One 15 year old patient received one dose of PROQUAD.; This spontaneous report was received from a nurse referring to a 15 years old male patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On 06-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot # R030803, expiration date 22-APR-2020; vaccine dosage detail and route of administration not reported) subcutaneous inject for prophylaxis which was reconstituted with sterile diluent (drug use in unapproved age group).  No adverse effects was reported. No product quality complaint (PQC) was involved in this case.
Sex: U
Vaccine: HPV9, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; multiple unspecified patient were probably administered improperly stored vaccines; This spontaneous report was received from an immunization official referring to multiple patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     Since 24-MAY-2019, multiple unspecified patients were probably vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S002639, expiration date 19-NOV-2020) (lot # R024025, expiration date 02-SEP-2020)(strength, dose and route were not reported), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R025726, expiration date 26-MAY-2021) (lot # R025730, expiration date 18-JUN-2021) (strength, dose and route were not reported) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R016790, expiration date 20-APR-2020)(orally; strength and dose were not reported) for prophylaxis (product storage error). It was not determined which lots had been administered or not. Temperature excursion was above 9 Centigrade Degrees (mainly at 10.2 Centigrade Degrees) for 15 minutes. Previous temperature excursion was above 9 Centigrade Degrees(mainly at 9 .1 Centigrade) for 15 minutes and above 9 Centigrade Degrees(mainly at 16.5 Centigrade Degrees) for 5 hours and 15 minutes. Data logger was involved. No adverse effects were reported.  This is a non-valid case due to lack of patients' identifier and number.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; The female patient was administered a dose of expired PNEUMOVAX 23.; This spontaneous report was received from a pharmacist concerning a 67-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 16-OCT-2019, the patient was vaccinated with her first dose of properly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot number N019348 with expiration date 08-FEB-2019 (expired product administered) (anatomical location, strength and dose were not reported) as age related vaccination (prophylaxis). No adverse effect was reported.   No product quality complaint was present.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the events. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).