chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 03-DEC-2012, at a pharmacy, the patient was vaccinated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-SEP-2012 (note: conflicting information: the date of vaccination is after the onset date of herpes zoster), the patient was treated by a physician  for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful juries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician and refers to a 19 year old non-pregnant female patient. The patient's concurrent conditions included adjustment reaction, childhood asthma and unspecified allergies. The physician indicated that the patient had no drug reactions/allergies. There was no information about the patient's medical history. The patient's concomitant therapies included LEXAPRO. On 08-AUG-2017, the patient was vaccinated with GARDASIL 9 dose 1, 0.5 ml, intramuscular for prophylaxis, lot # N007931, expiry date 17-NOV-2019. On 31-AUG-2017, the patient experienced swelling and tenderness at the injection site. The reporting physician indicated that there was no redness or heat at the injection site. It was reported that there was no lab diagnostics/studies performed or treatment given for the adverse events. At the time of the reporting, the patient was not recovered from the injection site pain and injection site swelling. The causal relationship between the events and therapy with GARDASIL 9 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N008077, expiration date: 09-MAR-2019, for prophylaxis (dose number and route of administration were unknown); which was reconstituted with properly stored sterile diluent. The dose was stored between 6 Fahrenheit (F) degrees and 14 Fahrenheit degrees for 6 hours and 15 minutes. The temperature excursion was detected by a digital data logger. No previous temperature excursion was performed and no adverse effects were reported.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, unknown after receiving MENVEO, the patient experienced injection site induration, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site swelling, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling, injection site warmth and injection site erythema to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient in the practice had received MENVEO, and then experienced a localized reaction, described as induration, redness, swelling, and warmth to touch, at the injection site. No patient or product information was available, but might be available upon follow up by fax. This was 1 of the 8 cases, reported by the same reporter.
Age: 54.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient developed a red bump or welt immediately after injection at site but did no experience anaphylactic shock. Patient has monitored for 30 mins, no Tx needed.
Age: 54.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site vesicles, Pain in extremity, Urticaria
Clinical narrative: Patient developed a red bump or welt immediately after injection at site but did no experience anaphylactic shock. Patient has monitored for 30 mins, no Tx needed.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Incoherent, Swelling, Tremor, Vomiting
Clinical narrative: Injection given approximately 10:45 AM. Girlfriend reported approximately 5:45 PM patient - shaking, swelling, vomiting - talking out of head - crying taken by ambulance to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dyskinesia, Dysstasia, Fatigue, Headache
Clinical narrative: Received the injection of HPV vaccine 9/5/17. Immediately a severe headache and fatigue occurred. A couple hours later the headache was so severe, crying in pain. Then vomiting severely. None stop. After that convulsions and loss of consciousness, seizure like symptoms. 911 was called and taken to the ER. Since that day, jerking, involuntary muscle movements, weak limbs, sensitivity to light which causes for constant use on sunglasses, swollen joints, purple splotches on the skin. Unable to stand because of leg pain and weakness. Unable to open things because of arm and hand weakness.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Joint swelling, Loss of consciousness, Muscular weakness, Pain
Clinical narrative: Received the injection of HPV vaccine 9/5/17. Immediately a severe headache and fatigue occurred. A couple hours later the headache was so severe, crying in pain. Then vomiting severely. None stop. After that convulsions and loss of consciousness, seizure like symptoms. 911 was called and taken to the ER. Since that day, jerking, involuntary muscle movements, weak limbs, sensitivity to light which causes for constant use on sunglasses, swollen joints, purple splotches on the skin. Unable to stand because of leg pain and weakness. Unable to open things because of arm and hand weakness.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Photophobia, Rash macular, Seizure, Seizure like phenomena
Clinical narrative: Received the injection of HPV vaccine 9/5/17. Immediately a severe headache and fatigue occurred. A couple hours later the headache was so severe, crying in pain. Then vomiting severely. None stop. After that convulsions and loss of consciousness, seizure like symptoms. 911 was called and taken to the ER. Since that day, jerking, involuntary muscle movements, weak limbs, sensitivity to light which causes for constant use on sunglasses, swollen joints, purple splotches on the skin. Unable to stand because of leg pain and weakness. Unable to open things because of arm and hand weakness.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Received the injection of HPV vaccine 9/5/17. Immediately a severe headache and fatigue occurred. A couple hours later the headache was so severe, crying in pain. Then vomiting severely. None stop. After that convulsions and loss of consciousness, seizure like symptoms. 911 was called and taken to the ER. Since that day, jerking, involuntary muscle movements, weak limbs, sensitivity to light which causes for constant use on sunglasses, swollen joints, purple splotches on the skin. Unable to stand because of leg pain and weakness. Unable to open things because of arm and hand weakness.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient is describing a radiating pain down arm and numbness, also having difficulty using the arm. Can pinpoint to exact spot of injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Pt has cellulitis near injection site on right arm. Dr visit treated. Patient is doing well as of 9/11/2017.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dysarthria, Dysgeusia, Electrocardiogram
Clinical narrative: Final third dose of Hepatitis B vaccine was administered in the right deltoid and approximately 10 minutes later the individual stated she had a metallic taste in her mouth. Shortly after she reported feeling chest tightness and pressure then developed slur of speech which the individual acknowledged and healthcare providers also found noticeable.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain around injection site with decreasing severity over 2 days.
Age: 39.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cough, Diarrhoea
Clinical narrative: Coughing and diarrhea.
Sex: F
Vaccine: ANTH
Symptoms: Chills, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Patient missed one day of work on 8/31/17 due to chills/fever.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Flu-like symptoms (chills, fever), Severe pain in arm which received injection. Swelling/redness at injection site.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms (chills, fever), Severe pain in arm which received injection. Swelling/redness at injection site.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: Patient describing a feeling of dizziness, light headedness, headache at date of immunization. Began feeling better before leaving pharmacy. Three days later patient still has complaint of soreness, swelling at injection site and dizziness.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, puffy at injection site.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest discomfort, Dyspnoea, Muscle tightness
Clinical narrative: Chest tightness, shortness of breath, and muscle tightness, given 25mg of BENADRYL and 2 liters of oxygen and taken to emergency room.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt received vaccine 9/6/17 and states she noticed "welps" the following day on arms that also appeared on other areas of body. Pt states she took OTC Benadryl to relive itching, and improvement has been taking place since starting that. Pt states she contacted her primary care provider today 9/11/17 before calling pharmacy, however she states that that provider is out of town this week.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, swollen, hot and painful. patient also feels weak and lethargic.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: Injection site is red, swollen, hot and painful. patient also feels weak and lethargic.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: PATIENT FELT EXTREME PAIN IN LEFT ARM SEVERAL HOURS AFTER SHOT. THE NEXT MORNING SHE AWOKE AT 5AM WITH SWEATS AND FEELING VERY LIGHT HEADED.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever TMAX 103, persistent emesis.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Throat irritation
Clinical narrative: Localized rash to right upper arm. "Throat complaints"- no reports of shortness of breath, asthma, and wheezing. Did not use epi pen. Rash increased prior to going to bed on 9/10/217.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoacusis, Hypoaesthesia, Photopsia, Syncope, Vision blurred
Clinical narrative: Fainted about 5 minutes after receiving vaccine. Readily recovered but reported couldn't hear normally in left ear, but didn't seem to last long. Call for follow: Mother reported that as they walked to car from this office, patient reported numbness starting in left hand, then in the car noted vision in left eye was blurry with flashing light sensation. At 4:45 (time of my call) patient was reporting left side of face was still feeling numb since car ride home. No numbness or discomfort in left arm at site of vaccine, just her hand and face. Call for follow up on 8/8/17. Spoke with mother and patient was back to baseline. All numbness cleared in about 3 hours after onset. Mother reports that patient did not seem anxious at all during the above event but did see giddier than usual.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Malaise, Muscle spasms, Pain, Respiratory rate increased
Clinical narrative: Patient received both vaccinations and walked away from the pharmacy. She returned about 2 or 3 minutes later stating she didn't feel well. She said her face felt funny. The pharmacist had the patient sit down and right after sitting down the patient started yelling and screaming and breathing quickly as though she was in a lot of pain. She kept saying her back her back. Because the situation did not seem to be resolving after about a min or so 911 was called. By the time the paramedics arrived the pain had subsided and the patient was able to talk. She said she first got this weird feeling over her face and then her back started to spasm and the spasm wouldn't stop. Everything checked out ok with the paramedics but they did recommend she go to the hospital to get evaluated b/c they did not know if this is something that would reoccur. The patient agreed.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Screaming
Clinical narrative: Patient received both vaccinations and walked away from the pharmacy. She returned about 2 or 3 minutes later stating she didn't feel well. She said her face felt funny. The pharmacist had the patient sit down and right after sitting down the patient started yelling and screaming and breathing quickly as though she was in a lot of pain. She kept saying her back her back. Because the situation did not seem to be resolving after about a min or so 911 was called. By the time the paramedics arrived the pain had subsided and the patient was able to talk. She said she first got this weird feeling over her face and then her back started to spasm and the spasm wouldn't stop. Everything checked out ok with the paramedics but they did recommend she go to the hospital to get evaluated b/c they did not know if this is something that would reoccur. The patient agreed.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site oedema, Injection site pruritus
Clinical narrative: Patient presented to the pharmacy on 09/08/17 after receiving two vaccines in her left deltoid on 09/06/17. Patient reported experiencing some erythema, pruritis, and edema to left lower bicep, away from injection site beginning approximately 2 hours post injection. Patient did not report these signs or symptoms to her physician, pharmacy, or any healthcare provider. Patient also did not do anything to help symptoms subside. On 09/08/17 the patients symptoms included erythema, pruritis, irritation, and edema to lower bicep which patient reports has not worsened in the last day and a half. I informed the patient that the symptoms appear to be consistent with a potential allergic reaction and I recommend that the patient notify her physician and/or take some benadryl for the possible allergic reaction and ibuprofen/tylenol for any pain or discomfort. Also told the patient to apply intermittent ice packs as needed. On 09/11/17 patient reports that most of the symptoms have subsided and only mild irritation remains. Patient used benadryl, ibuprofen, and intermittent ice-packs. Patient did not consult with physician.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Shortness of breath, Facial pruritis.
Age: 12.0
Sex: F
Vaccine: MNQ, PNC13, TDAP
Symptoms: Confusional state, Fatigue, Muscle spasms, Nausea, Paraesthesia
Clinical narrative: Shaking, confusion, muscle tics lasting for 36-48 hours. No fever. Nausea without vomiting. Fatigue with sleep interruption due to the muscle tics. Diffuse but more involving the legs bilaterally. No swelling at the injection site. Some tingling to both arms and carpal spasm both hands transiently. No swelling, headache, dysphagia, chest pain or dyspnea.
Age: 12.0
Sex: F
Vaccine: MNQ, PNC13, TDAP
Symptoms: Sleep disorder, Tic, Tremor
Clinical narrative: Shaking, confusion, muscle tics lasting for 36-48 hours. No fever. Nausea without vomiting. Fatigue with sleep interruption due to the muscle tics. Diffuse but more involving the legs bilaterally. No swelling at the injection site. Some tingling to both arms and carpal spasm both hands transiently. No swelling, headache, dysphagia, chest pain or dyspnea.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: PATIENT RECEIVED SHOT ON 9/8/17, DEVELOPED NUMBNESS, TINGLING, LOSS OF SENSATION IN LEFT SIDE OF FACE ON 9/9/17. SYMPTOMS HAVE PERSISTED TILL NOW WHEN HE REPORTS TO ME 9/11/17. PATIENT REPORTS NO PAIN AND NO WORSENING OF SYMPTOMS SINCE 9/9/17. PATIENT FEELS LIKE HE CANNOT BE EXPRESSIVE WITH FACIAL EXPRESSIONS. IS STILL ABLE TO FEEL TOUCH OF FINGERS WHEN TOUCHING HIS FACE.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Ear discomfort, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: PATIENT EXPERIENCED SYNCOPE UPON VACCINE ADMINISTRATION WITH PALENESS, SWEATING, DIZZINESS, AND LIGHTHEADNESS. THIS BEGAN IMMEDIATELY UPON VACCINE ADMINISTRATION. PATIENT REPORTED EARS SOUNDED PLUGED AND LEANED FORWARD WITH DIZZINESS. SYMPTOMS FULLY RESOLVED WITHIN 30 MINUTES.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: PATIENT EXPERIENCED SYNCOPE UPON VACCINE ADMINISTRATION WITH PALENESS, SWEATING, DIZZINESS, AND LIGHTHEADNESS. THIS BEGAN IMMEDIATELY UPON VACCINE ADMINISTRATION. PATIENT REPORTED EARS SOUNDED PLUGED AND LEANED FORWARD WITH DIZZINESS. SYMPTOMS FULLY RESOLVED WITHIN 30 MINUTES.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Flushing, Headache
Clinical narrative: Received FLUAD (65 +) at 3:00pm right deltoid; 4:18pm patient return to the flu clinic site complaining of feeling flush with a headache BP 163/92 HR 80 Resp 16 non labored, had her to lie down in bed with head elevated; took BP every 5 minutes; 4:24 pm she did not have a headache and no longer flush feeling BP 126/77 HR75; At 5:02 patient was standing and walking feeling "like my normal self now"; I walked patient to the car and let her take home the BP monitor to monitor over the weekend since doctor office was closed BP 164/96 at departure; Called patient at 7:30 pm BP was running 132-155/79-90; Told patient to call Dr.on Monday 9/11/2017;  I reported off to Dr. on 9/11/2017 at 9:30am (RN RPh.)
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the site. Described as a cellulitis. Required 1/2 day off from work.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Impaired work ability, Pyrexia, Swelling
Clinical narrative: Patient had redness, swelling, and tenderness. Patient also experienced fever and required time off from work.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient had redness, swelling, and tenderness. Patient also experienced fever and required time off from work.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site reaction, Urticaria
Clinical narrative: PATIENT CALLED ME INFORMING ME WIFE NOTICED SEMI-HARD WELT AT SITE OF INJECTION. i QUESTIONED PATIENT ABOUT POSSIBLE ANAPHYLACTIC  REACTION- SWELLING LIPS, SWELLING TONGUE, WELTS, HIVES OR DIFFICULTY BREATHING. PATIENT STATED HIS REACTION WAS ONLY LIMITED TO INJECTION SITE.  I INFORMED HIM TO TREAT WITH ICE AND 50MG OF BENADRYL 2 TO 3 TIMES DAILY.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Blood test, Central nervous system lesion, Diarrhoea, Laboratory test, Motor dysfunction
Clinical narrative: Fever, rash , vomiting, loss of motor skills, diarrhea, brain lesson.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Rash, Urine analysis, Vomiting
Clinical narrative: Fever, rash , vomiting, loss of motor skills, diarrhea, brain lesson.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Pt states that dr told her she had cellulitis after the PREVNAR shot.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Rash and swelling and pain in left arm only treated at walk-in clinic on 9/8/17. Given steroid and amoxicillin.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever 104.3 rectally. Fussy.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swelling, reactive lymphadenopathy L axilla.
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cough, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient started with pain in arms. Couldn't lift both arms up to head. Then develop mucous in chest and cough. Then arms swells and are red. Cough and mucous got really loud 2 weeks later. Patient had to go to ER. Patient got Azithromycin 250mg two day 1, one x4d. Patient still has redness on face under eyes and has not gone away until now.
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Respiratory tract congestion, Vaccination complication
Clinical narrative: Patient started with pain in arms. Couldn't lift both arms up to head. Then develop mucous in chest and cough. Then arms swells and are red. Cough and mucous got really loud 2 weeks later. Patient had to go to ER. Patient got Azithromycin 250mg two day 1, one x4d. Patient still has redness on face under eyes and has not gone away until now.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Vaccine provided to patient. A few minutes later, store staff said patient had passed out in store. Found patient in aisle, coming to. Mom came out of rest room. Told us that she has a history of pass out, in general. Mom not concerned. Patient and mom refused 911 call. Gave patient cold compress for back of neck and water. Left under her own power.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Respiratory rate decreased, Syncope
Clinical narrative: Pt. fainted after a couple minutes past shot. Breathing slowed, went pale but color would return. Called 911 they provided oxygen, and took patient away.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling on upper right arm. Clinic recommend leaving it alone as it will calm down.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema
Clinical narrative: Patient states Saturday morning she woke up with 2 strips of redness near armpit and under armpit the area was sore. She went to the walk in clinic where the P.A. gave a steroid cream and oral KEFLEX because she believed soreness under armpit was an infection. Patient used steroid cream Saturday and the redness resolved. No sign of fever, soreness feels much better but still a little sore.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling
Clinical narrative: Swelling of lips.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: She received her 4 yr shots on 9-5. On 9-6 am mom noted her left deltoid area was red and itchy. It progressed over the next 2 days and site and she came in today to have it evaluated 9-11-17-called and it is resolved-mom says only slight bruising.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: Rotavirus: Diluent given without vaccine component. Per parent report: pt was asymptomatic. Feeding and behaving normally.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Pyrexia
Clinical narrative: Had the high dose (for over 65) flu vaccine. I am a very healthy 69 y/o - run Half marathons twice a year. After 8 hours, had bad chills, body aches, stomach ache, head ache, fever. Hives appeared 24 hours later. It is 48 hours now and I still do not feel 100% better.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Had the high dose (for over 65) flu vaccine. I am a very healthy 69 y/o - run Half marathons twice a year. After 8 hours, had bad chills, body aches, stomach ache, head ache, fever. Hives appeared 24 hours later. It is 48 hours now and I still do not feel 100% better.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Eructation, Muscle tightness
Clinical narrative: Pt. was given high-dose flu-shot at approximately 3:15 PM 9/11/17. Pt. returned to pharmacy at approximately 3:30 PM complaining of bilateral tightness of jaw area radiating from tooth area. Described as feeling like pulling a muscle. No difficulty breathing, minor trouble swallowing and belching observed. Pt. was given 50 mg BENADRYL orally and observed. Pt. was observed by pharmacist until he stated he was feeling better. Customer was accompanied by wife who was instructed to notify EMS if symptoms return.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema
Clinical narrative: Redness, bruise -> Pt came to pharmacy and her arm was red/with a bruise pt did not have any swelling (pt said she has sensitive skin and easily gets bruised) pt denied any pain or itchiness. Pt contacted her MD was told to take acetaminophen and reports symptom improvement (Pt contacted on 9/8/17) (Saw patient on 9
Age: 30.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cough, Diarrhoea
Clinical narrative: Coughing and diarrhea.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Localized redness and warmth at injection site < 24hrs after administration.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain, Neck pain
Clinical narrative: Pain at injection site, pain radiating up shoulder and into the neck for 3 days, bruise at injection site 1 day after. No known self-treatment.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen left hand, painful and limited range of motion in left arm for 3 days; took NORCO some symptoms improvements after 4 days.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Injection site bruising
Clinical narrative: Bruising on arm around injection site and below site.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Ingrown hair, Lip swelling
Clinical narrative: I have no family Dr I said. Never take medicine from Dr. in 83 yrs only over counter vitamins. Never had a problem til I took shot (13).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: 8 days after receiving these two vaccines child presented to the clinic with an itchy rash which was getting progressively worse. At home he was running a fever. Twin sister received the same two vaccines the same day and is without rash or fever.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Information was received on 25-AUG-2017 from a pharmacist concerning a 71 year old female patient. No medical history or concomitant medications were reported. On 23-AUG-2017, the patient received a dose of PNEUMOVAX 23 (Lot M042785, expires 17-JUN-2018) vaccine,  0.5 ml intramuscularly (location not reported) for routine vaccination. The pharmacist stated that on 25-AUG-2017, the patient called the pharmacy stating that she developed a "4 inch spot of redness" at the site of the PNEUMOVAX 23 injection. The patient has not recovered as of the time of reporting. No treatment was given. No other information was provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema
Clinical narrative: Information was received on 25-AUG-2017 from a pharmacist concerning a 71 year old female patient. No medical history or concomitant medications were reported. On 23-AUG-2017, the patient received a dose of PNEUMOVAX 23 (Lot M042785, expires 17-JUN-2018) vaccine,  0.5 ml intramuscularly (location not reported) for routine vaccination. The pharmacist stated that on 25-AUG-2017, the patient called the pharmacy stating that she developed a "4 inch spot of redness" at the site of the PNEUMOVAX 23 injection. The patient has not recovered as of the time of reporting. No treatment was given. No other information was provided. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Depressed level of consciousness, Personality change, Pyrexia, Speech disorder
Clinical narrative: Fever within 24 hours. Lowered state of consciousness within 48 hours of administration that lasted several days. Personality changed. Speech diminished. It was as though patient had been hit with a tranquilizer.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports receiving both vaccinations in her upper left arm on 9/7/17. On 9/9/17 she stopped by the pharmacy to ask if the redness and swelling she was experience was normal. It was not. It was on the inside of her arm not at injection site. Visually, it was nearing the level of her elbow  and she reported that it went all the way up into her shoulder. She was advised at that time to seek medical attention if did not respond to diphenhydramine and OTC pain relievers. Upon contacting the patient on 9/11/17 she reported that she had gone to an emergency room and had been treated and was responding to the treatment.  Upon further discussion, she disclosed that within 4 hours of the vaccinations she had woken up chilled and feverish, with pain and swelling in her vaccinated arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient reports receiving both vaccinations in her upper left arm on 9/7/17. On 9/9/17 she stopped by the pharmacy to ask if the redness and swelling she was experience was normal. It was not. It was on the inside of her arm not at injection site. Visually, it was nearing the level of her elbow  and she reported that it went all the way up into her shoulder. She was advised at that time to seek medical attention if did not respond to diphenhydramine and OTC pain relievers. Upon contacting the patient on 9/11/17 she reported that she had gone to an emergency room and had been treated and was responding to the treatment.  Upon further discussion, she disclosed that within 4 hours of the vaccinations she had woken up chilled and feverish, with pain and swelling in her vaccinated arm.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Gianotti-Crosti syndrome, Pyrexia, Rash, Rash generalised, Roseola
Clinical narrative: One week after vaccine son developed fever lasting 3 days. When fever broke, he broke out in a rash on face and chest, lasting 4 days (resembling roseola type rash). 3 days later (over 2 weeks after vaccination) breaking out in a horrifying rash all over entire body which has been described to us by pediatrician's office and pediatric dermatologist as "Gianotti Crosti" - a severe viral related rash.  His entire body is covered and we are going on day 8 of this rash. We were told any rashes relating to MMR would be mild and last only a couple days. My son's rash is very severe and is not going away. We had multiple doctors examine him and everyone agreed this severe rash is a reaction to the MMR vaccine.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: One week after vaccine son developed fever lasting 3 days. When fever broke, he broke out in a rash on face and chest, lasting 4 days (resembling roseola type rash). 3 days later (over 2 weeks after vaccination) breaking out in a horrifying rash all over entire body which has been described to us by pediatrician's office and pediatric dermatologist as "Gianotti Crosti" - a severe viral related rash.  His entire body is covered and we are going on day 8 of this rash. We were told any rashes relating to MMR would be mild and last only a couple days. My son's rash is very severe and is not going away. We had multiple doctors examine him and everyone agreed this severe rash is a reaction to the MMR vaccine.
Age: 65.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test, Pain
Clinical narrative: Extreme pain from June - Sept 9th pain level 7- 10.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Chest discomfort, Dizziness, Headache, Musculoskeletal discomfort
Clinical narrative: Headache - treated with ADVIL, abated by Monday, 8/28/17 by noon, dizziness - treated with rest, abated by Sunday, 8/27/17 by midday feeling of discomfort in neck/chest - confirmed breathing was fine with dr visit at 3pm on 8/25/17 treated with rest, abated by Saturday, 8/26/17 by 5pm.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017, these patients were administered improperly stored GARDASIL 9 (lot# N001533 with expiration date 16-OCT-2019, lot# N004799 with expiration date 15-NOV-2019, lot# M034437 with expiration date 03-FEB-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004620: US-009507513-1709USA004622: US-009507513-1709USA004623: US-009507513-1709USA004619: US-009507513-1709USA004621.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of GARDASIL9 (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA004629: US-009507513-1709USA004630: US-009507513-1709USA004632: US-009507513-1709USA004633: US-009507513-1709USA004628: US-009507513-1709USA004627: US-009507513-1709USA004631:
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 year old male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 15-AUG-2017, the patient inadvertently received an expired vaccination of M-M-R II (lot# L030161, expiration date 11-AUG-2017, dose was unknown) intramuscularly for prophylaxis (incorrect route of drug administration). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates between 31-MAY-2017 and 21-JUN-2017, these patients were administered improperly stored ROTATEQ (lot# L048857 with expiration date 15-OCT-2017, 2 ml, oral) for prophylaxis. The vaccine was exposed to temperature excursion of 34 Fahrenheit (F) for 90 minutes and 49 Fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005364: US-009507513-1709USA005365.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test
Clinical narrative: This spontaneous report was received from a physician and referred to 47 patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported). The VARIVAX was reconstituted with sterile diluent (MERCK). The physician reported about the patients' "varicella titer" tests. The results were stating that the varicella titer was equivalent. The physician stated that he was not sure, what the term "equivalent" was referring to. The outcome of varicella titer equivalent was not reported. The causality assessment was not reported. Additional information has been requested. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008911.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. Since August 2015 (reported as "for the past two years"), the patients were vaccinated with improperly stored doses of PROQUAD (dose, route of administration, lot# and expiration date were not reported) for prophylaxis reconstituted with sterile diluent. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA013509: US-009507513-1708USA013510:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. Since August 2015 (reported as "for the past two years"), the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis reconstituted with sterile diluent. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013510: US-009507513-1708USA012799.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. Since August 2015 (reported as "for the past two years"), the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis reconstituted with sterile diluent. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012799: US-009507513-1708USA013509.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Information has been received from a nurse via a company representative referring to a currently 60 year old female patient. The patient's concurrent condition, concomitant therapy and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (vaccine dose, frequency, route, lot# and expiration date were unknown) for vaccine to prevent shingles.  On an unknown date the patient's arm was red and swollen after receiving ZOSTAVAX vaccine injection. No treatment was performed. The patient sought medical attention for the nurse. The outcome of the events was unknown. Causality was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (lot # M042169, expiry date: 22-JUN-2018; lot # M044398, expiry date: 16-JUN-2018) (dosing regimen and frequency unknown) for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. Lot number M044398 is an invalid lot number for ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000705: US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000667.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from healthcare professional refers to a 12 month old female patient. The patient did not have any medical history, concomitant medication or drug history. On 05-SEP-2017, the patient was vaccinated with VARIVAX lot # N008829 and expiry date: 16-MAR-2019, 0.5 ml for prophylaxis which has undergone temperature excursion. No adverse effects were reported. It was reported that the patient will receive a booster dose at the age of 4. There were no lab tests performed. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA002643: US-009507513-1709USA002626.
Sex: F
Vaccine: HPV9, MEN, UNK
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 11 (reported as 11 years and 11 months) year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-AUG-2017, the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly (strength, exact dose, lot # and expiration date were not reported) for the prevention of human papillomavirus (HPV). The patient was also administered with doses of meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis vaccine (unspecified) at the same time, but in the opposite arm. On the same day, the patient fainted after being administered with GARDASIL 9. The patient was in the office at time of the adverse event. The patient's vitals were checked, and coherence questions were asked, she was then given a popsicle. The patient recovered 30 minutes after the injection. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a 73 year old female patient, regarding herself. Her concomitant therapies included ZIOPTAN. The patient's concurrent conditions and medical history were not reported. Approximately in 2011 (reported as "about 4-6 years ago"), the patient was vaccinated with ZOSTAVAX route reported as "injection" (concentration, dose, frequency and anatomical place of vaccination were not reported), for prophylaxis. Other suspect therapies included sterile diluent. On 18-AUG-2017, the patient developed shingles even though she had received ZOSTAVAX. Therefore, she received an unspecified treatment. At the time of the reporting, the outcome of vaccination failure was unknown and the reporter did not provide a causality assessment between ZOSTAVAX and vaccination failure. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004175: US-009507513-1709USA004176.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nervousness
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 06-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On 06-SEP-2017, 1 day after onset of therapy the patient experienced nervousness and malaise and "was taken into the office in a wheelchair and was seen by unspecified healthcare staff but they did not need to send for an ambulance". The outcome of nervousness and malaise is unknown.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse concerning  a patient of unknown age.    No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 11-JUL-2014,  the patient was vaccinated with a first dose of GARDASIL lot batch# reported as: V014219, expiration date: 05-OCT-2015 for prophylaxis (route of administration was not reported). On 16-AUG-2014, the patient recived the second dose of GARDASIL for prophylaxis, expiration date:19-JUN-2016 (dose, route of administration and  lot number were not reported). On 13-JUL-2015, the patient was vaccinated with a third dose of GARDASIL lot#: L018286, expiration date: 13-APR-2017 for prophylaxis (route of administration was not reported). And then the patient received a fourth dose of GARDASIL 9 lot #: N004799, expiration date: 15-NOV-2019 for prophylaxis (route of administration was not reported), on 01-AUG-2017, this was outside the recommendations. No adverse effects reported. Lot number V014219 is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine.; Sender's Comments:  US-009507513-1709USA004392:
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 67 year old male patient. The patient did not have medical history, drug reactions or allergies neither concomitant therapies. Information regarding the patient's concurrent conditions was not reported. On 01-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011867 and expiration date 08-NOV-2018 (strength, dose and route were not provided) for prophylaxis. It was reported that in September 2017, the patient's injection site was swollen, red to touch and very painful, therefore, on 03-SEP-2017, the patient went to an unspecified urgent care where was diagnosed with cellulitis and was given KEFLEX as treatment. At the reporting time the patient's outcome was not recovered and the causality assessment between PNEUMOVAX 23 and the event was not reported. Upon internal review the event of Cellulitis was determined to be medically significant.