chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash macular
Clinical narrative: Red Dots; Burning; Shingles; Pain / Soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced pain. On 1st September 2019, the patient experienced shingles. On an unknown date, the patient experienced erythromacular rash and burning sensation. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, pain and erythromacular rash were recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   The reporter considered the shingles, pain, erythromacular rash and burning sensation to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left deltoid. The patient developed an area about 2 inches in diameter on the back inside of her right leg. The patient asked her neighbor who was a nurse practitioner to look at the area and she thought it appeared to be shingles.  The patient then went to the doctor on 3rd September 2019 and her physician thought it appeared to be shingles and prescribed Valacyclovir. Emergency room visit required The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Headache, Hot flush, Injection site erythema
Clinical narrative: Arm hurt; not feeling well / Feeling awfull; Hot flashes; Felt Hot; trouble sleeping; pain; redness; swelling at injection site; myalgia; fatigue; headache; fever; Gastrointestinal symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hot flashes.   On 4th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping, injection site pain, injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping and injection site pain were recovering/resolving and the outcome of the injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping, injection site pain, injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The patient reported that an hour after the injection, her arm hurt and she did not feel well which she described as "feeling awful." The patient felt hot and she was not certain if it was related to her ongoing hot flashes or from the vaccine. The patient attempted to lift a box with 4 items inside and her arm hurt worse and worse and she had trouble sleeping last night. The patient also experienced pain, redness, swelling at the injection site, myalgia, fatigue, headache, fever and gastrointestinal symptoms. The patient consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Malaise, Myalgia
Clinical narrative: Arm hurt; not feeling well / Feeling awfull; Hot flashes; Felt Hot; trouble sleeping; pain; redness; swelling at injection site; myalgia; fatigue; headache; fever; Gastrointestinal symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hot flashes.   On 4th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping, injection site pain, injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping and injection site pain were recovering/resolving and the outcome of the injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping, injection site pain, injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The patient reported that an hour after the injection, her arm hurt and she did not feel well which she described as "feeling awful." The patient felt hot and she was not certain if it was related to her ongoing hot flashes or from the vaccine. The patient attempted to lift a box with 4 items inside and her arm hurt worse and worse and she had trouble sleeping last night. The patient also experienced pain, redness, swelling at the injection site, myalgia, fatigue, headache, fever and gastrointestinal symptoms. The patient consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm hurt; not feeling well / Feeling awfull; Hot flashes; Felt Hot; trouble sleeping; pain; redness; swelling at injection site; myalgia; fatigue; headache; fever; Gastrointestinal symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hot flashes.   On 4th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping, injection site pain, injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping and injection site pain were recovering/resolving and the outcome of the injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell, hot flashes, feeling hot, difficulty sleeping, injection site pain, injection site erythema, injection site swelling, myalgia, fatigue, headache, fever and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The patient reported that an hour after the injection, her arm hurt and she did not feel well which she described as "feeling awful." The patient felt hot and she was not certain if it was related to her ongoing hot flashes or from the vaccine. The patient attempted to lift a box with 4 items inside and her arm hurt worse and worse and she had trouble sleeping last night. The patient also experienced pain, redness, swelling at the injection site, myalgia, fatigue, headache, fever and gastrointestinal symptoms. The patient consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Painful; Unable to raise arm that received the injection dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th April 2019, couple of hours after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reporter for herself. The patient received Shingrix her left arm.    A few hours after injection, she experienced painful and unable to raise arm that received the injection dose. The event was improved over the next few days and had resolved. The patient consented to follow up and provided her doctor's details.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was given and not mixed with ActHib lyophilized component and they just gave the liquid portion, no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography for whom it was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was given and not mixed with ACTHIB lyophilized component and they just gave the liquid portion, (lot number, expiry date, dose, route and site of administration not reported) on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the Pentacel vaccine and didn't realize she had to mix with ActHIB portion/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient who did not received Act-hib portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a only portion of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported.  It was of actual medication error due to Inappropriate reconstitution technique..  It was unknown whether any adverse event was observed or not...  The information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: pregnant females that were given the invalid Adacel, no side effects observed; caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case ID: 2019SA250873 and 2019SA250874 (same reporter).  This case involves a 22 year old female pregnant patient who was exposed to a second dose vaccine of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (dosage form: Prefilled Syringe) lot U6273AA via intramuscular route in the left arm on 20-Aug-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported administered invalid Adacel occurred at unknown gestation period. The date of last menstrual period was reported as 28-Jan-2019. The estimated due date is 28-Oct-2019. The patient previous pregnancy was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is a case of vaccine exposure during pregnancy. It was reported that excursion was caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed. Incorrect product storage.  It was reported that the patient had no adverse event following the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: the excursion was Negative 40 degrees C and 22.7 degrees C. Caller stated that these invalid Adacels were given to 3 pregnant patients, no side effects; the excursion (caused by Human Error) was Negative 40 degrees C and 22.7 degrees C. Caller stated that these invalid Adacels were given to 3 pregnant patients, no side effects; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case ID: 2019SA250873 and 2019SA250866 (same reporter).  This case involves a 49 year old female pregnant patient who was exposed to a second dose vaccine of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (dosage form: Prefilled Syringe) lot U6273AA, expiry date: 24-Apr-2021 via intramuscular route in the right arm on 23-Aug-2019.  The patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 32 weeks of pregnancy, during third pregnancy trimester.  The date of last menstrual period was reported as 09-Jan-2019.  The estimated due date is 16-Oct-2019.  The patient previous pregnancy was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were given.  It was a case of actual medication error due to product storage error and patient received it. It was reported that The Excursion (caused by human error) was Negative 40 degrees C and 22.7 degrees C. Caller stated that these invalid Adacels were given to 3 pregnant patients.  It is a case of vaccine exposure during pregnancy.  There were no side effects during this prenatal visit.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 14 year old was administered Fluzone High Dose, no AE; 14 year old was administered Fluzone High Dose, no AE; Initial and follow up information received on 06-Sep-2019 and 10-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to cases 2019SA251863 and 2019SA251864 (same reporter).  This case involves a 14 years old patient who was received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AA, Exp. Date 10-Apr-2020) via intramuscular route in the left deltoid on 05-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting no adverse reactions were 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.
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 25 year old was administered Fluzone High Dose, no AE; 25 year old was administered Fluzone High Dose, no AE; Initial and follow up information received on 06-Sep-2019 and 10-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to cases 2019SA251863 and 2019SA251857 (same reporter).  This case involves a 25 years old male patient who was received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AA, Exp. Date 10-Apr-2020) via intramuscular route in the left deltoid on 06-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting no adverse reactions were 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.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Ipol reached an unknown temperature for an unknown cumulative time since 06Sep2019, no AE; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old male patient who received vaccine IPV (VERO) [IPOL] (batch number and expiry date was not reported) 05-Sep-2019. The patient started a three dose series of Ipol every other month, due to facility regulations, the patient must keep the Ipol vial with him and transport back and forth to the administration facility. The Ipol is transported with ice packs but no specific temperature reading device. No additional information was available at the time of this report. It was also reported that vaccines reached an unknown temperature for an unknown cumulative time since 06-sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.   It was unknown if any adverse event occurred.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Expired product administered
Clinical narrative: expired Menactra being administered; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who received a 0.5 ml once dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U5986AA, expiry date: 24-Aug-2019) via unknown route and unknown site of administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation  It was an actual medication error due to expired vaccine used.   It was unknown if any adverse event occurred.  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: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Hyperhidrosis, Malaise, Tremor
Clinical narrative: patient reported profuse sweating and shaking 3 days after receiving the vaccine and general malaise in between.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Enterocolitis, Food allergy, Injection site calcification, Injection site mass
Clinical narrative: Got a calcified lump where she received the vaccine.  Also got cold like symptoms  10 days after vaccine.  Now has a severe anaphylactic reaction to peanuts. Also reacted to eggs as a baby and reacts with FPIES to dairy.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Milk allergy, Nasopharyngitis
Clinical narrative: Got a calcified lump where she received the vaccine.  Also got cold like symptoms  10 days after vaccine.  Now has a severe anaphylactic reaction to peanuts. Also reacted to eggs as a baby and reacts with FPIES to dairy.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Local reaction, Skin warm, Swelling
Clinical narrative: large, local reaction-redness, swelling, warmth, firmness reaction is 4.5 by 2.5 inches in size
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Enterocolitis, Food allergy, Milk allergy
Clinical narrative: Severe peanut allergy, egg allergy, FPIES to dairy.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Alanine aminotransferase normal, Anion gap normal, Aspartate aminotransferase normal, Base excess decreased, Bilevel positive airway pressure
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Bilirubin conjugated normal, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Blood bilirubin unconjugated normal, Blood calcium decreased, Blood chloride increased, Blood creatinine increased, Blood glucose increased
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Blood lactic acid increased, Blood methaemoglobin, Blood pH, Blood potassium normal, Blood sodium normal
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Blood urea increased, Calcium ionised decreased, Carbon dioxide normal, Carboxyhaemoglobin normal, Chest X-ray abnormal
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Fluid overload, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Hypotension, Hypoxia, Intensive care, Lung opacity, Mean cell haemoglobin concentration normal
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, PCO2 normal, PO2 decreased, Platelet count normal
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Pleural effusion, Protein total decreased, Pulmonary oedema, Pyrexia, Red blood cell count decreased
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Red cell distribution width increased, Respiratory viral panel, Tachycardia, Venous oxygen saturation decreased, White blood cell count increased
Clinical narrative: 12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: The day after the vaccine, the patient states she suddenly became very dizziness, to the point she could not move then once that passed she felt a tingling from her elbow to her index finger on the left arm.  It did not last long, the next day she noticed in in the pinky, and is still having slight numbness in the hand on the pinky side.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: hives, urticaria on chest and bilateral arms ; patient broke out in hives 15-20 mins after the injection
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Fatigue, Headache, Injection site reaction
Clinical narrative: Debilitating  headache, rise in body temperature, trouble sleeping, sever fatigue, red rash at injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Rash erythematous
Clinical narrative: Debilitating  headache, rise in body temperature, trouble sleeping, sever fatigue, red rash at injection site.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Heart rate increased, Palpitations, Pyrexia
Clinical narrative: Patient called reporting they had chills, fever, high pulse rate, heart palpitations, and headache.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: The patient experienced fever and malaise and other symptoms similar to when he had pneumonia. They ended up taking him to the emergency room and he was treated there and released.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Influenza like illness, Neck pain
Clinical narrative: Excruciating pain that traveled to brain/skull, flu like symptoms, weak, painful neck, loss of appetite, she described like she was in a car-crash and she has whiplash.
Age: 0.17
Sex: M
Vaccine: PNC13, UNK, UNK, UNK
Symptoms: Decreased eye contact, Flat affect, Hyporesponsive to stimuli
Clinical narrative: My baby lost eye contact for three days and capacity for varied expression.  Once smiling and interacting went to vacant and distant.  Reaction time slowed or was stunted
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Inflammation, Rash, Secretion discharge
Clinical narrative: Severe case of Shingles on upper inside of left thigh, groin area approximately a week after the vaccine. I saw my PCP on 8-13-19. I was prescribed  Gabapentin, Cephalexin and ValACYclovir. Had a follow-up on 8-19-19 with the PCP and the shingles seemed to be slightly improving. On 8-27-19 after finishing the Cephalexin the shingles flared up worst than before. There was quite a bit of discharge/fluid from the inflamed area.  Was sent to a dermatologist on 8-29-19 who upped my doses of Gabaapentin and ValACYclovir. On 9-6-19 I had a follow-up visit with Dr. at Dermatology - the rash had started spreading and the area was a mess! I was prescribed Fluconazole and a cream to apply twice a day. Follow-up visit with Dr on 9-13-19 fianlly saw improvement.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Discomfort, Headache, Pain in extremity, Swelling
Clinical narrative: Soar arm, discomfort sleeping, head ache, no energy, swollen shoulder
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient was injected in the right deltoid, and presented with swelling and redness below the injection site and continuing down to her hand.  Two days post injection when the patient returned to the pharmacy,  the redness, pain and swelling were resolving.  The pharmacy contacted her primary physician to advise of the condition, and the patient said she will call her doctor if the condition worsens or does not improve.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Formication
Clinical narrative: Patient called the pharmacy on 9/13/19 at approximately 130 pm and stated that she has complaining of dizziness and skin crawling for the past day and started feeling this way shortly after receiving her flu shot around 1130 am on 9/12/19
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms with aches and a headache for 2 days. The nurse said these side effects  could happen and were fairly common. Lasted for 2 days.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Dark circles under eyes, Dizziness, Fatigue, Feeling abnormal, Hypersensitivity
Clinical narrative: Fatigue/ tiredness, dizzy/ light-headed, foggy-headed, chronic allergies, inflammation, dark eyes and swollen eyelids.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Inflammation, Platelet count decreased, Swelling of eyelid
Clinical narrative: Fatigue/ tiredness, dizzy/ light-headed, foggy-headed, chronic allergies, inflammation, dark eyes and swollen eyelids.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Cough, Diarrhoea, Pyrexia, Respiratory tract congestion, Vaccination site pain
Clinical narrative: Nine days after receiving the rabies vaccine, donor developed soreness at the site of vaccination. He also developed a fever to 101.5, diarrhea, cough and congestion. These symptoms lasted for approximately four days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Ear congestion, Lethargy, Malaise, Nausea, Retching
Clinical narrative: Nausea, vomiting, dry heaving, lump in throat feeling, general lethargy and malaise, stuffed ears feeling
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of foreign body, Vomiting
Clinical narrative: Nausea, vomiting, dry heaving, lump in throat feeling, general lethargy and malaise, stuffed ears feeling
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pyrexia
Clinical narrative: PATIENT REPORTS LOW GRADE FEVER, SORENESS AT INJECTION SITE, AND LOSS OF FUNCTION BELOW THE WRIST
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Fatigue, Injection site swelling, Malaise, Pruritus
Clinical narrative: Rash, itching, swelling at injection site, general malaise, trouble breathing, fatigue
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash, itching, swelling at injection site, general malaise, trouble breathing, fatigue
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Balance disorder, Chest X-ray, Concussion, Fall
Clinical narrative: Received 2nd dose, 5 months after the first dose in same facility.  Started to feel very tired by supper.  At 10-11pm started to feel nauseous, tried to throw up but could not until 1 hour latervomited 3 times.  Patient took usual medications at night: Vitamins, Eliquis, Lisinopril, and Singulair. In the morning, woke up and felt very achy on back so put heating pad on couch.  Started to feel nauseous again so went to the bathroom and could not throw up.  On the way back to the couch, a strange feeling came over, and fainted.  Patient hit head on washer/dryer when fell down; not sure how long was out.   Woke up and went back to lay on down, put heating pack on back and icepack on head.   At about 9: 30am, patient's
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Head injury, Nausea, Scan
Clinical narrative: Received 2nd dose, 5 months after the first dose in same facility.  Started to feel very tired by supper.  At 10-11pm started to feel nauseous, tried to throw up but could not until 1 hour latervomited 3 times.  Patient took usual medications at night: Vitamins, Eliquis, Lisinopril, and Singulair. In the morning, woke up and felt very achy on back so put heating pad on couch.  Started to feel nauseous again so went to the bathroom and could not throw up.  On the way back to the couch, a strange feeling came over, and fainted.  Patient hit head on washer/dryer when fell down; not sure how long was out.   Woke up and went back to lay on down, put heating pack on back and icepack on head.   At about 9: 30am, patient's
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan brain, Syncope, Vomiting
Clinical narrative: Received 2nd dose, 5 months after the first dose in same facility.  Started to feel very tired by supper.  At 10-11pm started to feel nauseous, tried to throw up but could not until 1 hour latervomited 3 times.  Patient took usual medications at night: Vitamins, Eliquis, Lisinopril, and Singulair. In the morning, woke up and felt very achy on back so put heating pad on couch.  Started to feel nauseous again so went to the bathroom and could not throw up.  On the way back to the couch, a strange feeling came over, and fainted.  Patient hit head on washer/dryer when fell down; not sure how long was out.   Woke up and went back to lay on down, put heating pack on back and icepack on head.   At about 9: 30am, patient's
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Autoimmune dermatitis, Dermatitis allergic, Immune-mediated dermatitis
Clinical narrative: chronic immune mediated allergic autoimmune dermatitis
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Malaise, Tinnitus
Clinical narrative: after given the shot ask him to stay for 2 minutes,after 2 minutes I ask him to leave,then he said Iam not feeling well,feeling dizzy.ringing ears and sweating,then I put him on the floor and called 911,then slowly he recovered in couple of minutes and he sat on chair,after 10 minutes paramedical came and talk to me and the patient,then he said he is ok.paramedical asked him to come to hospital and check,then patient denied and he said fine,next day I called to patient and asked about his health,he said he is fine
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Complaint of severe pain to injection site 5 days after received. Redness and swelling to site present.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Malaise, Nausea, Pyrexia, Syncope
Clinical narrative: Patient was ok the day vaccine was administered - 9/12/19. The morning of 9/13/19 patient experienced nausea, sweating, malaise, fever (101.4), and fainted. She stayed in bed all day and reported events to pharmacist at 7:30 pm 9/13/19.  Patient was advised to seek medical attention.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Wrong product administered
Clinical narrative: Error - administered high dose flu vaccine instead of regular flu vaccine. Stiff, sore, painful arm.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT COMPLAINED OF RASH ON CHEST AND FOREHEAD. SHE WAS GIVEN STEROIDS FOR 5 DAYS. AN ADDITIONAL RASH WAS SEEN UNDER THE ARM THAT DID NOT RECEIVE THE VACCINATION
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on arm of injection site and trunk (chest/back)
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity, Wrong product administered
Clinical narrative: Error - administered high dose flu vaccine instead of regular flu vaccine. Stiff, sore, painful arm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: injection site reaction (painful, itchy, red, hard lump)
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: EMPLOYEE RETURNED TO WORK REPORTING RASH AND HIVES ON BILATERAL ARMS AND LEGS
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: The patient called the pharmacist today, 9/13/19 and states that she had a small red spot below the site of injection and it was warm to the touch. The patient was adviced to keep an eye out and see if it got worse.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Balance disorder
Clinical narrative: Patient got his HAVRIX vaccine last week with his mom and his brother cause the mom was worried about the incident that happens, after, he got the shot by nearly 15-20 minutes and while they are moving to go home, my tech noticed that he was loosing his balance, I got the epipen from the drawer and ran to him immediately , my tech and his brother lay him on the floor, trying to talk to him to keep him awake, in less than two minutes , he got the epipen shot. during this time , my other tech contact 911. they came in 5-10 minutes and went to the hospital the patient's mom called me the next day, everything went ok
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Per patient the arm was very swollen for 3 days
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Pyrexia, Rash, Vomiting
Clinical narrative: Rash pain fever vomiting dizziness
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Local reaction, Pruritus, Rash
Clinical narrative: Patient states reaction of swelling, itching, redness, rash, discomfort and lasted about 2 weeks. Patient spoke with PCP/NP and has had similar incidents with previous vaccines and patient reports that she has sensitivity with low tolerance and wants to continue receiving vaccinations routinely because these reactions are localized.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient states reaction of swelling, itching, redness, rash, discomfort and lasted about 2 weeks. Patient spoke with PCP/NP and has had similar incidents with previous vaccines and patient reports that she has sensitivity with low tolerance and wants to continue receiving vaccinations routinely because these reactions are localized.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pharyngeal paraesthesia, Swelling
Clinical narrative: Patient developed tingling sensation in throat while at home, 1 hour after receiving vaccination. She went to the emergency room and was treated for trouble breathing and swelling.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Erythema, Feeling hot, Lethargy, Oedema peripheral
Clinical narrative: patient reported symptoms of: local redness, excessive swelling/edema wrapping around almost entire upper arm, heat, headaches, dizziness, lethargy
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: patient reported symptoms of: local redness, excessive swelling/edema wrapping around almost entire upper arm, heat, headaches, dizziness, lethargy
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed redness, itching and mild swelling at injection site within a few minutes of administration. Directed to take benadryl, tylenol, ice by PCP No immediate direct care given.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Heart rate increased, Oxygen saturation decreased
Clinical narrative: On 8-29-19, patient's mother called us to report an increased heart rate to 212/min and oxygen desaturation to 83% During a feeding, he desaturated to 79% for four minutes. Mother called patient's neurologist to see what their thoughts were. His neurologist increased the seizure medication (trileptal) He did not have any further issues after this.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site nodule, Injection site oedema, Injection site pain, Ultrasound scan
Clinical narrative: Small painful bruised, mild edematous nodule size of a dime to the left deltoid area.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Pt received Havrix on 8/06/19. States he had some swelling but now has a small lump at injection site but no pain. He says it seems to be bigger than it was a few weeks ago. Showed MD when went for regular visit. MD not concerned
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Pt complained of swelling in arm and redness and pain around injection site and in arm.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Pt developed a local reaction (L) Deltoid region with pain, swelling & redness. She also developed flu-like symptoms as fatigue, malaise and weakness. Started several hours later - was evaluated on 08/28 and 08/29 - has continued to improve.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Local reaction, Malaise
Clinical narrative: Pt developed a local reaction (L) Deltoid region with pain, swelling & redness. She also developed flu-like symptoms as fatigue, malaise and weakness. Started several hours later - was evaluated on 08/28 and 08/29 - has continued to improve.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Immediate post-injection reaction, Nausea, Pain in extremity
Clinical narrative: PATIENT IMMEDIATELY FELT PAIN IN HER ARM AND BACK FOLLOWED BY NAUSEA AND VOMITING AND LIGHTHEADEDNESS.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: PATIENT IMMEDIATELY FELT PAIN IN HER ARM AND BACK FOLLOWED BY NAUSEA AND VOMITING AND LIGHTHEADEDNESS.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Pain in extremity
Clinical narrative: Patient began to experience sore arm and notice a bruise forming above the injection site with band-aid still on the arm the day after. Bruise was larger than quarter size and bright red when presented at the pharmacy on 09/13/2019 at 1pm. Patient will see primary care provider if bruise or symptoms worsen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dehydration, Headache, Myalgia, Pruritus
Clinical narrative: Muscle pains throughout body Fever  Headache Severe drop in blood pressure Dehydration Itching
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Muscle pains throughout body Fever  Headache Severe drop in blood pressure Dehydration Itching
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site warmth, Injection site erythema
Clinical narrative: Patient has redness at site of administration. Also stated site of administration is slightly warm upon touching.