chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives over most of body with groupings on torso and head. Took BENADRYL and applied Cortisone cream with relief of symptoms x 2 days.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Local reaction, Rash
Clinical narrative: The area where she had vaccinaton on right leg swelled up. PCV 13 was given in this location. It was red and bruised. We had discussed this and determined this was a local vaccination reaction. She did not have systemic symptoms. Mom had kept and eye on it. The redness and swelling have gone down. Seen for office visit on 10/8  she felt warm and had first fever. She has had a rash on her cheek. She has not had runny nose. No ear pain. No diarrhea or emesis. No cough or congestion. She is walking on leg normally. No additional concerns.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Left sided facial swelling after receiving an influenza injection at Daycare. No anaphylaxis-or trouble swallowing, or rash.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Intussusception, Urine analysis
Clinical narrative: Clinical intermittent intussusception.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body ache, shivering. Taking ibuprofen and acetaminophen. Still experiencing side effects at 24 hours post vaccination.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site exfoliation, Injection site extravasation, Injection site pain, Injection site swelling
Clinical narrative: 10/02 patient presented to office with left upper arm painful and red. Physical exam left arm over bicep muscle red, warm, swollen. Patient started on AUGMENTIN 500mg two times a day for 10 days. Recommended warm compresses. 10/08 patient seen for follow up. Left arm red, scaly and weeping however showed some improvement from 10/02. Patient to continue taking AUGMENTIN and warm compresses.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: 10/02 patient presented to office with left upper arm painful and red. Physical exam left arm over bicep muscle red, warm, swollen. Patient started on AUGMENTIN 500mg two times a day for 10 days. Recommended warm compresses. 10/08 patient seen for follow up. Left arm red, scaly and weeping however showed some improvement from 10/02. Patient to continue taking AUGMENTIN and warm compresses.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: During the night I woke with shivers, then am was hot and sweating. Also fighting a headache and sensitive stomach. And yes my left arm is quite sore as it was with the first shot.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: During the night I woke with shivers, then am was hot and sweating. Also fighting a headache and sensitive stomach. And yes my left arm is quite sore as it was with the first shot.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pyrexia, Wheezing
Clinical narrative: Pt said experieced Flu like symptoms over night(Fever, Chills, Wheezing). Said fever broke around 3:30am the following morning.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Blood test, Chest X-ray, Chills
Clinical narrative: Chills; Shortness of Breath; Back ache on left side; nausea; lack of appetite; no energy; red, itchy rash on entire torso of my body. Low grade ever (100). Treatment: Methylpred 4mg Pak Trige; Began treatment on 9/17/2018
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dyspnoea, Nausea, Pyrexia, Rash erythematous
Clinical narrative: Chills; Shortness of Breath; Back ache on left side; nausea; lack of appetite; no energy; red, itchy rash on entire torso of my body. Low grade ever (100). Treatment: Methylpred 4mg Pak Trige; Began treatment on 9/17/2018
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Ultrasound kidney
Clinical narrative: Chills; Shortness of Breath; Back ache on left side; nausea; lack of appetite; no energy; red, itchy rash on entire torso of my body. Low grade ever (100). Treatment: Methylpred 4mg Pak Trige; Began treatment on 9/17/2018
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Nausea, Vertigo
Clinical narrative: Patient post vaccine had severe vertigo that caused the patient to be nauseous and sick to her stomach. Still has vertigo as of 10/9/2018 no treatment in place and no outcomes yet.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: After giving pt vaccine, pt had swelling at site of injection. I explained that some people do have this reaction, but had pt stay in store for a while to be sure didn't get worse. Pt said she felt fine and had no pain or other issues after waiting. Before she left, I checked arm and swelling had gone down some. Pt stated she would go home and watch to be sure and would call if any questions. She again said she was fine and wanted to go home.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Irritability, Wrong product administered
Clinical narrative: VARIVAX, MMR, PREVNAR and Flu were ordered, but PROQUAD was given instead of the MMR. Notified provider and parent of incident. Called to follow up with mother on 10/8 and patients were doing well, denies redness or swelling at vaccines sites. Denies fever or fussiness 10/8. She stated patient and his twin were fussy 10/5 & 10/6.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: VARIVAX, MMR, PREVNAR and Flu were ordered, but PROQUAD was given instead of the MMR. Notified provider and parent of incident. Called to follow up with mother on 10/8 and patients were doing well, denies redness or swelling at vaccines sites. Denies fever or fussiness 10/8. She stated patient and his twin were fussy 10/5 & 10/6.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Breast swelling, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Lymphadenopathy and swelling of the left axilla and breast.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscle strain, Pain in extremity
Clinical narrative: Strain and pain in left arm, limiting motion for over 10 days now. Acute pain during the night.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to several female patients of unknown age. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies were provided. On an unknown date, it was reported that the patients were vaccinated with PNEUMOVAX 23 (lot number, expiration date, route of administration and dose were not provided) for prophylaxis. On an unknown date, several women experienced rash after vaccination with PNEUMOVAX 23. The outcome of the events and relatedness between the event rash and the PNEUMOVAX 23 were not provided. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1810USA000461.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R013565, expiry date 13-MAY-2020 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent. The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F (10.6F) for 96 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002750.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R013565, expiry date 13-MAY-2020 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent. The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F (10.6F) for 96 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002745.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored M-M-R II rHA lot number N014482 with expiration date of 10-MAY-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) and Merck sterile diluent for prophylaxis (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion 47.3 °F for 50 minutes and 34.9 °F for 1 hour. There was previous temperature excursion reported as 47.5F 48 minutes and 35.4F for 30 minutes. A "data logger" was involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1810USA003389: US-009507513-1810USA003390.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot number M034187 with expiration date of 17-MAY-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) and Merck sterile diluent for prophylaxis (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion 47.3 degrees F for 50 minutes and 34.9 degrees F for 1 hour. There was previous temperature excursion reported as 47.5F 48 minutes and 35.4F for 30 minutes. A "data logger" was involved. This is one of several cases received from  the same reporter. Sender's Comments: US-009507513-1810USA002882; US-009507513-1810USA003390.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored M-M-R II rHA lot number N014482 with expiration date of 10-MAY-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) and merck sterile diluent for prophylaxis (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion 47.3F for 50 minutes and 34.9F for 1 hour. There was previous temperature excursion reported as 47.5F 48 minutes and 35.4F for 30 minutes. A "data logger" was involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1810USA003389: US-009507513-1810USA002882.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: SHINGRIX vaccine - 50mcg/0.5 ml susr. First of 2 doses. Received shot the afternoon of 10/4/18. I have never had side effects from a vaccine, including flu and tetanus, not even soreness. In this case, there was pain, redness, and swelling within hours at the shot site (upper right arm). Had no trouble going to sleep, and I usually sleep well through the night, but woke up hours early and couldn't get back to deep sleep due to discomfort and disturbed brain. Significant pain at shot sight - couldn't rest on that side, and discomfort with arm movement. Low-grade fever and general body aches, both of which were relieved by ibuprofen. Two days since vaccine (today is 10/6), and sleeping fine, other disturbances gone, but still significant pain, redness, and some swelling at shot site. Not looking forward to dose 2 in a few months!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: SHINGRIX vaccine - 50mcg/0.5 ml susr. First of 2 doses. Received shot the afternoon of 10/4/18. I have never had side effects from a vaccine, including flu and tetanus, not even soreness. In this case, there was pain, redness, and swelling within hours at the shot site (upper right arm). Had no trouble going to sleep, and I usually sleep well through the night, but woke up hours early and couldn't get back to deep sleep due to discomfort and disturbed brain. Significant pain at shot sight - couldn't rest on that side, and discomfort with arm movement. Low-grade fever and general body aches, both of which were relieved by ibuprofen. Two days since vaccine (today is 10/6), and sleeping fine, other disturbances gone, but still significant pain, redness, and some swelling at shot site. Not looking forward to dose 2 in a few months!
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable Other HCP via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, at single dose and SHINGRIX, both via an unspecified route of administration on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. Pneumococcal 13-val conj vac (dipht crm197 protein) and varicella zoster vaccine rge (cho) were given concomitantly there was more swelling. Information on the batch number has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Eyelid rash, Injection site rash, Rash
Clinical narrative: This is a spontaneous report from a contactable other-HCP (registered medical assistant) calling for the doctor. A 17-year-old Caucasian female patient received the 1st dose of TRUMENBA, ( lot # TS2805 or T52805, it looks S to the reporter at the moment, as reported, Expiry Date Aug2019) intramuscular at 0.5 mg, single on 25Sep2018 for immunisation. The patient medical history and concomitant medications were none. The patient experienced a rash around the site and on the face starting underneath the eyes and then on top of eye lids on 26Sep2018. She took BENADRYL on 27Sep2018 for it. The outcome of the events was not recovered. Lab work were none. Causality was reported as related.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist reported that the patient did not want subsequent PNEUMOVAX 23 shot because their first pneumococcal shot, the year before this report, of pneumococcal 13-val conj vac (dipht crm197 protein) was too painful. The pharmacist further specified that the patient received pneumococcal 13-val conj vac (dipht crm197 protein) the year before this report and her arm was uncomfortable and sore to sleep on. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is first of two reports. A patient of an unspecified age and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist reported that the patient did not want subsequent PNEUMOVAX 23 shot because their first pneumococcal shot, the year before this report, of pneumococcal 13-val conj vac (dipht crm197 protein) was too painful. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018401777 same reporter, suspect drug and event, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A patient of an unspecified age and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist reported that the patient did not want subsequent PNEUMOVAX 23 shot because their first pneumococcal shot, the year before this report, of pneumococcal 13-val conj vac (dipht crm197 protein) was too painful. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018401776 same reporter, suspect drug and event, different patients.
Sex: M
Vaccine: MENB
Symptoms: Chills, Lethargy, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 17-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician would like and information on meningitis like symptoms, such as neck stiffness, lethargy and chills after a dose of meningococcal group B rlp2086. This patient was involved. Outcome of the events was unknown.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 69-year-old female patient received PREVNAR 13, via an unspecified route of administration on 04Oct2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle pain on an unspecified date. Outcome of the event was unknown. Information on batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Ear pain, Influenza like illness, Limb discomfort, Secretion discharge, Upper respiratory tract infection
Clinical narrative: This is a spontaneous report from a contactable consumer. A 71-year-old female patient received PREVNAR 13 (Lot number and Expiration date were not reported), with route of administration unspecified in Oct2017 at a single dose as pneumonia vaccine. Medical history included cancer and high blood pressure, both were ongoing; and a family history of pneumonia (husband died from pneumonia). Concomitant medications included an unspecified blood pressure medication. In Jan2018, the patient had ear ache; and a lot of mucous. On an unspecified date, the patient had flu-like symptoms; and had some discomfort in her arm when getting a flu shot; and had an upper respiratory infection. The outcome of the events was not recovered for 'ear ache' and 'a lot of mucous'; and was unknown for all the other events.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Rash maculo-papular, Skin warm
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 03-Oct-2018 from a other health care professional. This case involves a 71 years old female patient who experienced macular papular rash (red and hot), low grade fever, chills and body aches, while she received vaccine FLUZONE HIGH DOSE, TYLENOL 8 HOUR, PREDNISONE and CEFADROXIL [BID]. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI981AA, expiration date: 16-Mar-2019 via intramuscular route in the left deltoid. On an unknown date, the patient received a dose of TYLENOL 8 HOUR, PREDNISONE 10 mg and BID (CEFADROXIL). On an unknown date, the patient developed a non-serious macular papular rash (red and hot), low grade fever, chills and body aches (Unknown latency) following the administration of vaccine FLUZONE HIGH DOSE, TYLENOL 8 HOUR, PREDNISONE and CEFADROXIL [BID]. Other relevant tests included no lab data. Final diagnosis was body aches, chills, low grade fever and macular papular rash (red and hot). It was not reported if the patient received a corrective treatment. The patient outcome is unknown for all the events. List of documents held by sender : none.
Sex: F
Vaccine: FLU3, TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old female patient who received vaccine FLUZONE HIGH DOSE inadvertently. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TENIVAC for Immunization. On 02-Oct-2018, the patient received a Dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AA expiry date: 04-Sep-2019 via unknown route in the right deltoid. It was case of actual medication error due to Inappropriate age at vaccine administration and overdose. No side effects 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. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from non health care professional. This case involves an 86 years old male patient who was vaccinated with a dose of Flu shot in September of 2018 and also a 0.5 mL dose of FLUZONE HIGH DOSE (lot number: UA994AA and expiry date: 09-Apr-2019) via intramuscular route in the left arm on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 55 years old patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE  SUBVIRION VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. It was unknown whether 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.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Paraesthesia, Pharyngeal oedema, Pharyngeal paraesthesia
Clinical narrative: Had the FLULAVAL vaccine. I've never had an issue with any vaccine before, including the flu vaccine. I started to experience tingling moving up my arm to my face and throat. My throat swelled shut, I was unable to breathe. An EPIPEN was administered.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eczema, Fatigue, Injection site pain, Lethargy, Pain
Clinical narrative: Had the FLULAVAL vaccine. I've never had an issue with any vaccine before, including the flu vaccine. I started to experience tingling moving up my arm to my face and throat. My throat swelled shut, I was unable to breathe. An EPIPEN was administered.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Pharyngeal oedema, Pruritus
Clinical narrative: Had the FLULAVAL vaccine. I've never had an issue with any vaccine before, including the flu vaccine. I started to experience tingling moving up my arm to my face and throat. My throat swelled shut, I was unable to breathe. An EPIPEN was administered.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: 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 consumer/non-health care professional. This case involves an eight months old male patient and reported that 8 months, received an early dose of FLUZONE QUADRIVALENT, 0.25 ml, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 14-Sep-2018, the patient received a first 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6259NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abnormal faeces, Asthenia, Faeces discoloured, Flatulence, Gastrointestinal sounds abnormal
Clinical narrative: Pneumococcal Conjugate 13-Valent - PREVNAR 13 shot side affects: Constant gurgling stomach, gas, blackish green stools, raucous smell, 17 days and counting. Tried PEPTO-BISMOL, symptoms still with me. Have MS, weakness, numbness and spasticity in legs constant and greatly increased. Still waiting for symptoms to pass.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Muscle spasticity
Clinical narrative: Pneumococcal Conjugate 13-Valent - PREVNAR 13 shot side affects: Constant gurgling stomach, gas, blackish green stools, raucous smell, 17 days and counting. Tried PEPTO-BISMOL, symptoms still with me. Have MS, weakness, numbness and spasticity in legs constant and greatly increased. Still waiting for symptoms to pass.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypersomnia, Influenza, Nausea, Pain
Clinical narrative: After receiving the flu shot on Saturday, Oct. 6th, woke up Sunday Oct. 7th. With body ache, headache, nausea, and slept all day. Definitely flu symptoms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: Patient reported that she will not be receiving 2nd dose of SHINGRIX because after 1st dose given on 9/10/18 she developed a break out of herpes zoster in her mouth and her inner lip, she had to take valacyclovir for her breakout. She normally takes valacyclovir for PRN breakouts, but this one was more severe than normal.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient stated she had fever, chills, aches and pain from SHINGRIX and/or Flu vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Headache, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Received FLUZONE at my son's pediatrician office the morning of 10/6/2018. Twenty four hours later developed fever of 100.4; severe headache, lower back pain and lethargy. Injection site swelled and turned very red (area of swelling and redness close to 5 inches in diameter). Fever resolved by 10/7, headache was dulled but not resolved. Back pain has resolved.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Received FLUZONE at my son's pediatrician office the morning of 10/6/2018. Twenty four hours later developed fever of 100.4; severe headache, lower back pain and lethargy. Injection site swelled and turned very red (area of swelling and redness close to 5 inches in diameter). Fever resolved by 10/7, headache was dulled but not resolved. Back pain has resolved.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Hypoaesthesia, Muscle spasms, Neck pain, Paraesthesia
Clinical narrative: Client's mother contacted clinic on Friday 10/05/2018 stating that patient didn't go to school today because she has been having following symptoms since received TDaP vaccine yesterday: 15 minutes after getting her vaccine, in the car she started having tingling, numbness in her left arm, cramps and tingling in both legs, back and neck pain. When asked about her immunizations previously, mother stated that she had her first vaccines at age 3 and was given only 1 vaccine at a time and didn't have any reactions or side effects and her vaccines were spaced. On day of vaccination client was advised to wait in waiting room for 15 minutes per our policy, she was not complaining of any problems right after receiving TDaP vaccine and stated that she expected to have more pain. Mother was instructed to contact PMD regarding this problem, or go to local ER if client's condition worsens, and also let our clinic know how her daughter is doing. On October 9th mother was contacted to f/u on her daughter's condition and she stated that patient was feeling better and went to school today.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Heart rate increased, Impaired work ability, Nausea
Clinical narrative: Dizziness, nausea, very high heart rate, weakness, low grade fever. Missed 1.5 days of work. Treatment by rest and liquids.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Dizziness, nausea, very high heart rate, weakness, low grade fever. Missed 1.5 days of work. Treatment by rest and liquids.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine administered at 11:30 am, noticed itching, swelling, redness from shoulder to elbow and burning at 2:00 pm, reported to nurse at 2:20 pm and she administered BENADRYL 25 mg per company policy, and instructed to apply ice and report if symptoms worsened. Instructed to take another 25 mg BENADRYL 4-6 hours later if symptoms returned. Instructed to seek medical care for any symptoms of itching or swelling of throat or difficulty breathing. Follow-up on 10/9/2018: All symptoms resolved later that evening with some slight soreness at the sight lingering a day or so.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Experienced significant edema and redness at injection sight and severe pain for greater than 3 days. Mobility was severely impacted. Patient could not put on or remove shirt without assistance and required passive ROM in her right shoulder for one week to assist with improving mobility. In comparison, she had MenACWY vaccine in left deltoid the same day with no impairment in mobility or complaints. Patient typically has a high pain tolerance; has had knee surgery and broken wrist with minimal complaints during recovery. The pain following TRUMENBA was severe. Redness and swelling were greater than 10 cm for 3 days. No rash (other than the erythema) or respiratory or GI symptoms were noted.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Swelling
Clinical narrative: Experienced significant edema and redness at injection sight and severe pain for greater than 3 days. Mobility was severely impacted. Patient could not put on or remove shirt without assistance and required passive ROM in her right shoulder for one week to assist with improving mobility. In comparison, she had MenACWY vaccine in left deltoid the same day with no impairment in mobility or complaints. Patient typically has a high pain tolerance; has had knee surgery and broken wrist with minimal complaints during recovery. The pain following TRUMENBA was severe. Redness and swelling were greater than 10 cm for 3 days. No rash (other than the erythema) or respiratory or GI symptoms were noted.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, Irritability, Wrong product administered
Clinical narrative: MMR, Varicella, PREVNAR and Flu ordered. PROQUAD given instead of MMR. Patient did not have signs of adverse reaction at time of visit. Notified mother and provider of incident. Called to follow up with mother 10/8/18 and she stated pt and his twin brother were fussy 10/5 & 10/6, but are now acting well. Denies fever, fussiness, redness or swelling at vaccine administration sites.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MMR, Varicella, PREVNAR and Flu ordered. PROQUAD given instead of MMR. Patient did not have signs of adverse reaction at time of visit. Notified mother and provider of incident. Called to follow up with mother 10/8/18 and she stated pt and his twin brother were fussy 10/5 & 10/6, but are now acting well. Denies fever, fussiness, redness or swelling at vaccine administration sites.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Immediate post-injection reaction, Pyrexia, Urticaria
Clinical narrative: 1545 immediately after giving DEPO and Flu vaccine to patient, Mom brought patient back for allergic reaction. Hives noted, one on her R hand, L foot, and then one under her eye. Denies SOB, difficulty breathing, fast heartbeat, dizziness, weakness or swelling of the face or throat. Mom immediately gave her daughter BENADRYL. Dr aware, and at bedside. Will continue to monitor patient longer. 1615 patient discharged home, ok per Dr. Note pt had fever to 102 the next day.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Neuralgia
Clinical narrative: Neurological pain and weakness. Patient went to ER and was admitted to hospital as well for 2 days. Patient was treated with Gabapentin and Norco.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Patient describes headache and waves of nausea since vaccine, with arm pain from vaccine site down to wrist. Today (the next day) has shoulder pain. Last night had chills followed by fever of 104 today. Feels fatigued.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Patient describes headache and waves of nausea since vaccine, with arm pain from vaccine site down to wrist. Today (the next day) has shoulder pain. Last night had chills followed by fever of 104 today. Feels fatigued.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per pt, C/O chills, fever, body weakness, pain to the site and swollen. Warm to the touch after the Tdap shot. Scheduled pt to come back on the 4th and have it checked. Medications: Ibuprofen 600mg Tab, KEFLEX 500 mg Cap, Prednisone 20 mg tab and TYLENOL #3 300-30mg tab was given to pt for treatment. Try calling pt multiple times after office visit to check on pt, but pt didn't answer the phone calls.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Per pt, C/O chills, fever, body weakness, pain to the site and swollen. Warm to the touch after the Tdap shot. Scheduled pt to come back on the 4th and have it checked. Medications: Ibuprofen 600mg Tab, KEFLEX 500 mg Cap, Prednisone 20 mg tab and TYLENOL #3 300-30mg tab was given to pt for treatment. Try calling pt multiple times after office visit to check on pt, but pt didn't answer the phone calls.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: C/O pain, redness at injection site, pain extending down right arm (no time documented). Slight erythema noted at site of injection with minimal swelling. Local reaction. BENADRYL 50 MG at 12:20 PM; Cold compress, BENADRYL PRN. To Clinic if no improvement. As documented per Medical Event at School. School of Pharmacy students administered flu vaccine. 10-09-18 per School of Pharmacy Students and Pharmacist, two(2) other recipients of flu vaccines with same lot number C/O localized reactions. Evaluated by medical personnel at Event 10-06-18, cold compresses applied. No other treatment. The information needed to complete VAERS report on the other two(2) flu vaccine recipients were unavailable, Health Nurse.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Around 6pm experienced: Pain, redness, soreness, swelling at site and headaches, muscle aches at site. On 10/19/18 - still has redness, soreness, pain, warmth, some swelling, muscle ache, headache but treated with TYLENOL.
Sex: U
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from a Pharmacist on 03-Oct-2018. This case involves a patient (reported as senior, age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date, instead of FLUZONE HIGH DOSE. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered (reported as FLUZONE QUADRIVALENT was administered to a senior inadvertently. Was intended for senior to receive FLUZONE HIGH DOSE). It was unknown whether patient experienced any adverse event following vaccination. 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves 69 year old female patient who received two 0.5 ml dose of FLUZONE HIGH DOSE (batch number UI985AC, expiry date 22 Mar 2019, route and site of administration were not reported) on 24 Sep 2018 and again on 01 Oct 2018. It was a case of actual medication error as Extra dose administered. It was unknown if any adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 93.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case involves 93 year old patient who received two 0.5 ml dose of FLUZONE HIGH DOSE (batch number UI999AA, expiry date 06 April 2019 intramuscularly in right deltoid on 03 Oct 2018 at 11:30 am. It was reported that, patient also received INFLUENZA VACCINE few days ago. It was a case of actual medication error as Extra dose administered as patient had the FLUZONE HIGH DOSE vaccine given to him today, 10/03/2018 at 11:30 am. His family found him there and explained he just had a flu shot at the hospital a few days ago and this was his second flu shot. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional (physician assistant). This case involves a 10 years old male patient who was vaccinated with a dose of suspect IPOL, lot N1J451M, expiry date: 05-Oct-2019 via unknown route in the right deltoid on 02-Oct-2018, which was improperly stored. The patient's past vaccination(s) included Polio Vaccine with 3 Oral and 2 inactivated. The patient's past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that temperature excursion occurred and reached a low temp of 32.7 F for total time of 3 hours and 58 minutes. It was reported that no known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swollen left arm twice the size, red, itching, rash, pain, loss of arm mobility.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Swollen left arm twice the size, red, itching, rash, pain, loss of arm mobility.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Hives for 12-18 hours - red, hot, swollen arm, 24hrs later.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen arm from shoulder to elbow pain and hot to touch can't lift left arm without pain steroid shot 10/9/18.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Swollen arm from shoulder to elbow pain and hot to touch can't lift left arm without pain steroid shot 10/9/18.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Retching
Clinical narrative: Leg pain, nausea (dry heaves), beginning in middle of night per spouse.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Within 2 minutes of receiving the flu vaccine in RD client C/O itching all over with body rash noted.  Immediately gave 12.5mg of Benadryl liquid and within 10 minutes of the Benadryl the itching stopped and the rash was gone in 20 minutes. No signs of respiratory distress noted. BP=119/76  with P=63. Rechecked BP in 5 minutes and it was 116/69 and P=66.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Dyspnoea, Heart rate increased, Hypoaesthesia, Malaise
Clinical narrative: Employee was administered AFLURIA QUADRIVALENT flu Vaccine Lot # YF40008 on 10/5/18 during hospital wide flu clinic. Employee left to go home @ 1430, came back to ER with increased temperature of 103.5, Shortness of breath, malaise, increased HR, numbness feeling in upper and lower extremities.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Depression, Dysstasia, Gait disturbance, Hypoaesthesia
Clinical narrative: Numbness in legs, arms and face. Was difficult to stand and walk. Insomnia and night sweats. Anxiety and depression since the flu vaccine. I take medication for and they have been working well for years until I received my flu shot.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Night sweats
Clinical narrative: Numbness in legs, arms and face. Was difficult to stand and walk. Insomnia and night sweats. Anxiety and depression since the flu vaccine. I take medication for and they have been working well for years until I received my flu shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm swollen, itchy, started 10/6. Not gotten worse or better as of 10/8.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Malaise, Nightmare
Clinical narrative: Nightmare side effects, didn't feel great but didn't feel very sick.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, CSF test normal, Chills, Fatigue, Kernig's sign
Clinical narrative: About 2-3 hrs afterward, pt started having body aches, sore throat, chills, fatigue, nausea and joint pain.