chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Ear pain, Fatigue, Feeding disorder
Clinical narrative: had a stroke; Right-sided paralysis; Unable to close right eye; Soreness; headache; Extreamly painful ear; Tiredness; Inability to eat; Slurred speech; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th September 2019, 5 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant and clinically significant/intervention required), paralysis (serious criteria GSK medically significant and clinically significant/intervention required), lagophthalmos (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required), unable to eat (serious criteria clinically significant/intervention required) and slurred speech (serious criteria clinically significant/intervention required). The patient was treated with prednisone. On an unknown date, the outcome of the stroke, paralysis, lagophthalmos, pain, headache, ear pain, tiredness, unable to eat and slurred speech were not recovered/not resolved.   It was unknown if the reporter considered the stroke, paralysis, lagophthalmos, pain, headache, ear pain, tiredness, unable to eat and slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. On the following Saturday morning, she woke up with right-sided paralysis, unable to close right eye, soreness, headache, extremely painful ear, tiredness, inability to eat and slurred speech. The patient had to be seen in the emergency room (ER) and was put on prednisone which she wals still taking. The patient reported that she looks like she had a stroke. All of these symptoms have gotten worse and are not improving.   The patient asked what she could do to improve her symptoms medically and advised her to consult with her MD concerning any type of medical advice.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lagophthalmos, Pain, Paralysis
Clinical narrative: had a stroke; Right-sided paralysis; Unable to close right eye; Soreness; headache; Extreamly painful ear; Tiredness; Inability to eat; Slurred speech; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th September 2019, 5 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant and clinically significant/intervention required), paralysis (serious criteria GSK medically significant and clinically significant/intervention required), lagophthalmos (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required), unable to eat (serious criteria clinically significant/intervention required) and slurred speech (serious criteria clinically significant/intervention required). The patient was treated with prednisone. On an unknown date, the outcome of the stroke, paralysis, lagophthalmos, pain, headache, ear pain, tiredness, unable to eat and slurred speech were not recovered/not resolved.   It was unknown if the reporter considered the stroke, paralysis, lagophthalmos, pain, headache, ear pain, tiredness, unable to eat and slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. On the following Saturday morning, she woke up with right-sided paralysis, unable to close right eye, soreness, headache, extremely painful ear, tiredness, inability to eat and slurred speech. The patient had to be seen in the emergency room (ER) and was put on prednisone which she wals still taking. The patient reported that she looks like she had a stroke. All of these symptoms have gotten worse and are not improving.   The patient asked what she could do to improve her symptoms medically and advised her to consult with her MD concerning any type of medical advice.
Age: 72.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Swelling in right arm; Painful injection site / site soreness; Hot injection site; Red injection site; Itchy / itchiness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUAD .5 ml. On 17th September 2019, 1 hr after receiving Shingrix, the patient experienced swelling arm, injection site pain, injection site warmth, injection site erythema and pruritus. On 8th October 2019, the outcome of the swelling arm was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovered/resolved and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, injection site pain, injection site warmth, injection site erythema and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient received a flu vaccine, Fluad at the same time. The reporter stated that an hour later she started to have swelling in her right arm and a red, hot, painful injection site on her right arm, and she was itchy.  The reporter stated that all the symptoms except for the itchiness and some site soreness "when you press on it." persist at this time. The patient stated that all other symptoms resolved within "one and a half weeks" from 17th September 2019. The reporter does not have vaccine information for this adverse event. The reporter consent to healthcare professional follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extremely fatigued; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   On 4th October 2019, the patient received Shingrix (intramuscular) .5 ml. On 5th October 2019, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient got Shingrix on friday and started feeling extremely fatigued on Saturday.  The patient was still feeling the same way today. The reporter consented to follow up.  No further information was available.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Amnesia, Confusional state, Erythema, Inflammation, Myalgia
Clinical narrative: confused; arm was red and sore; memory loss, could not recognize names; myalgia; a fever; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 70 years old female patient who was confused (confusional state), her arm was red and sore (inflammation) had memory loss, could not recognize (amnesia), myalgia (myalgia), a fever (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  The patient was in a weakened states because she has Meniers disease and has suffered from 23 bouts of severe vertigo, causing constant emesis and weight loss, for about 7 months. She recently had surgery related to that illness. She reported that today is the first day that she hasn't run a fever.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid.  On 19-Sep-2019, the patient received dose of suspect VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) lot number not reported via unknown route in the left deltoid.   On an unknown date, , the patient was confused (confusional state), picked up a book to read and the words didn't make sense. She wanted to call a friend that is a nurse but couldn't remember her name. Patient had memory loss (amnesia), Several hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX.  On an unspecified date, her arm was red and sore (inflammation), myalgia (myalgia), a fever (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX.  Lab data was not reported.  Final diagnosis was confusional state, inflammation, amnesia, myalgia and pyrexia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the events.  Information on the batch number was requested.  List of document held by sender: none.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: confused; arm was red and sore; memory loss, could not recognize names; myalgia; a fever; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 70 years old female patient who was confused (confusional state), her arm was red and sore (inflammation) had memory loss, could not recognize (amnesia), myalgia (myalgia), a fever (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  The patient was in a weakened states because she has Meniers disease and has suffered from 23 bouts of severe vertigo, causing constant emesis and weight loss, for about 7 months. She recently had surgery related to that illness. She reported that today is the first day that she hasn't run a fever.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid.  On 19-Sep-2019, the patient received dose of suspect VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) lot number not reported via unknown route in the left deltoid.   On an unknown date, , the patient was confused (confusional state), picked up a book to read and the words didn't make sense. She wanted to call a friend that is a nurse but couldn't remember her name. Patient had memory loss (amnesia), Several hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX.  On an unspecified date, her arm was red and sore (inflammation), myalgia (myalgia), a fever (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX.  Lab data was not reported.  Final diagnosis was confusional state, inflammation, amnesia, myalgia and pyrexia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the events.  Information on the batch number was requested.  List of document held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 57 years old given the Fluzone HD in error, no AE; 57 years old given the Fluzone HD in error, no AE; 57 years old given the Fluzone HD in error instead of flu vacccine, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse via office staff.  This case involves a 57 years old male patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA VACCINE (flu vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rash.   On 22 Sep 2019, the patient received a 0.5 ml dose suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AB via intramuscular route in the left deltoid instead of INFLUENZA VACCINE .  It was a case of actual medication error due to Inappropriate age at vaccine administration, overdose and wrong vaccine administered.  At the time of the report, no adverse event was reported. (the patient was doing fine and had no complaints)  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 the sender: none
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: some of the medication came out the bottom side of the syringe, no AE; Product came out the bottom side of syringe, leaking during administration, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 76 years old female patient who experienced some of the medication came out the bottom side of the syringe, no ae and product came out the bottom side of syringe, leaking during administration, no ae, while she 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 30-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AA, Exp. 5/10/2020 via intramuscular route in the left arm.  It was a case of actual medication error due to vaccine underdose. It was also a case of syringe leak.  At the time of the 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 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 the sender: none
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant administered Flublok instead of standard dose to child patient; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient of an unknown age (child) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site on an unknown date instead of standard dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  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 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.  Documents held by sender: none.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pain
Clinical narrative: body aches; Shortness of breath; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a physician and nurse via sales representative.  This case is linked to cases 2019SA280603 and 2019SA280605 (same reporter).  This case involves a 91 years old female patient who experienced shortness of breath (dyspnoea) and body aches (pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included flu shots without any reactions. The patient's past medical history, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed shortness of breath (dyspnoea) and body aches (pain) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events. It was reported that the hospital personnel stated it was due to flu shot.  Other relevant tests not reported.   Final diagnosis was body aches and shortness of breath.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for shortness of breath and body aches.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case concerns a 91 years old female patient who developed dyspnoea and body pain after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. However, patient's medical condition at the time of vaccination was not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: patient had allergic reaction due to beef or pork component within vaccine and ended up in the hospital; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional (office staff).  This case involves a male patient of unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that patient had allergic reaction due to beef or pork component within vaccine and ended up in the hospital (allergy to vaccine).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received 1 dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced allergic reaction due to beef or pork component within vaccine and ended up in the hospital (allergy to vaccine). The patient was hospitalized for this event.  (Other relevant tests included no lab data.)  Final diagnosis was allergy to vaccine.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case involves a male patient of unknown age who experienced allergy to vaccine after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: giving the injection the medication leaked over the patient's arm/No AE; giving the injection the medication leaked over the patient's arm/NO AE; giving the injection the medication leaked over the patient's arm, needle was not on secure the needle on tight prior to the injection/NO AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] the injection the medication leaked over the patient's arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given this visit.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ241AB, Expiry 18/04/2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to vaccine underdose and Exposure via skin contact.  It was also the case of syringe leak. The needle was not on secure and she states she had the needle on tight prior to the injection. Does not know exactly where the syringe was leaking and none of the other questions under leaking apply since this was a syringe and not a vial. Caller states since the syringe was leaking she did not examine it too closely to tell where.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt. screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking/No AE; giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt. screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking/No AE; giving a patient a Fluzone High Dose and almost half of the dose came off on my shot and shirt. screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking/No AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], she was giving a patient a fluzone high dose and almost half of the dose came off on her shot and shirt. Screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given this visit.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ236AA, Expiry 04/04/2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to Exposure via skin contact and vaccine underdose.  It was also the case of syringe leak.  Reporter was giving a patient a Fluzone High Dose and almost half of the dose came off on her shot and shirt. She described screwing the needle on tight and as she was injecting the dose her gloved hand was suddenly wet from the vaccine leaking. She stated the leaking must have come from the barrel of the syringe on the side or perhaps the orange part of the needle because that is where her finger was resting. No damage noticed to the syringe or carton. Rph mentioned the other doses in the carton were fine to administer.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Device connection issue, No adverse event, Syringe issue, Underdose
Clinical narrative: there was a needle malfunction and some of the dose leaked out, the leakage was from syringe the needle may not have been attached properly/screwed in tight, unsure if patient received full dose/No AE; Poor connection with luer lok caused Fluzone syringe leakage/ no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographics patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in which there was a needle malfunction and some of the dose leaked out, the leakage was from syringe the needle may not have been attached properly/screwed in tight, unsure if patient received full dose, lot UJ242AA, expiry date: 04-MAY-2020 via intramuscular route in the right deltoid on 20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was a case of vaccine underdose and syringe leak.  At the time of report no adverse event was reported.  Poor connection with luer lock caused Fluzone syringe leakage.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: Received vaccine per work requirements on 9/30/2018 in right arm; upper right arm pain began approximately 2 days after, and progressively worsened to the point of limited range of motion, disruption in sleep patterns & difficulty completing activities of daily living; Sought physical therapy assessment & urgent care evaluation for pain control on 10/10/19;
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Blood lactic acid, C-reactive protein, Enema administration, Full blood count, Glycosylated haemoglobin
Clinical narrative: Intussusception, Hyperglycemia, Hypothermia
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Hyperglycaemia, Hypothermia, Intussusception, Metabolic function test, Urine analysis
Clinical narrative: Intussusception, Hyperglycemia, Hypothermia
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea, headache, shivers all night and especially this morning
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site urticaria
Clinical narrative: Huge hive breakout all over the upper left arm where injection site was
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain causing significant discomfort and limited range of motion (now 12 days later)
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Ear congestion, Fatigue, Muscle tightness, Oropharyngeal pain, Parotitis
Clinical narrative: 10/12 onset with tightness when opening mouth to eat, progressed to unilateral swelling of R side of face. Associated with fatigue, ear congestion and sore throat when drinking acidic beverages.  Presented 10/15 for assessment, afebrile 98.5 oral,  noted R sided parotitis- moderate, questionable L sided parotitis-vey mild. Injection site normal. Advised NSAID, acetaminophen, hydration, rest. Advised to work from home until parotitis resolves ( approx. 5-7d from onset) providing also afebrile. Advised pcp f/u for further evaluation as needed. Advised to seek emergency tx if worsening sx including abdominal pain, testicular symptoms.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: 10/12 onset with tightness when opening mouth to eat, progressed to unilateral swelling of R side of face. Associated with fatigue, ear congestion and sore throat when drinking acidic beverages.  Presented 10/15 for assessment, afebrile 98.5 oral,  noted R sided parotitis- moderate, questionable L sided parotitis-vey mild. Injection site normal. Advised NSAID, acetaminophen, hydration, rest. Advised to work from home until parotitis resolves ( approx. 5-7d from onset) providing also afebrile. Advised pcp f/u for further evaluation as needed. Advised to seek emergency tx if worsening sx including abdominal pain, testicular symptoms.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Sever pain (8) lasting about 30 seconds, upon stretching of left leg. The pain occurred at the site of a sever burn (partial thickness) to that area of the leg. The burn occurred June 18, 2018. Subsequent pain upon stretching or use has occurred in the following days, but at a much lower level (3). Incidence of pain is diminishing with time. Vaccination was received 10/10/2019. There has been no pain in the site since about 6 months after the injury.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles on right side of back
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dry throat, Nasopharyngitis, Oropharyngeal discomfort, Throat clearing
Clinical narrative: My throat began to feel uncomfortable when I swallowed, different from my "normal " cold would start with. Then after about 7 hours the throat felt better followed by mild cold symptoms followed by a dry throat and cough. At present, I am  constantly clearing throat and having bouts of coughing and using cough drops and liquids. No fever
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given an Adult Hepatitis A vaccine. He should have been given the pediatric dose. He had no complaints after immunization was given
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; multiple unspecified patients have received improperly stored PROQUAD.; This spontaneous report was received from an office supervisor and refers to multiple patients of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Since 14-DEC-2018, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, (PROQUAD) (recombinant Human albumin (rHA)), lot# reported as N023779, expiration date 08-AUG-2019 (dose and route of administration were not reported) and lot# reported as N024701, expiration date 08-SEP-2019 (dose and route of administration were not reported), for prophylaxis. The vaccines were improperly stored between 12/3.18 from 15 degrees Fahrenheit to 46 degrees Fahrenheit (26.3 F) for 2 hours and 30 minutes and between 11/7 from 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.3 F) for 40 minutes. Previous excursion was also reported (6-14 degrees Fahrenheit for 95 minutes and 15-46 degrees Fahrenheit for 1 hour 30 minutes). Data logger was involved. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported.  Lot number N023779 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live )(PROQUAD), recombinant Human albumin (rHA). Lot number N024701 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live )(PROQUAD), recombinant Human albumin (rHA) .  As of 09-OCT-2019, all telephone attempts trying to obtain additional information has been unsuccessful.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Inappropriate Schedule of Vaccine; Itching around injection site; Swelling aroun injection site; Hot to touch around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, couple of hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site warmth and incomplete course of vaccination. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Caller reports receiving 1st dose Shingrix vaccine presumably in her left arm a little over 6 months ago and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. A few hours following vaccination caller reports a little itching, swelling, and hot to touch around the injection site for approximately 24 to 48 hours. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Respiratory distress
Clinical narrative: Respiratory Distress; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a physician.  This case involves unknown demographic patient who experienced respiratory distress (respiratory distress), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient ongoing medical condition: severe Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date maybe(wasn't sure of the date) last year, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious respiratory distress (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.) Final diagnosis was respiratory distress.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for respiratory distress.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case involves a patient of unknown demographics who experienced respiratory distress (after vaccination with vaccine FLUZONE QUADRIVALENT. Time to onset is unknown. Moreover, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events reported. Pt was given a flu shot 2 weeks earlier at a different pharmacy per report after the event. Pharmacist at the time was not aware of this fact. Accidentally the second shot was administered. Both flu shots are inactivated.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Pain, Periorbital pain, Swelling of eyelid
Clinical narrative: Severely sore around eyes, swollen lower lid and hurts to smile since adds pressure to the under eye area; slightly dizzy and head feels hot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeding disorder, Headache
Clinical narrative: 1. all these symptoms lasted 48 hours: extreme blinding headache; extreme intolerance to any kind of light; aches and pains in every body joint; nausea;  inability to intake medicines or food; extreme tiredness; extreme thirst. 2. after the first 48 hours passed, it took me another two days to feel strong enough to drive and engage in normal activities. Appetite returned quickly.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Nausea, Photophobia, Thirst
Clinical narrative: 1. all these symptoms lasted 48 hours: extreme blinding headache; extreme intolerance to any kind of light; aches and pains in every body joint; nausea;  inability to intake medicines or food; extreme tiredness; extreme thirst. 2. after the first 48 hours passed, it took me another two days to feel strong enough to drive and engage in normal activities. Appetite returned quickly.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient stated her left shoulder is in severe pain and has limited range of motion.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Insomnia, Pain
Clinical narrative: Unpleasant side effect, whole body aches for first 36 hours, slight temp, shivers, stomachache, red swollen arm from shoulder to halfway down to elbow. Thought feeling better by day 5, but last 2 days both calves started to ache a lot. Didn't sleep at night due to ache. Went to urgent care 10/3. Told Tylenol and stay hydrated, which didn't help. All side effects gone in 10 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Unpleasant side effect, whole body aches for first 36 hours, slight temp, shivers, stomachache, red swollen arm from shoulder to halfway down to elbow. Thought feeling better by day 5, but last 2 days both calves started to ache a lot. Didn't sleep at night due to ache. Went to urgent care 10/3. Told Tylenol and stay hydrated, which didn't help. All side effects gone in 10 days.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Per receipient: The pain in my arm was immediate upon vaccination and progressively got worse in the first 12 hours post injection.  In addition to pain, I have the following symptoms: numbness in the arm from the shoulder down to my lower arm, a feeling of coldness throughout my arm down to my fingers, inability to move my arm as I was able to before injection, significant limited range of motion and pain in my arm in any direction while doing everyday things (such as putting on/removing a jacket, scratching my head, etc). All these symptoms are persistent when my arm is at rest, and increase significantly when I move my arm.  Pain and discomfort is persistently at a level that affects my daily routine and my sleep. It started immediately upon vaccination and is still occurring. I have modified my daily routine as a result of the symptoms. My medical provider wrote a prescription for Prednisone on October 11, 2019, which I began taking as directed the morning of October 12.  Prior to that, I took OTC Advil, 200 mg the morning after the injection and stopped Advil as directed when I began the Prednisone. I have no history of any issue with my left arm prior to the vaccination on October 8, 2019.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: Per receipient: The pain in my arm was immediate upon vaccination and progressively got worse in the first 12 hours post injection.  In addition to pain, I have the following symptoms: numbness in the arm from the shoulder down to my lower arm, a feeling of coldness throughout my arm down to my fingers, inability to move my arm as I was able to before injection, significant limited range of motion and pain in my arm in any direction while doing everyday things (such as putting on/removing a jacket, scratching my head, etc). All these symptoms are persistent when my arm is at rest, and increase significantly when I move my arm.  Pain and discomfort is persistently at a level that affects my daily routine and my sleep. It started immediately upon vaccination and is still occurring. I have modified my daily routine as a result of the symptoms. My medical provider wrote a prescription for Prednisone on October 11, 2019, which I began taking as directed the morning of October 12.  Prior to that, I took OTC Advil, 200 mg the morning after the injection and stopped Advil as directed when I began the Prednisone. I have no history of any issue with my left arm prior to the vaccination on October 8, 2019.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain at injection site.  Pain upper LA from site to elbow with swelling. HA, Chills. muscle aches body wide. Rash from chin to umbilicus. 4 days.  Treated with Ibuprofen 400 mg TID.  These side effects were 50% less in severity and duration than first dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pain at injection site.  Pain upper LA from site to elbow with swelling. HA, Chills. muscle aches body wide. Rash from chin to umbilicus. 4 days.  Treated with Ibuprofen 400 mg TID.  These side effects were 50% less in severity and duration than first dose.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient was reported to have received both above vaccines in left arm, but documentation states only pneumovax 23 was received in left arm and flu vaccine in R arm. Patient states both vaccines were given in left deltoid. This reported cannot confirm or deny actual administration site since this reporter did not administer vaccine. This reporter  can only confirm reaction was noted on exam on 10/13/2019 at 0900 where entire left upper extremity was red from should to elbow with mild swelling (edema) and pain. Mild low grade fever was present as well of 99.2 at 0802.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bedridden, Gait disturbance, Headache
Clinical narrative: 1. same symptoms as the first injection lasting a little over 48 hours: extreme, blinding headache; intolerance to any kind of natural or artificial light; nausea; inability to eat or take daily meds without bring them back up; extreme thirst; aches and pain in every bodily joint; physical weakness--inability to walk farther then nearby bathroom; bedridden this whole time. In addition, after this second injection the swelling lasted four days,  and covered about half of the upper arm, and was too painful to the touch to apply anything. Took nothing as I couldn't keep meds down. Today is day five and I feel stronger as I can eat normally now.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nail discolouration, Peripheral swelling, Photophobia, Tenderness, Thirst
Clinical narrative: 1. same symptoms as the first injection lasting a little over 48 hours: extreme, blinding headache; intolerance to any kind of natural or artificial light; nausea; inability to eat or take daily meds without bring them back up; extreme thirst; aches and pain in every bodily joint; physical weakness--inability to walk farther then nearby bathroom; bedridden this whole time. In addition, after this second injection the swelling lasted four days,  and covered about half of the upper arm, and was too painful to the touch to apply anything. Took nothing as I couldn't keep meds down. Today is day five and I feel stronger as I can eat normally now.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: 1. same symptoms as the first injection lasting a little over 48 hours: extreme, blinding headache; intolerance to any kind of natural or artificial light; nausea; inability to eat or take daily meds without bring them back up; extreme thirst; aches and pain in every bodily joint; physical weakness--inability to walk farther then nearby bathroom; bedridden this whole time. In addition, after this second injection the swelling lasted four days,  and covered about half of the upper arm, and was too painful to the touch to apply anything. Took nothing as I couldn't keep meds down. Today is day five and I feel stronger as I can eat normally now.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness to skin distal to injection site, along anterior and lateral humerus
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Full body rash
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Lip swelling, Lymphadenopathy, Pain
Clinical narrative: Started with scratchy throat mid-day.  Not sure if related.  In mid-afternoon, after eating apple with peanut butter, noted swollen lips (inside of mouth tissue around the lips as much as the lips themselves) and gland at center of mouth below tongue, then felt flu-like systems until present (11 am next day).  Took benadryl immediately upon swelling.  Starting to feel a bit better around now.  Symptoms have been the aches and chills and congestion similar to flu.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Throat irritation
Clinical narrative: Started with scratchy throat mid-day.  Not sure if related.  In mid-afternoon, after eating apple with peanut butter, noted swollen lips (inside of mouth tissue around the lips as much as the lips themselves) and gland at center of mouth below tongue, then felt flu-like systems until present (11 am next day).  Took benadryl immediately upon swelling.  Starting to feel a bit better around now.  Symptoms have been the aches and chills and congestion similar to flu.