chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Muscle abscess
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 23-Oct-2017. This case involves a female patient (age not reported), who was vaccinated once with 0.5 ml FLUZONE QIV via intramuscular route (batch number: UT5911NA, expiry date: 30-Jun-2018; dose in series and site of administration not reported) on 17-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed right deltoid abscess and cellulitis. Lab test and corrective treatment was not reported. Patient did not recover from the events. Case was reported serious for medically significant events. Documents held by sender: none.; Sender's Comments: Patient vaccinated FLUZONE QIV with Patient developed R Deltoid abscess and Cellulitis. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Diarrhoea, Erythema, Induration
Clinical narrative: Received ZOSTAVAX Inj Merck NCD: 00006-4963-41 at approximately 11:45 AM on 10/27/2017. By 2:45 PM, suffered w/onset of significant diarrhea. Induration/Erythema noted at 4:30 PM day of injection. By 8:00PM same day, onset of aches and generalized pain. On 10/28/17, 10/29/17 and 10/30/17 all symptoms continued. On 10/29/17, fever of 100.6 in the afternoon, relieved w/Acetaminophen. At this time of 9:00 on 10/30/17, joint aches, large Erythema, diarrhea and generalized feeling of debility continues.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Received ZOSTAVAX Inj Merck NCD: 00006-4963-41 at approximately 11:45 AM on 10/27/2017. By 2:45 PM, suffered w/onset of significant diarrhea. Induration/Erythema noted at 4:30 PM day of injection. By 8:00PM same day, onset of aches and generalized pain. On 10/28/17, 10/29/17 and 10/30/17 all symptoms continued. On 10/29/17, fever of 100.6 in the afternoon, relieved w/Acetaminophen. At this time of 9:00 on 10/30/17, joint aches, large Erythema, diarrhea and generalized feeling of debility continues.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Erythema, Pain, Pruritus
Clinical narrative: Received ZOSTAVAX Inj Merck NCD: 00006-4963-41 at approximately 11:45 AM on 10/27/2017. By 2:45 PM, suffered w/onset of significant diarrhea. Induration/Erythema noted at 4:30 PM day of injection. By 8:00PM same day, onset of aches and generalized pain. On 10/28/17, 10/29/17 and 10/30/17 all symptoms continued. On 10/29/17, fever of 100.6 in the afternoon, relieved w/Acetaminophen. At this time of 9:00 on 10/30/17, joint aches, large Erythema, diarrhea and generalized feeling of debility continues.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: Erythematic on the entire upper Arm post 7 days.
Age: 24.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, and chills that began about 15 minutes after vaccine administration.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Persistent and intense upper arm pain in the arm where the flu shot injection was given. The pharmacist told me that the vaccine I was receiving was a high dose recommended for people age 65 and older. I usually have a sore arm for a day or two but this has persisted for a month. Upper left arm aches most of the time and a sharp pain occurs when I move the arm in an upward motion.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient states " I got Flu shot on Left shoulder on 10/2/17. Pain when I first received it, and pain until today (10/30/17) . Small lump felt on shoulder".
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red rash and swelling around the injection site as well as itching. A couple, myself being one, had a rash on their entire arm.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site swelling, Pain in extremity, Rash
Clinical narrative: "Severe reaction flu shot, rash, severe Right arm pain, shoulder swelling, numbing of face, lips. Went to Urgent Care, treated with oral medication, prednisone and ibuprofen."
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Vaccination complication
Clinical narrative: "Severe reaction flu shot, rash, severe Right arm pain, shoulder swelling, numbing of face, lips. Went to Urgent Care, treated with oral medication, prednisone and ibuprofen."
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT SITE OF VARCELLA VACCINE, LEFT THIGH THAT DEVELOPED > 1 WEEK AFTER THE VACCINE WAS ADMINISTERED.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Motion sickness
Clinical narrative: Dizziness and motion sickness.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Eye pain, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: High fever (102+), nausea, vomiting, muscle ache, rapid heartbeat, eye pain, headache.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever (102+), nausea, vomiting, muscle ache, rapid heartbeat, eye pain, headache.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Back pain, Decreased appetite, Dizziness, Headache, Nausea
Clinical narrative: Influenza mfr: Glaxo Smith Kline. Severe body aches, nausea, low grade fever 100.5, headache, back pain, lightheaded, dizziness, no appetite. Had to give TYLENOL 500mg every 4 hours and ibuprofen 600mg every 6 hours regularly x 3 days. She had arm soreness, but no swelling, edema, hematoma/bruising at either site. She had side effects from her #2 HPV, but not as severe. She has regular flu shots every year with no side effects or problems. I feel it is related to the HPV due to her last injection of HPV.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Influenza mfr: Glaxo Smith Kline. Severe body aches, nausea, low grade fever 100.5, headache, back pain, lightheaded, dizziness, no appetite. Had to give TYLENOL 500mg every 4 hours and ibuprofen 600mg every 6 hours regularly x 3 days. She had arm soreness, but no swelling, edema, hematoma/bruising at either site. She had side effects from her #2 HPV, but not as severe. She has regular flu shots every year with no side effects or problems. I feel it is related to the HPV due to her last injection of HPV.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Disease prodromal stage, Dysgeusia, Speech disorder, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of taste metallic in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018. The patient's past medical history included convulsion disorder. Concomitant products included Spironolactone. On 23rd October 2017, the patient received FLUARIX QUADRIVALENT. On 23rd October 2017, 15 sec after receiving FLUARIX QUADRIVALENT, the patient experienced taste metallic, speech disorder, tremor and disease prodromal stage. On 23rd October 2017, the outcome of the taste metallic, speech disorder, tremor and disease prodromal stage were recovered/resolved. The reporter considered the taste metallic, speech disorder, tremor and disease prodromal stage to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter stated that, on 23rd October 2017 07:45, the patient had a metallic taste, prodromal symptoms, stated patient's speech was affected, and the patient had tremors in her right arm 15 seconds following a FLUARIX administration.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Pyrexia, Swelling
Clinical narrative: Pt walked into the clinic and asked to see the RN explained received shots yesterday. Left deltoid area hard, redden rash. Pt states she woke up left arm noticed it was much larger, but she had been moving her arm, it has decreased in size by 50%. Redden area measured 8 cm (marked with purple marker. Anterior area red rash was 13 x 13 cm. Pt states she felt feverish 10/30/17 but didn't take her temperature. Warm compresses and symptomatic support given ED precautions. Given return precautions, will call RN in our office with concerns if they arise. Given abx precautions. Vaccine updated as allergy for PT, RN to report VAERS. 11/1 Telephone call to daughter who states left arm is much better, little redness, swelling much reduced.
Age: 32.0
Sex: M
Vaccine: FLUC4, HEPA, TYP, YF
Symptoms: Dermatitis contact, Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Right deltoid area shows a 0.25 x 1 cm erythematous blister that is non tender and non-pruritic. Appears to be contact dermatitis likely from removal of Band-Aid 24 hours later.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. On an unknown date, the patient received the 1st dose of ENGERIX B adult, the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIX B adult. On an unknown date, unknown after receiving ENGERIX B adult, ENGERIX B adult and ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: This case was not reported previously to anyone. The age at vaccination was not reported. The certified pharmacy technician reported that she was immunized for hepatitis-B with ENGERIX, years ago. The patient reported that she went through the 3 series vaccine regimen, and on time. The patient was tested and was a Therapy non-responder. No information was known about the dates or other information other than, it was years ago.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: The evening after the vaccine administration, patient started to develop redness at the injection site. The redness spread throughout the entire upper arm, and part of the shoulder. Patient states reaction site was hot to the touch, and developed a fever of 103 degrees F. Patient reported to the pharmacy 2 days after the vaccine was given, stating she thought she had an allergic reaction to one of the vaccines she was given. Fever subsided overnight the day the vaccine was given, but 2 days later arm is still warm to the touch and redness still remains. Recommended that patient could take BENADRYL for the reaction, but had not previously taken.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Neuralgia, Skin disorder
Clinical narrative: Patient began itching on the arm where the vaccine was given. Itching later turned to what she described as nerve pain inside and down her arm. Skin eventually broke down and is still broken. She saw her physician as was told it could be a delayed reaction to the flu vaccine. Patient was prescribed Clobetasol ointment and Hydroxyzine HCl tablets. As of 10/31/17 skin is still broken and patient feels like it is much better but she continues to keep it covered with a large Band Aid.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Discomfort, Hypersensitivity, Injection site cellulitis, Injection site discolouration
Clinical narrative: On 10/16/17 Complaint of a/an area of redness on skin. The area of redness is located L upper arm, deltoid region. The redness was noticed 5 days ago after receiving the Tdap vaccination. Patient reports she noticed a red lump which increased in size over 5 days. Site is tender and warm. The patient has tried home or prescribed treatment(s): OTC hydrocortisone and cool compress. This is the patient's initial encounter. Associated symptoms includes, chills which started today. On 10/23/17 L arm localized allergic reaction/treatment for cellulitis - patient was seen in clinic last week and diagnosed with cellulitis of L deltoid for which taking antibiotics as prescribed. Patient returned to clinic 5 days after receiving Tdap booster in L deltoid with C/O worsening warmth, edema, redness and tenderness at injection site. Patient diagnosed with cellulitis and prescribed doxycycline x 10 days. Patient states itchiness, stinging and pain much improved. Site is healing however skin is darkened. Patient admits to Hx darkening of skin with healing. No further burning and rare itchiness. And on 10/27/17 The lesion has improved - she does still have intermittent itching and intermittent episodes of aching pain and pressure - much improved then they were initially but still present. There is a "knot" below the skin which she noticed after the vaccine that has decreased in size significantly. No redness, drainage, no fevers, no chills, nausea, vomiting, or diarrhea.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain
Clinical narrative: On 10/16/17 Complaint of a/an area of redness on skin. The area of redness is located L upper arm, deltoid region. The redness was noticed 5 days ago after receiving the Tdap vaccination. Patient reports she noticed a red lump which increased in size over 5 days. Site is tender and warm. The patient has tried home or prescribed treatment(s): OTC hydrocortisone and cool compress. This is the patient's initial encounter. Associated symptoms includes, chills which started today. On 10/23/17 L arm localized allergic reaction/treatment for cellulitis - patient was seen in clinic last week and diagnosed with cellulitis of L deltoid for which taking antibiotics as prescribed. Patient returned to clinic 5 days after receiving Tdap booster in L deltoid with C/O worsening warmth, edema, redness and tenderness at injection site. Patient diagnosed with cellulitis and prescribed doxycycline x 10 days. Patient states itchiness, stinging and pain much improved. Site is healing however skin is darkened. Patient admits to Hx darkening of skin with healing. No further burning and rare itchiness. And on 10/27/17 The lesion has improved - she does still have intermittent itching and intermittent episodes of aching pain and pressure - much improved then they were initially but still present. There is a "knot" below the skin which she noticed after the vaccine that has decreased in size significantly. No redness, drainage, no fevers, no chills, nausea, vomiting, or diarrhea.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Skin mass
Clinical narrative: On 10/16/17 Complaint of a/an area of redness on skin. The area of redness is located L upper arm, deltoid region. The redness was noticed 5 days ago after receiving the Tdap vaccination. Patient reports she noticed a red lump which increased in size over 5 days. Site is tender and warm. The patient has tried home or prescribed treatment(s): OTC hydrocortisone and cool compress. This is the patient's initial encounter. Associated symptoms includes, chills which started today. On 10/23/17 L arm localized allergic reaction/treatment for cellulitis - patient was seen in clinic last week and diagnosed with cellulitis of L deltoid for which taking antibiotics as prescribed. Patient returned to clinic 5 days after receiving Tdap booster in L deltoid with C/O worsening warmth, edema, redness and tenderness at injection site. Patient diagnosed with cellulitis and prescribed doxycycline x 10 days. Patient states itchiness, stinging and pain much improved. Site is healing however skin is darkened. Patient admits to Hx darkening of skin with healing. No further burning and rare itchiness. And on 10/27/17 The lesion has improved - she does still have intermittent itching and intermittent episodes of aching pain and pressure - much improved then they were initially but still present. There is a "knot" below the skin which she noticed after the vaccine that has decreased in size significantly. No redness, drainage, no fevers, no chills, nausea, vomiting, or diarrhea.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ~20 hrs after injection site is red, swollen, tender.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Ear pruritus, Ear swelling, Erythema, Eye pruritus, Eye swelling
Clinical narrative: Ears and eyes itched, swelled, turned red. That subsided within an hour. Injection site on arm also swelled and turned red, very painful. Was completely swollen, hard, and red through entire upper arm the following morning. Kid looked like a very sad Popeye. Unable to move arm without extreme pain. Benadryl and pain relievers helping at the moment.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Ocular hyperaemia
Clinical narrative: Ears and eyes itched, swelled, turned red. That subsided within an hour. Injection site on arm also swelled and turned red, very painful. Was completely swollen, hard, and red through entire upper arm the following morning. Kid looked like a very sad Popeye. Unable to move arm without extreme pain. Benadryl and pain relievers helping at the moment.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Ears and eyes itched, swelled, turned red. That subsided within an hour. Injection site on arm also swelled and turned red, very painful. Was completely swollen, hard, and red through entire upper arm the following morning. Kid looked like a very sad Popeye. Unable to move arm without extreme pain. Benadryl and pain relievers helping at the moment.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Injection site pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Immediate pain at injection site. Not typical for vaccine administration. Pain has not gotten better. Tenderness at injection site 2 weeks after administration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Skin exfoliation
Clinical narrative: PEELING SKIN AT PALM OF HANDS AND TIP OF FINGERS // JUST LIKE WHEN SKIN PEELS AFTER RECOVERING FROM SUNBURN.
Age: 35.0
Sex: F
Vaccine: DT
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: PATIENT IS 37 WEEKS INTO PREGNACY, NO COMPLICATIONS THUS FAR WITH PREGNACY, EXPECTED DELIVERY DATE 11-17-17.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Paralysis
Clinical narrative: Pt called the pharmacy the next day after the vaccines and stated that she felt "paralyzed temporarily".  She said it only lasted a little while. Suggested pt stop REGLAN and call dr ASAP.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, X-ray limb normal
Clinical narrative: Left deltoid pain 2 hours after injection, pain dulled by day 2 but never resolved. Difficulty raising arm and reaching to right side. Took TYLENOL 10/8. 10/10 saw nurse practitioner. Starting 10/11 took ALEVE BID for 7 days. 10/30/17 Saw Dr, eval and xray. MD prescribed prednisone for 7 days. To begin occupational therapy 11/2/17.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pallor
Clinical narrative: Patient presented as pale skinned and complained of lightheadedness. She was advised to lay on the floor. Blood pressure was 110/70. Patient was advised to drink water and then juice. Cold compress applied to patient's forehead. Patient returned to her normal feeling and activity within 45 minutes. Patient stated that she felt "fine" at that time.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 15 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot # N015625 with expiration date: 15-NOV-2018 (strength, route and anatomical location were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK) (strength, dose, route, lot #, expiration date and indication were not reported). The reporter stated that the patient was administered PROQUAD when the he/she was already 15 year old. No adverse effects reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: The patient experienced extreme nausea and headache started around bedtime. The symptoms began the night after receiving the flu vaccine (around 5pm).
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient is experiencing arm/shoulder pain. She is currently seeking treatment from an ortho doctor and has an appointment on Friday. I plan on following up with her next week to see how she is progressing/improving.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Parent arrived with child on 10-31-17 to Health Department to seek medical attention for painful swelling in Right Deltoid muscle. Father stated that he first noticed the swelling on 10-12-2017, the day after the HPV was given in the deltoid muscle. He thought the swelling would go down, but two weeks later it continues to be swollen, so he went to doctor's office for treatment, but they sent him to the health department. Nurse examined L Deltoid, muscle was swollen, slightly warm. Child reported some pain with movement. Referred child back to a medical facility for treatment. Doctor's office care or if unable to obtain care there, instructed to go to Emergency room. Child uninsured.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient still has muscle soreness in left upper arm and shoulder and going to the neck/chin area 2 days after receiving the vaccine. She is taking ADVIL and has some relief. She also got a PREVNAR shot in the other arm and it feels fine.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Contusion, Injection site pain, Injection site paraesthesia
Clinical narrative: Patient has what looks to be bruising down her arm much lower than the injection site. She said her arm felt tingly and hurt around the injection site and under her arm starting when she woke up the morning after her vaccine. She is worried that the injection leaked out into the subcutaneous tissue in her arm and will therefore not provide adequate flu protection.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: Flu Shot I dont know which one. Difficulty breathing shortness of breath.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nausea, Vision blurred
Clinical narrative: Patient said he was feeling weak, dizzy, nausea, blurred vision after receiving a flu vaccine the previous night. Went over the VIS statement with patient and most symptoms he was having was under problems that could happen after any injected vaccine section and for him to contact his health care provider (doctor).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was administered the FLUZONE 6-35 month vaccination on 10/16/17. He tolerated well and had no adverse reaction. We have had no contact with patient's family since his appointment on 10/16.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left upper forearm was extremely sore starting several hours after receiving the shot, and very warm to touch. The following day my left arm was more painful and I had fairly extreme pain in my left upper arm (top and bottom) and shoulder area, including significant swelling in my underarm area and next to left breast. It was difficult to move the arm in any direction and was still very warm to touch with noticeable redness, including sensitivity to slightest touch. On day 2 after the shot, arm is still very sore, warm to touch with visible redness; swelling is still noticeable in underarm area and very uncomfortable.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Left upper forearm was extremely sore starting several hours after receiving the shot, and very warm to touch. The following day my left arm was more painful and I had fairly extreme pain in my left upper arm (top and bottom) and shoulder area, including significant swelling in my underarm area and next to left breast. It was difficult to move the arm in any direction and was still very warm to touch with noticeable redness, including sensitivity to slightest touch. On day 2 after the shot, arm is still very sore, warm to touch with visible redness; swelling is still noticeable in underarm area and very uncomfortable.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Muscle injury
Clinical narrative: Patient was given flu shot in her left upper arm (but claims it was given in her the back part of her shoulder). She said she felt extreme pain and pressure when shot was given from her shoulder down her arm to her fingers. She states the pain started at that time until now. She said the pain got worse and then she could not raise her arm so she went to a doctor. He recommended an MRI.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema, Pain in extremity
Clinical narrative: Patient was given flu shot in her left upper arm (but claims it was given in her the back part of her shoulder). She said she felt extreme pain and pressure when shot was given from her shoulder down her arm to her fingers. She states the pain started at that time until now. She said the pain got worse and then she could not raise her arm so she went to a doctor. He recommended an MRI.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Localised oedema, Pain, Pruritus
Clinical narrative: Local redness, swelling and itching accompanied by headache, body ache and fever.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Local redness, swelling and itching accompanied by headache, body ache and fever.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: DIZZINESS.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient came in today (11/1) complaining of stiffness in her shoulder joint - specifically that she's unable to reach her arm up or grab things without assist from her other arm. Patient says when she received the shot it hurt and she yelled - she also said her injection went in to her arm much higher than she's ever received a shot before. She showed me a "hole" in her arm (light brown spot patient says is where her injection was administered) which was very high up on the shoulder. Patient says she thought the pharmacist hit bone when administering the PREVNAR. I asked if she's been to a doctor and she has not, but did tell me she's been taking ibuprofen 800 mg to relieve the pain/discomfort, however she still cannot lift her arm up without assistance.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Tendonitis
Clinical narrative: Flu vaccine was given in left upper arm. Area was sore for the first few days then began to hurt in certain positions and especially at nighttime, progressively worsening. By the third week after vaccine unable to move arm in certain positions due to pain at night. Unable to sleep due to pain. Difficulty breastfeeding baby due to pain in certain positions at nighttime. Daytime symptoms not as severe but constant aggravation and inability to move arm in certain positions.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Bone cyst, Grip strength decreased, Injection site pain, Neck pain
Clinical narrative: Patient stated she experienced right neck pain and right shoulder pain and low grip strength with her right hand, beginning the weekend after the vaccination was given (vaccination given Thursday, Oct 12). She states she rested tried Acetaminophen and ALEVE / MOTRIN and felt a little better the week after the symptoms began but pain never resolved. She states she called her primary doctor and they referred her to the Emergency Room, where the doctor diagnosed what may be a bone cyst and prescribed her a steroid dose pack and ibuprofen 800 mg.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse drug reaction, Allergy to metals, Alopecia, Anxiety, Arthralgia
Clinical narrative: Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Constipation, Decreased immune responsiveness, Dehydration, Dermatitis contact, Disturbance in attention
Clinical narrative: Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspepsia, Dyspnoea, Eczema, Feeling abnormal, Fluid intake reduced
Clinical narrative: Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Gastric emptying study, Gastritis, Hot flush, Hypersensitivity, Hypotension
Clinical narrative: Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Irritability, Lethargy, Nausea, Neck pain
Clinical narrative: Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Panic attack, Ultrasound abdomen normal, Ultrasound biliary tract, Weight decreased
Clinical narrative: Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
Age: 18.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Crying, Depressed level of consciousness, Loss of consciousness, Screaming, Tonic clonic movements
Clinical narrative: Client lost consciousness following the 3rd vaccine (out of 8 needed) with tonic arm movements, then would become semi-conscious with high pitched screaming/crying. This cycle repeated 8 times. EMS contacted and transports client to Hospital.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient is currently pregnant, after receiving vaccine, day 1 and 2 became very itchy, day 3-4, red, raised rash appeared to forearms, hands, and below knees on both legs. Due to pregnancy, only took BENADRYL to relieve itching. One week later, rash still red and present although to a lesser degree. Second year that this reaction has happened. Received FLUBLOK last year also.
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired GARDASIL vaccine during her annual exam. This was her first dose in a series of 3. The expiration date was not noted until after the medication was administered. No adverse reactions were noted. The manufacturer, Merck, was notified but they could not give any advice on what to do because they had no data on this issue. They said to leave it up to the physician. Pharmacy did provide information from the CDC- noting that this dose should not be counted as valid and to repeat the dose.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Middle insomnia
Clinical narrative: Woke up in the middle of the night and my balance was completely "off" This only lasted for a short period of time--minute or so.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Glucose urine present, Glycosuria, Polydipsia, Polyuria, Type 1 diabetes mellitus
Clinical narrative: Vaccine administered 4/27/16. Parent concerned that later that year (Oct 2016) patient developed signs of polyuria and polydipsia. Diagnosed with IDDM on 10/20/2016. Unclear of correlation.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyskinesia, Fall, Hyperaesthesia, Skin injury, Syncope
Clinical narrative: Child had received the flu vaccine with mother in attendance at a parent teacher conference. They had left the room where shot was given and were in the hallway when child fainted and had jerky movements of extremities lasting 10-15 seconds. This nurse did not see child faint, but it was witnessed by another mother present for her child to get the flu vaccine. This witness happens to be a registered nurse and reported the jerky movements. Child awoke after 15 seconds and was able to say her name and where she was correctly. Child had scrape on forehead and was found lying with her head against a brick wall. Uncertain if she hit her head when she fell or if she turned to side during the jerky movements that were reported. Mother took child to the Hospital to have her checked. Phoned child's mother the next day and she reported that the doctor felt everything was ok, but did check with a neurologist to make sure. Child attended school the next day and mother reported child just had sensitivity to touch where she had a "goose egg" on her forehead.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Extensive swelling of vaccinated limb, Headache, Skin warm
Clinical narrative: My son woke at 4:00AM the morning after receiving the flu vaccine with a headache and 100.7 temperature. I treated the symptoms with MOTRIN and then noticed later that morning that the arm he received the injection in was swollen twice the size of his other arm, bright red and hot to the touch. As soon as I discovered his swollen arm, I called the Pediatrician and they advised me to bring him in immediately. The Doctor examined him and said that he had a "type 4" reaction and she advised me to never give him the flu shot again. She also advised BENADRYL as needed to help with his reaction. When he woke the next day, after two doses of BENADRYL, his arm was less swollen, red and hot.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: My son woke at 4:00AM the morning after receiving the flu vaccine with a headache and 100.7 temperature. I treated the symptoms with MOTRIN and then noticed later that morning that the arm he received the injection in was swollen twice the size of his other arm, bright red and hot to the touch. As soon as I discovered his swollen arm, I called the Pediatrician and they advised me to bring him in immediately. The Doctor examined him and said that he had a "type 4" reaction and she advised me to never give him the flu shot again. She also advised BENADRYL as needed to help with his reaction. When he woke the next day, after two doses of BENADRYL, his arm was less swollen, red and hot.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Laboratory test, Neck pain, Pain in extremity, Paralysis, Vaccination site pain
Clinical narrative: Patient stated right arm where vaccine was sore for a week then pain started to travel around neck and into left arm. Felt sort of paralysis.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Rash generalised
Clinical narrative: PER SCHOOL NURSE APPROXIMATELY 30 MIN AFTER DOES ADMINISTERED, HE HAD FACIAL REDNESS, SWELLING TO SITE, AND GENERALIZED RASH. HE WAS GIVEN BENADRYL 25 MG PO AND MOM TOOK HIM TO MD OFFICE. PER SCHOOL NURSE HE WAS GIVEN 'ANOTHER SHOT' AND HE IS NOT BACK AT SCHOOL. SPOKE WITH SCHOOL NURSE AT 1:00 PM. HE IS DOING WELL AT THIS TIME.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Swelling, Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 78 year old female patient. The patient had allergies or reactions to DARVON and tetracycline. On 11-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis ("one shot", route of administration was not reported; lot # N023651, expiration date 20-MAY-2019). On 12-OCT-2017, the patient experienced an adverse reaction with PNEUMOVAX 23. She developed peripheral edema on the back side of the left arm. The patient also had redness, swelling, and the area was red and hot to the touch. The patient did not seek medical attention and did not receive treatment for the events. No product quality complaint was filed. At the time of the report, the patient had not recovered from the events. The reporter considered the adverse reaction to be related to therapy with PNEUMOVAX 23, while the causal relationship of the other events was not reported.