chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was used after the thirty day being opened We have used the IPV for a patient for 2 weeks after it should have been discarded / no AE; vaccine was used after the thirty day being opened We have used the IPV for a patient for 2 weeks after it should have been discarded / no AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient (with unknown demographics) who received vaccines IPV (VERO) [IPOL] (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to incorrect product storage and deteriorated drug administered.  At a time of reporting no adverse event reported.  It was reported that vaccine was used after the thirty day being opened We have used the IPV for a patient for 2 weeks after it should have been discarded  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.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: Daptacel was given to a 4 month old twice within 10 days/no AE; 14-feb-2020 dose was administered beyond expiry date of 07-Feb-2020/no AE; Initial information received on 17-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who received 0.5 ml single second dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] twice within 10 days (extra dose administered) on 04-Feb-2020 via intramuscular route in the right thigh) and another dose allegedly on 14-Feb-2020 (post expiry of batch) (lot C5366AA, expiry date: 07-Feb-2020) (Expired product administered) for prophylactic vaccination.  Patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) (no dosing details reported).  It was of actual medication error due to Expired vaccine used and Extra dose administered.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Chills, Heart rate increased, Nausea, Pallor, Tachycardia
Clinical narrative: Nausea, chills, Pale color 4 Hours post injection
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Myalgia, Oropharyngeal pain
Clinical narrative: Injection site reaction, progressing to redness/heat from elbow to shoulder; hives progressing to stomach; sore muscles; sore throat, progressing to mouth sores; Symptoms lasted 7-10 days minimum according to patient
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis, Urticaria
Clinical narrative: Injection site reaction, progressing to redness/heat from elbow to shoulder; hives progressing to stomach; sore muscles; sore throat, progressing to mouth sores; Symptoms lasted 7-10 days minimum according to patient
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Injection site reaction, progressing to redness/heat from elbow to shoulder; hives progressing to stomach; sore muscles; sore throat, progressing to mouth sores; Symptoms lasted 7-10 days minimum according to patient
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Injection site reaction, progressing to redness/heat from elbow to shoulder; hives progressing to stomach; sore muscles; sore throat, progressing to mouth sores; Symptoms lasted 7-10 days minimum according to patient
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Hypoaesthesia, Musculoskeletal discomfort, Nerve compression
Clinical narrative: CLIENT CALLED TODAY (2/21) STATING SHOT WAS GIVEN ON 2/3/20 AND HE EXPERIENCED DISCOMFORT IN HIS ELBOW LATER THAT SAME DAY BUT ON 2/13 HIS ARM WENT NUMB EVEN DOWN INTO HIS HAND.  THREE OF HIS FINGERS STILL REMAIN NUMB TO THIS DAY.  HE WENT TO THE ER ON 2/14 AND THE DR FELT IT WAS R/T A PINCHED NERVE IN HIS NECK.  HE HAS BEEN USING ICY HOT EVER SINCE AND HIS WIFE READ THE SIDE EFFECTS OF GETTING HEP A AND THINKS IT COULD BE RELATED SO HE CALLED  IN.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Nausea, Pain
Clinical narrative: Arm stayed warm, red and swollen for about 2.5 days.  Approximately 12 hours after injection, patient experienced systemic symptoms of nausea, dizziness, fever, body aches, and weakness which lasted for about 24 hours.  Patient took alleve and tylenol and rested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Arm stayed warm, red and swollen for about 2.5 days.  Approximately 12 hours after injection, patient experienced systemic symptoms of nausea, dizziness, fever, body aches, and weakness which lasted for about 24 hours.  Patient took alleve and tylenol and rested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fall, Fatigue
Clinical narrative: Chills, no fever, strength in legs gone, fatigued.   Fell twice day after vaccination.  Arm strength was OK, Day 2 could walk  and do steps.  Took acetaminophen 1000mg twice daily
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed hives on his face and neck 5 minutes after administering vaccine. Patient was given Benadryl 12.5mg PO and observed for 30 minutes, Hives started to subsided about 15 mins after administering Benadryl.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Product administered at inappropriate site
Clinical narrative: Injection was administered high and far back of upper left arm.  By far the most painful injection I've ever had.  Onset of severe left shoulder pain and limitation of movement of left arm occurred within hours of injection.  I had no prior pain or limits to movement of that arm prior to injection.  For four days, my  left arm was useless and pretty much hung at my side.  I had to lift it with my right hand.   The constant pain and limits to movement eased slightly 5 days post injection but have remained at those levels since and pain increases from late afternoon through evening hours.  I have been unable to sleep on left side since injection.  Ibuprofen, Tylenol, heat and/or ice have brought no relief.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Shoulder injury related to vaccine administration, Sleep disorder, X-ray limb abnormal
Clinical narrative: Injection was administered high and far back of upper left arm.  By far the most painful injection I've ever had.  Onset of severe left shoulder pain and limitation of movement of left arm occurred within hours of injection.  I had no prior pain or limits to movement of that arm prior to injection.  For four days, my  left arm was useless and pretty much hung at my side.  I had to lift it with my right hand.   The constant pain and limits to movement eased slightly 5 days post injection but have remained at those levels since and pain increases from late afternoon through evening hours.  I have been unable to sleep on left side since injection.  Ibuprofen, Tylenol, heat and/or ice have brought no relief.
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Developmental delay, Diet refusal, Disturbance in social behaviour, Language disorder
Clinical narrative: Within 24 hours patient developed a very high fever (the only high one he has had in his entire life), became lethargic,  and would not feed.  More importantly, he stopped babbling and the first words we had heard disappeared.
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia
Clinical narrative: Within 24 hours patient developed a very high fever (the only high one he has had in his entire life), became lethargic,  and would not feed.  More importantly, he stopped babbling and the first words we had heard disappeared.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: On 2/19/2020 area where Varivax was given parent noticed a red swollen knot.  Since then the knot has gotten smaller.  The provider diagnosed cellulitis of the left thigh on 2/21/2020.  the are felt warm.  Patient was a little fussy.  Provider treated the cellulitis with Keflex.. To be rechecked as necessary.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Irritability
Clinical narrative: On 2/19/2020 area where Varivax was given parent noticed a red swollen knot.  Since then the knot has gotten smaller.  The provider diagnosed cellulitis of the left thigh on 2/21/2020.  the are felt warm.  Patient was a little fussy.  Provider treated the cellulitis with Keflex.. To be rechecked as necessary.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Seizure
Clinical narrative: Patient passed away 12/13/18. Per parent report he has a seizure and died.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Office visit note from 12/10/2019 Subjective data: On December 1, 4 days after receiving the Shingrix vaccine, patient developed itchy hives over her torso.  Both sides of her body.  No scabbing. Then a full week later, patient developed hives near her axilla bilaterally. Patient cannot think of any other new things in her life, no new medications, shampoos, body wash, lotions, clothes, etc Pruritus is keeping her awake at night  Care Plan/Assessment:
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site discolouration, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Pt developed a circular reaction which was about 12 cm round. Area around the injection was pale/white and was about 6 cm surrounded by a 6 cm area of pink shade. Area was swollen, hard and warm. Pt took Benadryl at approximately 10:30 due to itching skin and noticed redness and swelling. Pt came to clinic at 2:00 pm  and was evaluated. Vital signs normal. Provider ordered 60 mg  Solumedrol to be injected IM.  Performed by reporter in right hip. Pt tolerated procedure and was feeling improvement. Pt was given instructions to take Benadryl and Tylenol as needed and use ice pack for swelling. Also given ER precautions.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pallor, Pruritus, Swelling
Clinical narrative: Pt developed a circular reaction which was about 12 cm round. Area around the injection was pale/white and was about 6 cm surrounded by a 6 cm area of pink shade. Area was swollen, hard and warm. Pt took Benadryl at approximately 10:30 due to itching skin and noticed redness and swelling. Pt came to clinic at 2:00 pm  and was evaluated. Vital signs normal. Provider ordered 60 mg  Solumedrol to be injected IM.  Performed by reporter in right hip. Pt tolerated procedure and was feeling improvement. Pt was given instructions to take Benadryl and Tylenol as needed and use ice pack for swelling. Also given ER precautions.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Crying, Urticaria
Clinical narrative: following vaccination, she cried for a period of 2 hours- inconsolable cry. Her body developed generalized Hives from head to toe, this appearance would go away and resurface for a total of 5 days until gone. First day was entire body, next day was upper trunk, 3rd day lower body, 4 th day just arms, last day, day 5 just legs
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient verbally states 4 days after receiving PCV13 vaccine, she develops itching, swelling, tenderness and redness to the injection site. As per the patient, 12/15/2019, she went to ER. Patient states at that point, she could hardly move her arm and the swelling had spread to the back of the arm. Patient verbally states that after several tests, she was told that she had an infection. Patient states two types of antibiotics were prescribed and after completing antibiotics, her arm was back to normal.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Patient verbally states 4 days after receiving PCV13 vaccine, she develops itching, swelling, tenderness and redness to the injection site. As per the patient, 12/15/2019, she went to ER. Patient states at that point, she could hardly move her arm and the swelling had spread to the back of the arm. Patient verbally states that after several tests, she was told that she had an infection. Patient states two types of antibiotics were prescribed and after completing antibiotics, her arm was back to normal.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Patient had shoulder pain following vaccine administration, started approximately one week after receiving vaccine. Came and talked with pharmacist on duty when it occurred and decided to wait to see if it was pain from administration and would go away with time. When talking with patient for second dose she stated pain never completely went away. Described the pain in her shoulder similar to a torn rotator cuff.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Decreased eye contact, Encephalitis, Irritability, Personality change
Clinical narrative: Patient had suffered a prior adverse reaction to Dtap/Rotavirus (see VAERS report 188063) but we gave MMR because of a possible outbreak.  The encephalitis side effects were not as pronounced as the prior adverse reaction but we noted that he became rather irritability, his personality changed to more withdrawn and his eye contact diminished.  These symptoms have persisted for years.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Social avoidant behaviour
Clinical narrative: Patient had suffered a prior adverse reaction to Dtap/Rotavirus (see VAERS report 188063) but we gave MMR because of a possible outbreak.  The encephalitis side effects were not as pronounced as the prior adverse reaction but we noted that he became rather irritability, his personality changed to more withdrawn and his eye contact diminished.  These symptoms have persisted for years.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 24 hrs after the injection I had pain at the injection site which lasted 3 days 6 days after the injection I had itching and pain at injection site and also a large reddened  raised area which was warm to touch  I put a over the counter Lidocaine ointment to area
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dry mouth, Erythema, Oral mucosal blistering, Rash
Clinical narrative: PATIENT WAS FINE WHEN THEY LEFT THE PHARMACY. REPORTED GETTING BLISTERS/RASH AROUND THE FACE AND NOSE STARTING 2-3 DAYS AFTER VACCINATION. STATED THAT THE BLISTERING/RASH DID NOT HURT, BUT THAT WHEN HE MOVED HIS MOUTH IT FELT DRY SO HE USED AN "ANTIBIOTIC CREAM" ON THE DRY AREAS. HE WASN'T SURE IF IT WAS A PRESCRIPTION OR NOT AND COULD NOT RECALL THE NAME OF IT. HE CAME IN TODAY (7 DAYS AFTER VACCINATION) AND HIS FACE SEEMED TO BE CLEARING UP. I SAW REDNESS/SLIGHT BLISTERING AROUND THE CORNERS OF THE MOUTH IN PARTICULAR AND REDNESS ON THE TIP OF THE NOSE.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came into the store today 3 days after vaccination and had a red band along the top part of this arm. It was about 5 inches long red and warm to the touch, it was located approximately 3 inches beneath where the vaccine was administered
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Conjunctivitis, Irritability, Malaise, Pyrexia, Rash
Clinical narrative: On 2/15/2020 my daughter developed eye conjunctivitis, since then she has had fever on and off and been extremely fussy. Today, on 2/21/2020 she has developed a rash over her body including her face and head. I was told it was a reaction to the vaccine she had 15 days ago. She is still feeling unwell and on and off fever with full body rash now. I was told not to worry.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Consciousness fluctuating, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: Patient had syncopal episode, turn ashen grey in face and past out. he did bump his head a little as he went down. His dad and I tried to slow fall. he went "in and out" for about 5 minutes, felt better and sat up. He then turn ashen  gray again and we layed him down with feet elevated for 5 to 10 minutes. Still going "in and out" I ask his dad if he wanted me to call 911 and he said yes. EMS arrived and transported him to hospital. About 6:15pm the dad called the pharmacy to say all was well. he was diagnosed with vagal syncopal episode.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient had syncopal episode, turn ashen grey in face and past out. he did bump his head a little as he went down. His dad and I tried to slow fall. he went "in and out" for about 5 minutes, felt better and sat up. He then turn ashen  gray again and we layed him down with feet elevated for 5 to 10 minutes. Still going "in and out" I ask his dad if he wanted me to call 911 and he said yes. EMS arrived and transported him to hospital. About 6:15pm the dad called the pharmacy to say all was well. he was diagnosed with vagal syncopal episode.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dysphagia, Dyspnoea, Pain in jaw, Urticaria
Clinical narrative: At 1600 both influenza vaccine and Gardasil were given. Patient was left in room with parents to monitor for reaction. At 1610 mother came and got the nurse stating that patient had developed hives and having jaw pain. This was reported to provider and 50mg of Benadryl was given and ice packs were put on injection site. Patient was monitored continually in the room with nurse. Patient then started to complain of it being hard to swallow and having a hard time breathing. This was reported to provider and provider order epi pen. 1635 0.3mg of epinephrine was given via epi pen. Pt was then transferred to the ER.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Myalgia
Clinical narrative: Patient presented to pharmacy 3 days after receiving her first dose of Shingrix stating the arm she received the vaccine in looked like it had been bruised underneath her arm and wrapped around her uderarm area, and also felt like her muscles were sore. She stated she did not have a fever, other rash, hives, or shortness of breath. It was recommended for her to take tylenol or ibuprofen for the pain and benadryl in case of allergic reaction. She was also told to seek medical attention if the condition did not improve within 1 week of receviing the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Tired, muscle pain, headache, shivering, nausea, redness & swelling at injection sight
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Tired, muscle pain, headache, shivering, nausea, redness & swelling at injection sight
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Approximately 1 hour after receiving vaccines, patient re-presented to clinic with hives on face and back, but no vomiting or difficulty breathing, vitals stable.  Was given 20 mg IM diphenhydramine (pt unable to take oral), hives resolved and then pt was discharged home, prescribed oral diphenhydramine PRN.  Follow up today, pt did not have any recurrent hives but had developed low grade fever (100.4F in clinic) and L arm had significant local reaction with redness, swelling, mild warmth and pain to palpation but normal ROM and neurovascularly intact. Flu vaccine site (higher up on arm) looked ok, so reaction presumed from MMR.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Approximately 1 hour after receiving vaccines, patient re-presented to clinic with hives on face and back, but no vomiting or difficulty breathing, vitals stable.  Was given 20 mg IM diphenhydramine (pt unable to take oral), hives resolved and then pt was discharged home, prescribed oral diphenhydramine PRN.  Follow up today, pt did not have any recurrent hives but had developed low grade fever (100.4F in clinic) and L arm had significant local reaction with redness, swelling, mild warmth and pain to palpation but normal ROM and neurovascularly intact. Flu vaccine site (higher up on arm) looked ok, so reaction presumed from MMR.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Tendon disorder
Clinical narrative: As of 2/21/2020 patient reports tendon popping sensation and pain in left shoulder area since receiving flu shot on December, 18 2019 (approximately 2 months now) and inquired as to whether this could be caused by flu shot. Patient had not previously reached out to us regarding any problems she was having since receiving the vaccine. Advised patient that this is not an expected reaction and that she should follow up with primary care dr to rule out other causes. and that I would file an adverse reaction report on her behalf.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: THE INJECTION SITE BECAME RED AND SWOLLEN FOR 4 DAYS THEY TOOK IBUPROFEN TO HELP AND THE ARE BECAME BETTER
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, C-reactive protein, Chills, Decreased appetite, Diarrhoea
Clinical narrative: The symptoms began 4 days ago. Symptoms have remained unchanged. The patient presents w/ chills, diarrhea, fatigue, fever, generalized weakness, headache, nausea and joint pain. The patient does not present with abdominal pain, anorexia, arthralgia, back pain, earache or vomiting. Patient had a response to medications (Tylenol) and a response to rest. The illness is associated with change in appetite and rash.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Differential white blood cell count, Fatigue, Full blood count, Headache, Metabolic function test
Clinical narrative: The symptoms began 4 days ago. Symptoms have remained unchanged. The patient presents w/ chills, diarrhea, fatigue, fever, generalized weakness, headache, nausea and joint pain. The patient does not present with abdominal pain, anorexia, arthralgia, back pain, earache or vomiting. Patient had a response to medications (Tylenol) and a response to rest. The illness is associated with change in appetite and rash.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Microscopy, Nausea, Pain, Pyrexia, Rash
Clinical narrative: The symptoms began 4 days ago. Symptoms have remained unchanged. The patient presents w/ chills, diarrhea, fatigue, fever, generalized weakness, headache, nausea and joint pain. The patient does not present with abdominal pain, anorexia, arthralgia, back pain, earache or vomiting. Patient had a response to medications (Tylenol) and a response to rest. The illness is associated with change in appetite and rash.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Red blood cell sedimentation rate, Urine analysis
Clinical narrative: The symptoms began 4 days ago. Symptoms have remained unchanged. The patient presents w/ chills, diarrhea, fatigue, fever, generalized weakness, headache, nausea and joint pain. The patient does not present with abdominal pain, anorexia, arthralgia, back pain, earache or vomiting. Patient had a response to medications (Tylenol) and a response to rest. The illness is associated with change in appetite and rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: patient reports moderate neck pain that radiates down her left arm. this arm is different than the one she got the vaccine in, but stated that it started right after the shot and is still causing problems as of 2/21/20
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Discomfort, Fatigue, Immediate post-injection reaction
Clinical narrative: I had a little reaction to the second Shingrix shot. Injection site was sore soon after receiving it; about 6 hours after injection I noticed stiffness in hips and ribs. During the night I awoke to flu-like symptoms including overall muscle soreness and joint stiffness/pain. I stayed in bed for next 10 hours. In the late morning, checked my temperature = 99.2F. Took 2 tylenol which reduced discomfort and continued with that.  Better the next day but still somewhat sore and tired. Back to normal the day after that.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Joint stiffness, Myalgia
Clinical narrative: I had a little reaction to the second Shingrix shot. Injection site was sore soon after receiving it; about 6 hours after injection I noticed stiffness in hips and ribs. During the night I awoke to flu-like symptoms including overall muscle soreness and joint stiffness/pain. I stayed in bed for next 10 hours. In the late morning, checked my temperature = 99.2F. Took 2 tylenol which reduced discomfort and continued with that.  Better the next day but still somewhat sore and tired. Back to normal the day after that.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Limb discomfort
Clinical narrative: pt. complained soreness, heaviness at the injection site 2 weeks after the vaccination, lasted several months.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: rash maculopapular on trunk arms & fever
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Expired product administered
Clinical narrative: Given expired dose of Boostrix as above. on 2/14/20 mom notified me staff has endorsed intermittent dizziness. I told her I do not believe it's related.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives to stomach, legs, itching Benadryl
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: was given proquad (MMR & varicella) instead of MMR.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety
Clinical narrative: Patient was administered Boostrix as documented above. Mom reports he has been more anxious from Jan-Feb 2020, wonders if it's related. No other concerning symptoms. I told her I don't think it's related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling & Redness & Itchiness
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Patient described arm pain and numbness during injection. Resolved after 20 min with ice pack. 2/20/20 follow up - Patient reports feeling ok.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Notable swelling of the entire upper arm, with heat near injection site. Severe pain in full arm, armpit, and right breast.  Pain is bad enough to interrupt sleep, and restrict mobility
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Sleep disorder
Clinical narrative: Notable swelling of the entire upper arm, with heat near injection site. Severe pain in full arm, armpit, and right breast.  Pain is bad enough to interrupt sleep, and restrict mobility
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV1
Symptoms: Eye movement disorder, Irritability, Seizure, Sleep terror
Clinical narrative: Patient had night terrors and looked like convulsions while rolling her eyes back. I didn't know what to do. I held her till it stopped. It started around 11pm off and on and stopped after 2am on February 21st and 22nd. She is better now, but very fussy.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint injection, Pain
Clinical narrative: Immense pain starting several hours after vaccination. Patient states he couldn't even put a shirt over his shoulder. Arm was in sling for approximately 1 week. Patient states he received cortisone shots to shoulder area due to vaccination "hitting nerve".
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia
Clinical narrative: Approximately nine hours after receiving the vaccination, I had chills and muscle aches that lasted for a few hours. Additionally there is pain at the site of the injection.
Age: 13.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site urticaria
Clinical narrative: - 7-8 cm slightly erythematous asymmetric annular almost welt around small visible injection site on right upper arm c/w hypersensitivity reaction.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Dizziness, Influenza virus test negative, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Approximately 12 hours post vaccine she had a fever, dizziness, vomiting and joint and muscle pain. As of today she still has pelvic pain, and neck pain.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Neck pain, Pelvic pain, Pyrexia, Vomiting
Clinical narrative: Approximately 12 hours post vaccine she had a fever, dizziness, vomiting and joint and muscle pain. As of today she still has pelvic pain, and neck pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Child has complained about pain, starting approximately five minutes after the shot was given, and still complaining two days later. Injection site has redness and swelling approximately 4-5 inches in diameter. Site is warm to touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Horrible chills, severe weakness, sweating, headache -- had to leave work, could not get up from bed without assistance, had difficulty sitting up -- lasted until during that night when I woke up the next morning I was much improved and returned to work  Soreness at the injection site and through the upper arm on that side, minor headache, minor fatigue -- continues and is much the same as after other vaccinations such as the flu vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Horrible chills, severe weakness, sweating, headache -- had to leave work, could not get up from bed without assistance, had difficulty sitting up -- lasted until during that night when I woke up the next morning I was much improved and returned to work  Soreness at the injection site and through the upper arm on that side, minor headache, minor fatigue -- continues and is much the same as after other vaccinations such as the flu vaccine
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Swelling
Clinical narrative: Immediately after injection, patient bled from the injection site to soak a cotton ball.  She developed a raised area approx. 1.25 inch in diameter and 0.25 inch raised.  After approximately 30 minutes the raised area had returned to normal appearance and patient had no pain or tenderness from injection.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: severe arm pain, tingle up arm and down to fingers. md prescribed ibu 600mg
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, C-reactive protein normal, Fatigue, Headache, Injection site pain
Clinical narrative: severe arm pain, tingle up arm and down to fingers. md prescribed ibu 600mg
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: severe arm pain, tingle up arm and down to fingers. md prescribed ibu 600mg
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Neuralgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: On 2/21/20 I received an email from company regarding a patient wanting to contact Pharmacy due to concerns about his flu shot administered on 10/18/19. I emailed my personal phone number and said to call whenever to discuss. The patient called and told me he has been experiencing pain in arm for 4 months. He finally went to his doctor office and states the vaccine was given in an incorrect location. I counseled patient on bursitis if vaccine is given too high in shoulder and showed empathy toward patient as well. He stated the vacine was given too low and now taking Gabapenting for nerve pain, he is unsure if damage will be temporary or permanent.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient started the next day with redness on his left leg at injection site. It was hard, hot to the touch and swollen. This happened over the weekend, so they had called the nurse who was on call. They were advised to draw a line where the redness ended, try cool compress and give Benadryl. It never went outside of the line drew. The redness, hard and hot to the touch lasted a couple of days. The patient never came into the office for evaluation. The parents did take pictures on their cell phone.
Age: 54.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Gaze palsy, Pyrexia
Clinical narrative: Day 1 AEs: Diarrhea, headache, slight fever (99.2°, which is a fever for me). Symptoms subsided by Day 3 and did not reappear with subsequent doses.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Breast pain, Chest pain, Confusional state, Hypoaesthesia
Clinical narrative: 2/16/2020:EVENING:  PT FELT CONFUSED.  2/17/2020: EVENING- PT FELT BURNING PAIN, NUMBNESS, OCCASIONAL SHARP STABBING PAIN IN LEFT CHEST AREA, BREAST AND NIPPLE, LEFT ARM AND LEFT UPPER BACK AREA.  ARM FEELS HEAVY.  RANGE OF MOTION IN LEFT SHOULDER WAS NOT AFFECTED.  PT WENT TO E.D. 2/20/20 FOR EVALUATION. PT STATES HEART ATTACK AND SHINGLES WAS RULED OUT.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Limb discomfort, Nipple pain, Pain, Pain in extremity
Clinical narrative: 2/16/2020:EVENING:  PT FELT CONFUSED.  2/17/2020: EVENING- PT FELT BURNING PAIN, NUMBNESS, OCCASIONAL SHARP STABBING PAIN IN LEFT CHEST AREA, BREAST AND NIPPLE, LEFT ARM AND LEFT UPPER BACK AREA.  ARM FEELS HEAVY.  RANGE OF MOTION IN LEFT SHOULDER WAS NOT AFFECTED.  PT WENT TO E.D. 2/20/20 FOR EVALUATION. PT STATES HEART ATTACK AND SHINGLES WAS RULED OUT.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: patient said it hurt immediately and continued to hurt. It did not improve and continued to hurt over the period of time when she followed up with me twice. (12/27/19 11:45am and 1/17 11:40am).  Description included stiff in the morning and hurt while reaching for things and was a dull achy feel.  It only hurts pin-point where the shot was given. I advised her each time that she should try ibuprofen for inflammation and may add Tylenol for pain as needed. I advised to alternate between heat and ice as needed for pain/inflammation as well. Following up the second time, patient had not done what I had advised. She seemed to understand that it may improve it instead of just waiting. She also lifts heavy items for her occupation which may contribute to the inability to heal if there is inflammation.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Break out in itchy bumps similar to hives
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Pain
Clinical narrative: Upper arm soreness, redness at injection site., headaches, fatigue, chills, fever, body aches.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Upper arm soreness, redness at injection site., headaches, fatigue, chills, fever, body aches.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: muscle aches, light headed, fainted, nausea, head ache, and diarrhea
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: muscle aches, light headed, fainted, nausea, head ache, and diarrhea
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Foetal death, Laboratory test abnormal, Premature delivery, Ultrasound antenatal screen abnormal
Clinical narrative: Twins were due in April but arrived 2 months premature after receiving vaccination. I wasn?t informed of the possible death of our child who was on my left side same side breast cancer appeared same side baby died on
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Rash
Clinical narrative: rash, dizzy
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Night sweats
Clinical narrative: Headache (11:00 pm), shivering, night sweat (2:00 - 5:30 a.m.) Treated with ibuprofen @ 6:30 a.m. Mild headache returned at 6:00 pm but side effect, besides sore are at the site of the injection.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Impaired work ability, Insomnia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: 2/15/20 - Patient  reported  continued left arm pain after receiving Flublok on 1/21/2020.  She doesn't have any other chronic conditions.  She used aspirin, but with no relief.  She says she's had difficulty sleeping on that arm, and hinders her job as a school teacher. (e.g. can't lift projector, etc.)   They went to urgent care today, the NP told her to see the pharmacy, and we'd refer them to a place.   I told her we don't have a clinic/prescriber for referral.     I advised her to see her primary care provider (PCP) ASAP, and I'll also be calling the PCP on Monday.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: local reaction
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: Fever 99f, coughing, fatigue
Age: 3.0
Sex: M
Vaccine: RV5
Symptoms: Gastrointestinal obstruction
Clinical narrative: Gastrointestinal blockage
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Diplopia
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Cough, Diplopia, Headache, Injection site pain
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test abnormal, Malaise, Nephropathy, Optic nerve injury, Pain in extremity
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Productive cough, Pyrexia
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Chills, Diplopia, Headache, Injection site erythema
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Laboratory test, Magnetic resonance imaging normal, Malaise
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: patient claims double vision beginning 02/14/20, and imbalance 02/15/20, claims has seen multiple physicians including a neurologist.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling cold, Pain in extremity, Swelling
Clinical narrative: PATIENT STSTES SHE BAGAN TO FEEL COLD THE EVENING OF 2/21, THEN INTO SATURDAY MORNING/EARLY AFTERNOON THE PATIENT BEGAN TO EXPERIENCE REDNESS, SWELLING AND PAIN IN HER LEFT LOWER ARM BELOW THE INJECTION SITE.  THE PATIENT PRESENTED TO THE PHARMACY ON 2/23 AND S=IT WAS SUGGESTED SHE FOLLOW-UP WITH HER PROVIDER ON  MONDAY, 2/24.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Arm  pain has not subsided. Feeling very nauseous and dizzy with a headache to the point I am unable to get out of bed.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Condition aggravated, Disturbance in attention, Dysphemia, Irritability, Poor quality sleep
Clinical narrative: Extreme stutter, new onset.  Mild developmentally appropriate stutter prior to vaccine.  Extreme stutter lasted 8 days.  Stutter is still more than normal at time of completing this form. Very irritable, and highly distracted ("zoned out"), poor sleep with early waking  x8 days.  (Again, significant difference from baseline).  Mild versions of these above baseline are also still present as I complete this form.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Terminal insomnia
Clinical narrative: Extreme stutter, new onset.  Mild developmentally appropriate stutter prior to vaccine.  Extreme stutter lasted 8 days.  Stutter is still more than normal at time of completing this form. Very irritable, and highly distracted ("zoned out"), poor sleep with early waking  x8 days.  (Again, significant difference from baseline).  Mild versions of these above baseline are also still present as I complete this form.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient had a 30 second syncopal event after administration of HPV vaccine. She did state that "this has happened before when I think about it too much afterwards".  EMS was activated, BP 85/55, patient refused to go with EMT to hospital for further evaluation.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Malaise
Clinical narrative: general feeling of being sick, not well, flu like symptoms
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Grip strength decreased, Hypoaesthesia, Insomnia, Pain, Paraesthesia
Clinical narrative: Patient reports feeling numbness and tingling the evening of vaccine on opposite arm (right arm/hand). It kept her up over night and prevented her from closing her hand around toothbrush or using hand to pick up any item.  Pain/numbness continued over 36 hours later. Referred patient to urgent care to be evaluated.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Pain, Swelling
Clinical narrative: Patient was out of country - came back from vaccination- noticed the bump today,  4 days later.  fluid like. at time of administration, the bump was not present- pharmacist felt area of injection and it was flat. patient said arm was sore days after injection, only found bump this morning
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Insomnia
Clinical narrative: Patient experienced insomnia the night following the vaccine starting at 8 hours post vaccination. She lost her voice entirely 4 days later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness and arm swollen to the size of a tennis ball
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient's daughter, states her mother has had arm pain since the flu shot. Her mom went to her doctor who told her it was " Vaccine Shoulder"
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Heart rate increased, Varicella
Clinical narrative: Pt complained of pox appearing all over the right arm, chronic diarrhea and increased heart rate following vaccine
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccination on 12/18/19 and developed arm pain after the vaccination that was not present prior to the vaccination. Patient reports on 2/23/20 that her arm still hurts and that she is going to see her doctor 2/24/20 in the morning about this.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Erythema, Hypersensitivity, Injection site erythema, Injection site inflammation
Clinical narrative: ? PATIENT CALLED PHARMACY AT 10:55 AM ON 2/22/2020 and stated, "she wanted to know if she should be concerned about the reaction she is having to her Shingles vaccine administered on 02/18/2020" ? She reported classic signs of an injection site reaction: localized itching, redness, sore arm, skin felt feverish/warm to the touch. only at the site of the injections. ? I informed patient that reactions is common for this vaccination, and gave her information on how to care for the reactions and possibles signs of concern when she might need to escalate care. ? Event: Injection-site reaction ? Symptoms: Soreness of injection site, Inflammation, Itching/Swelling ? Pharmacist Response: Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis. ? Informed patient we would follow up on Monday to check on the status of the reaction. Cont... 02/23/2020 - Patient came to pharmacy to show me the reactions. - The reaction was consistent with anaphylaxis "serious allergy" - The patient presented with generalized itching and erythema to the full upper right portion of the left arm. - No signs of Hives, shortness of breath, or cardiovascular issues were present. - Patient stated she would see treatment with an Urgent Care Provider. Event Details