chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE and again 0.5 mL dose of it (Batch number: UI981AB, expiration date: 16-Mar-2019, unknown route, in left deltoid, both doses on 27-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due extra dose administered (reported that the patient who accidentally received 2 doses of the High Dose flu shot on the same day). It was reported that the patient had received FLUZONE HD in previous seasons and it was discovered today that he had already received a FLUZONE HD immunization elsewhere this season. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Sep-2018. This case involves a 64 years female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration as the patient receive the FLUZONE HIGH DOSE at age 64 years old. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, FLU4, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female who was vaccinated with an 0.5 ml dose of HPV VACCINE and QUADRACEL (batch number C54978A and expiration date 17-JUL-2020) via intramuscular route in the arm on 28-SEP-2018 instead of HPV VACCINE. Concomitant medications included MENACTRA and FLUZONE for Immunisation. Also patient received first dose of ADACEL. The patient's medical history was not reported. It was an actual medication error due to wrong vaccine administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA274204, 2018SA274230 and 2018SA274229. This case involves a male patient (age not reported) who was vaccinated with a dose of  MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (it was reported that doses of vaccines stored outside the recommended range). It was reported that the patient had no side effects. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 24 years old female patient who was wanting a meningococcal b vaccination and instead got a MENACTRA injection, while he/she received vaccines MENACTRA instead of MENINGOCOCCAL VACCINE B. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-AUG-2018, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5835AB or J5835AB via unknown route, in the left deltoid instead of MENINGOCOCCAL VACCINE B. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA274204, 2018SA274203 and 2018SA274230. This case involves female patient who received doses of ADACEL stored outside the recommended range, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (from 30-Jul-2018 - 03 -Aug-2018), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. No known reports of side effect. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA274204, 2018SA274203 and 2018SA274229. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (received doses of vaccines stored outside the recommended range and exceeded the 72 hour).  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age and gender not reported) who received a vaccine FLUZONE HIGH DOSE lot UJ023AA, expiry date: 25-Apr-19 (route, dose and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. It was also case of syringe leak. It was reported that the vaccine seemed to leak at the bottom where the needle attaches to. Pharmacist stated that there was not issues or anything out of the ordinary that she noticed when attaching the needle to the pen and she thghtened it down as she always does. Pharmacist stated that she is unsure if the consumer received the full dose or not. It was unknown whether patient experienced any adverse reaction after vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited non-serious case received from an other health professional (physician's assistant). This case is related to 2018SA269762, 2018SA274519, 2018SA274520, 2018SA274521, 2018SA274522, 2018SA274523, 2018SA274524, 2018SA274525 (same reporter). This case involves 69 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI993AB), expiry date 18 Mar 2019 via intramuscular route that were not considered valid due to prolonged shipping and unknown temperatures on 18 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that Vaxserve delivered FLUZONE HD 0.5mL the week of 09 Aug 2018 and it took 3 days to deliver, was told by Vaxserve that doses were viable at that time and temp indicator in shipping container did not show a change in temp, then received call from Vaxserve on 25 Sep 2018 stating that doses were not viable from  hipping excursion, doses were given to nine patients. It was not reported whether the patient experienced any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited non-serious case received from an other health professional (physician's assistant). This case is related to 2018SA269762, 2018SA274507, 2018SA274520, 2018SA274521, 2018SA274522, 2018SA274523, 2018SA274524, 2018SA274525 (same reporter). This case involves 81 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI993AB), expiry date 18 Mar 2019 via intramuscular route that were not considered valid due to prolonged shipping and unknown temperatures on 21 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that Vaxserve delivered FLUZONE HD 0.5mL the week of 09 Aug 2018 and it took 3 days to deliver, was told by Vaxserve that doses were viable at that time and temp indicator in shipping container did not show a change in temp, then received call from Vaxserve on 25 Sep 2018 stating that doses were not viable from shipping excursion, doses were given to nine patients. It was not reported whether the patient experienced any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274521, 2018SA274523, 2018SA274524, 2018SA274525 and 2018SA274522 (same reporter). This case involves a 67 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that doses were viable at that time and temp indicator in shipping container did not show a change in temperature. It was unknown whether patient experienced any adverse reaction after vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274520, 2018SA274523, 2018SA274524, 2018SA274525 and 2018SA274522 (same reporter). This case involves a 65 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 12-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that temp indicator in shipping container did not show a change in temperature- that doses were not viable from shipping excursion, doses were given to nine patients. It was unknown whether patient experienced any adverse reaction after vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 27-Sep-2018 from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274521, 2018SA274524, 2018SA274525, 2018SA274520 and 2018SA274523 (same reporter). This case involves a 80 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 10-Sep-2018. The patients past medical history, concomitant medication(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage (doses were not viable from shipping excursion, doses were given to nine patients). It was reported that vaccine took 3 days to deliver. It was unknown whether patient experienced any adverse reaction after vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 27-Sep-2018 from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274521, 2018SA274524, 2018SA274525, 2018SA274520 and 2018SA274522 (same reporter). This case involves a 74 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 10-Sep-2018. The patients past medical history, concomitant medication(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that vaccine shipment took 3 days and doses were not viable from shipping excursion, doses were given to nine patients. It was unknown whether patient experienced any adverse reaction after vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274520, 2018SA274523, 2018SA274521, 2018SA274525 and 2018SA274522 (same reporter). This case involves a 70 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 24-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that vaccine shipment took 3 days and temp indicator in shipping container did not show a change in temperature- that doses were not viable from shipping excursion, doses were given to nine patients. It was unknown whether patient experienced any adverse reaction after vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to cases 2018SA269762, 2018SA274520, 2018SA274507, 2018SA274523, 2018SA274521, 2018SA274519, 2018SA274522 and 2018SA274524. (Same reporter). This case involves a 72 years old female patient who received vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 15-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due incorrect product storage. It was reported that vaccine shipment took 3 days and doses were not viable from shipping excursion, doses were given to nine patients. It was not reported that if any adverse event occurred or not. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in left cheek, left jaw, and backs of both hands and calves, started shortly after flu shot. This is the third year experiencing these symptoms after the flu shot. They typically last about a week.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram abdomen normal, Decreased appetite, Dehydration
Clinical narrative: Also had meningitis vaccine.....body aches (hurt to walk or ride in vehicle) low fever to high fever of 103.8. Skin rash, severe headache, nausea, dizziness, sleeping constantly, dehydration, stomach pain wouldn't eat or drink hardly. Blood shot eyes.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Hypersomnia, Influenza virus test negative, Nausea
Clinical narrative: Also had meningitis vaccine.....body aches (hurt to walk or ride in vehicle) low fever to high fever of 103.8. Skin rash, severe headache, nausea, dizziness, sleeping constantly, dehydration, stomach pain wouldn't eat or drink hardly. Blood shot eyes.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Ocular hyperaemia, Pain, Pyrexia, Rash
Clinical narrative: Also had meningitis vaccine.....body aches (hurt to walk or ride in vehicle) low fever to high fever of 103.8. Skin rash, severe headache, nausea, dizziness, sleeping constantly, dehydration, stomach pain wouldn't eat or drink hardly. Blood shot eyes.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Noticed itching at 11:55AM on 10/5/2018, saw redness of circle about one & a half inches in diameter at the site of injection. Slight discoloration only where needle entered. Some swelling.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Patient states arm is swollen and tender 28 days after injection of IMZ. No heat or pain present. Left arm noticibly larger than right arm.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: About 20 minutes after receiving this flu vaccine, patient developed large, red area on upper left arm which was very warm to touch and was very itchy. Large 1 inch area of induration noted. Band-Aid was not used for vaccine administration. No breathing issues or other areas of concern. Within 1 hour, area less red and hot. Patient did take a ZYRTEC 90 minutes after occurrence and 7 hours after injection, patient states area is smaller but warm (not hot) to touch.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure fluctuation, Dizziness, Electrocardiogram, Impaired work ability, Myocardial necrosis marker
Clinical narrative: Panic attacks and blood pressure fluctuation for 3 months following the vaccine. This occurred for two years in a row, one or two days following the vaccine. Nothing was found by my cardiologist or a mental health professional. The attacks and Blood pressure fluctuations that caused dizziness and absence from work lasted for about 3month following and then resolved on their own.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Panic attack, Ultrasound kidney, Ultrasound liver, Vaccine positive rechallenge
Clinical narrative: Panic attacks and blood pressure fluctuation for 3 months following the vaccine. This occurred for two years in a row, one or two days following the vaccine. Nothing was found by my cardiologist or a mental health professional. The attacks and Blood pressure fluctuations that caused dizziness and absence from work lasted for about 3month following and then resolved on their own.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Pain, Pain in extremity, Pruritus
Clinical narrative: Patient came to the office the next day after getting her BEXSERO shot. She said her arm hurt, was warm to touch and she was aching all over. She also c/o dizziness, headache and itching.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: Patient came to the office the next day after getting her BEXSERO shot. She said her arm hurt, was warm to touch and she was aching all over. She also c/o dizziness, headache and itching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Rash, Swelling face
Clinical narrative: DTAP/IPV injection site reddened, swollen to golf ball size. Facial swelling with spots. ER prescribed KEFLEX, prednisone, NAPROSYN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep. On 25th September 2018, the patient experienced joint pain, muscle pain and tiredness. On an unknown date, the outcome of the joint pain, poor quality sleep, muscle pain and tiredness were unknown. It was unknown if the reporter considered the joint pain, poor quality sleep, muscle pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The patient had terrible night sleep, awoke with muscle aches, joint pains and general tired feeling. The call center representative transferred the call to product specialist who works closely with this product and who was the pharmacist. The patient's husband said that the side effects reported by the pharmacist were pretty common, they seemed to be fading with exercise and general movement, but they both awoke with a SHINGRIX hangover. The patient's husband was going to see his doctor on Wednesday and the patient had immediate access to her doctor as well, they just wanted to touch base to see if this was a normal reaction, which it appeared to be. This case was linked with the case US2018GSK174204, reported for her husband.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of aphthous stomatitis in a 76-year-old male patient who received SHINGRIX (batch number 9349T, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of aphthous ulcer (1st dose received on 2nd June 2018, refer case US2018174603).  On 8th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced aphthous stomatitis. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the aphthous stomatitis was unknown.  It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were provided as follows: The patient reported to the pharmacist that he developed canker sores on his mouth again after 2nd dose of SHINGRIX.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Erythema left deltoid in area of injections.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Patient started having diarrhea 2 hrs. after vaccine. Got shot - ate pizza - got diarrhea - allergic to eggs (yolk) - had flu vax in past without any problems. Is diabetic (under control).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Injection site rash, Pallor
Clinical narrative: Day following vaccines patient complained of chest pain and shortness of breath while she was sitting at school. No dizziness and no palpitations. Per patient O2 Sat was 94% and then quickly came up. A similar episode happened before approximately 1 year ago. Got shots yesterday and school nurse said she looked very pale and when she went back to desk her chest hurt (hurt in very middle of chest), she felt like it was hard to take deep breath. No trouble now and chest does not hurt now. Chest started to hurt and difficulty breathing. O2 was 94% and then got higher. Was pale initially. No palpitations. When chest pain started she was sitting. No anxiety. This has happened 2-3 times before last episode was 1 mo ago. Lasted about 40 min. BP was fine yesterday. Rash on upper arms.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Skin Normal except as noted 13.5cm by 11.5cm area of erythema surrounding central punctate injection site on left vastus lateralis. Warm to touch with swelling at site of erythema. No streaking on extremity. No involvement of hip or knee joints. Covering for cellulitis with KEFLEX today. Advised using cool compresses and ok to continue ibuprofen and BENADRYL. Area of erythema and warmth marked with a pen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pyrexia, Tremor
Clinical narrative: Patient called the pharmacy around 9:30 am of 10/3/18 to inquire if severe uncontrollable shaking was a side effect of the SHINGRIX vaccine. She stated that she was very cold and could not stop shaking uncontrollably. I informed her that shaking is a possible side effect, however severe shaking should be evaluated. She was seen and per pt around 5pm on 10/3/18 she had a fever of 102 degrees F and had a heart rate close to 200bpm. Per pt, the possible Dx of febrile seizures resulting from the SHINGRIX vaccine was discussed. The patient came into the pharmacy on 10/5/18 and stated that she was feeling better. We discussed taking precautions prior to the subsequent vaccine in attempt to avoid the high fever.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Patient was here last 10/1/18 and had both high-dose flu shot and PNEUMOVAX in the same arm (right). The next day, patient states that she noted the area of injection to be red, swollen and painful. Denies any fever. Today, the redness is still present but as big and it has gone down in terms of swelling as well. She also states that yesterday, she felt that her muscles in her arm, chest and back were painful and was worse when she lies down. Denies any wheezing, denies any fever.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: The evening after receiving these vaccinations (10/2/2018) patient developed pain, stiffness, redness and firmness in her right upper arm. These sensations continued to worsen through the night and on 10/3/2018 morning she was unable to move her right arm. Patient applied ice to the affected locations and received some relief. The patient notified the pharmacy on the morning of 10/4/2018 at which time she was feeling better and could move her arm although it was still sore and red. She reported seeing a physician on 10/4/2018 for another purpose and showed that physician her arm. The physician assured her that he had seen similar reactions in the past which alleviated some of the patients fears. She came by the pharmacy about noon on 10/5/2018 to provide medication list and reported feeling better and expected a full recovery.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Joint noise, Joint range of motion decreased, Limb injury, Pain in extremity
Clinical narrative: I received the flu shot on Wednesday, September 19, 2018. Pregnant and due was October 5th. I was sore the next day, thinking it was normal. A week passes and my pain was worse, with limited range of motion and the feeling as though I was being punched in the arm everyday. Another week passes, and my pain is even worse, with very limited range of motion, a clicking in my shoulder and sharp pain whenever I'd make certain moves. Sometimes, I can't lift my arm at all. I went to the doctor and she said it was a shoulder injury. Prescribed me prednisone and physical therapy.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood glucose, Dizziness, Electrocardiogram, Fatigue, Hyperhidrosis
Clinical narrative: Red, swelling, hive light reaction localized at injection site, fatigue, sweaty, incoherent at times, lightheadedness. Started this AM, 24 hours, place ice pack locally on injection site, patient being sent to the emergency room.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Incoherent, Injection site erythema, Injection site swelling, Injection site urticaria, Urine analysis
Clinical narrative: Red, swelling, hive light reaction localized at injection site, fatigue, sweaty, incoherent at times, lightheadedness. Started this AM, 24 hours, place ice pack locally on injection site, patient being sent to the emergency room.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Client's mother called the Health Department at 3:48pm and left a message stating that her daughter "passed out and had a seizure" in the car on the way home after being vaccinated. Client was being taken to Medical Center.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient came to pharmacy on 10/3/18 complaining that her arm still hurts from her influenza vaccine she had received on 9/8/18. She states her pain and swelling commenced about 1&1/2 weeks after receiving the vaccine. She says she still has pain and swelling that has since radiated to her elbow. She is having a difficult time lifting her arm and extending her elbow.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Injection site pain, Insomnia
Clinical narrative: Patient stated the below symptoms started about 6 hours after injection - hurts at the right side of where the vaccine was inserted - diarrhea - couldn't sleep on arm - headache - cramp on leg. Leg cramping and GI distress resolved next day.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms
Clinical narrative: Patient stated the below symptoms started about 6 hours after injection - hurts at the right side of where the vaccine was inserted - diarrhea - couldn't sleep on arm - headache - cramp on leg. Leg cramping and GI distress resolved next day.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient has painful arm and cannot move it laterally properly. No other signs and symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING AND REDNESS OF THE INJECTION SITE. PAIN AT THE INJECTION SITE. SWELLING AND PAIN GOING DOWN. PATIENT RECOVERING.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Hot Red Swelling on arm from Shoulder to elbow and almost all the way around the arm. Low grade fever. Applied ice. Took ALEVE, Ibuprofen, BENADRYL. This is the 3rd day and still have quite a bit of swelling and is red and hot. Called the pharmacy and said this was unusual with the PNEUMOVAX 23 vaccine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Feeling abnormal, Gait inability
Clinical narrative: Four hours after injection began to experience mild "fogginess." Woke up day 2 October 2, 2018 (day after injection) at 0600 with "severe dizziness, nausea, diarrhea, stomach upset" Too dizzy to walk (had to crawl to bathroom) Symptoms persisted all day. Same sx persisted on day 3 October 3, 2018 (second day after injection) but less severe. Interviewed pt on 10/5/2018 and she stated that she still felt minor dizzy sx "like I am walking on a ship at sea".
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Four hours after injection began to experience mild "fogginess." Woke up day 2 October 2, 2018 (day after injection) at 0600 with "severe dizziness, nausea, diarrhea, stomach upset" Too dizzy to walk (had to crawl to bathroom) Symptoms persisted all day. Same sx persisted on day 3 October 3, 2018 (second day after injection) but less severe. Interviewed pt on 10/5/2018 and she stated that she still felt minor dizzy sx "like I am walking on a ship at sea".
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported a rapidly expanding swelling at the vaccine site. Day 1 50 cent size. Day 2 apple size. Day 3 grapefruit size, no fever. Reports tenderness and warmth at the site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hand swelling in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On 20th September 2018, 1 days after receiving SHINGRIX, the patient experienced hand swelling. On an unknown date, the outcome of the hand swelling was not recovered/not resolved. It was unknown if the reporter considered the hand swelling to be related to SHINGRIX. Additional details were provided as follows: The next morning the patient had swollen hands (both hands). It had been 5 days and they were still swollen.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the consumer for her physician. The age at vaccination was not reported. The symptoms were not delineated or explained by the reporter. The reporter denied permission to contact their physician.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 19th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: At 12:22 pm, the patient was administered SHINGRIX in the right arm. The patient reported that within one week of getting the dose of SHINGRIX, he experienced large lymph nodes on his neck, under his arm and on his collarbone. He had a physical two weeks prior to the vaccination and no enlarged lymph nodes were noted at that physical. The patient would have a biopsy a week after reporting date for lymphoma. The contact details of the physician was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis.  On 19th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, fatigue, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site pain were recovering/resolving and the outcome of the fatigue, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, fatigue, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received SHINGRIX on an unknown arm. About 12 hours after receiving the SHINGRIX, she had redness and swelling at the injection site, about the size of a baseball. It was also hot to the touch and it was sore when she used her arm, though not to touch. She also had some fatigue. The patient still had some of the redness, though it had improved, and her arm still hurts when used, though it was minor. The patient had denied permission to contact their physician. This case has been linked with the case US2018GSK181021, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis.  On 19th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, fatigue, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site pain were recovering/resolving and the outcome of the fatigue, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, fatigue, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received SHINGRIX on an unknown arm. About 12 hours after receiving the SHINGRIX, she had redness and swelling at the injection site, about the size of a baseball. It was also hot to the touch and it was sore when she used her arm, though not to touch. She also had some fatigue. The patient still had some of the redness, though it had improved, and her arm still hurts when used, though it was minor. The patient had denied permission to contact their physician. This case has been linked with the case US2018GSK181021, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 25th April 2018, the patient received SHINGRIX. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced pain in the arm for about 2 days after the injection, and then resolved. At the time of report, the patient stated that, this arm pain comes on intermittently ever since the injection. The patient stated, on and off again arm pain.