chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old male receiving Flublok Quadrivalent in error; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and reported that 10 year old male receiving Flublok Quadrivalent in error (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 04-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1924 via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: decreased range of motion two weeks post Flublok injection; left arm soreness; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an 89 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and experienced left arm soreness (musculoskeletal pain) and decreased range of motion two weeks post Flublok injection (mobility decreased).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 23-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  On an unknown date, following the vaccination the patient experienced left arm soreness (musculoskeletal pain) and decreased range of motion two weeks post Flublok injection (mobility decreased).  (Other relevant tests included no lab data.)  Final diagnosis was mobility decreased and shoulder soreness.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 32 months old male patient received a dose of Flublok Quadrivalent vaccine, No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA277265 (same reporter).  This case involves a 32 months old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1903 via intramuscular route in the left deltoid on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  Flu clinic visit on 03-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a eight years old female patient received a 0.5 ml dose of Flublok Quadrivalent, No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a eight years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QSAA1908, expiry date: 24-May-2020 via intramuscular route in the left deltoid on 30-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, 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.  List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a five years old female patient received a 0.5 ml dose of Flublok Quadrivalent, No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA277241 (same reporter).  This case involves a five years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QSAA1903, expiry date: 19-May-2020 via intramuscular route in the left deltoid on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  Flu clinic visit on 03-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event, Allergy to metals
Clinical narrative: allergic to mercury; adverse event NOS; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient (age unknown) who experienced allergic to mercury (allergy to metals) and adverse event nos (adverse event), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious allergic to mercury (allergy to metals) and adverse event nos (adverse event) (Unknown latency) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was adverse event nos and allergic to mercury.  It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for allergic to mercury and adverse event nos.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given Fluzone High Dose vaccination that was already expired, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA278111 (same reporter).  This case involves 77 years male patient who received 0.5 ml dose (4th dose) of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI995AB, expiry date: 01-Apr-2019) via intramuscular route in the right arm on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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.  List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given Fluzone High Dose vaccination that was already expired, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA278105 (same reporter).  This case involves 70 years male patient who received 0.5 ml dose (4th dose) of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI995AB, expiry date: 01-Apr-2019) via intramuscular route in the left arm on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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.  List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscle tightness, Paraesthesia oral
Clinical narrative: Left deltoid swollen, redden, burning, and tightness at back of upper arm. C/o of tingling lips, rash at lower left arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Left deltoid swollen, redden, burning, and tightness at back of upper arm. C/o of tingling lips, rash at lower left arm.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient has right are redness/swelling with a red ring at the injection site. Patient is treated with OTC Tylenol and ibuprofen for swelling and pain Q8H. Patient will be pre-medicated prior to next Gardasil vaccine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See: #2-4-5-6-8
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain (L) upper entire arm, swelling, Pink and warm after vaccines Did not improve with Ibuprofen
Age: 66.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient reports pain and swelling at injection site. He also reports a "burning" rash on right upper arm.
Age: 43.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: received flu and a TDAP and noticed red spots 10/8/19 received shot 10/7/19 no fever all over back & chest and stomach hives
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Chills, Diarrhoea, Feeling hot, Gastric disorder
Clinical narrative: On Jan 3 I had a pneumonia shot, vaccine 23. With in 3 hour I had trouble with pain in my legs, warming feeling. Shot was given in my left arm. Pain started in right arm, proceeded around to the top of my neck down my left arm. Pain was so bad that I could not have my blood pressure taken. Had diarrhea and Dr. put me on the BRAT diet. I was on this for 3 weeks and lost 10 lbs. right away. Finally pain subsided in three weeks and I was able to function pretty well still have a little numbness down my right arm. Still had problems with stomach. Dr. prescribed Famotidine. After taking one pill I was shaking with chills and the symptom of the shot returned. Soarness in left arm where shot was given and pain in the back of the neck. After a month I am pain free. However I am afraid to take any drug? The Dr say I am allergic to pneumovax and I should never have the shot again. Amen. How long will this drug remain in my body?
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site pain, Laboratory test normal, Neck pain, Pain in extremity
Clinical narrative: On Jan 3 I had a pneumonia shot, vaccine 23. With in 3 hour I had trouble with pain in my legs, warming feeling. Shot was given in my left arm. Pain started in right arm, proceeded around to the top of my neck down my left arm. Pain was so bad that I could not have my blood pressure taken. Had diarrhea and Dr. put me on the BRAT diet. I was on this for 3 weeks and lost 10 lbs. right away. Finally pain subsided in three weeks and I was able to function pretty well still have a little numbness down my right arm. Still had problems with stomach. Dr. prescribed Famotidine. After taking one pill I was shaking with chills and the symptom of the shot returned. Soarness in left arm where shot was given and pain in the back of the neck. After a month I am pain free. However I am afraid to take any drug? The Dr say I am allergic to pneumovax and I should never have the shot again. Amen. How long will this drug remain in my body?
Sex: F
Vaccine: PPV
Symptoms: Tremor, Weight decreased
Clinical narrative: On Jan 3 I had a pneumonia shot, vaccine 23. With in 3 hour I had trouble with pain in my legs, warming feeling. Shot was given in my left arm. Pain started in right arm, proceeded around to the top of my neck down my left arm. Pain was so bad that I could not have my blood pressure taken. Had diarrhea and Dr. put me on the BRAT diet. I was on this for 3 weeks and lost 10 lbs. right away. Finally pain subsided in three weeks and I was able to function pretty well still have a little numbness down my right arm. Still had problems with stomach. Dr. prescribed Famotidine. After taking one pill I was shaking with chills and the symptom of the shot returned. Soarness in left arm where shot was given and pain in the back of the neck. After a month I am pain free. However I am afraid to take any drug? The Dr say I am allergic to pneumovax and I should never have the shot again. Amen. How long will this drug remain in my body?
Sex: F
Vaccine: FLU4
Symptoms: Ear disorder, Headache, Influenza, Myalgia, Oropharyngeal discomfort
Clinical narrative: Side effects of flu shot. Muscle aches, headache, flu symptoms: ears and throat.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, C-reactive protein, Dizziness, Fatigue
Clinical narrative: Acute headache, joint aches and pains, fever (100.8), fatigue, dizziness, weakness
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Metabolic function test, Pain, Pyrexia
Clinical narrative: Acute headache, joint aches and pains, fever (100.8), fatigue, dizziness, weakness
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Acute headache, joint aches and pains, fever (100.8), fatigue, dizziness, weakness
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Red, warm to touch welp, grows bigger in size every day, under & to the right of injection site, painful to touch. Injection site is red, as well.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Arthralgia, Arthritis, Chills, Fatigue, Urticaria
Clinical narrative: Pt. broke out in hives all over back arms chest /body for almost 5 days had fatigue as well slept most of the day. Wasn't raised looked like a rash, joints sore/inflammed/chills
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Burning sensation, Erythema, Injection site bruising, Pain, Pain in extremity
Clinical narrative: Itch and burning sensation on left arm, and bruise at injection site.  Left arm has redish/pink color, with several small bumps, and dull aching pain.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Pruritus, Rash
Clinical narrative: Itch and burning sensation on left arm, and bruise at injection site.  Left arm has redish/pink color, with several small bumps, and dull aching pain.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: pt had a circular area of redness and mild inflammation that was warm to the touch around the injection site.  the area was described by pt to be the size of a plum and itchy.  she used benadryl otc and applied cold pack.  area was much better the next day according to phone conversation with patient.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Peripheral swelling, Rash erythematous, Rash macular, Skin warm
Clinical narrative: Next morning - limited arm movement, swollen arm down to elbow, warm to touch, red blotchy rash
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Pt received 2nd dose of Gardasil vaccine on 9/20/19. Reports swelling on LUE at site of Gardasil vaccine that appeared a couple days after 2nd dose- swelling has not gone down  +pain with palpation- tolerable, unable to give number on pain scale  very faint ecchymosis present at site of injection on LUE- see photo  ~1.5 cm nodule palpated, non fluctuant, no drainage, no erythema present
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Myalgia, Pain
Clinical narrative: Severe muscle aches spreading from right arm to neck, chest/back area and back of head (including headache).  Aching, fever and chills  lasting approximately 12 hours.  Attempted to sleep for entire day and following night.  Symptoms nearly 100% gone the next morning (08/11/2019)
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe muscle aches spreading from right arm to neck, chest/back area and back of head (including headache).  Aching, fever and chills  lasting approximately 12 hours.  Attempted to sleep for entire day and following night.  Symptoms nearly 100% gone the next morning (08/11/2019)
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, headache, chills, nausea, arm pain
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Hypersensitivity, Induration, Pruritus
Clinical narrative: Patient had red area that she described as little  harder than usual that was itchy.  Patient was counseled that she could take Benadryl to help with the allergic reaction.
Age: 67.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: pt states having  arm/shoulder pain
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Great grandson reported issue at approximately 6:30 pm. Extreme pain in the arm, could not lift arm. Still cannot lift arm 24+ hour later. Weak. Dizzy. Nauseous.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pruritus, Erythema, Immediate post-injection reaction, Oropharyngeal pain
Clinical narrative: left arm is reddened area 55m x 55 mm states ears are itchy + throat is sore. redness - immediate ears +throat - 24 hours later
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Mobility decreased
Clinical narrative: Patient claims to have started having pain and limited mobility in his right shoulder after receiving shot in his upper deltoid.  He feels like the joint may have been impacted during vaccination but the pain never became worse or strong enough for him to seek medical treatment.  He said that the mobility and pain have slowly become less and less severe but still does have some soreness in the joint 3 weeks later but still does not feel that medical treatment is currently necessary.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: fever, chills, nausea. the injection site and the entire upper arm was red, warm and she was diagnosed with cellulitis.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: fever, chills, nausea. the injection site and the entire upper arm was red, warm and she was diagnosed with cellulitis.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: at about 8:00pm last evening patient reports her arm began to hurt.  she went to bed around 10pm and woke up around 5:30am with a terrible headache and nausea.  She called her daughter who came over and took her the ER.  The ER gave her IV pain meds and a lidocaine patch on her arm.  Today when I spoke with patient at 1:25pm she still had a pretty bad headache.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Polymerase chain reaction, Vomiting
Clinical narrative: Vomited 20 times in <12 hours, 5-6 episodes diarrhea so far
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Pt received injection from pharmacy on Wednesday evening - she developed rash around injection site - fever + chills. Today she came in and the redness and swelling was baseball size around injection site.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Peripheral swelling, Swelling, Vomiting
Clinical narrative: Diffuse swelling & myalgias LUE, L chest, L breast vomiting x 1
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Defaecation urgency, Diarrhoea, Dizziness, Nausea
Clinical narrative: woke with nausea and vomiting day after vaccine administered, also with dizziness, chills, and loose/urgent stools. pt declined prescription anti-nausea medication, recommended hydration and otc anti-nausea meds as needed and to monitor symptoms a this time
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: woke with nausea and vomiting day after vaccine administered, also with dizziness, chills, and loose/urgent stools. pt declined prescription anti-nausea medication, recommended hydration and otc anti-nausea meds as needed and to monitor symptoms a this time
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Feeling hot, Headache, Myalgia
Clinical narrative: Chills, Internal Hot feelings, Fever, Headache, Muscle Aches, Bruising, Red Dot the evening of.  Instructed to take OTC Tylenol and to monitor the area, instructed to see PCP if symptoms worsened.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Chills, Internal Hot feelings, Fever, Headache, Muscle Aches, Bruising, Red Dot the evening of.  Instructed to take OTC Tylenol and to monitor the area, instructed to see PCP if symptoms worsened.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Blister rupture, Pruritus, Secretion discharge, Skin lesion
Clinical narrative: Reaction started two days later in the morning. Initially it showed up "as a large mosquito bite". Then more appeared, eventually totaling approximately 15 total. The center of the "lesion" had a "little bubble" in the center of it and when it broke open, a sticky exudate came out. They were extremely itchy. She was treated with a course of Prednisone starting the following Wednesday. That's when the itching stopped.  She still has lesions that have not completely gone away yet.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: I noticed pain in my arm as I was leaving the park lot.  My arm began to swell withing the first two hours after getting the vacine.  My arm was red and swollen down to the elbow.  It itched for a week.  It stayed swollen for 4-5 days.  I had to take benadryl the first night so it would stop swelling and hurting.  I sent a picture of my arm to nurse on site at clinic.  She told me it was a bad reaction and needed to be reported.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Giving IM instead of Subq.  CDC department determined vaccine valid.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness and pain at injection site about an hour or more after receiving injection.  Then she noticed a black and blue appeared and a red band appeared across her upper arm. By the next day the redness eventually spread to  under her arm pit. She came into the pharmacy to tell us and she was advised to see the clinic doctor immediately.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pyrexia, Tremor
Clinical narrative: Five hours after the high-dose flu shot, I developed shaking chills and a fever. This has been followed by a flu-like illness that is still active 10 days later.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Erythema
Clinical narrative: Erythema and ecchymosis distal to the deltoid muscle along the anterior upper arm
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: severe itching for two weeks
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Fluzone High- Dose was given instead of Fluarix Quadrivalent.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain, heat, redness & swelling in left arm.  Headache from 3:00 to 8 :00 p.m..  Woke the next day with arm still swollen and painful to the touch.
Age: 74.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Mobility decreased, Musculoskeletal pain, Swelling
Clinical narrative: Shoulder pain, swollen and red. Could not raise arm.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Contusion, Inflammation, Pain, Skin discolouration
Clinical narrative: Inflammation, pain, the area got purple/brown (similar to a bruise from a hit). Patient put ice on and then a water bubble sprout (it is understood that it was because of the ice). The patient sent to the ER on 10/11/2019 @ 11:30am where they administered silvadene and benadryl. The discharge instructions were to continue with silvadene.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Pain in extremity, Skin warm
Clinical narrative: Pain in (R) arm from shoulder to fingers. Red area, warm to touch.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cold sweat, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Patient called on 10/10/19, then came in to pharmacy. Severe and significant redness and swelling over entire bicep and tricep area reaching down to elbow from injection site. Patient reported radiating pain, high heat, fever, chills and feeling very clammy. Advised patient to go to clinic or urgent care. Also to take ibuprofen and use a cool pack. Pt states he has no PCP
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient called on 10/10/19, then came in to pharmacy. Severe and significant redness and swelling over entire bicep and tricep area reaching down to elbow from injection site. Patient reported radiating pain, high heat, fever, chills and feeling very clammy. Advised patient to go to clinic or urgent care. Also to take ibuprofen and use a cool pack. Pt states he has no PCP
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: his physician is recommending that be takes SHINGREX. After already having had ZOSTAVAX 3 or 4 years ago; his physician is recommending that be takes SHINGREX. After already having had ZOSTAVAX 3 or 4 years ago; This spontaneous report was received from a male patient of unknown age who was reporting on theirself. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On an unknown date in approximately 2016, 3 or 4 years ago, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported). The patient stated that his physician recommended to administer zoster rge vaccine (mammalian) (SHINGRIX), reported as SHINGREX, although he had already administered a dose of zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a nurse regarding a 59-year-old patient with unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported. On 07-OCT-2019, the patient received first dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, lot # R031812 and expiration date: 26-SEP-2020 (dose and anatomical location were unknown) intramuscularly for prophylaxis (product storage error). The temperature excursions were reported as 28.2 Fahrenheit for 22 hours and 32 minutes, 28.6 Fahrenheit for 6 hours and 54 minutes, 28.8 Fahrenheit for 23 hours and 2 minutes, 30.4 Fahrenheit for 6 hours and 36 minutes and 51.6 Fahrenheit for 1 hour and 3 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects reported. No product complaints (PQC) were involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; recieved improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.   On 23-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078 and expiration date: 19-FEB-2021) or (lot # R019237 and expiration date: 04-JUL-2020) for prophylaxis (strength, dose, unit, route and anatomical location was not reported). The vaccine was reconstituted with properly stored sterile diluent. It was unknown that which lot # of varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) of both lots experienced temperature excursion between -14ºC to 10ºC (-9.74ºC) for an unknown time frame (product storage error). There was no previous temperature excursion. The call was due to digital data logger. No adverse effect was reported. The outcome of product storage error was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; reconstitued with expired sterile diluent; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, drug allergy/reaction, medical history was not reported.  On 09-OCT-2019, the patient was administered with a dose of expired sterile diluent(STERILE DILUENT), (lot # N015479, expiry date: 23-JUL-2019) which was reconstituted with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, frequency, route, anatomical location was not reported) for prophylaxis (expired product administered). No adverse event was reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vaccine in use; This spontaneous report was received from a registered nurse refers regarding a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were unknown. The patient's concomitant therapy included sterile diluent. On 20-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (therapy type: digital data logger) (dose, frequency, anatomical location were unknown) (lot # S005078 and expiration date: 19-FEB-2021 or lot # R019237 and expiration date: 04-JUL-2020) ) for prophylaxis (Product storage error).  It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion in the range -14 degree Celsius to - 10 degree Celsius (-9.4 degree Celsius) as recorded by a data logger. The time frame was unknown. The vaccines had no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; received improperly stored varivax; This spontaneous report as received from a nurse refers to a patient of demographics. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 20-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with expiration date: 04-JUL-2020 or lot # S005078 with expiration date: 19-FEB-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent. The vaccines exposed to a temperature of  -14 degree celsius to -10 degree Celsius (-9.74 degree celsius). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Details     Site  Arm Upper, Left   Route  --    Dose  0.5   Unit  mL    Lot Number  K72SN   Expiration Date  JUN 30, 2020    Manufacturer  GlaxoSmithKline Biologicals
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Erythema, Injection site pain, Pruritus
Clinical narrative: PATIENT STARTED HAVING LOCAL INJECTION SITE PAIN SHORTLY AFTER RECEIVING THE SHOT . AFTER FEW HOURS, HER JOINTS AND BONES STARTED HURTING ALL NIGHT LONG . HER SHOULDER GOT REDDER AND HOTTER AND ON THE 6TH , SHE SAW SHINGLES LIKE RED SPOTS AND STARTED FEELING ITCHY  FROM ARM TO ELBOW AND THEN HER LEFT BREAST. AFTER 4 DAYS SHE STARTED FEELING BETTER AND IS FREE OF SYMPTOMS NOW.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin warm
Clinical narrative: PATIENT STARTED HAVING LOCAL INJECTION SITE PAIN SHORTLY AFTER RECEIVING THE SHOT . AFTER FEW HOURS, HER JOINTS AND BONES STARTED HURTING ALL NIGHT LONG . HER SHOULDER GOT REDDER AND HOTTER AND ON THE 6TH , SHE SAW SHINGLES LIKE RED SPOTS AND STARTED FEELING ITCHY  FROM ARM TO ELBOW AND THEN HER LEFT BREAST. AFTER 4 DAYS SHE STARTED FEELING BETTER AND IS FREE OF SYMPTOMS NOW.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Right arm began to swell, redness, and pain at site of Pneumovax 23 injection (left deltoid) with in 4 hours of injection. By next morning skin from left ear to left elbow was red, sensitive to touch,  hot, swollen, and patient had several moments of general fever. Patient self treated acetaminophen 1000mg about every 8 hours along with ice on the affected shoulder. 48 hours later - reduction in reaction symptoms but still notable swelling, some redness and pain.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Sensitive skin, Skin warm, Swelling
Clinical narrative: Right arm began to swell, redness, and pain at site of Pneumovax 23 injection (left deltoid) with in 4 hours of injection. By next morning skin from left ear to left elbow was red, sensitive to touch,  hot, swollen, and patient had several moments of general fever. Patient self treated acetaminophen 1000mg about every 8 hours along with ice on the affected shoulder. 48 hours later - reduction in reaction symptoms but still notable swelling, some redness and pain.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: They gave my mother her Shingrix SQ rather than IM in her left arm.  Her arm is bright red, swollen, and very warm to touch.  It is also very painful.  She was told to use cold/warm presses and take Tylenol.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: IMMEDIATELY AFTER RECEIVING PREVNAR VACCINE, RT BECAME VERY RED AND SWOLLEN. AREA DID BLEED AND SOME BRUISING NOTED. 7X7 CM AREA OF REDNESS OVER RIGHT THIGH.  ICE PACK WAS APPLIED IN OFFICE
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Patient started experiencing severe muscle pain and limited mobility of the left arm the evening after she received the flu vaccine. Patient is still experiencing these symptoms and is receiving steroid injections and physical therapy at this time to help treat symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Culture throat negative, Dyskinesia, Streptococcus test negative, Tic
Clinical narrative: New onset tic, turning head to side
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: developed hives 5 days after receiving vaccination
Age: 0.83
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Patient reports in left arm around the injection site a 4" diameter red spot, warm to the touch and swollen. In addition she has felt fevered/sweats, headache and nausea. She complains of "not feeling herself".    Patient called doctors office who instructed her to take ibuprofen and benadyl. If fever reoccurred or persisted then to go to urgent care with it being a Friday
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Patient reports in left arm around the injection site a 4" diameter red spot, warm to the touch and swollen. In addition she has felt fevered/sweats, headache and nausea. She complains of "not feeling herself".    Patient called doctors office who instructed her to take ibuprofen and benadyl. If fever reoccurred or persisted then to go to urgent care with it being a Friday
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Septic screen, Serum sickness-like reaction, Urticaria
Clinical narrative: Presented 2 weeks after the vaccination with evolving urticarial rash and low grade fever consistent with Serum sickness like reaction. He is currently in the hospital as an inpatient under monitoring.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Pyrexia, Rash, Urticaria
Clinical narrative: Presented 2 weeks after the vaccination with evolving urticarial rash and low grade fever consistent with Serum sickness like reaction. He is currently in the hospital as an inpatient under monitoring.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Had itchy rash that appeared on her arm of the injection site, which proceeded to spread to both arms and back. Nurse Supervisor gave Benadryl and that stop the symptoms. No other complications
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Swelling, itching, redness (question possible hives) under bilateral axillae. No treatment. Outcome: fading rash over 3 weeks slowly.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: fever, chills, severe pain in left arm and entire left upper side of body, including trunk and neck; headache, nausea
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever, chills, severe pain in left arm and entire left upper side of body, including trunk and neck; headache, nausea
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: none
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: fever 101.5 at peak coughing lasting a week sweating chills fatigue loss of appetite
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: fever 101.5 at peak coughing lasting a week sweating chills fatigue loss of appetite
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site swelling, Pain, Pallor, Paraesthesia
Clinical narrative: Approximately 2 hours post injection began to experience swelling  with numbness from Humeral head area to mid radial shaft of left arm. Palmar surface of left hand showed pallor with  reports of coolness. Fingers tingling. No decrease in range of movement.  Symptoms started to resolve by mid afternoon and improved gradually last evening last evening Today site appears normal, no numbness at present. Reports residual ache which is relieved by NSAID.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral coldness
Clinical narrative: Approximately 2 hours post injection began to experience swelling  with numbness from Humeral head area to mid radial shaft of left arm. Palmar surface of left hand showed pallor with  reports of coolness. Fingers tingling. No decrease in range of movement.  Symptoms started to resolve by mid afternoon and improved gradually last evening last evening Today site appears normal, no numbness at present. Reports residual ache which is relieved by NSAID.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and increased pain occurred anteriorly and inferiorly to the injection site, and these symptoms started about 1 day after the shot.  They worsened over next 24 hours, and I was able to observe this by comparing picture from yesterday to his arm today in clinic. I diagnosed him with cellulitis.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Pt experiencing chills, nausea, muscle aches, couldn't finish lunch after flu shot due to nausea. I advised her that these can be possible side effects of flu shot, but to go to urgent care if symptoms worsen. Pt came back to pharmacy a week later after dr's visit to report that she had had to go to emergency room with fever of 100.3F four hours after flu shot, was given Levaquin and fluids overnight. Had marked no fever on the consent form at the time of the flu shot. Diagnosis still unknown. Possible reaction to the flu shot.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Throat tightness
Clinical narrative: The patient experienced tightness in her through, difficulty breathing, and dizziness.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: none
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Fatigue, Hypoaesthesia oral, Rhinorrhoea
Clinical narrative: tongue swelling, tongue numbness, shortness of breath, fatigue, weakness, rhinorrhea
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: tongue swelling, tongue numbness, shortness of breath, fatigue, weakness, rhinorrhea
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Joint swelling, Pruritus, Rash
Clinical narrative: serum sickness 5-6 days later. Chills, tender swollen joints, beefy red rash covers his torso. Some itching. Seen today and started on prednisone and clariten and pepcid
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Serum sickness
Clinical narrative: serum sickness 5-6 days later. Chills, tender swollen joints, beefy red rash covers his torso. Some itching. Seen today and started on prednisone and clariten and pepcid
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, X-ray
Clinical narrative: Received flu shot very high in my arm, told the pharmacist that the injection hurt unusually and pinched a lot. In days to follow I started to experience a great deal of pain and started to lose range of motion in my arm. Currently I am still experiencing a great deal of pain and have lost range of motion, I keep my arm to my side throughout the day and limit movement. I have seen an orthopedic specialist and am scheduled for MRI.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site urticaria
Clinical narrative: Erythematous wheals / hive outside of injection site at the posterior left shoulder and bruising noted to left upper inner arm.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Joint swelling, Magnetic resonance imaging, Musculoskeletal pain
Clinical narrative: Severe shoulder pain 4 hours post-injection, limited range of motion continuously after 10 days, swelling of shoulder joint
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, Ear congestion, Full blood count, Injection site pain, Magnetic resonance imaging
Clinical narrative: PAIN AT THE INJECTION SITE FOR 3 DAYS. AURAL FULLNESS. TINNITTIS.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Tinnitus, Urine analysis
Clinical narrative: PAIN AT THE INJECTION SITE FOR 3 DAYS. AURAL FULLNESS. TINNITTIS.
Age: 84.0
Sex: M
Vaccine: FLU3, HEPA, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness below the elbow
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Pt stated her arm became swollen and lasted several days. She applied allergy cream and it went away.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site paraesthesia, Injection site swelling
Clinical narrative: Pt stated her arm became swollen and lasted several days. She applied allergy cream and it went away.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient complained of left deltoid pain that occurred some time after his injection and decreased ROM
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nodule, Peripheral swelling, Rash, Skin warm
Clinical narrative: Pts arm was warm to the touch, red and swollen/knot with rash