chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Feeding disorder, Feeling abnormal, Lethargy, Pallor, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of dazed in a 4-month-old male patient who received PEDIARIX (batch number 436M4, expiry date 30th August 2016). Co-suspect products included PEDVAXHIB (batch number J014281, expiry date 16th September 2016) and PCV13 (batch number H47689, expiry date May 2015). On 16th July 2014 11:15, the patient received the 2nd dose of PEDIARIX .5 ml. On 16th July 2014, the patient started PEDVAXHIB at an unknown dose and frequency and PCV13 at an unknown dose and frequency. On 16th July 2014, less than a day after receiving PEDIARIX, the patient experienced dazed, pallor, lethargic, difficulty feeding and fever. Rechallenge with PEDIARIX was negative. On an unknown date, the outcome of the dazed, pallor, lethargic, difficulty feeding and fever were recovered/resolved. The reporter considered the dazed, pallor, lethargic, difficulty feeding and fever to be possibly related to PEDIARIX. Additional information received on 07 October 2014: The patient wouldn't look at parents and seemed pretty out of it. These symptoms occurred soon after the vaccine was given and lasted 5-7 days. The reporter stated onset date unknown, but she would guess the adverse events onset date is the date of vaccination, 16 July 2014. The child also had fever that lasted less than 72 hours. The child just came in for 6 month visit and mom declined to continue to vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site after administration of ZOSTAVAX immunization.  Mostly outside of injection site and checked pt 20 minutes later and no change. Lot # K000995, exp 3/6/2015
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A spontaneous report was received on 14-NOV-2014 from a pharmacist concerning a female patient (age unknown). In April 2014, the patient received a dose of ZOSTAVAX. On 13-NOV-2014, the patient was inadvertently administered a second dose of ZOSTAVAX. No adverse effects were reported. 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 an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Amnesia, Chills, Dizziness, Headache, Lactation disorder
Clinical narrative: Information was received from a consumer who reported in follow-up to her daughters case (MARRS# 1410USA010376) that she had found on the Internet that other unspecified recipients of GARDASIL have also experienced breast leakage. No specific information was provided regarding the recipients and outcome of the event. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: Information was received from a consumer who reported in follow-up to her daughters case (MARRS# 1410USA010376) that she had found on the Internet that other unspecified recipients of GARDASIL have also experienced breast leakage. No specific information was provided regarding the recipients and outcome of the event. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Activities of daily living impaired, Bone pain, Breast discharge, Chills, Feeling abnormal
Clinical narrative: Information was received from a consumer who reported in follow-up to her daughters case (MARRS# 1410USA010376) that she had found on the Internet that other unspecified recipients of GARDASIL have also experienced breast leakage. No specific information was provided regarding the recipients and outcome of the event. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Feeling of body temperature change, Gait disturbance, Headache, Laboratory test, Memory impairment
Clinical narrative: Information was received from a consumer who reported in follow-up to her daughters case (MARRS# 1410USA010376) that she had found on the Internet that other unspecified recipients of GARDASIL have also experienced breast leakage. No specific information was provided regarding the recipients and outcome of the event. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Nausea, Rash
Clinical narrative: Information was received from a consumer who reported in follow-up to her daughters case (MARRS# 1410USA010376) that she had found on the Internet that other unspecified recipients of GARDASIL have also experienced breast leakage. No specific information was provided regarding the recipients and outcome of the event. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Breast discharge
Clinical narrative: Information was received from a consumer who reported in follow-up to her daughters case (MARRS# 1410USA010376) that she had found on the Internet that other unspecified recipients of GARDASIL have also experienced breast leakage. No specific information was provided regarding the recipients and outcome of the event. This is one of several reports received from the same source. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Burning sensation, Bursitis, Injection site joint movement impairment, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient is experiencing shoulder/arm pain in the arm where the Fluzone was given.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Tendonitis
Clinical narrative: Patient is experiencing shoulder/arm pain in the arm where the Fluzone was given.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient is experiencing shoulder/arm pain in the arm where the Fluzone was given.
Age: 85.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Patient states arm still very sore. Can't move it well. Said feels like broken. Waiting to see MD to do tests. In touch with patient. Talked with her on 11/21/14 said she would keep me posted.
Age: 85.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states arm still very sore. Can't move it well. Said feels like broken. Waiting to see MD to do tests. In touch with patient. Talked with her on 11/21/14 said she would keep me posted.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old female patient. The healthcare worker was informed by the physician that on 11-NOV-2014 the patient was vaccinated with a dose of PEDVAXHIB lot no. K002935 (dose, route of administration, expiry date were not reported) and with a dose of ROTATEQ lot no. J015063 (dose, route of administration, expiry date were not reported). On 12-NOV-2014 the patient experienced fever of 103.7F. The patient was seen by the physician. There was no lab studies performed. The patient was given a treatment for the event: TYLENOL and ibuprofen. The outcome of the event: fever of 103.7F was reported as recovered/resolved (on 13-NOV-2014). The causality between PEDVAXHIB, ROTATEQ and the event was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Death, Dyspnoea, Mobility decreased, Paralysis
Clinical narrative: Paralysis, could not breathe, could not get out of bed, was given antibiotics at emergency room and sent home.  Died 10 days later.
Age: 1.25
Sex: F
Vaccine: DTPPHIB, MMR
Symptoms: Cough, Crying, Decreased appetite, Ear infection, Pyrexia
Clinical narrative: Fever of 102, loss of appetite, inconsolable crying. Progressed to upper respiratory congestion and cough by 11/30/2014 with fever remaining. Diagnosed with "upper respiratory infection" and "ear infection" and placed on Omnicef.
Age: 1.25
Sex: F
Vaccine: DTPPHIB, MMR
Symptoms: Upper respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Fever of 102, loss of appetite, inconsolable crying. Progressed to upper respiratory congestion and cough by 11/30/2014 with fever remaining. Diagnosed with "upper respiratory infection" and "ear infection" and placed on Omnicef.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Oral pain, Urticaria
Clinical narrative: Hives covering arms, back and legs, progressing to forehead and intermittant mouth pain per child mild.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Inappropriate schedule of drug administration
Clinical narrative: This is a spontaneous report from a contactable Nurse reporting on a patient via a Pfizer sales representative. The 15 month old child (weighed 20 pounds 6 ounces) was given PREVNAR 13 (lot # J11488, exp date 30Nov2015, NDC 00005197102) in the left thigh, HIB (MERCK) in the left thigh, approximately one inch from the PREVNAR 13 injection, and PEDIARIX (GSK) in the right thigh, all received on 18Nov2014 at 09:48. The vaccine was administered by a medical assistant, at the physician's office and paid for with public funds. The patient had no past medical history and was not on any additional medications. The patient had no illnesses at the time of administration. The patient was not on any other medications and had no medical conditions. The child was healthy without a lot of clinic visits. The patient died 19Nov2014 around 09:50. It is not known where the child died, but the child was not hospitalized. The reporter states she does not know the cause of death. An autopsy is currently being done.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: This is a spontaneous report from a contactable Nurse reporting on a patient via a Pfizer sales representative. The 15 month old child (weighed 20 pounds 6 ounces) was given PREVNAR 13 (lot # J11488, exp date 30Nov2015, NDC 00005197102) in the left thigh, HIB (MERCK) in the left thigh, approximately one inch from the PREVNAR 13 injection, and PEDIARIX (GSK) in the right thigh, all received on 18Nov2014 at 09:48. The vaccine was administered by a medical assistant, at the physician's office and paid for with public funds. The patient had no past medical history and was not on any additional medications. The patient had no illnesses at the time of administration. The patient was not on any other medications and had no medical conditions. The child was healthy without a lot of clinic visits. The patient died 19Nov2014 around 09:50. It is not known where the child died, but the child was not hospitalized. The reporter states she does not know the cause of death. An autopsy is currently being done.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: This is a spontaneous report from a contactable Nurse reporting on a patient via a Pfizer sales representative. The 15 month old child (weighed 20 pounds 6 ounces) was given PREVNAR 13 (lot # J11488, exp date 30Nov2015, NDC 00005197102) in the left thigh, HIB (MERCK) in the left thigh, approximately one inch from the PREVNAR 13 injection, and PEDIARIX (GSK) in the right thigh, all received on 18Nov2014 at 09:48. The vaccine was administered by a medical assistant, at the physician's office and paid for with public funds. The patient had no past medical history and was not on any additional medications. The patient had no illnesses at the time of administration. The patient was not on any other medications and had no medical conditions. The child was healthy without a lot of clinic visits. The patient died 19Nov2014 around 09:50. It is not known where the child died, but the child was not hospitalized. The reporter states she does not know the cause of death. An autopsy is currently being done.
Age: 0.95
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: 0
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Lethargy, Pain, Pruritus, Pyrexia
Clinical narrative: Ran a fever of 101.4.  Spot on arm the size of a baseball that is red, itchy and painful. Feels lethargic. Pt was given Cephalexin 500mg TID x 7 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Injection site pruritus, Stomatitis
Clinical narrative: Patient said injection site was itchy the night of the vaccine.  She then got sores in her mouth and around her mouth. Pt visited an urgent care clinic and received Valacyclovir for 10 days and lidocaine for her mouth.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Back pain, Blood test, Inflammation, Injection site pain
Clinical narrative: Pain down left arm at site of injection, pains in lower back, physical therapy twice following week, pains got worse in back, steroid injection given, following week off work for a week as could not walk. MRI done Friday 10/24/2014, bulging discs, inflammation, given steroids for 6 days, helped, now pain is in piriformis muscle, down left side from upper arm to left ankle, PT twice a week, stiffness upon getting up from seat, pain lying down.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Intervertebral disc protrusion, Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Pain down left arm at site of injection, pains in lower back, physical therapy twice following week, pains got worse in back, steroid injection given, following week off work for a week as could not walk. MRI done Friday 10/24/2014, bulging discs, inflammation, given steroids for 6 days, helped, now pain is in piriformis muscle, down left side from upper arm to left ankle, PT twice a week, stiffness upon getting up from seat, pain lying down.
Age: 15.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Palpitations, Paraesthesia, Platelet count increased, Sinus tachycardia, Skin warm
Clinical narrative: This is a report from a study. A 15-year-old female subject received blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) on 07Jun2013 at 17:12 and presented with event acute anaphylactic reaction on the same day at 19:55. The reported subject's medical history included allergy to KEFLEX, Beta thalassemia minor tract, anxiety and depression. Concomitant medication included ZOLOFT. On 07Jun2013 at 17:12, the subject received her first dose of blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) intramuscularly in her left arm. No acute reaction occurred within 30 minute. The patient stated she felt fine and was discharged at 17:45. She then went straight home, didn't eat or drink anything and was not exposed to anything unusual. On the same day, around 19:55, 40 minutes prior to hospital Emergency Room arrival and 2 hours and 45 minutes after vaccination, the patient complained of lip swelling, heart racing, chest hurting, stomach ache with nausea. At 20:35, in the ER, the patient was found with upper lip slightly swollen, tachycardia, palpitations, chest pain, headache, tingling in hands, abdominal pain and nausea. Physical exam in the ER was notable for no respiratory distress. Vital signs on presentation: blood pressure (BP) 138/88 heart rate (HR) 140 20 respirations per minute, Temperature 98.4F. O2 Saturation was 99%. Repeat vital sings in the ER included BP 100/58, HR 95 at 22:00 and BP 106/57 HR 97 at 23:30. EKG indicated sinus tachycardia with a rate of 140 beats per minute. Relevant laboratory tests included WBC 23.3k/ul with neutrophils 85.1% and Lymphocytes 7.0%, normal serum chemistry, C-reactive protein 6.00 mg/dL, Serum albumin 5.2 g/dL, Rapid Influenza A and B negative, Rapid strep A test negative and Urinalysis was 4+ blood with leukocytes. The patient was treated with BENADRYL at 20:55, SOLUMEDROL at 21:10, ZANTAC at 21:12, all per IV and was put under cardiac monitoring. The patient was discharged home from ER on 08Jun2013 at 00:41. Upon discharge she was noted to be without pain with skin warm and pink. Discharge vital signs were BP 98/49, HR 95, RR 29, Temperature 98.4F, O2 Saturation 97.7. (Baseline BP in April 2013 was reported as 102/74). The patient was discharged on oral prednisone 40 mg for 5 days and diphenhydramine 25mg orally as needed. The subject received the first vaccination dose at visit 1, and then was withdrawn from the study prior to receiving any further vaccinations, so they did not complete the immunization schedule. The investigator considered the event acute anaphylactic reaction serious life threatening, and related to study drug but not related to clinical trial procedure and concomitant drug. On 14Jun2013 the blind code was broken by the Sponsor due to serious, related, unexpected event. Follow-up (31Oct14): new information includes: action taken changed from not applicable to permanently withdrawn. Follow-up (21Nov2014) New information includes: additional relevant lab tests from 07Jun2013.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, MMRV, TDAP, HEP, HEPA, MMRV, TDAP
Symptoms: Vaccination site rash
Clinical narrative: Mild local skin rash in the vaccination area, left deltoid and right deltoid area.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, MMRV, TDAP, HEP, HEPA, MMRV, TDAP
Symptoms: Injection site rash, Local reaction
Clinical narrative: Mild local skin rash in the vaccination area, left deltoid and right deltoid area.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, MMRV, TDAP, HEP, HEPA, MMRV, TDAP
Symptoms: Vaccination site rash
Clinical narrative: LOCAL REACTION: MILD SKIN RASH ON LEFT AND RIGHT DELTOID, BENADRYL HCl 12.5MG. GIVEN ONE DOSE OF 10ML PO.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, MMRV, TDAP, HEP, HEPA, MMRV, TDAP
Symptoms: Injection site rash, Local reaction
Clinical narrative: LOCAL REACTION: MILD SKIN RASH ON LEFT AND RIGHT DELTOID, BENADRYL HCl 12.5MG. GIVEN ONE DOSE OF 10ML PO.
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Injection site rash, Local reaction
Clinical narrative: LOCAL REACTION: MILD SKIN RASH ON LEFT AND RIGHT DELTOID, BENADRYL HCl 12.5MG. GIVEN ONE DOSE OF 10ML PO.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Chills, Erythema, Feeling abnormal, Hot flush
Clinical narrative: Around 11am or noon of the same day the vaccine was given, patient states he began feeling nauseated, right arm felt "hot" and sore to touch.  Then he started aching in legs and arms, chills, felt as if he had a fever. Felt bad the next day and did not go to work (11-12-14)  Went to work the next day, right arm started swelling with redness...now has redness from shoulder to elbow and is sore, has had some hot flashes.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Local swelling, Nausea, Pain, Pain in extremity
Clinical narrative: Around 11am or noon of the same day the vaccine was given, patient states he began feeling nauseated, right arm felt "hot" and sore to touch.  Then he started aching in legs and arms, chills, felt as if he had a fever. Felt bad the next day and did not go to work (11-12-14)  Went to work the next day, right arm started swelling with redness...now has redness from shoulder to elbow and is sore, has had some hot flashes.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Around 11am or noon of the same day the vaccine was given, patient states he began feeling nauseated, right arm felt "hot" and sore to touch.  Then he started aching in legs and arms, chills, felt as if he had a fever. Felt bad the next day and did not go to work (11-12-14)  Went to work the next day, right arm started swelling with redness...now has redness from shoulder to elbow and is sore, has had some hot flashes.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Diarrhoea, Myalgia
Clinical narrative: Severe diarrhea lasting approx 4 hours, lower back pain and muscle aches. No symptoms by the next morning.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac failure, Chest X-ray abnormal, Death, Extracorporeal membrane oxygenation, Feeling cold
Clinical narrative: Mother called mid morning that patient was cool and diaphoretic. Went to ED found to have worsening heart failure. Admitted to PICU 10/17/14, CXR with pneumonia, respiratory virus panel neg x 2, placed on ECMO 10/19/14. Patient died 11/16/14 of heart failure while on ECMO.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Intensive care, Pneumonia, Viral test negative
Clinical narrative: Mother called mid morning that patient was cool and diaphoretic. Went to ED found to have worsening heart failure. Admitted to PICU 10/17/14, CXR with pneumonia, respiratory virus panel neg x 2, placed on ECMO 10/19/14. Patient died 11/16/14 of heart failure while on ECMO.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Noted some redness of right leg within 30 minutes of vaccine. Swelling started later that night, worsening the following morning in same thigh. Pain with walking, limping. No fevers. Not complains of itching. No streaking. Normal oral intake and uop. No vomiting or diarrhea, no breathing problems. Given Allegra the evening that the swelling first started. When seen in the office had induration of 12X10 cm on right lateral thigh, centered around injection site, indurated area is warm, extremely tender to palpation, minimal erythema of right thigh compared to left, but diffuse, and not localized to injection site.  Right thigh circumference at site of injection 30.5 cm. Full passive ROM of right and left thigh.  Walks favoring right leg, but can bear weight on right leg. Swelling does not cross hip or knee. Swelling improved over the next 48 hours on Benadryl/Allegra, never developed worsening redness or fevers. Had same reaction to flu shot last year.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth, Pain
Clinical narrative: Noted some redness of right leg within 30 minutes of vaccine. Swelling started later that night, worsening the following morning in same thigh. Pain with walking, limping. No fevers. Not complains of itching. No streaking. Normal oral intake and uop. No vomiting or diarrhea, no breathing problems. Given Allegra the evening that the swelling first started. When seen in the office had induration of 12X10 cm on right lateral thigh, centered around injection site, indurated area is warm, extremely tender to palpation, minimal erythema of right thigh compared to left, but diffuse, and not localized to injection site.  Right thigh circumference at site of injection 30.5 cm. Full passive ROM of right and left thigh.  Walks favoring right leg, but can bear weight on right leg. Swelling does not cross hip or knee. Swelling improved over the next 48 hours on Benadryl/Allegra, never developed worsening redness or fevers. Had same reaction to flu shot last year.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Patient was given tdap vaccine in left deltoid 11-26-14 on evening of vaccine - patient felt pain while lying on injection site - patient spike fever to 103 11/28/14 was sent to ER. 67 y/o female s/p tetanus shot in (L) deltoid region 3 days ago, that evening she developed pain in the left arm, swelling, chills. The course of the next 2 days the swelling became gradually increased and she developed more chills, yesterday with shaking chills and teeth chattering though no objective fever. Swelling has starting to decrease since yesterday, actually says it is substantially improved today with less pain, left swelling, still some redness, no fevers or chills today. She has been taking TYLENOL with some relief.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Patient was given tdap vaccine in left deltoid 11-26-14 on evening of vaccine - patient felt pain while lying on injection site - patient spike fever to 103 11/28/14 was sent to ER. 67 y/o female s/p tetanus shot in (L) deltoid region 3 days ago, that evening she developed pain in the left arm, swelling, chills. The course of the next 2 days the swelling became gradually increased and she developed more chills, yesterday with shaking chills and teeth chattering though no objective fever. Swelling has starting to decrease since yesterday, actually says it is substantially improved today with less pain, left swelling, still some redness, no fevers or chills today. She has been taking TYLENOL with some relief.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 55 year old female consumer with allergic to sulfa drugs and no pertinent medical history refers to herself. On 20-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot #, expired date and route unspecified, one dose) and influenza virus vaccine (unspecified) (lot #, expired date, dose and route unspecified) at the same time. No concomitant therapy included. On 04-NOV-2014, the patient stated that she began suffering from the shingles. The patient sought medical attention and had been prescribed ZOVIRAX. No lab diagnostics studies performed. The outcome of shingles was unknown. Additional information has been requested.
Age: 1.59
Sex: M
Vaccine: FLU4
Symptoms: Rash, Skin lesion
Clinical narrative: Developed light rash to chest approximately 10 min after receiving flu vaccine. Total lesions approx 1 dozen to torso. No respiratory involvement. Gave 1/2 tsp of BENADRYL in office. Same reaction when child received flu vaccine Dec 2013. Gave BENADRYL then also. Rash resolved.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received on 14-NOV-2014 from a certified medical assistant who reported that doses of Oral, ROTATEQ and GARDASIL, which were exposed to a supported temperature excursion which was evaluated on 27-OCT-2014, had been administered to an unspecified number of patients on unspecified dates since 27-OCT-2014. No adverse effects have been reported or observed. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 1 DF. Other suspect therapies included RECOMBIVAX HB, ROTATEQ and VAQTA. On an unknown date the patient experienced were administered doses of improperly stored doses and no adverse events were reported. The outcome of were administered doses of improperly stored doses and no adverse events were reported is unknown. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J014851, expiration date: 24-OCT-2014, dose: 0.65 ml, subcutaneous which was expired. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
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. On an unknown date the unspecified number of patients were vaccinated with stored ROTATEQ (lot/batch#, expiration date and strength were not reported) 2 ml, oral, exposed to 30F for 4 hours, that was improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia oral, Lip swelling, Pruritus, Urticaria
Clinical narrative: Hives waist to knees, bilateral wrist/ankle itching, numbness/swelling to lips. Difficulty taking full breath. Pt given BENADRYL to resolve issue.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Computerised tomogram normal, Contusion, Lip injury, Syncope
Clinical narrative: Patient had a fainting episode after receiving HPV vaccine.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave 2nd Flu immunization Dr ordered.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Immunoglobulin therapy, Peroneal nerve palsy, Sensory loss, Walking aid user
Clinical narrative: Early 2013 started to feel no sensation in fingers and face. Continued to bite inside of mouth. Started to walk drop foot and had to use a cane for stability. Unable to do stairs. 9-5-13-diagnosed with CIDP-IVIG prescribed. Lifetime.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Pain in left arm since injection. Sore to lift arm. Painful to sleep on left side. Fingers tingle at night.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site anaesthesia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Patients reports numbness, pins and needles pain on her left arm where vaccine was administered. She reports no fever but say pain radiating to the back of her arm making it difficult to carry normal function. This was over a 10 day period.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apparent life threatening event, Blood lactic acid normal, Blood magnesium normal, Chest X-ray normal, Cyanosis
Clinical narrative: Infant with ALTE event x2. First event, patient turned blue in lips and face for about 20 seconds. Later that day, mom drove infant to MDs for scheduled circumcision and when mom turned to take out of care he was blue and limp, he was rushed to clinic where stimulated and given blow by oxygen. Episode lasted about 4 min.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Echocardiogram normal, Electrocardiogram normal, Hypotonia, Metabolic function test normal, Urine analysis normal
Clinical narrative: Infant with ALTE event x2. First event, patient turned blue in lips and face for about 20 seconds. Later that day, mom drove infant to MDs for scheduled circumcision and when mom turned to take out of care he was blue and limp, he was rushed to clinic where stimulated and given blow by oxygen. Episode lasted about 4 min.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Limb discomfort, Pain in extremity
Clinical narrative: Pt states that her arm suffers from pain and discomfort since the vaccine and states that the vaccine was not immunized properly.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Full blood count normal, Gait disturbance, Laboratory test normal, Pain
Clinical narrative: Received flu vaccine at 10:00 A - no immediate reaction. Three hours later, fever spiked to 103.8 degrees. Severe body aches mid-torso and legs causing difficulty breathing and ambulating. Taken to emergency room for IV fluids and antipyretics.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Received flu vaccine at 10:00 A - no immediate reaction. Three hours later, fever spiked to 103.8 degrees. Severe body aches mid-torso and legs causing difficulty breathing and ambulating. Taken to emergency room for IV fluids and antipyretics.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction-hives-BENADRYL PRN.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Blood test normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Fever and subsequent febrile seizure.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Blood test abnormal, Infectious mononucleosis, Local swelling, Lymphadenopathy
Clinical narrative: Client called 11/6/14 stating had swollen area under (Lt) armpit. Had not called prior to that but states, has had for awhile - had not see dr yet - recommended to do so. Saw dr next week - blood work done. Either was getting over or getting Mono so combo with vaccines caused lymph node to swell. Resolved shortly - fine when finally connected to pt 11/24/14.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Feeling abnormal, Local swelling, Musculoskeletal discomfort, Oedema peripheral
Clinical narrative: Received Flu shot 11-11-14. Began to develop swelling and discomfort in (R) axilla, clavicle and neck area with low grade fever (+-100 degrees). Feeling generally poorly.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Received Flu shot 11-11-14. Began to develop swelling and discomfort in (R) axilla, clavicle and neck area with low grade fever (+-100 degrees). Feeling generally poorly.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Pain at site right deltoid 27 days.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Headache, Musculoskeletal chest pain, Nausea
Clinical narrative: She called me on 11/25/2014 to report adverse reaction to flu shot received 12 noon 11/21/2014 at a company flu shot clinic. She took Ibuprofen after her shot because it had been several years since her last flu shot. At 4 PM she started to feel headache and sl. nausea. She states she had rib pain "crushing" like she had been "kicked", some shortness of breath - she did not seek medical attention - she went home to bed had chills and was better in the morning when she woke up.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: She called me on 11/25/2014 to report adverse reaction to flu shot received 12 noon 11/21/2014 at a company flu shot clinic. She took Ibuprofen after her shot because it had been several years since her last flu shot. At 4 PM she started to feel headache and sl. nausea. She states she had rib pain "crushing" like she had been "kicked", some shortness of breath - she did not seek medical attention - she went home to bed had chills and was better in the morning when she woke up.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Condition aggravated, Convulsion, Dry mouth, Ear pain
Clinical narrative: Pt Dx 2007 with Grade 5 Arteriovenous Malformation (RF Lobe); causes Simple Partial Seizures; three (3) anti-seizure medications to control seizures. Adverse Event, Symptoms, Duration: Within 12 hours after the injection, my 20 y/o son had an very serious adverse reaction to the flu shot. Awoke from sleep with massive headache, sharp, shooting pain "like a knife" in both ears and in both earlobes; sharp shooting pain in lower back of neck; "pins and needles" sensation in his torso (chest and back); arm pain; dry mouth; body temperatures was normal, but he felt cold, was shivering, teeth chattering, and needed to wrap himself up in a blanket. Be advised that these symptoms mimic the symptoms experienced by my son to the onset of a seizure. Pt did not, however, experience a seizure. Pt was not well enough to go to work, and lost a full day of pay; my husband came home from work to stay with patient. I reported the symptoms and the adverse event to both patient's neurologist and the pharmacy.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: Pt Dx 2007 with Grade 5 Arteriovenous Malformation (RF Lobe); causes Simple Partial Seizures; three (3) anti-seizure medications to control seizures. Adverse Event, Symptoms, Duration: Within 12 hours after the injection, my 20 y/o son had an very serious adverse reaction to the flu shot. Awoke from sleep with massive headache, sharp, shooting pain "like a knife" in both ears and in both earlobes; sharp shooting pain in lower back of neck; "pins and needles" sensation in his torso (chest and back); arm pain; dry mouth; body temperatures was normal, but he felt cold, was shivering, teeth chattering, and needed to wrap himself up in a blanket. Be advised that these symptoms mimic the symptoms experienced by my son to the onset of a seizure. Pt did not, however, experience a seizure. Pt was not well enough to go to work, and lost a full day of pay; my husband came home from work to stay with patient. I reported the symptoms and the adverse event to both patient's neurologist and the pharmacy.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: Pt Dx 2007 with Grade 5 Arteriovenous Malformation (RF Lobe); causes Simple Partial Seizures; three (3) anti-seizure medications to control seizures. Adverse Event, Symptoms, Duration: Within 12 hours after the injection, my 20 y/o son had an very serious adverse reaction to the flu shot. Awoke from sleep with massive headache, sharp, shooting pain "like a knife" in both ears and in both earlobes; sharp shooting pain in lower back of neck; "pins and needles" sensation in his torso (chest and back); arm pain; dry mouth; body temperatures was normal, but he felt cold, was shivering, teeth chattering, and needed to wrap himself up in a blanket. Be advised that these symptoms mimic the symptoms experienced by my son to the onset of a seizure. Pt did not, however, experience a seizure. Pt was not well enough to go to work, and lost a full day of pay; my husband came home from work to stay with patient. I reported the symptoms and the adverse event to both patient's neurologist and the pharmacy.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever-off and on. Red streak on arm day after and lasted a day. Rash on arm-day after lasting 2 days and again 2 wks later lasting a day. Burning sensation in entire arm-2 weeks after lasting 2 days. Yellowish skin color in arm-3 weeks later lasting a day. Headaches off and on. Arm hurt for 4 1/2 weeks after stating 6 hrs after shot.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Yellow skin
Clinical narrative: Fever-off and on. Red streak on arm day after and lasted a day. Rash on arm-day after lasting 2 days and again 2 wks later lasting a day. Burning sensation in entire arm-2 weeks after lasting 2 days. Yellowish skin color in arm-3 weeks later lasting a day. Headaches off and on. Arm hurt for 4 1/2 weeks after stating 6 hrs after shot.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Headache - 24 hours after getting his HPV #1, 5:30 pm, 11/6/14. Had his HPV 5:45 pm, 11/5/14. Patient had no fever, no vomiting, no nausea. Headache relieved by taking MOTRIN 600 mg PO (didn't take it regularly, only took if headache is intolerable). Headache lasted for 5 days. Headache located back of head and neck.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Influenza
Clinical narrative: Couldn't breathe or difficulty, took MUCINEX didn't help. Felt the exact same symptoms as if she got the flu. Went to the doctor and talked with him he gave her a MEDROL dose pack to fill if didn't start feeling better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling cold, Tremor
Clinical narrative: After 4 hrs. I developed severe shaking and felt extremely cold. An hour later I was fine but tired.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Hypersomnia, Injection site erythema
Clinical narrative: Injection site swollen, red, hot to touch 11/21 PM whole arm stiff, swollen area tender; Chills, fever (101), shakes; nausea, vomiting, loss of appetite; extreme fatigue (slept 20 of 24 hours) 11/22 - started to improve Sun 11/23 and progressively got better.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Nausea
Clinical narrative: Injection site swollen, red, hot to touch 11/21 PM whole arm stiff, swollen area tender; Chills, fever (101), shakes; nausea, vomiting, loss of appetite; extreme fatigue (slept 20 of 24 hours) 11/22 - started to improve Sun 11/23 and progressively got better.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Injection site swollen, red, hot to touch 11/21 PM whole arm stiff, swollen area tender; Chills, fever (101), shakes; nausea, vomiting, loss of appetite; extreme fatigue (slept 20 of 24 hours) 11/22 - started to improve Sun 11/23 and progressively got better.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Dry throat, Eye pruritus, Headache
Clinical narrative: Shot administered 11/19 and following night the patient had an itchy eyeball, dry throat, dry mouth, felt very nauseous and dizzy, had a headache and decreased vision.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Visual acuity reduced
Clinical narrative: Shot administered 11/19 and following night the patient had an itchy eyeball, dry throat, dry mouth, felt very nauseous and dizzy, had a headache and decreased vision.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red strip at injection site around arm. Warm to touch. Painful. Lasted 2 weeks.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site joint inflammation, Injection site reaction, Insomnia
Clinical narrative: Sore and tender left deltoid vaccination site and left shoulder arthritis/bursitis ache and pain.  Pain limited decreased range of motion in left shoulder. Unable to sleep on left side.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: Sore and tender left deltoid vaccination site and left shoulder arthritis/bursitis ache and pain.  Pain limited decreased range of motion in left shoulder. Unable to sleep on left side.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Chills, Condition aggravated, Dizziness, Gout
Clinical narrative: Light headed 30min after injections. Approximately 4 hours later - developed extreme gout-like flare in toes, ankles and finger joints (no prior gout except in big toes). Chills, stomach pain, aching muscles. Sore fissured tongue, short episodes of racing heart beat, also itchy and weeping spots on scalp. Side effects subsided in 48 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Palpitations, Plicated tongue, Pruritus, Secretion discharge
Clinical narrative: Light headed 30min after injections. Approximately 4 hours later - developed extreme gout-like flare in toes, ankles and finger joints (no prior gout except in big toes). Chills, stomach pain, aching muscles. Sore fissured tongue, short episodes of racing heart beat, also itchy and weeping spots on scalp. Side effects subsided in 48 hours.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm was red, warm and hot. Lasted approx 2 weeks.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given pediatric dose of Hepatitis A in place of adult dose: Lot ## 4B299 on 11/10/14 around 2:40 pm. Manufacturer - GSK.
Age: 0.52
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Diarrhoea, Full blood count, Pyrexia
Clinical narrative: 105 degree fever x 16 hrs, diarrhea, fever up to 103 degrees for next 4 days, no URI symptoms.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Immediately after administration the injection site began to swell. I removed the Band Aid to monitor. It looked red, swollen and "knot-like". I drew borders around it and watched it for about 20 mins. After 20 mins. no other symptoms appeared, pt felt fine and wanted to leave and the borders of the reaction had receded slightly. Pt refused BENADRYL due to work but took 2 with him just in case he needed it. It is unknown if pt ever took these.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Impaired driving ability, Local swelling, Pain in extremity, Sensitivity of teeth
Clinical narrative: On third day my left hand swelled and turned red, was very sore, could not drive 1st day, in 2 days I could drive, gone in 4 days but on Wed. Nov 12, my teeth became very sensitive to cool and cold drinks, OK by Sunday 11-16-14.
Age: 66.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Diplopia, Myalgia
Clinical narrative: Pt called stating he had PREVNAR 13 and Influenza on Tues 11/25/14 - symptoms Wed 11/26/14 - slight generalized muscle pain. Symptoms increased to severe muscle/joint pain on Thurs. 11/27/14. Pt also reported double vision on Sat and Sun 11/29/and 11/30 but resolved by 12/1/14.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Malaise, Pain
Clinical narrative: Reports within a few hours after vaccine started to feel "ill" by 1900 11/4/14 was "cold and achy" pt reports the chills were severe. By noon on 11/5 she was better and WNL on 11/6/14.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: 12 hrs after vaccine pt reports sudden onset body aches and chills that lasted approx 8 hrs, by 11/6/14 - pt reports he was completely WNL.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Lacrimation increased
Clinical narrative: Over 24 hrs after vaccination (L) deltoid area developed 5 x 6 cm red indurated area without blisters - had watery eyes after vaccination. To use heat, Ibuprofen or ALEVE and recheck on 11-4-14 in OHC.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Bronchitis, Oropharyngeal pain, Serum sickness, Upper respiratory tract infection
Clinical narrative: Got sore throat and upper respiratory infection the day after vaccination, he ended up with bronchitis treated with amoxicillin and steroids in hospital, then diagnosed with serum syndrome. Still in hospital as of 10/2/14.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: 3 days after vaccination: sweating, low grade fever, total body aches, nausea, weakness.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Syncope
Clinical narrative: Case number PHEH2014US023686, is an initial spontaneous report from a consumer (patient) via Agency received on 24 Nov 2014. This report refers to a male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412301, expiry date: 30 Jun 2015) from a multidose vial on 03 Oct 2014. After 5 minutes of vaccination, the patient fainted. The patient also complained of pain to head and left ankle. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of faint was upgraded based on information in the source documents.