chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture urine negative, Cyanosis, Dyskinesia, Dyspnoea, Electroencephalogram normal
Clinical narrative: Former 32 week preemie, received PENTACEL, ROTATEQ and PREVNAR 3/31/15. Red, hot swollen leg noted 4 hrs later, through evening pt had 3 episodes of very exaggerated startle reflex, one episode myoclonus. No fever at that time but developed fever to 102 next AM. Had several spells of choking, turning blue, apneic x 20 min with AM feed. The patient is a 12 week old female who presents for a follow up. This is a follow up visit for other (she was here yesterday for her 2 mo immunizations). Received PENTACEL in right leg, PREVNAR in left leg, and ROTATEQ by mouth. Right leg with some swelling, redness and warmth yesterday. Then last night mom noticed 3 episodes, about 15 secs apart, where patient had "stiffening of her legs and arms", and eyes rolled back in her head. Mom states that it was almost like an exaggerated startle reflex. Episodes lasted about 3 secs each. About 4 AM today, her left leg straightened, and then Dad saw some bouncing of her leg. This AM she woke up with a fever of 102. Her breathing has also been faster, louder, and more irregular than usual. Also, this AM she has had about 6 episodes of breath holding, and turning blue while taking her MBM bottle. Mom has blown in her face, and then she breathes again. She's been spitting up more forcefully and frequently than she did before yesterday. Child seemed perfectly well before getting vaccines yesterday AM, no fever, feeding well and gaining well. Parents are medical professionals (dad general surgery, mom RN) with no vaccine prejudices; older brother is fully vaccinated without any problems. As per yesterday's notes, after getting PENTACEL, PREVNAR and ROTATEQ developed marked fussiness, right thigh (site of PENTACEL) was red, hot and swollen. She did have an unusually loud cry and was very difficult to console. I saw her back in the office about 5 hours later and did confirm all the above findings. Afebrile on both visits. She continued to be very fussy through the night and did get BENADRYL and TYLENOL at about 6 PM. Increased salivation noted. At 9 PM mom started to change her diaper and patient had an unusual movement "like an exaggerated startle reflex" in which she stiffened, arms flew out in front of her with fingers spread, legs stiffened and toes pointed down, and her eyes grew very wide, then rolled back in her head. This only lasted about a second but was repeated 3 times over a minute. Then at midnight dad observed "myoclonic jerking" of left leg for a few seconds. She did vomit once last PM and has continued to spit up more than usual this AM. Temp of 102 at 8 AM today; mom was monitoring temperatures yesterday and those were normal. No fever noted at the time of the unusual motor movements. At 8:30 feed this AM child was fussy, crying and choking with feeds to the point of turning blue, apnea lasted for about 20 seconds. Several times mom had to withdraw bottle, blow in child's face and stimulate her to resume breathing. Last TYLENOL at 8 AM this AM, no fever here. Fed ok at 12:30 today.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Former 32 week preemie, received PENTACEL, ROTATEQ and PREVNAR 3/31/15. Red, hot swollen leg noted 4 hrs later, through evening pt had 3 episodes of very exaggerated startle reflex, one episode myoclonus. No fever at that time but developed fever to 102 next AM. Had several spells of choking, turning blue, apneic x 20 min with AM feed. The patient is a 12 week old female who presents for a follow up. This is a follow up visit for other (she was here yesterday for her 2 mo immunizations). Received PENTACEL in right leg, PREVNAR in left leg, and ROTATEQ by mouth. Right leg with some swelling, redness and warmth yesterday. Then last night mom noticed 3 episodes, about 15 secs apart, where patient had "stiffening of her legs and arms", and eyes rolled back in her head. Mom states that it was almost like an exaggerated startle reflex. Episodes lasted about 3 secs each. About 4 AM today, her left leg straightened, and then Dad saw some bouncing of her leg. This AM she woke up with a fever of 102. Her breathing has also been faster, louder, and more irregular than usual. Also, this AM she has had about 6 episodes of breath holding, and turning blue while taking her MBM bottle. Mom has blown in her face, and then she breathes again. She's been spitting up more forcefully and frequently than she did before yesterday. Child seemed perfectly well before getting vaccines yesterday AM, no fever, feeding well and gaining well. Parents are medical professionals (dad general surgery, mom RN) with no vaccine prejudices; older brother is fully vaccinated without any problems. As per yesterday's notes, after getting PENTACEL, PREVNAR and ROTATEQ developed marked fussiness, right thigh (site of PENTACEL) was red, hot and swollen. She did have an unusually loud cry and was very difficult to console. I saw her back in the office about 5 hours later and did confirm all the above findings. Afebrile on both visits. She continued to be very fussy through the night and did get BENADRYL and TYLENOL at about 6 PM. Increased salivation noted. At 9 PM mom started to change her diaper and patient had an unusual movement "like an exaggerated startle reflex" in which she stiffened, arms flew out in front of her with fingers spread, legs stiffened and toes pointed down, and her eyes grew very wide, then rolled back in her head. This only lasted about a second but was repeated 3 times over a minute. Then at midnight dad observed "myoclonic jerking" of left leg for a few seconds. She did vomit once last PM and has continued to spit up more than usual this AM. Temp of 102 at 8 AM today; mom was monitoring temperatures yesterday and those were normal. No fever noted at the time of the unusual motor movements. At 8:30 feed this AM child was fussy, crying and choking with feeds to the point of turning blue, apnea lasted for about 20 seconds. Several times mom had to withdraw bottle, blow in child's face and stimulate her to resume breathing. Last TYLENOL at 8 AM this AM, no fever here. Fed ok at 12:30 today.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a three children of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On 18-MAR-2015 the three patients were vaccinated with VARIVAX (Merck) (dose, route of administration, lot# and expiration  date not reported). The VARIVAX (Merck) was improperly stored. There were no adverse effects reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Biopsy skin abnormal, Injection site pruritus, Injection site scar, Injection site urticaria, Paraesthesia
Clinical narrative: Recurrent solitary urticarial lesion with pruritus at Jennerian scar site of previous smallpox vaccine. Rash, oth nonspecific skin eruption, Disturbance of skin sensation. We did biopsy evaluation and tryptase, showed some abnormalities but did not meet clinical diagnosis. We have given him a dx of recall urticaria, with trx of prn ZYRTEC.
Age: 20.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Rash, Tryptase
Clinical narrative: Recurrent solitary urticarial lesion with pruritus at Jennerian scar site of previous smallpox vaccine. Rash, oth nonspecific skin eruption, Disturbance of skin sensation. We did biopsy evaluation and tryptase, showed some abnormalities but did not meet clinical diagnosis. We have given him a dx of recall urticaria, with trx of prn ZYRTEC.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Rash, urticaria, pruritus and unilateral raised red bumps on chest and back.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certificated medical assistant referring to three patients of unknown age. On unspecified dates in February 2015 the patients were respectively vaccinated with a dose of VARIVAX (Merck) (dose, route and lot# unknown) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse via a company representative concerning his teenage son of unknown age. Information regarding concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and lot # were not reported, intramuscular). Concomitant therapy was not reported. The reporter said that the patient experienced lightheadedness that resolved within minutes on an unspecified date shortly after injection of GARDASIL. The reporter did not report that which GARDASIL product was involved. The patient was in doctor's office at the time to seek medical attention. There was no treatment given for the event. There was no lab diagnostics study performed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to a 24 hear old female patient. Patient's pertinent medical history and drug allergies were unspecified. On 02-MAR-2015 the patient received VARIVAX (Merck) (lot # J014152, expiry date: 07-NOV-2015), .5 ml, subcutaneous. Concomitant medications were unspecified. After receiving VARIVAX (Merck), she experienced significant swelling, redness, inflammation and itching in a 3-inch area at the injection site and the injection site was warm to touch on an unspecified date in March 2015. Patient sought medical attention on an unspecified date and went to see the nurse. Patient was treated with ice compress. Reporting nurse stated that she used the sterile diluents provided, but had not recorded the lot number. The outcome of the events was reported as recovering. Causality assessment was not provided. This is one of several reports from the same reporter (MARRS # 1503USA010513). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to a 24 hear old female patient. Patient's pertinent medical history and drug allergies were unspecified. On 02-MAR-2015 the patient received VARIVAX (Merck) (lot # J014152, expiry date: 07-NOV-2015), .5 ml, subcutaneous. Concomitant medications were unspecified. After receiving VARIVAX (Merck), she experienced significant swelling, redness, inflammation and itching in a 3-inch area at the injection site and the injection site was warm to touch on an unspecified date in March 2015. Patient sought medical attention on an unspecified date and went to see the nurse. Patient was treated with ice compress. Reporting nurse stated that she used the sterile diluents provided, but had not recorded the lot number. The outcome of the events was reported as recovering. Causality assessment was not provided. This is one of several reports from the same reporter (MARRS # 1503USA010513). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis
Clinical narrative: Celluliits-being treated with AUGMENTIN of left arm as per patient.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Hypersensitivity, Limb discomfort, Malaise, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist and the patient referring to a 59 year old female patient with diverticulitis and allergy to nickel. In approximately 1995, 20 years ago, while the patient was being treated for diverticulitis in a hospital, she received a dose of PNEUMOVAX 23 (reported as (unspecified) "pneumonia shot"), (lot number, expiry date, route, dose were not reported). Subsequently, the patient experienced a "severe allergic reaction". She stated the event as "I thought my arm was going to come off. My arm swelled to three times its size, and they had to call the doctor in the middle of the night". The patient also reported the bone in her arm hurt very badly. There were no lab diagnostics studies performed. The patient stayed in the hospital for one or two days because she "got so sick from the pneumonia shot". The events lasted a couple of days, and then recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Chemotherapy, Herpes zoster, Mastectomy, Rash
Clinical narrative: Information has been received from a 66 year old registered nurse referring to herself. Information regarding concurrent conditions and medical history was not provided. The patient had no drug reactions/allergies. In 2010 ("unspecified date approximately 5 years ago") the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot #, route and application site were not reported). Concomitant therapies included lisinopril (manufacturer unknown). On 20-MAR-2012 the patient was diagnosed, by an unspecified physician, with breast cancer in her left breast. A mastectomy was completed, by an unspecified physician, in June 2012, and she began treatment with chemotherapy, exact chemotherapy agent unspecified, for 6 months. Also in June 2012, she started radiation treatments; a total of 36 radiation treatments received with the completion date unspecified. The patient stated that she had been cancer free since being treated. On 26-MAR-2015 the patient developed a shingles rash. She did not seek assessment or treatment from a physician. The patient stated that she treated herself with cold compress, calamine lotion and BENADRYL. She stated that she was recovering from the rash at the time of report. The causality was not rated by reporter. Upon internal review, breast cancer was considered to be medical significant event. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HIBV, RV1
Symptoms: Crying, Erythema, Injection site erythema, Pyrexia, Screaming
Clinical narrative: Inconsolable crying, red faced screaming, fever, redness at injection sites.
Age: 27.0
Sex: F
Vaccine: HEPA, RAB, YF
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth, pain at yellow fever injection site diagnosed as cellulitis. Expansion of affected area noted on 3/30/15, borders marked and area markedly increased on 03/31/2015. Augmentin started on 03/30/2015 3 doses completed, discontinued 4/1/2015. Bactrim started 4/1/2015 for 10 days, improvement noted after 4 doses, plan to continue for 10 days.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 13-MAR-2015, the patient was inadvertently administered an expired dose of MMR II inject, lot # H017432, expiry date: 20-SEP-2014, (dose and route were not reported). No adverse effect reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 62 year old female patient. The patient's medical history was not reported. On 04-MAR-2015, the patient was vaccinated with single dose of ZOSTAVAX lot # K016320, expiration date 24-DEC-2015, subcutaneously (dose and administration site were not reported). The vaccine was reconstituted with sterile diluent lot # K011199, expiration date 29-MAY-2017. In March 2015 (reported as after receiving ZOSTAVAX, the patient experienced an area 2-3 inches with redness, that was hard and warm to touch. The outcome of injection site erythema, injection site induration and injection site warmth was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-AUG-2014 the patient was vaccinated with first dose of VAQTA (25/0.5 (units not provided), 0.5 ml, intramuscular). On 11-AUG-2014 the patient was vaccinated with second dose of VAQTA (dose, strength, route and site of administration not reported). On 27-MAr-2015 the patient was accidentally vaccinated with third dose of VAQTA (dose, strength, route and site of administration not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Dysphonia, Flushing, Hypersensitivity, Rash macular, Throat tightness
Clinical narrative: Approximately 30-45 minutes after vaccination, patient c/o allergic reaction, flushing, hoarseness and throat closing. Pt in clinic had her own diphenhydramine and took 25mg x 2 PO and injected her own Epi-pen. NP observed flushed face and neck and red blotches on her body. RN called EMS and started PIV. EMS injected diphenhydramine 50mg IV and transported to ED. Vital signs at 3:58 PM: BP 169/110, HR 100 02 sats 99%. In ED, patient received diphenhydramine 50mg IV at 1622, methylprednisolone 125mg IV at 1623, normal saline 500ml IV at 1644, KCL 40mEq PO at 1956 and 2049 (for low K+), ipratropium-albuterol nebulizer at 2050, lorazepam 1mg PO at 2218 and KCl 10mEq in 100ml NS at 2228.  Patient was observed and monitored in ED overnight and discharged in early AM on 4/2/15 with no additional reactions.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Immunoglobulin therapy, Laboratory test
Clinical narrative: Diagnosed with CIDP. Currently undergoing IVIG treatment.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored MMR II (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On 31-MAR-2015, the patient was vaccinated with expired dose of MMR II, lot # J003623, expiry date 22-MAR-2015, 0.5 milliliter (ml), subcutaneously, for an unknown indication. No symptoms reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No other details were provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 60 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. Information about the patient's drug reactions/allergies was not reported. On 03-MAR-2015, the patient was vaccinated with ZOSTAVAX, single dose, subcutaneous, lot # K016320 and expiration date 24-DEC-2015 for prevention of shingles. The pharmacist reported that the patient had ZOSTAVAX reconstituted with sterile diluent (lot # K011199, expiration date 29-MA-2017). On an unknown date, in approximately March 2015, the patient experienced injection site reaction. The patient sought medical attention via visiting a physician. The outcome of injection site reaction was unknown. The relatedness between the event and ZOSTAVAX and sterile diluent was not reported. The pharmacist requested via company representative a lot check on ZOSTAVAX, lot# K016320 and sterile diluent, lot # K011199. This is one of 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: Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose and route unspecified). No adverse effects reported. 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: Information has been received from a health professional concerning unspecified number of unspecified patients. No concurrent or historical conditions were reported. On unspecified dates since 01-NOV-2014, the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot number, dose and strength were not reported). No adverse effects were reported. This case was one of three cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown dates these patients were vaccinated with doses of improperly stored ROTATEQ (dose, frequency and lot# were not reported) orally. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Nervousness, Pallor
Clinical narrative: Within 5 minutes of vaccination, becaome short of breath, pale lightheaded and complained of not being able to breathe.  Received epinephrine at the office - 0.3 mg IM symptoms improved.  EMS called and taken to emergency room. Benadryl 50 mg IV was administered by EMS.  Still felt shaky on arrival to emergency room. Observed in ED for 2 additional hours with no further intervention required. No stridor, clear airway and able to walk without difficulty. PMH for childhood asthma.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Employee began to c/o "itching" on the evening of administration of Hep B vaccine.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Joint swelling, Vaccination site swelling
Clinical narrative: Patient started with pain in her left shoulder and swelling in the left upper arm at the vaccinations site.  Then in to her left hip. This has resolved but she now has pain and discomfort in her left knee.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dyspnoea, Sensation of foreign body
Clinical narrative: 90 mins after Hepatitis B shot pt had chest pain, SOB and lump in throat.
Sex: U
Vaccine: HPV4, HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. The patient was vaccinated with two doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose was unknown, intramuscular) which underwent an unsupported temperature excursion on 08-AUG-2014 and 09-SEP-2014 respectively. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. The patient was vaccinated with two doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose was unknown, intramuscular) which underwent an unsupported temperature excursion on 08-AUG-2014 and 09-SEP-2014 respectively. This is one of several reports received from same reporter. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Localised oedema, Pain
Clinical narrative: Got PENTACEL, Hep A and PCV13 booster couple hours later local edema, pain w/walking.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose, route of administration, thimerosal status and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Eye swelling, Face injury, Fall
Clinical narrative: Initial unsolicited case received from a neurologist, who is also the patient, on 25 March 2015. A female patient (age not reported), with no reported medical history, received an intramuscular, left deltoid injection of ADACEL (lot number U5081AA) on 02 March 2015. Immediately after vaccination, she experienced a numbing, aching sensation down her left arm. Within one hour, she began experiencing body aches, fever, chills, dizziness, and an ability to move her arm. She stated that she felt as if "bones had been crushed". She treated the symptoms with ADVIL and TYLENOL, however symptoms continued to worsen. While attempting to fall asleep, she noted severe arm pain, chills, and sweating. She got out of bed at 3:00 am and went to the kitchen, at which point she became dizzy and lost consciousness, falling to the floor and landing on her face. She stated that she was unconscious for an unknown amount of time, and upon arousing was only able to get to her living room couch. She continued to have severe arm pain, nausea, and sweating, and was unable to move or lift arm. She later noted swelling and a black and blue area around the right eye. She cancelled work for the next few days, and treated with TYLENOL and Aspirin; she noted improvement in her right eye, but pain and difficulty moving the left arm and shoulder continued. She had been seen by an orthopedic surgeon, who prescribed a course of steroids. She was planning to follow-up with the surgeon, as she still had pain and difficulty moving her arm. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Loss of consciousness
Clinical narrative: Initial unsolicited case received from a neurologist, who is also the patient, on 25 March 2015. A female patient (age not reported), with no reported medical history, received an intramuscular, left deltoid injection of ADACEL (lot number U5081AA) on 02 March 2015. Immediately after vaccination, she experienced a numbing, aching sensation down her left arm. Within one hour, she began experiencing body aches, fever, chills, dizziness, and an ability to move her arm. She stated that she felt as if "bones had been crushed". She treated the symptoms with ADVIL and TYLENOL, however symptoms continued to worsen. While attempting to fall asleep, she noted severe arm pain, chills, and sweating. She got out of bed at 3:00 am and went to the kitchen, at which point she became dizzy and lost consciousness, falling to the floor and landing on her face. She stated that she was unconscious for an unknown amount of time, and upon arousing was only able to get to her living room couch. She continued to have severe arm pain, nausea, and sweating, and was unable to move or lift arm. She later noted swelling and a black and blue area around the right eye. She cancelled work for the next few days, and treated with TYLENOL and Aspirin; she noted improvement in her right eye, but pain and difficulty moving the left arm and shoulder continued. She had been seen by an orthopedic surgeon, who prescribed a course of steroids. She was planning to follow-up with the surgeon, as she still had pain and difficulty moving her arm. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: Initial unsolicited case received from a neurologist, who is also the patient, on 25 March 2015. A female patient (age not reported), with no reported medical history, received an intramuscular, left deltoid injection of ADACEL (lot number U5081AA) on 02 March 2015. Immediately after vaccination, she experienced a numbing, aching sensation down her left arm. Within one hour, she began experiencing body aches, fever, chills, dizziness, and an ability to move her arm. She stated that she felt as if "bones had been crushed". She treated the symptoms with ADVIL and TYLENOL, however symptoms continued to worsen. While attempting to fall asleep, she noted severe arm pain, chills, and sweating. She got out of bed at 3:00 am and went to the kitchen, at which point she became dizzy and lost consciousness, falling to the floor and landing on her face. She stated that she was unconscious for an unknown amount of time, and upon arousing was only able to get to her living room couch. She continued to have severe arm pain, nausea, and sweating, and was unable to move or lift arm. She later noted swelling and a black and blue area around the right eye. She cancelled work for the next few days, and treated with TYLENOL and Aspirin; she noted improvement in her right eye, but pain and difficulty moving the left arm and shoulder continued. She had been seen by an orthopedic surgeon, who prescribed a course of steroids. She was planning to follow-up with the surgeon, as she still had pain and difficulty moving her arm. Outcome was not recovered. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Cholecystectomy, Gastrointestinal disorder, Incomplete course of vaccination, Laboratory test abnormal
Clinical narrative: This spontaneous report was received from a consumer (patient's father) refers to a 20 year old male patient. Concurrent conditions and medical history was not reported. On an unknown date in August 2012, the patient was vaccinated with GARDASIL INJ (dose 1, dose and therapy route was not provided). No concomitant therapy was reported. Shortly thereafter on an unknown date the patient started experiencing gastrointestinal symptoms and stomach pain. The patient then received a second dose of GARDASIL on an unknown date in October 2012 and again shortly thereafter the patient was hospitalized on an unknown date approximately in 2012. Ultimately after many tests (unspecified) the patient was diagnosed with pancreatitis (hospitalization and medically significant) on an unknown date in approximately in 2012. Patient sought medical attention and had office visits. The patient had been prescribed many pain medications (unspecified) and this was the only medical treatment identified. On an unknown date the gallbladder was removed after the pancreatitis diagnosis (after the year of 2012). Therapy with GARDASIL was discontinued and the patient never received its third dose and does not plan to do so. Reporter stated that his son should be compensated for the adverse effects. The outcome of the event pancreatitis was reported as not recovered and outcome of cholecystectomy was unknown. The causality assessment was not provided. There was no product quality issue reported. Upon internal review the event of cholecystectomy and pancreatitis were considered medically significant. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Pancreatitis
Clinical narrative: This spontaneous report was received from a consumer (patient's father) refers to a 20 year old male patient. Concurrent conditions and medical history was not reported. On an unknown date in August 2012, the patient was vaccinated with GARDASIL INJ (dose 1, dose and therapy route was not provided). No concomitant therapy was reported. Shortly thereafter on an unknown date the patient started experiencing gastrointestinal symptoms and stomach pain. The patient then received a second dose of GARDASIL on an unknown date in October 2012 and again shortly thereafter the patient was hospitalized on an unknown date approximately in 2012. Ultimately after many tests (unspecified) the patient was diagnosed with pancreatitis (hospitalization and medically significant) on an unknown date in approximately in 2012. Patient sought medical attention and had office visits. The patient had been prescribed many pain medications (unspecified) and this was the only medical treatment identified. On an unknown date the gallbladder was removed after the pancreatitis diagnosis (after the year of 2012). Therapy with GARDASIL was discontinued and the patient never received its third dose and does not plan to do so. Reporter stated that his son should be compensated for the adverse effects. The outcome of the event pancreatitis was reported as not recovered and outcome of cholecystectomy was unknown. The causality assessment was not provided. There was no product quality issue reported. Upon internal review the event of cholecystectomy and pancreatitis were considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with MMR II (manufacturer unknown) (lot #, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients received improperly stored GARDASIL (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.63
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash all over body, appeared 1 hour after vaccine was given. No fever. A little itchy.
Age: 26.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Heat from injection site, rash, swelling, pain.
Age: 24.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient describes a chief complaint of nausea and symptoms of localized erythema the size of a quarter, swelling and warmth at injection site that began 12 hours after receiving the vaccination. The patient denies any treatment for her complaint of symptoms, but stated a similar reaction when she received a FLU vaccine in 2009.
Age: 24.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Erythema, Nausea, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient describes a chief complaint of nausea and symptoms of localized erythema the size of a quarter, swelling and warmth at injection site that began 12 hours after receiving the vaccination. The patient denies any treatment for her complaint of symptoms, but stated a similar reaction when she received a FLU vaccine in 2009.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Rash papular
Clinical narrative: Patient presented with erythematous papule rash, stretching from his clavical to his deltoid.  Vesicles noted although with no eruption at this time, as patient presented on Day #1 of rash presentation.  Seen by ID physician, who diagnosed as classic shingles.  No other symptoms, as patient denies fever, malaise, headache.   Given Rx for Valtrex.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (strength, dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-APR-2015, the patient was vaccinated with a dose of GARDASIL dose: 0.5 ml, intramuscularly (lot # K005881, expiration date: 14-JAN-2017), that had been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with ROTATEQ (lot #, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receive from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with GARDASIL (lot#, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of ROTATEQ that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a employee according to the pharmacist and refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The relatedness between shingles and ZOSTAVAX was not reported. The outcome of herpes zoster was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LOCALIZED ALLERGIC REACTION REDNESS SWELLING AND EXTREME PAIN EXTENDING ABOUT 3 INCHES BEYOND INJECTION SITE.  LIGHTER REDNESS ON MOST OF THE BACK OF UPPER LEFT ARM
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Injection site pain, Injection site reaction, Irritability, Myalgia
Clinical narrative: Soreness at site. Edgy, irritable, sore, muscle pain.  The biggest symptom different from flu vaccines was the muscle pain. 4-3-2015 I had routine blood work and muscle above site extremely sore. Never happened before so I assume it's still the effect of Prevnar 13 on muscle that I'm experiencing this swollen bicep from the blood draw.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Soreness at site. Edgy, irritable, sore, muscle pain.  The biggest symptom different from flu vaccines was the muscle pain. 4-3-2015 I had routine blood work and muscle above site extremely sore. Never happened before so I assume it's still the effect of Prevnar 13 on muscle that I'm experiencing this swollen bicep from the blood draw.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Fever, aching left arm, redness, swelling and mild headache started 2nd day after flu vaccine given. Seen at ED, fever to 101.1, given ibuprofen 400 mg once in ED, another dose at home.  Fully recovered within 24 hours.
Age: 32.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 04/2/15 swollen and reddened midday.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chills, Dizziness, Feeling hot, Hyperaesthesia
Clinical narrative: Had no s/sx prior to shot. Got it at 4:15 pm. Woke at 4:30 a.m. w/ HA, felt weak; lightheaded; back to sleep; woke later (usual time) felt hot, had chills, muscles in "legs and hip" hurt, skin was sensitive, no rash, resp sx and no N/V/D. Sx gradually decreased over approximately 24h-36h.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Had no s/sx prior to shot. Got it at 4:15 pm. Woke at 4:30 a.m. w/ HA, felt weak; lightheaded; back to sleep; woke later (usual time) felt hot, had chills, muscles in "legs and hip" hurt, skin was sensitive, no rash, resp sx and no N/V/D. Sx gradually decreased over approximately 24h-36h.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Respiratory tract congestion, Sinus congestion
Clinical narrative: Constant cough, head and chest congestion night after getting inj. feels its a reaction to vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Biopsy skin abnormal, Hypersensitivity vasculitis, Pain in extremity, Pyrexia, Rash
Clinical narrative: Vaccines administered - 3/26/2015. Fever, leg pain then rash developed 3/27/2015-3/29/2015. Admitted to hospital - rash is a leukocytoclastic vasculitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Red tender nodule at right bilateral thigh at injection site.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients received improperly stored RECOMBIVAX HB (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV1
Symptoms: Rotavirus infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rotavirus infection in a child patient who received ROTARIX. On an unknown date, the patient received ROTARIX at an unknown dose. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced rotavirus infection. On an unknown date, the outcome of the rotavirus infection was unknown. It was unknown if the reporter considered the rotavirus infection to be related to ROTARIX. Additional information was provided as follow: The patient received series of ROTARIX and then got sick with the virus. There was no further details about the patient or the vaccine.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients received improperly stored PEDVAXHIB (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Balance disorder, Blood thyroid stimulating hormone, Dysarthria, Epstein-Barr virus test, Eyelid ptosis
Clinical narrative: Patient received last HPV 12/12/14 - was second dose. 1st dose was 10/6/14. Seen on 1/12/15 2pm for 3 wks of fatigue and intermittent episodes of right eye drooping, lip drooping on (R) and right arm and leg tremors. Also balance issues and slurring of speech which is intermittent.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Full blood count, Metabolic function test, Thyroxine, Tremor
Clinical narrative: Patient received last HPV 12/12/14 - was second dose. 1st dose was 10/6/14. Seen on 1/12/15 2pm for 3 wks of fatigue and intermittent episodes of right eye drooping, lip drooping on (R) and right arm and leg tremors. Also balance issues and slurring of speech which is intermittent.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient received last HPV 12/12/14 - was second dose. 1st dose was 10/6/14. Seen on 1/12/15 2pm for 3 wks of fatigue and intermittent episodes of right eye drooping, lip drooping on (R) and right arm and leg tremors. Also balance issues and slurring of speech which is intermittent.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Herpes zoster
Clinical narrative: Shingles on right side of forehead and right eye.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: 2-3 days after shingles vaccine, patient experiences swelling of her arm, and a red raised spot along with soreness and itching. She contacted her private insurance's 24 hour nursing line and was instructed to apply warm compress. She still (as of 1/17/14) had a small spot on her arm.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Rash and redness and swelling; cellulitis. Doxycycline 100 mg BID.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates, these patients received doses of improperly stored VARIVAX (Merck). No adverse effect was reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to VARIVAX (Merck). Additional information has been requested.