chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; a improperly stored dose of ROTATEQ was administered; This spontaneous report as received from a license practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R035369, expiration date 10-OCT-2020, orally, for prophylaxis (dosage schedule was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 50 degrees Fahrenheit for 49 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One dose of an improperly stored vaccine, VARIVAX, was administered to one patient of 9/12/2019; Assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-SEP-2019, the patient was vaccinated with an improperly stored vaccine of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, intramuscularly, lot# S002877, expiration date 29-JAN-2021, for prophylaxis (strength was not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT), possible lot # S000130, expiration date reported as 23-AUG-2021.  The temperature excursion was of 8.1 Fahrenheit degrees, during 20 minutes. However, a previous temperature excursion of 8.1°F for 17 minutes and 9.5°F for 21 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Pain
Clinical narrative: Inflammation; General aches and pains around my body; This case was reported by a consumer and described the occurrence of inflammation in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced inflammation and general body pain. On an unknown date, the outcome of the inflammation and general body pain were unknown.   It was unknown if the reporter considered the inflammation and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received second installment of vaccine the day before reporting. The patient had general aches and pains around body which he assumed that it was due to inflammation. The patient experienced some of the typical side effects and was wondering if an anti-inflmmatory would reduce the effectiveness of the vaccination. The patient would like to avoid damaging inflammation if possible. The reporter enquired whether the patient can take an anit-inflammatory such as diclofenac (75 mg) after vaccination. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Wrong technique in product usage process
Clinical narrative: Painful; Wrong injection technique; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain and wrong injection technique. On an unknown date, the outcome of the pain and wrong injection technique were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient received vaccine in unknown deltoid. The pharmacist stated she administered the first dose of Shingrix to patient who asked why the pharmacist was giving the injection in the deltoid muscle, which led to wrong injection technique. The reported stated she was researching this further, and was not sure whether the Shingrix was given subcutaneously. The pharmacist was not in the pharmacy at the time of this call, so limited details were available. The reporter consented to follow up. This case had been linked to the case US2019162813, reported by same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Rash on arm; swelling on arm; Pain / pain on his left arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 4 months after receiving Shingrix, the patient experienced rash, swelling arm and pain in arm. On an unknown date, the outcome of the rash, swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the rash, swelling arm and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The niece did not have the patient exact age and estimated that he was 56 years old. The patient received vaccine in unknown arm. The reporter did not knew the lot number or expiry date of vaccine. The patient received the initial dose of Shingrix in either May or June of 2019 and developed a rash, a swollen area approximately 2.5 inches wide and 3.5 inches long, and pain on his left arm.   These events resolved after 10 days. The reporter declined to provide an address. The reporter did not give permission to follow up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: that one of the nurses went to give a patient the Pentacel vaccine and didn't realize she had to mix with ActHIB portion of it, no adverse event; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse. Follow-up was done on 27-Aug-2019.  This case involves a patient of unknown demography for whom it was reported that one of the nurses went to give a patient the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and did not realize she had to mix with acthib portion of it (lot number, exp date, route and site of administration were 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 product preparation issue.   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: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: 2 months baby received Pentacel without the Acthib portion, no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a  office staff/non-hcp.  This case involves a 2 months old female received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6257AA expiry date: 27-Oct-2020 via intramuscular route in the right thigh) without the Act-Hib portion, on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: Menactra as a subcutaneous injection today in the right arm / no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old male patient who received 0.5 ml vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6179AA (Expiry date 29-Mar-2020) via subcutaneous route in the left arm, on 09- 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 route of vaccination.  It was reported that Menactra as a subcutaneous injection today in the right arm.  At a time of reporting no adverse effect reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Adacel given, no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years old male patient  who was administered an expired 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5726AA (Expiry date 11-Jul-2019) via intramuscular route in the right deltoid on 09-Sep-2019.  The patient's past medical history, vaccination(s) and family history were not provided.  Concomitant vaccination included Flu vaccine.    It was a case of actual medication error due to expired vaccine used.  At a time of reporting No adverse reactions reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 month old patient that inadvertently received Quadracel / no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 15 months old female patient who experienced 15 months old patient that inadvertently received 0.5 ml vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5532AB via intramuscular route in the left thigh on 09-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and (Varicella vaccine).  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that 15 month old patient that inadvertently received Quadracel.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: patient got Menactra SQ instead of IM, no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of unknown demography who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient got Menactra SQ instead of IM (incorrect route of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medicatiuon(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via subcutaneous route in unknown administration site.  It was a case of actual medication error due to inappropriate route of vaccination.  At the time of report, adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: FLU3
Symptoms: Injection site swelling
Clinical narrative: swelling the size of a golf ball at the injection site; swelling the size of a golf ball at the injection site; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old male patient who experienced swelling the size of a golf ball at the injection site (swelling and vaccination site reaction), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AA expiration date: 30-Apr-2019 via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious swelling the size of a golf ball at the injection site (swelling and vaccination site reaction) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  The pharmacist stated that she administers this patient's Fluzone HD vaccine yearly for the past 5 or 6 years and he has no history of a reaction such as this.  Final diagnosis was swelling and vaccination site reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both the events.  List of document held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Malaise
Clinical narrative: very sick; flu; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an female patient of unknown age who experienced flu (influenza like illness) and very sick (malaise), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route.  On an unknown date The patient developed a non-serious flu (influenza like illness) and was very sick (malaise) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab test reported.  Final diagnosis was very sick and flu.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported..  Information on the batch number was requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Localised oedema
Clinical narrative: arm swole up like a golf ball; arm swole up like a golf ball at the injection site (left deltoid); Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old male patient who experienced arm swole up like a golf ball at the injection site (left deltoid) (localised oedema, vaccination site swelling), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 09-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AA via unknown route in the left deltoid.  On an unknown date, The patient developed a non-serious arm swole up like a golf ball at the injection site (left deltoid) (localised oedema, vaccination site swelling) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was localised oedema, vaccination site swelling..   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for the events.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: vaccine some came out of the syringe, outside the patient/no AE; cracking sound when applying the needle to the syringe/no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult patient who received partial dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (pre-filled syringes).  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 partial dose of dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route.  It was of actual medication error due to Vaccine underdose and syringe issue..Reporting clinic staff complaint that Fluzone Quadrivalent pre-filled syringes crack and leak during preparation for injection.  It was unknown whether adverse event was experienced or not..  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: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth at injection site
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Mobility decreased
Clinical narrative: muscle pain, tired, fever, chills, swelling, headache, nausea, shivering, redness, arm pain. Tylenol used.  Could not get out of bed on day 2. Total 4 days until all side effects over. Worse side effects ever from any vaccination. I would never repeat Shingrix unless it gets changed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: muscle pain, tired, fever, chills, swelling, headache, nausea, shivering, redness, arm pain. Tylenol used.  Could not get out of bed on day 2. Total 4 days until all side effects over. Worse side effects ever from any vaccination. I would never repeat Shingrix unless it gets changed.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient is complaining of sore arm and received immunization on 9/05/2019
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Mastocytosis, Pruritus, Rash, Urticaria
Clinical narrative: Developed diffuse hives and itchiness few hours post immunizations that lasted for two days in addition to rash consistent with systemic mastocytosis
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: After given immunization while trying to chart Imm. I realized that I had given an adult dose of Hep a instead of a pediatric dose.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: Pt's grandmother called to report symptoms starting soon after injection - she states he has had a fever, hives  and lymphadenopathy on and off since the injection. His temp has been as high as 102. Grandmother is an NP.  Symptoms are improving.  There was no office visit.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dry mouth, Headache, Hypokinesia, Pain, Pain in extremity
Clinical narrative: extreme pain, could not lift or move arm, swelling and a hard lump that moved slowly  down my entire arm. Headache, dry mouth Painful to touch. Fatigue for 3 days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Vaccination site mass
Clinical narrative: extreme pain, could not lift or move arm, swelling and a hard lump that moved slowly  down my entire arm. Headache, dry mouth Painful to touch. Fatigue for 3 days.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema
Clinical narrative: Erythema in R arm at side of injection
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Patient stated that 1/2 hour after the vaccine, she developed severe shoulder joint pain that traveled to her elbow and wrist within an hour.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Headache, Oropharyngeal pain, Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: runny sinus and sore throat, slight headache, low fever, chills - all happened 4 hours after vaccine and have gotten worse but appear to be stable after 6 hours
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient reported swelling, redness, and itching around the vaccination site, starting the day after administration and subsiding after 3 days.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt had whole body tremors, high fever, chills beginning that evening.  Had loss of mobility in left arm, swelling, pain, and rash.   Currently has somewhat reduced mobility in the arm, along with some swelling and the rash.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Tremor
Clinical narrative: Pt had whole body tremors, high fever, chills beginning that evening.  Had loss of mobility in left arm, swelling, pain, and rash.   Currently has somewhat reduced mobility in the arm, along with some swelling and the rash.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Fatigue, Headache
Clinical narrative: Mother states patient got headache and felt fatigued.
Age: 24.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Asthenia, Fatigue, Headache, Nausea, Syncope
Clinical narrative: Fainted at point of vaccine, which is normal for me. However, since the vaccine I have experienced constant headache, nausea, weakness, and fatigue.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Enema administration, Haematochezia, Intussusception, Irritability
Clinical narrative: Mom reports that the next morning after the Rotavirus vaccine, he woke up screaming at 4 AM. He was seen in clinic after vomiting with loose stool. Sent home and asked to come back in a few hours, he was increasingly more fussy and had another episode of emesis. Family was asked to take him to the ER, he had an episode of bloody stool on the way to ER. In ER, diagnosed with intussusception which was reduced with air enema. Observed overnight at hospital and discharged home the next day .
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Screaming, Vomiting
Clinical narrative: Mom reports that the next morning after the Rotavirus vaccine, he woke up screaming at 4 AM. He was seen in clinic after vomiting with loose stool. Sent home and asked to come back in a few hours, he was increasingly more fussy and had another episode of emesis. Family was asked to take him to the ER, he had an episode of bloody stool on the way to ER. In ER, diagnosed with intussusception which was reduced with air enema. Observed overnight at hospital and discharged home the next day .
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: Patient presented with a blotchy rash 2 days after vaccination
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: pain with lifting shoulder at a 90degee.,cannot lift her left arm above my head. wake up from pain in arm/shoulder. took advil am & pm and got a doctor's note to get an MRI
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Swelling (worse at night), red patch, soreness, slight fever at night
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Minor Swelling/itching,warm at injection site.  Low grade fever, body ache, nausea
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Minor Swelling/itching,warm at injection site.  Low grade fever, body ache, nausea
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient experienced muscle pain and stiffness in her whole body starting about 12 hours after her shot and lasting for about 24 hours.  Her muscle pain and stiffness gradually disappeared and was completely gone after 24 hours.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was due to receive Meningococcal and got MMR instead and was not due for it at this time. patient was up to date on MMR
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: 0912.2019 -patient reporting side effects :arm sore(cannot lift),nausea,vomiting (2 times). fatigue,heaache,shivering,fatigue . 0914.2019-patient is ablet to move her arm but still nauseated and has fatigue. 09.16.2019-patient is feeling better and all side effects are resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: 0912.2019 -patient reporting side effects :arm sore(cannot lift),nausea,vomiting (2 times). fatigue,heaache,shivering,fatigue . 0914.2019-patient is ablet to move her arm but still nauseated and has fatigue. 09.16.2019-patient is feeling better and all side effects are resolved.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Aspiration joint abnormal, Injection site pain
Clinical narrative: Per nurse at Dr.'s office, and encounter notes form hospital:  the patient experienced severe pain in left deltoid 2 hours after administration of Shingrix on 9/10/19,  which revealed calcium pyrophosphate crystals on aspiration on 9/13/19
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chondrocalcinosis pyrophosphate, Injection site pain
Clinical narrative: Per nurse at Dr.'s office, and encounter notes form hospital:  the patient experienced severe pain in left deltoid 2 hours after administration of Shingrix on 9/10/19,  which revealed calcium pyrophosphate crystals on aspiration on 9/13/19
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injected limb mobility decreased, Injection site inflammation, Injection site warmth
Clinical narrative: At 8 pm on the same day of vaccination, patient experienced headache, upset stomach, terrible pain on the right arm and felt hot to touch/inflammation at injection site. Patient emphasized it's very severe for her. However, it was improved on Sunday (no more headache/upset stomach), but there is still sore (difficult with range of motion).
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: At 8 pm on the same day of vaccination, patient experienced headache, upset stomach, terrible pain on the right arm and felt hot to touch/inflammation at injection site. Patient emphasized it's very severe for her. However, it was improved on Sunday (no more headache/upset stomach), but there is still sore (difficult with range of motion).
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPRESENTATIVE WAS IN THE STORE THE DAY AFTER THE VACCINATION (9/14/2019) AND SAID THE PATIENT WAS COMPLAINING OF PAIN/SORENESS AT INJECTION SITE OF SHINGRIX.  I EXPLAINED THE SITE WOULD BE SORE FOR A DAY OR TWO FOLLOWING ADMINISTRATION.  TOLD HIM TO KEEP ANY EYE ON THE SITE FOR ANY FURTHER SYMPTOMS.  PATIENT CAME INTO THE PHARMACY TODAY (9/16/19) AND SHOWED ME HER ARM.  THERE WAS REDNESS AND SWELLING BELOW THE INJECTION SITE AND IT WAS WARM TO THE TOUCH.  SHE SAID IT WAS STILL SORE AND SOME OF THE SORENESS MOVED UP INTO HER NECK.  SHE SAID SHE WAS AT THE PCP OFFICE TODAY AND THEY TOLD HER IT WAS AN ALLERGIC REACTION TO THE SHINGRIX VACCINE.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Neck pain
Clinical narrative: PATIENT REPRESENTATIVE WAS IN THE STORE THE DAY AFTER THE VACCINATION (9/14/2019) AND SAID THE PATIENT WAS COMPLAINING OF PAIN/SORENESS AT INJECTION SITE OF SHINGRIX.  I EXPLAINED THE SITE WOULD BE SORE FOR A DAY OR TWO FOLLOWING ADMINISTRATION.  TOLD HIM TO KEEP ANY EYE ON THE SITE FOR ANY FURTHER SYMPTOMS.  PATIENT CAME INTO THE PHARMACY TODAY (9/16/19) AND SHOWED ME HER ARM.  THERE WAS REDNESS AND SWELLING BELOW THE INJECTION SITE AND IT WAS WARM TO THE TOUCH.  SHE SAID IT WAS STILL SORE AND SOME OF THE SORENESS MOVED UP INTO HER NECK.  SHE SAID SHE WAS AT THE PCP OFFICE TODAY AND THEY TOLD HER IT WAS AN ALLERGIC REACTION TO THE SHINGRIX VACCINE.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: PER PATIENT'S HUSBAND, SHE HAD A "RED STAR PATTERN AND A LUMP ABOUT 1 INCH FROM INJECTION SITE, AND IT WAS WARM."
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Malaise, Vomiting
Clinical narrative: Patient reports feeling very sick with emesis X3, swelling arour right ankle
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient did not report adverse event.  He was inadvertently given 9 doses of IPOL instead of 1.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache, Injection site swelling, Injection site warmth
Clinical narrative: swelling and hot at injection site and spread about six inches beyond, fever, rash, malaise, GI upset/nausea, dizziness, headache
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia, Rash
Clinical narrative: swelling and hot at injection site and spread about six inches beyond, fever, rash, malaise, GI upset/nausea, dizziness, headache
Age: 0.25
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Lethargy
Clinical narrative: for 9 days after above vaccines were given this baby appeared lethargic to mom; symptoms resolved thereafter
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Cough, Decreased appetite, Headache, Hypersomnia
Clinical narrative: severe flu symptons...extreme sore throat...weakness...no appetite...sleeping 15 hours a day...head aches...running nose...steady cough...ringing in ears
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Influenza, Oropharyngeal pain, Rhinorrhoea, Tinnitus
Clinical narrative: severe flu symptons...extreme sore throat...weakness...no appetite...sleeping 15 hours a day...head aches...running nose...steady cough...ringing in ears
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient had local reaction. Redness, swelling, and warm to the touch at site after 15minutes, kept patient an additional 20 minutes in clinic for observation. No change to reaction did not decrease or increase.
Age: 1.58
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Hyperhidrosis, Lethargy
Clinical narrative: Rash all over arms, stomach, legs and back, itchiness, abdominal pain, diahrea, slight fever, sweating, lack of appetite, lethargic for about a week.
Age: 1.58
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Rash all over arms, stomach, legs and back, itchiness, abdominal pain, diahrea, slight fever, sweating, lack of appetite, lethargic for about a week.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 2 inch diameter red spot around injection site. Spot is warm and firm to touch.  Patient reports that it is painful.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised, reddened area noted around site where MMR was given and where Varicella was given.  Dr. informed of reaction and Pt kept for additional observation (total observation time 35min) post vaccination. Improvement noted to sites prior to discharge. No dyspnea, hives, fever, or acute distress noted prior to discharge.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Hypersensitivity, Injection site mass, Nasal congestion, Pruritus
Clinical narrative: patient was in today 2 days after receiving flu shot and said it gave her a reaction that felt like allergies, stuffy nose, itchy throat, itchy around her neck. she had some patchy looking redness on her arm and said she felt a lump at the injection site.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Throat irritation
Clinical narrative: patient was in today 2 days after receiving flu shot and said it gave her a reaction that felt like allergies, stuffy nose, itchy throat, itchy around her neck. she had some patchy looking redness on her arm and said she felt a lump at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction on arm where vaccine was given, swelling and painful. Patient felt generally under the weather as well.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that she experienced a bad headache the evening she received the vaccination. The next day the injection site was swollen and red and painful. She has had a half-dollar sized bruise for 2 weeks. It is no longer swollen or painful. She saw her doctor and they informed her "the bruise may last for months and the vaccination administrator may have hit a nerve or blood vessel. Patient is a former nurse and states she "has never seen anything like this before".
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: the patient recieved the vaccine, she was doing well when she left the pharmacy. about 30min to an hour later, the daughter came reporting that her mother has been very nauseous and throwing up since she returned home. Counseld and advised patient, and made recommendations to control symtpoms, and followed up with the customer.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chest discomfort, Hypoaesthesia
Clinical narrative: Patient started having face numbness after about 3 minutes of administration of vaccines and chest tightness after 5 minutes. I administered an EpiPen 0.3mg in her left thigh which helped with her chest tightness after 3 minutes. My staff called 911 and the EMT's arrived and took her vitals. Her vitals were normal but they ended up taking her to the ER.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: Pale pinkness on bicep (away from the injection site - deltoid)
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Starting 14  hours after the administration of the vaccine , patient reported the following: chills, fever, flu-like symptoms, headache and swelling, redness and heat sensation just below the administration site. None of the adverse events were deemed serious enough by the patient to seek treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Starting 14  hours after the administration of the vaccine , patient reported the following: chills, fever, flu-like symptoms, headache and swelling, redness and heat sensation just below the administration site. None of the adverse events were deemed serious enough by the patient to seek treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Seizure
Clinical narrative: He had a seizure 2 days later, had to call 911 and see ER
Age: 4.0
Sex: M
Vaccine: MMR, UNK, UNK, UNK
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Woke up with a fever of 105 and very weak in the knees in the middle of the night. The fever went down with Motrin but remained in the 103-104 range for a few hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Dyspnoea, Headache
Clinical narrative: Very painful at site of injection, shortness of breath, Achy, Headache, Loss of Appetite, Dizziness, No Energy  Shortness of breath cleared up by late evening the day of injection; all other symptoms lasted through Wednesday, September 11.  Missed 3 days of work.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Very painful at site of injection, shortness of breath, Achy, Headache, Loss of Appetite, Dizziness, No Energy  Shortness of breath cleared up by late evening the day of injection; all other symptoms lasted through Wednesday, September 11.  Missed 3 days of work.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced onset of symptoms redness, swelling, soreness, injection site warm to the touch starting about 6 hours after administration and lasting through today.  The injection site is surrounded by a demarcated red area of approximately 3" diameter and extends down her arm appearing red and splotchy. Patient also c/o itching at injection site and site feeling painful with movement which was relieved with OTC acetaminophen.  Patient also experienced an immune response following vaccine including fatigue, and "just not feeling well."
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pain, Rash macular
Clinical narrative: Patient experienced onset of symptoms redness, swelling, soreness, injection site warm to the touch starting about 6 hours after administration and lasting through today.  The injection site is surrounded by a demarcated red area of approximately 3" diameter and extends down her arm appearing red and splotchy. Patient also c/o itching at injection site and site feeling painful with movement which was relieved with OTC acetaminophen.  Patient also experienced an immune response following vaccine including fatigue, and "just not feeling well."
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Swelling face
Clinical narrative: Patient received Afluria on 9/11/19. Then 4 hours after receiving vaccine, the patient reported that she felt "achy". She said she took 2 Alleve within 30 minutes. Then she had violent chills for 4 hours and her face was swollen. She called her primary care physician who instructed her to go to the emergency room. Patient went to the emergency room. The ER physician could not tell her exactly what was causing the reaction. Patient was discharged with Diphenhydramine and Prednisone. She called today, 9/15/19, to report the swelling and chills to us. She has had flu shots in the past without any severe reactions. Patient said she is doing better.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Called patient on09/16/2019 to have her come in for second dose shingrix. Patient informed that doctor does not want he to get any vaccine until her arm heals. Two months later, patient states she still has a large red swollen  area at injection site. she rates pain 7 out 10yet. States pain shoots all the way down to thumb. Patient states doctor is treating patient with prednisone and is thinking about starting gabapentin to control pain. Patient states okay to contact if more info needed.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin
Clinical narrative: April 10th I received the first dose of Shingrix vaccine. By April 21st I had a full on outbreak of shingles including severe derm pain on head and forehead.Nowhere in labeling is this reported as a side effect of this vaccine
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: My child received the MMR shot and had both a high fever for three days (7 days after shot) and also got a rash all over the trunk of her body which lasted 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Had shot at 1pm 9/7/19 at midnight I had a severe headache, fever, chills, body aches, nausea and then diarrhea two days later very weak and still have a slight headache and body ache
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Had shot at 1pm 9/7/19 at midnight I had a severe headache, fever, chills, body aches, nausea and then diarrhea two days later very weak and still have a slight headache and body ache
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site bruising, Injection site swelling
Clinical narrative: I got a bad flu, starting evening after I got my 2nd Zoster Vaccine (Recombinant) and was in bed for 2 days; I also got swelling and bruising on left arm where I go the shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Pain
Clinical narrative: Following our Dr's instructions I got my Shingrix shot on 9/4. The IM shot stung more then I would have expected. I have a pre existing condition with my left leg, I had a bulging disk at L4-5 approximately 19 years ago and again involving the right leg 3 years ago. With the left leg, every once in a blue moon I would have what feels like a wasp sting about mid shin on the outside of the leg which would cause me to jump when it hits. This would happen every couple of months or so or maybe when I exerted my lower back more then I should have. On the night of the 4th morning of the 5th after I went to bed, I had that stinging event occur. The bazaar thing was that I would lay quiet and it would hit, followed by two more times forcing me to move by sheer reaction. Then I would lay still and it would happen again, so I would move again and after a while it would start again, as long as I was in motion it wouldn't hit but when I laid still it would come back. Initial "sting" followed by two more if I stayed still. This went on all evening to the point my Fitbit didn't record any sleep at all; that was a first since I've it! When I got up in the morning for the day I no longer experienced the discomfort and it did not return the next night.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Cardiac stress test normal, Chest pain, Chills, Herpes zoster
Clinical narrative: Received second shingrex vaccine August 15, 2019. Had fever chills and shakes through the night. Tingles in left arm stayed with me. September 9, 2019 I was prescribed Amlodipine because my blood pressure was 199/124. Tingling in left arm continued. September 12, 2019 went to emergency room because tingling in other arm and left leg heading up to my neck and jaw. I had shooting pains in chest and right abdominal. I was kept overnight for a nuclear stress test. Test didn't show any severe blockage. I was prescribed Gabapentin for shingles symptoms and discharge.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pyrexia, Scan myocardial perfusion, Tremor
Clinical narrative: Received second shingrex vaccine August 15, 2019. Had fever chills and shakes through the night. Tingles in left arm stayed with me. September 9, 2019 I was prescribed Amlodipine because my blood pressure was 199/124. Tingling in left arm continued. September 12, 2019 went to emergency room because tingling in other arm and left leg heading up to my neck and jaw. I had shooting pains in chest and right abdominal. I was kept overnight for a nuclear stress test. Test didn't show any severe blockage. I was prescribed Gabapentin for shingles symptoms and discharge.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Diarrhoea, Eructation
Clinical narrative: Multiple adverse side effects 24 hours post injection: soreness, swelling, hardness at injection site; neck and shoulder muscle pain; extreme tiredness and weakness; headache; upset stomach; diarrhea; belly pain; gas (burping and flatulence; lasted three full days with several days of recovery
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Flatulence, Headache, Injection site induration, Injection site pain
Clinical narrative: Multiple adverse side effects 24 hours post injection: soreness, swelling, hardness at injection site; neck and shoulder muscle pain; extreme tiredness and weakness; headache; upset stomach; diarrhea; belly pain; gas (burping and flatulence; lasted three full days with several days of recovery
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Multiple adverse side effects 24 hours post injection: soreness, swelling, hardness at injection site; neck and shoulder muscle pain; extreme tiredness and weakness; headache; upset stomach; diarrhea; belly pain; gas (burping and flatulence; lasted three full days with several days of recovery