chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Drug administered at inappropriate site, Injection site joint movement impairment, Injection site pain, Pain in extremity
Clinical narrative: Telephone call received by RN, from (client) requesting a call back from Health Department on 11/02/2017 due to having pain in L arm and shoulder after receiving vaccines x3 when at the immunization clinic on Wednesday, 10/25/2017. Client reported that on Saturday, 10/28/2017, she went to the Urgent Care due to worsening pain in L shoulder joint and that provider there advised that, per client, the "injection site was too high and too far back and missed the deltoid." Urgent Care provider advised client to go to ER if signs and symptoms worsened and to call Health Department. Client reported to RN that she has increased pain and decreased mobility in her left shoulder. RN encouraged pt. to go to ER.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a rash near left arm pit on 10/29/17 patient was to dermatologist Dr. patient was then diagnosed with shingles.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient received this year's flu vaccine on Sept 8, 2017 while in training. She was revaccinated due to a clerical error. She had no SE to date. Designated Medical Officer and Regional Pharmacy Executive were notified of incident.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: VACCINATED CLIENT AGE 45 WITH INFLUENZA FLUZONE HIGH DOSE FOR 65 YEARS OF AGE AND OLDER. NO ADVERSE EVENT NOTED.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphagia, Dyspnoea, Erythema
Clinical narrative: After 30 minutes of receiving the flu vaccine, she became dizzy, lightheaded, had trouble swallowing and breathing. Her face and neck started turning red. She was seen in the ED within 1 hour of receiving the flu vaccine. She received BENADRYL IV and then sent home.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Nausea, Pyrexia
Clinical narrative: Severe left arm with burning, fever, nausea.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Breath holding, Crying, Cyanosis, Erythema, Injection site rash
Clinical narrative: After receiving PREVNAR 13 and ACTHIB, pt began to cry and held his breath longer than average patients, within seconds, pt became cyanotic and red, lasted for 45 secs - 1 minute. Pt took a short gasp and began to breathe slowly. Rashes in the chest and left thigh developed within seconds. 3 minutes after event, pt displayed s/x of pallor and malaise.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Malaise, Pallor, Rash
Clinical narrative: After receiving PREVNAR 13 and ACTHIB, pt began to cry and held his breath longer than average patients, within seconds, pt became cyanotic and red, lasted for 45 secs - 1 minute. Pt took a short gasp and began to breathe slowly. Rashes in the chest and left thigh developed within seconds. 3 minutes after event, pt displayed s/x of pallor and malaise.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Vaccine given at 3:20pm. Employee noted numbness in her left side of her face. Was referred to ER for evaluation. Employee was able to move her facial muscles. Denied pain, discomfort, dizziness, shortness of breath. Evaluated by Physician Assistant. Prescribed Benadryl 25mg. She took that once she got home. Called the next day stating that she was back to normal, no further problems with numbness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Infectious mononucleosis
Clinical narrative: This case was reported by a nurse and described the occurrence of mononucleosis in a 18-year-old female patient who received BEXSERO. In August 2017, the patient received the 1st dose of BEXSERO. In September 2017, less than a year after receiving BEXSERO, the patient experienced mononucleosis. On an unknown date, the outcome of the mononucleosis was unknown. It was unknown if the reporter considered the mononucleosis to be related to BEXSERO. Additional details were provided as follow: The next month after vaccination with BEXSERO, the patient came down with mononucleosis. The reporter was asking, if it would be safe for the patient to have her 2nd BEXSERO shot in November, if she felt better.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of welts in a 5-year-old female patient who received FLULAVAL QUADRIVALENT. On 23rd October 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. On 24th October 2017, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to FLULAVAL QUADRIVALENT. Additional details were reports as follows: The case was reported by a Registered Nurse. The age at vaccination was not reported but it might be 5 year or 6 years. The patient experienced a large raised welt the day after injection that covered either the whole upper arm or upper leg. However, it did not bother or limit activity. The reporter reported that they were seeing this a lot with FLULAVAL, but she did not had the specific numbers or information for other patients at the time of the call. This case had been linked with the case US2017GSK165322, reported by the same reporter for brother of the patient.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Arthralgia, Back pain, Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Extreme arm soreness of left arm, inability to move left arm, fever, sore back, sore knees, headache, splotches on upper left arm.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Pyrexia, Rash macular
Clinical narrative: Extreme arm soreness of left arm, inability to move left arm, fever, sore back, sore knees, headache, splotches on upper left arm.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Pain in extremity, Skin warm
Clinical narrative: PATIENT COMPLAINED OF ARM SORENESS AND HEAT FOR ABOUT 1 WEEK POST VACCINATION THAT RESOLVED. PATIENT THEN PRESENTED TO PHYSICIAN'S OFFICE ON 10/19/2017 WITH SMALL KNOT ON LEFT ARM (BACK OF ARM A FEW INCHES ABOVE THE ELBOW PER NURSE) AND ARM SORENESS.
Age: 1.58
Sex: M
Vaccine: MENB, PNC13
Symptoms: Decreased appetite, Fatigue, Gait inability, Malaise, Pruritus
Clinical narrative: Tearful, tired, temperature, loss of appetite, unable to put pressure on his legs so unable to walk for 3 days. After 3 days he began to seem better. But 5 days later he began be unwell again, clingy, tired, fever. 7 days later he still had a loss of appetite then came out in a rash. Seemed to have an itchy head and possibly ear ache. After about 4 weeks he was more like his usual self.
Age: 1.58
Sex: M
Vaccine: MENB, PNC13
Symptoms: Pyrexia, Rash, Tearfulness, Weight bearing difficulty
Clinical narrative: Tearful, tired, temperature, loss of appetite, unable to put pressure on his legs so unable to walk for 3 days. After 3 days he began to seem better. But 5 days later he began be unwell again, clingy, tired, fever. 7 days later he still had a loss of appetite then came out in a rash. Seemed to have an itchy head and possibly ear ache. After about 4 weeks he was more like his usual self.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Influenza like illness, Injection site pain, Peripheral swelling
Clinical narrative: Red swollen arm/flyu like symptoms pain around shoulder and inj site. for 5 days.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Sore left arm,  red swollen. 3 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: Red swollen upper arm. flu like symptoms for 5 days.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Headache, Pyrexia
Clinical narrative: 10 days after patient received the vaccine patient had a fever of 101, diarrhea, slight head ache, achy joints, lack of appetite but recovered after 24 hours.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria, BENADRYL and hydrocortisone cream, unknown outcome at this time.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dizziness, Loss of consciousness
Clinical narrative: The patient complained of feeling dizzy about 2 minutes after receiving the vaccine. He sat down and immediately fainted. I caught him and placed him on the floor with his head clear of the wall and the table and chairs in the room. At this point, his arms were tensed up, his wrists were bent inward, and his body was slightly shaking. I called out for help and went to get a wet paper towel. As another pharmacist arrived on the scene, he gained consciousness (he was out for about 30 seconds). A few minutes later, he sat up and was extremely pale. The EMTs were called while he was unconscious, and they arrived and took his vitals. His blood pressure was about 110/70 mmHg and his pulse was 30 BPM.  He again laid down, as he was dizzy again. He did not want to ride in the ambulance, and asked me to call his mother to bring him to the emergency department.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Posture abnormal, Syncope, Tremor
Clinical narrative: The patient complained of feeling dizzy about 2 minutes after receiving the vaccine. He sat down and immediately fainted. I caught him and placed him on the floor with his head clear of the wall and the table and chairs in the room. At this point, his arms were tensed up, his wrists were bent inward, and his body was slightly shaking. I called out for help and went to get a wet paper towel. As another pharmacist arrived on the scene, he gained consciousness (he was out for about 30 seconds). A few minutes later, he sat up and was extremely pale. The EMTs were called while he was unconscious, and they arrived and took his vitals. His blood pressure was about 110/70 mmHg and his pulse was 30 BPM.  He again laid down, as he was dizzy again. He did not want to ride in the ambulance, and asked me to call his mother to bring him to the emergency department.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of welts in a 7-year-old male patient who received FLULAVAL QUADRIVALENT. On 23rd October 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. On 24th October 2017, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced welts. The patient was treated with ibuprofen and BENADRYL. On an unknown date, the outcome of the welts was not recovered/not resolved. It was unknown if the reporter considered the welts to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The case was reported by a Registered Nurse. The age at vaccination was not reported but it might be 6 year or 7 years. The patient experienced a large raised welt the day after injection that covered either the whole upper arm or upper leg. However, it did not bother or limit activity. The patient still had welt so the nurse recommended ice pack. The reporter reported that they were seeing this a lot with FLULAVAL, but she did not had the specific numbers or information for other patients at the time of the call. This case had been linked with the case US2017GSK165323, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of welts in an unspecified number of patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The case was reported by a Registered Nurse. The age at vaccination of the patients was not reported. The reporter reported that they were seeing a lot of cases for the patients with welts after receiving FLULAVAL, but she did not had the specific numbers or information for other patients at the time of the call. This case had been linked with the cases US2017GSK165322 and US2017GSK165323, reported by the same reporter.
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacy student and refers to a female patient of unknown age. The patient did not have and drug reactions or allergies. Further information about her pertinent medical history, concurrent conditions and information about concomitant medications was not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose, route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced severe nausea and vomiting. The outcome of events was unknown. The reporter did not assess the relatedness between events and RECOMBIVAX HB.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's grandfather refers to a 2 month old patient of unknown gender. On 26-JUL-2017, the patient was vaccinated with ROTATEQ dose 1, oral (lot# and expiry date were not provided) for prophylaxis. As of the reporting time, the patient did not receive the second dose of ROTATEQ. According to the prescribing information, the patient should have received the second dose of vaccine between weeks 4 and 10, which was by 04-OCT-2017. The patient did not experience any side effects. Product quality complaint was not involved.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, and refers to a currently 81 year old male patient with heparin allergy. Concomitant therapies included metoprolol, nitroglycerin (manufacturer unknown), terazosin, furosemide (manufacturer unknown), atorvastatin, potassium (unspecified), fish oil, Vitamin B12, Vitamin D3, aspirin (manufacturer unknown). The patient's medical history was not reported. On 01-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX for immunization (strength, dose, route, frequency, lot/batch # and expiration date were not reported). Other suspects therapies included sterile diluent (manufacturer unknown) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). It was reported that the patient did have preexisting condition of lymphocytosis and normally had higher white blood cell count, however, after ZOSTAVAX vaccination, on an unknown date in 2017, the patient experienced increase in white blood cell count, it went up even higher from "39 to 51" (unknown units, "routine blood work"). The patient did not received treatment for the event, did not need intervention to prevent serious criteria, did not presented disability or incapacity, did not need hospitalization and the event was not life threatening event. The outcome of white blood cell count increased was unknown. The causality between white blood cell count increased with ZOSTAVAX and sterile diluent (manufacturer unknown) was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Sinusitis
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was concomitantly vaccinated with PROQUAD (dose, route of administration, lot# and expiration date were not provided) and VARIVAX (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced sinus infection (also reported as "no adverse events reported"). Since 17-OCT-2017, the patient was treated with amoxicillin. The outcome of sinusitis was not provided. The relatedness between the sinusitis and PROQUAD and VARIVAX was not provided.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of LIQUID PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012766:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, intramuscularly, lot # L036245, expiration date on 09-FEB-2018 (anatomical location of administration was not mentioned)  for prophylaxis. Subsequently, on 31-OCT-2017 (about 6 months after her first dose) she was vaccinated with the second dose of GARDASIL 9. No adverse events were reported.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Developed hives - Tx in ED with meds PO (prednisone, ATARAX, PEPCID) - discharged stable. Left upper arm at site reddened.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Crying, Eczema, Injection site eczema, Rash
Clinical narrative: Starting at 7:30pm, approximately 6 hours after the vaccines were administered, baby began a shrill, high-pitch shriek. This shriek persisted for almost an hour while his parents tried to comfort their unconsolable baby. This cry/shriek was unlike anything heard from that child before. Additionally, in the days/weeks following receiving these vaccines, the child formed a rash which was later diagnosed as eczema by his pediatrician. The eczema started on the backs of his legs and slowly spread to his arms and face. Prior to vaccines, the child had perfectly clear skin with no history of skin rashes. The eczema has persisted since these vaccines.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: The injection didn't hurt or burn but immediately afterwards it began to get hot, red, itchy and felt like a golf ball under my skin. This has continued and the pain has gotten worse today. The Physicians in my workplace have stated that I'm having an adverse reaction and advised that I take CLARITIN and Ibuprofen, neither of which helped at all.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Palpitations, Vaccination complication
Clinical narrative: The injection didn't hurt or burn but immediately afterwards it began to get hot, red, itchy and felt like a golf ball under my skin. This has continued and the pain has gotten worse today. The Physicians in my workplace have stated that I'm having an adverse reaction and advised that I take CLARITIN and Ibuprofen, neither of which helped at all.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Large area of redness, warmth and hardness with pain present within 24 hrs of vaccination.
Age: 0.17
Sex: M
Vaccine: DT
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Severe vomiting and not eating.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen red itchy arm and shoulder.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Crying, Influenza like illness, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Patient phoned into to after hours phone nursing at 11/1/17 describing "upper buttock pain and pain in joints, wrists, ribs, kind of pain that makes you cry in church, feels like I have a terrible flu". Nurse noted: Temp 99, has not had any prednisone since yesterday am when he took his last 10 mg  (he gave impression he did not taper down like he was supposed to), started with 30 mg, tapered felt bad in years past has a flare when tapers but "not this bad" is wondering if having both immunizations put in the same arm made a problem, this am had his flu and pneumonia shots. Nurse also noted: "Reassured caller the fact the shots were given close together in the same arm would not cause a problem but he should follow up with his provider about the joint pain".  Patient called Dr.'s office 11/2/17 and noted the same the same symptoms. Provider advised patient to monitor symptoms, use Tylenol and ibuprofen PRN and follow up if needed. Patient contacted our office again on 11/3/17 and requested to speak to the nursing supervisor as he states the pharmacist advised him that two shots should not have been given in the same arm and that was why he was having the symptoms. Advised patient of administration recommendations with vaccines and he verbalized understanding but requests a VAERS report be placed to document his symptoms.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Biopsy bone marrow, Immune thrombocytopenic purpura, Platelet count decreased, Splenectomy, Transfusion
Clinical narrative: Diagnosed with Chronic ITP a blood disorder 2 months after receiving shots. Has had severely low platelets. Has had multiple Blood infusions, been on steroids, bone marrow stimulators, had bone marrow testing and most recently 10/25/17 had spleen removed and put on Penicillin twice a week for the rest of his life. All due to the Chronic ITP. It is about 2 1/2 years now, and will have to deal with it for the rest of his life.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness, swelling, itching, mild pain at site of immunization only. No generalized effects.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm
Clinical narrative: Large red. Warm circular area noted to left arm.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Pt developed rash and swollen lymph nodes in the back of her neck and shoulder and left under arm and fever for almost 2wks now and no improvement.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Red, swollen bicep. Extremely painful to the touch. MD treated with BACTRIM DS 1 BIDx7 days.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Amnesia, Computerised tomogram head normal, Electrocardiogram normal, Full blood count normal, Transient global amnesia
Clinical narrative: Severe short term memory loss. Dx: Temporary global amnesia.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Urine analysis normal
Clinical narrative: Severe short term memory loss. Dx: Temporary global amnesia.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous, Skin warm
Clinical narrative: Following day after vaccination pt stated she had red rash on lower portion of arm that to her felt hot to the touch. Given on Thursday-evaluated on 10/28. No heat was noted, small rash a couple inches lower than vaccine site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Musculoskeletal pain, Neck pain, Tenderness
Clinical narrative: Patient described extreme pain when vaccination was given/pt raised out of chair. Since that time has experienced extreme soreness/tenderness of shoulder radiating into neck. Described shot being given very high up on shoulder. Has been using warm compressed every night.
Age: 30.0
Sex: U
Vaccine: FLU4
Symptoms: Mouth swelling, Paraesthesia
Clinical narrative: Patient received flu vaccine at 11:10 AM on 10/6/17. One hour and 15 minutes later, patient face started to tingle and she had a "full/swollen" feeling in her mouth. Patient did not feel that she needed to use her EPI PEN but did not have any BENADRYL with her. 14:01 VS: 132/80, P-94, R-16. PO BENADRYL, 25 mg give. 50 minutes later patient feeling better and returned to work. 4 hrs later at 06:30 PM patient had a rebound reaction and ended up in the Emergency Department, she received epinephrine injection and IV BENADRYL.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Fatigue, Flushing, Hyperhidrosis, Tremor
Clinical narrative: Patient states that she started having flushing, burning, sweating, trembling and throwing up about 20 minutes after receiving the flu shot. The next day she was just very tired.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient states that she started having flushing, burning, sweating, trembling and throwing up about 20 minutes after receiving the flu shot. The next day she was just very tired.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Ear congestion, Headache, Immediate post-injection reaction, Peripheral coldness
Clinical narrative: Patient immediately (within 30 seconds) complained of headache, cold hands, plugged ears and almost fell down (did not loose consciousness but had to be supported to stand). Symptoms resolved after about 20 minutes.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mass
Clinical narrative: Immediately after giving patient vaccination pt had white round lump that occurred under pts arm.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of entire left arm from shoulder to hand.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, swollen area where vaccine was given warm to touch.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site papule, Local reaction
Clinical narrative: Flu shot 10/25/17. Had significant local reaction (L) shoulder start next day. Erythema, edema, soreness and red papules. Asked me about it at doc visit 11/1/17. Resolved on its own by 11/2/17.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient stated that about 3 hours after vaccination she started having pain, numbness and limited movement in her arm. When notified by patient, I instructed patient to see her primary care physician. She contacted her physician's office and they advised her to apply ice and take TYLENOL or ibuprofen. The doctor's nurse instructed patient to notify them if she still had any problems after 10 days. Patient states that her movement has returned but her arm still bothers her when she sleeps.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Soreness and redness with increase growth on arm. Resolved at today's visit.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Child vaccinated in left deltoid and then about 15-20 minutes later developed eye swelling and redness to left eye. No itching, no SOB, no rash noted or reported. Eye did not swell completely shut, Benadryl PO given per school nurse, monitored child for approximately 20 minutes after with no further reaction noted or increase swelling. Mother present, a teacher at school and able to keep close eye on her daughter.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Borrelia test negative, C-reactive protein increased, CSF immunoglobulin, CSF test normal, CSF virus no organisms observed
Clinical narrative: She got a flu and pneumonia shot about 2 weeks ago. She last got a flu shot about 4 years ago and it made her sick with achiness of all over the body, but did not have any other issues. The patient could not void and started having progressive weakness and numbness in extremities that has progressed upward. Patient now noticing numbness in hands. Will be transferred to Hospital for possible plasmapheresis.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Computerised tomogram head normal, Enterovirus test negative, HIV test negative, Herpes simplex test negative, Hypoaesthesia
Clinical narrative: She got a flu and pneumonia shot about 2 weeks ago. She last got a flu shot about 4 years ago and it made her sick with achiness of all over the body, but did not have any other issues. The patient could not void and started having progressive weakness and numbness in extremities that has progressed upward. Patient now noticing numbness in hands. Will be transferred to Hospital for possible plasmapheresis.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging spinal normal, Polymerase chain reaction, Red blood cell sedimentation rate normal
Clinical narrative: She got a flu and pneumonia shot about 2 weeks ago. She last got a flu shot about 4 years ago and it made her sick with achiness of all over the body, but did not have any other issues. The patient could not void and started having progressive weakness and numbness in extremities that has progressed upward. Patient now noticing numbness in hands. Will be transferred to Hospital for possible plasmapheresis.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Respiratory viral panel, Treponema test negative, Urinary retention, West Nile virus test negative
Clinical narrative: She got a flu and pneumonia shot about 2 weeks ago. She last got a flu shot about 4 years ago and it made her sick with achiness of all over the body, but did not have any other issues. The patient could not void and started having progressive weakness and numbness in extremities that has progressed upward. Patient now noticing numbness in hands. Will be transferred to Hospital for possible plasmapheresis.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test, Condition aggravated, Rheumatoid arthritis
Clinical narrative: Approx. 2 weeks after receiving the vaccine, I woke up with diffuse joint pain. I saw my rheumatologist, who did a workup and stated that this was a flareup of my pre-existed RA which had previously been in remission for 12 years. Over the past year, I was treated with PLAQUENIL and Prednisone for help with the pain. After many doctors appts I was given shots of Cortisone to help with pain which lasted only a few days. Now it is a year later and I am still in some pain even with the meds.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Body temperature, Fatigue, Feeling abnormal, Tremor
Clinical narrative: Patient called the morning of 11/3/2017 reported feeling tired and shaky, beginning on 11/2/2017. Said she had a temperature on 11/2/2017 of 101.6F and "feels terrible" today.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Hives in both arms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Erosive oesophagitis, Herpes zoster, Influenza like illness
Clinical narrative: Four days after flu vaccine I had flu like symptoms followed by burning/pain in chest/back. I was diagnosed with espohgus erosion. The pain worsened and spread to right shoulder blade and right upper arm. The pain in my chest was so intense I thought I may be having a heart attack. I visited the local EMS office, they stated my heart rythms was good. I called my health care provider telling her I thought something else may be wrong. She acted though I was bugging her but, she ordered ultrasound on my belly. When she contacted me with results she said she was sticking to her diagonals. Within three days of talking to her I broke out with the shingles rash. This is the sickest I can remember being. Awake almost three nights now with intense pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Four days after flu vaccine I had flu like symptoms followed by burning/pain in chest/back. I was diagnosed with espohgus erosion. The pain worsened and spread to right shoulder blade and right upper arm. The pain in my chest was so intense I thought I may be having a heart attack. I visited the local EMS office, they stated my heart rythms was good. I called my health care provider telling her I thought something else may be wrong. She acted though I was bugging her but, she ordered ultrasound on my belly. When she contacted me with results she said she was sticking to her diagonals. Within three days of talking to her I broke out with the shingles rash. This is the sickest I can remember being. Awake almost three nights now with intense pain.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: On 11/03/17 patient returns to clinic and reports vaccine hurt at the time it was given and states soon after vaccination she began experiencing the feeling as if arm was going to sleep but not fully asleep. Patient unsure what to do. Advised patient to be further worked up by PCP as we're unsure if this is a reaction to the vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has swelling, redness, and hot to the touch below where the actual injections were. I spoke with her on 11/3/17 @ 2:12pm and the swelling is going down.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: After getting her flu shot she was standing up watching her dad get the flu shot and she passed out.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Vaccine given at 10:30 AM - by midafternoon began with chills/body aches, joint pain, fever 103 lasting until next morning.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: As stated by the patient: As the nurse was administering the vaccine into Left deltoid, I yelled aloud as it was painful. If felt as if the inj hit the bone. The nurse administering stated it felt hard to push the med into the arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Employee stated she began to feel increased pain in the left arm/shoulder making it difficult for her to lift her arm.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on right arm - Treated with 2 Benadryl and some cream to rash.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Skin warm, Swelling
Clinical narrative: Larger area of erythema, warmth, swelling and discomfort than usual. Patient applied an ice pack to area. Symptoms subsided in few days.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Mother reported that student started developing redness around injection site that worsened. Took her to ER 11/01/2017 and was diagnosed with cellulitis and was put on KEFLEX 500mg qid for 10 days.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Swelling, Urticaria
Clinical narrative: Severe hives on back, thigh, butt, face/legs, feet/hands and arms swollen red. Also had some trouble breathing.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 11 week-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.58
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 19 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient at was inoculated with ZOSTAVAX, 1 DF, (lot# and route unknown) vaccine on or about 04-AUG-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-NOV-2016 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX, calamine lotion, and hydrocortisone cream for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder, Ophthalmic herpes simplex, Ophthalmic herpes zoster, Pain
Clinical narrative: Information has been received on 31-OCT-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 12-APR-2011 by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent zoster keratitis and other eye disorders. On or about 23-NOV02011, the patient was treated by a physician at an eye health center for eye problems which were diagnosed as zoster keratitis, a painful ocular disorder involving vision interference due to the herpes zoster virus infecting the eye. On or about 25-NOV02011, the patient sought subsequent treatment from another physician at an eye health center for ongoing and worsening symptoms of keratitis. On or about 23-OCT-2014, the patient sought subsequent medical treatment from an eye care physician's office for ongoing and worsening symptoms, at which time the diagnosis of progressive disciform keratitis was affirmed. On or about 22-JUN-2015, the patient was treated again by an eye care physician for new and worsening symptoms, where new herpes infections were observed in the left eye. Between the dates of 10-NOV-2015 and 08-FEB-2017, the patient underwent continuous observation and treatment by a physician for complications of the viral condition in his eyes. The patient has been prescribed MEDROL, acyclovir, VIGAMOX, doxycycline-monohydrate, tea tree oil, REFRESH PLUS drops, and prednisone for management his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, persistent zoster keratitis, progressive disciform keratitis and new herpes infections were observed in the left eye were considered to be medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash pustular, Streptococcus test
Clinical narrative: Whole body rash, multiple dots that look like pox.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient experiencing redness, swelling moving down toward elbow.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Initially patient felt like the needle hit a nerve and could feel a nerve-like sensation down into her finger. Then she developed pain in the shoulder area that has not gone away yet. She went to see her physician and was prescribed hydrocodone to help her sleep at night and she is planning on getting a hydrocortisone injection in her shoulder to see if that helps with the pain.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Right arm pain and redness s/p receiving pneumonia vaccine 2 days ago. Red and swollen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haematoma, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Hematoma at injection site immediately after vaccination the site swelled and bruised.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, IPV, MENB, MMR
Symptoms: Body temperature increased, Fatigue, Rhinorrhoea, Viral rash, Wrong drug administered
Clinical narrative: Client was given Men B in error in place of a Hepatitis A. This was discovered in our office on Friday 10/27 when information was being entered into the Immunization Information System  (IIS).  Monday 10/30 the mother was called and notified of the error. At that time the parent stated that the client had been fatigued and had a mild rash on day 2 and 3 after vaccination. The child was taken to HCP and was diagnosed with a viral rash. The child did get better. On 11/2 I received a call from the father called to report that the child had run a low grade temp had a runny nose and a rash  for 2 days. I did educate the parent that the child received an MMR on 10/13 and these were symptoms of reaction to the vaccine that generally happen 10-14 days after receipt of MMR vaccine. Father expressed concern that this reaction was from the Men B vaccine the child received. Father also stated he would be taking his child back to the HCP for additional evaluation. I have requested the parent follow-up with us regarding diagnosis and treatment at the time of that visit.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Developed right shoulder pain after influenza vaccination.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Patient developed a large (3x4in) erythematous, warm, pruritic area at vaccine site within 24hrs of vaccine administration. Advised treatment with Zyrtec and warm/cold compresses and return to office if increased erythema, pain, or fever.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Hives and itching  10 minute  onset at site of injection, spread to hold arm then to body only after 15 minutes.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Exaggerated startle response, Sleep terror, Speech disorder, Tremor
Clinical narrative: Night terror begun approximately 10pm. Lasted about 5 minutes. Daughter's eyes were opened, but her speech wasn't making sense, she was repeating things, her body was shaking, and she had startled look in her eyes. I held her, quietly shushed her, said "Mommy's here, etc." until she went back to sleep. She expressed no memory of event the next morning.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Balance disorder, Chills, Dizziness, Myalgia, Nausea
Clinical narrative: Chills, neck pain, could not hold up head, nausea, dizziness, balance problems, muscle pain.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Posture abnormal
Clinical narrative: Chills, neck pain, could not hold up head, nausea, dizziness, balance problems, muscle pain.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Blood folate, Blood thyroid stimulating hormone, Full blood count, Seizure, Thyroxine free
Clinical narrative: Approximately 1 hour after FLUVIRIN admin the patient apparently had a seizure, became unresponsive and lost bladder control. EMS was activated and the patient was brought to the ED and discharged after condition improved. Wellbutrin therapy was put on hold for the time being. The patient's upcoming trip in 3 days was cancelled. Patient was referred to a neurologist and hematologist and Psych MD was updated that PCP put wellbutrin on hold. Patient has follow-up appointment scheduled today (the next day) with PCP to follow up on ED visit for seizure. Patient and family believe he had these symptoms one other time about 2 years ago not related to vaccination.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli, Urinary incontinence, Vitamin B12, Vitamin D
Clinical narrative: Approximately 1 hour after FLUVIRIN admin the patient apparently had a seizure, became unresponsive and lost bladder control. EMS was activated and the patient was brought to the ED and discharged after condition improved. Wellbutrin therapy was put on hold for the time being. The patient's upcoming trip in 3 days was cancelled. Patient was referred to a neurologist and hematologist and Psych MD was updated that PCP put wellbutrin on hold. Patient has follow-up appointment scheduled today (the next day) with PCP to follow up on ED visit for seizure. Patient and family believe he had these symptoms one other time about 2 years ago not related to vaccination.