chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Injection Site Itching; Injection Site Irritation; Sore arm/Difficulty laying on her side due to the sore arm; Chills; Sleepiness; Red 3 inch circle at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on face, about 10 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th September 2019, the patient experienced chills and sleepiness. On 12th September 2019, the patient experienced injection site erythema, injection site itching and injection site irritation. On an unknown date, the outcome of the pain in arm, chills, sleepiness and injection site erythema were recovered/resolved and the outcome of the injection site itching and injection site irritation were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, sleepiness, injection site erythema, injection site itching and injection site irritation to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix on left arm. On the day of getting the vaccine, the patient had sore arm that lasted for about 3 days.  Due to the sore arm, she had difficulty laying on her side.  On the next day, the patient experienced chills and sleepiness that lasted for about one day.  On day 3 after vaccination, the patient noticed red 3 inch circle at injection site associated with itching and irritation. After 7 days, the redness had faded but the itching and irritation were still present periodically. The patient did not consent to follow-up. This case has been linked to US2019AMR168832, reported by the same reporter. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Nausea, Vertigo
Clinical narrative: Vertigo; Dizziness; Nausea; Diarrhea; Fatigue; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2019, the patient received Shingrix. On 15th September 2019, 1 days after receiving Shingrix, the patient experienced fatigue. On 16th September 2019, the patient experienced vertigo, dizziness, nausea and diarrhea. On an unknown date, the outcome of the fatigue, vertigo, dizziness, nausea and diarrhea were recovering/resolving.   It was unknown if the reporter considered the fatigue, vertigo, dizziness, nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced fatigue, vertigo, dizziness, nausea and diarrhea. The reporter stated that, the events were much better at the time of reporting. No further information was provided at the time of reporting regarding vaccine and events. The reporter consented to follow up.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Skin warm, Swelling
Clinical narrative: injection site pain; joint pain; swelling; Arm warm to the touch; Arm partially immobile; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 30-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number P4DN4, expiry date 30th June 2020) for prophylaxis.   On 11th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, 2 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain, joint pain, swelling, skin warm and mobility decreased. On an unknown date, the outcome of the injection site pain, joint pain, swelling, skin warm and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, joint pain, swelling, skin warm and mobility decreased to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 season and 2 days later experienced pain at the injection site, joint pain, swelling, arm was warm to the touch, and had partial immobility. The reporter did not consent to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site erythema
Clinical narrative: Upper and lower arm are red / very red; Blister inside the upper arm; Redness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema. On 15th September 2019, the patient experienced erythema of extremities and blister. On an unknown date, the outcome of the injection site erythema, erythema of extremities and blister were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema of extremities and blister to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on unknown arm. About 5 days later the patient visited the pharmacy and there was redness at the injection site.  The patient said the redness started about 2 days after getting the vaccine.  The patient was instructed to put an icepack on the redness.  The patient was at the pharmacy again on day before reporting and 6 days after receiving Shingrix his upper and lower arm are red and there was a blister at the injection site. It was not itchy or painful, but very red. Upon call back to healthcare professional on day of reporting, they stated that the blister was not at the injection site on arm but inside the upper arm. The reporter consented to follow up. In the document outcome of events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness; Injection site swelling; Injection site warmth; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th November 2021) for prophylaxis.   On 14th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced injection site redness, warmth, and swelling. The healthcare professional reported the patient noticed the events two days later but could not provide an exact start date. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysarthria
Clinical narrative: Slurred Speech; This case was reported by a pharmacist via call center representative and described the occurrence of slurred speech in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number AH992, expiry date 8th March 2022) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced slurred speech. On an unknown date, the outcome of the slurred speech was unknown.   It was unknown if the reporter considered the slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient developed slurred speech for days after receiving Shingrix vaccine The reporter did not consent to follow up.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Sore; Difficulty lifting arm; Rash; Red; Tender; Hot to touch; Swollen to golf ball size; Inflamed; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 97-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 14th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced rash, erythema, tenderness, feeling hot, swelling and inflammation. On 15th September 2019, the patient experienced mobility decreased. On 16th September 2019, the patient experienced pain in arm. On an unknown date, the outcome of the rash, erythema, tenderness, feeling hot, swelling, inflammation and pain in arm were unknown and the outcome of the mobility decreased was recovering/resolving.   It was unknown if the reporter considered the rash, erythema, tenderness, feeling hot, swelling, inflammation, mobility decreased and pain in arm to be related to Shingrix.  Additional case details were provided as follows: This adverse event information was collected via chat. On the first day she received Shingrix, she had difficulty lifting her arm.  On the day of reporting, the patient could lift her arm but it was sore.  The patient complained of a golf sized rash, hot to touch, red and tender but not itchy.  The reporter confirmed that, the rash was like the size of golf ball and was not raised like it but was very inflamed. The reporter consented to follow up.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Tenderness
Clinical narrative: Sore; Difficulty lifting arm; Rash; Red; Tender; Hot to touch; Swollen to golf ball size; Inflamed; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 97-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 14th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced rash, erythema, tenderness, feeling hot, swelling and inflammation. On 15th September 2019, the patient experienced mobility decreased. On 16th September 2019, the patient experienced pain in arm. On an unknown date, the outcome of the rash, erythema, tenderness, feeling hot, swelling, inflammation and pain in arm were unknown and the outcome of the mobility decreased was recovering/resolving.   It was unknown if the reporter considered the rash, erythema, tenderness, feeling hot, swelling, inflammation, mobility decreased and pain in arm to be related to Shingrix.  Additional case details were provided as follows: This adverse event information was collected via chat. On the first day she received Shingrix, she had difficulty lifting her arm.  On the day of reporting, the patient could lift her arm but it was sore.  The patient complained of a golf sized rash, hot to touch, red and tender but not itchy.  The reporter confirmed that, the rash was like the size of golf ball and was not raised like it but was very inflamed. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Reaction after Shingrix vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The pharmacist asked any information on any cross ingredients between Boostrix and Shingrix. The health care professional stated that the patient would like Boostrix but had a previous reaction to the Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination Failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected  vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 3 years before the time of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. Last year, the patient completed a series of Shingrix. In 2019, the patient had a shingles outbreak. The reporter did not have any patient details to provide or dates of vaccination. This case was considered as suspected vaccination failure as details regarding, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Lymphoma
Clinical narrative: Lymphoma; This case was reported by a physician via call center representative and described the occurrence of lymphoma in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (1 dose received on 17th February 2005). Concomitant products included DTPa-HBV-IPV (Pediarix).   On 22nd June 2005, the patient received the 3rd dose of Pediarix. On 4th September 2009, 4 years and 75 days after receiving Pediarix, the patient experienced lymphoma (serious criteria GSK medically significant). On an unknown date, the outcome of the lymphoma was unknown.   It was unknown if the reporter considered the lymphoma to be related to Pediarix.  Additional details were provided as follows: The patient received her first three doses of Pediarix in 2005, but never completed the remainder of the DTaP or IPV due to being diagnosed with lymphoma.  They went into remission, but it came back at some point.  The patient completed their treatments about a year ago and was cleared to receive live vaccines. The reporter consented for follow up.
Sex: U
Vaccine: PNC13
Symptoms: Borrelia test positive, Headache, Lyme disease, Mental status changes, Pain
Clinical narrative: Tested and treated for lymes; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as 7/10) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given the vaccine on an unspecified date, reported as 7/10, and came back on an unspecified date, reported as 7/12, with fever, headache, body aches and altered mental status. The patient was tested and treated for lymes and was hospitalized. The nurse stated "not sure if related to vaccine but started 2 days after". The outcome of the event was recovered. It took 3 months for the patient to return to baseline.  The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Tested and treated for lymes; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as 7/10) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given the vaccine on an unspecified date, reported as 7/10, and came back on an unspecified date, reported as 7/12, with fever, headache, body aches and altered mental status. The patient was tested and treated for lymes and was hospitalized. The nurse stated "not sure if related to vaccine but started 2 days after". The outcome of the event was recovered. It took 3 months for the patient to return to baseline.  The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Asthenia, Fatigue, Myalgia, Nausea
Clinical narrative: Anxiety; Aching muscles; low energy; Fatigue; Nausea; This is a spontaneous report from a contactable other healthcare professional (medical assistant). A 64-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: AA7118, expiry: 31May2021, NDC: 00005197101), intramuscular in the left deltoid at the clinic on 16Sep2019 15:39 at 0.5 ml, single for immunization. Medical history included autoimmune disorder. There were no concomitant medications. On 20Sep2019, the patient experienced anxiety, aching muscles, low energy, fatigue and nausea. Outcome of the events was unknown. Events anxiety and aching muscles were reported as serious due to medically significant; for the other events were reported as non-serious. The patient was advised to go to the emergency room if any of her symptoms worsened.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of aching muscles cannot be excluded, considering the apparent temporal association and the known adverse event profile of the suspect vaccine;  anxiety more likely represents an emotional tension arising from immunization.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Physician gave a pregnant patient Fluzone Quadrivalent which was expired on 30-Jun-2019/No AE; Physician gave a pregnant patient Fluzone Quadrivalent which was expired on 30-Jun-2019/No AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female pregnant patient (age unknown) who was given a 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which was expired on 30-Jun-2019 administered by a physician lot number not reported via unknown route in unknown administration site on an unspecified date, while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Data regarding this pregnancy were received prospectively.  It was a case of vaccine exposure during pregnancy.  It was an actual medication error due to expired vaccine used.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Fluzone high dose and it leaked between the syringe / no AE; Fluzone high dose and it leaked between the syringe / no AE; injection the medication leaked over the patient's arm / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 82 years old patient who received 0.5 ml vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  lot UJ241AB (Expiry date Apr-2020) via intramuscular route in the right deltoid on 18-sep-2019.  It was case of syringe leak, vaccine underdose and Exposure via skin contact.  It was reported that prefilled syringes in the box were fine and this was the last one so she threw the leaking syringe and the box away after the infection therefore has limited information. States as she was giving the injection the medication leaked over the patient's arm.  At the time of reporting no adverse reaction was reported.  List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: patient received less than the full dose of Fluzone High-Dose due to the administering agent "squirted" most of the liquid out when they were removing the air from the syringe, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 years old female patient who received yearly 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  (lot number and Expiry date unknown) via unknown route in unknown administration site on 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine underdose.  It was reported that Received less than the full dose of Fluzone High-Dose due to the administering agent "squirted" most of the liquid out when they were removing the air from the syringe.  At the time of reporting no adverse reaction was reported.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered two dose of Fluzone High-Dose / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 80 years old female patient who received two doses of 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 17 Sep 2019, patient received dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (vaccination details regarding dose, route, site, batch, exp date was not reported)  On 19 Sep 2019, Patient received 05 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ253AB (Expiry date 06-May-2020) via unknown route in unknown in the left deltoid   It was an actual medication error case due to extra dose administered.   At a time of vaccination no adverse events 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked with case 2019SA267191; 2019SA267208 ; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193 (same reporter)  This case involves a female patient (elderly) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this Flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered.  It was a case of actual medication error due to incorrect product storage.  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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267208; 2019SA267209; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020 via intramuscular route in the left deltoid on an unspecified date which was 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant vaccine was Pneumococcal Conjugate Vaccine 13.  It was a case of actual medication error due to incorrect product storage.  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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193 (same reporter)  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020, via intramuscular route in the left deltoid on an unspecified date which was 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant vaccine included Pneumococcal vaccine.  It was a case of actual medication error due to incorrect product storage.  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.  Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, TDAP
Symptoms: Macule, Pallor, Peripheral swelling, Pruritus, Rash
Clinical narrative: swelling hands and feet, itchy, blanching rash on legs.  macules on arms.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and raised bump at injection site about 2 inches. no fever. no other symptoms
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Myalgia, Night sweats
Clinical narrative: Started with headache, muscle aches and feeling feverish.  Truly bad event in middle of night with sweating, stomach craps, diarrhea and vomiting lasting over one hour.  After two hours, felt normal again.  Could be bad timing, but if related thought you guys would want to know.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started with headache, muscle aches and feeling feverish.  Truly bad event in middle of night with sweating, stomach craps, diarrhea and vomiting lasting over one hour.  After two hours, felt normal again.  Could be bad timing, but if related thought you guys would want to know.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash, Rash vesicular
Clinical narrative: Patient had fever, body aches, and chills on 9/5/19. Patient who is RN states that on 9/11/19 she had Varicella like rash to her left leg and arm. Rash has resolved at this time.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Eye pruritus, Pruritus, Rhinitis, Rhinorrhoea, Wheezing
Clinical narrative: Pt returned to clinic 15-20 minutes after vaccine was given with wheezing throughout lungs, extreme pruritus to eyes/nose/ears/neck, copious rhinnorrhea, and sneezing. 2.5 mg albuterol nebulizer was given with resolution of wheezing and 25 mg of benadryl was given with improvement in pruritus and rhinnitis. No vomiting, no lip swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity, Rash
Clinical narrative: Pt reported heat, rash and soreness to the arm that last for several weeks.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant redness and swelling to left upper arm starting a few hours after receiving vaccine--took three days to improve
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Pain, swelling, redness persistent three days after the injection, fever of 101 approximately 24 hours after injection, joint pain, muscle pain, fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Pain, swelling, redness persistent three days after the injection, fever of 101 approximately 24 hours after injection, joint pain, muscle pain, fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Erythema, Injection site induration, Injection site rash
Clinical narrative: Rash started Tuesday afternoon after vaccines; Rash and induration at area on right thigh; 5X5cm. Area of rash 19X15cm. Erythema
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Lip swelling
Clinical narrative: angioedema, swollen lips
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Redness, pain, swelling of left arm. Began receding after two days
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called pharmacy on 9-26-19 complaining of pain in upper arm. She stated she has seen a physician since receiving the vaccine and was told by the physician that the vaccine was given too high in the arm.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Blood test normal, Fall, Feeling cold, Headache, Ocular hyperaemia
Clinical narrative: Patient said that he went to eat the evening in Park and after eating, he fell shaking cold with lots of headache.  His daughter in law which work for dispatching, took him to the ER.  He said the hospital took 5 pints of blood for different tests .  All came negative.    Patient came in today to the pharmacy and complained still of very red eyes.  I suggest him to see the doctor for check up today.   I was able to make apt to see doctor today at 3pm.  He just left the pharmacy to go straight to see his doctor
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Patient said that he went to eat the evening in Park and after eating, he fell shaking cold with lots of headache.  His daughter in law which work for dispatching, took him to the ER.  He said the hospital took 5 pints of blood for different tests .  All came negative.    Patient came in today to the pharmacy and complained still of very red eyes.  I suggest him to see the doctor for check up today.   I was able to make apt to see doctor today at 3pm.  He just left the pharmacy to go straight to see his doctor
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: pt developed a rash on her neck about a day after receiving immunizations, unknown if it is related to immunizations.  She has been taking benadryl otc, and will start using hydrocortisone otc also
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient having nerve pain down arm towards wrist and at site of injections.  Does not appear to be getting worse.  Patient following up with us this evening and knows to go to ER if worsens.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: patient's wife called the pharmacy and asked us to report to CDC that her husband had red purple swollen area where he got the shot
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, swelling/warmth to touch and tenderness with movement to lower right thigh (below site of injection)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Patient says her lips swelled post vaccination
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Hyperhidrosis, Lethargy, Pallor, Peripheral coldness, Vomiting
Clinical narrative: Symptoms included sweat, pallor, vomiting, lethargy, cold skin.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Patient injected with flucelvax flu shot shortly after 1pm, and called back after about an hour saying they just noticed a rash on their leg running along their calf, on their left side (same side as injection was administered) Patient instructed to take oral Benadryl, and recheck it after a couple hours. Instructed patient for warnings of more severe allergic symptoms, with directions to call 911 if they experienced and difficulty breathing. If rash did not diminish or grew in size to call back for further care instructions.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling cold, Injection site pain, Insomnia
Clinical narrative: shivering, very cold couldn't get warm and insomnia as well as pain at injection site
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient received PPSV23 on 9/19/19 she reported having swelling later in the evening with redness and warmth.  She reported to the office on 09/20/2019 and the provider checked her arm and told her to take Benadryl non-drowsy and to continue using cold compresses.  She presented to the office again on 09/23/2019 showing us her arm which showed improvement.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Neck pain, Pain
Clinical narrative: Shooting neck and back pain, arm pain at injection site for a day
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: IN LEFT ARM: REDDNESS, SWELLING, PAIN, HOT TO TOUCH. ADVISED PATIENT TO APPLY COLD COMPRESS, TAKE IBUPROFEN AND IF ITCHING OCCURS TO TAKE BENADRYL, ADVISED IF NOT BETTER OR IS WORSE BY TOMORROW TO SEEK MEDICAL TREATMENT.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: The day after all vaccines listed above were given patent developed a small rash on both inner arms. The rash continued to spread to other places on body. The rash started as a bright red speckled rash. The rash did not seem to be painful for the first week. Over the next several weeks the rash got worse. It was covering the entire body of the infant. The effected areas became sore and painful to touch.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Extreme swelling and redness at site of injection-(round circle 3" x 4" in diameter).  Flu like symptoms started in the middle of the night-fever, chills, body ache, nausea lasted 2 1/2 days. My mother who is eighty-one (81) also received her second dose of the vaccination the same day, and had the same symptoms.    My husband had his first dose who is sixty (60) and had these exact symptoms,   My concern is that these are not symptoms listed on the pamphlet.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme swelling and redness at site of injection-(round circle 3" x 4" in diameter).  Flu like symptoms started in the middle of the night-fever, chills, body ache, nausea lasted 2 1/2 days. My mother who is eighty-one (81) also received her second dose of the vaccination the same day, and had the same symptoms.    My husband had his first dose who is sixty (60) and had these exact symptoms,   My concern is that these are not symptoms listed on the pamphlet.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness, swelling and pain at the injection site that lasted one week; lethargy/fatigue that lasted a week; muscle aches all over body that lasted 4 days; chills that lasted one day for two hours; headache that lasted one day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Myalgia
Clinical narrative: Redness, swelling and pain at the injection site that lasted one week; lethargy/fatigue that lasted a week; muscle aches all over body that lasted 4 days; chills that lasted one day for two hours; headache that lasted one day.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Patient experienced headache, bilateral weakness & numbness of the upper and lower extremities.  He went to a general practitioner starting in August, but was later referred to a neurologist that diagnosed as Guillian Barre syndrome.  He was admitted to the hospital for IVIG therapy and was discharged after one day to continue therapy at home.  Patient is still undergoing therapy at home, and outcome is yet to be determined.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient had itchy hives appear on her right wrist after receiving her first Shingrix vaccine. They disappeared the following day.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: Large location reaction with associated swelling, erythema, and induration starting within several hours, worsening over first 24 hours
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Vomiting
Clinical narrative: Severe headache and vomiting in the middle of the night.  Also pain at injection site.  Flu like symptoms the day after the injection.
Sex: F
Vaccine: VARZOS
Symptoms: Mental status changes, Pneumonia, Sepsis, Upper respiratory tract infection
Clinical narrative: severe sepsis; altered mental status; diagnosed with an acute upper respiratory infection; pneumonia; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 17-SEP-2014, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Within one  week after receiving zoster vaccine live (ZOSTAVAX), the pt suffered altered mental status and was diagnosed with an acute upper respiratory infection, pneumonia, and severe sepsis.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The events of altered mental status, acute upper respiratory infection, pneumonia, and severe sepsis were determined to be disabling events.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; expired PNEUMOVAX 23 was administered; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On 23-SEP-2019, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (lot # N024385 with expiry date 18-MAY-2019, intramuscular; dose number and frequency unspecified) for prophylaxis (expired product administered). No adverse effects reported (no adverse event). The outcome of the events was unknown. No product quality complaint was involved.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: LEFT ARM SWELLING, REDNESS, ITCHING, HOT TO TOUCH, BURNING SENSATION AT AND AROUND INJECTION SITE, ALONG WITH HEADACHE. PATIENT ADVISED TO TAKE ZYRTEC 10ML DAILY AND PRESCRIBED PREDNISOLONE 15ML/5ML ORAL SOLUTION 10ML BY MOUTH EVERY DAY X 3 DAYS
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site warmth
Clinical narrative: LEFT ARM SWELLING, REDNESS, ITCHING, HOT TO TOUCH, BURNING SENSATION AT AND AROUND INJECTION SITE, ALONG WITH HEADACHE. PATIENT ADVISED TO TAKE ZYRTEC 10ML DAILY AND PRESCRIBED PREDNISOLONE 15ML/5ML ORAL SOLUTION 10ML BY MOUTH EVERY DAY X 3 DAYS
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: headache, muscle aches, fever, shivering, stomach pain, nausea, fatigue, fast heartbeat, pain and redness at site
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: headache, muscle aches, fever, shivering, stomach pain, nausea, fatigue, fast heartbeat, pain and redness at site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient was diagnosed with cellulitis from doctor's office, patient to complete a 10 day cycle of antibiotics.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration
Clinical narrative: 2nd shingrix dose given within 3 weeks of 1st shingrix.I checked with patient 2 days after immunization, she reports fatigue and chills for 24 hrs, these side effects should be related to fluzone hd and shingrix. Ive submitted this because I immunized too early for 2nd shingrix.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: patient called stating injection site had a raised, egg-sized, warm-to-the-touch, lump at the injection site. informed patient to call PCP, use Ibuprofen, and ice.  Within 24 hours, symptoms completely subsided