chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site joint movement impairment, Insomnia, Joint stiffness, Pain
Clinical narrative: Typical body aches associated with the flu, shoulder joint extremely stiff, lifting arm very painful, sharp pains when reaching across body. It is my left shoulder. It has been a month. Still is very painful and stiff. Hard to sleep, hand falls asleep, or is numb when trying to sleep. Tried stretching, heat packs, still hurts.
Age: 49.0
Sex: M
Vaccine: FLUN4
Symptoms: Anosmia
Clinical narrative: Gradual loss of olfactory sense over a period of 2 to 3 months.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Generalised erythema, Swelling
Clinical narrative: General redness and slight discomfort day of/day after injection. 12/1/15 - redness spread and swelled to approx. size of grapefruit. Pt came into pharmacy for us to check. We told her to use cool compress, Benadryl, etc. and let us know if it worsens and to call 9-1-1 or visit ER if becomes life threatening.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Pain in upper left arm (felt like arm was punched), severe circular bruise approx. 2" diameter at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Onset of varicella appearing rash on right shoulder, neck and chest.
Age: 0.42
Sex: M
Vaccine: MNQHIB, RVX
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Dyspnoea, Eye discharge, Headache, Heart rate increased
Clinical narrative: Headache. Body aches.  Chest pain.  Shortness of breath.   Accelerated heartbeat.  Muscle cramps.  Pussy eyes.  Vision blurriness.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Pain, Purulent discharge, Vision blurred
Clinical narrative: Headache. Body aches.  Chest pain.  Shortness of breath.   Accelerated heartbeat.  Muscle cramps.  Pussy eyes.  Vision blurriness.
Age: 45.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Noted Left arm painful the morning following the vaccination with erythema and welting (firmness extending laterally) and onset of Temp > 102 that evening. Erythema and welting continued to spread and fever continued, peaking at day 3 before gradually receding. He also missed one day of work due to feeling so poorly, but says he felt fine by day 4. Client did not seek medical assistance.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Blood test, CSF test, Chills, Cough, Enterovirus test
Clinical narrative: Approximately 10 hrs after vaccination (pt had nasal congestion but no fever or cough), pt had 2 generalized tonic clonic seizures. Taken to ED. Admitted to PICU. 3mo exFT previously healthy baby presenting with new onset seizures. Has had rhinorrhea and mild cough last few days but feeding, voiding (x10 daily), stooling (x2 daily), regularly. Received his 2 month shots on day of admission (per parents 2 shots and one oral), and was a little fussier than usual afterwards so mom gave TYLENOL x2 at home. No fevers at home however. Woke up from sleep and around 8pm noted to have full body GTC seizures with mouth foaming, unresponsive, blank stare that lasted about 1 minute. Acted normally afterwards until developed second seizure x1 minute similar to the first, en route to the hospital. No sick contacts, emesis, diarrhea, rashes. Traveled over weekend but no foreign travel. Unremarkable birth history. NICU admission (8/21/-8/22/15) for sepsis workup at 12 days old. Per parents at this time he had a few episodes of "intense shiver" that lasted a few seconds but they didn't think anything of. Had AGE symptoms at the time so brought him to ED. Sepsis ruled out and presumed to have milk protein allergy. Feeds on alimentum since diagnosed with milk protein allergy. Takes about 4 oz q1h. Feeding normally today.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Foaming at mouth, Generalised tonic-clonic seizure, Intensive care, Irritability, Milk allergy
Clinical narrative: Approximately 10 hrs after vaccination (pt had nasal congestion but no fever or cough), pt had 2 generalized tonic clonic seizures. Taken to ED. Admitted to PICU. 3mo exFT previously healthy baby presenting with new onset seizures. Has had rhinorrhea and mild cough last few days but feeding, voiding (x10 daily), stooling (x2 daily), regularly. Received his 2 month shots on day of admission (per parents 2 shots and one oral), and was a little fussier than usual afterwards so mom gave TYLENOL x2 at home. No fevers at home however. Woke up from sleep and around 8pm noted to have full body GTC seizures with mouth foaming, unresponsive, blank stare that lasted about 1 minute. Acted normally afterwards until developed second seizure x1 minute similar to the first, en route to the hospital. No sick contacts, emesis, diarrhea, rashes. Traveled over weekend but no foreign travel. Unremarkable birth history. NICU admission (8/21/-8/22/15) for sepsis workup at 12 days old. Per parents at this time he had a few episodes of "intense shiver" that lasted a few seconds but they didn't think anything of. Had AGE symptoms at the time so brought him to ED. Sepsis ruled out and presumed to have milk protein allergy. Feeds on alimentum since diagnosed with milk protein allergy. Takes about 4 oz q1h. Feeding normally today.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Nasal congestion, Pollakiuria, Polymerase chain reaction, Respiratory viral panel, Rhinorrhoea
Clinical narrative: Approximately 10 hrs after vaccination (pt had nasal congestion but no fever or cough), pt had 2 generalized tonic clonic seizures. Taken to ED. Admitted to PICU. 3mo exFT previously healthy baby presenting with new onset seizures. Has had rhinorrhea and mild cough last few days but feeding, voiding (x10 daily), stooling (x2 daily), regularly. Received his 2 month shots on day of admission (per parents 2 shots and one oral), and was a little fussier than usual afterwards so mom gave TYLENOL x2 at home. No fevers at home however. Woke up from sleep and around 8pm noted to have full body GTC seizures with mouth foaming, unresponsive, blank stare that lasted about 1 minute. Acted normally afterwards until developed second seizure x1 minute similar to the first, en route to the hospital. No sick contacts, emesis, diarrhea, rashes. Traveled over weekend but no foreign travel. Unremarkable birth history. NICU admission (8/21/-8/22/15) for sepsis workup at 12 days old. Per parents at this time he had a few episodes of "intense shiver" that lasted a few seconds but they didn't think anything of. Had AGE symptoms at the time so brought him to ED. Sepsis ruled out and presumed to have milk protein allergy. Feeds on alimentum since diagnosed with milk protein allergy. Takes about 4 oz q1h. Feeding normally today.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Staring, Unresponsive to stimuli, Urine analysis, Viral test
Clinical narrative: Approximately 10 hrs after vaccination (pt had nasal congestion but no fever or cough), pt had 2 generalized tonic clonic seizures. Taken to ED. Admitted to PICU. 3mo exFT previously healthy baby presenting with new onset seizures. Has had rhinorrhea and mild cough last few days but feeding, voiding (x10 daily), stooling (x2 daily), regularly. Received his 2 month shots on day of admission (per parents 2 shots and one oral), and was a little fussier than usual afterwards so mom gave TYLENOL x2 at home. No fevers at home however. Woke up from sleep and around 8pm noted to have full body GTC seizures with mouth foaming, unresponsive, blank stare that lasted about 1 minute. Acted normally afterwards until developed second seizure x1 minute similar to the first, en route to the hospital. No sick contacts, emesis, diarrhea, rashes. Traveled over weekend but no foreign travel. Unremarkable birth history. NICU admission (8/21/-8/22/15) for sepsis workup at 12 days old. Per parents at this time he had a few episodes of "intense shiver" that lasted a few seconds but they didn't think anything of. Had AGE symptoms at the time so brought him to ED. Sepsis ruled out and presumed to have milk protein allergy. Feeds on alimentum since diagnosed with milk protein allergy. Takes about 4 oz q1h. Feeding normally today.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of with M-M-R II (lot # K011188 expiration date: 01-DEC-2016 and lot # K022284 expiration date: 01-DEC-2016) (dose, indication, route of administration and albumin status were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014712; 1511USA014714; 1511USA014715). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 27-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as in past six months), the patient was vaccinated with ZOSTAVAX (unknown route and dose) lot # L028280 and expiry date of 28-OCT-2015 in left arm. Concomitant medications were not reported. The patient had come to pharmacy to complain of injection site adverse events post vaccination with ZOSTAVAX. The patient developed cellulitis like reaction of left arm that traveled from the injection site down the whole left arm. The patient was seen by her physician and treated with antibiotics. The outcome of the events was resolve don an unknown date in 2015. Causality assessment was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (lot # K007263, expiration date 09-JUN-2016), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history and drug reactions/allergies were not reported. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not reported). Then, on an unspecified date in 2015 (reported as the weekend), the patient went to a pharmacy requesting a dose of ZOSTAVAX, which was administered. On 30-NOV-2015, the patient called to the pharmacist to report that she was already vaccinated in 2008. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008621, expiration date 04-MAR-2017), dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. 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 Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ ORAL, (lot # K022993, expiration date 26-JUL-2016) and (lot # L004466, expiration date 02-AUG-2016) (L006184, expiration date 13-DEC-2015), orally, doses were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.35
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cough, Otitis media, Pneumonia, Pyrexia, Seizure
Clinical narrative: Cough, fever (up to 103 degrees F) and seizure activity at around 8 p.m 11/21/15. Was transport to ER by EMS given TYLENOL. Mother was told that patient have (L) OM and pneumonia, given AMOXIL.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Ecchymosis, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Received flu shot 9/22/15 in (L) arm developed pain, swollen red arm, then extend down upper arm, gets ecchymotic and itchy.
Age: 23.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Extreme arm pain from flu vaccine (L) deltoid.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Pt reported swelling of lips.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Developed fever and rash.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Redness/pain/swelling ecchymosis around injection site/area warm to touch. Dx: Allergic rx at doctor.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Redness/pain/swelling ecchymosis around injection site/area warm to touch. Dx: Allergic rx at doctor.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Oral herpes
Clinical narrative: Dizziness x 3 day, nausea w/o vomiting, perioral fever blisters lasting 2 weeks duration.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (over the last 90 days), the patients were vaccinated with ZOSTAVAX (unknown route and dose) for prevention of herpes zoster. Concomitant medications were not reported. The pharmacist stated that another pharmacist who works at another store had been receiving a "usually large" amount of complaints of injection site pain from patients who had ZOSTAVAX administered over the last 90 days. The outcome of the event was unknown. Causality assessment was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling at site of injection. Contacted MD -> pt. advised to visit urgent care. Was prescribed cephalexin 500 mg, #20 (twice a day) x 10 days. Follow up with pt. later today and Thurs 12/3/15.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Pain in extremity
Clinical narrative: Pt has had severe upper arm pain -> from the shoulder to the elbow and stated - she developed a hematoma where the vaccine was administered (left arm) she will go to her PCP.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Vaccine placed on 11/29/15. Patient started having arm pain that ultimately encompassed the whole left shoulder.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient received a flu shot on 10/23 and it's still hard for me to lift up her arm, she feels it all the time, muscle pain.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Influenza nasal mist administerd to pregnant teen on 11-30-15. On 12-1-15, reported runny nose and slight sore throat.
Age: 19.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Chills, Myalgia, Neck pain, Ocular hyperaemia, Paraesthesia
Clinical narrative: Case number PHEH2015US017995, is an initial spontaneous report received from a physician via sales representative on 10 Sep 2015. This report refers to a 19 year old male patient. Historical condition included asthma, vocal cord dysfunction, acne and vitamin D deficiency all these were well controlled and not active at time of immunization. Concomitant medications were not reported. He was vaccinated with first dose of BEXSERO (batch number: 148901A) at dose of 0.5 ml intramuscularly into left deltoid and FLUARIX (batch number: 7AJ5J) at a dose of 0.5 ml intramuscularly into right deltoid both on 03 Sep 2015 at 2:20 PM. On 08 Sep 2015, after vaccination, the patient experienced some chills, woke with myalgia, tactile fever and no rash. On 10 Sep 2015, the patient experienced paresthesia described as prickly stuff on the chest /abdomen not fingers or toes (prickly pain on his chest and arms that hurts to the touch), sore neck and red left eye/ redness of the eye. Clinical neurological examination shows no imaging, physical exam was normal and he had a good deep tendon reflexes. He was prescribed corticosteroids inhaled but he was not taking. The outcome of the event sore neck was not reported, some chills, woke with myalgia, tactile fever completely recovered by the end of day on 08 Sep 2015, paresthesia described as prickly stuff on the chest /abdomen completely recovered within 2 to 3 days from onset and for other red left eye/ redness of the eye it was reported as condition unchanged. The seriousness of the event tactile fever was not reported and for other events it was reported as non serious. The causality of the events myalgia, chills, paresthesia and red left eye were reported as suspected as related to BEXSERO and for other events it was not reported. Follow up report from the physician received on 26 Oct 2015: added new event (tactile fever), updated suspect products information (date, time, route, and dose), medical history, and outcome of the events (myalgia, chills, paresthesia and tactile fever), changed onset date of event from 07 Sep 2015 to 08 Sep 2015 (myalgia, chills).
Age: 19.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Pyrexia, Tenderness
Clinical narrative: Case number PHEH2015US017995, is an initial spontaneous report received from a physician via sales representative on 10 Sep 2015. This report refers to a 19 year old male patient. Historical condition included asthma, vocal cord dysfunction, acne and vitamin D deficiency all these were well controlled and not active at time of immunization. Concomitant medications were not reported. He was vaccinated with first dose of BEXSERO (batch number: 148901A) at dose of 0.5 ml intramuscularly into left deltoid and FLUARIX (batch number: 7AJ5J) at a dose of 0.5 ml intramuscularly into right deltoid both on 03 Sep 2015 at 2:20 PM. On 08 Sep 2015, after vaccination, the patient experienced some chills, woke with myalgia, tactile fever and no rash. On 10 Sep 2015, the patient experienced paresthesia described as prickly stuff on the chest /abdomen not fingers or toes (prickly pain on his chest and arms that hurts to the touch), sore neck and red left eye/ redness of the eye. Clinical neurological examination shows no imaging, physical exam was normal and he had a good deep tendon reflexes. He was prescribed corticosteroids inhaled but he was not taking. The outcome of the event sore neck was not reported, some chills, woke with myalgia, tactile fever completely recovered by the end of day on 08 Sep 2015, paresthesia described as prickly stuff on the chest /abdomen completely recovered within 2 to 3 days from onset and for other red left eye/ redness of the eye it was reported as condition unchanged. The seriousness of the event tactile fever was not reported and for other events it was reported as non serious. The causality of the events myalgia, chills, paresthesia and red left eye were reported as suspected as related to BEXSERO and for other events it was not reported. Follow up report from the physician received on 26 Oct 2015: added new event (tactile fever), updated suspect products information (date, time, route, and dose), medical history, and outcome of the events (myalgia, chills, paresthesia and tactile fever), changed onset date of event from 07 Sep 2015 to 08 Sep 2015 (myalgia, chills).
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Apnoea, Blood culture positive, Bradycardia, C-reactive protein increased, Continuous positive airway pressure
Clinical narrative: Incessantly needing stimulation (desats/bradycardia) and apnea 10/10 evening - required PPV with facemask/bag a few hours after receiving PEDIARIX. * Blood Cx of 10/10/15 2150 (+). 10/9/15 increased spells receiving stimulation - vigorous and BBO2. 10/11/15 (R) thigh slightly swollen and firm after PEDIARIX vaccination.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Injection site induration, Injection site swelling, Oxygen saturation decreased
Clinical narrative: Incessantly needing stimulation (desats/bradycardia) and apnea 10/10 evening - required PPV with facemask/bag a few hours after receiving PEDIARIX. * Blood Cx of 10/10/15 2150 (+). 10/9/15 increased spells receiving stimulation - vigorous and BBO2. 10/11/15 (R) thigh slightly swollen and firm after PEDIARIX vaccination.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Staphylococcal infection
Clinical narrative: Pt's right arm swelled up and working it's way down the arm after 2 days of receiving PNEUMOVAX vaccine. Went to see PCP and diagnosed with a staph infection.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Hypoaesthesia oral, Paraesthesia, Throat irritation
Clinical narrative: Approx 15 minutes after vaccine administered, pt. developed hoarseness, throat irritation. Was given 25 mg PO BENADRYL. Approx 50 minutes after administraiton, pt. developed mouth and tongue numbness and tingling. Took 50mg more of PO BENADRYL.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Pruritus, Rash generalised, Rash macular
Clinical narrative: Symptoms: Patient went to sleep in afternoon after vaccination w/FLUZONE QUAD. Awoke with itching on both sides of chin, which progressed to red blotches on face difficulty breathing, overall body rash, dizziness. Treatment: Patient waited 1 week to seek treatment < OTC BENADRYL ZYRTEC Cetaphil cleanser hydrocortisone valerate 0.24% ointment.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Employee states she received influenza immunization at 530am on 11-3-15 at work. She reports, on 11-6-15 430 AM, feeling more severe pain at right lower back, buttock. Treatment = massage therapist appointment at medical center.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: About ten minutes after injection I felt a flush through my body like the feeling of MRI dye and got a frontal headache that hasn't gone away in two days. Felt heart race and palpitations and arm very hot and painful. Next day noticed red hot raised rash below injection site.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Rash erythematous, Skin warm
Clinical narrative: About ten minutes after injection I felt a flush through my body like the feeling of MRI dye and got a frontal headache that hasn't gone away in two days. Felt heart race and palpitations and arm very hot and painful. Next day noticed red hot raised rash below injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus generalised
Clinical narrative: Rash at injection site. Per pt developed itching all over chest and back, starting on face. Took 3 doses of BENADRYL. Contacted PCP. Pt seeing MD today.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Urticaria
Clinical narrative: Client received TWINRIX on 12-1-15 the same evening she reports breaking out with rash to same arm but 2 inches below site of vaccine injection. No pain, itching or other s/s. Client reports to clinic next day with wheal to that area only. Still no other complaints. Somewhat irregular superficial localized to (L) arm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, (lot # L004014, expiration date 04-MAR-2017), (lot # L007560, expiration date 15-JUN-2017) and (lot # L011846, expiration date 16-JUN-2017), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from female consumer of unknown age referring on herself. The patient had a medical history of herpes zoster approximately in May 2011. On 11-MAR-2013, the patient was vaccinated with ZOSTAVAX (route, strength and dose unknown). There was no concomitant medication reported. Approximately in February 2014, after she received the vaccination with ZOSTAVAX, the patient experienced shingles again. It was also reported that on November 2015, the patient had experienced shingles again. The outcome of shingles developed in February 2014 was considered as recovered. The outcome of shingles developed in November 2015 was unknown. The relatedness between the events and ZOSTAVAX was unknown. The seriousness assessment was not provided. Additional information is not expected as no contact information was provided.
Age: 37.0
Sex: M
Vaccine: FLUC3
Symptoms: Condition aggravated, Haematocrit normal, Haemoglobin normal, Haemorrhage, Immune thrombocytopenic purpura
Clinical narrative: Hx of ITP with mild, progressive decline of platelets over several months. However, 2 weeks after 9/30/2015 influenza vaccine, plts dropped nearly 40,000 to 8K total platelets, with accompanying bleeding.
Age: 37.0
Sex: M
Vaccine: FLUC3
Symptoms: Platelet count decreased
Clinical narrative: Hx of ITP with mild, progressive decline of platelets over several months. However, 2 weeks after 9/30/2015 influenza vaccine, plts dropped nearly 40,000 to 8K total platelets, with accompanying bleeding.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Herpes zoster, Hypoaesthesia, Influenza like illness, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Shingles - tingling and numbness - left side of face, neck, shoulder and arm - 36 hrs. after injection - flu like symptoms. Treatment - 5 courses of VALTREX - still prescribed 3 mos. post injection.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Shingles - tingling and numbness - left side of face, neck, shoulder and arm - 36 hrs. after injection - flu like symptoms. Treatment - 5 courses of VALTREX - still prescribed 3 mos. post injection.
Sex: F
Vaccine: RAB, TDAP
Symptoms: Dizziness, Pharyngeal oedema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dizziness in a adult female patient who received BOOSTRIX. Co-suspect products included RABAVERT. Concomitant products included CYMBALTA. On 3rd November 2015, the patient received BOOSTRIX and RABAVERT. on 4th November 2015, 1 days after receiving BOOSTRIC and RABAVERT, the patient experienced dizziness and throat swelling. The patient was treated with prednisone and antihistamine. On an unknown date, the outcome of the dizziness and throat swelling were unknown. The reporter considered the dizziness and throat swelling to be possibly related to BOOSTRIX and RABAVERT. Additional details were received as follows: On 3rd November 2015, in the evening, the patient received a dose of BOOSTRIX and RABAVERT. On 4th November 2015, in the morning the patient experienced dizziness and swollen throat.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was inadvertently vaccinated with a pediatric dose of VAQTA (lot#, expiration date, strength, dose and route were unknown). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional concerning a patient of unknown gender and age. The patient pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot # L040415, expiration date: 13-APR-2017) (route not provided). No adverse effects were provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaeous report was received from a healthcare worker and refers to a 5 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two healthcare professionals concerning unspecified patients (demographics unknown). On unspecified dates since 07-OCT-2015, 3 doses of VARIVAX (Merck) (Lot# K008823; expiration date: 19-JUN-2016) which were exposed to temperatures outside of the recommended range, were administered to the unspecified patients. No adverse effects had been reported. It was also reported that no additional doses of VARIVAX (Merck) were administered. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. The patients medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL lot # K008931, expiration date: 04-MAR-2017 (dose and route were not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On 23-NOV-2015, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L006184 and expiration date 13-DEC-2016, lot # reported as L008051 and expiration date 17-NOV-2016, lot # L008057 and expiration date 01-DEC-2016, exact doses were not reported, route of administration defaulted to oral). It was unknown which of the lots of the vaccine were administered on that date, so all lots for the product were listed. No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. The patients medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II lot # L001336, expiration date: 13-JAN-2017 (dose and route were not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with 13 improperly stored doses of VARIVAX (Merck) injection (dose, lot#, route of administration and expiration date were not reported). No adverse effects reported. This is one of the two reports from the same source. 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On 23-NOV-2015, the patients were vaccinated with improperly stored doses of VAQTA (lot # K018181 and expiration date 04-JUN-2017, lot # L018499 and expiration date 25-FEB-2017, lot # L028666 and expiration date 04-NOV-2016, exact doses and route of administration were not reported). It was unknown which of the lots of the vaccine were administered on that date, so all lots for the product were listed. No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On 23-NOV-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HIB (lot # L016427 and expiration date 13-APR-2017, lot # L018501 and expiration date 22-JUN-2017, lot # L025738 and expiration date 14-AUG-2017, exact doses and route of administration were not reported). It was unknown which of the lots of the vaccine were administered on that date, so all lots fro the product were listed. No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. The patients medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) lot # reported as L025206, expiration date: 07-JUL-2017 (dose and route were not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient developed a rash.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as in past six months), the patient was vaccinated with ZOSTAVAX (unknown route and dose) lot # L028280 and expiry date of 28-OCT-2015 in left arm. Concomitant medications were not reported. The patient had come to pharmacy to complain of injection site adverse events post vaccination with ZOSTAVAX. The patient developed injection site reaction of left arm that was circumference of egg size, raised, warm, painful on an unknown date in 2015. The outcome of the events was unknown. Causality assessment was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Middle insomnia, Pain, Pain in extremity
Clinical narrative: I received flu injection, upper left arm on 10/27/15. For a second I felt faint and a heavy rush feeling through my arm. Later that evening my arm began to hurt with certain movements. During the night the pain grew more severe and woke me up every hour. The pain was a sharp ache mostly in my inner bicep area. Now at time tenderness in my shoulder and elbow joint, tender when pressure applied. After 7 days, still having severe pain through the night and off and on during the day, I saw the doctor, on 11/9/15; he prescribed Gabapentin 100 mg and Hydrocodone-Acetaminophen 5-325. As of 11/25/15 I am still experiencing pain, and cannot raise my arm over my head without pain.
Age: 1.01
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 26-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vomiting in a 31-year-old male patient who received FLUARIX quadrivalent (batch number 2SN22, expiry date 30th June 2016). In 2015, the patient received FLUARIX quadrivalent. In 2015, 4 hrs after receiving FLUARIX quadrivalent, the patient experienced vomiting, fever and diarrhea. On an unknown date, the outcome of the vomiting, fever and diarrhea were unknown. It was unknown if the reporter considered the vomiting, fever and diarrhea to be related to FLUARIX quadrivalent. Additional details provided were as follows: The patient experienced fever greater than 101 degree F.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 23-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562 and expiration date 08-PR-2017, lot # K016966 and expiration date 10-MAY-2017, exact doses and route of administration were not reported). It was unknown which of the lots of the vaccine were administered on that date, so all lots for the product were listed. No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. From an unspecified date in June 2015, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # was reported as J002621, expiration date 29-NOV-2015; strength, route and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. From an unspecified date in June 2015, the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23 (lot # L014458, expiration date 11-FEB-2017; strength, route and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers unspecified number of patients of unknown age and gender who on 24-NOV-2015 were vaccinated with improperly stored VARIVAX (Merck) [lot # L001334, Expiry date: 10-JUN-2017, Lot# L001334, Expiry date: 13-JAN-2017]. No adverse events were reported. This case is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers unspecified number of patients of unknown age and gender who on 24-NOV-2015 were vaccinated with improperly stored PROQUAD (Merck) lot # L032759, Expiry date: 24-FEB-2017, Lot # L033698, Expiry date: 28-FEB-2017. No adverse events were reported. This case is one of the two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L007226, expiry date 03-MAR-2017 or lot# L019126, expiry date 27-MAY-2017 (routes and doses were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to at least 5 patients of unknown demographics. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L016428, expiry date: 30-JUL-2017) (confirmed that it was not GARDASIL). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck), (lot # L031600 expiration date: 18-FEB-2017 and lot # L019998 therapy type rHA, expiration date: 02-DEC-2016) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014713; 1511USA014714; 1511USA014715). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with 11 improperly stored doses of PROQUAD (Merck) injection (dose, lot#, route of administration and expiration date were not reported). No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.