chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Moderate swelling/tenderness & mild erythema at site of injection noted on 10/08/2015. Patient returned 10/12/2015.  It was noted that there was a large area of erythema & mild induration around injection site and extending to medial arm down to elbow level.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Woke up with delayed erythema (5days) on right deltoid 10 cm x 11.5 cm. Some swelling. No pain. Warm to touch, no induration.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever and febrile seizure.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: Hives, redness, & itching surrounding injection site on arm, all over back, and down both legs. Took 2 Benadryl.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, redness, & itching surrounding injection site on arm, all over back, and down both legs. Took 2 Benadryl.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Deafness unilateral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hearing loss in a 53-year-old male patient who received FLULAVAL quadrivalent (batch number 93T79, expiry date unknown). On an unknown date, the patient received FLULAVAL quadrivalent .5 ml. On an unknown date, 3 hrs after receiving FLULAVAL quadrivalent, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved. The reporter considered the hearing loss to be unlikely related to FLULAVAL quadrivalent. Additional details were provided as follows: The patient experienced hearing loss in his right ear. The patient went to an urgent care facility. They stated there is no correlation from receiving Flu shot. The patient followed up with physician and his physician stated that there was a correlation. On 7th October 2015, the hearing loss was ongoing. This case was a reported as a follow-up report of a case reported on 6th October 2015. However the initial report was not traceable so a new case was created.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received flu shot at pharmacy. Came in 3 days later w/redness, swelling, pain around injection site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: All over body aches night of receiving shot. Day after, large red, swollen, warm area around injection site. Few inches in diameter present today.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Burning sensation, Injection site pain, Pain in extremity
Clinical narrative: Pt states (L) arm was sore at injection site the next day then pain went away. 3 - 4 days later, it became sore again with distant pain and "burning feeling". By 10/11/15, his whole arm and upper back were affected and he is still in pain. He went to doctor 10/14/15 and was resolved VICODIN, prednisone and cyclobenzaprine with slight relief. Pt states that last year after receiving his flu shot, the same thing happened, but they never reported it.
Age: 64.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received BOOSTRIX (batch number B7PC3, expiry date 12th September 2016). Co-suspect products included FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). On 22nd September 2015, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 23rd September 2015, 1 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On the same day, the patient received BOOSTRIX in left deltoid and FLUARIX vaccine in right deltoid. The patient experienced a rash on his both upper arms. The patient did not experience pain, itching and fever. On 7th October 2015, the patient told the pharmacist that the rash was not resolved.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Eye pain, Fatigue
Clinical narrative: Hives, sore eyes, aches, headache, itching, fatigue, dizzy, sore throat, swollen face, weakness, chills.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal pain, Pain, Pruritus, Swelling face
Clinical narrative: Hives, sore eyes, aches, headache, itching, fatigue, dizzy, sore throat, swollen face, weakness, chills.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, sore eyes, aches, headache, itching, fatigue, dizzy, sore throat, swollen face, weakness, chills.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Client reports noticed starting getting red on 10/13/15 on the back LA where got shingles shot. It is sore and itches. No improvement or change since first day received immunization. Encourage cool compress and BENADRYL and/or Ibuprofen for itching or soreness. Client to see MD as needed if desires or if no improvement.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in unspecified number of patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patients received FLULAVAL QUADRIVALENT. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patients experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that several patients or employees received FLULAVAL and they complained of localized pain, redness and swelling at the injection site. At the time of reporting, the reporter did not have access to the patient identifiers or further product details. The reporter stated that these complaints of adverse events had been a lot more frequent that in the past and the events were occurring with patients or employees who had reported not having these complaints before. No further information was reported regarding the event.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching redness around injection site. BENADRYL 50mg given orally, ice applied. Primary MD updated and agreed in treatment and to monitor.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Feeling drunk
Clinical narrative: Pt. started with feeling lightheaded and then feeling like she was "drunk". Stated that she left work, slept it off but felt tired and fatigued for the rest of the weekend.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Aphonia, Cough, Joint swelling, Lip swelling, Swollen tongue
Clinical narrative: Received shot 10-2-15 at 1:30pm at pharmacy, 10-4-15 Sunday morning at 5:00am I woke up because my tongue felt funny, I looked at it in the mirror and saw it was swollen and my lips also, I waited till noon then I started to lose my voice so I went to the hosp. When I got to the emergency room I could hardly talk, there the doctor put me on an IV, the hosp report I have enclosed with this info. 10-6-15 I called my Dr and told them what happened, they said if the swallowing had gone down I should be ok, it had so I skipped one day of prednisone 10-7-15, then on 10-8-15 my lips swelled up again so I called Dr up and they had me come in 10-9-15, I had started the last of my prednisone 10-8-15 and by the evening the swallowing had gone down again, on 10-9-15 Dr gave me another script for prednisone and checked me out and said it was a reaction to the flu shot. Sunday 10-4-15 I also developed hives over my entire body, on my back, stomach, armpits, arches, buttocks, legs, top of my feet, rib cage, arms. When I was at the hospital my wrist started to swell up. On 10-3-15, I started coughing, this was around 6:00pm.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Received shot 10-2-15 at 1:30pm at pharmacy, 10-4-15 Sunday morning at 5:00am I woke up because my tongue felt funny, I looked at it in the mirror and saw it was swollen and my lips also, I waited till noon then I started to lose my voice so I went to the hosp. When I got to the emergency room I could hardly talk, there the doctor put me on an IV, the hosp report I have enclosed with this info. 10-6-15 I called my Dr and told them what happened, they said if the swallowing had gone down I should be ok, it had so I skipped one day of prednisone 10-7-15, then on 10-8-15 my lips swelled up again so I called Dr up and they had me come in 10-9-15, I had started the last of my prednisone 10-8-15 and by the evening the swallowing had gone down again, on 10-9-15 Dr gave me another script for prednisone and checked me out and said it was a reaction to the flu shot. Sunday 10-4-15 I also developed hives over my entire body, on my back, stomach, armpits, arches, buttocks, legs, top of my feet, rib cage, arms. When I was at the hospital my wrist started to swell up. On 10-3-15, I started coughing, this was around 6:00pm.
Age: 10.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Chills, Headache, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Within 12 hrs of vac. admin - fever >103+, chills, severe head pain, injection site (right upper arm) warn and swollen.  "Jolting" episode in spine 9/16 PM sx clearing and fever down after 36 hrs.
Age: 10.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Spinal pain
Clinical narrative: Within 12 hrs of vac. admin - fever >103+, chills, severe head pain, injection site (right upper arm) warn and swollen.  "Jolting" episode in spine 9/16 PM sx clearing and fever down after 36 hrs.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Feeling hot, Pyrexia, Tremor
Clinical narrative: Started getting really hot-feverish/chilling, very weak, shaking really uncontrollably about 12 hours after I got the shot.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt should have received the Influenza Trivalent split 6-35 mos 0.25 mL. By mistake the pt was given inj listed below. Mother notified, states no reaction at inj site, no fever, no swelling, no fussiness.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Urticaria
Clinical narrative: Patient said approximately 24 hours after receiving flu vaccine she developed hives that got worse over the course of the day. About 12 hours after developing hives patient passed out twice. 2 days after receiving the vaccine patient went to see PCP.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Local reaction, Myalgia, Oedema, Pyrexia
Clinical narrative: Fever 101, myalgias, weakness, local reaction, edema and color.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin discolouration
Clinical narrative: Fever 101, myalgias, weakness, local reaction, edema and color.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Dysphagia, Eyelid oedema, Rash macular, Rash pustular
Clinical narrative: Pustules lips. Rash feet - macular. Swelling eyelids. Difficulty swallowing. TX BENADRYL, Prednisone ER.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Pustules lips. Rash feet - macular. Swelling eyelids. Difficulty swallowing. TX BENADRYL, Prednisone ER.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Radiculitis brachial, X-ray
Clinical narrative: Left arm hurts throughout the day with certain movements and worsens at night. NSAIDS for the pain. Patient visited Orthopedic surgeon: diagnosed as Brachial neuritis.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Woke up with arm sore, warm to the touch, and red with some swelling.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder area that just got progressively worse to the extent I could not lift my arm.  Have range of motion now but still have pain while lifting arm.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection was red in a circle the size of a baseball. The red area was raised and warm to the touch.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Participant was given 1 ml flu vaccine instead of required dose of .5ML; over dosage of influenza vaccine.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Over dosaage was administered to the participant, 1 ML of influenza was given instead of the recommended does of .5ML.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Over Dosage of influenza vaccine was administered to participant. Recommended dose is .5 Ml and 1 ml was administered.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient states arm was red and swollen.  She didn't have a fever or rash.  The swelling went all the way down to her elbow.  She didn't take anything for the swelling.  I advised her to go to urgent care/ER.  I called her the following Friday to check up on her and she had developed Cellulitis and is taking antibiotics.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Over dosage of influenza was administered, recommended dosage is .5ML. 1ML dosage was administered in error.
Age: 27.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized redness, pain, swelling on arm site of pneumonia vaccine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Over dosage of influenza was administered, recommended dosage is .5ML. 1ML dosage was administered in error.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash appeared in both elbows creases and lower legs. Patient applied hydrocortisone which she states helped. Advised patient to follow-up with primary care doctor.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: RED, SWOLLEN, PAINFUL ARM. WARM TO TOUCH.
Age: 34.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness occurred across right side of chest and right cheek/face.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local rxn to MMRV (at site MMRV given) - red and firm 6 x 6 cm.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Nodule, Pruritus
Clinical narrative: Within 18 minutes of getting flu vaccine, patient experienced moderate-> severe itching on (L) side of neck - redness noted - no rashes - BENADRYL 3/4 tsp given at 1057 am with immediate relief of symptoms. Lump clear bilaterally to auscultation.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Within 15-18 minutes after vaccine given, patient was c/o moderate itching of her throat. Lungs clear to ascultation bilaterally - no wheezing, no throat welling. BENADRYL 1 tsp given 1057AM with immediate relief of symptoms. No rashes.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: C-reactive protein increased, Crying, Erythema infectiosum, Eye swelling, Full blood count abnormal
Clinical narrative: PC 10/7/15 -> pinpoint red rash all over, yellow eye discharge - appt for next morning, give TYLENOL/MOTRIN for fever, discomfort, BENADRYL for hs. OV 10/8/15 -> dx with viral exanthem vs MMR reaction - supportive care. PC 10/9/15 -> still crying, fussy, rash but no fever - to give pain reliever - rash will fade and to call if present after 3-4 days - poss. Fifth's disease. 10/10 OV - rash fading - viral exanthem dx. PC 10/12 - hives developed, eyes swollen with discharge. Sent for stat BW.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Irritability, Metabolic function test abnormal, Petechiae, Rash, Rash erythematous
Clinical narrative: PC 10/7/15 -> pinpoint red rash all over, yellow eye discharge - appt for next morning, give TYLENOL/MOTRIN for fever, discomfort, BENADRYL for hs. OV 10/8/15 -> dx with viral exanthem vs MMR reaction - supportive care. PC 10/9/15 -> still crying, fussy, rash but no fever - to give pain reliever - rash will fade and to call if present after 3-4 days - poss. Fifth's disease. 10/10 OV - rash fading - viral exanthem dx. PC 10/12 - hives developed, eyes swollen with discharge. Sent for stat BW.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Rash generalised, Urticaria, Viral rash
Clinical narrative: PC 10/7/15 -> pinpoint red rash all over, yellow eye discharge - appt for next morning, give TYLENOL/MOTRIN for fever, discomfort, BENADRYL for hs. OV 10/8/15 -> dx with viral exanthem vs MMR reaction - supportive care. PC 10/9/15 -> still crying, fussy, rash but no fever - to give pain reliever - rash will fade and to call if present after 3-4 days - poss. Fifth's disease. 10/10 OV - rash fading - viral exanthem dx. PC 10/12 - hives developed, eyes swollen with discharge. Sent for stat BW.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Peripheral swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received FLUARIX QUADRIVALENT (batch number 5GF43, expiry date 30th June 2016). On 22nd September 2015, the patient received FLUARIX QUADRIVALENT. On 23rd September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, swelling arm, pain in arm and extremities hot feeling of. The patient was treated with CIPRO. On an unknown date, the outcome of the erythema, swelling arm and extremities hot feeling of were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the erythema, swelling arm, pain in arm and extremities hot feeling of to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced hotness, tenderness, redness and swelling in her arm. The swelling in the arm was described as like a potato under the skin. On 25th September 2015, the patient was prescribed with an unspecified dose of CIPRO for 7 days, and most of the symptoms were resolved except tenderness remained ongoing. No additional information could be obtained.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in an unspecified number of patients who received FLULAVAL QUADRIVALENT (batch number AT3CC, expiry date 31st May 2016). This case was associated with a product complaint. On an unknown date, the patients received FLULAVAL QUADRIVALENT (intramuscular). On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patients experienced injection site redness, injection site pain, injection site swelling and pharmaceutical product complaint. On an unknown date, the outcome of the injection site redness, injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the injection site redness, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: The reporter stated that, the specific batch of FLULAVAL QUADRIVALENT, was causing redness, pain, swelling at injection site and this was experienced by numerous patients and was more severe then in the past year. It was unknown if the product was available for return. The number of patients, doses were unknown.
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX. On 21st September 2015, the patient received FLUARIX. On 21st September 2015, less than a day after receiving FLUARIX, the patient experienced pain in arm, shoulder pain and general body pain. On an unknown date, the outcome of the pain in arm, shoulder pain and general body pain were unknown. The reporter considered the pain in arm, shoulder pain and general body pain to be probably related to FLUARIX. Additional details were received as follows: The patient experienced severe pain in arm, pain in shoulder and body pain. The reporter did not have any further information.
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of sickness in a patient who received FLULAVAL quadrivalent. On 2nd October 2015, the patient received FLULAVAL quadrivalent. On 5th October 2015, 3 days after receiving FLULAVAL quadrivalent, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This is one of the 7 cases reported by the same reporter. The reporter indicated that FLULAVAL vaccines were administered to a group of individuals at a company or clinic. The sales rep stated that the reporter said six other individuals called out sick (possibly October 5th) after receiving the Flu vaccine but details were unknown and it was not known if related.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 53-year-old female patient who received FLULAVAL quadrivalent (batch number C92E7, expiry date June 2016). Concomitant products included FLONASE. ALLEGRA, SINGULAIR, lisinopril, omeprazole, SYMBICORT and SYNTHROID. On 5th October 2015, the patient received FLULAVAL quadrivalent .5 ml. On 6th October 2015, 1 days after receiving FLULAVAL quadrivalent, the patient experienced injection site bruising, tiredness and injection site pain. On an unknown date, the outcome of the injection site bruising, tiredness and injection site pain were not recovered/not resolved. The reporter considered the injection site bruising, tiredness and injection site pain to be related to FLULAVAL quadrivalent. Additional details were received as follows: This case was previously reported to doctor. The reporter stated that, she received the prepackaged FLULAVAL quadrivalent, in her left shoulder area. The patient experienced bruise the size of a tennis ball, soreness and feeling tired. The reporter reported the adverse event back to the staff of the employee health where she received the vaccine.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 34-year-old male patient who received FLUARIX quadrivalent (batch number 9Z429, expiry date 30th June 2016). Concomitant products included PROTONIX. On 5th October 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On 6th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced chills, general body pain, fever and headache. On 9th October 2015, the patient experienced vomiting, sweating, loss of energy and sore throat. On an unknown date, the outcome of the chills, general body pain, fever, headache, vomiting, sweating, loss of energy and sore throat were not recovered/not resolved. The reporter considered the chills, general body pain, fever, headache, vomiting, sweating, loss of energy and sore throat to be possibly related to FLUARIX quadrivalent. Additional details provided were as follows: This case was reported by a medical assistant. On 5th October 2015, at 10:45, the patient received a dose of FLUARIX quadrivalent vaccine. On 6th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced chills, body aches, fever and headache. On 9th October 2015, 4 days after vaccination, the patient experienced vomiting, sweating, no energy and sore throat. The medical assistant reported that the patient planned to continue follow-up with the office on an unknown date. No further information was available.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 34-year-old male patient who received FLUARIX quadrivalent (batch number 9Z429, expiry date 30th June 2016). Concomitant products included PROTONIX. On 5th October 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On 6th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced chills, general body pain, fever and headache. On 9th October 2015, the patient experienced vomiting, sweating, loss of energy and sore throat. On an unknown date, the outcome of the chills, general body pain, fever, headache, vomiting, sweating, loss of energy and sore throat were not recovered/not resolved. The reporter considered the chills, general body pain, fever, headache, vomiting, sweating, loss of energy and sore throat to be possibly related to FLUARIX quadrivalent. Additional details provided were as follows: This case was reported by a medical assistant. On 5th October 2015, at 10:45, the patient received a dose of FLUARIX quadrivalent vaccine. On 6th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced chills, body aches, fever and headache. On 9th October 2015, 4 days after vaccination, the patient experienced vomiting, sweating, no energy and sore throat. The medical assistant reported that the patient planned to continue follow-up with the office on an unknown date. No further information was available.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a male patient who received Influenza vaccine. Concurrent medical conditions included bleeding tendency (and the patient was on anticoagulant therapy). Concomitant products included Anticoagulant. In 2014, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced injection site bruising, injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site bruising, injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site bruising and injection site pain to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient's wife. Last year in 2014, the pharmacist administered Flu vaccine to the patient not only in the wrong place on his arm but on his back muscle, which led to administration of the vaccine at inappropriate site. This maladministration also resulted in a huge bruise at injection site with additional pain.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Patient complains of pain in left shoulder and arm (above the elbow) and also tingling sensation.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: Patient complains of pain in left shoulder and arm (above the elbow) and also tingling sensation.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Pruritus, Swelling face
Clinical narrative: No reaction on day vaccines were administered 10/15/15 on morning 10/16/15 patient called to report her left cheek seemed swollen and some numbness on left cheek and her back was itchy. No other symptoms. No reaction at injection site.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: First noticed area of swelling and redness @ L upper arm evening of 10/13/15.  Site was larger in morning of 10/14/2015, so patient went to ER.  Patient was given steroids shots and 5 day steroid.
Age: 90.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cough
Clinical narrative: Approximately two hours after administering Prevnar and Fluzone High Dose the patient experienced excessive coughing.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Patient stated she had headaches, fever and sore arm for 2 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Noticed swelling, redness, and itching.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Blood glucose normal, Dyspnoea, Hyperventilation, Hypoaesthesia
Clinical narrative: Patient had to be transported to Hospital.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Blood glucose normal, Burning sensation, Drug screen positive, Dyspnoea
Clinical narrative: Patient had to be transported to Hospital.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Mobility decreased, Monoplegia, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Patient had to be transported to Hospital.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Panic attack, Presyncope, Pulmonary function test abnormal, Respiratory disorder, Sensory disturbance
Clinical narrative: Patient had to be transported to Hospital.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Sensory loss, Tinnitus
Clinical narrative: Patient had to be transported to Hospital.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Dizziness, Nausea
Clinical narrative: Mild constant Dizziness. Nausea a couple of times the first night.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient developed significant swell at area of vaccine administration on date of administration that became gradually larger, painful and erythematous.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Complains of Right Shoulder Pain. Gabapentin, Shoulder Xray, Opioid Analgesics, Rest.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, General physical health deterioration, Wheezing
Clinical narrative: Heavy wheezing, tightness in chest, short of breath. Duration 15+ days. Treatment steroids pills, shots, extra albuterol treatments with no improvement and steady decline. Will be admitted to hospital for more aggressive treatment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Surrounding area on L posterior arm red, hot to touch, swollen. Cold compress provided.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of arm around injection site redness and a ring around injection site.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion
Clinical narrative: Patient experienced bruising the following morning that lasted for about 5 days.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: All over muscle aches. Back pain located in lumbar region. Common cold symptoms such as stuffy nose, headache and fatigue. Drowsiness. Unclear thoughts.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Nasopharyngitis, Somnolence
Clinical narrative: All over muscle aches. Back pain located in lumbar region. Common cold symptoms such as stuffy nose, headache and fatigue. Drowsiness. Unclear thoughts.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Discomfort, Dizziness
Clinical narrative: About 30 minutes or so after receiving the flu shot I started feeling like my heart was racing and lightheaded.  I felt like there was a brick on chest. I was also really weak.  I got home around 3 and immediately layed down.  When I woke up my throat felt like it was swelling.  My heart was still racing and I was uncomfortabley jittery.  I took both my blood pressure and pulse, which were both elevated.  I got scared and called my husbands' parents (my father in law is a nurse).  I took 2 Benadryl and some Nasacort.  My husbands parents then came over to deliver an Epipen and watch out for me.  As the Benadryl started to work my blood pressure and pulse went down.  My throat still felt consticted but it wasn't getting worse.  When I woke up the next morning my throat didn't feel as constricted but was real sore.  Felt jittery till about 1:00PM that afternoon.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling jittery, Heart rate increased, Palpitations, Pharyngeal oedema, Throat tightness
Clinical narrative: About 30 minutes or so after receiving the flu shot I started feeling like my heart was racing and lightheaded.  I felt like there was a brick on chest. I was also really weak.  I got home around 3 and immediately layed down.  When I woke up my throat felt like it was swelling.  My heart was still racing and I was uncomfortabley jittery.  I took both my blood pressure and pulse, which were both elevated.  I got scared and called my husbands' parents (my father in law is a nurse).  I took 2 Benadryl and some Nasacort.  My husbands parents then came over to deliver an Epipen and watch out for me.  As the Benadryl started to work my blood pressure and pulse went down.  My throat still felt consticted but it wasn't getting worse.  When I woke up the next morning my throat didn't feel as constricted but was real sore.  Felt jittery till about 1:00PM that afternoon.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: Within 30 seconds of receiving a flu vaccine at a drive thru flu clinic, the patient became lightheaded.  He pulled his vehicle to the side of the traffic lane. Approximately 90 seconds later the patient lost consciousness.  He was with a trained medical responder, who called for assistance.  His vitals were taken and a physician was immediately on site and examined him.  He determined this was a vaso-vagal reaction.  Patient stated he has had issues with being light headed with previous medical procedures involving needles.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Chest pain, Dyspnoea, Hyperhidrosis, Movement disorder
Clinical narrative: Patient received his HD flu shot 10/7/2015. at 5:40pm patient and wife showed up at clinic c/u inability to move bilateral legs at home, increased sweating, chest pain, and dyspnea. 911 called and patient transferred to ER.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient received his HD flu shot 10/7/2015. at 5:40pm patient and wife showed up at clinic c/u inability to move bilateral legs at home, increased sweating, chest pain, and dyspnea. 911 called and patient transferred to ER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Oval rash at site of injection, approximately 2 inches in diameter. Pt states the area, itches and burns and is warm to the touch.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The injection site became red, warm, and painful. 1-3 days after administration.  Then a welt grew, approximately the size of ½ golf ball several days later.  Pain, redness, and the welt persist 3 weeks after administration.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Left arm pain more than the usual annual flu shot. Having the symptoms of a heart attack (arm pain extending all the way down) without the sweating or indigestion. Eventual discomfort and mild pain from extending arm upward, outward or inward.  Today is the 16 and mild pain and discomfort when raising left arm.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Pt developed red rash w/ itching and pain and swelling, pt reported said event 8 days after injection and went to doctor. Doctor stated it was due to contamination at injection site and gave cephalexin.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, then chills, then fever reaching 103.7. Lasting 12 hours. Took Tylenol.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Reaction at the injection site. Fatigue in general. Heat, burning and swelling at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient developed a red circle a little bigger than a quarter around the injection site.  She indicated that it was itchy and warm to touch.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Malaise, Rash pruritic, Rash vesicular
Clinical narrative: Itchy vesicular rash and malaise.  No treatment.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head normal, Full blood count normal, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: PAIN AND NUMBNESS TO LEFT SHOULDER, NECK AREA WITH NUMBNESS TO LEFT ARM AND RADIATING TO LEFT SIDE OF FACE. THE NEXT MORNING LEFT LEG AND ARM NUMBNESS WITH BURNING PAIN AND WEAKNESS TO BOTH LEFT ARM AND LEFT LEG.  NUMBNESS AND WEAKNESS PERSISTING AND ON 10/15/2015 RIGHT ARM AND RIGHT LEG WITH NUMBNESS AND WEAKNESS.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Liver function test normal, Metabolic function test, Muscular weakness, Neurological examination, Nuclear magnetic resonance imaging brain
Clinical narrative: PAIN AND NUMBNESS TO LEFT SHOULDER, NECK AREA WITH NUMBNESS TO LEFT ARM AND RADIATING TO LEFT SIDE OF FACE. THE NEXT MORNING LEFT LEG AND ARM NUMBNESS WITH BURNING PAIN AND WEAKNESS TO BOTH LEFT ARM AND LEFT LEG.  NUMBNESS AND WEAKNESS PERSISTING AND ON 10/15/2015 RIGHT ARM AND RIGHT LEG WITH NUMBNESS AND WEAKNESS.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: PAIN AND NUMBNESS TO LEFT SHOULDER, NECK AREA WITH NUMBNESS TO LEFT ARM AND RADIATING TO LEFT SIDE OF FACE. THE NEXT MORNING LEFT LEG AND ARM NUMBNESS WITH BURNING PAIN AND WEAKNESS TO BOTH LEFT ARM AND LEFT LEG.  NUMBNESS AND WEAKNESS PERSISTING AND ON 10/15/2015 RIGHT ARM AND RIGHT LEG WITH NUMBNESS AND WEAKNESS.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: PAIN AND NUMBNESS TO LEFT SHOULDER, NECK AREA WITH NUMBNESS TO LEFT ARM AND RADIATING TO LEFT SIDE OF FACE. THE NEXT MORNING LEFT LEG AND ARM NUMBNESS WITH BURNING PAIN AND WEAKNESS TO BOTH LEFT ARM AND LEFT LEG.  NUMBNESS AND WEAKNESS PERSISTING AND ON 10/15/2015 RIGHT ARM AND RIGHT LEG WITH NUMBNESS AND WEAKNESS.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Erythema, Induration, Injection site reaction, Injection site urticaria
Clinical narrative: Large hive-angioedema of upper arm by injection site.  Became extremely "itchy" and when looked in mirror was reddened, about 3 inches by 3 inches.  Also, hardened.  Given Benadryl and the again next day. 10/13/2015 swelling down but soreness remained.  10/15/2015 no further problem. Never had problem with Pneumovax (received # 23 lot # 012042).
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Large hive-angioedema of upper arm by injection site.  Became extremely "itchy" and when looked in mirror was reddened, about 3 inches by 3 inches.  Also, hardened.  Given Benadryl and the again next day. 10/13/2015 swelling down but soreness remained.  10/15/2015 no further problem. Never had problem with Pneumovax (received # 23 lot # 012042).
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever ranging from 101-103 TYLENOL used for treatment.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Vomiting
Clinical narrative: Arm felt heavy in few hours after. Few hours (1-2) cold, shivers, 1 emesis, fell asleep, next day low grade headache, fatigue, slept all day. Normal d #3.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Arthropathy, Asthenia, Computerised tomogram normal, Eye pain, Fatigue
Clinical narrative: Patient is a previously healthy 11 year old female who was admitted from the Emergency Center with a one day history of headache and altered mental status. Per mother, patient was in her usual state of health until yesterday 9/23/15. She received her Tdap and meningitis vaccines and almost immediately after receiving the meningitis vaccine she began to drop her head, feel weak, and was more tired. There was no immediate syncope. Mother next took her to school, however shortly after dropping her off patient experienced a syncopal episode in class. This was reportedly witnessed by a teacher and patient's sister. There was no reported head trauma with the syncope. Patient herself cannot recall the event. Mother then took patient to hospital where initial lab work included CBC, CMP, pregnancy test, and UDS were reportedly negative. Given her history of a new onset of light headache, a CT and MRI scan were performed, both of which were unremarkable. Patient was discharged home after receiving an unknown pain medication. On the way home, patient had her first "dazed" episode where mother states she would stare off into space. There was no deviation of her eyes, movements of her limbs, or loss of bowel/bladder control. Mother states that she could "snap her out of it" by snapping her fingers. The episodes would last approximately one minute and patient would return back to her baseline. Once home that same day, patient's headache continued to worsen and was located primarily behind her eyes. She denies any lacrimation or injection of her eyes. At approximately 20:30 on the evening prior to admission, patient was walking downstairs when mother noted her knees buckled but patient did not fall. At that moment, mother said patient walked from dark, to light, to dark and mother did not notice her pupils reacting the way they were supposed. This prompted mother to return to the ED at which point a physician reportedly also noted that the pupils were not reactive. The was not documented on review of the EC notes. Patient was then transferred to another EC for further evaluation. While en route, she was given IV ketorolac and a bolus of IV fluids which reportedly helped reduced her headache to a 2/10. At the EC, her physical exam was unremarkable. She was admitted for further evaluation and management of her headache and altered mental status spells.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Feeling abnormal, Full blood count normal, Headache, Mental status changes, Metabolic function test normal
Clinical narrative: Patient is a previously healthy 11 year old female who was admitted from the Emergency Center with a one day history of headache and altered mental status. Per mother, patient was in her usual state of health until yesterday 9/23/15. She received her Tdap and meningitis vaccines and almost immediately after receiving the meningitis vaccine she began to drop her head, feel weak, and was more tired. There was no immediate syncope. Mother next took her to school, however shortly after dropping her off patient experienced a syncopal episode in class. This was reportedly witnessed by a teacher and patient's sister. There was no reported head trauma with the syncope. Patient herself cannot recall the event. Mother then took patient to hospital where initial lab work included CBC, CMP, pregnancy test, and UDS were reportedly negative. Given her history of a new onset of light headache, a CT and MRI scan were performed, both of which were unremarkable. Patient was discharged home after receiving an unknown pain medication. On the way home, patient had her first "dazed" episode where mother states she would stare off into space. There was no deviation of her eyes, movements of her limbs, or loss of bowel/bladder control. Mother states that she could "snap her out of it" by snapping her fingers. The episodes would last approximately one minute and patient would return back to her baseline. Once home that same day, patient's headache continued to worsen and was located primarily behind her eyes. She denies any lacrimation or injection of her eyes. At approximately 20:30 on the evening prior to admission, patient was walking downstairs when mother noted her knees buckled but patient did not fall. At that moment, mother said patient walked from dark, to light, to dark and mother did not notice her pupils reacting the way they were supposed. This prompted mother to return to the ED at which point a physician reportedly also noted that the pupils were not reactive. The was not documented on review of the EC notes. Patient was then transferred to another EC for further evaluation. While en route, she was given IV ketorolac and a bolus of IV fluids which reportedly helped reduced her headache to a 2/10. At the EC, her physical exam was unremarkable. She was admitted for further evaluation and management of her headache and altered mental status spells.