chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 17 years old patient who experienced painful linear "rash" all the way across and under both breast, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included Flu vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was none reported as No other vaccine was given. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6301LA via unknown route in the right deltoid. On an unknown date, the patient developed a non-serious painful linear "rash" all the way across and under both breast (rash) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was painful linear "rash" all the way across and under both breast. It was not reported if the patient received a corrective treatment. It was also reported that Pharm D recommended Hydrocortisone cream and Benadryl. The patient outcome is reported as Unknown for painful linear "rash" all the way across and under both breast. List of documents held by sender: none.
Sex: F
Vaccine: DTP, FLUX, PNC13
Symptoms: Chest pain, Costochondritis, Fall, Influenza, Lymphadenopathy
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional via other company (Pfizer). This case involves a 65 years old female patient (96.62 kg) who experienced costochondritis, severe chest pain, swollen lymph nodes under the arm, flu and feeling sick and fell and broke arm, while she received vaccines PREVNAR 13, INFLUENZA VACCINE and DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. 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 VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious costochondritis following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious severe chest pain (chest pain) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious swollen lymph nodes under the arm (lymphadenopathy) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious flu and feeling sick (malaise) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious fell and broke arm (upper limb fracture) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. (Other relevant tests included No lab data.) Final diagnosis was fell and broke arm, flu and feeling sick, swollen lymph nodes under the arm, severe chest pain and costochondritis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for costochondritis, as Recovered / Resolved on an unknown date for severe chest pain, as Unknown for swollen lymph nodes under the arm, as Unknown for flu and feeling sick and as Unknown for fell and broke arm. List of documents held by sender: none.
Sex: F
Vaccine: DTP, FLUX, PNC13
Symptoms: Malaise, Upper limb fracture
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional via other company (Pfizer). This case involves a 65 years old female patient (96.62 kg) who experienced costochondritis, severe chest pain, swollen lymph nodes under the arm, flu and feeling sick and fell and broke arm, while she received vaccines PREVNAR 13, INFLUENZA VACCINE and DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. 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 VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious costochondritis following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious severe chest pain (chest pain) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious swollen lymph nodes under the arm (lymphadenopathy) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious flu and feeling sick (malaise) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. On an unknown date, the patient developed a non-serious fell and broke arm (upper limb fracture) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE, following the administration of INFLUENZA VACCINE and following the administration of PREVNAR 13. (Other relevant tests included No lab data.) Final diagnosis was fell and broke arm, flu and feeling sick, swollen lymph nodes under the arm, severe chest pain and costochondritis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for costochondritis, as Recovered / Resolved on an unknown date for severe chest pain, as Unknown for swollen lymph nodes under the arm, as Unknown for flu and feeling sick and as Unknown for fell and broke arm. List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA291015 (10 year old patient). This case involves a 7 years old male patient who received a pediatric dose 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259NA and expiration date 30-Jun-2019) via intramuscular route in the left deltoid on 13-Oct-2018. The patients past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was not reported if the patient experienced 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  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: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA291005. This case involves a  10 years old male patient who received a pediatric dose 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259NA and expiration date 30-Jun-2019) via intramuscular route in the left deltoid on 13-Oct-2018. The patients past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was not reported if the patient experienced 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5 years old male patient who experienced fever, pain, large area of erythema, induration and tenderness, while he received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 15-Oct-2018, the patient received a dose of suspect QUADRECEL VACCINE lot C5497AA via unknown route. On an unknown date, the patient developed a non-serious fever (pyrexia) following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious pain following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious large area of erythema (erythema) following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious induration following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious tenderness following the administration of QUADRACEL VACCINE. It was also reported that on 18-Oct-2018 patient came back with a reaction on his arm at injection site. Developed large area of erythema, duration and tenderness of the right deltoid with defined lines. On 20-Oct-2018 following up for reevaluation. (Other relevant tests included No lab data.) Final diagnosis was tenderness, induration, and large area of erythema, pain and fever. The patient was treated with KEFLEX. The patient outcome is reported as Unknown for fever, as Unknown for pain, as Unknown for large area of erythema, as Unknown for induration and as Unknown for tenderness. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5 years old male patient who experienced fever, pain, large area of erythema, induration and tenderness, while he received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 15-Oct-2018, the patient received a dose of suspect QUADRECEL VACCINE lot C5497AA via unknown route. On an unknown date, the patient developed a non-serious fever (pyrexia) following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious pain following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious large area of erythema (erythema) following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious induration following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious tenderness following the administration of QUADRACEL VACCINE. It was also reported that on 18-Oct-2018 patient came back with a reaction on his arm at injection site. Developed large area of erythema, duration and tenderness of the right deltoid with defined lines. On 20-Oct-2018 following up for reevaluation. (Other relevant tests included No lab data.) Final diagnosis was tenderness, induration, and large area of erythema, pain and fever. The patient was treated with KEFLEX. The patient outcome is reported as Unknown for fever, as Unknown for pain, as Unknown for large area of erythema, as Unknown for induration and as Unknown for tenderness. List of documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old male patient who received vaccine TYPHIM VI. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 17-Oct-2018, the patient received injection of suspect Typhoid VI Polysaccharide Vaccine, lot N1K811M, expiry date 29-Oct-2019 via unknown route in the left deltoid. It was an actual medication error due to vaccine underdose and syringe issue. It was reported that TYPHIM VI prefilled syringe was leaking from tip when administering the dose, uncertain if patient received any amount of vaccine, pharmacist observed leakage on the patient. The patient did not experience 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 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: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA291567 (same reporter). This case involves 2 patients of unknown demographics who received a dose of expired vaccine FLUZONE QUADRIVALENT (lot number and expiration date not reported) via unknown route and 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 expired vaccine used. It was not reported that the patient experienced 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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA291553 same reporter. 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 an unspecified date, 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 actual medication error due to Expired vaccine used. It was case of vaccine exposure during pregnancy. It was reported that administered expired influenza vaccine to their employees and 1 of the employees happens to be pregnant. It was unknown whether patient experienced any adverse reaction after the injection. Pregnancy outcome was unknown at the time of report. 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: FLU3
Symptoms: Overdose, Pain, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who experienced pain, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI985AC, expiry date: 22-Mar-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also the case of actual medication error due to overdose and Inappropriate age at vaccine administration. Other relevant tests included no lab data. Final diagnosis was pain. It was unknown if the patient received a corrective treatment. The outcome of the 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 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: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 85 years old female patient who received vaccine FLUZONE HIGH DOSE instead of PNEUMONIA SHOT. The patients past medical history, concomitant medication and family history were not provided. On 03-Oct-2018, the patient received a first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date she also received a second dose of the same vaccine lot UJ037AA, expiry date 12-May-2019 via intramuscular route in the right deltoid instead of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur lot number not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that patient came into pharmacy and was administered the FLUZONE HD vaccine and then stated I am glad I received my pneumonia shot, when the pharmacist asked the patient for further information, the patient thought she was receiving the pneumonia injection today and reported she had previously received the FLUZONE HD. 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 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: FLU4
Symptoms: Contraindication to vaccination, Drug interaction
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from Practitioner. This case involves patient of an unknown demographics who received vaccine FLUZONE QUADRIVALENT lot number not reported (dose, expiry date, route and site of administration were unknown). The patient's past medical history included Heart transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was a case of Drug interaction. It was reported that the patient has had a heart transplant and is taking an anti-rejection drug (immunosuppressive therapy). Other relevant tests included no lab data. It was not reported if the patient received a corrective treatment. Documents held by sender: none.
Age: 1.83
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22 months old female patient who experienced vaccine expired 10 days ago, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2018, the patient received a 4th dose 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, lot C5065AA, expiry date- 08-Oct-2018 via intramuscular route in the right thigh. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for vaccine expired 10 days ago. 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: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown gender 15 months old patient who was vaccinated with a 0.5 ml dose of DAPTACEL (Batch number: C5065AA, expiration date: 08-Oct-2018, route: intramuscular and site of administration: left thigh) on 10-Oct-2018. The patients medical history and concomitant medications were not reported. Nurse reporting the incident did not know if the any other vaccines were given. It was an actual medication error due to expired vaccine used (It was reported that inadvertently administered DAPTACEL that expired on 08-Oct-2018, no AE). No adverse event reported at time of call. 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: FLUR4
Symptoms: Dyspnoea, Headache, Hypertension, Urticaria
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 12 adult patients (age and gender was not reported) who experienced hives, high BP, headache and shortness of breath, while he/she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot QFAA1821 via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious hives (urticaria), high BP (hypertension), headache, shortness of breath (dyspnoea), following the administration of Influenza Quadrivalent Recombinant Vaccine. No lab data reported. Final diagnosis was shortness of breath, headache, high BP and hives. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling, Tendon rupture
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown demographic patient who experienced ripped tendons and arms swelled double in size, while he/she received vaccines PREVNAR 13 and INFLUENZA VACCINE. The patient's past medical history included allergic to chlorine and a long list of other unspecified things. The patient's past vaccination included pneumonia vaccine (reported as pneumonia shots). The patient's medical treatment(s), and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site and a dose of suspect PREVNAR 13 lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious ripped tendon and arms swelled double in size (Unknown latency) following the administration of INFLUENZA VACCINE and PREVNAR 13. (Other relevant tests included No lab data.) Final diagnosis was arms swelled double in size and ripped tendons. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for ripped tendons and as Unknown for arms swelled double in size. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pain, Pain in extremity
Clinical narrative: After injection into left deltoid, had pain, burning, all the way down arm into hand. Two weeks later arm still hurts, sharp pain when lifted certain way, arm constantly burns.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: None stated.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hallucination, auditory, Urinary incontinence
Clinical narrative: Auditory hallucinations and 3 cases of urinary incontinence.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flu shot erroneously given to child under 6 months of age.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Macule
Clinical narrative: Woke up this morning with a red spot about 3 inches in diameter about 2 inches below injection site.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Clostridium test, Diarrhoea, Full blood count, Lipids, Metabolic function test
Clinical narrative: Patient acquired hives, diarrhea, nausea, and vomiting about 10 to 12 hours after the injection. He took Benadryl for the hives with relief. He is still having diarrhea today.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Parasitic test, Urticaria, Vomiting
Clinical narrative: Patient acquired hives, diarrhea, nausea, and vomiting about 10 to 12 hours after the injection. He took Benadryl for the hives with relief. He is still having diarrhea today.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dysstasia, Nausea
Clinical narrative: Patient reports at 10pm having severe nausea, weakness, dizziness. Difficulty standing.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Injection site pain, Injection site pruritus, Pruritus, Throat irritation
Clinical narrative: About 15 mins after receiving flu shot Pt. started having itching and burning  at the injection site (left deltoid). Then a short time later started having itching in her face and down into her throat and started having tightness of breathe. Patient was send to emergency department of this facility. Pt was given Pepcid, Benadryl, and a steroid IV. After treatment patient was returned to work.
Age: 44.0
Sex: F
Vaccine: HEP, MMRV, MMRV
Symptoms: Cellulitis, Clostridium difficile infection, Erythema, Induration, Malaise
Clinical narrative: On the 3rd day 9/20/2018 my arm was red, hot and hard to my elbow. Went to doctor on 21st and they said cellulitis and put me in KEFLEX. Within 2 weeks I was diagnosed with Clostridium Difficile from the KEFLEX. My arm is scarred and I've been sick since. The doctor has apologized and reprimanded the MA for giving me the wrong vaccine in the wrong location. I was only supposed to get an MMR but she administered MMR w/ varicella and she put it under my left arm.
Age: 44.0
Sex: F
Vaccine: HEP, MMRV, MMRV
Symptoms: Product administered at inappropriate site, Scar, Skin warm, Ultrasound scan, Wrong product administered
Clinical narrative: On the 3rd day 9/20/2018 my arm was red, hot and hard to my elbow. Went to doctor on 21st and they said cellulitis and put me in KEFLEX. Within 2 weeks I was diagnosed with Clostridium Difficile from the KEFLEX. My arm is scarred and I've been sick since. The doctor has apologized and reprimanded the MA for giving me the wrong vaccine in the wrong location. I was only supposed to get an MMR but she administered MMR w/ varicella and she put it under my left arm.
Age: 44.0
Sex: F
Vaccine: HEP, MMRV, MMRV
Symptoms: Cellulitis, Ultrasound scan
Clinical narrative: On the 3rd day 9/20/2018 my arm was red, hot and hard to my elbow. Went to doctor on 21st and they said cellulitis and put me in KEFLEX. Within 2 weeks I was diagnosed with Clostridium Difficile from the KEFLEX. My arm is scarred and I've been sick since. The doctor has apologized and reprimanded the MA for giving me the wrong vaccine in the wrong location. I was only supposed to get an MMR but she administered MMR w/ varicella and she put it under my left arm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site rash
Clinical narrative: Employee reported having a rash, erythema and welts begin to develop at injection site immediately after receiving the vaccine, then over the next 24 hours worsened too involve entire left arm and right-hand 5th finger only, which she reported as "having a change in sensation- like numbness, tingling in that finger."  Employee also had a Tb skin test placed that same day on the left forearm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Paraesthesia, Rash, Urticaria
Clinical narrative: Employee reported having a rash, erythema and welts begin to develop at injection site immediately after receiving the vaccine, then over the next 24 hours worsened too involve entire left arm and right-hand 5th finger only, which she reported as "having a change in sensation- like numbness, tingling in that finger."  Employee also had a Tb skin test placed that same day on the left forearm.
Age: 67.0
Sex: F
Vaccine: MENB
Symptoms: Dyskinesia, Fall, Head injury, Pyrexia, Syncope
Clinical narrative: Slight fever, then fainted, fell hit head and had jerking back and forth, no continue, of stool then was fine.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain
Clinical narrative: Patient reported 10 minutes after the flu shot she had severe pain, redness-2 inches around her bandaid and warmth on her left arm where the shot was given. She reported over the next 5 days she had no range of motion of left arm, the pain was very severe she said a 10 on  a scale of 1-10 it went up around her neck and up above her scapula and just above her elbow down her arm She stated she used hot and cold packs on her arm. The pain got better on Sunday the 21st but today when she came in she said her range of motion is still 80% and it still hurts a bit to lift her arm or reach out. She did not have a fever or dizziness. I told her to reach out to her doctor if the pain got worse again or she had a fever. She has not gone to the doctor - she does have a regular appointment on November 16th.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reported 10 minutes after the flu shot she had severe pain, redness-2 inches around her bandaid and warmth on her left arm where the shot was given. She reported over the next 5 days she had no range of motion of left arm, the pain was very severe she said a 10 on  a scale of 1-10 it went up around her neck and up above her scapula and just above her elbow down her arm She stated she used hot and cold packs on her arm. The pain got better on Sunday the 21st but today when she came in she said her range of motion is still 80% and it still hurts a bit to lift her arm or reach out. She did not have a fever or dizziness. I told her to reach out to her doctor if the pain got worse again or she had a fever. She has not gone to the doctor - she does have a regular appointment on November 16th.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Contact pt or check medical records if details required.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Lymphadenopathy, Measles post vaccine, Mobility decreased, Pain
Clinical narrative: 8 days after shot came down with the full blown measles, I had a high fever for 3 days could barely move or talk. My tonsils and all my lymph nodes swelled up! After the fever broke came down with a rash all over my body! It has been 3 months and my tonsils and lymph nodes are still swollen, also got painful tonsillitis and had to pay out of pocket for an ENT to see me! And once he found out I was vaccine injured he pushed it under the rug. And I have been having joint pain and tonsils still swollen! I don't have the money to actually see what's going on so who knows what this vaccine has really done to my health.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Peritonsillar abscess, Pyrexia, Rash generalised, Speech disorder, Tonsillar hypertrophy
Clinical narrative: 8 days after shot came down with the full blown measles, I had a high fever for 3 days could barely move or talk. My tonsils and all my lymph nodes swelled up! After the fever broke came down with a rash all over my body! It has been 3 months and my tonsils and lymph nodes are still swollen, also got painful tonsillitis and had to pay out of pocket for an ENT to see me! And once he found out I was vaccine injured he pushed it under the rug. And I have been having joint pain and tonsils still swollen! I don't have the money to actually see what's going on so who knows what this vaccine has really done to my health.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Tonsillitis
Clinical narrative: 8 days after shot came down with the full blown measles, I had a high fever for 3 days could barely move or talk. My tonsils and all my lymph nodes swelled up! After the fever broke came down with a rash all over my body! It has been 3 months and my tonsils and lymph nodes are still swollen, also got painful tonsillitis and had to pay out of pocket for an ENT to see me! And once he found out I was vaccine injured he pushed it under the rug. And I have been having joint pain and tonsils still swollen! I don't have the money to actually see what's going on so who knows what this vaccine has really done to my health.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hyperhidrosis, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain and swelling at injection site. Sweating, feeling ill though not nauseous. Pain in joints of arm and wrist lasting into second day and following day.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Blood test normal, Diet refusal, Electroencephalogram normal, Erythema, Eye movement disorder
Clinical narrative: Infant started having seizures 6-7 hours after given first dose of vaccine. Body was seizing with eyes rolling into back of head. Rash and inflammation of the face, eyes, arms, torso and top of head was red and swollen. Eyes swollen and would not open. Infant refused to feed and has to be given formula orally by syringe. Transported by air to NICU level 3 unit. Diagnoses with seizures and put on pheonobarbital.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Inflammation, Intensive care, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Rash
Clinical narrative: Infant started having seizures 6-7 hours after given first dose of vaccine. Body was seizing with eyes rolling into back of head. Rash and inflammation of the face, eyes, arms, torso and top of head was red and swollen. Eyes swollen and would not open. Infant refused to feed and has to be given formula orally by syringe. Transported by air to NICU level 3 unit. Diagnoses with seizures and put on pheonobarbital.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Seizure, Swelling, Swelling of eyelid
Clinical narrative: Infant started having seizures 6-7 hours after given first dose of vaccine. Body was seizing with eyes rolling into back of head. Rash and inflammation of the face, eyes, arms, torso and top of head was red and swollen. Eyes swollen and would not open. Infant refused to feed and has to be given formula orally by syringe. Transported by air to NICU level 3 unit. Diagnoses with seizures and put on pheonobarbital.
Age: 13.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Agitation, Altered state of consciousness, Dyspnoea, Malaise, Muscular weakness
Clinical narrative: Patient was not feeling well. Next day she got pale, could not breathe, collapsed, and got seizure.  Patient taken to ER and was released. Has followed-up with primary care several times. In August, gynecologist (Women's Clinic) identified that pt had cyst in her ovaries. Patient still has fainting spells, weakness in her legs, and is very agitated. Took her to ER visit for similar symptoms a second time. Since first incident no other seizures but pt goes regularly to school nurse because she feels like she will pass out. For lower extremity pain, patient takes over-the-counter ALEVE but does not seem to help. Problems are getting worse because she is not getting better.
Age: 13.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Ovarian cyst, Pallor, Seizure, Syncope
Clinical narrative: Patient was not feeling well. Next day she got pale, could not breathe, collapsed, and got seizure.  Patient taken to ER and was released. Has followed-up with primary care several times. In August, gynecologist (Women's Clinic) identified that pt had cyst in her ovaries. Patient still has fainting spells, weakness in her legs, and is very agitated. Took her to ER visit for similar symptoms a second time. Since first incident no other seizures but pt goes regularly to school nurse because she feels like she will pass out. For lower extremity pain, patient takes over-the-counter ALEVE but does not seem to help. Problems are getting worse because she is not getting better.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: Patient received two vaccines (FLUZONE HIGH DOSE and PNEUMOVAX) on 10/19/18. Patient had no allergies listed and had tolerated vaccines in the past. Patient Questionnaire fully covered with patient. Patient developed rash under injection site just over halfway around. Rash did not itch and did not burn. Patient had no chest pain, no difficulty breathing and no wheezing. Patient still experienced some aches at injection site. Patient described having immune response including weakness, fever, pain and body aches, which were mostly resolved but last about 2-3 days. Patient thought he might have a slight middle finger tremor on left hand (same arm as injections), which is most likely not related.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Patient received two vaccines (FLUZONE HIGH DOSE and PNEUMOVAX) on 10/19/18. Patient had no allergies listed and had tolerated vaccines in the past. Patient Questionnaire fully covered with patient. Patient developed rash under injection site just over halfway around. Rash did not itch and did not burn. Patient had no chest pain, no difficulty breathing and no wheezing. Patient still experienced some aches at injection site. Patient described having immune response including weakness, fever, pain and body aches, which were mostly resolved but last about 2-3 days. Patient thought he might have a slight middle finger tremor on left hand (same arm as injections), which is most likely not related.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient became dizzy and lightheaded immediately and felt like she was about to pass out. Pain at injection site was felt immediately and has progressed over the past week, including worsening range-of-motion limitations and radiating pain up to the neck and down the arm up to the elbow.  Patient has follow up with primary care to address these issues. No exterior signs or symptoms; no redness or swelling on the arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient became dizzy and lightheaded immediately and felt like she was about to pass out. Pain at injection site was felt immediately and has progressed over the past week, including worsening range-of-motion limitations and radiating pain up to the neck and down the arm up to the elbow.  Patient has follow up with primary care to address these issues. No exterior signs or symptoms; no redness or swelling on the arm.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain, Peripheral swelling, Pyrexia, Swelling, Tenderness
Clinical narrative: Injection on 10/18 along with flu shot on left arm. 10/19 low grade fever, slight swelling and pain but not horrible. Progressively got worse and went to urgent care on 10/22. Arm was swollen huge and very painful to touch.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reaction or allergies were not reported. On 03-OCT-2018, the patient was vaccinated with an unspecified dose in immunization series of improperly stored M-M-R II injection (strength, route of administration, lot# with expiration date were not reported) for prophylaxis. M-M-R II was stored in the temperature of 12 degrees Celsius for 2 hours. Sterile diluent was stored properly. No previous temperature excursions were not reported. Data logger was not involved. No adverse effects were reported.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MNQ, VARCEL
Symptoms: Abnormal faeces, Crying, Diarrhoea, Gastroenteritis, Irritability
Clinical narrative: Information has been received from an office manager referring an approximately 15 month old female patient without pertinent medical history or drug allergies. On 18-SEP-2018 the patient was in the office for her "well exam". At the same date she was administered vaccinated with VARIVAX(Subcutaneous,1 dose, lot # R002508, expiration date 25-JAN-2020) that was reconstituted with sterile diluent for prophylaxis. Other suspect therapies included DTAP and Meningococcal Protein Conjugate (manufacturer unknown). On an unknown date (reported as " couple days later") the patient experienced a "fever, diarrhea with vomiting and fussiness". The patient returned to the office with her mother on 01-OCT-2018. 2018 with a "macular rash on her abdomen and inguinal area" the patient was seen at the physician's office on 08-OCT-2018 with white creamy stools, vomiting, fussiness and crying constantly for the last few days. The patient had been diagnosed with gastroenteritis and exanthem. Unspecified treatment provided at Physician's office. The patient's mother was instructed to "keep patient hydrated, avoid heat and observe. The outcome of exanthem was recovered on an unspecified date of 2018. The outcome of other events was unknown. The causality assessment between the suspect medications and events was not reported.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MNQ, VARCEL
Symptoms: Pyrexia, Rash, Rash macular, Vomiting
Clinical narrative: Information has been received from an office manager referring an approximately 15 month old female patient without pertinent medical history or drug allergies. On 18-SEP-2018 the patient was in the office for her "well exam". At the same date she was administered vaccinated with VARIVAX(Subcutaneous,1 dose, lot # R002508, expiration date 25-JAN-2020) that was reconstituted with sterile diluent for prophylaxis. Other suspect therapies included DTAP and Meningococcal Protein Conjugate (manufacturer unknown). On an unknown date (reported as " couple days later") the patient experienced a "fever, diarrhea with vomiting and fussiness". The patient returned to the office with her mother on 01-OCT-2018. 2018 with a "macular rash on her abdomen and inguinal area" the patient was seen at the physician's office on 08-OCT-2018 with white creamy stools, vomiting, fussiness and crying constantly for the last few days. The patient had been diagnosed with gastroenteritis and exanthem. Unspecified treatment provided at Physician's office. The patient's mother was instructed to "keep patient hydrated, avoid heat and observe. The outcome of exanthem was recovered on an unspecified date of 2018. The outcome of other events was unknown. The causality assessment between the suspect medications and events was not reported.