chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Ear infection
Clinical narrative: Inflammation in the ear; Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of otitis in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th June 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced otitis and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the otitis and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the otitis to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix in September and then started a Prednisone therapy that lasted for three months. The patient was planning to delay the second dose for a period longer than six months after the second dose, which led to circumstance or information capable of leading to medication error. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: RV5
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: Site of shot very painful after 2 hours.  Then upper arm became red and hot within 2 hours.  Next 24 hours the upper arm from the injection site and up became very red and hot...then spread to my upper back on the left...and then spread across my upper back entirely.  Still there after 48 hours.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Peripheral swelling, Rash
Clinical narrative: Pt received Vaqta on 1/6/20.  Tuesday, 1/7/20, parents noticed a small rash on torso.  Throughout the day, the rash worsened, spreading.  Called doctor's office.  Instructed to give Benadryl.  Shortly after that, pt's foot started swelling.  Called doctor's office again and was instructed to go to Immediate Care.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscle twitching
Clinical narrative: Patient's muscle in arm and 2 middle fingers have a jumping sensation occasionally
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Malaise
Clinical narrative: Had ice pick stabbing on the left side of my head and ear which continued for 36 hours.  Stabbing stopped and a general headache stayed on left side and spread to the back of head; the head felt sore when  massaged.  This continued into the third day post injection.  Took aspirin initially for one day, then switched to gabapentin.  These two meds did nothing of note.  Headache was bad enough that I missed work for 2 days which includes today, as I am not feeling well.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: Pt was administered Diluent only.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Nausea, headaches, body aches, poor appetite, injection site red and swollen started the day after vaccination
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Nausea, headaches, body aches, poor appetite, injection site red and swollen started the day after vaccination
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pruritus, Rash, Rash vesicular
Clinical narrative: Extremely painful, feverish rash- resembling shingles, on the left arm  approximately 3 inches below the injection site.  the rash and pain lasted for about 4 days.  It also caused an outbreak of hives under the skin, which on occasion, breakthrough and become itchy. As listed above, I have chronic Hashimoto's thyroidism and one of the symptoms is Urticaria  The hives are still the on the forearms and left wrist.  I contacted the NurseLine.  I was advised that there was no warning about patients with thyroid conditions.   I was also told that if the hives continued, I should take an antihistamine.   Although the hives are visible, the itch isn't constant  and they break through the skin only occasionally.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Extremely painful, feverish rash- resembling shingles, on the left arm  approximately 3 inches below the injection site.  the rash and pain lasted for about 4 days.  It also caused an outbreak of hives under the skin, which on occasion, breakthrough and become itchy. As listed above, I have chronic Hashimoto's thyroidism and one of the symptoms is Urticaria  The hives are still the on the forearms and left wrist.  I contacted the NurseLine.  I was advised that there was no warning about patients with thyroid conditions.   I was also told that if the hives continued, I should take an antihistamine.   Although the hives are visible, the itch isn't constant  and they break through the skin only occasionally.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram normal, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: I received Shingrix on 10/25/2019.  Within two days my left arm was very sore.  Movement was difficult and still is. The clinic had two different times prescribed two anti-inflammatory drugs  When I was taking the pills the pain went away. When the pills were completed - the pain returned.  The pain disrupts my sleep at night.
Age: 13.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Eye movement disorder, Immediate post-injection reaction, Loss of consciousness, Muscle spasms, Pallor
Clinical narrative: Immediately upon receiving the Meningococcal vaccine, after already receiving the Influenza, she had a vasovagal response and passed out and her face went pale. Patient's body then began to tense up and spasm while eyes rolled all over. She after about 5 seconds of the spasms, she lost control of her bladder and urinated on the exam table.
Age: 13.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Presyncope, Tension, Urinary incontinence
Clinical narrative: Immediately upon receiving the Meningococcal vaccine, after already receiving the Influenza, she had a vasovagal response and passed out and her face went pale. Patient's body then began to tense up and spasm while eyes rolled all over. She after about 5 seconds of the spasms, she lost control of her bladder and urinated on the exam table.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Limb discomfort, Shoulder injury related to vaccine administration
Clinical narrative: Mom states that 2 days after recieving the HPV vaccine patient had discomfort in the arm that the vaccine was given. Patient's mom never called the office to report such events. Patient saw Orthopedic doctor Dr and Physiatrist Dr. Dates of evaluations are unavailable at this time. On December 9, 2019 mom came into the office to report that the Orthopedic doctor diagnosed SIRVA or shoulder injury resulting from vaccine administration. Merck Rep notified of such events on January 8, 2020 at 10:30 AM.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Aspiration bursa, Bursal fluid accumulation, Injection site pain, Magnetic resonance imaging normal, Nerve block
Clinical narrative: Mom states that 2 days after recieving the HPV vaccine patient had discomfort in the arm that the vaccine was given. Patient's mom never called the office to report such events. Patient saw Orthopedic doctor Dr and Physiatrist Dr. Dates of evaluations are unavailable at this time. On December 9, 2019 mom came into the office to report that the Orthopedic doctor diagnosed SIRVA or shoulder injury resulting from vaccine administration. Merck Rep notified of such events on January 8, 2020 at 10:30 AM.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Neuralgia, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Mom states that 2 days after recieving the HPV vaccine patient had discomfort in the arm that the vaccine was given. Patient's mom never called the office to report such events. Patient saw Orthopedic doctor Dr and Physiatrist Dr. Dates of evaluations are unavailable at this time. On December 9, 2019 mom came into the office to report that the Orthopedic doctor diagnosed SIRVA or shoulder injury resulting from vaccine administration. Merck Rep notified of such events on January 8, 2020 at 10:30 AM.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site discomfort, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Mom states that 2 days after recieving the HPV vaccine patient had discomfort in the arm that the vaccine was given. Patient's mom never called the office to report such events. Patient saw Orthopedic doctor Dr and Physiatrist Dr. Dates of evaluations are unavailable at this time. On December 9, 2019 mom came into the office to report that the Orthopedic doctor diagnosed SIRVA or shoulder injury resulting from vaccine administration. Merck Rep notified of such events on January 8, 2020 at 10:30 AM.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm was very sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, 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 Flu vaccine.  Additional details were received as follows: The age at vaccination was not reported. The patient after receiving flu vaccine noted her arm was very sore. The patient did not recall the name of the flu vaccine at the time of reporting. The patient stated that was due more to technique of giving the vaccine vs the vaccine itself.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: achy; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were unknown.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, her friends experienced achy and tiredness after vaccination with 2nd dose of Shingrix. No additional details were provided. The reporter did not consent to follow up. This case has been linked with cases US2020000911, US2020000907, US2020000901, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: temperature excursion for Shingrix being stored at -6.5°F for 5 hours; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional information received as follows: The age at vaccination was not reported.  Pharmacist called on Jan 6th 2019 to report a below temperature excursion for Shingrix being stored at 6.5°F for 5 hours, which led to incorrect storage of vaccine.  Consent to Follow up was not given.  Batch number for Shingrix was provided.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Chills, Dizziness, Miosis, Pain
Clinical narrative: pupils contracting; eyes twitching; fever up to 102 F; achiness; chills; dizziness; This case was reported by a consumer via call center representative and described the occurrence of constricted pupils in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknonw date.).   On 4th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 4th January 2020, less than a day after receiving Shingrix, the patient experienced constricted pupils, eyelid twitching, fever, pain, chills and dizziness. The patient was treated with paracetamol (Tylenol) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the constricted pupils, eyelid twitching, fever, pain, chills and dizziness were recovered/resolved.   It was unknown if the reporter considered the constricted pupils, eyelid twitching, fever, pain, chills and dizziness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix later that evening after receiving the dose she experienced her pupils contracting, eyes twitching, fever up to 102 F, achiness, chills and dizziness.  Reporter dd not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pupils contracting; eyes twitching; fever up to 102 F; achiness; chills; dizziness; This case was reported by a consumer via call center representative and described the occurrence of constricted pupils in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknonw date.).   On 4th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 4th January 2020, less than a day after receiving Shingrix, the patient experienced constricted pupils, eyelid twitching, fever, pain, chills and dizziness. The patient was treated with paracetamol (Tylenol) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the constricted pupils, eyelid twitching, fever, pain, chills and dizziness were recovered/resolved.   It was unknown if the reporter considered the constricted pupils, eyelid twitching, fever, pain, chills and dizziness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix later that evening after receiving the dose she experienced her pupils contracting, eyes twitching, fever up to 102 F, achiness, chills and dizziness.  Reporter dd not consent to follow-up.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: urticaria; full body macular papular rash; This case was reported by a nurse via call center representative and described the occurrence of urticaria in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA199A, expiry date 30th September 2020) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXA14BA, expiry date 31st March 2021) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Menveo (intramuscular) .5 ml and the 1st dose of Bexsero (intramuscular) .5 ml. In January 2020, less than a week after receiving Menveo and Bexsero, the patient experienced urticaria and maculopapular rash. On an unknown date, the outcome of the urticaria and maculopapular rash were unknown.   It was unknown if the reporter considered the urticaria and maculopapular rash to be related to Menveo and Bexsero.  Additional details were received as follows: The reporter stated that the patient received a dose of Menveo and Bexsero on the same day and had a full body macular papular rash and urticarial.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Pain
Clinical narrative: redness; soreness; discomfort; This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, pain and arm discomfort. On an unknown date, the outcome of the erythema, pain and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the erythema, pain and arm discomfort to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced redness, soreness and arm discomfort with the first dose. This case has been linked to US2020002546, reported by the same reporter
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Within 1-2 minutes following injection patient began to feel lightheaded (Syncope) and complain of stomach ache. Patient had just had lunch prior to coming to receive vaccine. Mother and I laid him on the floor and asked him to turn on the side. He was communicative at all times and did not display any signs of  anaphylaxis. 911 was called for precaution due to his age. He slowly began to feel better and after about 15 minutes was on his feet again. No treatment was administered. 911 arrived and checked his vitals. He was okay. He was not taken to hospital.  Mother said she would follow up with Doctor.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dizziness, Ear pain, Headache, Injection site haemorrhage
Clinical narrative: Family member states pt was given 4 vaccines, 2 in each arm at the Health Department 1/2/2020. Since that day she has been dizzy, feverish, vomiting, with a cough and headache. She has pain in left upper arm at injection site with ecchymosis still present at site. She also has left ear pain.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pyrexia, Vomiting
Clinical narrative: Family member states pt was given 4 vaccines, 2 in each arm at the Health Department 1/2/2020. Since that day she has been dizzy, feverish, vomiting, with a cough and headache. She has pain in left upper arm at injection site with ecchymosis still present at site. She also has left ear pain.
Age: 66.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site discomfort, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient reports that vaccine given in right arm was given "very high, almost above the deltoid". She began to experience discomfort at injection site about 30 minutes later.  Discomfort got worse over the next 2 days and 11 days later is still tender to the touch. She experiences pain at injection site when she lays on at night. Patient would like to follow up with an MD.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pustule, Skin warm, Swelling
Clinical narrative: Approx. 36 hours later she noticed warm, red swollen area approx 3 to 4 inches wide then almost 3 days later developed little white pustules about like pimples just in the area.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: hospitalized with Guillian-barre syndrome
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling
Clinical narrative: the next day experienced redness and swelling in upper left arm and enlargement of lymph nodes under left arm and in left side of neck; the next day experienced redness and swelling in upper left arm and enlargement of lymph nodes under left arm and in left side of neck; Enlargement of lymph nodes under left arm and in left side of neck; This is a spontaneous report from a contactable nurse. This report was received via a sales representative.  A 4-decade-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration from an unspecified date to an unspecified date at UNK for immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The next day following vaccination, the patient experienced redness and swelling in upper left arm and enlargement of lymph nodes under left arm and in left side of neck.  The outcome of all events were not recovered.  The action taken in response to the event(s) for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: pt was given PCV23 today thinking it was 1st ever.  Both provider and assistant had checked chart and Alert and no PCV23 seen. After shot given found in chart PCV23 was given 8/2011
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Pain in extremity
Clinical narrative: Patient is still having arm soreness as of 1/7/20 and have trouble using it like driving. She will see orthopedic md 1/9/20
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Condition aggravated, Cyclic vomiting syndrome, Diarrhoea
Clinical narrative: The day after receiving the vaccine she developed cyclical vomiting, diarrhea, headache, weakness, fatigue, chills and brain fog. The vomiting ceased later in the day and her other symptoms have steadily improved. She is also experiencing palpitations at night but they have been improving. She also had an outbreak of her gential herpes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Genital herpes, Headache, Palpitations
Clinical narrative: The day after receiving the vaccine she developed cyclical vomiting, diarrhea, headache, weakness, fatigue, chills and brain fog. The vomiting ceased later in the day and her other symptoms have steadily improved. She is also experiencing palpitations at night but they have been improving. She also had an outbreak of her gential herpes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain
Clinical narrative: LETHARGIC SHIVERING BODY ACHES
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site mass, Insomnia, Lip swelling
Clinical narrative: Immediately upon administration on 1/5/2020, a lump formed at the site and patient felt she was bruised.  She suffered from insomnia that night due to the pain in her arm, and developed nausea on 1/6/2020.  On the night of 1/7/2020, her lip felt tight and developed into swelling on 1/8/2020.  Patient called the pharmacy on 1/8/2020 to report this new development.  She was counseled on signs and symptoms of allergic reaction and OTC treatment options.  She had diphenhydramine tablets on hand but was concerned about drowsiness AE as she was at work when she called.  She was told she can call her doctor or the pharmacy if she has any follow-up questions or concerns.  As of the conversation on 1/8/2020, she was declining calling the doctor or taking a Benadryl tablet at that moment for fear of side effects but knowing the dosing to take once she was ready to take it.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Immediately upon administration on 1/5/2020, a lump formed at the site and patient felt she was bruised.  She suffered from insomnia that night due to the pain in her arm, and developed nausea on 1/6/2020.  On the night of 1/7/2020, her lip felt tight and developed into swelling on 1/8/2020.  Patient called the pharmacy on 1/8/2020 to report this new development.  She was counseled on signs and symptoms of allergic reaction and OTC treatment options.  She had diphenhydramine tablets on hand but was concerned about drowsiness AE as she was at work when she called.  She was told she can call her doctor or the pharmacy if she has any follow-up questions or concerns.  As of the conversation on 1/8/2020, she was declining calling the doctor or taking a Benadryl tablet at that moment for fear of side effects but knowing the dosing to take once she was ready to take it.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 3in area of pink with diffuse border, very mild swelling at site of Kinrix injection: dx-> Localized Rxn LA
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Received vaccines on 1/3/2020 afternoon. Woke up on 1/4/2020 with left leg swollen around injection site. Warm to touch. Mom placed ice pack. Swelling did come down that day. Seen on 1/6/2020 by physician. No infection was seen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left thigh with 20cm by 14cm redness moderate swelling, hard to touch, tender in office today 11/8/2020.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On right deltoid area there is and area of redness is oval shape of 4cm x 5cm. It is slightly warm to touch. Patient denies pain. He endorses slight itch
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian-Barre See medical record attached.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm redness/swelling/pain
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Influenza, Mobility decreased, Nausea
Clinical narrative: Day #1 4hrs arm pain/fever, chills, nausea could not lift arm, up all night night sweats  Day #2 Flu sx arm pain Day #3-Improving/sore arm Day #4- Day #5 feeling better/arm swollen (+) Heat (+) Erythema
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Day #1 4hrs arm pain/fever, chills, nausea could not lift arm, up all night night sweats  Day #2 Flu sx arm pain Day #3-Improving/sore arm Day #4- Day #5 feeling better/arm swollen (+) Heat (+) Erythema
Sex: M
Vaccine: FLUN3
Symptoms: Anxiety, Infection via vaccinee, Influenza like illness, Obsessive-compulsive disorder, Oropharyngeal pain
Clinical narrative: SORE THROAT; ANXIOUS MOOD; RASH; INFECTION VIA VACCINEE; OBSESSIVE-COMPULSIVE DISORDER; PANDAS SYMPTOMS DEVELOPED SOON AFTER SCARLET FEVER; SCARLET FEVER; FLU LIKE SYMPTOMS; Flu like symptons; A spontaneous report has been received from a consumer via the regulatory authority concerning a 5 year old male patient with height of 120 centimeters and with weight of 19 kilograms.    No medical history was reported. No concomitant products were reported.    On 11-Oct-2015, the patient was administered with Fluenz (influenza vaccine (live, attenuated)), via nasal route.     On 15-Oct-2015, the patient experienced flu like symptoms (preferred term: Influenza like illness). On 21-Oct-2015, the patient experienced scarlet fever (preferred term: Scarlet fever).   On an unknown date, the patient experienced obsessive-compulsive disorder (preferred term: Obsessive-compulsive disorder), pandas symptoms developed soon after scarlet fever (preferred term: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection), sore throat (preferred term: Oropharyngeal pain), anxious mood (preferred term: Anxiety), infection via vaccinee (preferred term: Infection via vaccinee) and rash (preferred term: Rash).     The patient recovered from the event of flu like symptoms after 6 days on 21-Oct-2015. The patient recovered with sequelae from the event of scarlet fever after 1 month on 30-Nov-2015. At the time of reporting, the event of pandas symptoms developed soon after scarlet fever was ongoing. The outcome of the events of obsessive-compulsive disorder, sore throat, anxious mood, rash and infection via vaccinee was unknown.     The events were considered serious (disability and important medical event) by the reporter.; Sender's Comments: Obsessive-compulsive disorder (OCD), Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS), Influenza like illness, Scarlet fever, Oropharyngeal pain, Anxiety, Infection via vaccinee are not listed events in the company core data sheet for Fluenz Tetra. Young age and Infection via vaccinee could be a risk factor for scarlet fever, which could explain the development of influenza like illness with oropharyngeal pain and the development of PANDAS with subsequent OCD and anxiety. Due to missing information on more details of the Infection via vaccinee, complete etiologic and diagnostic workup, medical history, comorbidities and concomitant drugs it is not possible to make a conclusive assessment of the causal relationship of Infection via vaccinee and suspect drug.
Sex: M
Vaccine: FLUN3
Symptoms: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Rash, Scarlet fever
Clinical narrative: SORE THROAT; ANXIOUS MOOD; RASH; INFECTION VIA VACCINEE; OBSESSIVE-COMPULSIVE DISORDER; PANDAS SYMPTOMS DEVELOPED SOON AFTER SCARLET FEVER; SCARLET FEVER; FLU LIKE SYMPTOMS; Flu like symptons; A spontaneous report has been received from a consumer via the regulatory authority concerning a 5 year old male patient with height of 120 centimeters and with weight of 19 kilograms.    No medical history was reported. No concomitant products were reported.    On 11-Oct-2015, the patient was administered with Fluenz (influenza vaccine (live, attenuated)), via nasal route.     On 15-Oct-2015, the patient experienced flu like symptoms (preferred term: Influenza like illness). On 21-Oct-2015, the patient experienced scarlet fever (preferred term: Scarlet fever).   On an unknown date, the patient experienced obsessive-compulsive disorder (preferred term: Obsessive-compulsive disorder), pandas symptoms developed soon after scarlet fever (preferred term: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection), sore throat (preferred term: Oropharyngeal pain), anxious mood (preferred term: Anxiety), infection via vaccinee (preferred term: Infection via vaccinee) and rash (preferred term: Rash).     The patient recovered from the event of flu like symptoms after 6 days on 21-Oct-2015. The patient recovered with sequelae from the event of scarlet fever after 1 month on 30-Nov-2015. At the time of reporting, the event of pandas symptoms developed soon after scarlet fever was ongoing. The outcome of the events of obsessive-compulsive disorder, sore throat, anxious mood, rash and infection via vaccinee was unknown.     The events were considered serious (disability and important medical event) by the reporter.; Sender's Comments: Obsessive-compulsive disorder (OCD), Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS), Influenza like illness, Scarlet fever, Oropharyngeal pain, Anxiety, Infection via vaccinee are not listed events in the company core data sheet for Fluenz Tetra. Young age and Infection via vaccinee could be a risk factor for scarlet fever, which could explain the development of influenza like illness with oropharyngeal pain and the development of PANDAS with subsequent OCD and anxiety. Due to missing information on more details of the Infection via vaccinee, complete etiologic and diagnostic workup, medical history, comorbidities and concomitant drugs it is not possible to make a conclusive assessment of the causal relationship of Infection via vaccinee and suspect drug.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: second dose was given two weeks later after the first dose of the Fluzone-no ae; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 18 months old patient who received second dose, two weeks later after the first dose (inappropriate schedule of product administration) of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE  two weeks later after the first dose[lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of product administration.  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.  Information on the batch number was requested.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone Quadrivalent was administered to a 2 month old, no AE; Initial information received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2 months old male patient was vaccinated with a 0.5 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA, expiry date: 30-Jun-2020) via intramuscular route in the right vastus lateralis on 31-Dec-2019.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation on 31-Dec-2019.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired IPOL vaccine was administered/no AE; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional in the.  This case was linked to 2020SA002276 (via same reporter).  It was reported that 4 years old female patient received expired Ipol vaccine /no AE(expired product administered) of vaccine IPV (VERO) [IPOL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Jan-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) lot N1K921M via unknown route in the left deltoid.  It was actual medication error due to expired vaccine used.  It was also a case of off label use as it was prescribed by Medical Doctor.  At the time of this 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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired IPOL vaccine was administered/no AE; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to 2020SA002268 (via same reporter).  It was reported that 6 years old female patient received expired Ipol vaccine /no AE(expired product administered) of vaccine IPV (VERO) [IPOL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Jan-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) lot N1K921M via unknown route in the left deltoid.  It was actual medication error due to expired vaccine used.  It was also a case of off label use as it was prescribed by Medical Doctor.  At the time of this 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 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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: one diluent was remaining in a box of ActHib and assumes the powder half of the dose had been given to a patient with sterile water instead, no adverse event; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002811, 2020SA002812 and 2020SA002456 (same reporter).  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] on 20-Dec-2019, (lot number UJ175AAA and expiration date 26-Nov-2020), other dosing details were not reported.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution as Act-HIB was accidentally mixed with sterile water instead of the diluent that came with product and had been administered to the patient.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: she cannot raise her arm more than 45 degrees, it is also painful to touch.; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 69 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and reported she cannot raise her arm more than 45 degrees, it is also painful to touch(Pain in extremity).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Nov-2019, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1951 via intramuscular route in the left arm.  On 02-JAN-2020, the patient cannot raise her arm more than 45 degrees, it is also painful to touch(pain in extremity) 1 month 15 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was also reported that she received vaccine over a month ago, the next day she could not lift her arm due to pain.  No lab data was reported.  Final diagnosis was pain in extremity.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient outcome was Not Recovered from the event.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: accidentally mixed ActHIB with sterile water instead of the diluent/no AE; Initial information was received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002455, 2020SA002811, 2020SA002812, 2020SA004004, 2020SA004004 and 2020SA002456 (same reporter).  This case involves a 3 month old patient who received HIB (PRP/T) VACCINE [ACT-HIB] which mixed with sterile water instead of the diluent.  Medical history, medical treatment, vaccination and family history were not provided.  On 17-Dec-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AAA, expiry date- 26-11-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: accidentally mixed ActHIB with sterile  water instead of the diluent/No AE; Initial information was received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002811, 2020SA002455, 2020SA002456 and 2020SA004004 (same reporter).  This case involves a patient of an unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB] which mixed with sterile water instead of the diluent.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AAA, expiry date- 26-11-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Pentacel described as the ActHIB portion being reconstituted with sterile water 0.5 mL and the DTap-IPV portion not administered; Initial information received on 03-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that Pentacel described as the Act-Hib portion being reconstituted with sterile water 0.5 ml and the DTaP-IPV portion not administered (product preparation issue). Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 03-Jan-2020, the patient received a third dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse event at the time of reporting.  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.  Information on the batch number was requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Zostavax given to patient in pharmacy (info below) back in 11/2019. Pt stated she got a 4cm lump with redness & heat at site. pt states very painful at times. Pt is here today 1-8-20 for apt & still has redness and palpable lump at same site.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Administration error, client was administered diluent component of Menveo before reconstitution with vaccine component occurred.  Client did not receive vaccine as intended.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: It was noted that the pharmacy had an extra adjuvant in stock and so we gathered that a diluent was used in combination with the antigen.  It was incorrectly reconstituted
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring normal, Cervical vertebral fracture, Echocardiogram normal, Glomerular filtration rate normal
Clinical narrative: Sudden loss of consciousness, Syncope event.  Occurred while on bicycle resulting in accident and neck fracture. Surgery and hospitalization.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Positron emission tomogram normal, Road traffic accident, Scan myocardial perfusion normal, Surgery
Clinical narrative: Sudden loss of consciousness, Syncope event.  Occurred while on bicycle resulting in accident and neck fracture. Surgery and hospitalization.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Sudden loss of consciousness, Syncope event.  Occurred while on bicycle resulting in accident and neck fracture. Surgery and hospitalization.