chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Musculoskeletal pain, Myositis, Nausea, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Tenderness, Transfusion
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction, White blood cell count increased
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Endoscopy, Gastrointestinal haemorrhage, Mobility decreased, Myositis, Transfusion
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on chest, back, ears, neck and face.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Asthenia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Chills. Injection site hot red swollen hard. Weakness. Diarrhea. No appetite. Muscle aches. Headache. Racing mind, Rapid heartbeat. Sharp pain in upper right abdomen. Sleeplessness. Thirsty. Still weak and achy this morning 11/05/2015 but feeling better.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Heart rate increased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Chills. Injection site hot red swollen hard. Weakness. Diarrhea. No appetite. Muscle aches. Headache. Racing mind, Rapid heartbeat. Sharp pain in upper right abdomen. Sleeplessness. Thirsty. Still weak and achy this morning 11/05/2015 but feeling better.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Insomnia, Myalgia, Tachyphrenia, Thirst
Clinical narrative: Chills. Injection site hot red swollen hard. Weakness. Diarrhea. No appetite. Muscle aches. Headache. Racing mind, Rapid heartbeat. Sharp pain in upper right abdomen. Sleeplessness. Thirsty. Still weak and achy this morning 11/05/2015 but feeling better.
Age: 1.34
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Within 10 mins of receiving vaccines pt. presented with hives on face, extremities and trunk. Dr was notified. Epinephrine 1:1000, 0.12 ml subq administered, steroids prescribed.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Rash, Skin reaction
Clinical narrative: Patient started developing rash on 11/3/15 at night. Patient now has erythematous rash around injection site. Reaction is delayed 1 week after vaccine administration. Steroid ointment given.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, warm to touch at injection site, down to elbow.
Age: 31.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 31 year old female patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 02-NOV-2015, the 31 year old patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (strength, dose, route of administration, lot #, albumin status and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner concerning a patient of unknown age and gender. Neither concurrent nor historical conditions were reported. On 10-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 (route, dose and lot number were not reported). On 10-AUG-2015, the patient was vaccinated with the second dose of GARDASIL 9 (route, dose and lot number were not reported) (inappropriate schedule of drug administration). No adverse event was informed. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza A virus test positive, Nasopharyngitis, Pyrexia
Clinical narrative: A report has been received from a pharmacist via Abbvie concerning a 12 year old, male patient, height: 60.0 inches; weight: 80.0 pounds. The patient took no concomitant medications. The concomitant diseases of the patient were not provided. On 19-Oct-2015 the patient received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration (0.1mL per nostril). The patient complained of cold symptoms referred to nasopharyngitis started on 21-Oct-2015. The patient went to his doctor with a fever and had a nasal swab done which was positive for type A influenza on 22-Oct-2015. FLUMIST QUADRIVALENT was continued. The outcome of the events was unknown. The event of type A influenza was considered as serious with the serious criteria of important medical event by company physician. The events of cold symptoms referred to nasopharyngitis and fever were considered as non-serious by company physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L021216, expiration date 10-JUN-2017 (dose and route of administration were not reported). Tehre was no adverse effect reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: Information was received on 26-OCT-2015 from a pharmacist who reported that a patient (age and gender not specified) received the first dose of the series of an unspecified M-M-R II or PROQUAD (unspecified lot/expiration date and dosage) at 10 months old. The patient also received two additional vaccination doses of unspecified M-M-R II or PROQUAD (unspecified lot/expiration date or dosage) on unspecified dates. The patient is in the pharmacy seeking a fourth dose of M-M-R II for a school requirement on 26-OCT-2015. It was confirmed that a fourth dose of M-M-R II was not administered to the patient. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. No concurrent conditions or medical history were provided. The patient reported to be taking an unspecified antiviral medication, which she discontinued taking (no date specified) prior to receiving ZOSTAVAX. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, site and route of administration, lot# and expiry date unspecified). No concomitant medications were reported. The patient reported an immediate injection site swelling with a 2 to 3 inch red circle at the injection site. The injection site swelling became a raised red lump that stayed for 8 days. The redness and swelling has since disappeared (dates not specified). There was also a soreness in her arm, which was still present at the reporting time, however, it was recovering. The relatedness between the events and ZOSTAVAX was not provided. It was also stated that the therapy with ZOSTAVAX was not discontinued. Additional information is not expected as no demographics were provided for the physician.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 29-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L005563, expiration date 03-NOV-2016 (strength, dose and route of administration were not provided). On 29-OCT-2015 (reported as "a couple hours after administration"), the patient developed severe pain at the injection site and on 30-OCT-2015 (reported as "a couple hours after administration"), the patient developed severe pain at the injection site and on 30-OCT-2015 (reported as "the next day"), the injection site was swollen and very painful. On 31-OCT-2015, the patient went to an unspecified urgent care facility for treatment and was given an unspecified antibiotic. The patient sought medical attention via visiting the urgent care facility. The outcome of the events (the patient's present status) was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patient were inadvertently vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Neck pain, Pain in extremity, Throat irritation, Tremor
Clinical narrative: Pain radiating up to left side of neck and down arm, sweating, shaking and itchy throat.
Age: 38.0
Sex: M
Vaccine: FLUX, TD
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 100 degree fever, chills, body aches.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: PAIN RADIATING UP LEFT SIDE OF NECK AND DOWN ARM. LEFT FINGERS TINGLING.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Erythema, Incisional drainage, Rash generalised, Stevens-Johnson syndrome
Clinical narrative: Rash started 9/30/2015 on face and hands/feet.  Rash spread to all extremities and trunk and blisters developed within three days.  She was hospitalized for two days with diagnosis of Stevens-Johnson Syndrome where her large blisters were drained.  All blisters were healed within 4 weeks of onset.  Continues with faint red marks to this day.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Viral test
Clinical narrative: Rash started 9/30/2015 on face and hands/feet.  Rash spread to all extremities and trunk and blisters developed within three days.  She was hospitalized for two days with diagnosis of Stevens-Johnson Syndrome where her large blisters were drained.  All blisters were healed within 4 weeks of onset.  Continues with faint red marks to this day.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Mass, Tenderness
Clinical narrative: Lump, redness and tenderness noted to area below the injection site.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Dizziness, Gait disturbance, Immediate post-injection reaction, Injection site joint pain
Clinical narrative: I immediately felt sick at the stomach and light headed. I felt this way all day. The Next morning, 10/30/2015 my left knee was swollen and I had trouble walking, so much so I wore a knee brace all day. Later on in the day I found I had hives on my hands, arms and shoulders. I became very itchy, especially on my arms, face and head. On 10/31/2015 my knee was less swollen but my right wrist now had a knot and I did not have full mobility. The hives and itching was still present. On 11/01/2015 I did not take my recurring medications, Metoprolol (blood pressure) and Bupropion (antidepressant) to see if that would help. On 11/02/15 I went to my PCP and she advised me to take Claritin and Pepcid AC which I did and it helped with the hives and itching but later that day they came back and has been back ever since. I now have joint pain in my injection shoulder and my left knee. I can not lift my arm entirely and my knee feels very painful and swollen.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Joint swelling, Nodule, Orthosis user, Pruritus, Urticaria
Clinical narrative: I immediately felt sick at the stomach and light headed. I felt this way all day. The Next morning, 10/30/2015 my left knee was swollen and I had trouble walking, so much so I wore a knee brace all day. Later on in the day I found I had hives on my hands, arms and shoulders. I became very itchy, especially on my arms, face and head. On 10/31/2015 my knee was less swollen but my right wrist now had a knot and I did not have full mobility. The hives and itching was still present. On 11/01/2015 I did not take my recurring medications, Metoprolol (blood pressure) and Bupropion (antidepressant) to see if that would help. On 11/02/15 I went to my PCP and she advised me to take Claritin and Pepcid AC which I did and it helped with the hives and itching but later that day they came back and has been back ever since. I now have joint pain in my injection shoulder and my left knee. I can not lift my arm entirely and my knee feels very painful and swollen.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Initial unsolicited case received from a physician on 22-Oct-2015 and additional information received on 23-Oct-2015 and 24-Oct-2015. This case involves a female patient (age not reported) had vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, dose number, route of administration were not reported) in right deltoid on unspecified date. Medical history and concomitant medications were not reported. Illness at time of vaccination was not reported. On unspecified date the patient experienced swelling, redness and hardness of right arm. On unspecified date patient has been hospitalized for observation, as the reaction continued to spread. Laboratory examinations were not reported. Corrective treatments included antibiotics. At the time of this report, the outcome of the event was reported as not recovered and patient was discharged from the hospital on 22-Oct-15. Documents held by sender: none.
Sex: U
Vaccine: DTAP, FLUX, PNC13
Symptoms: Febrile convulsion, Laboratory test
Clinical narrative: Initial unsolicited case received from literature on 21-Oct-2015. Abstract: OBJECTIVES: In the Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and pneumococcal conjugate vaccine (PCV13) during the 2010-2-11 influenza season, adjusted for concomitant DTaP. Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination. METHODS: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0-1 days) versus control interval (14-20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records. RESULTS: No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95 percent confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95 percent CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95 percent CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100,000 with same day administration, 95 percent  CI 25.68 to 6.09). CONCLUSIONS: No statistically significant increased risk of FS was found for 2010-2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination. This case involves one hundred forty two people (aged 6 to 59 months) had received a dose of DTaP (manufacturer: unknown, batch number, dose in series, route and site of administration were not reported), a dose of influenza vaccine (manufacturer: unknown, batch number, dose in series, route and site of administration were not reported) and a dose of Pneumococcal conjugate vaccine (PVVD 13) (manufacturer: other, batch number, dose in series, route and site of administration were not reported) on unspecified dates. Medical history and concomitant medications were not reported. On unspecified dates after 2010-2011, patients experienced seizure and fever (i.e., a measured temperature of about 38 Degree Celsius or tactile fever within 24 hours of a seizure or a physician's diagnosis of a concomitant febrile illness or a physician's diagnosis of a Febrile Seizure). On unspecified date, study, IRRs, another study used a design with chart confirmation of FS were performed. Other tests were not reported. Corrective treatments were not reported. At the time of report, outcome of the event was not reported. Upon internal review, the case was considered as serious due to important medical event: febrile seizure. List of Documents held by Sender: none.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Adverse drug reaction, Antinuclear antibody, Autoantibody test, Dystonia, Hypothyroidism
Clinical narrative: Hugely anxious past history. Increasing anxiety 9/16/14 vaccines 9/19/14. 10/28/14 OCD symptoms. 12/23/14 Dystonic reaction to risperidone. 01/02/15 work up revealed hypothyroidism.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Obsessive-compulsive disorder, Thyroid function test
Clinical narrative: Hugely anxious past history. Increasing anxiety 9/16/14 vaccines 9/19/14. 10/28/14 OCD symptoms. 12/23/14 Dystonic reaction to risperidone. 01/02/15 work up revealed hypothyroidism.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Papilloedema
Clinical narrative: VISUAL LOSS LEFT EYE ONSET 3-4 DAYS AFTER FLU VACCINE.
Age: 56.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Rash
Clinical narrative: Patient received two vaccines on Monday 11/2/15 (Prevnar 13 and Influenza) - rash that night; spread further over course of week; never any oral reaction but diffuse from face to feet.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Fatigue, Grip strength decreased, Injection site erythema, Injection site induration
Clinical narrative: Employee came to Employee Health in AM on 10/1/15 complaining of localized reaction to Flu vaccine.  Approximately 2 in indurated area with erythema to R shoulder.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness, Oral mucosal blistering
Clinical narrative: Employee came to Employee Health in AM on 10/1/15 complaining of localized reaction to Flu vaccine.  Approximately 2 in indurated area with erythema to R shoulder.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Rash, Swelling
Clinical narrative: Employee came to Employee Health in AM on 10/1/15 complaining of localized reaction to Flu vaccine.  Approximately 2 in indurated area with erythema to R shoulder.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Blood pressure decreased, Loss of consciousness
Clinical narrative: On 11/5/15, 19 yo F was brought to clinic for an annual exam. During visit, pt was ordered to receive inluenza vaccine and dose #2 of HPV vaccine quadrivalent IM (GARDASIL). Pt tolerated the influenza vaccine without incident. At 1106, pt was administered the HPV quadrivalent vaccine 0.5 mL in right deltoid (Manufacturer: Merck & Co. Inc, NDC: 0006-4109-01, Lot #L026034). After the injection, the pt passed out briefly. Pt's blood pressure was checked and found to be 84/58. Pt was provided with apple juice & allowed to rest for a unreported period of time. BP recheck at 1120 was back WNL at 112/68. Pt did report that she had eaten prior to appointment. Pt recoved completely and was discharged in stable condition.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature fluctuation, Chills, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea and large swings in body temperature, from shivering to sweating, between 7 pm and 10 pm. Took paracetamol around 9. Shivering and nausea started again around 2 am, vomited at 3 am. Body temperature returned to normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Received ZOSTAVAX vaccine on October 20, 2015. Broke out in shingles rash on (L) side of back and spread to (L) abdomen. Rx with VALTREX and NEURONTIN.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itchy red bumps appeared on right upper arm 18 hrs after flu shot on 10-21-15. Pt took BENADRYL otc.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Significant persistent pain at site of injection. Pain later presented at various sites (unassociated) of body leg/foot, others.
Age: 66.0
Sex: U
Vaccine: UNK
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dyspepsia, Eructation
Clinical narrative: 10-9-15 after vaccine leaving office could taste medicine quickly went away. From about 10-10-15 to 10-13-15 experiencing sharp, stinging sensation in chest felt like electric shocks. 10-17-15 Emergency Room visit. AV nodal re-entry tachycardia. Week of Oct. 19, 2015 discomfort both leg joints. 10-23-15 Emergency Room palpitations. Also during the time after 10-9-15 periods of wheezing and bad indigestion with belching having to sleep with head raised from 10-16-15 until 10-22-15.
Age: 66.0
Sex: U
Vaccine: UNK
Symptoms: Musculoskeletal discomfort, Paraesthesia, Product taste abnormal, Sleep disorder, Supraventricular tachycardia
Clinical narrative: 10-9-15 after vaccine leaving office could taste medicine quickly went away. From about 10-10-15 to 10-13-15 experiencing sharp, stinging sensation in chest felt like electric shocks. 10-17-15 Emergency Room visit. AV nodal re-entry tachycardia. Week of Oct. 19, 2015 discomfort both leg joints. 10-23-15 Emergency Room palpitations. Also during the time after 10-9-15 periods of wheezing and bad indigestion with belching having to sleep with head raised from 10-16-15 until 10-22-15.
Age: 66.0
Sex: U
Vaccine: UNK
Symptoms: Wheezing
Clinical narrative: 10-9-15 after vaccine leaving office could taste medicine quickly went away. From about 10-10-15 to 10-13-15 experiencing sharp, stinging sensation in chest felt like electric shocks. 10-17-15 Emergency Room visit. AV nodal re-entry tachycardia. Week of Oct. 19, 2015 discomfort both leg joints. 10-23-15 Emergency Room palpitations. Also during the time after 10-9-15 periods of wheezing and bad indigestion with belching having to sleep with head raised from 10-16-15 until 10-22-15.
Age: 24.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Induration, Local swelling
Clinical narrative: 7 mm raised circular induration (R) arm. 5 mm raised circular induration (L) arm.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt developed a red rash at location of injection in back of arm. Took BENADRYL, APAP and used cold compress on location to help. Is painful for patient. It is on arm ZOSTAVAX was given.
Age: 1.76
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Pyrexia, Rash, Rash papular, Urticaria
Clinical narrative: Rash that is papular, ecchymotic and extending round patch approximately 4-5 cm on the right hip proximal to area of thigh vaccinated. Mother self-treated with hydrocortisone and area persisted for 8 days at my evaluation. Additionally child with hives erupting 8 days after vaccination with fever 9 days after vaccination without other clear etiology.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Cough, Erythema, Head banging
Clinical narrative: Headaches, sore throat, chills, elevated blood pressure, red face, slight cough.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Headaches, sore throat, chills, elevated blood pressure, red face, slight cough.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, dizziness, fever (increased to 103 degrees), chills, rigors. (Took flu medicine).
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Feeding disorder, Mobility decreased
Clinical narrative: Pain in stomach. Can not eat. Can not sit up. BP 162/86. Pulse 56. Doing ok next day. No symptoms next day. Did not see doctor.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Delirium, Mobility decreased, Pyrexia
Clinical narrative: Pt reporter high fevers, chills, delerium after 3 hours of receiving vaccination to point she couldn't leave  couch. Pt family member contacted physician stated fromHD flu shot.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Bronchitis, Chills, Confusional state, Decreased appetite
Clinical narrative: Continuous vomiting, body pain, lightheaded, severe chills, abdominal pain, bronchitis, hypertension, pancreatic levels elevated, vaginal bleeding, confusion, trouble speaking and understanding, shortness of breath, severe fatigue, no appetite.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Fatigue, Hypertension, Laboratory test
Clinical narrative: Continuous vomiting, body pain, lightheaded, severe chills, abdominal pain, bronchitis, hypertension, pancreatic levels elevated, vaginal bleeding, confusion, trouble speaking and understanding, shortness of breath, severe fatigue, no appetite.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pancreatic enzymes increased, Speech disorder, Vaginal haemorrhage, Vomiting
Clinical narrative: Continuous vomiting, body pain, lightheaded, severe chills, abdominal pain, bronchitis, hypertension, pancreatic levels elevated, vaginal bleeding, confusion, trouble speaking and understanding, shortness of breath, severe fatigue, no appetite.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Pt noticed 3 days after vaccine administration a red itchy patch on the inner arm of the same arm the vaccine was given.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Received PNEUMOVAX at 10 Am by 1 PM vert severe arm pain and even swelling. Some relief with ZYRTEC. Pain was severe, hardly slept that night - pain at site of PNEUMOVAX injection.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Broke out in rash. Treated with antihistamine, CLARITIN. Possible egg allergy.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever to 103.4 evening of vaccine 11-4-15 101 at 7 am 11-5-15. No local reactioned noted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: 7:30 PM 11-2-15 area of imms 3 x 1 inch red rash with blisters below inj site left arm. 1:30 PM 11-3-15 seen in office. No redness still has small blisters.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Nov 3, 2015 patient reported decreased ROM of (L) shoulder, dull ache when not moving arm and sharp intense pain with sudden (L) arm movement. C/O tingling in (L) hand and pain in (L) collarbone. Dr. diagnosis left shoulder inflammatory reaction.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Headache, Hyperhidrosis, Injection site swelling, Nausea
Clinical narrative: Patient developed severe swelling at injection site, nausea, diaphoresis, severe headache, arm pain. Decreased appetite.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient developed severe swelling at injection site, nausea, diaphoresis, severe headache, arm pain. Decreased appetite.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L021215 exp. 10-JUN-2017 and lot # reported as "L019128" exp. "27-MAY-2017", (route and dose were not provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Malaise, Pain, Urticaria
Clinical narrative: This spontaneous report was received from a physician (also reported as registered nurse) who was also the patient. The patient was a female of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date in 2015, patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported) and on 21-OCT-2015, with a second dose of PNEUMOVAX 23 in the left arm. Concomitant medication included an unspecified flu shot, administered on 21-OCT-2015 in her right arm. On 21-OCT-2015, the patient developed a welt on the left arm and felt "sick, achey and tired". The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information is not expected as the physician did not consent for further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L023587, expiration date- 26-JUN-2017, for (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L024124, expiration date 30-DEC-2016 and lot # L031600, expiration date 18-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K010215, expiration date- 05-MAY-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Arm got red and swollen. Patient got a tingling all over his body. The next day a fever began and he felt sick all over his body. Pneumococcal vaccine 0.5 ML once.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 3 days after receiving ZOSTAVAX, patient had a 5 inch area that was red, raised, and warm across the back of her arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain in arm not going away. Went to MD appt and having MRI done on arm.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # was reported as "L012837" exp. "11-MAR-2018", (dose and route were not provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # was reported as "L032761" exp. "24-FEB-2017", (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Pyrexia, Vomiting
Clinical narrative: Fever and vomiting. The patient presents with fever and vomiting. Mother states patient has had a worsening fever for the last 4 hours. Frequent vomiting since onset. Mother notes patient had his immunizations earlier today. The onset was 4 hours ago. The course/duration of symptoms is worsening. Associated symptoms: vomiting, denies cough and denies diarrhea. Temperature is 102 Fahrenheit on arrival to ED. Risk factors consist of none. Prior episodes: none. Therapy today: Acetaminophen.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and unknown gender. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiry date not specified). On an unknown date after vaccination (reported as which lasted for 6 weeks now), the patient developed rash. The outcome of rash was unknown. Causality assessment was not provided. This was one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 unspecified patients of unknown age and gender. On 03-NOV-2015, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # L019127 and exp. 27-MAY-2017. No adverse effects reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site joint effusion, Injection site pain, Injection site reaction
Clinical narrative: Shoulder pain. Pain started at injection site, that evening, pain level increased to a 9 by next afternoon. I had held it idle as much as possible, during this times as it was sore. But when I went to move my shoulder, I felt a rubbing noise, it felt like fluid in my joint, felt like things were scraping, and if felt like my shoulder was popping/slipping out of joint when I moved it. Arm? shoulder felt weak, like it was weighed 150#, felt swollen, and achy, and and numb like. Could not raise my arm. It felt like the weight of my arm was pulling the joint out of place. Lots of excruciating pain.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Joint crepitation, Joint dislocation, Limb discomfort, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Shoulder pain. Pain started at injection site, that evening, pain level increased to a 9 by next afternoon. I had held it idle as much as possible, during this times as it was sore. But when I went to move my shoulder, I felt a rubbing noise, it felt like fluid in my joint, felt like things were scraping, and if felt like my shoulder was popping/slipping out of joint when I moved it. Arm? shoulder felt weak, like it was weighed 150#, felt swollen, and achy, and and numb like. Could not raise my arm. It felt like the weight of my arm was pulling the joint out of place. Lots of excruciating pain.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, nausea.  Diagnosed with flu syndrome.
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Patient states that numbness started at top of left arm, by midnight numbness was from top of left arm  to about 3/4 down arm. Numbness still the same.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Pyrexia, Tremor
Clinical narrative: High Fever (greater than 101); Chills Shakes, Coughing.  OTC medication to moderate symptoms. Not finished as of 11.5.2016 PM
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: Severe Dizziness/Vertigo.  Almost fell down upon rising from bed to use restroom during middle of night.  This began roughly 14-15 hrs after vaccine administered.  Noticeably dizzy, especially when bending over and re-rising to standing position.  This persisted for 3 full days beyond date of vaccination.  By 10/27/2015, the dizziness/vertigo subsided fully.  Have had no symptoms after 10/27/2015.  Very distressing though for the 3 days I did feel the dizziness/vertigo.  Have never experienced this before.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client states area was reddened, hot to the touch, much more involved than when she presented to the clinic 11/4/15 @ 2pm where after taking OTC Benadryl the previous night, the site was 3x5" reddened, swollen and warm to the touch below the injection site.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L011846 exp. 16-JAN-2017 and lot # L014415 exp. 25-JUL-2017, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional inofmration has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient's concurrent condition and medical history were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiry date not specified). Concomitant medications were unknown. On an unknown date, within a week of after vaccination, the patient developed rash. The patient sought medical attention with the pharmacist and it was unspecified whether the patient was treated or not. The outcome of rash was unknown. Causality assessment was not provided. This was one of two reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4
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 59-year-old female patient who received FLUARIX quadrivalent. On 10th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 10th October 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details provided were as follows: This case was reported by the patient herself. The patient experienced soreness at the left arm (injection site). The patient has denied permission to contact their physician. The caller stated that, she did not wish to receive mailing of safety report.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling hot, Induration, Pruritus
Clinical narrative: Redness, induration, blister, heat and itching.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Confusional state, Feeling hot, Groin pain, Headache
Clinical narrative: 10-23-15 vaccine administered. 10/24-10/28 complains of occipital headache, neck pain, under arm and groin pain reported as "hot and painful" 11-28-15 reports severe confusion lasting approximately 2 mins.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: 10-23-15 vaccine administered. 10/24-10/28 complains of occipital headache, neck pain, under arm and groin pain reported as "hot and painful" 11-28-15 reports severe confusion lasting approximately 2 mins.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous, (lot # and expiration date were not provided). On an unknown date, after the injection, the patient experienced injection site redness. At the time of this report, the outcome of injection site redness was unknown. Additional information is not expected as the reporter refused additional contact.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation
Clinical narrative: Patient developed a one inch wide, red, slightly inflamed patch with an irregular border. This developed 3 inch from injection site.
Age: 73.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient presented with chicken pox 1 day after administration of vaccine, had negative varicella titer prior to admin; was treating shingles lesions on his wife prior to vaccine administration.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Pt called on 11/4/15 and stated approx 2-3 hrs after administration of the vaccine she experienced pain, nausea and had bouts of diarrhea. She has never had the high-dose before and it didn't "set right" with her. She was also very weak and tired that night.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Skin discolouration, Skin warm
Clinical narrative: The whole underside of my upper arm (fr armpit to elbow) turned into red, hot welt - that itched and hurt. I had to take CLARITIN and BENADRYL for 2 weeks (per my doctor). My doctor told me never was I to take another shingles vaccine - ever. Nor am I to get any other vaccines with any of the shingles vaccine ingredients. My daughter took pictures of my arm (did not print so well) but I would be able to email one if you like. It has now been exactly 4 weeks since the vaccine and I still have a large area of discoloration on my underarm. I consider this an adverse reaction. Apparently, because my arm did not fall off the pharmacist does not think so - but I had to contact my doctor - twice - take medicine that cost $ - it is an adverse reaction. My husband also had the shingles vaccine and he only had a small welt - nothing like mine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Vaccination complication
Clinical narrative: The whole underside of my upper arm (fr armpit to elbow) turned into red, hot welt - that itched and hurt. I had to take CLARITIN and BENADRYL for 2 weeks (per my doctor). My doctor told me never was I to take another shingles vaccine - ever. Nor am I to get any other vaccines with any of the shingles vaccine ingredients. My daughter took pictures of my arm (did not print so well) but I would be able to email one if you like. It has now been exactly 4 weeks since the vaccine and I still have a large area of discoloration on my underarm. I consider this an adverse reaction. Apparently, because my arm did not fall off the pharmacist does not think so - but I had to contact my doctor - twice - take medicine that cost $ - it is an adverse reaction. My husband also had the shingles vaccine and he only had a small welt - nothing like mine.
Age: 66.0
Sex: M
Vaccine: DTP, FLU3
Symptoms: Dysphagia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Unknown date and time of onset. Sometime in January 2015 when patient was traveling. Muscle weakness in legs, which eventually resolved, and trouble swallowing as residual effects which have not fully resolved.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Once he awoke in the morning, he had a high fever of 102 F, in additional the injection site was hot, red & swollen.  The symptoms lasted 2 days so far.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Irritability
Clinical narrative: Patients mom reported that patient was tired, lacking energy, sleeping more than usual, vomiting, diarrhea, decreased appetite and irritable.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Vomiting
Clinical narrative: Patients mom reported that patient was tired, lacking energy, sleeping more than usual, vomiting, diarrhea, decreased appetite and irritable.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reported by mother- 3 inch in diameter, red, raised, warm are located around the injection site.  Administered Tylenol and applied ice.  No streaking and no systemic fever.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site haematoma, Injection site pain, Injection site warmth
Clinical narrative: Patient complains of pain and about a 2inch hematoma noted to the left deltoid at injection site. Slightly warm to touch. Denies any fever. Advised to use warm/cold compresses. Patient stated that she has taken Ibuprofen and it has helped with pain.