chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were reported as follows: The reporter reported, she heard that her friend's niece received a SHINGRIX shot and later passed out in the shower. No further details were available from reporter.
Sex: U
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an 18 months old patient who received vaccine QUADRACEL more than once. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none reported as no other vaccine was received. On an unknown date, the patient received a booster dose of suspect QUADRACEL lot number not reported via unknown route. It was case of actual medication error due to extra dose administered and Inappropriate age at vaccine administration. It was not reported that if any adverse event was not 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 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. List of documents held by sender: none.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA279966, 2018SA279967, 2018SA281637, 2018SA279973, 2018SA279979, 2018SA281635, 2018SA281634 and 2018SA281687. This case involves a 17 years old patient who received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AB. It was a case of actual medication error due to product storage error. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 14 months old female patient who experienced fever for 3 days, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via unknown route. On an unknown date, the patient developed a non-serious fever for 3 days (pyrexia) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. (Other relevant tests included No lab data.) Final diagnosis was fever for 3 days. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fever for 3 days. List of documents held by sender: none
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who experienced only received the dtap/ipv portion of the vaccine, powdered acthib portion inadvertently not mixed in or given, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PREVENAR 13 for Immunisation. On 19-Oct-2018, the patient received a  only received the second 0.5 ml dtap/ipv portion of the vaccine, powdered acthib portion inadvertently not mixed in or given from suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5447AB, expiry date- 15-NOV-2019 via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. The patient outcome is reported as Not Applicable for only received the dtap/ipv portion of the vaccine, powdered acthib portion inadvertently not mixed in or given. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves unknown number of patients over 65 years of age (demographics unknown) who received vaccine ADACEL (lot number not reported) via unknown route in unknown administration site on an unknown date. 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 inappropriate age at vaccine administration. It was reported that the patients experienced no adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 34.0
Sex: U
Vaccine: FLU4
Symptoms: Furuncle, Injection site reaction
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA304593 (same reporter). This case involves a 34 years old patient (gender was not reported) who developed a boil at the injection site, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date not reported) via intramuscular route in unknown administration site. On an unknown date, the patient developed a non-serious boil at the injection site (furuncle) 3-4 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. Final diagnosis was developed a boil at the injection site. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for developed a boil at the injection site. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient (age unknown) who received PENTACEL instead of vaccine QUADRACEL. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect PENTACEL lot C5444AB, expiry date 22-Nov-2019 via unknown route in unknown administration site instead of injection of suspect QUADRACEL lot number, expiry date not provided. It was an actual medication error due to wrong vaccine administered and wrong technique in product usage process. It was reported that a patient inadvertently received the Dtap/IPV portion of PENTACEL instead of the ordered QUADRACEL. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of unknown demography who inadvertently received the Dtap/IPV portion of PENTACEL instead of the ordered QUADRACEL (lot number not reported for both the vaccines) via unknown route in unknown administration site. 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 wrong vaccine administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 42.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 42 years old female patient who was vaccinated with 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UP6259KA and expiry date: 30-Jun-2019) (dose in series, route and site of administration were not reported) on 02-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to vaccine under dose because patient was given 0.25 mg/ml FLUZONE QUADRIVALENT Pediatric dose instead for the 0.5 mg/ml dose. No reactions were 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.   Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 45 years old male patient who experienced experienced pain in the affected arm with limited range of motion, tender and sore, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 20-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6258MA and expiry date: 30-Jun-2019) via intramuscular route in the left arm. On an unspecified date, the patient developed a non-serious experienced pain in the affected arm with limited range of motion (injection site pain and mobility decreased)administration of INFLUENZA QUADRIVAL A-B VACCINE  On an unspecified date, the patient developed a non-serious he was tender and sore (tenderness) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient was visited to the emergency room on 02-Nov-2018. Other relevant tests included No Lab data was reported. Final diagnosis was he was tender and sore and experienced pain in the affected arm with limited range of motion. The patient was treated with 60 mg PREDNISONE (PREDNISONE) and 1 week taper starting on 02-Nov-2018. The patient outcome is reported as Unknown (reported as limited range of motion that is progressively getting worse) for experienced pain in the affected arm with limited range of motion and as Unknown for he was tender and sore. Documents held by the sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Influenza
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a female patient of an unknown age who was received vaccine FLUZONE QUADRIVALENT (batch number, expiry date, dose, route and site of administration were unknown) on 11-Feb-2018, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 7 months pregnant when she received vaccine. On an unknown date, the patient developed a non-serious viral flu disease (Flu like symptoms) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The event outcome was unknown on an unknown date. List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation error
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child patient who was vaccinated with a diluent of the vaccine PENTACEL lot C5592AA, via oral route in unknown administration site on 08-Oct-2018. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccination involved PREVNAR and rotavirus. It is a actual medication case error due to Product preparation error. It was reported that the patient was vaccinated with the PENTACEL Diluent instead of the PENTACEL itself. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA306289 and 2018SA306332. This case involves a 6 months old male patient who experienced received expired PENTACEL, while he received vaccine PENTACEL. Patient has received PREVNAR and Rotavirus vaccine (also reported as Rhodavirus) as concomitant medications. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Nov-2018, the patient received a 0.5 ml once dose of suspect PENTACEL lot C5439AA, expiry date- 29-Oct-2018 in right thigh. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient had any adverse event or not after receiving the expired vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient (age and gender not reported) who was vaccinated with a dose of expired vaccine PENTACEL (lot number not reported) on an unknown date. 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. It was not reported whether the patient had any adverse events following the vaccination. 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. Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 47 years old female patient and reported that inadvertently administered a dose of DAPTACEL instead of ADACEL and inappropriate age at vaccine administration, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DAPTACEL (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 29 months old female patient who received PENTACEL but already had received ACT-HIB and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE at her 20 month visit. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE and HEPATITIS A VACCINE (administration site: left thigh). On 05-Nov-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5530AA in Right Thigh. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported. It was a case of actual medication error due to extra dose administered. It was unknown whether any adverse event occurred or not. 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: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site joint pain
Clinical narrative: PATIENT COMPLAINS OF SHOULDER JOINT PAIN IN THE DAYS FOLLOWING ADMINISTRTAION OF 2ND DOSE OF SHINGRIX VACCINE. THINKS THE VACCINE WAS INJECTED TOO HIGH ON HIS DELTOID. EXPLAINED TO THE PATIENT THE ROUTINE IN WHICH THE VACCINE WAS GIVEN. EXPLAINED THAT MY FINGERS WRAPPED AROUND THE DELTOID BEFORE INJECTING VACCINE INTO ARM TO ENSURE THAT VACCINE WAS BEING GIVEN PROPERLY INTO THE DELTOID MUSCLE.
Age: 23.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Concussion, Fall, Head injury, Skin laceration, Suture insertion
Clinical narrative: Pt fainted, hit head during fall, suffered scalp laceration, required sutures, on way home began throwing up, and sent to ER for concussion protocol.
Age: 23.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Syncope, Vomiting
Clinical narrative: Pt fainted, hit head during fall, suffered scalp laceration, required sutures, on way home began throwing up, and sent to ER for concussion protocol.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Recipient contacted Health Department on 10/15/18 reporting lingering left arm pain since flu vaccine administration. Reports pain, poor range of motion and inability to sleep on left side. Sought private physician evaluation and was sent for orthopedic evaluation. Reports she was cleared of any orthopedic anomaly and was prescribed anti-inflamatory medications.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Significant local reaction. Photographs  in medical records.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, PNC13
Symptoms: Gastrointestinal tube insertion, Pyrexia
Clinical narrative: Pt called and had a fever that went up to 104. Pt was seen in the clinic the next day.11/08/2019. Pt was still having a fever.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Diarrhoea, Haematochezia, Infantile spitting up, Mucous stools
Clinical narrative: Departed Emergency Room Hospital 11/07/18 8:23 PM 11/07/18 9:40 PM MD. Office visit on 11/08/2018: The patient presents with diarrhea. These symptoms began 3 days ago. He is not having fever or vomiting. Other comments include: decreased urine output. Had ROTATEQ on Mon. and Sx started on Tue. Yesterday w/6 episodes of bloody mucousy stools, today 3 episodes since 4 AM. Some spitting up. Dec. intake of ENF, only 1-3 oz/feeding, Q2-3HR. Voided 3-4x yesterday. Today voided 2x. Crying more freq, not typical.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urine output decreased
Clinical narrative: Departed Emergency Room Hospital 11/07/18 8:23 PM 11/07/18 9:40 PM MD. Office visit on 11/08/2018: The patient presents with diarrhea. These symptoms began 3 days ago. He is not having fever or vomiting. Other comments include: decreased urine output. Had ROTATEQ on Mon. and Sx started on Tue. Yesterday w/6 episodes of bloody mucousy stools, today 3 episodes since 4 AM. Some spitting up. Dec. intake of ENF, only 1-3 oz/feeding, Q2-3HR. Voided 3-4x yesterday. Today voided 2x. Crying more freq, not typical.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Band neutrophil count increased, Cellulitis, Neutrophil count increased, White blood cell count increased
Clinical narrative: Cellulitis to left arm.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site oedema, Injection site pain, Muscular weakness
Clinical narrative: Pain started 1 hour after receiving injection. Pain radiated from L shoulder to hand and fingers. Also reports L arm weakness, numbness, pain, like frozen shoulder now 2 weeks after injection. Initially treated with prednisone, acetaminophen and ice 10/29/18. Then prescribed tramadol and referred to orthopedist 11/9/18.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain started 1 hour after receiving injection. Pain radiated from L shoulder to hand and fingers. Also reports L arm weakness, numbness, pain, like frozen shoulder now 2 weeks after injection. Initially treated with prednisone, acetaminophen and ice 10/29/18. Then prescribed tramadol and referred to orthopedist 11/9/18.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: Left supraclavicular adenopathy 2 days s/p vaccination.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reports no allergies and had no symptoms until the day after receiving when the area of right upper arm became red. Day 2 of receiving this vaccine, the area of upper arm was very red and warm to touch; no induration but redness was approx. 65mmx85mm. She reports no fever, pain or itchiness. She reports never having a reaction to vaccine in past.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Staff RN administered an additional HIB to a patient during a clinic visit. Patient did not receive the Hep B as ordered by the provider.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Arm swelling, redness, and warmth at site of injection beginning several hours after the injection was given and worsening over the following day. She was taken to her pediatrician who gave her benadryl which decreased the swelling and discomfort. Her mother applied benadryl cream topically and gave bendryl by mouth over the next 48 hours until the discomfort subsided. Alternative manufacturer options were discussed with her mother so she can be given an alternative vaccine next year.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives develop has administration of Influenza vaccine at local pharmacy, sought treatment 1 day later at Urgent care.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Defaecation urgency, Electrocardiogram normal, Eye discharge
Clinical narrative: Within three hours of receiving flu vaccine from a Public Health Nurse at a flu clinic held at the local Senior Center on 11/7/2018, the client noticed tingling and mild numbness in his chin, followed by migration of sensations to throat with feeling of a lump in his throat; then his eyes began to hurt, became bloodshot, and thick mucous filled both eyes. Client developed a headache, all-over aches and pains, felt chilled and was shivering. Client developed abdominal distress with non-diarrheal evacuation and became very hot. Sensations slowly subsided after about 20 hours. He described this as a two-week course of the flu in 20 hours, and stated that he felt the same as he had 45 years ago when he had the only other flu shot of his life. He came to Public Health to report episode on 11/8/2018.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Feeling cold, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: Within three hours of receiving flu vaccine from a Public Health Nurse at a flu clinic held at the local Senior Center on 11/7/2018, the client noticed tingling and mild numbness in his chin, followed by migration of sensations to throat with feeling of a lump in his throat; then his eyes began to hurt, became bloodshot, and thick mucous filled both eyes. Client developed a headache, all-over aches and pains, felt chilled and was shivering. Client developed abdominal distress with non-diarrheal evacuation and became very hot. Sensations slowly subsided after about 20 hours. He described this as a two-week course of the flu in 20 hours, and stated that he felt the same as he had 45 years ago when he had the only other flu shot of his life. He came to Public Health to report episode on 11/8/2018.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Ocular hyperaemia, Pain, Paraesthesia, Sensation of foreign body
Clinical narrative: Within three hours of receiving flu vaccine from a Public Health Nurse at a flu clinic held at the local Senior Center on 11/7/2018, the client noticed tingling and mild numbness in his chin, followed by migration of sensations to throat with feeling of a lump in his throat; then his eyes began to hurt, became bloodshot, and thick mucous filled both eyes. Client developed a headache, all-over aches and pains, felt chilled and was shivering. Client developed abdominal distress with non-diarrheal evacuation and became very hot. Sensations slowly subsided after about 20 hours. He described this as a two-week course of the flu in 20 hours, and stated that he felt the same as he had 45 years ago when he had the only other flu shot of his life. He came to Public Health to report episode on 11/8/2018.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Influenza virus test, Nausea, Pain
Clinical narrative: Pt had flu like symptoms...low grade fever, chills, overall body aches, nausea, and headache. Pt got ZPAK and had flu test which was negative. Pt is feeling fine today 11/9/18.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt had flu like symptoms...low grade fever, chills, overall body aches, nausea, and headache. Pt got ZPAK and had flu test which was negative. Pt is feeling fine today 11/9/18.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site swelling, Local reaction
Clinical narrative: Local reaction, no signs of infection. May apply ice to help with swelling/ discomfort. Hydrocortisone PRN.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Left arm redness, inflammation, tenderness, and sore.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus, Injection site urticaria, Oedema, Pruritus
Clinical narrative: Pt received vaccine in AM at approximately 0845. Then, she returned to clinic at 1515 on the same day reporting pruritic hives (one on her left arm- lateral surface, 2nd on the superior area of her L shoulder, and 3rd on the top of her R shoulder. Lesions are erythematous, edematous, and not open or draining. The lesions are the size of dime or a nickel. Pt denies dyspnea and denies SOB. No facial or oropharyngeal edema.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Skin lesion, Urticaria
Clinical narrative: Pt received vaccine in AM at approximately 0845. Then, she returned to clinic at 1515 on the same day reporting pruritic hives (one on her left arm- lateral surface, 2nd on the superior area of her L shoulder, and 3rd on the top of her R shoulder. Lesions are erythematous, edematous, and not open or draining. The lesions are the size of dime or a nickel. Pt denies dyspnea and denies SOB. No facial or oropharyngeal edema.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Renal disorder
Clinical narrative: Patient states about 30 minutes after receiving the SHINGRIX vaccine he experienced left facial paralysis & problems with his kidneys which lasted a couple of days.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Left arm redness, inflammatiom, tenderness, and sore.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Arm pain following administration of PNEUMOVAX 23. Patient's wife reported that the pain started shortly after receiving the vaccination and initially the pain was localized to the injection site (left deltoid) but developed later to extend to cover the whole arm from shoulder to hand.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site swelling, Mobility decreased, Neck pain
Clinical narrative: 11/8/2018 5:30pm Headache, neck ache, difficulty moving arm, swollen injection site. 11/9/2018 5:00pm Mild headache, all other symptoms resolved.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Immediately after vaccine was given, pt had a small swollen lump at site of administration on his left arm. An ice pack was put on it for 10 minutes and patient was monitored. He felt okay, and after 10 minutes the swelling had gone down to almost nothing. Called patient at 5:05pm to check up on the patient. He reported he felt okay besides some muscle soreness and still a little swollen at site of injection. He was instructed to report to the pharmacy if anything changed or got worse.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Erythema, Pallor, Rash generalised, Rash papular
Clinical narrative: Rash started on 11/7/2018, on forehead and arms, now spread everywhere. Many scaterred 1-2 mm erythematous blanching papules on forehead, behind ears, back of neck, throughout trunk and arms. Blanching red spots on palms and soles.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Incontinence, Musculoskeletal stiffness, Mydriasis, Seizure
Clinical narrative: Pt had verified seizure after a vaccine for meningitis and HPV. The seizure was brief - about 2 min and was accompanied by shaking and stiff limbs, incontinence and a bitten tongue..heart rate was never low. His seizure occurred roughly about 1-2 min after the injection.  He has dilated pupils afterwards. We kept him for 25 min after his seizure cleared and he was normal on exam before he left.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Tongue biting, Tremor
Clinical narrative: Pt had verified seizure after a vaccine for meningitis and HPV. The seizure was brief - about 2 min and was accompanied by shaking and stiff limbs, incontinence and a bitten tongue..heart rate was never low. His seizure occurred roughly about 1-2 min after the injection.  He has dilated pupils afterwards. We kept him for 25 min after his seizure cleared and he was normal on exam before he left.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Erythema, Pain in extremity
Clinical narrative: PT BEGAN TO FEEL DIZZY AND SHORT OF BREATH LATER THAT EVENING. THE NEXT DAY HER ARM WAS SORE AND DEVELOPED BIG RED SPOTS ON HER ARM. 2 DAYS LATER SHE CAME TO THE PHARMACY TO REPORT IT. SHE STATED SHE WAS FEELING BETTER AND FOUND OUT LATER SHE HAD INNER EAR PROBLEMS. SYMPTOMS ARE LESSENING.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Poor quality sleep
Clinical narrative: Pt received the vaccine at 4pm on 11/6/18. By that evening, his left arm was sore.  He awoke at 3 am due to arm pain, slept poorly due to pain. Arm was swollen, but not red, and difficult to move. Took ibuprofen/TYLENOL with miminal relief. Icing helped temporarily. Called our clinic the next day, was asked to continue same treatment and be seen the next day if not better. Seen on 11/8/18, as symptoms didn't improve. Presented with swelling in left deltoid, difficulty moving arm, minimal redness. No sign of infection or cellulitis. Pt went out of town on 11/9/18, so unsure whether symptoms have resolved. Pt was given NORCO for pain.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Pt received the vaccine at 4pm on 11/6/18. By that evening, his left arm was sore.  He awoke at 3 am due to arm pain, slept poorly due to pain. Arm was swollen, but not red, and difficult to move. Took ibuprofen/TYLENOL with miminal relief. Icing helped temporarily. Called our clinic the next day, was asked to continue same treatment and be seen the next day if not better. Seen on 11/8/18, as symptoms didn't improve. Presented with swelling in left deltoid, difficulty moving arm, minimal redness. No sign of infection or cellulitis. Pt went out of town on 11/9/18, so unsure whether symptoms have resolved. Pt was given NORCO for pain.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Patient stated she started experiencing coughing, wheezing and shortness of breath the day after she received her 2nd Hep. B vaccine. She stated she also remembers experiencing the same symptoms after she received her 1st Hep. B vaccine, but didn't think anything of it at the time. She stated after the 2nd vaccine she was sure the coughing, wheezing and shortness of breath was due to her vaccine. Her vaccine was administered on 10/16/18. She decided to see her physician on 11/3/18 to seek care.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient reported that events started the evening of the vaccination, with redness, swelling, and pain at and around the injection site, including shooting pain down his arm and tingling sensation in the fingers. He came in to the pharmacy on 11/9/18 saying the pain was still present around the injection site, with lessening redness and swelling to the right of the injection site. He said it was not itchy or hot, but still painful. He had tried using ice on it, but didn't get any relief from that. He was going to try diphenhydramine today when he left.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Patient reported that events started the evening of the vaccination, with redness, swelling, and pain at and around the injection site, including shooting pain down his arm and tingling sensation in the fingers. He came in to the pharmacy on 11/9/18 saying the pain was still present around the injection site, with lessening redness and swelling to the right of the injection site. He said it was not itchy or hot, but still painful. He had tried using ice on it, but didn't get any relief from that. He was going to try diphenhydramine today when he left.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient showed redness at the site of the injection. It didn't appear swollen, and the patient said it doesn't hurt and has full mobility of her arm. She was instructed to put ice at the site for 20 minutes off and on and the pharmacy will call her in 2 days time to follow up on her.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Exposure via skin contact, Immunisation, Syringe issue
Clinical narrative: The BD Integra syringe used for administration was faulty. The vaccine came out of the back of the syringe when the plunger was pushed. A second injection was made with the patient's consent since the first injection had run down his arm.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt presented with itching, swelling  and redness around the injection site in the upper right arm all the way to the elbow.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site discomfort, Malaise
Clinical narrative: Some soreness in right upper arm where shot was given for 30 hours. However, by the next morning (Nov. 8) I suffered from a general tiredness and malaise which lasted most of the day.  I had the same experience when I had the first shot (Aug. 24, 2018) at a different pharmacy (hence a different batch).
Age: 15.0
Sex: U
Vaccine: FLU4, HPV9
Symptoms: Migraine, Pharyngeal oedema
Clinical narrative: Mother reported patient had a reaction to the immunizations. Had a migraine headache and was feeling some throat swelling. Was given a Claritin and this helped with throat swelling. Went to medical provider PA-C. Was given a shot of Toradol for the headache. Took Benadryl later that evening and the next day with relief.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Lethargy, Pain in extremity, Rash
Clinical narrative: Chills, weakness, lethargic, pain in arm that received injection, rash.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injection site pain
Clinical narrative: INJECTION SITE IS PAINFUL AND HARD TO THE TOUCH AND ARM IS INFLAMED. PAIN WORSENS  WHEN I MOVE MY ARM. I HAVE AN APPOINTMENT TOMORROW TO SEE MY PHYSICIAN.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Skin swelling, Skin warm
Clinical narrative: Red  -  swollen  - hot to tough  -   measured in two areas 18x20 and 50x50.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Patient called 7 weeks after getting the imz to state that his shoulder has been hurting intermittently.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Laboratory test normal, Loss of consciousness
Clinical narrative: 11/7/18....  reported tiredness 11/8/18.... tiredness ongoing, dizziness started around 6:30pm, passed out, went to ER, all tests run there checked out normal 11/9/18....  tiredness, dizziness, nausea and vomiting, went to Doctor today, given ZOFRAN, better this evening but still "not himself".
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: 11/7/18....  reported tiredness 11/8/18.... tiredness ongoing, dizziness started around 6:30pm, passed out, went to ER, all tests run there checked out normal 11/9/18....  tiredness, dizziness, nausea and vomiting, went to Doctor today, given ZOFRAN, better this evening but still "not himself".
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient described symptoms of possible bursitis. Patient complained of lingering pain, and no mobility in arm where injection was given.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Pain, Rash, Skin warm
Clinical narrative: Local swelling, redness up to the shoulder, warm to touch, 3 inch rash in a curve around the arm, temperature of 100.6, pain that radiates.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Local swelling, redness up to the shoulder, warm to touch, 3 inch rash in a curve around the arm, temperature of 100.6, pain that radiates.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient received her 2nd dose of SHINGRIX on 11/7/18, and the next night she developed two small spots of shingles, perhaps 1/2 inch in diameter. She had received her 1st dose on 07/01/2018 and developed shingles on 10/3/18. She stated she no longer had the rash present from her October shingles outbreak, so it was determined ok to give the 2nd shot based on recommendations. She went to the doctor and was treated with valacyclovir 1 gram tid for 7 days for both shingles episodes. Keep in mind she is being treated for chronic leukemia with SPRYCEL. It appears she did receive a quadrivalent influenza vaccine on 10/27/2018. She did not receive it at our facility but I was able to look it up in a statewide vaccination database.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported continued arm pain since 10/3/2018. She went to her physician reporting that she has not been able to lift her arm since the vaccine. The physician recommended physical therapy.
Age: 19.0
Sex: F
Vaccine: FLUC4, HEP
Symptoms: Posture abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: After administration of the flu and Hep B dose 2 of the series, the patient fainted for approximately 10 seconds. She was sitting in a chair and begin slouching down and lowered her head. I asked if she was ok and received no response. I lowered patient to the floor, and laid her flat on her back and began to sternal rub her. She arouse to this. Vital signs were taken and stable. She remained conscious and lying down for about 10 minutes following the episode. Father was in the waiting area and notified of the event. She denied headache, blurry vision, confusion, difficulty breathing, shortness of breath or other associated symptoms. Had patient arise slowly from a lying position to a sitting position after 10 minutes. Patient remained sitting for another 10 minutes or so. She continued to deny ill feelings or effects following the episode. Following the episode she and father stated that she has had similar fainting episodes with blood draws, but never vaccines. Advised to follow up with PCP or Urgent Care in 1-2 days for re evaluation. Advised to report to ER if symptoms of fainting return or other associated symptoms present. Patient understands and agrees with plan of care. No further action taken.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Mania
Clinical narrative: The patient's wife asked me if any mental health type side effects had been reported with SHINGRIX, and I looked it up and said I couldn't find anything. She stated that her husband had been diagnosed with being bipolar for a long time, but that a few days after receiving his 1st SHINGRIX dose he went into a very scary manic episode. She did not provide me with any details besides that he was hospitalized. She wasn't sure if this was necessarily the cause but found the timing peculiar. She did not state whether this was the worse episode he has ever had, but I have known them for 3 and 1/2 years and I haven't heard of any other episodes prior to this. She said it seemed that he was on a steady but slow upward slide with his manic state and a few days after receiving the shot it appeared to be more precipitated. I stated I would at least report the information.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in shoulder/arm....injection sight looked too high in arm.