chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Hyperhidrosis, Loss of consciousness
Clinical narrative: PATIENT LOSS COUNCIUSNESS FOR ABOT 20 SECOND AFTER VACCINATION WAS GIVEN.  IT WAS REALLY HOT OUTSIDE AND PATIENT REPORTED NOT DRINKING WATER SINCE MORNING. PATIENT ALSO HAVE NEEDLE FOBIA. 911 WAS CALLED, BY THE TIME HELP CAME PATIENT WAS DOING FINE. WE GAVE HIM PEDIALITE WHICH HELPD HIM WITH SWEATING. FIRST RESPONDER CLEAR HIM AFTER BP AND EKG CHECK. PATIENT DENIED GOING TO THE HOSPITAL FOR ANY FURTHER HELP.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received a HD flu shot in left arm and Shingrix in right arm on 9/24. Pt came in to pharmacy on 9/27 to show her right arm had an injection site reaction.  There was an area about the size of a 2 inch square that was pink/red in color.  Pt said it was tender and warm to the touch/ swollen.  The reaction happened a day or two after getting the vaccine and she stated that it was a lot worse before she came in on 9/27.  Pharmacist explained that this looks like an injection site reaction from Shingrix and that patient should ice the area for about 15 min three times daily until better and to also take tylenol for the pain.. Patient was fully recovered after following up with her 2 days later.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Pain
Clinical narrative: Cellulitis left arm below injection site. Lasted 2 days. No treatment need.  Very sore the first night.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the high dose influenza vaccination before his 65th birthday 10/01/20 (at 64 years 10 months).  Reporting as a precaution, no adverse effects to report.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Heart rate increased, Injection site swelling, Pruritus, Rash
Clinical narrative: PATIENT REPORTED SWELLING AT INJECTION SITE, WHICH IS A COMMON REACTION FOR HER, AND A SLIGHT RASH/ITCHING.  SHE WEARS AN APPLE WATCH THAT DETECTS HER HEART RATE, AND IT WOKE HER UP FROM HER SLEEP AT AROUND 9PM ALERTING HER THAT HER HEART RATE WAS OVER 100. SHE SAID IT WOULD REGISTER AS HIGH AS 130 BPM AT TIMES, AND SHE FELT IT BEATING RAPIDLY.  THIS CONTINUED UNTIL 11PM, AT WHICH IT DECLINED BUT SHE SAID IT WOULD AVERAGE IN THE 90S.  THE MORNING SHE CALLED THE PHARMACY, SHE SAID IT WAS "NORMAL".  WHEN INQUIRED FURTHER, SHE REPORTED NO OTHER SYMPTOMS AND THIS HAS NOT HAPPENED BEFORE. SHE DID NOT HAVE A BLOOD PRESSURE MONITOR AT HOME TO TEST, BUT I ADVISED HER THAT SHE SHOULD CALL HER PROVIDER OR SEEK MEDICAL HELP IF IT HAPPENS AGAIN/ESCALATES/WORSENS.  I FURTHER COUNSELED HER THAT THIS REACTION MAY OR MAY NOT BE RELATED TO HER VACCINE, AND COULD BE AN UNDERLYING MEDICAL CONDITION THAT SHE WAS PREVIOUSLY UNAWARE OF.  SHE SAID SHE HAD A "DOCTOR FRIEND" WHO WOULD BE ABLE TO TAKE HER BLOOD PRESSURE IF IT HAPPENED AGAIN AND SHE WOULD CALL HER DOCTOR AS WELL.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Headache
Clinical narrative: PATIENT COMPLAINED OF HEADACE
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever, redness, swelling, warmth right arm (upper arm circ 21.75 cm vs 17cm left)
Age: 75.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: After receiving the vaccinations the patient went home and began to have swelling in the left arm then fever, then swelling of the face, and left lower limbs.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Injection site vesicles
Clinical narrative: Patient had hives, itching, blister-like rashes on her upper arm towards the back on both sides.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Syncope
Clinical narrative: Patient fainted 2 times for a few seconds after getting  Shingrix vaccine. Patient stated this was not her first time.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that she had a sore arm & difficulty moving the arm, restlessness, chills, sore joints starting the evening she received the vaccine.  The next day she said she felt very tired and slept for about 6 hours during the day.   When she called here, about 24 hours after the vaccine was administered, she stated that she was feeling mostly better.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Restlessness, Somnolence
Clinical narrative: Patient stated that she had a sore arm & difficulty moving the arm, restlessness, chills, sore joints starting the evening she received the vaccine.  The next day she said she felt very tired and slept for about 6 hours during the day.   When she called here, about 24 hours after the vaccine was administered, she stated that she was feeling mostly better.
Age: 32.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient complained of significant arm pain after having 2 vaccines administered. Pt believed that the intern who administered the shot was too high on the arm near the shoulder
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt states he developed shingles after having received the Shingrix vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdomen scan normal, Abdominal X-ray, Blister, Pain, X-ray normal
Clinical narrative: Pt states he developed shingles after having received the Shingrix vaccine.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Eye pain, Pyrexia, Throat tightness
Clinical narrative: Extremely red eyes with pain, tight throat, cough, fever, weakness
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: She came into the pharmacy today after an off-site flu clinic at her place of employment yesterday.  She had a local reaction the previous year so she marked with a sharpie where the shot was this year.  The arm turned red and hot and was swollen all the way down to her elbow.
Age: 44.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately after injection of 2 vaccines (1 on either arm) patient stood up to leave and within 1-3 minutes started to feel "not myself" "Felt dizzy".  pharmacist noted patient began to sweating profusely and rph told patient to sit down.  Blood pressure was read 46/23, after moving into consultation room blood pressure was 99/63 then 10 minutes later was 119/99
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Full body hives that would not calm down with Benadryl and Claritin combination. Nothing else in environment or diet was new or different.  Duration of 7-8 days.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness postural, Fall, Immediate post-injection reaction
Clinical narrative: Right after vaccine was administered patient stood up and start feeling dizzy, as he was walking towards the exit he fell but didn't loose consciousness. When paramedics arrived they measured his blood pressure, it was very low (68/34). Patient was transported to hospital.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Swelling, redness and pain at injection site.  Severe headache, dizziness, stiffness in neck, joint pain
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swelling, redness and pain at injection site.  Severe headache, dizziness, stiffness in neck, joint pain
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction, EpiPen administered and patient recovered fully, Further evaluated through ED and Decadron provided there. Discharged to home with EpiPen.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Patient states she tolerated the injection fine, then that evening went to a fitness class.  After the fitness class she was doing her usual stretching where she laid on the floor, crossed her arms across her body at the elbows and held the pose to stretch her back. She states she always does this stretch after her class.  When she released her stretch she immediately felt pain in the arm she had her injection in.  Pain that shot down to her wrist and then up to and through her shoulder, neck, and to her head.  She continued to feel this pain all night, it was not relieved by OTC NSAIDS and it kept her from sleeping.  She called the pharmacy the next day as her arm was still hurting, to the extent that she said she "couldn't do anything with it".  She states she has never had any adverse reaction to any other vaccine.  She is not one of our regular patients, but she did include on her VAR she had received a "regular flu shot" in the past 4 to 8 weeks.  It sounded like she went to a vigorous fitness class, but she said this was her normal class, and normal amount of physical exertion. she called to ask if she should contact her physician, and was told she could and should if the pain did not resolve with self-treatment, but it is unknown at this time whether she has sought out treatment.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Patient states she tolerated the injection fine, then that evening went to a fitness class.  After the fitness class she was doing her usual stretching where she laid on the floor, crossed her arms across her body at the elbows and held the pose to stretch her back. She states she always does this stretch after her class.  When she released her stretch she immediately felt pain in the arm she had her injection in.  Pain that shot down to her wrist and then up to and through her shoulder, neck, and to her head.  She continued to feel this pain all night, it was not relieved by OTC NSAIDS and it kept her from sleeping.  She called the pharmacy the next day as her arm was still hurting, to the extent that she said she "couldn't do anything with it".  She states she has never had any adverse reaction to any other vaccine.  She is not one of our regular patients, but she did include on her VAR she had received a "regular flu shot" in the past 4 to 8 weeks.  It sounded like she went to a vigorous fitness class, but she said this was her normal class, and normal amount of physical exertion. she called to ask if she should contact her physician, and was told she could and should if the pain did not resolve with self-treatment, but it is unknown at this time whether she has sought out treatment.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: 09/30/2020 Patient claimed experiencing extreme fatigue 15 minutes after the vaccination with sore arm and dizziness.  10/01/2020 condition has improved, but still tired and little dizziness. Not seek any medication attention.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain of R upper arm. decrease range of motion in R shoulder
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: SkinRash & Rash
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Feeling abnormal, Hypersensitivity
Clinical narrative: 7:02 - Temp taken - 97.5 7:03 - Patient given flu vaccine 7:13 - Patient feeling fine with no problems -leaves, goes back to work. 7:25 - Patient comes  back, not felling well - nausea, vomiting, dizzy,  no redness at site, no hives or SOB. 911 called and paramedics in route as a precaution.  7:50 - Patient continues to feel bad, Temp. 99, lies down on floor (L) side 7:57 Patient sits up very suddenly, begins to have  trouble breathing, gasping and  making noise when struggling to breathe. Moving and reaching out both arms to grab  something. EpiPen given in (R) outer thigh. 911 called again. 8:01 am - Patient sitting up and breathing normally.  8:04 - Ambulance at company, patient taken to  Hospital Main Emergency Department. Tests run,  and MD states patient had allergic reaction to flu shot with syncope episode and to never  take flu shot again. Patient discharged and home doing well.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Malaise, Nausea, Syncope, Vomiting
Clinical narrative: 7:02 - Temp taken - 97.5 7:03 - Patient given flu vaccine 7:13 - Patient feeling fine with no problems -leaves, goes back to work. 7:25 - Patient comes  back, not felling well - nausea, vomiting, dizzy,  no redness at site, no hives or SOB. 911 called and paramedics in route as a precaution.  7:50 - Patient continues to feel bad, Temp. 99, lies down on floor (L) side 7:57 Patient sits up very suddenly, begins to have  trouble breathing, gasping and  making noise when struggling to breathe. Moving and reaching out both arms to grab  something. EpiPen given in (R) outer thigh. 911 called again. 8:01 am - Patient sitting up and breathing normally.  8:04 - Ambulance at company, patient taken to  Hospital Main Emergency Department. Tests run,  and MD states patient had allergic reaction to flu shot with syncope episode and to never  take flu shot again. Patient discharged and home doing well.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hypertension, Injection site pain, Tachycardia
Clinical narrative: HYPERtension, Tachycardia & pain at injection site, chills
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Hyperhidrosis, Respiration abnormal
Clinical narrative: One hour after the vaccine patient became diaphoretic with headache and chills. Mom said breathing was abnormal. She gave him ibuprofen which helped. He slept it off.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately following immunization patient reported feeling light headed  Patient remained seated for approximately 15 minutes after immunization and returned to normal. Patient stated he typically has this reaction after needle sticks and/or blood draws.
Age: 65.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Redness, itching, warm and painful (Pharmacist recommended Hydrocortisone cold pressure and Tylenol/Ibuprofen. 09-29-2020: Patient went to urgent cAre received Prescriptione for BActrim DS, Banophen and MethylPrednisone
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Pyrexia
Clinical narrative: Dizziness, low grade fever, diarrhea
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Petechiae, Rash
Clinical narrative: Rash started on face then spread to the entire body. Rash is not itchy. No fever, runny nose, congestion, cough or sore throat. Diffuse rash started about 10 days after MMR vaccine given. Petechial rash isolated to nose. Parent's advised to watch and call if any worsening/spreading and blood work will be ordered.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling redness and induration to site of injection
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient received shingles vaccine on 10/23/2019. Patient said pain happened for a few days then it turned into soreness and tenderness. Patient reports that he is not able to raise arms above head and that he has trouble rotating arms. Patient received second dose on 1/20/20 and experienced same symptoms in other arm. Patient also reports pain in hand around thumb joint in palm of hand since injections.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Myalgia
Clinical narrative: Patient described pain in the deltoid after inoculation stating it felt like she had been punched.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Flushing, Pain in extremity, Skin discolouration, Temperature intolerance
Clinical narrative: Soreness transitioned from top/outside of shoulder to the upper bicep in 24 hrs. It is continuing to transition down the bicep. Minor soreness and discoloration at lower bicep at 48 hrs. Skin is flushed and sensitive to heat Bicep turned yellow once dissipated Recovered by 9/29/20
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Yellow skin
Clinical narrative: Soreness transitioned from top/outside of shoulder to the upper bicep in 24 hrs. It is continuing to transition down the bicep. Minor soreness and discoloration at lower bicep at 48 hrs. Skin is flushed and sensitive to heat Bicep turned yellow once dissipated Recovered by 9/29/20
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Paraesthesia
Clinical narrative: Left side - acute pain in shoulder joint - radiating towards scapula - down the arm  limited range of motion  tingling sensation down arm to hand
Age: 17.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Balance disorder, Dizziness, Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain; Reduced range of motion/ cannot lift arm above shoulder; reduced feeling in arm; Shoulder swollen/ severe swelling of shoulder; This is a spontaneous report from a contactable physician. This physician reported similar events for five patients. This is the second of five reports.   A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA lot number: AT1920) intramuscular on the left arm on 26Aug2020 at a single dose (reported as 1,1,1 of 2) for Men B/immunisation, 2nd dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA lot number: 46541AA) intramuscular on the right arm on an unspecified date at a single dose for immunization, and 2nd dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9 lot number: 1621929) intramuscular on the right arm on an unspecified date at an unknown dose for immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took a 1st dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and 1st dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) both on an unspecified date. The patient experienced shoulder swollen on 27Aug2020; pain and reduced range of motion on an unspecified date. Patient developed severe swelling of shoulder, cannot lift arm above shoulder. Patient also has reduced feeling in arm. The events required a visit to the physician office. Patient was given hydrocordone and physical therapy as treatment. Patient to have EMC, culture was not preformed. The patient was not hospitalized due to the events. The outcome of events was not recovered. Events were considered non-serious. It was reported that there is a reasonable possibility that the events were related to the suspect product.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drugs and events, different patient
Age: 17.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Pain; Reduced range of motion/ cannot lift arm above shoulder; reduced feeling in arm; Shoulder swollen/ severe swelling of shoulder; This is a spontaneous report from a contactable physician. This physician reported similar events for five patients. This is the second of five reports.   A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA lot number: AT1920) intramuscular on the left arm on 26Aug2020 at a single dose (reported as 1,1,1 of 2) for Men B/immunisation, 2nd dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA lot number: 46541AA) intramuscular on the right arm on an unspecified date at a single dose for immunization, and 2nd dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9 lot number: 1621929) intramuscular on the right arm on an unspecified date at an unknown dose for immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took a 1st dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and 1st dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) both on an unspecified date. The patient experienced shoulder swollen on 27Aug2020; pain and reduced range of motion on an unspecified date. Patient developed severe swelling of shoulder, cannot lift arm above shoulder. Patient also has reduced feeling in arm. The events required a visit to the physician office. Patient was given hydrocordone and physical therapy as treatment. Patient to have EMC, culture was not preformed. The patient was not hospitalized due to the events. The outcome of events was not recovered. Events were considered non-serious. It was reported that there is a reasonable possibility that the events were related to the suspect product.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drugs and events, different patient
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Headache, Pain
Clinical narrative: Pain; headache; vertigo; This is a spontaneous report from a contactable physician. This physician reported similar events for five patients. This is the 5th of 5 patients.  A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CN8296), intramuscular on left arm on 12Aug2020 10:05 at a single dose (reported as 1-1- 1 of 2) for Men B/immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain, headache and vertigo on 13Aug2020 at 10:00. The patient was not admitted in the hospital. Patient advised to take Benadryl 50g and Advil oral 400mg every 6 hours on 13Aug2020 as treatment for the events. Pain and vertigo lasted about 1 week. The outcome of the events pain and vertigo recovered on Aug2020 while headache recovered on unspecified date. The events were reported as non-serious. The physician considered that the suspect drug had a causal effect to the adverse events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drugs and events, different patient
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Pain, Vertigo
Clinical narrative: Pain; headache; vertigo; This is a spontaneous report from a contactable physician. This physician reported similar events for five patients. This is the 5th of 5 patients.  A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CN8296), intramuscular on left arm on 12Aug2020 10:05 at a single dose (reported as 1-1- 1 of 2) for Men B/immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain, headache and vertigo on 13Aug2020 at 10:00. The patient was not admitted in the hospital. Patient advised to take Benadryl 50g and Advil oral 400mg every 6 hours on 13Aug2020 as treatment for the events. Pain and vertigo lasted about 1 week. The outcome of the events pain and vertigo recovered on Aug2020 while headache recovered on unspecified date. The events were reported as non-serious. The physician considered that the suspect drug had a causal effect to the adverse events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drugs and events, different patient
Age: 11.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Abdominal pain upper, Product administered to patient of inappropriate age
Clinical narrative: An 11 year old patient was administered Flublok Quadrivalent, no AE; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an 11-year-old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no concomitant medications.   On 22-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2028, expiry: 30-Jun-2021, Strength: standard, frequency: once) once via intramuscular route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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.
Age: 11.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: An 11 year old patient was administered Flublok Quadrivalent, no AE; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an 11-year-old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no concomitant medications.   On 22-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2028, expiry: 30-Jun-2021, Strength: standard, frequency: once) once via intramuscular route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Arthralgia, Blood glucose increased, Fatigue, Feeling hot, Inflammation
Clinical narrative: About 2pm, patient went home and felt very achy on joints, muscles like if got the Flu.   Around 4pm felt exhausted and woke up the next day feeling horrible.   At night, from 7pm to 2am in the morning started dosing with insulin to bring sugar down--it took about 7 hours since it was over 300.   Next day felt bad, had neuropathy that day.  Finally felt sleep and woke up in the morning and felt fine.   Patient reports no other problems since. Patient called doctor on 2nd day to let him know what happened.   Patient has had same vaccine in prior years with no problems.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Tenderness
Clinical narrative: About 2pm, patient went home and felt very achy on joints, muscles like if got the Flu.   Around 4pm felt exhausted and woke up the next day feeling horrible.   At night, from 7pm to 2am in the morning started dosing with insulin to bring sugar down--it took about 7 hours since it was over 300.   Next day felt bad, had neuropathy that day.  Finally felt sleep and woke up in the morning and felt fine.   Patient reports no other problems since. Patient called doctor on 2nd day to let him know what happened.   Patient has had same vaccine in prior years with no problems.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Arthralgia, Blood glucose increased, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: About 2pm, patient went home and felt very achy on joints, muscles like if got the Flu.   Around 4pm felt exhausted and woke up the next day feeling horrible.   At night, from 7pm to 2am in the morning started dosing with insulin to bring sugar down--it took about 7 hours since it was over 300.   Next day felt bad, had neuropathy that day.  Finally felt sleep and woke up in the morning and felt fine.   Patient reports no other problems since. Patient called doctor on 2nd day to let him know what happened.   Patient has had same vaccine in prior years with no problems.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Myalgia, Neuropathy peripheral
Clinical narrative: About 2pm, patient went home and felt very achy on joints, muscles like if got the Flu.   Around 4pm felt exhausted and woke up the next day feeling horrible.   At night, from 7pm to 2am in the morning started dosing with insulin to bring sugar down--it took about 7 hours since it was over 300.   Next day felt bad, had neuropathy that day.  Finally felt sleep and woke up in the morning and felt fine.   Patient reports no other problems since. Patient called doctor on 2nd day to let him know what happened.   Patient has had same vaccine in prior years with no problems.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Anger, Blood test normal, Electroencephalogram normal
Clinical narrative: 9/2/2020 ? Visit to Pediatric Dr. for 3 year old Wellness Exam & 1st dose of MMR. No neurological or behavioral issues/concerns by parents or doctor.  9/9/2020 ? Drastic neurological/behavioral changes ? throwing things, flipping chairs, shoving little sister, hitting, screaming, constantly rubbing elbows, and chewing on cheeks. 9/14/2020 ?Visit to Pediatric Dr. ? concluded ?adverse neurological reaction to vaccine?. Dr. reports reaction to Department of Health. 9/14/2020 ? Visit to the ER at Hospital ? admitted for neurological/behavioral changes. Stayed at the hospital for 4 days: 9/14-9/17. 9/15/2020 ? Saw neurologist at hospital and ordered MRI and LP (Lumbar Puncture/"spinal tap"). 9/16/2020 ? Saw psychiatrist at hospital and gave two doses of Risperidone (one dose on 9/16 & 9/17) to help with rages. 9/16/2020 ? Sedated MRI and LP were completed. 9/17/2020 ? EEG was completed. All results from MRI, LP, and EEG came back normal. All preliminary blood work came back normal. Still awaiting results from more extensive blood work as well as from titer testing for MMR.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Lumbar puncture normal, Magnetic resonance imaging normal, Measles antibody, Mumps antibody test, Neurological symptom
Clinical narrative: 9/2/2020 ? Visit to Pediatric Dr. for 3 year old Wellness Exam & 1st dose of MMR. No neurological or behavioral issues/concerns by parents or doctor.  9/9/2020 ? Drastic neurological/behavioral changes ? throwing things, flipping chairs, shoving little sister, hitting, screaming, constantly rubbing elbows, and chewing on cheeks. 9/14/2020 ?Visit to Pediatric Dr. ? concluded ?adverse neurological reaction to vaccine?. Dr. reports reaction to Department of Health. 9/14/2020 ? Visit to the ER at Hospital ? admitted for neurological/behavioral changes. Stayed at the hospital for 4 days: 9/14-9/17. 9/15/2020 ? Saw neurologist at hospital and ordered MRI and LP (Lumbar Puncture/"spinal tap"). 9/16/2020 ? Saw psychiatrist at hospital and gave two doses of Risperidone (one dose on 9/16 & 9/17) to help with rages. 9/16/2020 ? Sedated MRI and LP were completed. 9/17/2020 ? EEG was completed. All results from MRI, LP, and EEG came back normal. All preliminary blood work came back normal. Still awaiting results from more extensive blood work as well as from titer testing for MMR.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody test, Screaming
Clinical narrative: 9/2/2020 ? Visit to Pediatric Dr. for 3 year old Wellness Exam & 1st dose of MMR. No neurological or behavioral issues/concerns by parents or doctor.  9/9/2020 ? Drastic neurological/behavioral changes ? throwing things, flipping chairs, shoving little sister, hitting, screaming, constantly rubbing elbows, and chewing on cheeks. 9/14/2020 ?Visit to Pediatric Dr. ? concluded ?adverse neurological reaction to vaccine?. Dr. reports reaction to Department of Health. 9/14/2020 ? Visit to the ER at Hospital ? admitted for neurological/behavioral changes. Stayed at the hospital for 4 days: 9/14-9/17. 9/15/2020 ? Saw neurologist at hospital and ordered MRI and LP (Lumbar Puncture/"spinal tap"). 9/16/2020 ? Saw psychiatrist at hospital and gave two doses of Risperidone (one dose on 9/16 & 9/17) to help with rages. 9/16/2020 ? Sedated MRI and LP were completed. 9/17/2020 ? EEG was completed. All results from MRI, LP, and EEG came back normal. All preliminary blood work came back normal. Still awaiting results from more extensive blood work as well as from titer testing for MMR.
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain at and around injection site. Soreness, tenderness, swelling, redness. Pain on movement. Moderate pain somewhat alleviated by acetaminophen. Persisting for two days at tie of reporting but improving.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Administration of improperly stored vaccines were given to a patient during temperature excursion; This spontaneous report was received from a registered nurse referring to a 13-month-old patient of unknown gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown date (onset date also reported as 15-SEP-2020), the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter with lot # S020160 and expiration date on 30-JUN-2021, and of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter with lot # S032357 and expiration date on 14-OCT-2021; both administered for prophylaxis  (route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccines experienced a temperature excursion -13.4 degrees Celsius and -8.2 degrees Celsius for 2 hours, there was no record by a data logger, and there was no previous temperature excursion. There was no adverse event reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008419:
Age: 1.5
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Temperature excursion case for PROQUAD; The child received the vaccine while under temperature excursion; This spontaneous report has been received from a medical assisstant concerning an 18-month-old child of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 22-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (lot # S022104 with expiration date 12-JAN-2021) 0.5 milliliter (route of administration not reported) for prophylaxis; while under temperature excursion at -5.5 celsius degrees (C) during a time frame of 3 minutes. The vaccine had not been exposed to previous temperature excursions. The temperature excursion was called by data logger. No additional adverse event (AE) was reported.
Sex: M
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC details provided.; PNUEMOV AX 23 was administered to 2-3 male patients today; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot # T010779, expiration date reported as 30-JAN-2022). No additional adverse event details provided.  According to the reporter, the vaccine that was stored in their refrigerator that broke and reached a temperature of 68 degrees Fahrenheit for 12 hours on 21-SEP-2020 (product storage error), without any previous temperature excursion; which was detected by a digital data logger.  This is one of two reports form the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA010049:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: the patient received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 09-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R022232 wit expiration date of 16-APR-2020 (upon intenla validation) for prophylaxis. No additional or clarifying information provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R022232; expirationdate: 16-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is being admitted to facility as a new patient and caller received his immunizations, while reviewing his immunizations she noticed that ROTATEQ was administered at 5 weeks versus 8 weeks; Patient is being admitted to facility as a new patient and caller received his immunizations, while reviewing his immunizations she noticed that ROTATEQ was administered at 5 weeks versus 8 weeks; This spontaneous report has been received from a consumer concerning a 5-week-old patient of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were no reported.   On an unspecified date, the patient was admitted to a facility (hospitalization) for an unknown reason (adverse event) as a new patient. During admission, the patient's previous immunizations were reviewed. It was noticed that the patient had been vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen, vaccine batch/lot number and expiration date were not reported) orally, for prophylaxis; at 5-weeks-old instead of 8-weeks-old (product administered to patient of inappropriate age). The outcome of unspecified the event was not reported, neither was the causality assessment between the unspecified event and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Tremors in her legs; This spontaneous report was received from a pharmacist thecnician concerning a 75 year-old female patient. The patient's concurrent conditions included allergy to codeine (reported as "codine") and quinolones (reported as "quinolonds"). The patient's concomitant therapies included unspecified influenza medication and other unspecified medications.     On 17-SEP-2020, the patient was vaccinated with 1 shot in the right arm with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and expiration date were not provided) according to doctor's recommendation because of her age for prophylaxis.      On 24-SEP-2020, the patient experienced tremors in her legs. No treatment was prescribed for the event. At the time of the report, the outcome of the event was not recovered.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: a dose of RECOMBIVAX HB was given today wilh a dose of PEDIARIX; This spontaneous report was received from a registered nurse concerning a 2 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 24-SEP-2020, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) with a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid  (PEDIARIX) (strength, dose, route, lot# and expiration date were not provided for any suspect therapies) for prophylaxis.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; The injections were administered at 0, 2, and 4 months; This spontaneous report    was received from a nurse concerning     a 19 year-old female patient    The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 12-AUG-2019 and 14-OCT-2019, the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# 1602283, expiration date 18-AUG-2021 (strength, dose and route were not provided)     for prophylaxis. On 16-DEC-2019,  the patient was administered with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# E025729 (strength, dose, route and expiration date were not provided). The injections were administered at 0, 2 and 4 months. No additional adverse event was reported.  Lot Number E025729 is not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient received only one dose of GARDASIL 9; no adverse effect; This spontaneous report was received from a pharmacist and refers to a 24 year old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date (reported as about a year to 1 and 1/2 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were not reported).         The patient received only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from a vaccine coordinator and refers to an unknown number of unspecified patients. Information regarding the patients' concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patients were vaccinated with the following improperly stored vaccines: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # T009931, expiration date 16-SEP-2021 and lot # T006792 (rHA), expiration date 24-AUG-2021 administered as prophylaxis; and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T000698, expiration date 07-JAN-2022 and lot # S030227, expiration date 26-SEP-2021 administered as prophylaxis. Caller stated all the vaccines were administered after the previous excursion, however, not administered after the current excursion.  The improperly stored doses of the suspect vaccines experienced a temperature excursion of -9 degree Celsius (°C) to 8°C (+3.1°C) for 1 hour and 45 minutes on 25-SEP-2020; a previous temperature excursion was reported, of -9°C to 8°C (1.3°C) for 2 hours and 45 minutes.  The call was made due to a digital data logger.  This case was classified as non-valid due to no patients identifiers
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: one improperly stored dose VARIVAX was administered to the patient; This spontaneous report was received from the office manager referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.      On 28-SEP-2020, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S032357, expiration date 14-OCT-2021 for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The office manager reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored.    The vaccine was stored in a temperature of 6.9 degree Fahrenheit (°F)  for 11 minutes as recorded by a data logger. There was no previous temperature excursion reported.