chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Bruising, swelling, redness, itching and warmth around injection site which worsened over time. Patient applied ice to the area. Patient was seen in our office on 09/17/2015 and treated for Cellulitis. She was placed on Cefadroxil for 10days.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Bruising, swelling, redness, itching and warmth around injection site which worsened over time. Patient applied ice to the area. Patient was seen in our office on 09/17/2015 and treated for Cellulitis. She was placed on Cefadroxil for 10days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Burning sensation, Feeling hot, Mobility decreased, Myalgia
Clinical narrative: When he gave the injection, I felt pretty typical.  It did feel a little thicker, like an odd pressure, but not alarming.  I get flu shots every year, so I know how they should feel.  About 20 minutes later, I felt some heat in my injection arm and hand.  Not an all over general warmth, but felt like my vein in my arm and hand were stinging and burning.  Lasted about 5 minutes.  Then the typical sore muscle feeling started the next day.  Again, normal stuff.  Now, it is 13 days later, and in STILL have enough pain in my arm where I can't raise it over my head easily.  I am not able to do what I need to do for regular daily things without pain.  Usually, this pain lasts 3-4 days.  NEVER has taken this long to heal.  What can I do to relieve this pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: When he gave the injection, I felt pretty typical.  It did feel a little thicker, like an odd pressure, but not alarming.  I get flu shots every year, so I know how they should feel.  About 20 minutes later, I felt some heat in my injection arm and hand.  Not an all over general warmth, but felt like my vein in my arm and hand were stinging and burning.  Lasted about 5 minutes.  Then the typical sore muscle feeling started the next day.  Again, normal stuff.  Now, it is 13 days later, and in STILL have enough pain in my arm where I can't raise it over my head easily.  I am not able to do what I need to do for regular daily things without pain.  Usually, this pain lasts 3-4 days.  NEVER has taken this long to heal.  What can I do to relieve this pain.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Muscle spasms, Nausea
Clinical narrative: Legs felt strange, Laid down because she felt like throwing up. She had joint cramps and Charley horse in her legs. Dizzy which is still continuing through today, Thursday 9/24, spent all day Wed in bed sleeping. Stomach still does not feel well.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: 9/16-Patient received flu shot at off-site clinic.9/17-chills then sweating. 9/18-generalized aching until evening, began to feel better. 9/19-very fatigued.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysgeusia, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Approx, 8 hrs after vaccine, c/o chills intil 0100 9-24-15; then 90 min, later c/o very hot and sweaty (profuse); no vomiting c/o bad tast in mouth the entire time; Headache-severe. Fever comes and goes (chill/fever).
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Approx, 8 hrs after vaccine, c/o chills intil 0100 9-24-15; then 90 min, later c/o very hot and sweaty (profuse); no vomiting c/o bad tast in mouth the entire time; Headache-severe. Fever comes and goes (chill/fever).
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness
Clinical narrative: SEVERE DIZZINESS.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Severe vomiting, diarrhea, & chills.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site reaction, Local reaction, Urticaria
Clinical narrative: Localized rxn at injection site followed by systemic urticaria. No respiratory involvement.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient returned next day to the pharmacy with red, swollen and tender upper arm.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Blood culture negative, Computerised tomogram normal, Muscular weakness, Myalgia
Clinical narrative: Patient was readmitted for fever (101-103), myalgias/arthralgias, muscle weakness until fever resolution.  Hospital course may have been lengthened by other conditions, not directly related to potential vaccine reaction.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Ultrasound scan normal, White blood cell count increased
Clinical narrative: Patient was readmitted for fever (101-103), myalgias/arthralgias, muscle weakness until fever resolution.  Hospital course may have been lengthened by other conditions, not directly related to potential vaccine reaction.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm pain, arm redness, arm swelling, fever, myalgias.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site urticaria, Injection site warmth, Pyrexia
Clinical narrative: Redness, Inflammation, Fever, Welt at injection site (approximately half-dollar size).
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Body temperature increased, Dermatitis allergic, Dizziness, Erythema, Nausea
Clinical narrative: Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Body temperature increased, Cellulitis, Chills, Dizziness, Erythema
Clinical narrative: Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Fatigue, Full blood count normal, Hyperhidrosis, Hypersensitivity, Injected limb mobility decreased
Clinical narrative: Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site swelling, Nausea, Pain
Clinical narrative: Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Age: 58.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Red, Swollen arm, lightheaded, nausea, elevated temperature (100%). Follow-up physician appointment on 09/23/2015.  Physician thought it was an allergic reaction.  I said it looked like cellulitis.  I requested antibiotics, but request was denied. Arm is still red and very swollen--it is now 2 days later.  I will make a follow-up report in a few days.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Ataxia, Computerised tomogram head abnormal, Dizziness, Headache, Muscle twitching
Clinical narrative: Became light headed, dizzy, and severe headache 2 hrs post-immunization. Severe headache lasted 18 hrs. Ataxic gait developed next morning, c/o twitching legs. Dizziness and ataxia gradually improved, but persisted x several days. See at ER 9-18-15. Neuro exam normal.
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Tachycardia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 14 September 2015. This case involves a female patient (age not reported) who was vaccinated with FLUZONE HD [batch number, dose, dose in series, route and site of administration were not reported] on an unknown date (two years ago). The patient had received high dose for first time. The patient's medical history and concomitant medications were not reported. On an unknown date, two hours following the vaccination, the patient had experienced atrial fibrillation and tachycardia. Laboratory data and corrective treatment were not reported. The outcome of the events was unknown. Upon medical review, the case was considered as serious due to important medical event: atrial fibrillation. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Choking, Cough, Dysgeusia, Gastrooesophageal reflux disease
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single in Jun2015. Medical history included rheumatic fever at 8 years old, dehydration at 4 and a half years old. The patient's concomitant medications were not reported. The patient previously took diphtheria vaccine and experienced allergy to vaccine at 4 and a half years old. The patient experienced respiratory pneumonia (medically significant) on Sep2015 with outcome of unknown. In 2015, also she developed choking and gagging with outcome of not recovered, have had terrible allergies with outcome of not recovered, cough with outcome of not recovered, had horrible taste on Jun2015 with outcome of not recovered, nose irritation in 2015 with outcome of unknown, acid reflux in 2015 with outcome of unknown, constant irritation in her throat / itchy tickling feeling in her throat in 2015 with outcome of not recovered. The patient underwent lab tests and procedures which included chest x-ray; respiratory pneumonia on Sep2015. She further described her symptoms as: after receiving the shot for the next hour or two she had a horrible taste and feeling in her throat and don't know how long it lasted. Her allergies started up and there was a constant irritation in her throat that made her cough, this started in Jun2015 or Jul2015. The coughing did not start right after the shot. When inquired if she still had the symptoms, she stated she has the itchy tickling feeling in her throat and it causes her to cough and choke to almost gagging. She mentioned had nose irritation. Therapeutic measures taken as a result of the events included administration of Cefazroxil, ZANTAC, Z-pack, CLARITIN. Follow up (15Sep2015): This follow-up report is being submitted to confirm seriousness for the event choking.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Nasal discomfort, Pneumonia, Retching, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single in Jun2015. Medical history included rheumatic fever at 8 years old, dehydration at 4 and a half years old. The patient's concomitant medications were not reported. The patient previously took diphtheria vaccine and experienced allergy to vaccine at 4 and a half years old. The patient experienced respiratory pneumonia (medically significant) on Sep2015 with outcome of unknown. In 2015, also she developed choking and gagging with outcome of not recovered, have had terrible allergies with outcome of not recovered, cough with outcome of not recovered, had horrible taste on Jun2015 with outcome of not recovered, nose irritation in 2015 with outcome of unknown, acid reflux in 2015 with outcome of unknown, constant irritation in her throat / itchy tickling feeling in her throat in 2015 with outcome of not recovered. The patient underwent lab tests and procedures which included chest x-ray; respiratory pneumonia on Sep2015. She further described her symptoms as: after receiving the shot for the next hour or two she had a horrible taste and feeling in her throat and don't know how long it lasted. Her allergies started up and there was a constant irritation in her throat that made her cough, this started in Jun2015 or Jul2015. The coughing did not start right after the shot. When inquired if she still had the symptoms, she stated she has the itchy tickling feeling in her throat and it causes her to cough and choke to almost gagging. She mentioned had nose irritation. Therapeutic measures taken as a result of the events included administration of Cefazroxil, ZANTAC, Z-pack, CLARITIN. Follow up (15Sep2015): This follow-up report is being submitted to confirm seriousness for the event choking.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 86-year-old female patient started to receive PREVNAR 13 (Lot # L43700, NDC number 0005-1971-05, Expiry Date Dec2016), intramuscular at 0.5 ml single in the right arm, on 09Sep2015 11:00 am. The patient medical history was not reported. Concomitant medication included FLUZONE (Lot # UI454AA, Expiry date 21Apr2016) intramuscular at 0.5 ml single in the left arm, on 09Sep2015. On 14Sep2015, the patient experienced an injection site reaction that was warm to the touch at the site, it was inflamed, a big circle of redness on the patient right arm underneath where the shot was administered, as medically significant. The outcome of the events was recovering.
Sex: F
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: This case was reported by a physician and described the occurrence of seizure in a adult female patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine. On an unknown date, less than a week after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to DTPa vaccine. Additional details were provided as follows: The patient experienced seizure within one week after vaccination with DTPa. This case was linked to case US2015GSK133554, as it concerned with the subsequent vaccination.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Hyperhidrosis, Pyrexia, Seizure, Tremor, Vomiting
Clinical narrative: Shaking, body seizing up, sweating, fever, throwing up all night.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Sudden and unexplained dizziness when moving.  Can be explained as a sort of "floaty" feeling.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Localized redness and itching at injection site.  No other signs or symptoms reported by patient or observed by provider.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Swelling in armpit, extremely tender. 7/10 constant pain.
Age: 38.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: CD4 lymphocytes decreased, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Rash, on right arm where site of injection occurred, painful, swollen veriy itchy, had lesion of chicken pox on site, head, extremities.
Age: 38.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Varicella, White blood cell count decreased
Clinical narrative: Rash, on right arm where site of injection occurred, painful, swollen veriy itchy, had lesion of chicken pox on site, head, extremities.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Activities of daily living impaired, Dyskinesia, Muscle twitching, Streptococcus test, Thyroid function test
Clinical narrative: It started with involuntary head movements at school. Friday September 11 in the afternoon.  At 8:30 that evening we noticed nonstop tapping.  Then by Saturday 9/12/15 the involuntary head movement was non stop. Sunday morning at 9:30 AM constant snapping of fingers started.  Sunday evening at around 6 PM involuntary lifting of right hand would make him hit things when it rose. He was not able to attend school Monday September 13. Facial twitching Monday September 13 started while at doctor appointment we scheduled at 5 PM.  Tuesday September 14 returned to school after working with school staff. Vocal tic clicking of the tongue and having to say "moo". The vocal tic didn't last. However, the continued involuntary head movement, snapping and right arm lifting has.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Tic
Clinical narrative: It started with involuntary head movements at school. Friday September 11 in the afternoon.  At 8:30 that evening we noticed nonstop tapping.  Then by Saturday 9/12/15 the involuntary head movement was non stop. Sunday morning at 9:30 AM constant snapping of fingers started.  Sunday evening at around 6 PM involuntary lifting of right hand would make him hit things when it rose. He was not able to attend school Monday September 13. Facial twitching Monday September 13 started while at doctor appointment we scheduled at 5 PM.  Tuesday September 14 returned to school after working with school staff. Vocal tic clicking of the tongue and having to say "moo". The vocal tic didn't last. However, the continued involuntary head movement, snapping and right arm lifting has.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Antibody test negative, Dyskinesia, Thyroid function test normal, Tic
Clinical narrative: It started with involuntary head movements at school. Friday September 11 in the afternoon.  At 8:30 that evening we noticed nonstop tapping.  Then by Saturday 9/12/15 the involuntary head movement was non stop. Sunday morning at 9:30 AM constant snapping of fingers started.  Sunday evening at around 6 PM involuntary lifting of right hand would make him hit things when it rose. He was not able to attend school Monday September 13. Facial twitching Monday September 13 started while at doctor appointment we scheduled at 5 PM.  Tuesday September 14 returned to school after working with school staff. Vocal tic clicking of the tongue and having to say "moo". The vocal tic didn't last. However, the continued involuntary head movement, snapping and right arm lifting has.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and tenderness of lymph nodes in neck and around collarbone of left side (injection was in left arm).
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Cough, Dyspnoea, Headache
Clinical narrative: 9/22 body aches, head ache,r unny nose, cough. 9/23 numbness and tingling right hand and foot. 9/24 chest tightness, sore throat, runny nose, cough, shortness of breath, generalized weakness.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Oropharyngeal pain, Pain, Paraesthesia, Rhinorrhoea
Clinical narrative: 9/22 body aches, head ache,r unny nose, cough. 9/23 numbness and tingling right hand and foot. 9/24 chest tightness, sore throat, runny nose, cough, shortness of breath, generalized weakness.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Reaction to preservatives
Clinical narrative: Patient presented with a rash and went to primary care's office; MD said that pt is most likely allergic to preservative in vaccine as she has had the influenza vaccine in years past.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Immediate post-injection reaction, Swelling
Clinical narrative: Case number PHEH2015US018295 is an initial spontaneous report from a consumer (patient's parent) via Pharmacy received on 15 Sep 2015. This report refers to a 17-year-old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: A15009, expiry date: May 2016) at a dose of 0.5 ml intramuscularly on an unknown date. Immediately after vaccination, the patient experienced swelling, difficult time breathing/ shortness of breath and dizziness. The treatment for the events was sought by the emergency room and with primary care physicians. The outcome and seriousness of the events were not reported. The medical providers suggested that the events were as a result of the virus contained in the vaccine. Seriousness assessment of the events (swelling, shortness of breath and dizziness) upgraded based on the available information in the source document.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Starting day after administration, she had excruciating pain inside her upper arm and numbness inside her forearm. She went to Doctor and started on Gabapentin 300mg every 6 hours as needed Monday 9/21/15.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 40-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). Concurrent medical conditions included drug allergy (a lot of medicine allergies). On 15th September 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, injection site cellulitis, injection site warmth, injection site tenderness and injection site erythema. The patient was treated with clindamycin. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site tenderness were unknown and the outcome of the injection site cellulitis and injection site warmth were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site cellulitis, injection site warmth, injection site tenderness and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On 15th September 2015, the patient received FLULAVAL QUADRIVALENT, at left deltoid, at 8:30. By dinnertime on the night of 15th September, after receiving FLULAVAL QUADRIVALENT, the patient experienced swelling, redness and was diagnosed with cellulitis. Her arm looked like she had a blood clot and there was a 5x5 inch area on her left arm of warmth, tenderness and focal area swelling with no streaking. These events were noted when the patient was seen at the doctor office on the 16th September 2015. The patient required an emergency visit. The patient was seen again on 17th September 2015, and it was noted as a local reaction to the flu shot but the patient was not allergic to the immunization. There was also no cellulitis, upper arm was normal temperature, there was slight redness around the injection site and it was tender to palpate with full range of motion. Pulse, movement and strength were normal. The patient was sent for an ultrasound and given 20 tablets of clindamycin 300 mg every 6 hours. This case was linked to case US2015134386, as it concerned with the same reporter. The reported batch number was 77546, which does not exist and was updated to be 7754S as per sales database.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 40-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). Concurrent medical conditions included drug allergy (a lot of medicine allergies). On 15th September 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, injection site cellulitis, injection site warmth, injection site tenderness and injection site erythema. The patient was treated with clindamycin. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site tenderness were unknown and the outcome of the injection site cellulitis and injection site warmth were recovered/resolved and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site cellulitis, injection site warmth, injection site tenderness and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On 15th September 2015, the patient received FLULAVAL QUADRIVALENT, at left deltoid, at 8:30. By dinnertime on the night of 15th September, after receiving FLULAVAL QUADRIVALENT, the patient experienced swelling, redness and was diagnosed with cellulitis. Her arm looked like she had a blood clot and there was a 5x5 inch area on her left arm of warmth, tenderness and focal area swelling with no streaking. These events were noted when the patient was seen at the doctor office on the 16th September 2015. The patient required an emergency visit. The patient was seen again on 17th September 2015, and it was noted as a local reaction to the flu shot but the patient was not allergic to the immunization. There was also no cellulitis, upper arm was normal temperature, there was slight redness around the injection site and it was tender to palpate with full range of motion. Pulse, movement and strength were normal. The patient was sent for an ultrasound and given 20 tablets of clindamycin 300 mg every 6 hours. This case was linked to case US2015134386, as it concerned with the same reporter. The reported batch number was 77546, which does not exist and was updated to be 7754S as per sales database.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a other health professionals via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceutical product complaint. On an unknown date, the outcome of the erythema and pharmaceutical product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133740, US2015133746, US2015133760 and US2015433773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Raised area, below injection site, about size of small orange area was not warm or discolored.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13, TD
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Rt arm pain after tetanus shot. Arm and elbow sore. No fever. Slight swelling. Tender lateral deltoid, tricep and brachioradials. No warmth. Hurts at night. No chills.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt. reports hives on her face but nowhere else on body or near inj. site. She said occurred a little while after vaccine. Pt. also reports using a new moisturizer.
Age: 54.0
Sex: F
Vaccine: ANTH
Symptoms: Antinuclear antibody negative, Arthralgia, Blood thyroid stimulating hormone, Blood uric acid normal, C-reactive protein normal
Clinical narrative: Severe and debilitating multi-joint arthralgia.  Prior to this event, I did have some arthralgia, but nothing like the severity experienced starting 8/9.  Unable to roll over in bed, unable to bend knees, unable to lift arms using shoulders, unable to grasp and pull on socks, unable to lift coffee mug, unable to bend wrists, unable to turn head - without excessive pain or manual assistance.  Elbows, ankles, and thoracic spine and below not affected.  No apparent heat or swelling on any joint.  Muscle and tendon pain accompanied joint pain.  Duration approx. 2 weeks.  After this, pain began to improve slightly until Dr. appt.  Methylprednisolone dose pack resolved symptoms within 1 day.
Age: 54.0
Sex: F
Vaccine: ANTH
Symptoms: Condition aggravated, Grip strength decreased, Mobility decreased, Myalgia, Pain
Clinical narrative: Severe and debilitating multi-joint arthralgia.  Prior to this event, I did have some arthralgia, but nothing like the severity experienced starting 8/9.  Unable to roll over in bed, unable to bend knees, unable to lift arms using shoulders, unable to grasp and pull on socks, unable to lift coffee mug, unable to bend wrists, unable to turn head - without excessive pain or manual assistance.  Elbows, ankles, and thoracic spine and below not affected.  No apparent heat or swelling on any joint.  Muscle and tendon pain accompanied joint pain.  Duration approx. 2 weeks.  After this, pain began to improve slightly until Dr. appt.  Methylprednisolone dose pack resolved symptoms within 1 day.
Age: 54.0
Sex: F
Vaccine: ANTH
Symptoms: Rheumatoid factor negative, Tendon pain, Thyroxine free normal, Tri-iodothyronine free normal
Clinical narrative: Severe and debilitating multi-joint arthralgia.  Prior to this event, I did have some arthralgia, but nothing like the severity experienced starting 8/9.  Unable to roll over in bed, unable to bend knees, unable to lift arms using shoulders, unable to grasp and pull on socks, unable to lift coffee mug, unable to bend wrists, unable to turn head - without excessive pain or manual assistance.  Elbows, ankles, and thoracic spine and below not affected.  No apparent heat or swelling on any joint.  Muscle and tendon pain accompanied joint pain.  Duration approx. 2 weeks.  After this, pain began to improve slightly until Dr. appt.  Methylprednisolone dose pack resolved symptoms within 1 day.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness pain and swelling radiating out from injection site.
Age: 75.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Patient had a reaction to the Prevnar 13 vaccine about one week after getting the shot. The reaction was red, and was a large circular (2 inch diameter) wheal/rash on the right deltoid.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Injections site reaction:  red, itchy rash.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13, VARCEL
Symptoms: Abasia, Asthenia, Blood test, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient got a fever, had no energy, broke out in a rash and could not walk or bear weight.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Weight bearing difficulty, X-ray
Clinical narrative: Patient got a fever, had no energy, broke out in a rash and could not walk or bear weight.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Sleep apnoea syndrome, Stress, Weight decreased
Clinical narrative: Severe sleep apnea, quit breathing 90 times an hour sleeping, crippling joint paint.   I lost 30+ pounds with body in stress sleeping over 6 months waiting for sleep study.  Put on morphine and Norco for pain.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Peripheral swelling
Clinical narrative: Swelling down left arm to hand, severe pain, chills.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: Red rash and large blister.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Infection, Rash erythematous, Rash pruritic, Skin texture abnormal
Clinical narrative: Red rash and large blister.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Eye pain, Headache, Hypersomnia
Clinical narrative: Face went numb then collapsed on kitchen floor but did not lose consciousness.  Slept for biggest part of that day.  Have been experiencing dizziness, eye pain, severe headache, nausea, chills and leg/ muscle weakness ever since.  Consulted physician and pharmacy where I got the shot. They told me to rest and come in if symptoms worsened or did not get better.  Will go in to my physician today.  This was my first reaction to the flu vaccine and my 3rd time receiving it.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Nausea, Syncope
Clinical narrative: Face went numb then collapsed on kitchen floor but did not lose consciousness.  Slept for biggest part of that day.  Have been experiencing dizziness, eye pain, severe headache, nausea, chills and leg/ muscle weakness ever since.  Consulted physician and pharmacy where I got the shot. They told me to rest and come in if symptoms worsened or did not get better.  Will go in to my physician today.  This was my first reaction to the flu vaccine and my 3rd time receiving it.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Patient had itching of the upper arm the night the shot was given.  A rash developed the next day, which grew in size over a week. September 19th-21st the rash was still present but stable. The patient reported mild to moderate itching. There were no bug bites present.  The rash was an erythematous macular rash, ovoid 8cm with mild warmth. The rash and itching occcured below the site of injections. The patient was instructed to use a cool compress if the rash was itchy and an antihistamine as needed.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Petit mal epilepsy
Clinical narrative: ABSENCE SEIZURE.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat irritation
Clinical narrative: Patient received vaccine 9/23/15, face began swelling and throat got scratchy. Took BENADRYL and went to ER.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Decreased appetite, Dizziness, Tremor
Clinical narrative: Received PREVNAR 13 and FLUZONE HD on 9/16/15 in the afternoon. The next morning around 7 am, pt woke up with chills, body shaking all over. Pt stated she got a blanket and wrapped it around herself. She states her body shook for about 3 hours-she sat in a chair, no treatment, shaking subsided after about 3 hours and pt then felt a little "woozie" but then felt a little better. Pt stated she also had no appetite all day.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Headache, Nausea
Clinical narrative: Pt complained of severe headache and cold sweats all night after receiving vaccine. Nauseated today 9/24/15.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Hyperhidrosis, Pallor
Clinical narrative: Sweating. Weakness. Trouble breathing. Loss of color.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain
Clinical narrative: Head ache light headedness nausea body aches and very fatigued.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site induration, Injection site oedema, Injection site pain, Oedema
Clinical narrative: Pain & Edema in upper left are from elbow to shoulder extending down under arm pit & side of breast.  No fever or redness.  Hard edematous area present at injection site.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Headache and nausea.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Head injury, Loss of consciousness, Seizure, Syncope
Clinical narrative: Just as I finished administering the injection, the patient fainted. He was sitting down at a table, so when he fainted his head hit the table. When we moved the patient to the floor, he had a seizure that lasted a few seconds. He regained conciousness and was alert right after the seizure. He was checked out by his regular physician and then sent home for the day, with no further follow-up needed. The patient has had flu shots before with no problems, but did mention he had a slight fear of needles.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: REDNESS AND PAIN AT AND AROUND INJECTION SITE INCLUDING UPPER ARM.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash/hives on face, neck, itching on back, following administration of 2nd Hepatitis B vaccine - accelerated.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Lethargy, Pain, Pyrexia
Clinical narrative: PATIENT BECAME LETHARGIC, ACHY, DEVELOPED A FEVER AND HAD REDNESS AT THE VACCINE SITE.
Age: 58.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Blood pressure decreased, Diarrhoea, Dizziness, Dyspepsia, Headache
Clinical narrative: 9/20 sneezing, mild headache, stiffness. 9/21 muscle aches, vomiting, diarrhea, fever, fainting, loss of blood pressure. 9/22 dizziness, indigestion.
Age: 58.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia, Sneezing, Syncope
Clinical narrative: 9/20 sneezing, mild headache, stiffness. 9/21 muscle aches, vomiting, diarrhea, fever, fainting, loss of blood pressure. 9/22 dizziness, indigestion.
Age: 58.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Vomiting
Clinical narrative: 9/20 sneezing, mild headache, stiffness. 9/21 muscle aches, vomiting, diarrhea, fever, fainting, loss of blood pressure. 9/22 dizziness, indigestion.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dizziness, Dry mouth, Dyspnoea, Nausea
Clinical narrative: Dizzy, nausea, lightheaded, tightness in chest, trouble breathing, dry mouth.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: I gave the Fluvirin prefilled syringe lot (157605) with BD eclipse needle lot 3198468 exp 7/18.  The plunger would not depress, so I pulled the shot back and bit and it still wouldn't depress.  I discarded it and gave another one from the same lot and it worked just fine.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initially, soreness at site awakened patient from sleep. On 9/18/15 she came in to clinic.  Site was red, warm with localized reaction approximately golf-ball sized, with hardness in center.  On 9/24/15 she returned to clinic.  Redness has spread across width of upper arm and has a tag moving toward axilla.  Warm to touch and itching.  Central area of hardness is much smaller.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Pruritus, Skin warm
Clinical narrative: Initially, soreness at site awakened patient from sleep. On 9/18/15 she came in to clinic.  Site was red, warm with localized reaction approximately golf-ball sized, with hardness in center.  On 9/24/15 she returned to clinic.  Redness has spread across width of upper arm and has a tag moving toward axilla.  Warm to touch and itching.  Central area of hardness is much smaller.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Ocular hyperaemia
Clinical narrative: Hoarseness, red eyes, difficulty breathing onset about 2 to 3 hours later.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Electrocardiogram, Hypoaesthesia
Clinical narrative: Facial Numbness that migrated to neck and arm.  Later (13 days)became widespread after discharge.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Ultrasound Doppler
Clinical narrative: Facial Numbness that migrated to neck and arm.  Later (13 days)became widespread after discharge.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported pain at site of injection (right deltoid) with radiation down the right arm and subsequent swelling of the right hand.
Sex: M
Vaccine: FLUX
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: 14.5 cm x 8.5 cm tenderness and swelling to (L) thigh.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Patient developed redness, swelling, pain, and tingling to left arm/deltoid region 8 days after vaccination was administered. Believed to developed cellulitis, with possible muscle involvement.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm where Tdap was given (and MCV4) became red and swollen after vaccination. It lasted a few days. No hopitalizaton or office visit required.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Disturbance in attention, Dysarthria, Feeling abnormal
Clinical narrative: I went to Urgent care to get the Influenza vaccination, after 10 to 15 minutes later I started to feel strange; my lips started to swell and I could taste the medication on my tongue. I felt as if I was on drugs, such as in a slow motion, non focus, blurry and my speech was slurred. I felt pain in the middle of stomach it made me feel nausea, that I needed to vomit. My mental state was non-focus. The weakness lasted about 3 to 4 hours. When I went home, I laid down and fell asleep, when I woke up at 8:30pm I was still drowsy. When I woke up this morning, I felt normal. (Note: I did not take anything nor went to the Emergency Department.)
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Nausea, Product taste abnormal, Somnolence, Vision blurred
Clinical narrative: I went to Urgent care to get the Influenza vaccination, after 10 to 15 minutes later I started to feel strange; my lips started to swell and I could taste the medication on my tongue. I felt as if I was on drugs, such as in a slow motion, non focus, blurry and my speech was slurred. I felt pain in the middle of stomach it made me feel nausea, that I needed to vomit. My mental state was non-focus. The weakness lasted about 3 to 4 hours. When I went home, I laid down and fell asleep, when I woke up at 8:30pm I was still drowsy. When I woke up this morning, I felt normal. (Note: I did not take anything nor went to the Emergency Department.)
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient complained of itching, the area was red on the entire upper arm, and it was warm to the touch.
Age: 84.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PT STATING THAT HE WAS HAVING DIFFICULTY MOVING HIS RIGHT ARM AND THAT IT WAS VERY PAINFUL.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Localized swelling at site of immunization administration.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pallor
Clinical narrative: PATIENT WAS VISIBILY PALE, WEAK, AND NAUSEOUS AFTER VACCINE ADMINISTRATION.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Gait disturbance, Pain, Pyrexia, Tremor
Clinical narrative: Chills, shaking, fever, aching, stumbling.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called in the evening explaining she had severe swelling and pain, and it has worsened to the point of swelling from upper arm to elbow and now is in a sling because she cant handle the pain if she moves her arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: AT INJECTION SITE.  ONSET 24 HOURS AFTER INJECTION.  PATIENT REPORTED: RAISED, SWOLLEN, HARD, RED AREA. AREA SORE AND CAUSING MILD-MODERATE PAIN AND DISCOMFORT. DESCRIBED SWOLLEN AREA AS THE SIZE OF SMALL ORANGE OR LEMON. DURATION 2 DAYS. NOT RESOLVED YET.
Age: 0.17
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Injection site rash, Irritability, Rash generalised, Restlessness
Clinical narrative: Rash and bumps started on legs at injection site and spread all over body. She was fussy and restless.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient has severe swelling of the arm.  Patient wanted both Afluria and Pneumovax injected in same arm.  She didn't have any issues with either vaccine in the past.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Body Rash.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pneumonia, Pyrexia, Seizure like phenomena, Sepsis
Clinical narrative: Patient experienced fever > 102 degrees F and chills. Also what his wife described as "seizure-like movements" lasting approximately 4 hours beginning approximately 2 hours post vaccine. Patient was taken to ED and was hospitalized for 2 days with diagnosis of sepsis/community acquired pneumonia.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Ovarian cyst, Ovarian cyst ruptured
Clinical narrative: This spontaneous report was received from a consumer referring to her granddaughter, a 19 year old female patient. Concurrent conditions or pertinent medical history were not reported. On an unknown date in 2006, the patient was vaccinated with a dose of GARDASIL (lot#, dose, frequency, route of administration and anatomical location were not specified). The patient had none concomitant medications. The reporter stated that it was unknown when the first symptom occurred (adverse event), but the patient has been hospitalized ("several hospitals but no names were revealed"), that throughout the years, the patient had menstrual bleeding issues (unspecified) and cyst in her ovaries that have busted and then new ones have formed. At the time of the report, the outcome of adverse event, ovarian cyst ruptured, ovarian cyst and menstrual disorder was unknown. The relatedness of GARDASIL with the adverse events was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Pt called pharmacy to report swelling, tender to touch, redness and pain due to injection. Also reports hear and itchiness->advised pt to seek medical care at MD/hospital.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Pt called pharmacy to report swelling, tender to touch, redness and pain due to injection. Also reports hear and itchiness->advised pt to seek medical care at MD/hospital.