chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored rotateq was inadvertently administered to the one patient; No adverse effects; This spontaneous report as received from a medical assistant refers to a patient of unknown age, gender and ethnicity. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-NOV-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1658256; expiration date: 18-NOV-2020; dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in above 9 Celsius degrees (9.4 Celsius degrees) within 20 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002735: US-009507513-1911USA002785: US-009507513-1911USA002713: US-009507513-1911USA003116:
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: tell us about the route of pneumococcal vaccine in thigh of a two and half months baby; This spontaneous report as received from a physician and refers to a two and a half month patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) in the tight, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter was wondering if the route of administration should be intramuscular or subcutaneous.
Age: 68.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects; a 68 year old patient received a dose of PROQUAD; This spontaneous report was received from a nurse regarding a 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2018, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, exact dose, route of administration, lot number and expiration date were not reported) for prophylaxis during an office visit (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaints were involved.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood test, Migraine, Speech disorder
Clinical narrative: pt said thought was having a migraine on 11/19/2019 . went to hospital experiencing  a migraine and speech difficulty
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen on Right deltoid where vaccinations where given. No treatment needed.
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: the morning after the injection arm became red and hot and that same night small pimple like bumps appeared on arm
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eczema, Rash
Clinical narrative: Patient broke out in a rash and went to the dermatologist.  The dermatologist confirmed it was eczema.  The rash occurred after both doses of Shingrix and resolved with the application of steroid cream prescribed by her dermatologist for the eczema break-out.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient states that a rash developed on her torso the day after getting her flu shot.  She claims the rash to be localized to the torso and has not spread anywhere else, reports no abnormal skin around the injection site.  Describes the rash as being red, not raised. Has not gotten any worse since the day after the vaccine but has not gotten any better either, this is day 4.  She will try benadryl and follow up with her physician if symptoms worsen or do not get better within the next day or two.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Feeling abnormal, Nausea, Pain
Clinical narrative: 11:45pm chills, nausea, aches. It?s now 10:04 am and I?m still feeling poorly.   This happened after my first dose in August 2019.   Lot no. May be 58160-0823-11
Age: 65.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash started on hands with intense itching, then spread to chest and abdomen over a 4 day period
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Eye oedema, Face oedema, Pruritus
Clinical narrative: Edema in face and eyes, itchy all over the body, not relieved with antihistamines.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: After vaccine administration on 11/4/19, the patient's deltoid muscle became quite sore. The soreness waned over two weeks but worsened significantly on 11/19/19 and still hurts significantly today 11/20/19. The patient denies swelling, redness, should joint pain, fever, chills.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Full blood count, Influenza A virus test
Clinical narrative: My daughter got high fever for 8 days. The highest temperature was 105.5. She was kind of unconscious in one of the morning. No crying, no movement.  We took her to both emergency room and urgent  care.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Influenza B virus test, Loss of consciousness, Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: My daughter got high fever for 8 days. The highest temperature was 105.5. She was kind of unconscious in one of the morning. No crying, no movement.  We took her to both emergency room and urgent  care.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Patient received vaccine from community based pharmacy on 11/15/19; 2 days later (11/17/19), developed confluent, highly erythematous popular with few vesicles rash on left posterior upper back, shoulder, anterior armpit, chest following C8-T1 dermatome distribution and few popular lesions on left medial forearm (C8 distribution); not painful but itchy but rash character highly consistent with shingles lesions. No systemic symptom except mild fatigue day prior to onset of rash. Treated empirically with Valacyclovir.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Limb mass, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patients arm got severly swollen red hot to touch huge lump. It's sore it hurts he can't lay on it. It's the size of a baseball swollen. Just giving him Tylenol and ibuprofen to help with swelling And pain.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose, Dizziness, Erythema
Clinical narrative: Patient being seen in office for follow up visit. Provider ordered Pneumovax 23 injection. Patient had received Prevnar 13 20 days prior. Nurse giving injection did not question provider order, and administered injection. Within 10 minutes, patient's face turned red, and he began to feel lightheaded/dizzy. Associate called myself (triage RN), and patient was taken to triage room. BG checked per provider recommendation, and patient was given ice and water. Vital signs within normal limits. Patient given instructions to go home and rest for the remainder of the day.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient states she got her flu shot on Monday woke up tuesday with rash and hives. Took benadryl and everything resolved
Sex: U
Vaccine: FLU4
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: Continuous dull achy pain in my left arm, shoulder, axilla. Can barely left arm.  Short period of relief with naproxen. Arm has been hurting since 5 hours after receiving vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: C-reactive protein normal, Chest X-ray normal, Cyanosis, Full blood count normal, Influenza virus test negative
Clinical narrative: Baby had 2-3 episodes of turning blue during a feeding on the evening that the vaccination was given.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Metabolic function test normal, Respiratory syncytial virus test negative
Clinical narrative: Baby had 2-3 episodes of turning blue during a feeding on the evening that the vaccination was given.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced a large red area with raised bump on arm where injection was given.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced a large red area with raised bump on arm where injection was given.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arachnoiditis, Areflexia, Asthenia, CSF culture negative, CSF glucose normal
Clinical narrative: 61-year-old gentleman with a history significant for HTN & HLD who presented with proximal bilateral lower extremity paresis of 1 day duration.  While he was still able to walk, he noted that his thighs felt weak and his knees kept buckling.  He has had multiple falls since the onset without serious injury.  His weakness had been worsening, prompting him to go to the ED for management.  He is noted tingling in the bilateral toes without sensory changes in the upper extremity.  MRI of thoracic and lumbar spine demonstrated enhancement of the cauda equina nerve roots.  Lumbar puncture demonstrated cytoalbuminologic dissociation.  He had received the influenza and shingles vaccine 10 days prior to onset of symptoms.  He was admitted to the General Neurology Service.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: CSF immunoglobulin G index, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative
Clinical narrative: 61-year-old gentleman with a history significant for HTN & HLD who presented with proximal bilateral lower extremity paresis of 1 day duration.  While he was still able to walk, he noted that his thighs felt weak and his knees kept buckling.  He has had multiple falls since the onset without serious injury.  His weakness had been worsening, prompting him to go to the ED for management.  He is noted tingling in the bilateral toes without sensory changes in the upper extremity.  MRI of thoracic and lumbar spine demonstrated enhancement of the cauda equina nerve roots.  Lumbar puncture demonstrated cytoalbuminologic dissociation.  He had received the influenza and shingles vaccine 10 days prior to onset of symptoms.  He was admitted to the General Neurology Service.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fall, Guillain-Barre syndrome, Immunoglobulin therapy, Intervertebral disc degeneration, Laboratory test
Clinical narrative: 61-year-old gentleman with a history significant for HTN & HLD who presented with proximal bilateral lower extremity paresis of 1 day duration.  While he was still able to walk, he noted that his thighs felt weak and his knees kept buckling.  He has had multiple falls since the onset without serious injury.  His weakness had been worsening, prompting him to go to the ED for management.  He is noted tingling in the bilateral toes without sensory changes in the upper extremity.  MRI of thoracic and lumbar spine demonstrated enhancement of the cauda equina nerve roots.  Lumbar puncture demonstrated cytoalbuminologic dissociation.  He had received the influenza and shingles vaccine 10 days prior to onset of symptoms.  He was admitted to the General Neurology Service.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: 61-year-old gentleman with a history significant for HTN & HLD who presented with proximal bilateral lower extremity paresis of 1 day duration.  While he was still able to walk, he noted that his thighs felt weak and his knees kept buckling.  He has had multiple falls since the onset without serious injury.  His weakness had been worsening, prompting him to go to the ED for management.  He is noted tingling in the bilateral toes without sensory changes in the upper extremity.  MRI of thoracic and lumbar spine demonstrated enhancement of the cauda equina nerve roots.  Lumbar puncture demonstrated cytoalbuminologic dissociation.  He had received the influenza and shingles vaccine 10 days prior to onset of symptoms.  He was admitted to the General Neurology Service.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Paraparesis, Sensory disturbance
Clinical narrative: 61-year-old gentleman with a history significant for HTN & HLD who presented with proximal bilateral lower extremity paresis of 1 day duration.  While he was still able to walk, he noted that his thighs felt weak and his knees kept buckling.  He has had multiple falls since the onset without serious injury.  His weakness had been worsening, prompting him to go to the ED for management.  He is noted tingling in the bilateral toes without sensory changes in the upper extremity.  MRI of thoracic and lumbar spine demonstrated enhancement of the cauda equina nerve roots.  Lumbar puncture demonstrated cytoalbuminologic dissociation.  He had received the influenza and shingles vaccine 10 days prior to onset of symptoms.  He was admitted to the General Neurology Service.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced a large red area with raised bump on arm where injection was given.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced a large red area with raised bump on arm where injection was given.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Chest X-ray normal, Full blood count normal, Immunoglobulins normal
Clinical narrative: Have dealing with significant muscle/joint pain, weakness, night sweats, and low grade fever
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Lumbar puncture normal, Myalgia, Night sweats, Pyrexia, Ultrasound abdomen normal
Clinical narrative: Have dealing with significant muscle/joint pain, weakness, night sweats, and low grade fever
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Complained of tingling and numbness of left hand and fingers and slight soreness at the site of injection at 03:00 AM. Ice pack to site at 03:00 AM. At 08:30 AM tingling  and numbness was moving up the left arm, tingling and numbness to facial cheeks and tongue and slight pick color to the injection site. Was sent to Urgent Care and was release with instruction to rest, apply warm packs and was dismissed from work for the rest of the day.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia oral
Clinical narrative: Complained of tingling and numbness of left hand and fingers and slight soreness at the site of injection at 03:00 AM. Ice pack to site at 03:00 AM. At 08:30 AM tingling  and numbness was moving up the left arm, tingling and numbness to facial cheeks and tongue and slight pick color to the injection site. Was sent to Urgent Care and was release with instruction to rest, apply warm packs and was dismissed from work for the rest of the day.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope.  patient fainted while walking towards clinic lobby.  patient was assessed by MD who cleared patient of any injury.  patient was allowed to lie down and drink water until he felt stable enough to stand and walk on his own.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 25-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength and dose were not reported) for prophylaxis. No adverse effects were reported in the patient. Administered dose of vaccine experienced the temperature excursion of below 36 Fahrenheit degrees (F) / 2 Celsius degrees (C) (35 F) for 430 minutes. The digital data logger was not involved in recording the temperature excursion details. There were no previous excursions reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; A patient received an improperly stored ROTATEQ; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On approximately 04-NOV-2019 (reported as: 04-NOV-2019 or 05-NOV-2019), the patient received an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis (lot number S004253 and expiration date 21-OCT-2020 have been verified to be a valid; dose, route of administration and anatomical site were not provided). The lowest temperature the vaccine was exposed to was below 36 Fahrenheit degrees / 2 Celsius degrees (1.3 Celsius) within a time frame of 2 hours and 18 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports from the same reporter (information captured #:1911USA002388, 1911USA001917, 1911USA004087, 1911USA002263, 1911USA001946, 1911USA002198, 1911USA002043, 1911USA002053 and 1911USA002033); Sender's Comments:  US-009507513-1911USA002388: US-009507513-1911USA001917: US-009507513-1911USA004087: US-009507513-1911USA002263: US-009507513-1911USA001946: US-009507513-1911USA002198: US-009507513-1911USA002043: US-009507513-1911USA002053: US-009507513-1911USA002033:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; One expired dose of RECOMBIVAX was administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not provided. On 15-NOV-2019, the patient was vaccinated with one expired dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) injection 10/1 microgram/milliliter (mcg/ml) lot # N006321, expiration date: 08-NOV-2019 (dose number, anatomical location and route of administration were not provided) for prophylaxis (expired product administered). No adverse symptoms reported. No product quality complaints (PQC) were involved.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported in the patient; The patient recieved her first dose of ROTATEQ at age of 14 weeks; This spontaneous report was received from a medical assistant regarding a 14 weeks female patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 15-NOV-2019, the patient received her first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dose, lot number S004398, expiration date 31-OCT-2020 (strength and route of administration was not provided) at age of 14 weeks (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Hypoaesthesia, Malaise
Clinical narrative: Numbness on the arm; dizziness; He was not feeling well; This is a spontaneous report from a contactable physician.  A 18-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient developed numbness on the arm, dizziness and he was not feeling well in general after the administration of the vaccine, on an unspecified date. After one day the symptoms gave away and he recovered from the events on an unspecified date. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Blister
Clinical narrative: Experienced blisters after administration; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration, on an unspecified date at single dose for immunisation . The patient medical history and concomitant medications were not reported. The patient experienced blisters after administration, on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: MEN, MENB
Symptoms: Pain
Clinical narrative: Severe pain; This is a spontaneous report from a contactable physician via Pfizer sales representative.   A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA) at single dose on unknown date for immunization. On the same date the patient also received meningococcal vaccine B (MENB). Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced severe pain. The outcome of the event was unknown.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Eye swelling, Facial pain, Feeling hot, Headache
Clinical narrative: Red, swollen, squinty, watery eyes, red face, face hurt.  Had some itchiness and bumpy pinpoint rash on arms and upper chest.  Rash presented more on inner arm than outer arms.  Face felt hot.  Took benadryl Sunday (11/10) which helped with the rash on arms but not the face.  Monday (11/11) eyes seemed worse and could barely see.  Had a headache.  Went to the clinic at 8:30am and received prednisone.  Took patient until Friday (11/15) to recover.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Lacrimation increased, Ocular hyperaemia, Pruritus, Rash, Strabismus
Clinical narrative: Red, swollen, squinty, watery eyes, red face, face hurt.  Had some itchiness and bumpy pinpoint rash on arms and upper chest.  Rash presented more on inner arm than outer arms.  Face felt hot.  Took benadryl Sunday (11/10) which helped with the rash on arms but not the face.  Monday (11/11) eyes seemed worse and could barely see.  Had a headache.  Went to the clinic at 8:30am and received prednisone.  Took patient until Friday (11/15) to recover.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Visual impairment
Clinical narrative: Red, swollen, squinty, watery eyes, red face, face hurt.  Had some itchiness and bumpy pinpoint rash on arms and upper chest.  Rash presented more on inner arm than outer arms.  Face felt hot.  Took benadryl Sunday (11/10) which helped with the rash on arms but not the face.  Monday (11/11) eyes seemed worse and could barely see.  Had a headache.  Went to the clinic at 8:30am and received prednisone.  Took patient until Friday (11/15) to recover.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Redness and edema to the left upper extremity.  The left upper extremity is hot and hard to touch at the injection site.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient had low grade fever (99F) and swelling/redness/itching at site of injection.  Patient's daughter called back 11/18/19 to report these symptoms.  We advised to take Tylenol for fever & pain.  We followed up 11/19/19 and fever had resolved, but still having swelling/itching/redness.  Told to continue Tylenol & use ice pack for swelling.  Patient went to ER on 11/20/19 and received prescription for prednisone for swelling/itching.  MD told her this was an allergic reaction, but not anaphylactic.  She was told to get the vaccines in separate arms next time.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Death
Clinical narrative: Pt was reported to be found dead the morning after vaccination. There is no clear association between vaccination and death, considering patient age and comorbidities. Medical examiner office informed clinic the next day
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Woke up with swollen eyes.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Laryngitis, Pharyngeal swelling
Clinical narrative: pt stated 4 hours after shot throat started swelling went home, her husband had epi-pen at home if needed, Got up next am and was worse 'felt like golf ball in throat', called on dr on demand and they told her to go to er, er  said pt had laryngitis  and would not consider allergic rxn although pt states throat had not been sore and had not been sick
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: right arm at site of injection bleed and then swelled within 2 minutes of vaccination of pneumovax.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: Patient received vaccine at approx. 1500, then an hour later the patient checked himself into the ER.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Within several minutes of receiving flu vaccine, client came to nurse with hives on neck. BP at the time was 180/90.  Client chose to take PO benadryl from her purse and her symptoms started to improve. Client remained with the nurse for 45 minutes and felt much better. Client was advised to inform her PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Nervousness, headache, sleeplessness first night.  Morning and following 2 days: fatigue, nausea, dizziness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness
Clinical narrative: Nervousness, headache, sleeplessness first night.  Morning and following 2 days: fatigue, nausea, dizziness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Circumstance or information capable of leading to medication error, Crying, Gait disturbance, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediately (within seconds) after receiving the Pentacel vaccination, he had a 10 x 10cm raised wheal and erythema and swelling to his L thigh.  He was moving a lot as the shot was given but my MA felt like she gave it IM as per normal protocol.  He was crying continuously, but observed for 30 minutes at the clinic and did not develop signs of anaphylaxis.   Ice and topical diphenhydramine were applied.  He had difficulty walking on this leg for the first day and then the reaction improved over several days.  He had previously tolerated both Daptacel and Pentacel without any major reactions.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Immediately (within seconds) after receiving the Pentacel vaccination, he had a 10 x 10cm raised wheal and erythema and swelling to his L thigh.  He was moving a lot as the shot was given but my MA felt like she gave it IM as per normal protocol.  He was crying continuously, but observed for 30 minutes at the clinic and did not develop signs of anaphylaxis.   Ice and topical diphenhydramine were applied.  He had difficulty walking on this leg for the first day and then the reaction improved over several days.  He had previously tolerated both Daptacel and Pentacel without any major reactions.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Pain
Clinical narrative: PATIENT REPORTS SEVERE PAIN IN THE ARMPIT ON THE SAME SIDE SHE RECIEVED THE SHINGRIX DOSE. THIS WAS THE 2ND DOSE AND SHE STATED MINIMAL TO NO PAIN ON THE ARM ITSELF AT THE SITE OF INJECTION, BUT 'FAIRLY SIGNIFICANT' PAIN RAIDIATING FROM HER ARMPIT. PAIN LASTED FROM 10/22(DAY AFTER SHOT) UNTIL ABOUT 10/26TH WITH LESSENING SEVEREITY. PT DIDN'T CALL PHARMACY AT THAT TIME, HOWEVER, PT WAS IN FOR A FLU SHOT LATER ON AND REPORTED HER EXPEREINCE WITH HER 2ND SHINGRIX DOSE AT THAT TIME.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Injection site pain, Pain in extremity
Clinical narrative: PATIENT REPORTS SEVERE PAIN IN THE ARMPIT ON THE SAME SIDE SHE RECIEVED THE SHINGRIX DOSE. THIS WAS THE 2ND DOSE AND SHE STATED MINIMAL TO NO PAIN ON THE ARM ITSELF AT THE SITE OF INJECTION, BUT 'FAIRLY SIGNIFICANT' PAIN RAIDIATING FROM HER ARMPIT. PAIN LASTED FROM 10/22(DAY AFTER SHOT) UNTIL ABOUT 10/26TH WITH LESSENING SEVEREITY. PT DIDN'T CALL PHARMACY AT THAT TIME, HOWEVER, PT WAS IN FOR A FLU SHOT LATER ON AND REPORTED HER EXPEREINCE WITH HER 2ND SHINGRIX DOSE AT THAT TIME.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swollen left arm. Larger than an egg size bump at injection site redness and swelling. Fever 103. Joint pain. Headache
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Swollen left arm. Larger than an egg size bump at injection site redness and swelling. Fever 103. Joint pain. Headache
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Granulocyte percentage, Headache, Lymphocyte percentage, Nausea
Clinical narrative: Patient presented to primary care clinic for routine appointment on 11/13/19 in the morning, given 2 vaccines as part of health maintenance.  Presented to same facility's ER on 11/14/19 mid-day reporting symptoms that started approximately 1700 the day prior (later on the same day as the vaccines were given).  Symptoms reported include headache, nausea, chills, body aches.  Took OTC Goody powder without relief.  Denied dizziness, vomiting, paralysis, rhinitis, sneezing, cough, chest pain, shortness of breath, sore throat, chest/nasal congestion.  Denied travel or ill contacts.  Good oral intake and appetite maintained.  No medications given in the ER, discharged with ondansetron as needed for nausea and acetaminophen as needed for pain/headache as well as instructed to rest and drink plenty of fluids.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain, White blood cell count normal
Clinical narrative: Patient presented to primary care clinic for routine appointment on 11/13/19 in the morning, given 2 vaccines as part of health maintenance.  Presented to same facility's ER on 11/14/19 mid-day reporting symptoms that started approximately 1700 the day prior (later on the same day as the vaccines were given).  Symptoms reported include headache, nausea, chills, body aches.  Took OTC Goody powder without relief.  Denied dizziness, vomiting, paralysis, rhinitis, sneezing, cough, chest pain, shortness of breath, sore throat, chest/nasal congestion.  Denied travel or ill contacts.  Good oral intake and appetite maintained.  No medications given in the ER, discharged with ondansetron as needed for nausea and acetaminophen as needed for pain/headache as well as instructed to rest and drink plenty of fluids.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient woke up next morning with nausea, chills, low grade fever (99.6), muscle aches.  Slept in bed all day due to reaction.  could not eat anything other than ice chips and some crackers later in day.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Patient woke up next morning with nausea, chills, low grade fever (99.6), muscle aches.  Slept in bed all day due to reaction.  could not eat anything other than ice chips and some crackers later in day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed shingles
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient, at least 24 hours after the vaccine, had swelling, redness, warmth and discomfort throughout the majority of his upper left arm. The swelling, redness and warmth started below the injection site and was the majority of his arm down to around his elbow. We called the doctor a few hours after first noticing it and when it seemed as if it had swelled more, we were advised to keep an eye on it, administer a pain medicine to help his discomfort as well as swelling and that it should go down within 24-48 hrs. He woke up the next morning still swollen and compalining of it hurting, was given pain medicine again and just watched througout the day.The discomfort and swelling, etc has not detracted from his daily life. At this point (about 24 hours after noticing the reaction), he still has minor complaints about the discomfort, some swelling, but the color has returned to normal, it is not warm and the swelling has been reduced, although not completely gone at this point. The reason I marked question #20 as "No" is just that the reaction has not completely resolved at this point, although it appears as though it will.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Last week patient mentioned that he was getting a rash on his chest. Rash is small oddly shaped reddish and raised. The rash is not too itchy unless he gets hot and sweaty. The rash has gotten worse in the week since he first reported it. It occured to me today that this might be an adverse reaction to this vaccine. I am aware that this rash may also not be related to the vaccination but I wanted to have it documented in case he has any further issues. We have been putting a general antibiotic ointment on the worst of the sores. We have not sought out medical attention yet in the hopes that it will clear up on its own.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced immediate pain at injection site, followed by worsening of pain within 5 minutes of shot.  Upper arm is firm to touch and hot. Patient states she cannot raise her arm above shoulder level without severe pain
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Joint stiffness, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: I woke up the next morning completely frozen-  all muscles and joints.  I eventually received a diagnosis of Rheumatoid Arthritis, for which Dr. did Not find a definitive blood test for in my history.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient presented to clinic for influenza vaccination on 10/30/19.  Vaccine was administered on 10/30/19 at 11:49AM per PH protocol by myself (RN).  Per chart records, patient presented again to the clinic on 11/18/19 and 11/19/19 with severe right shoulder pain, and was seen by FNP.  Patient reports that the pain started soon after the vaccine was administered on 10/30/19.  NSAIDS prescribed and referral ordered.
Age: 57.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: The patient described his symptoms to pharmacist on duty on 11/18/2019.  He stated at the time of injection, he "felt it all the way down to fingertips." He has had pain since the injection in the left shoulder. It hurts to lift his arm.  He has applied rub on it. He believes the injection was administered too far up his arm, too close to the shoulder joint.  Pharmacist recommended that the patient be evaluated either by his PCP or at a Clinic to decide the next course of action for his treatment.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; The patient was inadvertently administered an expired dose of GARDASIL 9; The vaccine has experienced a temperature excursion during transport from the pharmacy to the doctor's office; This spontaneous report was received from a pharmacist regarding a 21 year-old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not provided.   On 19-NOV-2019, the patient was inadvertently administered an expired dose (expired product administered) HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number R024264, expiration date 29-OCT-2019 (dose and route of administration was not provided). Also, the medical assistant who administered the vaccine called back to confirmed that the vaccine had experienced a temperature excursion (product storage error) during transport from the pharmacy to the doctor's office. The vaccine experienced temperature excursion of 73 degrees Fahrenheit (°F) for 30 minutes. No data logger was involved. There was no more temperature excursions reported. No adverse symptoms were reported (no adverse events).
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient experienced severe pain and was unable to raise arm 4 hours after vaccination. Patient went to Emergency room 24 hours later and received Percocet and Zofran. ER Physician believed needle placement may have played a part in pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Next day, site of injection was red, warm and in pain.  By night, affected area was more swollen and expanded; not sure if put ice.   Patient went to bed.  By Wednesday, affected area worsened and it expanded more. Patient called the doctor who recommended Advil/Tylenol.   Since rash was spreading patient went to doctor on Wednesday. Doctor prescribed a 10-day use of Doxycycline and  Mupirocin ointment.  Patient went back to doctor on 10/15 since arm still hurt and ache. Doctor did not extend prescription; by then area was a greyish bruise, not inflamed, but turned red when rubbing. Doctor described problem as infection of pathway of lymph nodes but did not provide any instructions in terms of care.  Patient went back to pharmacist on 11/18 and pharmacist was not sure if patient covered for shingles.   Recovery at 50% lingering ache where rash was. Patient received Flu on same facility as vax administrator.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pain in extremity, Rash
Clinical narrative: Next day, site of injection was red, warm and in pain.  By night, affected area was more swollen and expanded; not sure if put ice.   Patient went to bed.  By Wednesday, affected area worsened and it expanded more. Patient called the doctor who recommended Advil/Tylenol.   Since rash was spreading patient went to doctor on Wednesday. Doctor prescribed a 10-day use of Doxycycline and  Mupirocin ointment.  Patient went back to doctor on 10/15 since arm still hurt and ache. Doctor did not extend prescription; by then area was a greyish bruise, not inflamed, but turned red when rubbing. Doctor described problem as infection of pathway of lymph nodes but did not provide any instructions in terms of care.  Patient went back to pharmacist on 11/18 and pharmacist was not sure if patient covered for shingles.   Recovery at 50% lingering ache where rash was. Patient received Flu on same facility as vax administrator.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red swollen hot skin at injection site
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Left shoulder has severe pain.  Arm could not be moved for 2 days even now the pain is awful.  I was given a c pack for 6 days and now I'm on meloxicam 15 mg.   Pain level is still at a 9-10 in the evenings.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Subdural haematoma
Clinical narrative: bilat subdural hematoma on 9/3/2019-currently slowly resolving
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Late Saturday felt tired and went to bed early. Woke up on and off and was shivering severely; took Tylenol.  Next day woke up and was wet all over, felt cold, and was shivering on and off.   Also felt tired, had headache, diarrhea, and rapid heart beat. Blood pressure and pulse rate stable usually stable at 110 because of medication she takes.  By bed time, BP had risen from the normal 120/70 to 144/94; patient had nausea but did not vomit.  Patient reports no problems after the first dose of shingles or after Zostavax vaccine.  Patient did not call doctor at any time over the weekend.  Symptoms continued by 1pm Sunday.  By Sunday evening symptoms resolved completely. Patient will notify pharmacist of incident. Patient did not get a sore arm.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Nausea
Clinical narrative: Late Saturday felt tired and went to bed early. Woke up on and off and was shivering severely; took Tylenol.  Next day woke up and was wet all over, felt cold, and was shivering on and off.   Also felt tired, had headache, diarrhea, and rapid heart beat. Blood pressure and pulse rate stable usually stable at 110 because of medication she takes.  By bed time, BP had risen from the normal 120/70 to 144/94; patient had nausea but did not vomit.  Patient reports no problems after the first dose of shingles or after Zostavax vaccine.  Patient did not call doctor at any time over the weekend.  Symptoms continued by 1pm Sunday.  By Sunday evening symptoms resolved completely. Patient will notify pharmacist of incident. Patient did not get a sore arm.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Skin warm
Clinical narrative: Patient reports that he has been getting a red bug bite appearing mark at injection sites, no pain or itching,  but they are hot to the touch.  Intermittent and not at the same time, resolve after a few days and then reappear.  No treatment has been tried.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: On Nov 17 about 10am slight rash below injection site; On Nov 19 about Noon my arm was very hot and at 1:pm Pharmacists saw that the area below the injection site was very red and hot to the touch; After 24 hours of intermittent icing location and not sleeping on that right side the redness and heat had lessened. Photos are available by request.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received vaccine 11/8, did not notice reaction until 11/9. Reaction resulted in swelling of upper arm. The entire upper arm was red, hot and painful. Pt reported feeling foggy for several days and very anxious. Took Benadryl as well as Benadryl cream topically to affected area. Reported event to hospital on 11/9, advised to continue Benadryl. Reported event to Pharmacy on 11/20. Stated only one sore area left on arm but feeling better. Stated took about a week and a half for the swelling to dissipate.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pt received vaccine 11/8, did not notice reaction until 11/9. Reaction resulted in swelling of upper arm. The entire upper arm was red, hot and painful. Pt reported feeling foggy for several days and very anxious. Took Benadryl as well as Benadryl cream topically to affected area. Reported event to hospital on 11/9, advised to continue Benadryl. Reported event to Pharmacy on 11/20. Stated only one sore area left on arm but feeling better. Stated took about a week and a half for the swelling to dissipate.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient was given two shots 11/18/19. Patient came back to clinic 11/19/19 with complaint of intense right arm pain, patient was seen for a clinic visit and  patient was given a Right Should Immobilizer, and given pain medications along with an antibiotic.
Age: 16.0
Sex: F
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Seizure
Clinical narrative: After the client received vaccines, she complained of dizziness and shortly after passed out and appeared to seize for approximately 30 seconds. When the client became conscious and alert again, she complained of shortness of breath. Client was helped into recovery position and vitals were taken (BP: 81/46, HR:46). Called 911 due to shortness of breath and symptoms. Took vitals again after 3 minutes, BP was 97/64, HR was 56. Ambulance arrived within 4 minutes and assessed patient. Per Medics, client was within normal limits however they advised the patient be assessed at the Hospital and parent agreed. Parent came by later to collect paperwork and stated that the patient was doing fine and was released from the hospital with no issues.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash on right thigh- two areas in L-2 dermotome
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: ALSO RECEIVED FLUZONE HD LOT UJ307AA EX 06-29-2020 IN LEFT DELTOIC
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Vision blurred
Clinical narrative: chills, fever, injection site soreness, and blur vision for 3 days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Pruritus, Pyrexia
Clinical narrative: 1) Itchiness on chest and back within 10 minutes of shot. Dissipated after a couple of hours. 2) Feverish, chills and flu-like symptoms, on and off for 2 days. Came in waves. 3) General weakness for 2 days, on and off.
Age: 12.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, TD
Symptoms: Erythema, Face injury, Fall, Lip haemorrhage, Somnolence
Clinical narrative: Patient here for vaccine only appointment . Vaccines given at 3:45P Due to receive today per  Shots & checked by employee: Flulaval, TD, Hep A, Hep B, HPV, IPV. PTID x 2 Allergies reviewed. VIS given to parent & after care of vaccine discussed. Vaccine checked by provider. T emp 98 RN Child fell off bed suddenly after vaccines were given at & fell onto scale floor face down. Child had just spoken to Uncle & myself & gave no signs of fainting. Child placed on bed ,lying on back in trendelenburg by uncle & myself. Bleeding noted from under left nostril & right bottom lip. Child responding & denied any pain with red area on top of right hand & right temporal area. . Seen by employee & Dr. BP 110/80, P 59,RR 20 & O2 sat 99. Given juice & tolerated well. Kept for observation. V/S at 4:10P BP 110/54,P 87, RR 24 & O2 sat 99. Child denies nausea,dizziness,blurry vision,headache or any other pain. Staes a bit sleepy. Seen by DR at 4:25 P . Child still denies pain sleepiness at this time or any other sx. Child is living with Uncle,as parents are in another country. Instructed to watch for child unable to stay awake (except during night time, when he will wake child every 2 hrs) , nausea vomiting, headache,blurry vision,dizziness. Please take to ER if he has any of these sx. Given antibiotic oint to use on cut under nostril. If any pus is seen for either cut please have checked. Given appointment for 11/12/19 3:30P with Dr for follow up. Aware he can call our office 24 hrs per day & there will be a covering doctor he can speak with. Uncle voiced understanding. RN