chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Anger, Back pain, Crying, Emotional disorder
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 30Aug2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe pain in her back, very emotional, upset and crying with outcome of unknown.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient received FLULAVAL QUADRIVALENT vaccine the afternoon of 09/07/17; later that evening patient presented with fever of 102; aches and chills.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Body temperature increased, Bronchitis, Chest discomfort, Cough
Clinical narrative: Bronchitis symptoms, tightness in chest, coughing back pain, temperature 3 points above normal, sweating. Saw doctor 9/5/17 - could not rule out pneumonia. Prescribed Azithromycin 250mg pack, DIFLUCAN 150 mg, PROAIR HFA. Gradual improvement since then.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis
Clinical narrative: Bronchitis symptoms, tightness in chest, coughing back pain, temperature 3 points above normal, sweating. Saw doctor 9/5/17 - could not rule out pneumonia. Prescribed Azithromycin 250mg pack, DIFLUCAN 150 mg, PROAIR HFA. Gradual improvement since then.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Dizziness
Clinical narrative: 12 yo female here for follow up on "seizure-like" activity last week. States that after HPV on 9/1 she did well however went to school and started feeling weird during PE. She states that she was not in full control of her body and that she felt dizzy. Then she started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and rested but then one hour later she fainted and was shaking. Mom took her to the ER where an extensive work up including blood work, EKG, EEG, CT, UA were all negative. Since that time she has felt foggy, fatigued, and just not herself. She has had retro amnesia and could not do tasks that she normally would. States that she has been sleeping ok, going down about 10pm and waking up normally but then feeling tired throughout the day. No more dizziness, HA, blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking ok, normal output. No fever. No meds at this time. Does state that her right arm has also been hurting since the immunization and then IV placement in the same arm. Hurts when she is writing for a long time or using it for a long time. Denies any numbness, tingling or loss of function.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Drug screen negative, Dysarthria, Electrocardiogram normal, Electroencephalogram normal, Fatigue
Clinical narrative: 12 yo female here for follow up on "seizure-like" activity last week. States that after HPV on 9/1 she did well however went to school and started feeling weird during PE. She states that she was not in full control of her body and that she felt dizzy. Then she started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and rested but then one hour later she fainted and was shaking. Mom took her to the ER where an extensive work up including blood work, EKG, EEG, CT, UA were all negative. Since that time she has felt foggy, fatigued, and just not herself. She has had retro amnesia and could not do tasks that she normally would. States that she has been sleeping ok, going down about 10pm and waking up normally but then feeling tired throughout the day. No more dizziness, HA, blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking ok, normal output. No fever. No meds at this time. Does state that her right arm has also been hurting since the immunization and then IV placement in the same arm. Hurts when she is writing for a long time or using it for a long time. Denies any numbness, tingling or loss of function.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal, Pain in extremity
Clinical narrative: 12 yo female here for follow up on "seizure-like" activity last week. States that after HPV on 9/1 she did well however went to school and started feeling weird during PE. She states that she was not in full control of her body and that she felt dizzy. Then she started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and rested but then one hour later she fainted and was shaking. Mom took her to the ER where an extensive work up including blood work, EKG, EEG, CT, UA were all negative. Since that time she has felt foggy, fatigued, and just not herself. She has had retro amnesia and could not do tasks that she normally would. States that she has been sleeping ok, going down about 10pm and waking up normally but then feeling tired throughout the day. No more dizziness, HA, blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking ok, normal output. No fever. No meds at this time. Does state that her right arm has also been hurting since the immunization and then IV placement in the same arm. Hurts when she is writing for a long time or using it for a long time. Denies any numbness, tingling or loss of function.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pregnancy test negative, Retrograde amnesia, Seizure like phenomena, Serum ferritin abnormal, Syncope
Clinical narrative: 12 yo female here for follow up on "seizure-like" activity last week. States that after HPV on 9/1 she did well however went to school and started feeling weird during PE. She states that she was not in full control of her body and that she felt dizzy. Then she started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and rested but then one hour later she fainted and was shaking. Mom took her to the ER where an extensive work up including blood work, EKG, EEG, CT, UA were all negative. Since that time she has felt foggy, fatigued, and just not herself. She has had retro amnesia and could not do tasks that she normally would. States that she has been sleeping ok, going down about 10pm and waking up normally but then feeling tired throughout the day. No more dizziness, HA, blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking ok, normal output. No fever. No meds at this time. Does state that her right arm has also been hurting since the immunization and then IV placement in the same arm. Hurts when she is writing for a long time or using it for a long time. Denies any numbness, tingling or loss of function.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Urine analysis normal
Clinical narrative: 12 yo female here for follow up on "seizure-like" activity last week. States that after HPV on 9/1 she did well however went to school and started feeling weird during PE. She states that she was not in full control of her body and that she felt dizzy. Then she started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and rested but then one hour later she fainted and was shaking. Mom took her to the ER where an extensive work up including blood work, EKG, EEG, CT, UA were all negative. Since that time she has felt foggy, fatigued, and just not herself. She has had retro amnesia and could not do tasks that she normally would. States that she has been sleeping ok, going down about 10pm and waking up normally but then feeling tired throughout the day. No more dizziness, HA, blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking ok, normal output. No fever. No meds at this time. Does state that her right arm has also been hurting since the immunization and then IV placement in the same arm. Hurts when she is writing for a long time or using it for a long time. Denies any numbness, tingling or loss of function.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Headache, Muscular weakness, Nausea, Oropharyngeal pain
Clinical narrative: Severe, debilitating stomach pain, muscle weakness in legs, sore throat, nausea, headache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: PT AS RPH TO CHECK ARM AFTER 6 MIN. ARM APPEARED TO BE RED AND WAS TENDER TO TOUCH WITH MINIMAL SWELLING.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Headache, Nausea
Clinical narrative: Severe, debilitating stomach pain, weakness, nausea, diarrhea, headache.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient had vasovagal syncope and passed out immediately after receiving the vaccination. She immediately came too and presented no further symptoms from the incident. Upon follow up with the patient the next morning, she was not having any symptoms and felt normal.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Pharyngeal oedema
Clinical narrative: Per the patient herself: She received the flu shot at pharmacy no sooner she walked out of the building her throat started to swell. Her husband took her to the ER where they would not treat her. She went to the local Urgent Care where her lips and feet started turning blue. Urgent Care in turn called the ambulance. The ambulance arrived and the EMT administered Epinephrine, Benadryl and Sodium Chloride. Patient states within minutes she was feeling better and her throat loosened. She also stated that she has gotten the flu shot every year for years with no reaction.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Inflammatory marker increased, Myalgia, White blood cell count increased
Clinical narrative: Patient had myalgias and diarrhea, presented to ED, found to have WBC count of 40.7 with elevated inflammatory markers. WBC returned to normal in 36 hours and inflammatory markers are downtrending.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pain
Clinical narrative: Complaints of Joint Pain and full body aches for 48 hours+. She did not report adverse event until 8/28/2017.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red rash to the left thigh. Small red dot not at injection site. 1 inch below the vaccine site there is superficial light erythema extending down to below the knee. The underlying tissue is soft and puffy but not hot or tender. It does not appear to be in the joint. He can flex the knee and can bear weight.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Dermatitis, Dermatitis atopic, Erythema, Injection site bruising
Clinical narrative: This spontaneous report as received on 28-AUG-2017, from a female registered nurse concerning a one year old female child (as reported). The registered nurse reported the patient had the pertinent medical history of "sensitive skin". The patient had no concomitant medications.  The patient had no drug reactions/allergies. The registered nurse reported that the one year old child had an adverse reaction to VARIVAX (Lot number M049126, expiration date 15-DEC-2018 (as reported)) (Dose reported as "first dose", route of administration reported as subcutaneous, indication reported as "routine") administered on 08-AUG-2017 and parents noticed rash on child 10-AUG-2017 and 11-AUG-2017, described as white, then red, then scabbing on both elbows, left leg swollen with a red area on left lateral calf with scabbing. Medical attention was sought: The child visited the physician office 16-AUG-2017 and had two circular scabbed lesions, no blisters, and no scabbing or redness. Elbows had dried papules on dorsal surface with scabbing. Physician diagnosed Atopic Dermatitis Unspecified. On 21-AUG-2017, parents took child to an Urgent Care because child developed a rash all over body with big red pimple on right arm. VARIVAX administered to right lower arm on 08-AUG-2017. On 24-AUG-2017, parents brought child for another physician visit. Rash still present, red raised on both arms and parents said it "hurt". A bruise was noted on upper right arm with tiny red papules and scaling on right elbow with a few spots on legs. Physician diagnosed infant Papular and Acro Dermatitis with Gianotti-Crosti Syndrome 3 days after VARIVAX vaccine. (Information received also reported no treatment was given for the adverse event. No lab diagnostics or studies performed. Present status was reported as not recovered.) At the time of the receipt of this report, the outcome of the events was reported as not recovered. The child has an appointment with a dermatologist on 29-AUG-2017. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Papule, Peripheral swelling, Rash erythematous
Clinical narrative: This spontaneous report as received on 28-AUG-2017, from a female registered nurse concerning a one year old female child (as reported). The registered nurse reported the patient had the pertinent medical history of "sensitive skin". The patient had no concomitant medications.  The patient had no drug reactions/allergies. The registered nurse reported that the one year old child had an adverse reaction to VARIVAX (Lot number M049126, expiration date 15-DEC-2018 (as reported)) (Dose reported as "first dose", route of administration reported as subcutaneous, indication reported as "routine") administered on 08-AUG-2017 and parents noticed rash on child 10-AUG-2017 and 11-AUG-2017, described as white, then red, then scabbing on both elbows, left leg swollen with a red area on left lateral calf with scabbing. Medical attention was sought: The child visited the physician office 16-AUG-2017 and had two circular scabbed lesions, no blisters, and no scabbing or redness. Elbows had dried papules on dorsal surface with scabbing. Physician diagnosed Atopic Dermatitis Unspecified. On 21-AUG-2017, parents took child to an Urgent Care because child developed a rash all over body with big red pimple on right arm. VARIVAX administered to right lower arm on 08-AUG-2017. On 24-AUG-2017, parents brought child for another physician visit. Rash still present, red raised on both arms and parents said it "hurt". A bruise was noted on upper right arm with tiny red papules and scaling on right elbow with a few spots on legs. Physician diagnosed infant Papular and Acro Dermatitis with Gianotti-Crosti Syndrome 3 days after VARIVAX vaccine. (Information received also reported no treatment was given for the adverse event. No lab diagnostics or studies performed. Present status was reported as not recovered.) At the time of the receipt of this report, the outcome of the events was reported as not recovered. The child has an appointment with a dermatologist on 29-AUG-2017. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Scab, Vaccination complication
Clinical narrative: This spontaneous report as received on 28-AUG-2017, from a female registered nurse concerning a one year old female child (as reported). The registered nurse reported the patient had the pertinent medical history of "sensitive skin". The patient had no concomitant medications.  The patient had no drug reactions/allergies. The registered nurse reported that the one year old child had an adverse reaction to VARIVAX (Lot number M049126, expiration date 15-DEC-2018 (as reported)) (Dose reported as "first dose", route of administration reported as subcutaneous, indication reported as "routine") administered on 08-AUG-2017 and parents noticed rash on child 10-AUG-2017 and 11-AUG-2017, described as white, then red, then scabbing on both elbows, left leg swollen with a red area on left lateral calf with scabbing. Medical attention was sought: The child visited the physician office 16-AUG-2017 and had two circular scabbed lesions, no blisters, and no scabbing or redness. Elbows had dried papules on dorsal surface with scabbing. Physician diagnosed Atopic Dermatitis Unspecified. On 21-AUG-2017, parents took child to an Urgent Care because child developed a rash all over body with big red pimple on right arm. VARIVAX administered to right lower arm on 08-AUG-2017. On 24-AUG-2017, parents brought child for another physician visit. Rash still present, red raised on both arms and parents said it "hurt". A bruise was noted on upper right arm with tiny red papules and scaling on right elbow with a few spots on legs. Physician diagnosed infant Papular and Acro Dermatitis with Gianotti-Crosti Syndrome 3 days after VARIVAX vaccine. (Information received also reported no treatment was given for the adverse event. No lab diagnostics or studies performed. Present status was reported as not recovered.) At the time of the receipt of this report, the outcome of the events was reported as not recovered. The child has an appointment with a dermatologist on 29-AUG-2017. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a practice manager refers to a multiple patients of unknown age. On unknown dates, the patients were vaccinated with improperly store doses of RECOMBIVAX HB for prophylaxis. No adverse effects reported. The temperature and time involved were not reported.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site infection, Injection site reaction, Mobility decreased
Clinical narrative: Patient son returned 9/8/17 to report 3 days after administration patient went to primary care Dr. for possible reaction. Patient was told to wait to see if resolved. Son states today patient admitted to hospital with severe infection and unable to move arms/neck.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: The injection site reaction on right arm was 3 inches in length and 2 inches in width, raised, red, and hot to touch. Patient experienced dull pain radiating from wrist to shoulder.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash
Clinical narrative: Patient spiked a fever and developed a rash on the chest.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient presented for second dose of Hepatitis B vaccine. Pharmacist administered the vaccine. Patient came back a month later to inform that her arm is sore, warm, and a bit swollen. She says it feels like a lump is in there.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reported that she has had shoulder pain that radiates down her arm since receiving the vaccination on 8/15/17. It has been occurring since vaccination and has not let up. She called the primary care provider. PCP recommended her to take an NSAID and alternate ice and warmth, which she has been doing without improvement.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with bicep area of left arm swollen and red. Skin felt feverish. No redness or swelling noted at the actual injection site.  Instructed patient to take ibuprofen to help with swelling and to use cool compress.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Potential cellulitis of area where flu injection was given. Redness.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Pt. mom called stating that 4 hours after Rabies #2 he developed fever of 103F. Nausea and severe headache that kept him up until 4 am. At 4 am he was completely fine and went to sleep. No problems today. He had similar issue with TRUMENBA dose #2 but was hospitalized at that time for a week with fever and headache. He will not be receiving Rabies #3 and is aware that no protection is obtained. Mom was very thankful for the discussion.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Fatigue, Neck pain, Visual impairment
Clinical narrative: Dizziness, fatigue, sore neck, visual changes at 2pm all at once.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: Erythema, firmness and inflammation at injection site. Slightly warm to touch.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Patient received both shots but in different arms Monday around 5:00pm. The following morning, she had the following symptoms: vomiting, chills, body aches, swollen glands, headache, fever. By Tuesday even her symptoms lessened but did not go completely away until Wednesday evening.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vomiting
Clinical narrative: Patient received both shots but in different arms Monday around 5:00pm. The following morning, she had the following symptoms: vomiting, chills, body aches, swollen glands, headache, fever. By Tuesday even her symptoms lessened but did not go completely away until Wednesday evening.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: Pt has a twin brother that was getting vaccines also. Instead of 1st PREVNAR given the pt received 2 PENTACEL injs. parents were still here when noticed. We were getting ready to give brother his inj when 2 PREVNAR were noticed on counter still. Mother was informed and we are catching him up at 9 months.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea, Pallor
Clinical narrative: After giving the pt the flu shot, she got in her mart cart and her and her daughter started leaving. They only got about 2 feet when patient stopped driving and her daughter stated the patient couldn't breathe. I went to the customer and she was struggling to breathe. I got her down on the floor because I didn't want her to pass out and hit her head. She was still struggling to breathe. At 324pm, I administered one epinephrine 0.3mg pen in her right thigh. At 327pm, her BP was 162/117. At 328pm, I administered 10ml diphenhydramine 12.5mg/5ml. Her breathing and color improved. The fire department arrived around 330pm. They took the customer to the hospital. Patient never lost consciousness and was speaking the entire time. Her lips were blue and she was pale in color.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Rash
Clinical narrative: Per patient via phone call 9/8/17, she had a knot, redness, and soreness on the left arm (where she got the injection). It is also warm to the touch. She said the redness started yesterday 9/7/17 and extends about an inch around. I told her the suggestions to ease the reaction-use a cold compress, TYLENOL or ibuprofen, or BENADRYL for the localized reaction. (Also told her about side effects for those). Told her what signs of a severe allergic reaction would be and told her that if the reaction continues to spread or worsen, to contact the doctor and if she has any signs of anaphylaxis, to go to the emergency room.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Patient was given both FLUZONE and PNEUMOVAX 23 in the same arm, 1 inch apart. Patient reported that evening, she felt feverish the night of the injection. Her arm was red and inflamed in the injection site, forming a band around the arm the next day. She did not go to the doctor's or emergency. Patient stated she took TYLENOL as self treatment and redness subsided but she is still feeling redness/ inflamed.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient noticed slight bruising and soreness in her right arm several hours after receiving the vaccine.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blister, Blood culture negative, Blood test normal, Erythema, Peripheral swelling
Clinical narrative: Patient received both vaccines in the same arm, 1 inch apart. The evening of the vaccinations, patient stated he felt feverish and took some Tylenol OTC. On Sept 07, 2017, patient noticed his arm was very inflamed and red and symptoms are down to his elbow. He went to the emergency when he had a large inflamed blister all to his wrist. Doctors treated him with Cefdinir 300mg TID x 10 days. His symptoms are now subsiding slowly.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Ultrasound scan, White blood cell count increased, Wound drainage
Clinical narrative: Patient received both vaccines in the same arm, 1 inch apart. The evening of the vaccinations, patient stated he felt feverish and took some Tylenol OTC. On Sept 07, 2017, patient noticed his arm was very inflamed and red and symptoms are down to his elbow. He went to the emergency when he had a large inflamed blister all to his wrist. Doctors treated him with Cefdinir 300mg TID x 10 days. His symptoms are now subsiding slowly.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Light headed, placed on ground, monitored gave water patient returned to normalness.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia, Pruritus
Clinical narrative: The patient called the pharmacy the day after he received his flu vaccination, 9-8-17 around 9:30 am. The patient said he was experiencing itching, tingling in his limbs, and dizziness. The patient said the itching on his limbs started the day of the vaccination on 9-7-17 but that the tingling in his limbs and dizziness did not start until the morning after the vaccination, 9-8-17. The patient mentioned that he has atrial fibrillation and is taking potassium, so he was not sure if his health issues were the cause or if they contributed to the possible reaction. I, RPh encouraged the patient to call his primary care physician right away due to concern for the signs and symptoms described. I left a voicemail message with the patient on 9-8-17 in the evening for him to call us for follow-up, but I did not hear back from the patient as of 9 pm close on 9-8-17.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Urticaria
Clinical narrative: Pt had hives, fever, and chills. We recommended OTC ibuprofen and BENADRYL. Call dr. if not improved in 72 hours or gets worse. Head to ER if hard to breathe.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Patient first called the evening of the 6th complaining of swelling and redness and injection site and was told to take some Benadryl and Tylenol to help counteract the reaction, and if not better to come in and see us. Patient observed swelling at injection site of left arm, which wrapped around the inside of the arm close to the elbow. Area was was sensitive to touch and very warm. Patient was advised to go to urgent care after showing both pharmacists on duty around 5:00 pm on the 7th, the reaction occurring. The patient was seen by Urgent Care diagnosed with an allergic-type reaction and given several medications to counteract the reaction. New prescriptions were brought into the pharmacy for a Medrol Dose Pk, Loratadine 10mg, and Famotidine 20mg, and Cephalexin 500mg, and a line was drawn below the swelling and told if rash goes beyond the line,  she needs to go to the emergency room.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: Patient with large circular reaction at site of injection. No induration, but hard to touch with dusky/ecchymotic color and bright red ring on outside of lesion. Lesion diameter approx 4 cm. No systemic symptoms. Treated with steroid topical cream.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash, Wheezing
Clinical narrative: Wheezing, shortness of breath, difficulty breathing, and rash to the upper chest/throat area (reaction occurred approximately 3 to 4 minutes after injection).
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Patient didn't feel well and had to go to the hospital.
Sex: U
Vaccine: FLUX
Symptoms: Allergic reaction to excipient
Clinical narrative: This serious initial spontaneous case was received from other non-health professional via Merck (other pharma) on 04-Sep-2017, concerning a patient of an unspecified age and gender. On an unspecified date, the patient was administered with influenza vaccine (dose, frequency, batch number, expiry date, manufacturer: unknown, trade name, route of administration and anatomical location: not reported). On an unspecified date, the patient had a several allergic reactions to the egg component of the vaccine. It was reported that, the patient got medical attention. At the time of this report, the outcome of the event was not reported. The reporter considered the causality between the event and suspect medicinal product (INN Flu Vaccine Seasonal) as related. Case comment: Due to missing information about exact time to onset, clinical presentation, medical history and treatment given, the causal role of suspect vaccine cannot be assessed. The company assessed the report as serious (medically significant).
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received (R) outer arm 1030 varicella-noticed some itching at 2 am and this morning swollen/warm to touch.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Nodule, Pain, Pain in extremity, Skin warm
Clinical narrative: Arm sore to move. Golfball size knot. Very hot to touch. Reported on Friday 9/1/2017 patient told to call Dr if does not get better/worse and use a warm compress for swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Local warm erythematous reaction (L) upper arm at site of vaccine administration.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a child male patient who received BEXSERO. In July 2017, the patient received the 1st dose of BEXSERO .5 ml. In July 2017, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not reported. The mother reported that the patient was a football player. The patient had 1st dose one month before the reporting date and he was due for his 2nd dose. However, the reporter wanted to wait for the 2nd injection because his initial dose made him sore at the area of injection and the area hurt for a few days. The area of soreness was approximately the size of an apple.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, unknown after receiving MENVEO, the patient experienced injection site induration, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site swelling, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling, injection site warmth and injection site erythema to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient in the practice had received MENVEO, and then experienced a localized reaction, described as induration, redness, swelling and warmth to touch, at the injection site. No patient or product information was available, but might be available upon follow up by fax. This was 1 of the 8 cases, reported by the same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, unknown after receiving MENVEO, the patient experienced injection site induration, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site induration, injection site swelling, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling, injection site warmth and injection site erythema to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient in the practice had received MENVEO, and then experienced a localized reaction, described as induration, redness, swelling, and warmth to touch, at the injection site. No patient or product information was available, but might be available upon follow up by fax. This was 1 of the 8 cases, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient received vaccine on 8/29/17 and started experiencing symptoms on 8/30/17. She feels dizzy and is having blurred vision.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Whelp appeared on her arm after flu vaccine given 10:00 am 9/6/17.
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cough, Diarrhoea, Nasopharyngitis, Vomiting
Clinical narrative: Patient received Typhoid and Anthrax at group event on Aug 26. Patient states he began with "head cold" symptoms on Aug 26 after began to have 'severe' diarrhea. On Sunday 9-4 come down with severe cough with vomiting, went to ER then on 9-4.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Pyrexia, Syncope
Clinical narrative: Pt experience dizziness and fainting beginning 9/6/17 and a low grade fever, dizziness, although improved, still exists.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fall, Pyrexia, Syncope
Clinical narrative: Pt experience dizziness and fainting beginning 9/6/17 and a low grade fever, dizziness, although improved, still exists.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Lip swelling, Pruritus
Clinical narrative: Patient contact pharmacy after receiving ZOSTAVAX immunization the day before. Patient stated that she was itching on diff. parts of the body (no rash) and lips swelled a little up and felt burned on inside. She went to ER in evening and was put on steroid.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Swelling, Urticaria
Clinical narrative: Hives on face and body. Swelled up neck as per parents history.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Loss of consciousness
Clinical narrative: After giving influenza and PNEUMOVAX in separate arms, the pt passed out in her chair. She was caught and kept from injuring herself. She immediately came back to consciousness and said she had not eaten. She was given orange juice while still in chair. Pt stated she felt better. School nurse escorted pt back to classroom where she ate a turkey sandwich. Rechecked on pt 30 min and 1 hour later. She reported feeling fine.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Incorrect route of drug administration, Injection site bruising, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extremities hot feeling of in a 11-year-old female patient who received MENVEO (batch number M16159, expiry date 31st October 2018). On 25th August 2017, the patient received MENVEO (subcutaneous) .5 ml. In August 2017, 1 day 12 hrs after receiving MENVEO, the patient experienced extremities hot feeling of, pain in arm, injection site bruising, swelling arm and erythema of extremities. On 25th August 2017, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of, pain in arm, injection site bruising and erythema of extremities were recovering/resolving and the outcome of the swelling arm and intramuscular formulation administered by other route were unknown. The reporter considered the extremities hot feeling of, pain in arm, injection site bruising, swelling arm and erythema of extremities to be almost certainly related to MENVEO. Additional details were reported as follows: The patient was inadvertently vaccinated with MENVEO subcutaneously, which led to inappropriate route of vaccine administration. The patient subsequently experienced a horrific local reaction. Less than a day after vaccination, the patient experienced injection site bruising and arm redness. The patient first reported the reaction to her mother 24 hours after vaccination, but the healthcare professional was uncertain exactly when the reaction actually began.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extremities hot feeling of in a 11-year-old female patient who received MENVEO (batch number M16159, expiry date 31st October 2018). On 25th August 2017, the patient received MENVEO (subcutaneous) .5 ml. In August 2017, 1 day 12 hrs after receiving MENVEO, the patient experienced extremities hot feeling of, pain in arm, injection site bruising, swelling arm and erythema of extremities. On 25th August 2017, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of, pain in arm, injection site bruising and erythema of extremities were recovering/resolving and the outcome of the swelling arm and intramuscular formulation administered by other route were unknown. The reporter considered the extremities hot feeling of, pain in arm, injection site bruising, swelling arm and erythema of extremities to be almost certainly related to MENVEO. Additional details were reported as follows: The patient was inadvertently vaccinated with MENVEO subcutaneously, which led to inappropriate route of vaccine administration. The patient subsequently experienced a horrific local reaction. Less than a day after vaccination, the patient experienced injection site bruising and arm redness. The patient first reported the reaction to her mother 24 hours after vaccination, but the healthcare professional was uncertain exactly when the reaction actually began.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Local reaction, Nausea, Pruritus
Clinical narrative: Red spot all over arm. Localized allergic reaction, hives and itching. Nausea day after immunization. Patient took 4 doses of BENADRYL 25 mg. Cleared up to a great extent.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Red spot all over arm. Localized allergic reaction, hives and itching. Nausea day after immunization. Patient took 4 doses of BENADRYL 25 mg. Cleared up to a great extent.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Peripheral swelling, Rash pruritic
Clinical narrative: Redness and swelling of both arms itchy rash.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Same reaction as allergic reaction to eggs general bad feeling-malaise.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient developed erythematous rash in both thighs. Pt was seen in local ER prior to office visit and given BACTRIM. Was improving at office visit. F/U in 2 days: Asymptomatic.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Condition aggravated, Dyskinesia, Dysphemia, Migraine, Muscle twitching
Clinical narrative: Started with a severe headache, followed by severe vomiting. Then convulsions. All within hours of the injection. We had to call 911. She was taken to the hospital and was monitored. She is now having involuntary muscle movements. Sensitivity to light. Sensitivity to noise. Leg aches. Constant headache. Unable to stand or walk without pain. Constant fatigue. Was seen the following day by the pediatrician, who has referred us to a neurologist.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Photophobia, Speech disorder, Vomiting
Clinical narrative: Started with a severe headache, followed by severe vomiting. Then convulsions. All within hours of the injection. We had to call 911. She was taken to the hospital and was monitored. She is now having involuntary muscle movements. Sensitivity to light. Sensitivity to noise. Leg aches. Constant headache. Unable to stand or walk without pain. Constant fatigue. Was seen the following day by the pediatrician, who has referred us to a neurologist.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Dyskinesia, Fatigue, Headache, Hyperacusis, Pain
Clinical narrative: Started with a severe headache, followed by severe vomiting. Then convulsions. All within hours of the injection. We had to call 911. She was taken to the hospital and was monitored. She is now having involuntary muscle movements. Sensitivity to light. Sensitivity to noise. Leg aches. Constant headache. Unable to stand or walk without pain. Constant fatigue. Was seen the following day by the pediatrician, who has referred us to a neurologist.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Pain in extremity, Photophobia, Seizure, Vomiting
Clinical narrative: Started with a severe headache, followed by severe vomiting. Then convulsions. All within hours of the injection. We had to call 911. She was taken to the hospital and was monitored. She is now having involuntary muscle movements. Sensitivity to light. Sensitivity to noise. Leg aches. Constant headache. Unable to stand or walk without pain. Constant fatigue. Was seen the following day by the pediatrician, who has referred us to a neurologist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large red itchy spot on site of injection. Applied BENADRYL cream to area. Presently still visible and red.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient developed fever, chills, headache and sore throat. Patient also developed a cough which lasted longer than the other symptoms.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Chills, Disorientation, Disturbance in attention
Clinical narrative: Started with drowsiness, laid down and got a severe case of chills and shakes.......which lasted for around 4 hours. Began with sore throat, swollen and the epiglottis. Had difficulty getting out of bed. Very weak and disoriented. May have had fever. Had difficult time becoming steady on feet and be able to move around. Hard to focus and get moving to get out of apt. took 2 days to feel self again. 16 years..had a shot every year, never had any reaction.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Oropharyngeal pain, Pharyngeal oedema, Somnolence, Tremor
Clinical narrative: Started with drowsiness, laid down and got a severe case of chills and shakes.......which lasted for around 4 hours. Began with sore throat, swollen and the epiglottis. Had difficulty getting out of bed. Very weak and disoriented. May have had fever. Had difficult time becoming steady on feet and be able to move around. Hard to focus and get moving to get out of apt. took 2 days to feel self again. 16 years..had a shot every year, never had any reaction.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Pruritus, Rash macular
Clinical narrative: Woke up the morning after vaccines with small erythematous macules behind ears and on backs, spread over next 24 hours, itchy, not raised, not hives.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Both flu and pneumo given in right deltoid.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient has history of passing out after any vaccination. Vaccine was administered, patient was fine. Then patient passed out down from chair. Helped patient up, elevated patients feet and requested to remain at consultation room for 30 minutes to make sure no allergic reaction. Patient was ok and left.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient had severe diarrhea and vomiting started Wednesday Aug. 30th around 7pm, took her in to  Hospital Emergency Room on Friday September 1st, the emergency room doctor stated it was a vaccine reaction and to treat her with pedialyte. On Friday September 8th took her back to her pediatrician for a check up, her diarrhea and vomiting have cleared.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Rash macular, Rash morbilliform, Rash pruritic
Clinical narrative: The patient developed a few fine erythematous macular lesions on the upper back and chest on 8/23/17. The rash spread progressively to the neck, face, abdomen and extremities over the next 2 days and became more confluent. The father noted that the rash was slightly itchy for the patient and she was itching it from time to time. She also seemed more fussy than usual. The patient was evaluated on 8/25/2017 in the office and found to have a morbilliform rash. She was active, playful, well hydrated with a normal physical exam for all her systems except the skin. The rash gradually resolved over the next few days post evaluation.
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: Very sore arm, hard to lift, hot to the touch red raised area near the site of injection. noticed it after going to bed and laying on it. (figure roughly 12 hours after injection).
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm experienced redness, pain, stiffness, and swelling hours after receiving the vaccine; the arm was also very hot to the touch. The majority of his left upper arm was affected.  Patient took benadryl and ibuprofen for relief. Patient came back to the pharmacy on 9/9/17 to report the issue. His doctor was also notified and instructed patient to take benadryl and ibuprofen for symptoms. Patient is doing well, but still has some residual redness, pain, and stiffness.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's left arm experienced redness, pain, stiffness, and swelling hours after receiving the vaccine; the arm was also very hot to the touch. The majority of his left upper arm was affected.  Patient took benadryl and ibuprofen for relief. Patient came back to the pharmacy on 9/9/17 to report the issue. His doctor was also notified and instructed patient to take benadryl and ibuprofen for symptoms. Patient is doing well, but still has some residual redness, pain, and stiffness.