chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to a 14 year old, no adverse event; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to case 2019SA269551 (same reporter).  This case involves a 14 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] QFAA1913, exp date (06-Jun-2020)  via intramuscular route in the right deltoid on 23-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccine was given.    It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expiration date of 18SEP2019 on the label was given today/no AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old female patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5254AA via intramuscular route in the left thigh.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced.  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: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered expired daptacel vaccine, no AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (dose number: 4) (lot C5254AB, exp.date: 18-Sep-2019) via intramuscular route in right Vastus Lateralis on 20-Sep-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: 15.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone Quadrivalent was administered to a patient which was was unstable, plus it took a long time before delivery, no AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with 2019SA274480 (same reporter).  This case involves a 15 years old male patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6654KA, expiry date: 13-Jun-2020) via intramuscular route in the left deltoid on 06-Sep-2019, which was incorrectly stored.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual mediation error due to incorrect product storage. It was reported that vaccine was unstable, plus it took a long time before delivery. Shipment come and it took 3-4 days to be delivered. Vaccine was out of range and unstable.  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.  Documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Back pain, Headache, Neck pain
Clinical narrative: pain on his neck and back; pain on his neck and back; unsteady headaches; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old male patient who experienced pain on his neck and back (bac pain and neck pain), and unsteady headaches (headache), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past vaccination(s): The patient stated that he had received the series of Imovax vaccines in the past and everything was fine.  The patient's past medical history, medical treatment(s) and family history were not provided.  No other vaccine was given.   On 24-Aug-2019, the patient received a first dose of 1 ml suspect RABIES (HDC) VACCINE lot CP1C85, exp date: 25-Sep-2020, via intramuscular route in the left arm. for an unknown indication.  On an unknown date, the patient developed a non-serious pain on his neck and back (neck pain and back pain) and unsteady headaches (headache) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  case details: Physician stated that the Imovax vaccine was administered and being experiencing headache from  time to time since. He was supposed to receive two doses but didn't do to the side effects of the fisrt dose. He went to see his doctor on the September 3th who confirmed the symptoms were due to the vaccine. As of today September 26th , he is still experiencing unsteady headaches. . His doctor suggested that he see a neurologic and he is going to see one today.  (Other relevant tests included no lab data.)  Final diagnosis was unsteady headaches, pain on his neck and back and pain on his neck and back.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for unsteady headaches, as Unknown for pain on his neck and back and as Unknown for pain on his neck and back.  Causality: Physician confirmed the symptoms were due to the vaccine.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone Quadrivalent was administered to a patient which was was unstable, plus it took a long time before delivery, no AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with 2019SA270664 (same reporter).  This case involves a 21 years old female patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6654KA, expiry date: 13-Jun-2020) via intramuscular route in the left deltoid on 17-Sep-2019, which was incorrectly stored.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual mediation error due to incorrect product storage. It was reported that vaccine was unstable, plus it took a long time before delivery. Shipment come and it took 3-4 days to be delivered. Vaccine was out of range and unstable.  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.  Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MENB, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Blood glucose normal, Fall, Head injury, Loss of consciousness
Clinical narrative: Shortly after 6 vaccine injections were given today, her cousin states that she got up from the table and felt nauseated and vomited and passed out completely, landing on the floor and hitting the back of her head against the bottom of the IPAD stand, and then regained consciousness almost immediately and felt weak. At that point cousin stepped out of the room and asked for help. Dr and Dr along with the clinical nurse supervisor and MA's went into the room immediately and patient was getting up with assistance from cousin. Rapid response was called and immediately after Urgent care nurse and urgent care provider also arrived. Incident was noted to have occurred at 10:10 am. Blood sugar was 90. She was noted to be alert and oriented with strong pulses and regular rhythm and even respirations. Initial BP 100/62, pulse 72, temps 94.9° F, respiratory rate 16, O2 sat 100% pain 0 out of 10. She was given some food and a repeat BP was 102/70 pulse 80, respirations 16, 02 sat 100% pain 0 out of 10. Orthostatic BP were taken 15 minutes later, prior to discharge and were at the same at 100/70 and 100/59. She then left with cousin, was back to her usual self.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MENB, MNQ, TDAP, VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: Shortly after 6 vaccine injections were given today, her cousin states that she got up from the table and felt nauseated and vomited and passed out completely, landing on the floor and hitting the back of her head against the bottom of the IPAD stand, and then regained consciousness almost immediately and felt weak. At that point cousin stepped out of the room and asked for help. Dr and Dr along with the clinical nurse supervisor and MA's went into the room immediately and patient was getting up with assistance from cousin. Rapid response was called and immediately after Urgent care nurse and urgent care provider also arrived. Incident was noted to have occurred at 10:10 am. Blood sugar was 90. She was noted to be alert and oriented with strong pulses and regular rhythm and even respirations. Initial BP 100/62, pulse 72, temps 94.9° F, respiratory rate 16, O2 sat 100% pain 0 out of 10. She was given some food and a repeat BP was 102/70 pulse 80, respirations 16, 02 sat 100% pain 0 out of 10. Orthostatic BP were taken 15 minutes later, prior to discharge and were at the same at 100/70 and 100/59. She then left with cousin, was back to her usual self.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: About 24 h after shot, pt notice a low-grade fever (99 degrees) and then a 3in diameter red patch (slightly beneath injection site on the left arm). She reported otherwise feeling fine.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: patient received influenza and pneumonia vaccines. both vaccines given in left deltoid. very reddened and swollen. temperature 101.5
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Employee complaining of redness, swelling, heat, and pain at injection site later that day. The following day had a "slight fever" and swelling was worse. Went to Urgent Care and was told she had cellulitis and was put on antibiotics.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Employee complaining of redness, swelling, heat, and pain at injection site later that day. The following day had a "slight fever" and swelling was worse. Went to Urgent Care and was told she had cellulitis and was put on antibiotics.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy Tuesday late afternoon 10/01/2019 and asked if she could use advil after a flu shot. The pharmacist said yes. Patient visited pharmacy today 10/03/2019 stating her arm hurt all day 10/02/2019 and a little this morning. She wanted to report the experience. I told her that I would make a report for her.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue
Clinical narrative: dizziness, tiredness, feelings of faintness
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, No reaction on previous exposure to drug, Urticaria
Clinical narrative: 2 inch circumference raised, red hive-like area that appeared within 24 hrs at site of injection.  Remained for over 48 hrs with no other complications.  Had annual flu vaccines throughout life with no previous reactions.  Sister vaccinated at same time had a milder, but similar reaction at same time as well.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Furuncle, Injection site erythema, Localised infection
Clinical narrative: Patient reported that the arm was "infected". Within 24 hours of the vaccine, a "boil" appeared and was leaking fluid and pus for 2 weeks. Upon examination, there are no signs of infection. The area of the injection site is slightly pink  as expected with a healing lesion. There is no swelling, pain, or significant redness.  No increased temperature/fever. The patient and his caregiver stated that the appearance today is greatly improved.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site pustule
Clinical narrative: Patient reported that the arm was "infected". Within 24 hours of the vaccine, a "boil" appeared and was leaking fluid and pus for 2 weeks. Upon examination, there are no signs of infection. The area of the injection site is slightly pink  as expected with a healing lesion. There is no swelling, pain, or significant redness.  No increased temperature/fever. The patient and his caregiver stated that the appearance today is greatly improved.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Student presented to school nurse office with headache followed nausea and vomiting. No fever was present.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Shock
Clinical narrative: shock, cellulitis
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Hypersomnia, Nasal congestion, Nausea
Clinical narrative: After 2 hours my arm was so sore I could not movelm by itself. I had a fever, chills, nausea, nasal congestion, boydyaches. I slept for 12 hours straight. Did not eat for 24 hours. The next day I still slept all day and finally the symtoms subsided on Sunday evening.  I felt terrible and almost had my daughter take me to the emergency room. If I had been a caregiver I would not have been able to take care of anyone
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: After 2 hours my arm was so sore I could not movelm by itself. I had a fever, chills, nausea, nasal congestion, boydyaches. I slept for 12 hours straight. Did not eat for 24 hours. The next day I still slept all day and finally the symtoms subsided on Sunday evening.  I felt terrible and almost had my daughter take me to the emergency room. If I had been a caregiver I would not have been able to take care of anyone
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Back pain, Dizziness
Clinical narrative: Joint pain all over my body. No energy. Bad headaches. Shooting pains across shoulder blades and up the back of my neck. My neck is also stiff. Middle and lower back pain. Middle back stiffness. Dizzy spells. GI discomfort. On day 2, I could hear my heart beating in my ears. Injection site very sore and has heat in it. It is also swollen. I am not able to lay on that side in bed at all. Lifting that arm also causes pain at the injection site.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Joint pain all over my body. No energy. Bad headaches. Shooting pains across shoulder blades and up the back of my neck. My neck is also stiff. Middle and lower back pain. Middle back stiffness. Dizzy spells. GI discomfort. On day 2, I could hear my heart beating in my ears. Injection site very sore and has heat in it. It is also swollen. I am not able to lay on that side in bed at all. Lifting that arm also causes pain at the injection site.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Pain, Palpitations
Clinical narrative: Joint pain all over my body. No energy. Bad headaches. Shooting pains across shoulder blades and up the back of my neck. My neck is also stiff. Middle and lower back pain. Middle back stiffness. Dizzy spells. GI discomfort. On day 2, I could hear my heart beating in my ears. Injection site very sore and has heat in it. It is also swollen. I am not able to lay on that side in bed at all. Lifting that arm also causes pain at the injection site.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy at 9am on 10/03/2019 to report arm tenderness, redness, swelling, warmness below and interior of right upper arm. Pharmacist on duty on 10/03/2019 informed patient to be seen by physician. Pharmacist on duty called physicians office to inform of patients side effects. Nurse stated she would put it in the chart.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Foaming at mouth, Mouth haemorrhage, Seizure, Unresponsive to stimuli
Clinical narrative: Seizure: saliva (foaming), bleeding from mouth, unresponsive
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Patient requested tp receive her annual employee flu vaccination on 10/01/2019. The injection was given IM into the R deltoid muscle after was wiped clean with an alcohol prep pad. Within 5 minutes of the injection, the employee began to complain of excessive itching at the injection site. Approximately 10 minutes later, a visible light red ring appeared around the injection site  about 2" in diameter. After about another 30 minutes, the employee complained of a "hard knot" under the injection site and the ring had become a full darker red circle on her arm that was warm to the touch from inflammation. On 10/03/2019, it was observed that the "knot" and circle are still present. There are no complaints of fever or other symptoms by the employee at this time.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Ice applied 8/5/19 Advised to call Agency 910/3/19
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Ill-defined disorder, Wrong product administered
Clinical narrative: Hep B was supposed to be given. Hep was given instead. Patient reported no symptoms of illness.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Bone pain, Headache, Injection site pain
Clinical narrative: Headache. Acute Joint & Muscular pain. 99.8 temp. Feeling Shakey. Pain in Left Arm shoulder, especially. pain in  cheekbones, strangely. Lying down caused acute pain every time I moved. First time any reaction to flu shot.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Tremor
Clinical narrative: Headache. Acute Joint & Muscular pain. 99.8 temp. Feeling Shakey. Pain in Left Arm shoulder, especially. pain in  cheekbones, strangely. Lying down caused acute pain every time I moved. First time any reaction to flu shot.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site abscess sterile, Lip erythema, Lip exfoliation, Lip pruritus, Lip swelling
Clinical narrative: ON 9/4/19 PT RECEIVED HEP A #1. ON 9/17/19 PT WAS BROUGHT TO OFFICE FOR AN ITCHY RED RAISED RASH ON BOTH LEGS NOTED FOR ONE WEEK. MOM ALSO STATED AT THAT TIME THAT ON THE EVENING OF THE DAY SHE RECEIVED THE HEP A VACCINE, PT'S UPPER  AND LOWER LIPS SWELLED W/ REDNESS AND ITCHING AND LATER PEELED.  NO WHEEZING/COUGHING/TONGUE SWELLING/HIVES NOTED. SYMPTOMS RESOLVED ON THEIR OWN OVER THE NEXT TWO WEEKS. THE SWELLING WAS AT FIRST CONTINUAL FOR ONE WEEK, THEN OFF AND ON FOR THE SECOND WEEK.  MOM STATED THIS HAPPENED AFTER BOTH FIRST AND SECOND DOSES OF HPV ALSO, ON 9/12/17 AND 8/28/18.  PT WAS SEEN AFTER 9/12/17 DOSE IN THE OFFICE ON 10/10/17 FOR WHAT WAS DETERMINED TO BE A STERILE ABSCESS AT SITE OF INJECTION. MOM SHOWED A PHOTO OF LIP SWELLING TO DR. AT THAT VISIT, BUT SHE WROTE THAT THE SWELLING WAS DIFFICULT TO APPRECIATE IN PHOTO.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: ON 9/4/19 PT RECEIVED HEP A #1. ON 9/17/19 PT WAS BROUGHT TO OFFICE FOR AN ITCHY RED RAISED RASH ON BOTH LEGS NOTED FOR ONE WEEK. MOM ALSO STATED AT THAT TIME THAT ON THE EVENING OF THE DAY SHE RECEIVED THE HEP A VACCINE, PT'S UPPER  AND LOWER LIPS SWELLED W/ REDNESS AND ITCHING AND LATER PEELED.  NO WHEEZING/COUGHING/TONGUE SWELLING/HIVES NOTED. SYMPTOMS RESOLVED ON THEIR OWN OVER THE NEXT TWO WEEKS. THE SWELLING WAS AT FIRST CONTINUAL FOR ONE WEEK, THEN OFF AND ON FOR THE SECOND WEEK.  MOM STATED THIS HAPPENED AFTER BOTH FIRST AND SECOND DOSES OF HPV ALSO, ON 9/12/17 AND 8/28/18.  PT WAS SEEN AFTER 9/12/17 DOSE IN THE OFFICE ON 10/10/17 FOR WHAT WAS DETERMINED TO BE A STERILE ABSCESS AT SITE OF INJECTION. MOM SHOWED A PHOTO OF LIP SWELLING TO DR. AT THAT VISIT, BUT SHE WROTE THAT THE SWELLING WAS DIFFICULT TO APPRECIATE IN PHOTO.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Pain, Palpitations
Clinical narrative: After the first shot I began feeling weak and achy all over, from my head to my feet. I was hobbling the pain was so bad. The palms of my hands hurt, my legs, my arms. It was very scary and I was in near tears. The next morning I called doc services and the doctor said to be seen by a doctor to check my white blood cells. (My physical shows all my numbers are normal every year). I went to urgent care about 11 am and he said because I didn?t have a fever there wasn?t need for concern. He prescribed methylprogesterone. Since that said to start in the morning, I simply took ibuprofen. By the next morning I was feeling better and did not take the medication.  For the second shot, I pre-medicated using the prescription I didn?t use the first time. The pain was nominal about four hours post shot and I almost finished that. The last two days however, I have had constant noticeable heart palpitations. Although I was told years ago I had a heart murmur it has not affected me, so this was puzzling then I read the pkg insert saying if this happens just after the shot to contact the doctor. Since this shot was given on Sunday 9/29/19 at 2:00pm I didn?t think this was just after. If it persists I?ll contact my doctor.
Age: 78.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inflammation, Pain
Clinical narrative: Pt reports extreme pain and inflammation.  Ice does not resolve pain.  She feels like he injected in her bone.
Age: 78.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Pain, Swelling
Clinical narrative: Pt reports extreme pain and inflammation.  Ice does not resolve pain.  She feels like he injected in her bone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: PATIENT PRESENTED URTICARIA RASH APROX 5 MINUTES AFTER SHOTS. LUNGS CLEAR AT EXAMINATION. GIVEN BENADRYL 25MG PO. BESIDES, RASH. PATIENT IN GOOD CONDITIONS.  GIVEN PRESCRIPTION FOR PREDNISONE PO.  WILL REFER TO ALLERGIST BEFORE NEXT DOSE OF SHOTS
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site. Patient has not taken anything. She did not report to her primary care provider. I will contact them.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Asthenia, Diarrhoea, Dyspnoea, Hyperhidrosis
Clinical narrative: Patient said he experienced vomitting, diarrhea, sweating, weakness, bloating, he had shortness of breath and difficulty breathing.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient said he experienced vomitting, diarrhea, sweating, weakness, bloating, he had shortness of breath and difficulty breathing.
Age: 76.0
Sex: F
Vaccine: FLU3, TYP, VARCEL, YF
Symptoms: Erythema, Neck pain, Pain, Swelling
Clinical narrative: Oct. 1 experienced pain, reddness and swelling Oct. 2  pain in left side of neck Oct. 2. Using my left to pick up a solid item, I felt water drops on my left hand
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: The patient developed a big knot, bruising, redness and swelling at the injection site; The patient developed a big knot, bruising, redness and swelling at the injection site; The patient developed a big knot, bruising, redness and swelling at the injection site; The patient developed a big knot, bruising, redness and swelling at the injection site; This spontaneous report was received from a pharmacist concerning a 63-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 02-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on the left arm, via intramuscular, lot number R033342, and expiration date on 03-AUG-2020 (strength and dosage schedule were not reported) to prevent pneumonia (prophylaxis).  On 03-SEP-2019, she developed a big knot (injection site nodule), bruising (injection site bruising), redness (injection site erythema) and swelling (injection site swelling) at the injection site in the left arm.  The patient did not seek medical attention. Therefore, she did not receive treatment for the events or had any laboratory diagnostics/studies performed. The outcome of the events injection site nodule, injection site bruising, injection site erythema and injection site swelling was not recovered.  The causal relationship between all the aforementioned events and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.      Upon internal review, the events injection site nodule, injection site bruising, injection site erythema and injection site swelling were determined to be events of significant disability or incapacity.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain
Clinical narrative: Patient states that the got the shivers, nausea and aches after receiving vaccination.  Informed patient that these are known possible side effects to vaccination. Call doctor if they persist
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Dizziness, Hypoaesthesia, Injected limb mobility decreased, Nausea
Clinical narrative: pressure like pain to right arm, feels like she cannot stretch arm, right forearm and right fingers are tingling, right pinky finger numb-ish, dizziness, nausea
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: pressure like pain to right arm, feels like she cannot stretch arm, right forearm and right fingers are tingling, right pinky finger numb-ish, dizziness, nausea
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain, Peripheral swelling, Skin discolouration, Urticaria
Clinical narrative: Patient reported pain traveling up from injection site on arm up through shoulder and neck and a white bump that developed under the vaccination site and traveled down the arm. The patient also reported hives developing on the arm and leg below. She reported symptom resolution by day of report on 10/3/2019 and hive resolution 2 days after treating with Benadryl at home.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: patient stated that she was shivering with high fever (around 103F) and had body aches at around 8pm of the same night she got her flu shot. She went to the hospital for the condition.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in hives on 10/2/2019 and call the health Department on 10/3/2019.  Public Health Nurse went out to day care to check on 10/3/2019 and there was no more rash/hives and the injection site was clear.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient stated the day after receiving the vaccine she felt chills, dizzy, sweating, slight diarrhea and fainted.
Age: 86.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient's daughter called on 10/3/19@3:30PM reporting that her mother is having the red rash on the right hand and inside of right wrist. Patient was asking if that is the reaction to one of the vaccine that the patient was received on 10/2/19 (shingrix given on LA and fluzone HD on RA). Daughter was advised to contact PCP.   10/3/19 @ 3:37PM - (pharmacy intern) contacted Dr. and left a message.  10/3/19 @349PM - pharmacist talked to the caregiver about the rash on the right knuckle no rash at the injection site.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin warm
Clinical narrative: Before the vaccine was administered,vaccine administrator noticed that there was a bruise (about 1/2 thumb in size) near the elbow area; patient specified that she bumped her arm.  Next day, patient's bruise, not on vaccine site, grew to about 2 fingers wide, it was hot/warm to touch; bruise had brown area.  On Saturday, patient went back to pharmacy; per patient, bruise was getting better but was still there.  Patient did not do any treatment at home or call the doctor. Patient asked vaccine provider to report event.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Skin warm, Tenderness
Clinical narrative: Red rash, hot to the touch, tenderness upper arm area.
Age: 54.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Computerised tomogram head, Dyspnoea, Laboratory test, Musculoskeletal pain
Clinical narrative: By 1240-1 pm my shoulder started hurting and feeling very painful. By 230 I took pain meds and tried to get relief at 431 on I called 911 because the pain had spread and become so severe and my arm was locked to my side and I was having issues breathing. I was transported to the Er
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen left arm below injection site around the bicep/elbow area in the anterior section of arm for 1.5 days, +erythema, +pain. No fevers. Taking ibuprofen for pain.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: The patient came to pharmacy and complained her arm has been swollen for several days and warm to touch
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt's mother called the clinic stating that her daughter received 3 vaccines yesterday and that the pt is having redness, tenderness, and welling on her Rt leg. Upon chart review, I  saw that only one vaccine was documented as administered on her Rt thigh and that was the Hep B vaccine. Mom reports that the pt's left leg "is fine and that's where 2 vaccines were administered." Mom denies any other s/s outside of localized redness and swelling at vaccine site. Mom added that pt is c/o tenderness and soreness of her rt leg when she is walking. I asked if pt had experienced something similar to this event when pt received her previous Hep B vaccines. Mom stated that pt did have similar findings with the previous administrations of the Hep B which pt had recovered from.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm started hurting a little that night.  Arm got worse and couldn't sleep well.  Next day, had flu-like symptoms, was tired, and arm was very sore.   Patient couldn't do much all day. Patient took Tylenol which helped to cut level of pain. On Sunday felt a little better; still tired but was able to move around. Today,  arm still very tender, swollen, hot area 2 inches below injection site.  Called doctor this morning; and was told to keep eye on it to see if worsens.   Recovery at 95%, it is mainly the sore arm that is not back to normal.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Arm started hurting a little that night.  Arm got worse and couldn't sleep well.  Next day, had flu-like symptoms, was tired, and arm was very sore.   Patient couldn't do much all day. Patient took Tylenol which helped to cut level of pain. On Sunday felt a little better; still tired but was able to move around. Today,  arm still very tender, swollen, hot area 2 inches below injection site.  Called doctor this morning; and was told to keep eye on it to see if worsens.   Recovery at 95%, it is mainly the sore arm that is not back to normal.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysstasia, Gait inability, Pyrexia, Urinary incontinence
Clinical narrative: Pt had fever/chills, vomiting, uncontrolled urination, and temporarily unable to stand/walk. Pt is still using walker day after, but is able to move about.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, Walking aid user
Clinical narrative: Pt had fever/chills, vomiting, uncontrolled urination, and temporarily unable to stand/walk. Pt is still using walker day after, but is able to move about.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gastrointestinal pain, Headache, Injection site pain, Myalgia
Clinical narrative: Nausea, upper g.i. cramping, headache, followed by aching whole body muscle pain, chills, headache, left arm pain to elbow
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Nausea, upper g.i. cramping, headache, followed by aching whole body muscle pain, chills, headache, left arm pain to elbow
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Mobility decreased
Clinical narrative: patient had soreness in neck and couldn't lift arm above head, pt went to er and was told to take Tylenol and ice, re=-checked with patioen on 10-3 and she is doing some better, also some pain in armpit area but no redness or pain at site of injection
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal pain
Clinical narrative: Mother came in complaining that daughter has had left shoulder pain since injection on 8/29/2019. Patient is scheduled to see our provider next Wed. 10/09/2019 at 0830. Mother provided with Biofreeze, hot packs and warm packs until patient can be seen.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Pt was given an expired vaccine.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Large amount of blood in stool with mucous 2 days after Rotarix  given. Normal stools until one week later when patient again had blood in stool, less amount
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm redness, swelling, hot to the touch. No fever noted on exam.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: The patient had a swollen lymph node on her clavicle on the left side.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Rash, Rash erythematous, Rash macular
Clinical narrative: Tolerated  the injection in office ok but later at night mom noted redness at Quadracel vaccine site on rt shoulder/upper arm area.  Subsequently had spotty rash next day on rt chest.   No itch or discomfort.  No fever.  Was able to use arm ok and acting usual self.   Rash lasted 1-2 days.   Photo sent on day 2 showed faint pink rash  in chest/axilla area  (could not distinguish much else).
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Fatigue, Impaired work ability, Influenza like illness, Muscular weakness
Clinical narrative: The morning after getting this flu shot I suddenly came down with fever, chills, muscle aches, fatigue, muscle weakness, and sore throat.  It feels exactly like I have the full-blown flu.  I went to work in the early morning and had to leave at 11 because I couldn't keep my head up anymore.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: The morning after getting this flu shot I suddenly came down with fever, chills, muscle aches, fatigue, muscle weakness, and sore throat.  It feels exactly like I have the full-blown flu.  I went to work in the early morning and had to leave at 11 because I couldn't keep my head up anymore.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Right axillary lymphadenopathy
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: Splitting headache, extreme fatigue/flu like symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Day after administration the patient felt pain at injection site.  There was a large bulge described as the size of an orange.  It was red and painful.  The next day the bulge still existed but became itchy and less painful but appeared to be same size.  Advised to seek medical care.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Fever up to 102.2 for 36 hours, severe chills, nausea, stomach ache, headache, muscle soreness throughout, injection site became quite red, swollen
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever up to 102.2 for 36 hours, severe chills, nausea, stomach ache, headache, muscle soreness throughout, injection site became quite red, swollen
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Pollakiuria, Rash erythematous, Skin warm, Tremor
Clinical narrative: Tremors started to get worse by 9:30pm.  Around 11:30pm pain started on lower part of abdomen and back.  Tried to get up but could not; she had no strength on legs in bathroom. Patient had to wait for husband to arrive and by then she wet the bed.   Patient noticed that arm was fine at vaccination site however at about 4 inches from elbow got a red huge rash that was hot.  Patient went back to bed.    A second time at night, patient tried to get out of bed and could not--she wet bed again.  She went back to sleep. Husband slept in room next door to be closer in case patient needed help again.   Patient has never gone to the bathroom so much in one night especially since she takes Myrbetriq; she just couldn't hold it long enough to get to the toilet.  Next morning, patient felt so weak that needed help to get out of bed and could not walk without the walker. Patient took normal medicinesno medications out of norm. Patient did take some Tylenol but did not help. Since Saturday morning, tremors continue and they are getting worse. Because of tremors patient could not even eat cereal by herself this morning.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Walking aid user
Clinical narrative: Tremors started to get worse by 9:30pm.  Around 11:30pm pain started on lower part of abdomen and back.  Tried to get up but could not; she had no strength on legs in bathroom. Patient had to wait for husband to arrive and by then she wet the bed.   Patient noticed that arm was fine at vaccination site however at about 4 inches from elbow got a red huge rash that was hot.  Patient went back to bed.    A second time at night, patient tried to get out of bed and could not--she wet bed again.  She went back to sleep. Husband slept in room next door to be closer in case patient needed help again.   Patient has never gone to the bathroom so much in one night especially since she takes Myrbetriq; she just couldn't hold it long enough to get to the toilet.  Next morning, patient felt so weak that needed help to get out of bed and could not walk without the walker. Patient took normal medicinesno medications out of norm. Patient did take some Tylenol but did not help. Since Saturday morning, tremors continue and they are getting worse. Because of tremors patient could not even eat cereal by herself this morning.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Onset of erythema within 4 hours of injection at injection site.  Onset of Fatigue, Headache with muscle aches approx. 12 hours after injection.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain upper, Crying
Clinical narrative: The next morning child was crying and holding her stomach complaining of stomach pain. From September  24, 2019 every morning she wakes up and says " tummy hurts"  holding her stomach with both hands, crying from pain. I took patient to Dr. today October 3, 2019
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: Bloody nose
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Facial paralysis
Clinical narrative: Right side Bell?s palsy
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, shivering, and muscle aches. Fatigue. Soreness in left arm. Symptoms persisting to present, 25 hours after injection.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, shivering, and muscle aches. Fatigue. Soreness in left arm. Symptoms persisting to present, 25 hours after injection.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: pt having extreme pain in arm and it's causing nausea and also mentioned dizziness- she called me at about 4 hours post vaccination
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Fine motor skill dysfunction, Pain, Pain in extremity, Paraesthesia, Rash macular
Clinical narrative: Received flu shot at work. About 2 am, I was awoken with tingling and pain in both my thumbs and index fingers. By 6 am, it had spread to all 10 fingers. Difficulty with fine motor, using an utensil etc.  By 6pm, I had red splotches on both hands and throbbing pain with use and at rest.  Consulted with employee health and agreed to wait and see.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Nasopharyngitis, Nausea, Vomiting
Clinical narrative: A half hour after receiving vaccine, pt got head cold symptoms, nausea, and vomiting.  Lasted a few hours for vomiting.  The next day felt better but had a "hung over" feeling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: about 12 hours after the vaccination, I developed fever to 102, shivers, weakness, and chills, and muscle aches.  after Tylenol, it took about another 12 hours for all symptoms to clear.  The vaccine was administered at pharmacy after I had visited my oncologist with a good report.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash pruritic, Urticaria
Clinical narrative: Developed headache soon after receiving second Shingrix dose.  Headache persisted for 2 days, and pt then developed an itchy urticarial rash over neck, chest, and abdomen
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Morning after daughter had pain and large lump around site of shot in her upper arm .  Lump was about 4 inches wide vertically and 2 inches wide. Painful and alittle red.  She  iced it and took advil.  Same results 2 days after but more red.    I left message for nurse. They are closed now. Will call them back tomorrow.
Age: 21.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Muscle strain, Pain in extremity, Paraesthesia, Swelling
Clinical narrative: Patient received both flu and pneumonia shots in the left arm. She states that later that day it was swollen and very painful with muscle strain. She states that her upper arm is painful to the touch and that her lower forearm has a tingling sensation that radiates to her fingers. She has been using oral and topical NSAIDS but that doesn't help. She states that the feeling she has was similar to when she had a blood clot, so she went to the doctor for an ultrasound and results were negative. The doctor thinks it might be cellulitis, so they prescribed her some antibiotics to help with her reaction but the patient doesn't feel like it's working.
Age: 21.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Patient received both flu and pneumonia shots in the left arm. She states that later that day it was swollen and very painful with muscle strain. She states that her upper arm is painful to the touch and that her lower forearm has a tingling sensation that radiates to her fingers. She has been using oral and topical NSAIDS but that doesn't help. She states that the feeling she has was similar to when she had a blood clot, so she went to the doctor for an ultrasound and results were negative. The doctor thinks it might be cellulitis, so they prescribed her some antibiotics to help with her reaction but the patient doesn't feel like it's working.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Purulent discharge
Clinical narrative: the patient came in the pharmacy with a severe inflamed arm. it looked red, inflamed and it had pus coming out of it. I advise the patient to immediately go to a minute clinic or urgent care to have this checked by doctor. Patient said he was going to the doctor and would let me know the outcome.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site inflammation, Injection site pain, Mobility decreased
Clinical narrative: Start as inflammation at injection site with pain, unable to raise arm, developed into infection which had to go to hospital for, now in treatment with doxycycline.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria for 10 days.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Red rash, that was warm to the touch. Pain also.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle injury, Pain in extremity
Clinical narrative: Patient experience a sore arm following the vaccination that has not improved since the vaccination. Patient sought medical treatment and received a steroid shot. Patient stated that MD examining arm stated that the deltoid muscle in the arm was collapsed and would take time to recover. Patient is continuing to seek medical care and will follow up with the pharmacy if there are any new developments in health status. Patient experienced no issues with the 1st dose of the shingrix vaccine