chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTPIPV, FLUX, MMR, VARCEL
Symptoms: Asthenia, Crying, Disorientation, Headache, Hypotension
Clinical narrative: Information has been downloaded from Regulatory Authority (US-CHIRONMA-PHHY2014US006398). Information has been received from a consumer referring to a 5 year old female patient. Information of concomitant therapy, concurrent condition and medical history was not reported. On 14-NOV-2013, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown); influenza virus vaccine (unspecified) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown); diphtheria toxoid, pertussis vaccine (unspecified); poliovirus vaccine inactivated (unspecified), tetanus toxoid (1 dosage form, strength, frequency, route, lot# and expiration date were unknown) and varicella virus vaccine live (unspecified) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown) for immunisation. On 14-NOV-2013, the patient experienced blood pressure low, brain hurt, cry, disoriented, fainted, pale, unresponsive and weak. The outcome of the events was reported as recovered. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (reported as reasonable possibility). The reporter considered the events of blood pressure low, brain hurt, disoriented, fainted, pale and unresponsive were related to influenza virus vaccine (unspecified). All the events were determined to be medically significant by the reporter.
Age: 5.0
Sex: F
Vaccine: DTPIPV, FLUX, MMR, VARCEL
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been downloaded from Regulatory Authority (US-CHIRONMA-PHHY2014US006398). Information has been received from a consumer referring to a 5 year old female patient. Information of concomitant therapy, concurrent condition and medical history was not reported. On 14-NOV-2013, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown); influenza virus vaccine (unspecified) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown); diphtheria toxoid, pertussis vaccine (unspecified); poliovirus vaccine inactivated (unspecified), tetanus toxoid (1 dosage form, strength, frequency, route, lot# and expiration date were unknown) and varicella virus vaccine live (unspecified) (1 dosage form, strength, frequency, route, lot# and expiration date were unknown) for immunisation. On 14-NOV-2013, the patient experienced blood pressure low, brain hurt, cry, disoriented, fainted, pale, unresponsive and weak. The outcome of the events was reported as recovered. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (reported as reasonable possibility). The reporter considered the events of blood pressure low, brain hurt, disoriented, fainted, pale and unresponsive were related to influenza virus vaccine (unspecified). All the events were determined to be medically significant by the reporter.
Sex: U
Vaccine: PNC13
Symptoms: Induration, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received PREVNAR 13, (lot number: X13882, expiration date: 30Sep2020), intramuscular on left deltoid from 10Dec2018 to 10Dec2018 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 10Dec2018, the patient got a PREVNAR 13 injection, 1M 0.5 mL, on left deltoid. After two days, the patient still had the soreness, pain, and hardness on arm. He or she got a red, bumpy, itchy rash across the arm. On 13Dec2018, at 9 am, the patient went again to the clinic to have arm checked. The nurse practitioner gave and had the patient take 2 tablets of ZANTAC, 1 tablet of ALAVERT and 1 tablet of prednisone. She asked the patient to come back at 4 pm to check on the outcome from taking the medication. The rash has turned to pinkish color, and apparently slowly disappearing. The nurse prescribed prednisone 20 mg to with the loratadine and ranitidine for three days. The patient was recovering from the vaccination site erythema and vaccination site rash; unknown for the event vaccination site pruritus; and not recovered for the rest of the events.
Sex: U
Vaccine: PNC13
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received PREVNAR 13, (lot number: X13882, expiration date: 30Sep2020), intramuscular on left deltoid from 10Dec2018 to 10Dec2018 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 10Dec2018, the patient got a PREVNAR 13 injection, 1M 0.5 mL, on left deltoid. After two days, the patient still had the soreness, pain, and hardness on arm. He or she got a red, bumpy, itchy rash across the arm. On 13Dec2018, at 9 am, the patient went again to the clinic to have arm checked. The nurse practitioner gave and had the patient take 2 tablets of ZANTAC, 1 tablet of ALAVERT and 1 tablet of prednisone. She asked the patient to come back at 4 pm to check on the outcome from taking the medication. The rash has turned to pinkish color, and apparently slowly disappearing. The nurse prescribed prednisone 20 mg to with the loratadine and ranitidine for three days. The patient was recovering from the vaccination site erythema and vaccination site rash; unknown for the event vaccination site pruritus; and not recovered for the rest of the events.
Sex: F
Vaccine: FLU3
Symptoms: Bacterial disease carrier, Blood pressure increased, Lymphadenopathy, Nasopharyngitis, Neck pain
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2017SA163839, same patient. This case involves an unknown age female patient who experienced C. diff colonizations, neck pain and swollen lymph nodes all over her body, cold and elevated BP while she received vaccine FLUZONE HIGH DOSE. The patients past medical history included 1 small swollen lymph node in her neck for 1 year and has C. Diff history - and told was completely resolved. The patient's concomitant medication and family history were not provided. The patient is highly allergic to lot of things. On 01-Nov-2018 or 04-Nov-2018 (patient could not recall), received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On unknown date, the patient developed a serious C. diff colonizations (clostridium difficile infection) with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On unknown date, the patient developed a non-serious neck pain with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On unknown date, the patient developed a non-serious swollen lymph nodes all over her body with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was referred to health care professional. The patient told that recently after taking FLUZONE HD, the patient took COLD-EZE for her cold and her blood pressure became very elevated (latency and onset date unknown). Other relevant tests included - On unknown date - MRI - Which showed swollen lymph nodes all over body. Final diagnosis was swollen lymph nodes all over her body, neck pain, cold, blood pressure became very elevated and C. diff colonizations. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all events. List of documents held by sender - none. Sender's Comments: This case concerns an patient with unknown age who developed C. diff colonizations, neck pain and swollen lymph nodes all over her body after vaccination with FLUZONE HIGH DOSE. The exact time to onset is unknown. The patient has previous history of swollen lymph node in her neck and C. Diff. However, patient's condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. May be present events related to previous history of patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial information received on 21-Dec-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2017SA163839, same patient. This case involves an unknown age female patient who experienced C. diff colonizations, neck pain and swollen lymph nodes all over her body, cold and elevated BP while she received vaccine FLUZONE HIGH DOSE. The patients past medical history included 1 small swollen lymph node in her neck for 1 year and has C. Diff history - and told was completely resolved. The patient's concomitant medication and family history were not provided. The patient is highly allergic to lot of things. On 01-Nov-2018 or 04-Nov-2018 (patient could not recall), received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On unknown date, the patient developed a serious C. diff colonizations (clostridium difficile infection) with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On unknown date, the patient developed a non-serious neck pain with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On unknown date, the patient developed a non-serious swollen lymph nodes all over her body with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was referred to health care professional. The patient told that recently after taking FLUZONE HD, the patient took COLD-EZE for her cold and her blood pressure became very elevated (latency and onset date unknown). Other relevant tests included - On unknown date - MRI - Which showed swollen lymph nodes all over body. Final diagnosis was swollen lymph nodes all over her body, neck pain, cold, blood pressure became very elevated and C. diff colonizations. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all events. List of documents held by sender - none. Sender's Comments: This case concerns an patient with unknown age who developed C. diff colonizations, neck pain and swollen lymph nodes all over her body after vaccination with FLUZONE HIGH DOSE. The exact time to onset is unknown. The patient has previous history of swollen lymph node in her neck and C. Diff. However, patient's condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. May be present events related to previous history of patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture positive, Herpes zoster, Rash
Clinical narrative: Patient received both doses of varicella vaccine as a child per CDC schedule. Had a mild case of shingles that was confirmed by swab at 14 years old (12/17/2018).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Came into office on o 01/02/2019. Had a rash on right thigh at injection site of MMR. The upper right thigh had redness and warmth at and round injection site about half dollar in size. Physicians plan of care is to monitor site for any worsening or if parent has further concerns. Questioned whether this is a true reaction to vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Very tired and headache. Pain at injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenopia, Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Sore muscles on evening of shot. Flu like symptoms this morning. Sore all over, site sore, aches, eyes heavy, exhausted.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sore muscles on evening of shot. Flu like symptoms this morning. Sore all over, site sore, aches, eyes heavy, exhausted.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Pain started I think the next morning. Pain in lt arm and shoulder, worse at night, wakes from sleep. Some difficulty raising arm, undressing and reaching for items. Pain and discomfort persist 3.5 months later. Orthopedic Surgeon recommended MRI. Insurance denied.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pain started I think the next morning. Pain in lt arm and shoulder, worse at night, wakes from sleep. Some difficulty raising arm, undressing and reaching for items. Pain and discomfort persist 3.5 months later. Orthopedic Surgeon recommended MRI. Insurance denied.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Significant swelling, reddened patch 7.5 cm, itching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Tremor
Clinical narrative: Severe shaking and chills for 3 hours; achy joints 48 hours.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Severe arm pain of the arm injection was in immediately following injection and for 1 week afterwards. Patient stated "it felt like someone punched me in the arm."
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Acne, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Child's mom called 01/03/2019 @ 1005 to report 12/28 or 12/29 he started to get little red bumps "like pimples" close to where he had vaccines bilateral thighs- denies history of vaccine reaction at 2 month vaccination. Mom also reports "fever, a small light fever" questioned how high mom reports "100 degrees" states "it was over the holidays so I couldn't get in to see the Dr., but I called today and left message for nurse to call me" RN at clinic asked to let the health department know after talking with or see the child's primary care physician. Plan to follow up with child's mom later today 01/03/2019.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RVX
Symptoms: Agitation, Discomfort, Pyrexia, Vaccine positive rechallenge
Clinical narrative: About 3 hours after my son received 3 vaccines in his thigh and one orally, he began to have a low grade fever (99.9) and just became very agitated and uncomfortable. These vaccines were given at his 4 month checkup as well as his 2 month check up in which he had the exact same reaction both times. He continued to be febrile for about 15 hrs post vaccine both times until the fever finally broke after treating with TYLENOL.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Otitis media, Pyrexia, Salivary hypersecretion, Staring
Clinical narrative: Received Flu Booster dose on 12/31 (#1 was given 10/29/18). That NOI febrile, per mom had staring spell with increased saliva, no seizure movement noted, staring spell lasted 10 min. Seen ER, did not feel was febrile seizure. Seen in our office 1/2 DX BOM. DX BOM 1/2 in our office pt given AUGMENTIN.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Rash
Clinical narrative: Received vaccine at 11:10am on 12/19/2018. That same day at 6:00pm sudden rash developed on chest, neck and cheeks accompanied by a fever.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt's mother reports that pt broke out in Hives morning after receiving flu vaccine. Pt was seen in Urgent care, given benadryl for hives.
Age: 1.58
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Injection site erythema, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Approximately 5-6 hours after immunization, mom recalls child being fussy and crying. Left leg appeared red and warm to touch at injection site.  At approximately 4am on the day after immunization mom was awoke with child screaming and crying and a fever of 102.0. Ibuprofen was given and temp went down to 99.0. At 10:00 on same day, mom noticed fever returning and another dose of Ibuprofen was given.
Age: 1.58
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Screaming
Clinical narrative: Approximately 5-6 hours after immunization, mom recalls child being fussy and crying. Left leg appeared red and warm to touch at injection site.  At approximately 4am on the day after immunization mom was awoke with child screaming and crying and a fever of 102.0. Ibuprofen was given and temp went down to 99.0. At 10:00 on same day, mom noticed fever returning and another dose of Ibuprofen was given.
Age: 13.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient has not suffered any reaction form vaccine. Patient is going to come back for pediatric doses of Hep A and Hep B.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Pt was given ROTARIX that was expired. Does the pt need to be given another ROTARIX to replace this one? He did not have any reaction to it. Patient was given vaccine on 10/24/18 and it expired on 08/05/18. Please advise.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Patient reported left hip pain approximately 30 minutes after receiving flu shot one month ago. She stated pain has been constant for one month.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: Patient called us on 12-26-18 she called about possible reaction to immunizations. Got PREVNAR 13 and Flu vaccine on 12-19-18. Pt reports her (L) arm where she got the PREVNAR 13 was very sore and tender to touch for at least 4-5 days but seemed to get less tender and denies any swelling, but started itching on 12-23-18 and noticed on 12-25-18 she had big round red areas like welts on her back and breast. They are not raised or open, they are under the skin like a welt. Pt can't think of anything different in routine and has not eaten/drank/ etc anything new in the past few days. She was wondering if it was from the vaccines. We had her use BENADRYL and if that does not clear it up she will need to be seen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Breast cancer female
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received first dose of PREVNAR 13, via an unspecified route of administration in 2014 at the age of 65 years old for immunization. The patient medical history and concomitant medications were not reported. The patient wanted to know if she needs a booster of pneumococcal 13-val conj vac (dipht crm197 protein) if she received the first dose in 2014 when she was 65 years old. The patient stated she had breast cancer for 2 years in 2017 but now her treatment was done. The outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Diarrhoea, Influenza like illness, Injection site pain, Limb discomfort
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult female patient who experienced flu like symptoms, nausea, vomiting, diarrhea, joint pain, left shoulder upper arm pain, heaviness and left neck swelling of lymph node, while she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2018, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA via intramuscular route in the left deltoid. The patient developed a non-serious flu like symptoms <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious nausea <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious vomiting <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious diarrhea <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious joint pain <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious left shoulder upper arm pain <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious heaviness <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious left neck swelling of lymph node <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Final diagnosis was left neck swelling of lymph node, heaviness, left shoulder upper arm pain, joint pain, diarrhea, vomiting, nausea and flu like symptoms. No corrective treatment was received. The patient outcome is reported as Recovering / Resolving for flu like symptoms, as Recovering / Resolving for nausea, as Recovering / Resolving for vomiting, as Recovering / Resolving for diarrhea, as Recovering / Resolving for joint pain, as Recovering / Resolving for left shoulder upper arm pain, as Recovering / Resolving for heaviness and as Recovering / Resolving for left neck swelling of lymph node.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Lymphadenopathy, Nausea, Vomiting
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult female patient who experienced flu like symptoms, nausea, vomiting, diarrhea, joint pain, left shoulder upper arm pain, heaviness and left neck swelling of lymph node, while she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2018, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA via intramuscular route in the left deltoid. The patient developed a non-serious flu like symptoms <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious nausea <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious vomiting <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious diarrhea <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious joint pain <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious left shoulder upper arm pain <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious heaviness <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. The patient developed a non-serious left neck swelling of lymph node <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Final diagnosis was left neck swelling of lymph node, heaviness, left shoulder upper arm pain, joint pain, diarrhea, vomiting, nausea and flu like symptoms. No corrective treatment was received. The patient outcome is reported as Recovering / Resolving for flu like symptoms, as Recovering / Resolving for nausea, as Recovering / Resolving for vomiting, as Recovering / Resolving for diarrhea, as Recovering / Resolving for joint pain, as Recovering / Resolving for left shoulder upper arm pain, as Recovering / Resolving for heaviness and as Recovering / Resolving for left neck swelling of lymph node.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult female patient who experienced was late for second dose and received it on day 4, while she received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported. It was a case of actual medication error due to Drug dose administration interval too long. Patient (believed to be previously un-vaccinated) received Day 0 dose, was late for second dose and received it on Day 4. She is now presenting at Day 11 and late for her third dose. It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves elderly patient (age not reported) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot UI933AB, expiry date: 18-Mar-2019) via intramuscular route in the left deltoid on an unknown date. The patient's medical history and concomitant medications were not reported. It was a case of syringe issue since 0.5 ml dose was running down the patient's arm that could have leaked from the needle hub or there could have been a crack in the syringe. It was unknown if any adverse event occurred following the vaccination. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: On 10-24-18 pt presented to the ED with a raised local reaction to his (R) deltoid region, it was raised and warm to the touch. Pt was treated with BENADRYL and an ice pack.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hyperaesthesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness & Swelling near injection site. Pt received PNEUMOVAX vaccination 2 days ago, painful left upper arm yesterday, edema and erythema starting this morning along w/ increased sensitivity. No f/c/s. No Hx reaction to vaccinations in the past. Treat with BACTRIM DS twice daily for 1 week.  Follow-up in 48 hours to reevaluate. If it is progressing in the meantime, he is to notify us immediately. Outline of the cellulitic area marked with a SHARPIE pen.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Redness & Swelling near injection site. Pt received PNEUMOVAX vaccination 2 days ago, painful left upper arm yesterday, edema and erythema starting this morning along w/ increased sensitivity. No f/c/s. No Hx reaction to vaccinations in the past. Treat with BACTRIM DS twice daily for 1 week.  Follow-up in 48 hours to reevaluate. If it is progressing in the meantime, he is to notify us immediately. Outline of the cellulitic area marked with a SHARPIE pen.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeding disorder, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient experienced severe exhaustion, chills, fever, aches and pains starting about 8 hours after vaccine and continuing for approximately 72 hours after. He could not eat for approximately 36 hours.  In his own words he was down and non-functioning for those 36 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced severe exhaustion, chills, fever, aches and pains starting about 8 hours after vaccine and continuing for approximately 72 hours after. He could not eat for approximately 36 hours.  In his own words he was down and non-functioning for those 36 hours.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiopulmonary failure, Death
Clinical narrative: Approx 1 week after administration cause of death reported to be cardio/pulmonary failure.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Customer called within 1.5 hours of receiving vaccine and indicated that she had developed a headache " a couple of hours after" receiving vaccine. She asked if anyone else had reported getting a headache (she was told that I had not heard of anyone expressing this side-effect), was it the normal vaccine that people were getting this year (yes), was it a live virus vaccine (no), how many strains did it contain (four) and what were the names of the strains (I told her that I did not have that information in front of me but should be able to be accessed online). She was given the VIS at the time she filled out her vaccine questionnaire form, prior to getting the vaccine. She was also told that the side-effects could be mild cold, or flu-like, symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Erythema near right arm pit. appeared about a day and a half after immunization. Pt states it is not painful.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Insomnia
Clinical narrative: PATIENT DESCRIBES HAVING CHILLS, HEART PALPITATIONS, HEADACHE, STOMACH ACHE, TIRED, COULD NOT SLEEP, LOW GRADE FEVER LASTED ABOUT 2 DAYS.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: PATIENT DESCRIBES HAVING CHILLS, HEART PALPITATIONS, HEADACHE, STOMACH ACHE, TIRED, COULD NOT SLEEP, LOW GRADE FEVER LASTED ABOUT 2 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented with redness, swelling, and pain surrounding the injection site. Father reported pain and swelling have decreased however redness has persisted.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Shortly after receiving vaccination patient noticed sore right arm. Next arm became swollen, red and painful. Next day (today, 1/3/2019) patient came to see doctor, prescribed OMNICEF.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, X-ray normal
Clinical narrative: Left shoulder and upper arm pain which has not resolved in nearly 3 months.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: SHINGRIX 50 MCG Inj (IM) SNGDSE VL10pk reaction: rash above the injection site, pain where shot was given, swelling where shot was given, feeling tired and weak.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Severe chills of entire body with intense shaking post injection of 1st SHINGRIX vaccine. The episode lasted 30-45 minutes. I had the injection at approximately 3:35pm on 01/02/2019 and the chills began approximately 3:15am the following morning.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram head normal, Echocardiogram normal, Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to a 84 year old male patient. The patent had no relevant medical history. The patient's concomitant medications included simvastatin and lisinopril. It was reported that codeine and morphine both gave the patient gastrointestinal symptoms. On 26-OCT-2016, the patient recived a dose of PREVNAR and as follow up vaccination on 24-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly, in the left deltoid, lot # R007721, and expiration date 01-MAR-2020, (strength not reported). On the morning of 25-OCT-2018, the patient experienced pain in the left arm (pain in extremity). Then, on an unknown date in October 2018 (reported as a few days after receiving PNEUMOVAX 23), the patient began to feel total body aches (pain) and myalgia. Later on 28-OCT-2018, the patient was admmited to the hospital due to syncope. The patient received treatment for the adverse events and additionally, the physician reported that on unspecified dates between 28-OCT-2018 and 31-OCT-2018, the patient had a series of diagnostic testing done: echocardiogram, head CT, carotid ultrasounds, lower extremity ultrasounds which were assessed as normal.The outcome of syncope, myalgia, pain and pain in extremity was reported as not recovered. Causal relationship between PNEUMOVAX 23 and the mentioned events was unknown. Upon internal review, the event syncope was considered to be medically significant. The reporter considered the events syncope, myalgia, pain and pain in extremity to be disabling in a moderate degree.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Syncope, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 84 year old male patient. The patent had no relevant medical history. The patient's concomitant medications included simvastatin and lisinopril. It was reported that codeine and morphine both gave the patient gastrointestinal symptoms. On 26-OCT-2016, the patient recived a dose of PREVNAR and as follow up vaccination on 24-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly, in the left deltoid, lot # R007721, and expiration date 01-MAR-2020, (strength not reported). On the morning of 25-OCT-2018, the patient experienced pain in the left arm (pain in extremity). Then, on an unknown date in October 2018 (reported as a few days after receiving PNEUMOVAX 23), the patient began to feel total body aches (pain) and myalgia. Later on 28-OCT-2018, the patient was admmited to the hospital due to syncope. The patient received treatment for the adverse events and additionally, the physician reported that on unspecified dates between 28-OCT-2018 and 31-OCT-2018, the patient had a series of diagnostic testing done: echocardiogram, head CT, carotid ultrasounds, lower extremity ultrasounds which were assessed as normal.The outcome of syncope, myalgia, pain and pain in extremity was reported as not recovered. Causal relationship between PNEUMOVAX 23 and the mentioned events was unknown. Upon internal review, the event syncope was considered to be medically significant. The reporter considered the events syncope, myalgia, pain and pain in extremity to be disabling in a moderate degree.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 47 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-AUG-2018, the patient was vaccinated with the first dose of VAQTA 50/1.0 U/ml intramuscularly for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). Then on 21-DEC-2018, the patient was vaccinated with the second dose of VAQTA 50/1.0 U/ml intramuscularly lot number R027987 and expiration date of 09-AUG-2019 for prophylaxis (dose and anatomical location were not reported). No adverse effects were reported.
Sex: M
Vaccine: PNC13
Symptoms: Lumbar puncture abnormal, Meningitis bacterial, Pneumonia pneumococcal, Streptococcus test positive, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 7-month-old male patient received 3 doses of PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced streptococcus pneumoniae and white blood cell count of 30,000 on an unspecified date. Reporter assessed for streptococcus pneumoniae seriousness as per hospitalization. Course of events: On an unspecified date the patient ended up being admitted to hospital where streptococcus pneumoniae was diagnosed and the child had a white blood cell count of 30,000. They did a spinal tap and it was positive for bacterial meningitis for streptococcus pneumonia. The patient was treated with vancomycin and ceftriaxone intravenously. The outcome of the events was unknown. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient towards the occurrence of bacterial meningitis positive for streptococcus pneumonia cannot be completely excluded.
Age: 0.67
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Vomiting/throwing up.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Behaviour disorder, Condition aggravated, Eczema, Failure to thrive, Head banging
Clinical narrative: My child at age 2 began to have unexplained seizures, head banging, failure to thrive, and behavioral issues. Saw many DRs whom would not pin point the diagnose he had. Recently we have discovered he suffers with the MTFHR gene which vaccines causes a huge reaction to. Being that a confirmed diagnose was never given but all this his symptoms besides eczema have improved since stopping vaccines it is believe that the MTFHR gene causes a toxin build up and caused the reactions. HEP B and 2-4 months vaccine combos are to blame.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Seizure
Clinical narrative: My child at age 2 began to have unexplained seizures, head banging, failure to thrive, and behavioral issues. Saw many DRs whom would not pin point the diagnose he had. Recently we have discovered he suffers with the MTFHR gene which vaccines causes a huge reaction to. Being that a confirmed diagnose was never given but all this his symptoms besides eczema have improved since stopping vaccines it is believe that the MTFHR gene causes a toxin build up and caused the reactions. HEP B and 2-4 months vaccine combos are to blame.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site reaction, Injection site urticaria, Injection site warmth
Clinical narrative: 48hrs after the vaccine spiked a 103 fever right upper arm broke out in red rash, warm to the touch, sore arm. Took child into clinic on 12/5/18 after arm was not getting any better. Provider states it looks like hives and to give him BENADRYL.  Provider calling it an allergic reaction to the DtaP vaccine. After about 5 doses of BENADRYL the hives started clearing up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 48hrs after the vaccine spiked a 103 fever right upper arm broke out in red rash, warm to the touch, sore arm. Took child into clinic on 12/5/18 after arm was not getting any better. Provider states it looks like hives and to give him BENADRYL.  Provider calling it an allergic reaction to the DtaP vaccine. After about 5 doses of BENADRYL the hives started clearing up.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Fluid retention, Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: Received flu shot at Pharmacy on Nov 2nd. Extreme pain in right upper arm. Could barely raise arm to remove clothing, coat, etc. Could not sleep on that side. Pain continued for weeks and then I finally went to the doctor on December 5th. Until then I had tried ibprofen, hot/cold packs on arm, heating pad. Nothing would help on a continuous basis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Received flu shot at Pharmacy on Nov 2nd. Extreme pain in right upper arm. Could barely raise arm to remove clothing, coat, etc. Could not sleep on that side. Pain continued for weeks and then I finally went to the doctor on December 5th. Until then I had tried ibprofen, hot/cold packs on arm, heating pad. Nothing would help on a continuous basis.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Patient is c/o pain, numbness, heaviness and weakness in her right arm since receiving the Influenza vaccine. She reports being sent to physical therapy without improvement. At times she finds it almost impossible to even lift her right arm. She also reports similar symptoms from last year's Influenza vaccine which was given in her left arm but thought it was caused by the needle possibly "hitting a nerve" when it was injected. She received the FLUARIX QUADRIVALENT Influenza last year as well.
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient has experienced extreme itching and redness at injection site. The area of redness covers majority of her upper arm and is increasing in size. The patient has been under care of her physician for monitoring and treatment with antibiotics.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Eye swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: Lips tingly, itchy swollen feeling eyes, tongue felt tingly and swollen 12 hrs after the shot--improved by BENADRYL PO 25mg.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Groin pain, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Significant other of vaccinated member developed a lesion on right knee, presented to Hospital ER 28 December with complaint of painful/itching lesion. Pt reported knee pain with groin and thigh pain/lymphadenopathy.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Significant other of vaccinated member developed a lesion on right knee, presented to Hospital ER 28 December with complaint of painful/itching lesion. Pt reported knee pain with groin and thigh pain/lymphadenopathy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: Received vaccine at 3 on Wednesday. Felt okay at 9 next morning but by 1 in afternoon felt achy with head ache. Took temp it was 99. 4. Took 3 ibuprofen. Waiting for relief.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Injection site discomfort, Injection site erythema, Injection site movement impairment, Injection site swelling
Clinical narrative: Child woke 5am next day both thighs were swollen and red, temp 100. Unable to bend legs and was in discomfort. I the mother gave child TYLENOL and warm rag. Called doctor when opened. She went back to sleep at 9am gave child morning and a bath with episom salt. Doctor office called back temp had when down. Nurse said to continue pain meds us needed. I alternated TYLENOL and MOTRIN. Swelling same but not worse.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal discomfort, Headache, Hypersomnia, Sinus pain, Throat tightness
Clinical narrative: The patient reports a reaction to the shot as follows: "My throat became somewhat restricted. I took a BENADRYL and an Asthma treatment and that seemed to help. Of greater concern is that within an hour and for the next 24 hours I had severe vertigo to the point that I could not move beyond a few steps, could not watch any moving such as people or TV. I took several doses of Meclizine and had severe sinus pain (I did not have any of those symptoms prior to the shot), vertigo subsided after about 24 hours and lots and lots of sleep, but still some small vertigo on Sunday. I also had low grade headaches (not migraine). I had digestive upset as well, but blame that on the meclizine and sinus medicine I was taking to try to control my symptoms." Patient reports symptoms did completely resolve but she requested this reaction be reported.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Vertigo
Clinical narrative: The patient reports a reaction to the shot as follows: "My throat became somewhat restricted. I took a BENADRYL and an Asthma treatment and that seemed to help. Of greater concern is that within an hour and for the next 24 hours I had severe vertigo to the point that I could not move beyond a few steps, could not watch any moving such as people or TV. I took several doses of Meclizine and had severe sinus pain (I did not have any of those symptoms prior to the shot), vertigo subsided after about 24 hours and lots and lots of sleep, but still some small vertigo on Sunday. I also had low grade headaches (not migraine). I had digestive upset as well, but blame that on the meclizine and sinus medicine I was taking to try to control my symptoms." Patient reports symptoms did completely resolve but she requested this reaction be reported.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt had a severely sore arm even 12 days after receiving the vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Nausea, Pain, Pain in extremity
Clinical narrative: Sore, red, and swollen arm, fever, body aches, nausea, loss of appetite. Took Aleve and baby aspirin.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Sore, red, and swollen arm, fever, body aches, nausea, loss of appetite. Took Aleve and baby aspirin.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Patient reports of muscle spasms in his back five minutes after vaccination, followed by a fever.
Sex: U
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Circumstance or information capable of leading to medication error, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a child patient of unknown age and gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-DEC-2018, the patient was vaccinated with VARIVAX (lot # R017637, expiration date 20-JUN-2010) and sterile diluent (lot # and expiration date unknown by the reporter). The unspecified child "moved during administration" and an unspecified amount of VARIVAX "squirted" into the eye of the medical assistant while she was administering the dose (underdose). No adverse effects reported, and no additional information was provided. This is one of 2 reports from the same reporter (information captured in MARRS case #1812USA003303). Sender's Comments: US-009507513-1812USA003303.