chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: F
Vaccine: MEN
Symptoms: Death, Meningitis, Pyrexia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (patient's relative) via social media on 01 August 2015. A 07-month-old female infant, whose medical history and concomitant medications were not reported, had received a dose of meningococcal vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Reporter stated that her neighbour back in the eighties was not fortunate enough as on an unknown date her daughter contacted meningitis after receiving the vaccination (time from first dose to onset not specified) and she died within few hours of having fever which her mother thought to be a simple fever. Laboratory investigations and corrective treatments were not reported. It was unknown if autopsy was performed. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Dizziness, Head injury, Syncope
Clinical narrative: CLIENT WALKED TO CAR AND FAINTED, HITTING HIS HEAD ON THE SIDE OF THE CAR.  911 CALLED.  VITALS:  BP 118/70 HR 68, RR 16, ALERT AND ORIENTED.  COMPLAINED OF DIZZINESS AND UPSET STOMACH.  CLIENT DECLINED NEED TO BE TRANSPORTED TO HOSPITAL.  EDUCATED CLIENT AND MOTHER ON S/S IN WHICH TO REACH OUT TO PCP OR CALL 911, STATED UNDERSTANDING.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: 7/28 mild tenderness took an Naproxen. 7/29 had increase in swelling and more redness in the area of the injection-iced area and took Naproxen. 7/30 increased swelling, increased swelling upper arm, also noticed swelling on medial forearm took Naproxen times 3. 7/31 less redness and decreased swelling in upper arm and forearm. Still sore and painful to touch. Treatment: Alvert daily and Benadryl at bedtime and continue to ice.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Patients mother stated that patient had plum size ball on leg where injection was given on both the right and left thigh. (anterolateral) She tried to massage and place heat but it stayed that size throughout the weekend and is slowly going down.  Denies any redness or warm to touch now.  Patients mother did state she noticed a hive at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site reaction, Pain
Clinical narrative: Dull achy pain from armpit to elbow, redness on injection site, headache.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Arthralgia, Immediate post-injection reaction, Injection site pain, Injection site reaction
Clinical narrative: At time of injection, sharp pain, tingling, different than any other vaccination I have ever recieved. Got worse every day. Today it hurts to raise my arm even slightly, sharp pain from shoulder to fingers, severe pain in elbow. Hand is tingling as if it fell asleep. Could hardly dress myself this morning, favoring right hand (injection in left).
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: At time of injection, sharp pain, tingling, different than any other vaccination I have ever recieved. Got worse every day. Today it hurts to raise my arm even slightly, sharp pain from shoulder to fingers, severe pain in elbow. Hand is tingling as if it fell asleep. Could hardly dress myself this morning, favoring right hand (injection in left).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Confusional state, Muscle twitching
Clinical narrative: Parents noted twitching in left shoulder then both shoulders, with confusion and more frequent week of 07/29/2015. Parent called to notify health department. Told parent to seek immediate medical care. As of 7/30/15 parent has not taken child to MD, mother says no confusion noted. Seen by Urgent Care on 8/05/15 and referred to specialist per mother.
Age: 20.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Patient received Varicella and TDAP in her left arm on 7/24/2015. Over the next 2-3 days she developed erythema, swelling and a rash. Patient was treated with Prednisone, Zyrtec, and Ibuprofen.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: Broke out in rash all over face. She received another vaccination on 06/09/2015 and broke out in a rash on her face, arms, and legs.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Hypoaesthesia, Injection site pain, Muscle tightness, Muscular weakness
Clinical narrative: Severe pain in L arm, shooting pain in L shoulder and into neck, numbness & tingling in left hand, weakness in L hand, muscle tightness & pain in most of body, fever, and fatigue.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Severe pain in L arm, shooting pain in L shoulder and into neck, numbness & tingling in left hand, weakness in L hand, muscle tightness & pain in most of body, fever, and fatigue.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Rash, Rash papular
Clinical narrative: Mild papular rash on neck, back, chest and abdomen.
Age: 12.0
Sex: F
Vaccine: TYP, YF
Symptoms: Paraesthesia oral, Pharyngeal oedema, Throat irritation, Throat tightness
Clinical narrative: Pt was given YF vaccine and Typhoid injection at 4:45pm. After vaccine was given pt was instructed to wait in waiting room for 25 minutes following administration. At 4:50pm, pt came back into nurses station, c/o lips tingling, throat was feeling itchy, and swelling up. Pt reports that her throat feels like it does after I come into contact with peanuts. Notified NP. NP here, and assessed patient. Pt was given Benadryl 25mg orally at 4:55pm. Pt's HR-was 100. Pt was layed down in supine position, and Epi Pen (0.3mg was given to pt into right vastus lateralis at 5:00pm). After Epi Pen was injected VS were checked-Temp=98.1 degrees orally, HR-98, and BP=118/54. Pt denied having any further lip tingling or itching in throat. Pt stated that she still thought she had some tightening/bumps in the back of the throat. At 5:05 pm, BP-125/91, HR-69. At 5:10 pm.BP-106/76, HR-82. At 5:15pm, notified MD. Dr. to assess pt. Pt's BP at 5:15pm-102/78, HR-92. Dr. called and spoke with Dr. in urgent care. Pt denied SOB, tingling in lips, itchy throat, n/v, or throat swelling. Pt did state that she still feels some "nodules" in the back of her throat. Pt's mom is here and aware. Pt was transfered to Urgent Care to be assessed at 5:20pm.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immunization site (Left Arm) was Red, swollen, and full of heat.  Painful to touch.
Age: 0.76
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: Patient developed a fever that eventually spiked to 102.9 degrees Fahrenheit and was lethargic and fussed inconsolably upon waking in the morning.  Patient was treated with infants' ibuprofen with some alleviation of symptoms.  Fever lasted intermittently for 12 hours.  Lethargy lasted concurrently with fever.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Patient was given an unnecessary dose of Dtap.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Blood test abnormal, Decreased appetite, Lumbar puncture abnormal, Myelitis transverse
Clinical narrative: Vomitting, loss of appetite, high fever, paralysis.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging abnormal, Paralysis, Pyrexia, Vomiting
Clinical narrative: Vomitting, loss of appetite, high fever, paralysis.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Dehydration, Diarrhoea, Human metapneumovirus test positive, Muscular weakness, Myelitis transverse
Clinical narrative: Vomitting, loss of appetite, high fever, paralysis.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Otitis media, Pyrexia, Vomiting
Clinical narrative: Vomitting, loss of appetite, high fever, paralysis.
Age: 0.53
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a Hep A instead of a Hep B.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injections was hot, swollen and sore.  4 weeks later, site is still swollen and sore.
Age: 75.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm hard, red, swollen, hot and painful.  Local treatment advised unless pt develops signs of infection.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Injection site bruising, Injection site swelling, Peripheral swelling
Clinical narrative: Patient presented with purple bruising down entire Left arm, swelling and reaction.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient presented to pharmacy 2 days after receiving vaccine. Entire back of patient's left arm was red. Around injection site there was a hard knot about 3-4 inches in diameter and the area was warm to the touch. On third day the swelling/redness/warmth was not much better. Patient went to an urgent care and was given a prescription for Keflex antibiotics due to possible infection.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy 2 days after receiving vaccine. Entire back of patient's left arm was red. Around injection site there was a hard knot about 3-4 inches in diameter and the area was warm to the touch. On third day the swelling/redness/warmth was not much better. Patient went to an urgent care and was given a prescription for Keflex antibiotics due to possible infection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching.  Redness and swelling resolved in a couple days.  The area is still itching 1 month later 8/11/15.
Age: 11.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Excessive swelling, hardness, itching, rash and pain at the sight of injection for meningitis vaccine.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a 52-year-old female consumer on 06-AUG-2015, who is the patient, who reported receiving PNEUMOVAX 23 injection, sometime in June. The patient stated the next day she "became sick" and had to go to the emergency room (ER). The patient gave no other information due to she wanted to verify everything with the provider. The consumer called back on the same day, 06-AUG-2015 and stated that 24-JUN-2015 was the date she received the PNEUMOVAX 23 injection, intramuscular. She sought unspecified treatment in the emergency room (ER). The patient also reported she was admitted to the hospital, name and location of hospital was unspecified, and it was unspecified the amount of time she spent in the hospital for the event. Outcome of the "became sick" event was unknown. Present status of the patient was unknown. No additional information was provided. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: ANTH, HEPA, TD
Symptoms: Alopecia, Arthralgia, Arthritis, Asthenia, Chromaturia
Clinical narrative: Limited movement of Left Arm. Difficulty with swallowing. Joint and muscle pain. Shortness of breath. Unusual tiredness and weakness. Dark colored urine. Difficulty with moving. Hair loss and Thinning of hair. Muscle cramps and spasms. Trouble sleeping. Inflammatory arthritis. Fatigue.
Age: 43.0
Sex: M
Vaccine: ANTH, HEPA, TD
Symptoms: Dysphagia, Dyspnoea, Fatigue, Injected limb mobility decreased, Insomnia
Clinical narrative: Limited movement of Left Arm. Difficulty with swallowing. Joint and muscle pain. Shortness of breath. Unusual tiredness and weakness. Dark colored urine. Difficulty with moving. Hair loss and Thinning of hair. Muscle cramps and spasms. Trouble sleeping. Inflammatory arthritis. Fatigue.
Age: 43.0
Sex: M
Vaccine: ANTH, HEPA, TD
Symptoms: Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: Limited movement of Left Arm. Difficulty with swallowing. Joint and muscle pain. Shortness of breath. Unusual tiredness and weakness. Dark colored urine. Difficulty with moving. Hair loss and Thinning of hair. Muscle cramps and spasms. Trouble sleeping. Inflammatory arthritis. Fatigue.
Age: 19.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt. fainted for just a few seconds after the shot and once he gained consciousness he informed us that he could hear everything and apologized for not informing us earlier that he always passes out for less than a minute for any shots due to immense fear of shots. He was absolutely fine in less than a minute and said it wasn't because of vaccines.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at injection site, golf ball size.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever, redness, sore arm, malaise entire body more than 24 hours post.
Age: 0.7
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an 8 months old male patient. On 07-AUG-2015 the patient was inadvertently vaccinated with GARDASIL 9 (dose, strength and route were not reported, lot # reported as L011846, expiry date: 16-JUN-2017) (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA, lot # K012457, expiry date 04-JUN-2017, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 12 year old patient of unknown gender. There was no medical history or concurrent condition reported. The patient was vaccinated with 3 doses of PEDVAXHIB (lot#, expiration date, dose and route not reported) on 16-JUL-2003, 23-OCT-2003 and 22-JUN-2004, respectively. On 27-MAY-2015 the patient was vaccinated with a fourth dose of PEDVAXHIB (dosage, strength and route were not reported). There was no concomitant medication provided. At the time of the report, no adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K023537, expiry date 22-JUN-2016, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: Pt c/o right shoulder rash w/ body aches and chills. Area became red and swollen approx. 6 days after vaccine. Pt advised to use ice 10-15 min prn and ADVIL OTC prn pain.
Age: 78.0
Sex: F
Vaccine: TTOX
Symptoms: Blood culture, Injection site haematoma, Injection site haemorrhage, Injection site infection, Ultrasound scan
Clinical narrative: Received a tetanus shot on 6/29/15, for a puncture wound (R) arm; the next day my (L) arm developed a hematoma/infected area (L) upper arm-ecchymosis from injection site to elbow.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: (L) arm neuropathic pain.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Td administered Rt deltoid-red hot at injection site. Pain.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Nausea, Vomiting
Clinical narrative: Vomiting, nauseous, cramping.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: Fever of 102. Headache. Weak.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pruritus, Pyrexia, Tremor
Clinical narrative: Fever, shaking, chills, pain and itching at site area 4" x 3" around site.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Formication, Pruritus generalised
Clinical narrative: After shot pt started itching in arm, the following day patient started itching from head, neck, arms, and torso and MD said to use BENADRYL. Itching went away for 1.5 hours then came back and started feeling bugs crawling on skin. Recommended CLARITIN.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Fatigue, Sinusitis
Clinical narrative: She received MENVEO vaccine at 10:00 AM by 5:00pm became very tired, developed chills. On 7/17/15 went to walk in and had full blown sinus infection. Was given OMNICEF for 14 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Genital swelling, Lip swelling, Peripheral swelling
Clinical narrative: Pt vaccinated at 10 am on 7/13/15 with DTaP #3 and Hep B #3. Parents returned to clinic at 3:10 pm with patient complaining of swelling of lips, hands and genitals. Pt's temp was 98.6 axillary. Parents advised to monitor swelling and temp and go to ED if any increase in symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 48 hours after administration, patient experienced erythema, swelling and itchiness at injection site. Symptoms have since subsided without any treatment necessary.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Crying, Hypoaesthesia, Hypoaesthesia oral, Speech disorder
Clinical narrative: Mother brought child back into clinic at 11:40 AM. Reports she is crying and not making any sense with words. Ex: saying he when she should be saying she. Not knowing where she is. Reports right hand numb, right side face=tongue numb. Didn't feel right after vaccine gave but, didn't report to RN. Client reports numbness gone at 12:00 PM when left with mother, ambulating without assist. RN scheduled appt. today with PCP to evaluate.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh vaccine was administered was swollen, red, painful and warm to touch.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Varicella and MMRV given both today.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Electrocardiogram, Throat tightness, Wheezing
Clinical narrative: Patient left and within 15 minutes began to feel throat tighten and have difficulty breathing. Came back to clinic and was audibly wheezing and dyspneic. Gave epi/BENADRYL and sent to ER.
Age: 0.64
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Tachycardia, Urticaria
Clinical narrative: Hives within 5 minutes, also tachycardia. Received BENADRYL and monitoring.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Paraesthesia
Clinical narrative: Pt rec'd immunization at 8:30 am. Called office at 9:20 reporting episodes of "hot electrical shocks" lasting seconds. Took BENADRYL 50mg. Call back to pt at 9:45. Increase in episodes both frequency and length. BP 166/100 and episodes of SOB-used inhaler-sent to ED.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood glucose normal, Disorientation, Dyskinesia, Fall, Immediate post-injection reaction
Clinical narrative: Pt given MENACTRA. Then given HPV in other arm. Immediately after injection pt crossed arms around herself, fell backward and jerking arms and legs. Eyes open. Lasted 3-4 sec. No recollection of episode. Shaking and disoriented after for few seconds. No history of syncope with vaccines or seizures. Monitored 20 min and ok. No erythema around injection.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tremor
Clinical narrative: Pt given MENACTRA. Then given HPV in other arm. Immediately after injection pt crossed arms around herself, fell backward and jerking arms and legs. Eyes open. Lasted 3-4 sec. No recollection of episode. Shaking and disoriented after for few seconds. No history of syncope with vaccines or seizures. Monitored 20 min and ok. No erythema around injection.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Increased pain left upper arm and shoulder with movement of arm. No redness or swelling. Patient thinks injection given too high.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received ZOSTAVAX immunization on 7/9/15, followed up with pharmacy on 7/12 describing arm soreness, swelling, redness and warm sensation in 2 locations on same arm.
Age: 42.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, itching, grew to the size of about 3" x 3" injection site lasted a week and w/ the adverse effects hot to touch, sore.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Peripheral swelling, Pyrexia
Clinical narrative: Fever, arm swelling, headache.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site reaction, Local reaction
Clinical narrative: Local reaction at injection site upper left arm. Joints pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness site of injection associated with induration and pain, started evening of day of injection.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Area red/warm to touch/swollen x 2 days.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Less than 24 hours after child developed a hard, red swollen area around injection site, several blisters were present. Parents felt child had fever, no recorded temp but gave TYLENOL. Resolved by 8/3/15.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 8 cm. erythema at site, slightly warm. Applying ice to area 10-20 mins several times/day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster
Clinical narrative: Patient was diagnosed with shingles and cellulitis.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure, Syncope
Clinical narrative: Syncope and generalized tonic-clonic convulsions for approximately 10-15 seconds after last vaccine given (HPV) about 1-2 mins after vaccine received.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's left arm became red and swollen at injection site.
Age: 44.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Erythema and raised area, 85 x 70 cm, oblong in shape to MMR vaccination site.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Induration, Rash erythematous, Skin warm
Clinical narrative: Red rash, hard to the touch and hot to touch for 7 hours. To take BENADRYL 25 mg every 6 hours and Ibuprofen 200 mg 2 every 6 hours.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Rash started on 7/17/15, 10 days after vaccine given-rash got worse, spread from trunk to face and took to ER on 7/18/15 when welts appeared-T 98.9-gave Ibuprofen Q 6 h prn.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: I got shot 7-27, 7/29 I had itchy bumps on face, when I got home, hives all over my legs, I took 1 BENADRYL. 7/30 still there but not itching.
Age: 0.24
Sex: F
Vaccine: DTAP, RV1
Symptoms: Diarrhoea, Faeces pale, Haematochezia, Mucous stools
Clinical narrative: Was having one yellow seedy stool a day after mother eliminated airy in diet, exclusive breastfed. Previously had gross blood (occasional) loose and mucusy stools. After getting vaccines stools daily mucusy, one time with gross bld one stool a day. Breastfed. TX->increase ZANTAC observe for worsening. Cont. restrict dairy in diet. Continue exclusive breastfeeding.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Left hip pain 9 days after vaccination was administered on 7/28 pain more severe. On 7/29 feeling much better.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling and aching in left forearm and wrist.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has reported redness/swelling/pain at injection site. Visited clinic Dx: cellulitis.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Patient states of soreness x 4 days, then began to swell (size of grapefruit) and red and warm to touch and hard. Recommendation ice and hydrocortisone cream. Will call in AM to check on.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm, Staphylococcal infection
Clinical narrative: 7/13/15-patient reported red, hot, rash. Called pharmacy to report. RPh referred pt to doctor. Pt went to urgent care within 2 hrs of reporting. Rx-clindamycin 300mg three times a day for 10 days. 7/28/15 patient fully recovered.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Anxiety, Fatigue, Headache, Lethargy, Nightmare
Clinical narrative: Wheezing, required inhaler use at 15 min after shot, again 2 hrs later, again 8 hrs later. Arm swelling and pain. One hour of fever. Body aches and pains. Lethargy and fatigue. Anxiety. Nightmares. Headache. All of the above continued for 7 days except inhaler use; still wheezing but not used inhaler.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Pain in extremity, Peripheral swelling, Wheezing
Clinical narrative: Wheezing, required inhaler use at 15 min after shot, again 2 hrs later, again 8 hrs later. Arm swelling and pain. One hour of fever. Body aches and pains. Lethargy and fatigue. Anxiety. Nightmares. Headache. All of the above continued for 7 days except inhaler use; still wheezing but not used inhaler.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Tdap and MCV4 vaccine given in (L) arm on 8/3/15-mother came in with child on 8/4/15-(L) deltoid area red and very swollen-seen in urgent care prescribed medication.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Pt. received vaccinations at 1008. Pt. became dizzy, diaphoretic, dizzy, N/V at 1020. Temp 99.2, BP 110/75, HR 125. Pt. laid down, given juice, water, wet cloth. BP 102/70, HR 104 at 1025. Went home with mom at 1030. Educated mom to contact PCP provider if she felt needed and to contact HD with any further questions if needed.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Induration, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Rt arm swelling and induration approx. 20x10 cm. Also had fever 100, heaviness of chest and general malaise. Continue with ibuprofen which she was already taking. ?Cellulitis put on KEFLEX.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and redness on left thigh area. Hydrocortisone cream on local area as needed for itching.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episode lasting approx. 2 minutes immediately following vaccine adm. Recovered fully within 2 min.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episode immediately following immunizations. Pt recovered within 10 min. F/u 2 hours later - pt. WNL.
Age: 1.81
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Diarrhoea, Full blood count, Hypersensitivity, Pruritus, Pyrexia
Clinical narrative: Body allergy, itching, fever, vomiting (1), diarrhea (1).
Age: 1.81
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Viral infection, Vomiting
Clinical narrative: Body allergy, itching, fever, vomiting (1), diarrhea (1).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a health care worker refers to an unspecified number of patiens of unknown age. On an unknown date in between 02-JUL-2015 and 04-AUG-2015, the unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K007828 and expiry date: 02-MAR-2017). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Oral herpes, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a registered pharmacist referring to a 54 year old female patient with none pertinent medical history and none drug reactions/allergies. On 25-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, route and dose were unknown). Concomitant medication included thyroid medication. On an unspecified date in 2015, the patient then developed a rash that was itchy and red at injection site. The patient returned to the pharmacy on 06-AUG-2015. She showed the pharmacist the rash that was fading and was no longer itchy. There was redness around the injection site of the ZOSTAVAX. The patient also reported that she had a cold sore (in 2015) and did not specify where the cold sore was located on her body. The patient visited an unspecified physician on an unspecified date in 2015 for the cold sore and was prescribed FAMVIR. The patient declined the varicella zoster virus (VZV) analysis. The outcome of injection site rash was reported as recovering/resolving. The outcome of cold sore was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. On 06-AUG-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # K020750, expiration date 30-APR-2016) and a dose of VARIVAX (Merck) (lot # K009758, expiration date 09-JUL-2016) (overdose). No adverse experiences were reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 4 male patients of unknown age. No concurrent condition or medical history was reported. The patients were vaccinated with improperly stored GARDASIL (lot # K011562, Exp. 08-APR-2017, dose and route of administration not provided) from 29-JUL-2015 through 04-AUG-2015 (Incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. Product quality issue was not involved. This is one of the two reprots from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a male patient of unknown age. No concurrent condition or medical history was reported. On 02-AUG-2015, the patient was vaccinated with improperly stored M-M-R II (lot # K016153, Exp. 24-SEP-2016, dose and route of administration not provided) (Incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. Product quality issue was not involved. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Pt came in describing rash and bumps on her arm. Stated it was swollen from shoulder to elbow starting 8/8/15. Rash on arm was about 3 inches long by 2 inches wide. Advised pt to take some loratadine 10mg and call MD if symptoms persist.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiry date 02-MAR-2017, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Received DTaP on 07 Aug 2015 afternoon and had fever of 100.1 orally and increased red welt to right upper arm. Hot to touch. Softball size. Pt. went to urgent care.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Immediate post-injection reaction, Pallor
Clinical narrative: Patient received immunizations on 8/10/15. He first rec'd MCV4 and Tdap in (R) arm. He then rec'd HPV9 in (L) arm. Immediately, patient became pale, lightheaded and had brief fainting event. He hit (R) side of head when he fell to floor but recovered quickly. Diagnosed by me with vasovagal syncope related to immunizations/mild head trauma -> recovered fully, no serious sequelae.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient received immunizations on 8/10/15. He first rec'd MCV4 and Tdap in (R) arm. He then rec'd HPV9 in (L) arm. Immediately, patient became pale, lightheaded and had brief fainting event. He hit (R) side of head when he fell to floor but recovered quickly. Diagnosed by me with vasovagal syncope related to immunizations/mild head trauma -> recovered fully, no serious sequelae.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent condition and medical history. On 10-JUL-2015, the patient was inadvertently vaccinated with a dose of M-M-R II (lot # J007930, expiration date: 28-JUN-2015, strength, dose and route unknown) (expired product administered). At the time of reporting, no adverse event was reported. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Fever of 102 degrees, chills, body aches, lost 5 lbs over 5 days, injection site pain, redness, warm to touch. (All since injection on 8/5/15).
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 102 degrees, chills, body aches, lost 5 lbs over 5 days, injection site pain, redness, warm to touch. (All since injection on 8/5/15).
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Hallucination, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt woke up 8/8/15 at 2 AM with pain, redness and swelling in her (L) deltoid. She had a fever of 102 degrees and was dizzy and having hallucinations. Her arm was swollen the size of a baseball. She states that by Saturday evening her fever was gone and she was feeling better.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Pt woke up 8/8/15 at 2 AM with pain, redness and swelling in her (L) deltoid. She had a fever of 102 degrees and was dizzy and having hallucinations. Her arm was swollen the size of a baseball. She states that by Saturday evening her fever was gone and she was feeling better.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a 22 year old female patient. There was no information about concurrent condition and historical medication. On 18-FEB-1993, the patient was vaccinated with first of RECOMBIVAX HB, second dose on 12-MAR-1993 and third dose was given on 19-SEP-1993. There was no information about concomitant medication. On 28-JUL-2015, titers were drawn for immunity to Hepatitis B. The results of the serological testing were negative for Hepatitis B (Hepatitis B surface antibody negative). No product quality complaint (PQC) was involved. Patient was not given treatment for the event. The outcome of serological testing were negative was unknown. Causality between serological testing were negative and RECOMBIVAX HB was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity, Paraesthesia, Pharyngeal oedema, Red blood cell sedimentation rate normal
Clinical narrative: Bilateral arm pain below elbows and hand tingling, throat swelling within 12 hrs of vaccine.
Age: 36.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Pharyngeal oedema
Clinical narrative: Bilateral arm pain below elbows and hand tingling, throat swelling within 12 hrs of vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Gait disturbance, Headache, Influenza like illness, Injection site swelling
Clinical narrative: 8/6/15 Patient called c/o arm pain, body aches, fatigue, headache, swelling/warm to touch at site, cold/flu like symptoms, unsteady gait, lower extremities sore. Per patient applied cold compress with minor relief.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: 8/6/15 Patient called c/o arm pain, body aches, fatigue, headache, swelling/warm to touch at site, cold/flu like symptoms, unsteady gait, lower extremities sore. Per patient applied cold compress with minor relief.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patiens were vaccinated with improperly stored doses of M-M-R II lot # K024038, expiry date 26-NOV-2016, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Body temperature increased, Erythema, Movement disorder, Musculoskeletal stiffness, Swelling
Clinical narrative: Temp 101 degrees F, stiff arm, redness and swelling, unable to abduct arm past 90 degrees for 2 days where vaccine given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L010595 with expiration date of 12-NOV-2016; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This 14 yr old came to clinic for well child visit. He was due for a varicella vaccine and was given ZOSTAVAX.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unkonwn age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # L000718 with expiration date of 28-APR-2017, L009445 with expiration date of 01-JUN-2017 and lot# L007559 with expiration date of 01-JUN-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Administered 8/9/15. Pt noticed redness and itchiness a few hours later. Called on 8/11/15 to report site was better on 8/10/15 but has since gotten somewhat worse on 8/11/15. Suggested 50mg diphenhydramine and consult with Primary Care in morning of worsens.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Hep A, MCV4 were both administered with different needles on left deltoid. Pt was talking to me, 2 min later pt tried to get up, and fell, hit his head, called out for help. After pt woke up, had him lay down, breathe. Sat him down on chair, gave him Sprite to drink, took VP, resp. had him walk around.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # J014855, expiry date 16-APR-2016, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.71
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Vomiting severe x 24 hrs.
Age: 0.71
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Vomiting severe x24 hrs.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthenia, Dyspnoea, Pain
Clinical narrative: Body aches, weakness, shortness of breath.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored dose of ROTATEQ (lot # K016313, expiration date 31-MAY-2016, strength and dose not reported), oral. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Eye movement disorder, Fall, Seizure
Clinical narrative: After administering 5 vaccines the last 2 being Hep A and Tdap, the child swayed, eyes rolled back, fell back on table, convulsed for approx 20 seconds, sat up and asked what happened. BP = 73/38 at 1535. 911 called. Child taken to hospital via private vehicle in stable condition followed by ambulance.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot# J011629 with expiration date of 20-SEP-2015, lot# K005958 with expiration date of 09-FEB-2017, lot# K010579 with expiration date of 12-FEB-2017, lot# reported as L007559 with expiration date of 01-JUN-2017)(dose strength and route unknown). No concomitant therapy was provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from an unspecified reporter via company representative referring to 3 patients of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL intramuscular injection (dose, lot # and frequency unspecified). No concomitant medications were reported. On an unknown date, 3 of the patients experienced syncope after receiving GARDASIL 9. Reporter states no other known information concerning this event. No further information reported. The outcome of syncope was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pallor, Local reaction
Clinical narrative: Severe local reaction w/ erythematous blanchable rash 10cm x 15cm around injection site. No systemic symptoms.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Left deltoid swelling, soreness, fever 100.1.