chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Pruritus, Skin warm, Sleep disorder
Clinical narrative: extreme itching, redness and heat profuse over trunk, arms, thighs, hands, feet, back of neck over 4 days,Difficulty sleeping at night due to extreme itching,; required visit to Urgent Care physician,   Prednisone dose pack consisting of total 15- 10 mg tablets over 10 days; Benadryl 25-50mg HS, Zyrtec bid, Aveeno colloidal oatmeal baths (sr citizen with reduced mobility)  Currently finishing first 10 Prednisone (bid X5 days) sx reoccur each afternoon
Age: 18.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Per patient arm redness, occured approximately 1 day after administration of vaccine. Arm was slightly red then increased swelling and redness. Arm was warm, itching later in day. Patient took Benadryl and Benadryl ointment to site. Patient called Doctor for a tele visit with NP
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Severe, constant pain in shoulder lasting 3 weeks now
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Peripheral swelling, Skin warm, Tension, Vaccine positive rechallenge
Clinical narrative: Arm swelled 24 hours after injection from shoulder to hand - warm and tense - NO fever. Minimal pain. Same exact thing happened last year to same child. May be sensitive to an ingredient.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Alopecia, Arthralgia, Asthenia, Fatigue, Impaired work ability
Clinical narrative: 10/3:  started with feeling tired, no energy around 4 pm.  I just wanted to sleep.  By 5 pm left arm below injection site with rash, arm swelling, hard and painful.  Fever low grade 100.9.  By 7 pm, unable to move, whole body pain, joint pain, fever up to 102.  Took Ibuprofen and went to bed.  Rough night, not feeling well, off and on sleep.  Body stressed.  Took more Ibuprofen 10/4 at 3am.  Unable to work.  Woke up around 10 am on 10/4, no change in arm swelling and rash, fatigued, but no fever.  No energy all day.  10/5 Less fatigued.  Loss of hair from stress.  Arm swelling reduced somewhat but rash exists.  Rest all day.  10/6 My mother noticed hair loss, arm rash still present, just slightly swollen arm, more
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site swelling, Malaise
Clinical narrative: 10/3:  started with feeling tired, no energy around 4 pm.  I just wanted to sleep.  By 5 pm left arm below injection site with rash, arm swelling, hard and painful.  Fever low grade 100.9.  By 7 pm, unable to move, whole body pain, joint pain, fever up to 102.  Took Ibuprofen and went to bed.  Rough night, not feeling well, off and on sleep.  Body stressed.  Took more Ibuprofen 10/4 at 3am.  Unable to work.  Woke up around 10 am on 10/4, no change in arm swelling and rash, fatigued, but no fever.  No energy all day.  10/5 Less fatigued.  Loss of hair from stress.  Arm swelling reduced somewhat but rash exists.  Rest all day.  10/6 My mother noticed hair loss, arm rash still present, just slightly swollen arm, more
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Pain, Pyrexia, Sleep disorder, Somnolence
Clinical narrative: 10/3:  started with feeling tired, no energy around 4 pm.  I just wanted to sleep.  By 5 pm left arm below injection site with rash, arm swelling, hard and painful.  Fever low grade 100.9.  By 7 pm, unable to move, whole body pain, joint pain, fever up to 102.  Took Ibuprofen and went to bed.  Rough night, not feeling well, off and on sleep.  Body stressed.  Took more Ibuprofen 10/4 at 3am.  Unable to work.  Woke up around 10 am on 10/4, no change in arm swelling and rash, fatigued, but no fever.  No energy all day.  10/5 Less fatigued.  Loss of hair from stress.  Arm swelling reduced somewhat but rash exists.  Rest all day.  10/6 My mother noticed hair loss, arm rash still present, just slightly swollen arm, more
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Stress
Clinical narrative: 10/3:  started with feeling tired, no energy around 4 pm.  I just wanted to sleep.  By 5 pm left arm below injection site with rash, arm swelling, hard and painful.  Fever low grade 100.9.  By 7 pm, unable to move, whole body pain, joint pain, fever up to 102.  Took Ibuprofen and went to bed.  Rough night, not feeling well, off and on sleep.  Body stressed.  Took more Ibuprofen 10/4 at 3am.  Unable to work.  Woke up around 10 am on 10/4, no change in arm swelling and rash, fatigued, but no fever.  No energy all day.  10/5 Less fatigued.  Loss of hair from stress.  Arm swelling reduced somewhat but rash exists.  Rest all day.  10/6 My mother noticed hair loss, arm rash still present, just slightly swollen arm, more
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Fever (100.5) approx. 24 hours after receiving shot. Lasted 3-6 hours, followed by 24-48 hours of fatigue and slight shortness of breath.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient reports shoulder/arm injury related to vaccine administration. She reports not being able to lift her arm more than 6-8 inches from body. She has pain from her shoulder down to her elbow. Patient was given the vaccine around 9:45am, and pain started around noon.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: The vaccine caused my to experience the following : headache, tiredness, weakness, runny nose,  pained swelling in my arm,  and vomiting, which I am still experiencing today.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: The vaccine caused my to experience the following : headache, tiredness, weakness, runny nose,  pained swelling in my arm,  and vomiting, which I am still experiencing today.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site warmth
Clinical narrative: Bleeding at injection site upon injection.  The arm was painful all night, and it made sleeping difficult.  Bruising all around injection site the size of an egg.  Halfway down my arm between the injection site and the elbow is an area about 4 inches across by 2 inches high on my arm that is hot to the touch and red in appearance.  Arm pain is not as bad as first day.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Bleeding at injection site upon injection.  The arm was painful all night, and it made sleeping difficult.  Bruising all around injection site the size of an egg.  Halfway down my arm between the injection site and the elbow is an area about 4 inches across by 2 inches high on my arm that is hot to the touch and red in appearance.  Arm pain is not as bad as first day.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: Patient states he had pain in right arm, that he could not comfortably rest arm. Patient did not state when pain started in relation to vaccine. Patient went to urgent care 10-12-20
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: TALKED TO PATIENT ON 10/9/20 AND 10/12/2020. NONE WERE REPORTED BY PATIENT.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient reports fever on the same day of administration and the day after administration of vaccine. Patient also states that she experienced arm swelling and redness the day after vaccination which started to resolve on day 3.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient received vaccine on day of discharge 10/07/2020 and did not have a reaction prior to leaving within approximately 15 minutes. After being home patient reported to home care RN that she had a rash on her body. Home care RN instructed patient to go to the ER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Pt stated they observed redness the day following administration.  The redness began to subside days following administration and then roughly a week after the redness and itching came back.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Injection site pain
Clinical narrative: Patient stated pain at moment of injection which became worse over the month following the vaccine.  The pain was such that she had trouble performing tasks at her job.  Patient opted not to see her doctor.  I followed up  with her 6 days later and she felt it was improving.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling greater than half dollar, pain and heat at injection site
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: patient got a rash near his elbow that went up diagonal around his arm, but not at or near the injection site
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: At 11:00 pm the evening the vaccines were given the patient began to experience fatigue. The fatigue progressed into chills and nausea. These symptoms were still present through at least the next morning at 10 am. The patient took tylenol and ibuprofen to treat symptoms.
Age: 13.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Syncope
Clinical narrative: Syncope ~2 min after administration of injection. Was supported by mother and was sat to ground. Once able to stand, patient was supported on chair to sit. Patient took about 30 minutes to recover.
Age: 13.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Hyperhidrosis, Loss of consciousness, Nausea, Syncope
Clinical narrative: Syncope ~2 min after administration of injection. Was supported by mother and was sat to ground. Once able to stand, patient was supported on chair to sit. Patient took about 30 minutes to recover.
Age: 13.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Syncope
Clinical narrative: Full syncopal episode approximately one minute after receiving the vaccine.  Unconscious 5 seconds after lowered to the ground. Nausea and diaphoresis for 20 minutes following. Weakness for one hour.
Age: 13.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Hyperhidrosis, Loss of consciousness, Nausea, Syncope
Clinical narrative: Full syncopal episode approximately one minute after receiving the vaccine.  Unconscious 5 seconds after lowered to the ground. Nausea and diaphoresis for 20 minutes following. Weakness for one hour.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema
Clinical narrative: Patient presented at the pharmacy on 10/12/2020 and had a several inch wide, rectangular-shaped red area on her arm. The area was several inches below and to the side of the injection site. She stated it had gotten larger throughout the day. She said it did not itch and was not hot to the touch.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Headache, Movement disorder, Peripheral swelling, Skin warm
Clinical narrative: IMZ AT 1200 SATURDAY AND BY 5PM SHE SAID SHE ALMOST FELT "PARALYZED" AND "FELT LIKE SHE WAS GOING TO BREAK WITH EACH STEP"; SHE ALSO REPORTED A HEADACHE AND A "FEVER" IN HER ARM AND SWOLLEN ARM; SHE SAID IT WAS BETTER ON SUNDAY, AND STILL SWOLLEN ON MONDAY BUT NOT AS BAD AND OTHER SYMPTOMS SIGNIFICANTALLY LESS. PT DID NOT SEEK OUT ANY MEDICAL ATTENTION AS OF YET.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient was given immunization and started bleeding heavily at site of injection and then instantly had a welt-like swollen area under injection. When I assessed the area prior to immunization, I did not feel a bump or hardened area at the site and patient was unaware of there being anything on her arm before the injection. After 1 hour the swelling did decrease but still had a small swollen area almost like an insect bite. Patient stopped bleeding within a few minutes.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: patient developed a band shaped rash 3 inches below the injection site. The rash was swollen and feels hot to the touch
Age: 70.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Patient called and stated that at about 9 pm the night of 10/9/20 some 5 1/2 to 6 hours after receiving her vaccines  complained of elevate blood pressure 126/103 and a rapid heart rate pulse rate of 176 after drinking some ice water within 30 minutes the symptoms subsided and went away. Patient rested comfortably the rest of the evening and into Saturday afternoon. The patient said that she is feeling just fine . I advised her to contact her physician and if this symptom occurred again to call 911 and seek medical attention.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Inflammation, Rash
Clinical narrative: rash starting day two on arm progessed to full body rash day 4 also headache red inflamed arm
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Axillary pain, Injection site pain, Oedema peripheral, Pyrexia
Clinical narrative: HER ARM IS PAINFUL AT THE SITE OF INJECTION AND SHE HAS A FEVER. ALSO HER ARMPIT ON THE VACCINATED ARM HURTS AND IS SWOLLEN
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Developed redness, swelling and tenderness in the right arm about 2 days after receiving both vaccines.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dysphonia, Dyspnoea, Hyperhidrosis, Lacrimation increased, Lip swelling
Clinical narrative: Patient was wheezing, lips swollen, teary eyes, and sweating. She stated that her throat was swollen and that  she was having trouble breathing.   She was alert and well oriented but her voice was muffled. With consent, she was administered an epi pen  on he left thigh. Within a few  minutes, she said that the swelling was going down and she was taken care of the 911 services before vitals were taken and they took over.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pharyngeal swelling, Wheezing
Clinical narrative: Patient was wheezing, lips swollen, teary eyes, and sweating. She stated that her throat was swollen and that  she was having trouble breathing.   She was alert and well oriented but her voice was muffled. With consent, she was administered an epi pen  on he left thigh. Within a few  minutes, she said that the swelling was going down and she was taken care of the 911 services before vitals were taken and they took over.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Lip swelling, Pharyngeal swelling, Wheezing
Clinical narrative: Patient was wheezing, lips swollen, teary eyes, and sweating. She stated that her throat was swollen and that  she was having trouble breathing.   She was alert and well oriented but her voice was muffled. With consent, she was administered an epi pen  on he left thigh. Within a few  minutes, she said that the swelling was going down and she was taken care of the 911 services before vitals were taken and they took over.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dysphonia, Dyspnoea, Hyperhidrosis, Lacrimation increased, Lip swelling
Clinical narrative: Patient was having trouble breathing , wheezing, swollen lips. She complained off swollen throat. Epinephrine was administered. She improved within 5 minutes ( decreased wheezing, shortness of breath, and stated that throat swelling was going down)
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pharyngeal swelling, Wheezing
Clinical narrative: Patient was having trouble breathing , wheezing, swollen lips. She complained off swollen throat. Epinephrine was administered. She improved within 5 minutes ( decreased wheezing, shortness of breath, and stated that throat swelling was going down)
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Lip swelling, Pharyngeal swelling, Wheezing
Clinical narrative: Patient was having trouble breathing , wheezing, swollen lips. She complained off swollen throat. Epinephrine was administered. She improved within 5 minutes ( decreased wheezing, shortness of breath, and stated that throat swelling was going down)
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal discomfort, Cough, Dyspnoea, Oral pruritus, Oxygen saturation decreased
Clinical narrative: Pt developed itching of her mouth with upset stomach within minutes of receiving vaccine. She then developed dyspnea with cough within 5-10 minutes of administration. On exam she had wheezes in her bilateral bases with desaturation of SpO2 to 87%. Pt was given adult Epi Pen and sx resolved. However, after 10 minutes, sx returned and pt was redosed with epinephrine and given IM BENADRYL. Pt was sent to ED and Observed for a period of 8 hours during which symptoms did not return and pt was found fit for discharge.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Wheezing
Clinical narrative: Pt developed itching of her mouth with upset stomach within minutes of receiving vaccine. She then developed dyspnea with cough within 5-10 minutes of administration. On exam she had wheezes in her bilateral bases with desaturation of SpO2 to 87%. Pt was given adult Epi Pen and sx resolved. However, after 10 minutes, sx returned and pt was redosed with epinephrine and given IM BENADRYL. Pt was sent to ED and Observed for a period of 8 hours during which symptoms did not return and pt was found fit for discharge.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Influenza, Oropharyngeal pain
Clinical narrative: Unknown influenza vaccine in 2008, caused flu symptoms for several days afterward, including cough, sore throat, congestion, headache, fatigue, body ache, fever, etc. Possibly re-aggravated childhood allergies, eventually required allergy shots again after vaccine, continue to suffer severe allergies, which had been under control for years before vaccine. Link is not certain, but possible. Was not aware of reporting system until now.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Unknown influenza vaccine in 2008, caused flu symptoms for several days afterward, including cough, sore throat, congestion, headache, fatigue, body ache, fever, etc. Possibly re-aggravated childhood allergies, eventually required allergy shots again after vaccine, continue to suffer severe allergies, which had been under control for years before vaccine. Link is not certain, but possible. Was not aware of reporting system until now.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient got  flu shot on 9/28/20 and came to the store on 10/9/20 to say that her shoulder still hurts from the flu shot and that it hurts to lift it all the way. She states she thinks that possibly the shot was given too high and maybe caused bursitis. She states that she has a doctors appointment on 10/14/20 and she will discuss it with her doctor.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives on neck after re diving flu vaccine
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema multiforme, Pruritus, Sleep disorder
Clinical narrative: Doctors' diagnostic: Erythema Multiforme  Rash in whole body,  itching and burning could not sleep   out of control, have to use Prednisone ( Steroid) : 40mg for 4 day, and it is still on 20 mg
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Tongue spasm
Clinical narrative: Child displayed constant, persistent, & intense muscle spasm in tongue beginning about 1hr after receiving vaccine at approximately 08:45AM and continuing until about approximately 11:00PM. Pediatrician's office was called at 05:03 PM as the muscle spasm did not cease after the child drank water, ate food, nursed, or slept. On call doctor for the pediatrician's office recommended taking child in to a pediatric urgent care center. Urgent care center referred to pediatric emergency room via phone. Vitals were normal at pediatric emergency room, physician's assistant was unable to make a diagnosis or recommend a course of treatment. Muscle spasm eventually ceased on the drive home from the emergency room around 11:00PM. Still evident next morning (10/09/2020), but not consistently - spasm continues to occur randomly for several minutes at a time throughout the day but is not consistent or persistent.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Approximately 1 inch below the injection site, I have an oval hard knot about the side of half of a baseball, oblong in nature.  Extremely hot, sore and also itches.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Blood magnesium normal, Cellulitis, Laboratory test normal, Pain in extremity, Skin warm
Clinical narrative: Mother called service over the weekend that he has had soreness to his left arm since getting the FLU shot on 10/7. He is being admitted to 5T for IV Abx care for his cellulitis of the left arm. It is painful and warm to the touch since 10/11. It measures 7.5mm by 12mm. Marked with a pen. Received first dose of Clindamycin IV in clinic (12pm) and will continue inpt q8hrs. Sent a MRSA swab from clinic as that needs to be f/u. Dc'ed Mg today d/t Mg of 2. Continues on Siro taper as below. VSS, no fever, labs WNL. Soft tissue ultrasound showed cellulitis, no evidence of drainable fluid. When admitted, switch IV Abx to cefazolin due to known resistance with clindamycin.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Staphylococcus test, Ultrasound scan abnormal
Clinical narrative: Mother called service over the weekend that he has had soreness to his left arm since getting the FLU shot on 10/7. He is being admitted to 5T for IV Abx care for his cellulitis of the left arm. It is painful and warm to the touch since 10/11. It measures 7.5mm by 12mm. Marked with a pen. Received first dose of Clindamycin IV in clinic (12pm) and will continue inpt q8hrs. Sent a MRSA swab from clinic as that needs to be f/u. Dc'ed Mg today d/t Mg of 2. Continues on Siro taper as below. VSS, no fever, labs WNL. Soft tissue ultrasound showed cellulitis, no evidence of drainable fluid. When admitted, switch IV Abx to cefazolin due to known resistance with clindamycin.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Swollen tongue
Clinical narrative: GOT A PHONE CALL FROM THE PATIENT ON 10-11-20, STATING THAT AFTER 2-3 DAYS, SHE GOT AN ALLERGIC REACTION FROM THE VACCINE. PATCHES OF FLAT RED SPOTS ALL OVER HER BODY AND TONGUE SWELLED UP. SHE SAID NOT CAUSED BY ANYTHING SHE ATE OR SOMETHING SHE APPLIED ON HER SKIN. SHE SAID SHE TOOK BENADRYL FOR IT AND STILL TAKING IT. SHE SAID IT'S IMPROVING BUT CONTINUE TAKING IT ANYWAY TO RESOLVE THE RED SPOTS ON HER SKIN.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort, Chills, Hyperaesthesia, Pain
Clinical narrative: Pt. called our office 2pm c/o chills this am; followed by bodyaches and hypersensitive to touch. pt also tightness lower rib area last 1 hr. Denies SOB. pain with respiration no skin redness, rash or fever. Took motrin 400mg @ 10am today. seen in office 3:30 pm 10/9/20: Seen in office; no obvious distress VS stable temp 99.1 p - 72 resp 18 BP 170/72 No obvious rash or flushing alert oriented. Injection site free of rash or redness. Instructed pt in signs and symptoms to be seen in ER if develop.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Erythema, Headache, Malaise, Myalgia
Clinical narrative: Shot given 7-21-20. 10:00 A.M. - 7-22 - Dinner feeling kinda sick - 34th feeling depressed and sick again. small headache, muscle pain ithing several places. 25th feeling better" still muscle pain - 26th - itching on same arm of shot. 27th still red on same arm - 27th Big whelp,swelled, getting hungry again  28th Noitching - a little red and real hungry -
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Shot given 7-21-20. 10:00 A.M. - 7-22 - Dinner feeling kinda sick - 34th feeling depressed and sick again. small headache, muscle pain ithing several places. 25th feeling better" still muscle pain - 26th - itching on same arm of shot. 27th still red on same arm - 27th Big whelp,swelled, getting hungry again  28th Noitching - a little red and real hungry -
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy symptoms. Approx 13 - 14 hours after injection . Seen at urgent care treated with prednisone and valacyclovir. Symptoms lasted 2+ weeks and are minimally still present on right side of face.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Cough, Dyspnoea
Clinical narrative: Within 24 HRS: Shortness ofbreath - (productive) asthma coughing together with increasing shortness of breath Took Benadryl for approx. 2 weeks every nite.  Congestion continued for over 2 weeks, w/ severity slowly decreasing over time -
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Heart rate increased, Hypoaesthesia
Clinical narrative: face got numb, rapid heart beat both lasted about 2 min. Felt weak the rest of the day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Lethargy, Nausea, Oxygen saturation decreased, Vomiting
Clinical narrative: Patient said 4 hours after shot, she had nausea, vomitting, shortness of Breath, lethargic. Her pulse ox dropped to 80. She went to ER to Rule out Food poisoning. She said she Felt like she was having a heart attack. ER MD told her it must have been the flu shot.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Hives reported 9/16/2020 10AM Benadryl 50mg po Every 6 hours
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills. Headache fever - 103. fatigue Bodyaches.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Mom called our office to report that developed local hives at site of vaccine about 8 hours after admin. Resolved with Benadryl
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient got Shingrix vaccine on 9/19/2020. Right arm Patient returned to pharmacy to report reaction near the injection site. Site slightly larger than silver dollar, was red, warm, tender, & "hard or lumpy" under skin. Patient will monitor, and go to urgent care if necessary
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Semi numb tongue, hive face, (swelling of face, hands, arms, feet, ankles, legs).
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called because there was a large circular area around the injection site that was red + swollen. I recommended she be seen by a physician.
Age: 1.42
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash on face and abdomen
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Pruritus, Swelling, Urticaria
Clinical narrative: Hives (red) swelling - Left side by neck. Diarrhea, Itching in chest by hives Reported to Doctor Friday. Doctor instructions are to purchase Benadryl Liquid 25 mg and Benadryl Cream for itching on 10/9/20.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of a sore arm after receiving vaccination. He says that he cannot lift arm.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Disorientation, Myalgia, Nausea, Tremor
Clinical narrative: Starting around 3pm day of injection patient experienced uncontrollable shakiness, muscle aches, nausea and vomiting and patient seems disoriented and confused. This continued throughout the night into the following day. At point of last contact (morning of 10/10/2020) the patients daughter was reaching out to patients physician for further guidance.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Starting around 3pm day of injection patient experienced uncontrollable shakiness, muscle aches, nausea and vomiting and patient seems disoriented and confused. This continued throughout the night into the following day. At point of last contact (morning of 10/10/2020) the patients daughter was reaching out to patients physician for further guidance.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Dysstasia
Clinical narrative: knee pain Not able to stand admitted x 2 weeks
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Swelling, cellulitis L arm
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Administered in (L) Delt. Patient has had residual soreness x 1 month following including restricted range of motion. Pt believes immunization was given too high.
Age: 10.0
Sex: F
Vaccine: MMRV
Symptoms: Exposure to vaccinated person, Varicella
Clinical narrative: Pt. believed to get varicella from sibling that received MMRV on 9-11-20 Pt fully immunized.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented w/RA red, swollen, itchy,  warm to touch at injection site. Could feel a knot.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother states patient reacted the day after vaccine was administered. Swollen and redness was notice around the injection site. Cold compresses for further treatment.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Localised infection, Peripheral swelling
Clinical narrative: Patient arm was red and swollen from the shot from Saturday afternoon. She went to the doctor on Tuesday morning as swelling and red did not go down. Doctor told her it was a localized infection from a flu shot, for her to take benadryl, ice the area, and rest. If the area expanded or patient developed fever she was to return to the doctor. We called the patient back on Thursday 10/8 and she was doing much better and did not need to return to the doctor.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: Patient developed cellulitis that was resolved using Cephalexin 500mg, 1 capsule three times daily for 7 days. The rash resolved within 3 days of starting the cephalexin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling, Urticaria
Clinical narrative: Upon injection patient states it felt like vaccine was running down her arm. (It was not) Redness, soreness, hives. 1 week later hives reappeared in different location on arm. Swelling again. Felt like fever broke and then all symptoms were gone.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Angiogram normal, Blood creatine phosphokinase, C-reactive protein, Computerised tomogram head normal, Full blood count
Clinical narrative: Child was not responsive; The patient was listless.; Information was obtained on request by the Company from the FDA (VAERS # 839114) under the Freedom of Information Act on 25-SEP-2020. Information has been received from a nurse, referring to a 13-year-old male patient. There was no allergies to medications, food or other products. There was no other illness at the time of vaccination and up to one month prior. There was no prescription, over-the-counter medications, dietary supplements or herbal remedies being taken at the time of vaccination. It was unknown if the patient had had an adverse event following any previous vaccine. Chronic or long standing health conditions included autism and unspecified sensorineural hearing loss.   On 04-OCT-2019 A.M., the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R021633, expiration date not reported, but upon internal validation established as 08-MAY-2021; strength and dose were unknown) intramuscularly in the right arm for prophylaxis.  On 04-OCT-2019, at 10:25, within a few minutes after vaccination, the patient's parent came out of room and advised that child was not responsive. When provider and staff entered room, patient was listless. 911 was called. The patient was sent to an emergency room/ department or urgent care and transferred to hospital for 3 days. On an unknown date in October 2019, computed tomography (CT) without (w/o) contrast brain/ head was negative. On an unknown date in October 2019, CT angiography brain and neck was negative. Complete blood count (CBC), C-reactive protein (CRP), basic metabolic panel (BMP) and creatine phosphokinase (CPK) were done but no results were provided. The outcome of the events was unknown. The causality assessments between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events were unknown.  Follow-up has been received from a chief compliance officer on 09-OCT-2020. The reporter was able to "backtrack" and locate the details of the report and stated that the registered nurse and physician involved were no longer employed by the facility, so she was unsure how much information she would be able to provide. The patient was still a patient at the facility. The reporter would gather and return more information after locating the patient's chart. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R021633; expirationdate: 08-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Listless, Metabolic function test, Unresponsive to stimuli
Clinical narrative: Child was not responsive; The patient was listless.; Information was obtained on request by the Company from the FDA (VAERS # 839114) under the Freedom of Information Act on 25-SEP-2020. Information has been received from a nurse, referring to a 13-year-old male patient. There was no allergies to medications, food or other products. There was no other illness at the time of vaccination and up to one month prior. There was no prescription, over-the-counter medications, dietary supplements or herbal remedies being taken at the time of vaccination. It was unknown if the patient had had an adverse event following any previous vaccine. Chronic or long standing health conditions included autism and unspecified sensorineural hearing loss.   On 04-OCT-2019 A.M., the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R021633, expiration date not reported, but upon internal validation established as 08-MAY-2021; strength and dose were unknown) intramuscularly in the right arm for prophylaxis.  On 04-OCT-2019, at 10:25, within a few minutes after vaccination, the patient's parent came out of room and advised that child was not responsive. When provider and staff entered room, patient was listless. 911 was called. The patient was sent to an emergency room/ department or urgent care and transferred to hospital for 3 days. On an unknown date in October 2019, computed tomography (CT) without (w/o) contrast brain/ head was negative. On an unknown date in October 2019, CT angiography brain and neck was negative. Complete blood count (CBC), C-reactive protein (CRP), basic metabolic panel (BMP) and creatine phosphokinase (CPK) were done but no results were provided. The outcome of the events was unknown. The causality assessments between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events were unknown.  Follow-up has been received from a chief compliance officer on 09-OCT-2020. The reporter was able to "backtrack" and locate the details of the report and stated that the registered nurse and physician involved were no longer employed by the facility, so she was unsure how much information she would be able to provide. The patient was still a patient at the facility. The reporter would gather and return more information after locating the patient's chart. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R021633; expirationdate: 08-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: entire arm down to fingers were swollen; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age.  The patients concurrent conditions, pertinent medical history or concomitant medications were not reported.  On 28-SEP-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) given intramuscularly,  (dose number, anatomical location of administration, lot# or expiration date were not provided) for prophylaxis.   Pharmacist states that within 3 hours of the vaccine being administered the patient's entire arm down to her fingers were swollen, lasting 4 days (peripheral swelling). It was mentioned that the patient went to the urgent care but no further information was received.    The outcome of peripheral swelling was unknown. The causal relationship between vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and peripheral swelling was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin burning sensation
Clinical narrative: entire arm down to fingers were swollen; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age.  The patients concurrent conditions, pertinent medical history or concomitant medications were not reported.  On 28-SEP-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) given intramuscularly,  (dose number, anatomical location of administration, lot# or expiration date were not provided) for prophylaxis.   Pharmacist states that within 3 hours of the vaccine being administered the patient's entire arm down to her fingers were swollen, lasting 4 days (peripheral swelling). It was mentioned that the patient went to the urgent care but no further information was received.    The outcome of peripheral swelling was unknown. The causal relationship between vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and peripheral swelling was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: entire arm down to fingers were swollen; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age.  The patients concurrent conditions, pertinent medical history or concomitant medications were not reported.  On 28-SEP-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) given intramuscularly,  (dose number, anatomical location of administration, lot# or expiration date were not provided) for prophylaxis.   Pharmacist states that within 3 hours of the vaccine being administered the patient's entire arm down to her fingers were swollen, lasting 4 days (peripheral swelling). It was mentioned that the patient went to the urgent care but no further information was received.    The outcome of peripheral swelling was unknown. The causal relationship between vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and peripheral swelling was not reported.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: the consumer got a rash "a few inches below the injection site"; This spontaneous report was received from a registered pharmacist and refers to a 66-year-old female patient. The patient's concurrent conditions included hypothyroidism and latex allergy. Her concomitant medications included levothyroxine sodium, paroxetine hydrochloride (PAXIL) and unspecified medication reported as "CLONA VETAN". No information regarding the patient's medical history and drug reactions was provided.   On 06-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) 0.5 milliliter injection, lot # T021485 was confirmed to be valid, expiration date 15-MAR-2022 (exact route and site of administration were not provided), for prophylaxis (reported as "she is 66 so it was recommend for her age").  On 07-OCT-2020, the patient experienced a rash a few inches below the injection site (localized rash). It was reported that there were no fever and no pain or tenderness at inaction site. She sought a medical attention, but had no laboratory diagnostics performed. A cephalexin (KEFLEX) was prescribed as a treatment. The outcome of localized rash was reported as not recovered at the reporting time.  The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV, PPV
Symptoms: Injection site rash, Rash
Clinical narrative: the consumer got a rash "a few inches below the injection site"; This spontaneous report was received from a registered pharmacist and refers to a 66-year-old female patient. The patient's concurrent conditions included hypothyroidism and latex allergy. Her concomitant medications included levothyroxine sodium, paroxetine hydrochloride (PAXIL) and unspecified medication reported as "CLONA VETAN". No information regarding the patient's medical history and drug reactions was provided.   On 06-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) 0.5 milliliter injection, lot # T021485 was confirmed to be valid, expiration date 15-MAR-2022 (exact route and site of administration were not provided), for prophylaxis (reported as "she is 66 so it was recommend for her age").  On 07-OCT-2020, the patient experienced a rash a few inches below the injection site (localized rash). It was reported that there were no fever and no pain or tenderness at inaction site. She sought a medical attention, but had no laboratory diagnostics performed. A cephalexin (KEFLEX) was prescribed as a treatment. The outcome of localized rash was reported as not recovered at the reporting time.  The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: Felt like I had the flu for 3 days after the shot. I had a flu shot in the left arm at the same time, but no reaction to it (never had a previous reaction to flu shot for many years prior).  Had headache, body aches, feverish, and sore right bicep muscle.  Flu-like symptoms went away after 3 days, but  right bicep has large red sore area after 4 days.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Felt like I had the flu for 3 days after the shot. I had a flu shot in the left arm at the same time, but no reaction to it (never had a previous reaction to flu shot for many years prior).  Had headache, body aches, feverish, and sore right bicep muscle.  Flu-like symptoms went away after 3 days, but  right bicep has large red sore area after 4 days.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The day after receiving shot, patient had pain in pneumovax 23 shot given arm, and had extreme difficulty moving arm, especially laterally upward motion.  Patient needed help in doing simple motions such as raising arm enough to place purse over shoulder.  This continued to hinder her, gradually getting better, over the next three days, until it was back to normal around day 4 (with around 3 total days where full motion/pain free) of arm was felt.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: The patient received improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed practice nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On an unspecified date in August 2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, lot # T000702 with expiration date 01-OCT-2021, route was not reported) for prophylaxis.       The vaccine experienced improperly stored and was stored at above 9 degree Celsius (13.4 degree Celsius) for 51 hours and 36 minutes. There was no previous temperature excursion. The call was because of a data logger involved.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: not a rash, did not look inflamed, and looked like red blotches with circles around them; This spontaneous report was received from a pharmacist referring to a 73 years old female patient. The patient had no drug reactions/allergies. Information about medical history, concurrent conditions and concomitant therapies were not provided.    On 22-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T016160, expiration date 13-FEB-2022; dose and route were not reported) for prophylaxis.    On 24-SEP-2020, the patient experienced red blotches with circles around them, not a rash, did not look inflamed. It was reported that the skin issue was localized to the same arm of administration. On the same day (reported as 2 days after the vaccination), the patient went to pharmacy and did not go to the emergency room (ER) or hospital. The patient received topical hydrocortisone cream for the event. The outcome of the event unknown. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016160; expirationdate: 13-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent