chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: Vaccine given at onsite workplace clinic at 8:50 am. 20 minutes after vaccination patient reports becoming dizzy. 30 minutes after vaccination he became very nauseous and had 2 episodes of dry heaving. He went home from work around 10:10 am and reported increasing dizziness and nausea at this time as well has body aches and feeling "feverish." By 2 pm he reported vomiting 4-5 times. He reported having a 100 degree F fever and took some TYLENOL. Later in evening he went to the ER because he could not stop vomiting and was in severe pain all over and was hypersensitive to physical stimulus. He was given fluids and antiemetics and had bloodwork done. Was given prescription for ZOFRAN and was sent home. The next day he reported he was feeling a bit better because the ZOFRAN was decreasing his nausea and he was less achy than before but he still is running a temp of 99-100.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a Registered Nurse, via a company representative, referring to a 71 year old female patient. The patient did not have medical history, concurrent conditions or concomitant therapies. On an unspecified date in September 2017 (also reported as "in the last 2 weeks"), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N011305, expiration date of 20-JAN-2019, intramuscularly (dose, anatomical location and expiration date were not reported) for prophylaxis. On an unknown date in September 2017 (reported as "within a day of receiving the vaccine"), the patient developed cellulitis. The reporting registered nurse stated that on an unspecified date, the patient was examined and treated with unspecified antibiotics at the facility. The outcome of the cellulitis was reported as recovering and the causality between the vaccination with and the event was not reported. Upon internal review, the cellulitis was considered as a medically significant event. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA001897: US-009507513-1710USA001898.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 63 year old male patient with diabetes mellitus, blood cholesterol increased and hypertension. The patient had not drug reactions nor allergies. On 27-SEP-2017, the patient was vaccinated with 0.5 ml of PNEUMOVAX 23 (lot # N019348, expiration date 08-FEB-2019) intramuscularly, for the prevention of pneumococcal disease (prophylaxis). Concomitant medications were not reported. On 28-SEP-2017 (reported as: the morning after receiving the vaccine), the patient reported having swelling at the injection site. Then, it was reported that the patient went to an unspecified clinic and was treated for cellulitis.  At the time of the report, the outcome of cellulitis and injection site swelling was reported as recovering. The relatedness assessment between PNEUMOVAX 23 and cellulitis and injection site swelling was not provided. Upon internal review, cellulitis was considered to be medically significant.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a Registered Nurse, via a company representative, referring to a 70 year old female patient. The patient did not have medical history, concurrent conditions or concomitant therapies. On an unspecified date in September 2017 (also reported as "in the last 2 weeks"), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N011305, expiration date of 20-JAN-2019, intramuscularly (dose, anatomical location and expiration date were not reported) for prophylaxis. On an unknown date in September 2017 (reported as "within a day of receiving the vaccine"), the patient developed cellulitis. The reporting registered nurse stated that on an unspecified date, the patient was examined and treated with unspecified antibiotics at the facility.  The outcome of the cellulitis was reported as recovering and the causality between the vaccination with and the event was not reported. Upon internal review, the cellulitis was considered as a medically significant event. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA001898: US-009507513-1709USA014175.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a Registered Nurse, via a company representative, referring to a 71 year old female patient. The patient did not have medical history, concurrent conditions or concomitant therapies. On an unspecified date in September 2017 (also reported as "in the last 2 weeks"), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N011305, expiration date of 20-JAN-2019, intramuscularly (dose, anatomical location and expiration date were not reported) for prophylaxis. On an unknown date in September 2017 (reported as "within a day of receiving the vaccine"), the patient developed cellulitis. The reporting registered nurse stated that on an unspecified date, the patient was examined and treated with unspecified antibiotics at the facility. The outcome of the cellulitis was reported as recovering and the causality between the vaccination with and the event was not reported. Upon internal review, the cellulitis was considered as a medically significant event. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA014175: US-009507513-1710USA001897.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 70 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 03-OCT-2017 (reported as yesterday), the patient was vaccinated with an expired dose of ZOSTAVAX injection, 1 dosage form (reported as one shot) (route and site of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. No further information was provided. Product quality complaint was not involved.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Contusion, Mobility decreased, Pain
Clinical narrative: Bruise size of quarter, burning sensation, soreness, difficulty in moving.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: SMALL PATCH OF REDNESS 2 INCHES FROM INJECTION SITE APPEARED ONE DAY AFTER, CURRENTLY RED PATCH HAS EXPANDED TO 6X3 INCHES, ITCHING PRESENT.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Hypoaesthesia, Paraesthesia oral, Tongue disorder
Clinical narrative: Pt. return to flu clinic with complaints of tongue "thickening" and tingling sensation. Pt. was given 25MG of BENADRYL (liquid) at 3:01PM and then given 25MG of BENADRYL at 3:05PM also liquid. Pt. was observed for 1 hour with watching pt. oxygen and pulse rate and observing pt. breathing. Pt. denied any SOB. We consult via telephone with our medical director who advised us to administer BENADRYL and observe pt. At time 4:00PM pt. was stated that she was feeling better. Pt. was advised that if symptoms return to call 911 and to contact her PCP. Pt. voiced understanding. I spoke to pt. today (10/05/17) via telephone and she states that she woke up with headache this morning, still has tingling in the corner of her mouth, and fingertips are a little numb. Pt. states that she has contacted her PCP and he advised to not get flu vaccine anymore and to start taking ALLEGRA and stop ZYRTEC.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pain in extremity, Tenderness
Clinical narrative: Small red area at injection site on left arm; not raised. Additional red not raised area 2 inches below injection site measuring 1 cm x 5 cm (left arm). Whole left arm is tender and aches.
Age: 1.42
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine was removed from the freezer. Staff member thought she grabbed MMR but grabbed Proquad instead. Patient was monitored for approximately 20 minutes after vaccine was given for any reactions. No reactions were noted. Parents informed of mistake and advised to watch for any signs of increase of fever. Instructed to call our office with any concerns.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Anti-ganglioside antibody, Areflexia, Asthenia, Back pain, CSF glucose normal
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative, Condition aggravated, Cytomegalovirus test negative
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness, Diarrhoea, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Endotracheal intubation, Facial paresis, Feeding disorder, Guillain-Barre syndrome
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: HIV test negative, Hypertension, Hypothyroidism, Immunoglobulin therapy, Mobility decreased
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging spinal abnormal, Peripheral nerve decompression, Plasmapheresis
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory loss, Trigeminal neuralgia, Vomiting, West Nile virus test negative
Clinical narrative: Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Skin warm, Tenderness
Clinical narrative: Erythema 15 cm x 17 cm over the dorsal aspect of left arm, extending from injection site. Increased warmth, mild tenderness. No abscess.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Large area of erythema and swelling. Three days after the vaccine it's 11 x 16 cm.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Aphonia, Dizziness, Injection site reaction, Oropharyngeal pain, Pain
Clinical narrative: When I came home, I was running a fever, dizzy, sore throat and lost my voice, developed a rash on my right side, body aches. Today I have about a 2?x1? welt at the site of injection and my arm is so sore I can barely move it.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Rash, Urticaria
Clinical narrative: When I came home, I was running a fever, dizzy, sore throat and lost my voice, developed a rash on my right side, body aches. Today I have about a 2?x1? welt at the site of injection and my arm is so sore I can barely move it.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient loss consciousness seconds after shot was administered. He woke up 5 seconds after stating that he was just sleeping. He was seen by his Provider, and was sent home with mother. Patient was doing ok at this time with no symptoms.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-10-02.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever of 103. No other symptoms.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PPSV23 on 10/4/17 in the AM, by the same afternoon patient noted arm to be swollen, painful, warm, and red area covering his whole shoulder area. Had improved by 10/5/17 but still red rash present.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Patient received PPSV23 on 10/4/17 in the AM, by the same afternoon patient noted arm to be swollen, painful, warm, and red area covering his whole shoulder area. Had improved by 10/5/17 but still red rash present.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, UNK
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2017-10-02.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Crying, Hyporesponsive to stimuli, Musculoskeletal stiffness, Pyrexia
Clinical narrative: It was so long ago but I'm reporting now because I just recently learned that, even though we told the Dr. (she was wonderful), that doesn't necessarily mean it was reported to the CDC. That shocked me. We've since moved and have a new pediatrician. On the day he received the DTaP (which Nurse though was most likely the culprit of his reaction) Patient also received HepB, HIB, & PCV7. Within 20-30 minutes patient's demeanor was entirely changed. His eyes became wide, his legs and arms stiff and straightened in his car seat. He became minimally responsive in affect and appeared to be in a state of shock. Patient was highly articulate and expressive at this age and it was disturbing to see him identifiably altered. He appeared to be unable to respond to my initiated interactions of any kind--again, it looked like a serious state of shock. When we arrived home approximately 20 minutes later, patient began wailing. Though a very content, carefree child, he was virtually inconsolable for approximately 24 hours without many interruptions. He alternated between loud wailing to exhausted crying. He cried almost the entire night with very brief periods of dozing before waking alarmed again and wailing. It was incredibly disconcerting and disturbing. Patient ran a slight fever during this time as well which concerned us much less than the other reaction. If I remember correctly we called the pediatrician's office the next day and he was seen either one or two days after the vaccine. By the time he was seen in the office again, his crying had tapered significantly though he was still very upset off and on. It was a horrifying two days and we both feared he could have been permanently damaged. Thankfully, we observed no long term side effects and his behavior was basically normalized within several days.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin reaction, Skin warm
Clinical narrative: Local skin reaction 8 X 5 1/2 cm errythema. Slightly warm to touch. No induration and no streaking.  Treated with cool compresses and monitoring. No medication prescribed.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Local erythema 4.5x6.5 cm about injection site, tenderness, mild swelling & itching.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Muscle disorder, Neuralgia, Pain in extremity
Clinical narrative: Patient had arm pain that was substantial, followed by partial immobility and limited range of motion of the injection arm. States feels like nervous system pain or muscular impairment.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pruritus
Clinical narrative: INTENSE ITCHING AND REDNESS NEAR INJECTION SITE LASTING A 2 HOURS (PATIENT WAS GIVEN BENADRYL 50MG AND APPLIED ICE PACK TO AREA.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Influenza like illness, Pyrexia, Rash
Clinical narrative: Flu-like symptoms, fever, chills and rash in right underarm.
Age: 53.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea, Pyrexia
Clinical narrative: Patient c/o headache and nausea at 7:00 PM on day of administration. Next day c/o Pain at injection site of left arm, could not move arm, and temperature 101. 3rd day Patient states she took Tylenol and fever went away, she could move arm better. 4th day all symptoms went away.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Injection site erythema, Pyrexia
Clinical narrative: Patient stated she started running 102 degree fever the evening of the vaccination (2 days ago). Her injection site has progressively gotten bigger and redder since that day. She tried ice, OTC pain reliever (Tylenol/Ibuprofen), and oral and topical Benadryl, none of which helped the side effects. She is sweating today.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Patient's arm is red and inflamed. Patient is not worried and will monitor for worsening symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day following injection, patient developed redness and swelling around injection site, spreading to upper arm and bicep. Came to pharmacy a day later, and said it was improving. Told her to continue to monitor it, and if it gets worse or doesn't continue improving, to seek medical attention.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt presented for influenza vaccine. IM vaccine was given in the left deltoid. Pt tolerated the vaccine well and was then observed for 15 minutes for any adverse reactions. Pt called the office 2 1/2 hours after receiving the vaccine and states that approximately an hour after receiving the vaccine, he developed severe left shoulder pain and difficulty moving his arm. With being a rare but potential reaction from the vaccine as listed on the VIS form, pt was advised to apply an ice pack to the area and take ibuprofen for the discomfort. A follow up phone call was attempted the next day, but a return call was not made.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Rash papular, Skin reaction, Skin warm
Clinical narrative: Local skin reaction. 10 X 8 1/2 cm mildly warm to touch. Errythema throughout with increased errythema at the edge along with a mild papular nonvesicular, nonpustule rash noted. Benadryl recommended prn, cool compresses. No medication prescribed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Child given MMRV and Varicella. Medical Assistant that administered immunizations thought she was giving MMR and Varicella separate. Child got two doses of Varicella.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, muscle aches from groin to back of head, headache. Blood.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain in extremity
Clinical narrative: I felt faint 10 minutes after the shot (that came on quickly), then felt slightly dizzy, but after a couple of hours felt okay. Last night and today - noticeable soreness in left arm. Slight chills today (can't quite get warm). I am not sure about the type of flu shot (there were many listed) and definitely don't know the manufacturer.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Upper arm turned pink, warm and slightly painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red indurated area 3 in x 1 in around injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Asthenia, Injection site erythema, Injection site induration, Pain
Clinical narrative: Information has been received from a 56 year old female patient reporting on herself. The patient had no concurrent conditions or pertinent medical history. The patient's or concomitant medication included aspirin (manufacturer unknown) and losartan potassium (manufacturer unknown). On 23-SEP-2017, the patient was vaccinated with ZOSTAVAX for preventing shingles (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in September 2017, after the administration of ZOSTAVAX the patient experienced injection site redness and it was hard. She had a tingle on the left side of her face and it was also swollen. She also said that her left side intestines were swollen (abdominal distension). She was taking acetaminophen (TYLENOL) and Ibuprofen for the pain. Also her body felt weak like she was about to have a fever (asthenia). The patient reported that no lab diagnostics/studies were performed and she did not sought medical attention. The outcome of injection site erythema, paraesthesia, pain, abdominal distension, swelling face, asthenia and injection site induration was reported as not resolved. The causal relationship between the aforementioned events and therapy with ZOSTAVAX was not reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Information has been received from a 56 year old female patient reporting on herself. The patient had no concurrent conditions or pertinent medical history. The patient's or concomitant medication included aspirin (manufacturer unknown) and losartan potassium (manufacturer unknown). On 23-SEP-2017, the patient was vaccinated with ZOSTAVAX for preventing shingles (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in September 2017, after the administration of ZOSTAVAX the patient experienced injection site redness and it was hard. She had a tingle on the left side of her face and it was also swollen. She also said that her left side intestines were swollen (abdominal distension). She was taking acetaminophen (TYLENOL) and Ibuprofen for the pain. Also her body felt weak like she was about to have a fever (asthenia). The patient reported that no lab diagnostics/studies were performed and she did not sought medical attention. The outcome of injection site erythema, paraesthesia, pain, abdominal distension, swelling face, asthenia and injection site induration was reported as not resolved. The causal relationship between the aforementioned events and therapy with ZOSTAVAX was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Herpes zoster, Neuritis, Ocular discomfort
Clinical narrative: This spontaneous report was received from a currently 61 year old patient referring to herself. The patient didn't have medical history or drug reactions/allergies to be reported. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX for prophylaxis (route, lot number, and expiration date were not provided). Concomitant medications included thyroid medicine, one tablet, daily (details unspecified). On an unknown date (reported as "a few months ago") the patient got shingles  even though she had the ZOSTAVAX vaccine 2 years ago. She further stated that her face was itching and hurting due to the swelling. The patient also had horrible headaches so she could not hold her head up or even talk. Also, on an unknown date, the patient had discomfort in her eyes and went to see an eye doctor where he told her that her nerves were swollen which was the reason why she was experiencing headaches. She also stated that she was more affected on the right side of her face and also had some on her back and leg, but they eventually went away. She then further stated that it hurt so bad that she could not sit or even brush her hair. Her doctor did prescribe: Gabapentin (100mg, 3 times a day), Famciclovir (3 times, a day), and also Calamine (which was "helping and clearing them up a little") (details unspecified). The patient's outcome for the aforementioned events was not recovered. The causality assessment between suspect therapy and reported adverse events was unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Pruritus, Speech disorder, Swelling face, Vaccination failure
Clinical narrative: This spontaneous report was received from a currently 61 year old patient referring to herself. The patient didn't have medical history or drug reactions/allergies to be reported. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX for prophylaxis (route, lot number, and expiration date were not provided). Concomitant medications included thyroid medicine, one tablet, daily (details unspecified). On an unknown date (reported as "a few months ago") the patient got shingles  even though she had the ZOSTAVAX vaccine 2 years ago. She further stated that her face was itching and hurting due to the swelling. The patient also had horrible headaches so she could not hold her head up or even talk. Also, on an unknown date, the patient had discomfort in her eyes and went to see an eye doctor where he told her that her nerves were swollen which was the reason why she was experiencing headaches. She also stated that she was more affected on the right side of her face and also had some on her back and leg, but they eventually went away. She then further stated that it hurt so bad that she could not sit or even brush her hair. Her doctor did prescribe: Gabapentin (100mg, 3 times a day), Famciclovir (3 times, a day), and also Calamine (which was "helping and clearing them up a little") (details unspecified). The patient's outcome for the aforementioned events was not recovered. The causality assessment between suspect therapy and reported adverse events was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain, Paraesthesia, Peripheral swelling, Varicella zoster virus infection
Clinical narrative: This initial spontaneous report was received on 03-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 04-JUN-2013, at a pharmacy, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract the varicella virus and a host of painful and life-altering complications. On or about 14-MAY-2015, the female patient began treatment with a physician at a medical practice, for painful burning, swelling and tingling in her feet and legs, which was diagnosed as severe peripheral neuropathy, secondary to varicella zoster infection (shingles). Peripheral neuropathy is a chronic condition of permanent damage to the peripheral nervous system that can affect and impair every part of the body, including causing internal organs to fail. Peripheral neuropathy also causes abnormal sensitivity, or lack of sensation that results in excruciating burning and pain. The patient has been prescribed valacyclovir (VALTREX) and gabapentin in continued and incrementally increased dosages for management of her ongoing symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX. Upon internal review, diagnosed as severe peripheral neuropathy, secondary to varicella zoster infection (shingles) were determined to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 29-SEP-2017, the patient was mistakenly vaccinated with VARIVAX with lot number M015735 and expiration date on 30-MAR-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). No adverse effects were reported.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Tenderness
Clinical narrative: Patient reported bruise on vaccinated arm (left) the size of a baseball with tenderness. No other reported common symptoms (denies fever, headache, nausea). Patient was vaccinated around 11:30am 9/29/2017 and first reported symptoms to pharmacy 4:28pm 10/5/17. First noticed bruising 10/4/17 when husband noticed her arm.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Feeling hot
Clinical narrative: At 3pm, five minutes after administration of vaccinations, the patient stated she was feeling warm and slight lightheadedness. I provided her with water and a granola bar. She had no local reaction at site of injections. I paged her primary care physician, but no answer. After 25 more minutes at 3:30pm, she refused any medical treatment by store management and stated she felt completely better.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful injection. Nine days after, patient developed increase in tenderness and warmth at injection site. By 10/5, the area was still tender to touch with a slight fullness at the injection site.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: NOTED ON 10/03/2017 WHEN MOTHER PRESENTED TO OFFICE FOR POLIO INJECTION THAT THE VACCINES WERE GIVEN EARLIER THAN RECOMMENDED ON 8-22-2017. CHILD DID NOT EXPERIENCE ANY ADVERSE REACTION, NO COMPLAINT VOICED FROM PARENT REGARDING ANY SIDE EFFECTS. MOTHER'S ONLY CONCERN WAS THE CHILD GOING TO HAVE ANY PROBLEMS RELATED.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Very sore arm the next day, aches in all muscles, extremely fatigued.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Her arm swelled very large as soon as I finished injection. I gave her an ice pack, a 10mg loratadine, and 2 ibuprofen 200mg tabs. She sat for 15 minutes swelling had gone down slightly at that time.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, Myalgia
Clinical narrative: Patient was vaccinated 9/29/17 at approximately 11:45am with AFLURIA. He called the pharmacy to report side effects/adverse reactions 10/4/17. Both he and his wife report having a different reaction after having their flu shots this year. He continues to have muscle soreness and is complaining of nosebleeds he attributes to the vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Severe swelling from shoulder to elbow, redness, burning, and hot to the touch in the area of the injection. This increased in severity each day until I was prescribed an antibiotic to control. At this time there is significant dry skin with peeling in the area of the injection.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Skin exfoliation
Clinical narrative: Severe swelling from shoulder to elbow, redness, burning, and hot to the touch in the area of the injection. This increased in severity each day until I was prescribed an antibiotic to control. At this time there is significant dry skin with peeling in the area of the injection.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Rash, Rash generalised, Rash maculo-papular, Rash pruritic
Clinical narrative: The following morning after the influenza vaccine, the patient awoke with widespread rash to trunk, extremities and neck that was pruritic. Rash was maculopapular and widespread. Patient was instructed to take BENADRYL and that likely it was not an allergic reaction but an immune reaction to the virus. She was informed she could receive the flu vaccine again in the future. No other history of immunization reactions to the patient who was 35 weeks pregnant and had received flu vaccines in the past. No other known exposures to suggest causing the rash.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site bruising, Injection site haemorrhage, Injection site pain, Paraesthesia
Clinical narrative: VERY PAINFUL INJECTION SITE, BRUISED, NUMBNESS IN ARM AND TINGLING DOWN TO FINGERS. BLEED A LOT AFTER THE SHOT.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient presents at 4pm with hives. States noticed rash appear at around 11am. Flu vaccine most likely administered at 8:30 am today. Admits to pruritus. Denies OTC medications attempted. Denies SOB, wheezing, and retractions with breathing no other concerns.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rash pustular
Clinical narrative: Mild, but notable for potential research purposes: Overall achy, mild fever, sore throat, visible pus nodules in throat. I've always had flu shots and generally trust them. I've never had mild fever and pus nodules in the throat after a flu shot before.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue, headache, muscle aches, nausea, temperature of 99 degrees Fahrenheit.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt received also PNEUMOVAX 23 N012127/01/2019 in the right arm at her request. Pt reported redness, soreness, swelling, and skin feeling hot.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Extreme pain in left arm by 10:00 same say as immunization. Woke up next day with high fever and rash all over body head to knees. Left arm extremely red and swollen- patient states that she had trouble moving her arm up.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash generalised
Clinical narrative: Extreme pain in left arm by 10:00 same say as immunization. Woke up next day with high fever and rash all over body head to knees. Left arm extremely red and swollen- patient states that she had trouble moving her arm up.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness, swelling of upper left arm-nausea.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient went to store on 10/4/17 and had the pharmacist on duty look at the injection site which was raised and red around it. Pharmacist told her to watch and to make sure it didn't spread. Pt stopped in again on 10/5/17 and had other pharmacist look at it, stated that it seemed to be going down but still watch it and if not better go see the doctor.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Blindness unilateral, Ophthalmological examination normal
Clinical narrative: Patient states she lost vision in the left eye approximately 10 minutes after receiving the vaccine for about 10 minutes. She states she sat and waited for her vision to return. She has not had this reaction before to a vaccine. I instructed her to call her physician to be sure there wasn't any thing else they wanted her to do. She did go to an eye doctor for exam and he didn't find anything wrong with her eye .
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Painful redness.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Big red bump and painful.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Wheal over injection site noticed the next day, approximately 3.5 x 4.5 cm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Hallucination, Laboratory test, Screaming
Clinical narrative: Symptoms: hallucination, tired, weakness, scream in her sleep. Treatment: patient went to urgent care and later was seen by primary care physician for lab work. Her primary doctor prescribed her sleep aid and electrolytes.
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Patient is 55 years old, and was inadvertently immunized with FLUAD for patients 65+ instead of FLUCELVAX QUAD due to two very similar syringes placed in readiness next to one another. Patient was advised of error, and reports no problems or issues - she was instructed to contact the pharmacy should any adverse events occur.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Patient visited primary physician for a skin reaction around injection site.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash on torso front and back, itchy, red.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Breast pain, Musculoskeletal pain, Myalgia
Clinical narrative: Patient's husband called on Saturday 09/30/2017 to ask if anyone else had reported muscle pain due to the flu shot. He stated patient was having shoulder pain and pain in/and around the upper breast area. He stated she didn't recall pulling a muscle but it felt that way. He also stated that he had his shot the same day at a later time, I also administered his, and he was feeling fine without any pain. I asked them to call me if they needed anything and offered to follow up Monday. I called on Monday 10/02/2017 and husband answered the phone. He stated patient had a bad weekend but didn't go to a urgent care even though he suggested it. He stated she went to school (she's a teacher) on Monday and was going to try to make it through the day. I asked him/them to please call with anything they needed and to follow up with me. No one called between Monday 10/02/2017 and Thursday 10/05/2017. I tried to reach them again this evening, no one answered.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT FEELS DIZZY, LEFT ARM WHERE SHOT GIVEN HAS MEDIUM SIZE REDNESS AND SWELLING.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Localised infection
Clinical narrative: Patient arrived at pharmacy on 10/5/17 to pick up antibiotics being sent in from dr. Pt had flu and pneumonia vaccinations given on 10/3/17, and said that her arm steadily kept turning red over the next days. The red part kept getting bigger and bigger until she went to the dr. Dr says it is an infection, rather than a reaction and gave her antibiotics.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Injection site swelling, Pain
Clinical narrative: Swelling of arm around injection site, pain, bruising. FLUZONE HD vaccination administered in other arm.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Symptoms: tired, flu-like symptoms.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Patient reports itchy rash without difficulty or pain in moving arm on injected side. Rash appears roughly 4 to 5 inches in diameter.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Pt arm swelled up right after needle was pulled out and a bruise formed. We had her wait around for 20-30 minutes recommended her to take BENADRYL and ice arm when she got home. Pt felt fine swelling went down before she left. Told her it takes up to 24 hours for an allergic reaction and to have someone watch her and to go to ER if breathing issues happen.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Right arm pain and swelling, Right arm with TPP, surrounding superficial erythema without warmth, no abscess formation. Pt. was advised to use cool compresses 4-6 times a day, Tylenol 500mg every 6 hours as needed for pain. RTC is pain worsens, fever or chills or increase in swelling.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Symptom onset started the day after the injection (Sunday), she complained of severe arm pain with some associated joint pain in the shoulder. She was instructed to take Naproxen OTC 2 tablets to start then 1 every 12 hours until feeling better, take TYLENOL 500 mg, 2 tablets every 6 hours (max 4000 mg /24 hours) and to ice the injection site. This was started on Sunday in the evening. Patient was called Monday for follow up and stated she was feeling better, but still sore, followed up on Thursday, and stated that she was still feeling better, but still sore.