chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness, Opisthotonus
Clinical narrative: Passed out in chair, regained consciousness for 2 minutes, back arched and legs kicked out, paramedics came and administered O2. BP was low (70/35) but rose as O2 was administered.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in arm after injection.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in arm after injection.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Administered FLUVIRIN at offsite clinic, around 7:00 am on 10-12-15. School nurse called and reported that she was found in responsive and in an apparent seizure at 10L00 at the school. Patient was transported to ER. She was responsive upon transport.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient received the vaccine in her (L) deltoid on Monday, 10/5 and developed a 5x5 cm red and indurated area at the site of injection noted at 7:30 AM the following morning. She took OTC ibuprofen on Tuesday 10/6 while at work with relief of most of the pain. By report it was still raised and warm through Wednesday. She was off work on Wednesday for an unrelated migraine. She was not examined in employee health until Thursday afternoon by which time the (L) deltoid was normal appearing.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine
Clinical narrative: Patient received the vaccine in her (L) deltoid on Monday, 10/5 and developed a 5x5 cm red and indurated area at the site of injection noted at 7:30 AM the following morning. She took OTC ibuprofen on Tuesday 10/6 while at work with relief of most of the pain. By report it was still raised and warm through Wednesday. She was off work on Wednesday for an unrelated migraine. She was not examined in employee health until Thursday afternoon by which time the (L) deltoid was normal appearing.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling at and around injection site, tired and weak. This was at injection site of PREVNAR 13/not FLUZONE.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Hyperhidrosis, Nausea, Pharyngeal oedema
Clinical narrative: Nausea, stomach pain, facial itching, lips itchy, sweating, weak feeling, throat swelling. Started approximately 1 hour after injection. Took 2 BENADRYL between 1 and 2 pm and used albuterol inhaler. Saw doctor at 4:30 pm - symptoms greatly improved.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Nausea, stomach pain, facial itching, lips itchy, sweating, weak feeling, throat swelling. Started approximately 1 hour after injection. Took 2 BENADRYL between 1 and 2 pm and used albuterol inhaler. Saw doctor at 4:30 pm - symptoms greatly improved.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Joint swelling, Oedema peripheral
Clinical narrative: Severe bruising along arm. Swelling in armpit and at elbow. Started 1 day after IZ (10/10/15).
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Hypoaesthesia, Paraesthesia
Clinical narrative: 1 hr after left deltoid injection, patient developed numbness and tingling of the left han. Finger 4th and 5th soon after that noticed metalic taste on his mouth with slight light headedness on left. Also tingling on the (Rt) ear that now went away.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Hard, red, hot, painful lump at injection site approx 1 1/2 inches.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Hallucination, Headache, Pyrexia
Clinical narrative: Approx 22 hrs after vaccine, pt. developed H/A 98.9 with fever. Antipyretic given by mom. Temp. 102 degrees F by 3:30 pm. Temp increase to 104 degrees w/hallucinations that night. Seen by dr on 10-8-15. am.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site/arm starting later in day of injection.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site rash
Clinical narrative: Rash around injection site. Bruise at injection site. Rash appeared 5 day after admin below site and spread up to site. As the rash spread more prominent (red color) on surrounding area.(Flu and PREVNAR LA0
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Per pt-not seen in person-left side (arm and leg) swelling and in pain. Pt had trouble walking, weakness, dizziness. Pt reported to MD, given ibuprofen. Pt reported to be ok next day when we followed up.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Small bump under skin at injection site on left arm. Painful to touch. No treatment given. Not aware of when it started/formed.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt reports pain in arm for 2 weeks after vaccine administration. MD aware, pt will have ultrasound in 2 weeks.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Eye discharge, Eye pain, Hypoaesthesia oral, Rhinorrhoea
Clinical narrative: About 2 1/2-3 hrs after flu shot her gums started to feel numb, eyes began to hurt. Claims she had trouble swallowing. Runny nose and discharge from her eyes. 2 1/2 hours after these symptoms appeared went to ER. Was given BENADRYL and DECADRON 1 dose of each.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Skin warm
Clinical narrative: (R) arm swelling and redness round firm induration hot to touch pain w/arm movement x 4 days slowly getting better.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Skin warm, Urticaria, Vomiting
Clinical narrative: Welt/hive the size of an apple on her LA arm-warm to the touch, hurt. Fever, vomiting started at about 6-7:00 pm the 6th of October-this welt started as the size of a quarter and then the next day was the size of an apple.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Had soreness on injection site. No fever
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Induration, Injected limb mobility decreased
Clinical narrative: Headache, erythema, induration, inability to lift left arm where injection was given.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site in left arm. Referred patient to urgent care.
Age: 37.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Local swelling, Peripheral swelling, Rash generalised, Swelling
Clinical narrative: Swelled; rash-full body; head, neck and arm swelling; welts and red streaks. BENADRYL 2 tabs twice a day x 4 days then symptoms resolved completely.
Age: 37.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Urticaria
Clinical narrative: Swelled; rash-full body; head, neck and arm swelling; welts and red streaks. BENADRYL 2 tabs twice a day x 4 days then symptoms resolved completely.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Started developing rash beginning 10/9/15 approximately 9pm raised, red rash, hot to touch - approx. 4" diameter, got worse through 10/12/15 approx. 5" diameter. Treated with hydrocortisone cream and diphenhydramine tabs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Headache, Pyrexia
Clinical narrative: 5 x 4 cm erythematous area; headache and fever per history, 2d ago. Erythema at this time resolving and patient asymptomatic.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 5 cm x 6 cm faint erythema with swelling and mild tenderness. Full strength and normal sensation in both arms.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, MNQHIB, PNC13, RV1
Symptoms: Diarrhoea, Haematochezia, Occult blood positive
Clinical narrative: Blood in stool and diarrhea. Same day as rotavirus vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt called 48 hours after DTaP administration with "Red, swollen and hot to touch at site." (R) arm. Pt went to ER 10/7/15 Dx: (1) Local reaction to vaccine. (2) Cellulitis that cannot be totally ruled out. Antibiotics given and BENADRYL. Sx resolved.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On 9/23/15 gave the PREVNAR vaccine to pt in the (L) deltoid. Pt called 10/5/15 to described redness, swelling, pruritus at the site of the injection.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Decreased appetite, Dizziness, Erythema, Headache, Induration
Clinical narrative: Dizziness, headache, decreased appetite, vomiting, inability to move left arm, erythema, induration.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Mobility decreased, Vomiting
Clinical narrative: Dizziness, headache, decreased appetite, vomiting, inability to move left arm, erythema, induration.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Mobility decreased, Oedema, Vomiting
Clinical narrative: Dizziness, headache, decreased appetite, vomiting, inability to move left arm, erythema, induration.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: C-reactive protein normal, Hypoaesthesia, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: "Noticed on 9/23/15 that my feet were hurting (soreness). Gradually my lower legs felt tingling and numb. The next day both my arms and legs felt tingling and numb. Saw my primary care physician, she felt I had the symptoms of possible Guillain Barre. Referred to neurologist for F/u on 10/7/15."
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Rheumatoid factor negative
Clinical narrative: "Noticed on 9/23/15 that my feet were hurting (soreness). Gradually my lower legs felt tingling and numb. The next day both my arms and legs felt tingling and numb. Saw my primary care physician, she felt I had the symptoms of possible Guillain Barre. Referred to neurologist for F/u on 10/7/15."
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Nausea, Pain, Pyrexia
Clinical narrative: Fever (102 degrees), cold sweats, nausea, body aches throughout night. Feeling better next day, no treatment except ibuprofen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10/7/15 Pt came in with Left deltoid area baseball size red warm area from reaction to MCV-4 given on 10/5/15 15:00 PM. Pred dose Pak 5 mg, BENADRYL 12.5mg/5ml given 10/7/15 15:57 PM.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: (L) arm painful after injection and 2 days later noticed upper arm (L) to (L) side of neck "really swollen". Did not seek medical attention. Still taking BENADRYL in PM no arm or neck still swollen - but improving slow improvement.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Within 1 hour, swelling, redness and warmth at injection site (R) deltoid. Fever of 99.2 persisted for 24 hours. General malaise for > 24 hours.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Blister, Full blood count, Joint swelling, Pyrexia, Rash erythematous
Clinical narrative: 3 days after vaccine given, patient had small red bumps on his leg. The pedi had told us if he had a reaction it would be around the 4rd day. By the next morning the spots were much worse-larger and darker red. By the evening of the 19th the large red spots covered his face, arms, and legs. His joints were so swollen he couldn't stand he started running a fever of 102 F. By April some spots had faded, others blistered and popped, and scabbed. It was not until the middle of September that all spots were gone. Our pedi diagnosed it as HSP and says it's unrelated but I disagree I have lots of pictures if you would like to see.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Scab
Clinical narrative: 3 days after vaccine given, patient had small red bumps on his leg. The pedi had told us if he had a reaction it would be around the 4rd day. By the next morning the spots were much worse-larger and darker red. By the evening of the 19th the large red spots covered his face, arms, and legs. His joints were so swollen he couldn't stand he started running a fever of 102 F. By April some spots had faded, others blistered and popped, and scabbed. It was not until the middle of September that all spots were gone. Our pedi diagnosed it as HSP and says it's unrelated but I disagree I have lots of pictures if you would like to see.
Age: 1.32
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Febrile convulsion, Pyrexia, Upper respiratory tract infection
Clinical narrative: Patient seen for routine WCCK in morning. Received Hib and PCV 13. That evening spiked fever and had two febrile seizures. Seen in ER. Exam normal. Pt had mild URI sx at time of WCCK but no fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site induration
Clinical narrative: Received call from PMC office that pt had gone there 2 days after vaccine administration with induration (R) arm 16 cm x 11 cm and temp increased 101. Treated with KEFLEX x 10 days.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: Shots given 4:10 pm - patient passed out 4:20. Awakened, but having vision problems, patient taken to E.R. approx 420-440 pm per Dr. Check on patient in ER 4:50 - awake doing fine.
Age: 8.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling about 2 inches long and 1 inch wide that began on Wednesday Oct. 7th warm to touch. Pt denied pain. (L) deltoid treat with BENADRYL and ice to arm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal disorder, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling without redness at vaccination site. Swelling subsided within a few days, but pain has persisted for at least one month with resultant decreased function of patient's arm.
Age: 11.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Disturbance in attention, Dysstasia, Fatigue, Pain in extremity
Clinical narrative: Patient experienced trouble standing, unable to focus, fatigue, very sore arm.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site bruising, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Bruising, swelling, and pain at injection site still one week later following immunization. Numbness and tingling in arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Nausea, Paraesthesia, Vomiting
Clinical narrative: Dizziness- nausea - vomiting - tingling in arms lite head. Approx 6 to 8 hours after all symptoms resolved 10/12/15 - pt started WELLBUTRIN same day 10/10.15.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Altered state of consciousness, Chest X-ray normal, Computerised tomogram normal, Electrocardiogram normal, Flushing
Clinical narrative: Received call from pt c/o rash buttocks - legs, arms - abd - called back to give pt. doctor's instructions daughter had called ambulance - speech garbled - face flushed pt almost passed out - was treated in ER - hypotension.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Hypotension, Rash, Speech disorder
Clinical narrative: Received call from pt c/o rash buttocks - legs, arms - abd - called back to give pt. doctor's instructions daughter had called ambulance - speech garbled - face flushed pt almost passed out - was treated in ER - hypotension.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Nausea
Clinical narrative: This case was reported by a pharmacist via a call center representative and described the occurrence of feeling cold in a 79-year-old male patient who received BOOSTRIX (batch number H5299, expiry date unknown). On 2nd October, the patient received OOSTRIX .5 ml. On 2nd October 2015, 6 hrs after receiving BOOSTRIX, the patient experienced feeling cold, chills, feeling hot, nausea and headache. On an unknown date, the outcome of the feeling cold, chills, feeling hot, nausea and headache were recovered/resolved. It was unknown if the reporter considered the feeling cold, chills, feeling hot, nausea and headache to be related to BOOSTRIX. Additional details were received as follows: The patient and his wife both were vaccinated with BOOSTRIX. The patient experienced feeling of extremity cold to the bone, shaking and nauseous, and then he became very hot, took of clothing. There events were lasted for few hours. On 2nd October 2015, 6 hrs after receiving BOOSTRIX, the patient experienced feeling cold, chills, feeling hot and nausea. On 2nd October 2015, less than a day after receiving BOOSTRIX, the patient experienced headache. This lasted for 3 to 4 hours. The patient did not have a fever or signs of allergic reaction. The patient has a normal pulse and heart rate.
Sex: U
Vaccine: VARCEL
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. In October 2015 the patient was inadvertently received a dose of expired VARIVAX (Merck) (Lot# J012381, exp: 03-OCT-2015; 0.5ml once) that had not undergone any temperature excursion (Expired vaccine used) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient had no pertinent medical history or drug reactions/allergies. On 01-JUL-2015 the patient was vaccinated with a 0.5 ml PNEUMOVAX 23 (lot # K009874, expiration date: 19-MAR-2016, subcutaneous). On the next day, 02-JUL-2015 the patient experienced an injection site reaction. The injection site reaction was described as "a swollen arm, redness, pain, and warm to the touch". The patient sought medical attention by office visiting and was prescribed an unspecified dose of Ibuprofen by an unspecified physician. There were no lab diagnostics studies performed. The patient recovered from the event in July 2015 (reported as "in a few days"). Causality between the event and PNEUMOVAX 23was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L019996, expiration date 02-DEC-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On unspecified dates the patients were vaccinated with GARDASIL (dosage, strength, route and lot # were not reported), which had been improperly stored. At the time of the report, no adverse effects were reported. This is one of several report from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Feeling cold, Mobility decreased, Musculoskeletal pain, Rash erythematous
Clinical narrative: Information has been received from a 60 year old male patient concerning himself. The patient had no pertinent medical history and was allergic to thimerosal. On 02-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, frequency and route were not reported). There was no concomitant medication. On 02-OCT-2015, about 3 hrs (about 11 PM) after the vaccination, the patient experienced extreme (excruciating) pain in his upper shoulder. The patient later woke up in the middle of the night with every joint aching and he "could not get warm". On 03-OCT-2015 (reported as "the following day") he experienced a large rash from his upper arm to his elbow. The patient was seen by the pharmacist on an unknown date and was given antihistamine, hydrocortisone cream and ALEVE as treatment for the above mentioned events. Later on unknown dates in October 2015 the patient experienced a lump about 2 inches long and 3/4 inch wide above where the shot was given. Then on an unknown date in October 2015, the patient also had a "welt on his back and it had quadrupled in size". The patient mentioned he might go to the urgent care because he woke up in the last couple was days "gasping for air and wheezing" and he felt like his breathing was restricted (Onset dates of the events: October 2015). No lab diagnostics studies were performed. Outcome of the events "feeling cold" and "rash" was recovering. Outcome of the event "musculoskeletal pain" and "arthralgia" was recovered (reported as "the pain he experienced was gone"). Outcome of the events "urticaria", "wheezing" and "dyspnoea" was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Dyspnoea, Feeling cold, Musculoskeletal pain, Rash
Clinical narrative: Information has been received from a 60 year old male patient concerning himself. The patient had no pertinent medical history and was allergic to thimerosal. On 02-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, frequency and route were not reported). There was no concomitant medication. On 02-OCT-2015, about 3 hrs (about 11 PM) after the vaccination, the patient experienced extreme (excruciating) pain in his upper shoulder. The patient later woke up in the middle of the night with every joint aching and he "could not get warm". On 03-OCT-2015 (reported as "the following day") he experienced a large rash from his upper arm to his elbow. The patient was seen by the pharmacist on an unknown date and was given antihistamine, hydrocortisone cream and ALEVE as treatment for the above mentioned events. Later on unknown dates in October 2015 the patient experienced a lump about 2 inches long and 3/4 inch wide above where the shot was given. Then on an unknown date in October 2015, the patient also had a "welt on his back and it had quadrupled in size". The patient mentioned he might go to the urgent care because he woke up in the last couple was days "gasping for air and wheezing" and he felt like his breathing was restricted (Onset dates of the events: October 2015). No lab diagnostics studies were performed. Outcome of the events "feeling cold" and "rash" was recovering. Outcome of the event "musculoskeletal pain" and "arthralgia" was recovered (reported as "the pain he experienced was gone"). Outcome of the events "urticaria", "wheezing" and "dyspnoea" was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Upper extremity mass, Urticaria, Wheezing
Clinical narrative: Information has been received from a 60 year old male patient concerning himself. The patient had no pertinent medical history and was allergic to thimerosal. On 02-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, frequency and route were not reported). There was no concomitant medication. On 02-OCT-2015, about 3 hrs (about 11 PM) after the vaccination, the patient experienced extreme (excruciating) pain in his upper shoulder. The patient later woke up in the middle of the night with every joint aching and he "could not get warm". On 03-OCT-2015 (reported as "the following day") he experienced a large rash from his upper arm to his elbow. The patient was seen by the pharmacist on an unknown date and was given antihistamine, hydrocortisone cream and ALEVE as treatment for the above mentioned events. Later on unknown dates in October 2015 the patient experienced a lump about 2 inches long and 3/4 inch wide above where the shot was given. Then on an unknown date in October 2015, the patient also had a "welt on his back and it had quadrupled in size". The patient mentioned he might go to the urgent care because he woke up in the last couple was days "gasping for air and wheezing" and he felt like his breathing was restricted (Onset dates of the events: October 2015). No lab diagnostics studies were performed. Outcome of the events "feeling cold" and "rash" was recovering. Outcome of the event "musculoskeletal pain" and "arthralgia" was recovered (reported as "the pain he experienced was gone"). Outcome of the events "urticaria", "wheezing" and "dyspnoea" was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Induration, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient did not have any pertinent medical history, drug reaction or allergies. She did not take any concomitant medications. The patient's historical medication included PREVNAR administered in January 2015. On 06-OCT-2015, the patient was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23 lot # k009874, expiration date 19-MAR-2016 (dose not reported) as a routine vaccination. In the morning of 07-OCT-2015, the patient noticed that her injection site was "swollen to the size of a baseball". On the same day (also reported as "last night") the pharmacist inspected the injection site was "swollen to the size of a baseball". On the same day (also reported as "last night") the pharmacist inspected the injection site in the pharmacy. He/she reported that the injection site area was "hard and hot." The pharmacist instructed the patient to take TYLENOL of unspecified dosage and to put ice on the affected area. The patient did not discuss her injection site reaction with her primary healthcare provider. No lab diagnostics studies were performed. At the time of the report, the pharmacist did not know whether or not the patient was recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient did not have any pertinent medical history, drug reaction or allergies. She did not take any concomitant medications. The patient's historical medication included PREVNAR administered in January 2015. On 06-OCT-2015, the patient was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23 lot # k009874, expiration date 19-MAR-2016 (dose not reported) as a routine vaccination. In the morning of 07-OCT-2015, the patient noticed that her injection site was "swollen to the size of a baseball". On the same day (also reported as "last night") the pharmacist inspected the injection site was "swollen to the size of a baseball". On the same day (also reported as "last night") the pharmacist inspected the injection site in the pharmacy. He/she reported that the injection site area was "hard and hot." The pharmacist instructed the patient to take TYLENOL of unspecified dosage and to put ice on the affected area. The patient did not discuss her injection site reaction with her primary healthcare provider. No lab diagnostics studies were performed. At the time of the report, the pharmacist did not know whether or not the patient was recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient did not have any pertinent medical history, drug reaction or allergies. She did not take any concomitant medications. The patient's historical medication included PREVNAR administered in January 2015. On 06-OCT-2015, the patient was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23 lot # k009874, expiration date 19-MAR-2016 (dose not reported) as a routine vaccination. In the morning of 07-OCT-2015, the patient noticed that her injection site was "swollen to the size of a baseball". On the same day (also reported as "last night") the pharmacist inspected the injection site was "swollen to the size of a baseball". On the same day (also reported as "last night") the pharmacist inspected the injection site in the pharmacy. He/she reported that the injection site area was "hard and hot." The pharmacist instructed the patient to take TYLENOL of unspecified dosage and to put ice on the affected area. The patient did not discuss her injection site reaction with her primary healthcare provider. No lab diagnostics studies were performed. At the time of the report, the pharmacist did not know whether or not the patient was recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing
Clinical narrative: Patient received his flu shot, got up, thanked the pharmacist, walked with me down the aisle, and then went down to the floor on his knees and doubled over.  He grabbed his throat and turned bright red.  He couldn't breathe.  He had a hard time speaking but said hoarsely "I can't breathe.  My throat.  My throat."  He coughed a lot and drooled a little bit.  He couldn't get up off of the floor.  I dragged him back to the pharmacy and a pharmacist called 911. The pharmacist who administered the flu shot gave him an Epi-pen injection in his leg.  After a few seconds, he was able to breathe.  After about 8 minutes, he seemed better and was able to get onto the EMS stretcher.  EMS monitored his vitals for a while afterwords and then released him to go home. After the incident, patient mentioned to me that the first thing that hurt when he got up after the flu shot was his stomach/chest area and that is why he said he went down on the ground doubled over.  He said that then his throat closed up and he couldn't breathe.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abdominal pain upper, Chest pain, Cough, Drooling, Dysphonia
Clinical narrative: Patient received his flu shot, got up, thanked the pharmacist, walked with me down the aisle, and then went down to the floor on his knees and doubled over.  He grabbed his throat and turned bright red.  He couldn't breathe.  He had a hard time speaking but said hoarsely "I can't breathe.  My throat.  My throat."  He coughed a lot and drooled a little bit.  He couldn't get up off of the floor.  I dragged him back to the pharmacy and a pharmacist called 911. The pharmacist who administered the flu shot gave him an Epi-pen injection in his leg.  After a few seconds, he was able to breathe.  After about 8 minutes, he seemed better and was able to get onto the EMS stretcher.  EMS monitored his vitals for a while afterwords and then released him to go home. After the incident, patient mentioned to me that the first thing that hurt when he got up after the flu shot was his stomach/chest area and that is why he said he went down on the ground doubled over.  He said that then his throat closed up and he couldn't breathe.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Erythema, Fall, Hypersensitivity, Throat tightness
Clinical narrative: Patient received his flu shot, got up, thanked the pharmacist, walked with me down the aisle, and then went down to the floor on his knees and doubled over.  He grabbed his throat and turned bright red.  He couldn't breathe.  He had a hard time speaking but said hoarsely "I can't breathe.  My throat.  My throat."  He coughed a lot and drooled a little bit.  He couldn't get up off of the floor.  I dragged him back to the pharmacy and a pharmacist called 911. The pharmacist who administered the flu shot gave him an Epi-pen injection in his leg.  After a few seconds, he was able to breathe.  After about 8 minutes, he seemed better and was able to get onto the EMS stretcher.  EMS monitored his vitals for a while afterwords and then released him to go home. After the incident, patient mentioned to me that the first thing that hurt when he got up after the flu shot was his stomach/chest area and that is why he said he went down on the ground doubled over.  He said that then his throat closed up and he couldn't breathe.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Vaccination complication
Clinical narrative: Patient received his flu shot, got up, thanked the pharmacist, walked with me down the aisle, and then went down to the floor on his knees and doubled over.  He grabbed his throat and turned bright red.  He couldn't breathe.  He had a hard time speaking but said hoarsely "I can't breathe.  My throat.  My throat."  He coughed a lot and drooled a little bit.  He couldn't get up off of the floor.  I dragged him back to the pharmacy and a pharmacist called 911. The pharmacist who administered the flu shot gave him an Epi-pen injection in his leg.  After a few seconds, he was able to breathe.  After about 8 minutes, he seemed better and was able to get onto the EMS stretcher.  EMS monitored his vitals for a while afterwords and then released him to go home. After the incident, patient mentioned to me that the first thing that hurt when he got up after the flu shot was his stomach/chest area and that is why he said he went down on the ground doubled over.  He said that then his throat closed up and he couldn't breathe.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat, aching, chills, light head, nausea, tired.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sore throat, aching, chills, light head, nausea, tired.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Dysphagia, Dyspnoea
Clinical narrative: Diffuse hives, difficulty breathing and swallowing. BP 137/90 HR 90 T 97 O2 100% sat. BENADRYL 25mg IV x2. SOLU MEDROL 125mg IV. PEPCID 40mg. EPIPEN 0.3mg 3x. WBC, 6.5; Hct, 40; Plat, 190; Na, 141; K+, 3.5; Gluc, 97. Admitted. States has hx of unknown "allergy" has seen allergist tests negative.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit normal, Platelet count normal, Urticaria, White blood cell count normal
Clinical narrative: Diffuse hives, difficulty breathing and swallowing. BP 137/90 HR 90 T 97 O2 100% sat. BENADRYL 25mg IV x2. SOLU MEDROL 125mg IV. PEPCID 40mg. EPIPEN 0.3mg 3x. WBC, 6.5; Hct, 40; Plat, 190; Na, 141; K+, 3.5; Gluc, 97. Admitted. States has hx of unknown "allergy" has seen allergist tests negative.
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Rotavirus infection, Surgery
Clinical narrative: This spontaneous report was received from a physician (infectious disease specialist) via field representative regarding a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown dates, the patient was vaccinated with ROTATEQ orally (dose and lot number unknown). The patient had received 3 doses of ROTATEQ. Concomitant medications were not reported. The patient developed intussusception on an unspecified date after receiving ROTATEQ. The "patient needed to have two surgeries and he also developed the rotavirus infection". The patient was hospitalized on an unknown date for an unknown duration. The patient sought medical attention, he had visited the physician, infectious specialist and had received treatment for the adverse event. Treatment details were not specified. Action taken with ROTATEQ was not applicable. The outcome of the events were unknown. The reporter had not provided the causality assessment between the events and ROTATEQ. Upon internal review, surgery was considered to be medically significant. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site granuloma, Surgery
Clinical narrative: Information has been received from a physician via a representative referring to a 14 year old male patient. On an unspecified date in August of 2015 the patient was vaccinated with GARDASIL 9 (first dose in the series, dose, lot# and route were unknown). In September 2015, 30 days after receiving the therapy the patient came into the physician's office and was diagnosed with a palisading granuloma at the injection site. The physician referred the patient to an unspecified surgeon. A surgery was performed and the surgeon removed the palisading granuloma from the patient's arm. The surgeon reported that this happened sometimes with vaccines, but it was rare. The outcome of the event was unknown. The causality was not reported. Upon internal review, injection site granuloma needed surgery was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Parkinsonism, Partial seizures, Tremor
Clinical narrative: Information has been received from a physician referring to a current 60 years old male patient. There was no pertinent medical history. Information about drug reactions and concomitant medication was not reported. On unknown dates the patient was vaccinated with a dose of ZOSTAVAX (strength, dosage, frequency and route unspecified), PNEUMOVAX 23 (strength, dosage, frequency and route unspecified) and influenza virus vaccine (strength, dosage, frequency and route unspecified) in the left deltoid area within days of each other. On an unspecified date (reported as "now"), the patient was experiencing a tremor in his left wrist and hand when his hand was at rest. The patient denies pain or motor/sensory loss and the patient was fully alert and oriented. The patient sought medical attention. The physician was suspicious of the ZOSTAVAX, traveling up the patient's nerve tract to the patient's central nervous system. The physician reported that this tremor was non-existent before the patient received these vaccines and had ordered an Magnetic Resonance Imaging (MRI) to evaluate the source of the tremor (date and result unspecified). The physician stated that he suspected either a focal seizure or parkinsonian symptoms. Action taken of the suspected therapies also reported as continued. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Dyspnoea, Palpitations, Sneezing
Clinical narrative: Sneezing, hard to breathe, forehead and ears were on fire, heart was pounding.
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was ordered to receive MMR and Varivax.  Pt received Proquad and Varivax. No symptoms as of yet.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was ordered to receive MMR and Varivax.  Pt received Proquad and Varivax. No symptoms as of yet.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Broke out in Hives through out body. Was not noticeable until the afternoon.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Day 2 - pain in arm and running a fever. Day 3 - redness/swelling.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Swelling around eyes, right worse than left.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Pain, Pyrexia
Clinical narrative: Chills, fever, aches, large redness on arm.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PAIN AND SORENESS WHERE THE BAND AID WAS, ARM SORNESS THROUGHOUT THE NIGHT.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Temporomandibular joint syndrome
Clinical narrative: TMJ on right side along with headache.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Malaise, Mouth ulceration, Pain, Pain in extremity
Clinical narrative: Fever~ 101 , body aches Malaise. 9/22 pain at injection site, large  ulcer on roof of mouth. Arm sore for 12 days, fever ~ persisted for 48 hours boday aches and malaise several days. Ulcer healing slowly, not completely resolved after 20 says.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia
Clinical narrative: Fever~ 101 , body aches Malaise. 9/22 pain at injection site, large  ulcer on roof of mouth. Arm sore for 12 days, fever ~ persisted for 48 hours boday aches and malaise several days. Ulcer healing slowly, not completely resolved after 20 says.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Temporomandibular joint syndrome
Clinical narrative: TMJ and headache.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Dyskinesia, Eyelid function disorder, Headache, Hypoaesthesia
Clinical narrative: I noticed on 10/8/15 that my tounge felt like I had burned it and starting to loose my taste. Then on 10/9/15, I noticed that I had developed a pain on the left side of my head under my ear. I thought it was a headache and took Tylenol. Then on 10/10/15 when I tried eatting my breakfast I could not open my mouth all the way. It felt like I had gone to the dentist and I lost all feeling on the left side of my face. I thought I was experiencing a stroke because I couldn't close my left eye, couldn't smile or open my mouth all the way. The left side of my face was paralized. I could only experience taste on the right side of my tounge. I quickly called the OB doctor on call and was told to go to Urgent Care. I was then diagnosed with Bell's Palsy.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: I noticed on 10/8/15 that my tounge felt like I had burned it and starting to loose my taste. Then on 10/9/15, I noticed that I had developed a pain on the left side of my head under my ear. I thought it was a headache and took Tylenol. Then on 10/10/15 when I tried eatting my breakfast I could not open my mouth all the way. It felt like I had gone to the dentist and I lost all feeling on the left side of my face. I thought I was experiencing a stroke because I couldn't close my left eye, couldn't smile or open my mouth all the way. The left side of my face was paralized. I could only experience taste on the right side of my tounge. I quickly called the OB doctor on call and was told to go to Urgent Care. I was then diagnosed with Bell's Palsy.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness approx. golf ball sized at site of injection. Itching, pain, and hot to the touch.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Muscular weakness
Clinical narrative: Tightness in chest.  Could not draw a deep breath.  General weakness in legs and arms.
Age: 71.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Chromaturia, Decreased appetite, Dysgeusia, Hepatitis A, Hepatitis A virus test positive
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Hepatitis A vaccine. Co-suspect products included Hepatitis A vaccine and Atorvastatin unknown for an unknown indication. Concomitant products included estradiol and PNEUMOVAX. On 28th August 2015, the patient received the 2nd dose of Hepatitis A vaccine. On 19th February 2015, the patient received the 1st dose of Hepatitis A vaccine. In September 2015, the patient started Atorvastatin at an unknown dose and frequency. On 30th September 2015, 33 days after receiving Hepatitis A vaccine, 223 days after receiving Hepatitis A vaccine and not applicable after starting Atorvastatin, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis A, upper respiratory tract infection, chills, sweating, weakness, energy decreased and appetite absent. On 3rd October 2015, the patient experienced nausea, taste altered, tremor and fever. On 4th October 2015, the patient experienced urine discoloration. On an unknown date, the patient experienced elevated liver enzymes. On 3rd October 2015, the outcome of the upper respiratory tract infection, chills, sweating and appetite absent were recovered/resolved. On 4th October 2015, the outcome of the tremor and fever were recovered/resolved. On an unknown date, the outcome of the vaccination failure, hepatitis A and elevated liver enzymes were unknown and the outcome of the weakness, energy decreased, nausea and taste altered were recovering/resolving and the outcome of the urine discoloration was unchanged. It was unknown if the reporter considered the vaccination failure, hepatitis A, upper respiratory tract infection, chills, sweating, weakness, energy decreased, appetite absent, nausea, taste altered, tremor, fever, elevated liver enzymes and urine discoloration to be related to Hepatitis A vaccine, Hepatitis A vaccine and Atorvastatin. Additional details were provided as follows: The patient reported that she received her first dose of hepatitis A vaccine on 19th February 2015. She received her second dose on 28th August 2015. As of July 2015, her lab values were normal. The patient reported that around 30th September 2015 she started experiencing issues that included an upper respiratory infection, chills, sweating, low energy, no appetite and weakness. Over the past weekend beginning, 3rd October 2015 she experienced nausea, food tasted bad, shaking and a fever of 104 degrees Fahrenheit. The patient went to the doctor and after lab work was completed her results showed elevated liver enzymes including ALT, AST and Bilirubin. She reported that her Hepatitis A panel was reactive as well and she was told that she had Hepatitis A. This case was considered as a vaccination failure case. The patient stated that she started Atorvastatin about a month ago and she felt that this product was actually the cause of all of her issues and not the hepatitis A vaccine.