chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Palpitations, Paraesthesia, Rash vesicular
Clinical narrative: 4 day history of numbness and tingling in left arm. Was gardening when symptoms started in left hand/thumb. Then progressed to wrist. Felt surface numbness on back of hand, then numbness/tingling progressed to left forearm and left biceps.   Feeling like today she is having left triceps and left-sided chest palpitations/tingling. Eventually developed dermatomal vesicular rash in area of numbness/tingling.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Erythema, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Mom called and stated that there were red whelts down arm in 6-7 areas around deltoid; pt exhibited itchy and burning; back tingling x1 hour; mom gave Benadryl x3d; no streakiness ; upper arm swelled-noticeably larger than other arm
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Mom called and stated that there were red whelts down arm in 6-7 areas around deltoid; pt exhibited itchy and burning; back tingling x1 hour; mom gave Benadryl x3d; no streakiness ; upper arm swelled-noticeably larger than other arm
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt was seen in the Emergency Department at Medical Center with rash consistent with shingles on 12/1/19.  Rash started on 11/28/19.  He was brought to his well child check on 12/3/19 and exam was entirely consistent with shingles.  Pt does not have known history of chickenpox.  He received his varicella vaccine at his one year well child check.  He was started on acyclovir and is recovering as expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chromaturia, Decreased appetite, Fatigue, Headache
Clinical narrative: Got my second shot on 30 November 2019 around 11:30 am.  Experienced stronger side effects than from the first shot.  The initial side effects were the ones documented as common; muscle and joint pain, fever, headache, tired, loss of appetite, swollen glands in neck (flue like symptoms).  These started early afternoon on the 30th.  The fever subsided around 2 am on Dec 1st.   I then started to experience a side effect I did not see identified for this vaccine.  I noticed on Dec 1st that my urine was darker in color than normal.  It was more yellow / brown in color.  At first, I did not pay much attention as I figured that because the vaccine caused me to lose my appetite I had not been eating or drinking as much.  I figured my urine was just more concentrated due to drinking less water although it did have a slightly brown tinge rather than just a darker yellow that is more characteristic for me when I start to get dehydrated.   The next morning, December 2nd my urine was a very dark (slightly reddish) brown color.  (It may have been this color during the night but I did not check when emptied my bladder at night as only have a night light in the bathroom at night so don?t turn on a room light.)  I did not feel like I was dehydrated or thirsty.  I was still drinking some water because that is what I normally do but not as much as I was not thirsty.  I did not feel the urge to urinate as frequently that day.  When I urinated late afternoon, my urine was still a very dark (slightly reddish) brown color.  After urinating the water in the bowel looked like the color after having diarrhea (but of course no solid matter in this case).  At that point I started drinking much more water regardless of thirst.   I am continuing to monitor the situation and if it has not cleared up by the end of the day on December 3rd, I will go to see a doctor on December 4th.  It is my assumption that I have blood in my urine (but it is not fresh red) or perhaps bilirubin.  Unfortunately, I did not think to get a urine sample for testing (I don?t have a sterile container to collect it in).  I have not experienced pain or discomfort when urinating.  I have no health problems and am not on any medications.  So far on December 3rd my urine color has not been the very dark brown.  It has lightened to more of a dark yellow brown.  I am continuing to hydrate more heavily.   NDC number: 58160-0823-11  Expiration date of lot is 04/24/2022.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Got my second shot on 30 November 2019 around 11:30 am.  Experienced stronger side effects than from the first shot.  The initial side effects were the ones documented as common; muscle and joint pain, fever, headache, tired, loss of appetite, swollen glands in neck (flue like symptoms).  These started early afternoon on the 30th.  The fever subsided around 2 am on Dec 1st.   I then started to experience a side effect I did not see identified for this vaccine.  I noticed on Dec 1st that my urine was darker in color than normal.  It was more yellow / brown in color.  At first, I did not pay much attention as I figured that because the vaccine caused me to lose my appetite I had not been eating or drinking as much.  I figured my urine was just more concentrated due to drinking less water although it did have a slightly brown tinge rather than just a darker yellow that is more characteristic for me when I start to get dehydrated.   The next morning, December 2nd my urine was a very dark (slightly reddish) brown color.  (It may have been this color during the night but I did not check when emptied my bladder at night as only have a night light in the bathroom at night so don?t turn on a room light.)  I did not feel like I was dehydrated or thirsty.  I was still drinking some water because that is what I normally do but not as much as I was not thirsty.  I did not feel the urge to urinate as frequently that day.  When I urinated late afternoon, my urine was still a very dark (slightly reddish) brown color.  After urinating the water in the bowel looked like the color after having diarrhea (but of course no solid matter in this case).  At that point I started drinking much more water regardless of thirst.   I am continuing to monitor the situation and if it has not cleared up by the end of the day on December 3rd, I will go to see a doctor on December 4th.  It is my assumption that I have blood in my urine (but it is not fresh red) or perhaps bilirubin.  Unfortunately, I did not think to get a urine sample for testing (I don?t have a sterile container to collect it in).  I have not experienced pain or discomfort when urinating.  I have no health problems and am not on any medications.  So far on December 3rd my urine color has not been the very dark brown.  It has lightened to more of a dark yellow brown.  I am continuing to hydrate more heavily.   NDC number: 58160-0823-11  Expiration date of lot is 04/24/2022.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash
Clinical narrative: Post herpetic neuralgia; diagnosed with herpes zoster/shingles; Information has been received from a lawyer and the patient regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   In or around 19-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "shortly after receiving the vaccine"), the patient suffered painful rash to her left flank. She was diagnosed with herpes zoster/shingles and postherpetic neuralgia, as the nerve pain and burning continued in the area of her shingles outbreak. The reporter stated that the patient's symptoms resulted in physical limitations not present prior to vaccination, and that she was experiencing mental and emotional distress due to resulting physical limitations and seriousness of her condition. Moreover, the patient suffered sustained severe and permanent personal injuries and 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.   By the time of this report, the patient had not recovered from shingles and postherpetic neuralgia. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered shingles and postherpetic neuralgia were considered to be disabling events.
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Eyelid pain, Herpes zoster, Iritis, Ophthalmic herpes simplex
Clinical narrative: herpes zoster keratitis; herpes simplex iritis and herpes zoster keratitis; bacterial infection; shingles; herpes simplex dendrites; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 05-MAY-2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. Shortly after the receiving the vaccine, the patient suffered severe pain and soreness around the right eye and right eyelid along with popular vesicular rash on the right forehead. The patient was diagnosed with a bacterial infection and shingles/herpes zoster. After the initial outbreak, she started to experience multiple outbreaks around the eye and forehead along with blurred vision and was also diagnosed with herpes simplex dendrites, herpes simplex iritis and herpes zoster keratitis (herpes simplex, ophthalmic herpes simplex and herpes zoster keratitis). As a direct and proximate result, the patient suffered severe 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. In addition, incurred damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not recovered and the events were related to zoster vaccine live (ZOSTAVAX).   All the events were considered disabling events, as they caused permanent and incurable injuries.   Upon internal review, the events ophthalmic herpes zoster and ophthalmic herpes simplex were considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Periorbital pain, Rash, Rash papular, Vision blurred
Clinical narrative: herpes zoster keratitis; herpes simplex iritis and herpes zoster keratitis; bacterial infection; shingles; herpes simplex dendrites; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 05-MAY-2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. Shortly after the receiving the vaccine, the patient suffered severe pain and soreness around the right eye and right eyelid along with popular vesicular rash on the right forehead. The patient was diagnosed with a bacterial infection and shingles/herpes zoster. After the initial outbreak, she started to experience multiple outbreaks around the eye and forehead along with blurred vision and was also diagnosed with herpes simplex dendrites, herpes simplex iritis and herpes zoster keratitis (herpes simplex, ophthalmic herpes simplex and herpes zoster keratitis). As a direct and proximate result, the patient suffered severe 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. In addition, incurred damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not recovered and the events were related to zoster vaccine live (ZOSTAVAX).   All the events were considered disabling events, as they caused permanent and incurable injuries.   Upon internal review, the events ophthalmic herpes zoster and ophthalmic herpes simplex were considered medically significant.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Pain, Swelling, Yellow skin
Clinical narrative: yellowing; swelling; pain; This case was reported by a pharmacist via call center representative and described the occurrence of yellow skin in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 74A7L, expiry date 22nd October 2021) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a day after receiving Shingrix, the patient experienced yellow skin, swelling and pain. On 1st August 2019, the outcome of the yellow skin, swelling and pain were recovered/resolved.   It was unknown if the reporter considered the yellow skin, swelling and pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient experienced yellowing, swelling and pain under her armpit after receiving Shingrix.  The patient did not have any symptoms in her arm. The symptoms started within 24 hours of receiving Shingrix and proceeded to resolve within 24 hours. The patient did see her doctor about the symptoms. The patient did receive her 2nd dose on 24th October 2019 and has not reported any adverse events. Emergency room visit required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: Age at vaccination was not reported. The pharmacist did not provide the batch number nor the expiration date of the vaccine. She did not know the year the patient was born, just the day and month, so she provided an incomplete date of birth. The reporter consented to follow up.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: injection site reaction described as redness,the redness on area was about 3 inches long and 2 inches wide and having pain; injection site reaction described as redness,the redness on area was about 3 inches long and 2 inches wide and having pain; Initial information received on 18-Oct-2019 and additional information received on 21-Oct-2019, regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 71 years old female patient who developed injection site reaction described as redness, the redness on area was about 3 inches long and 2 inches wide and having pain (inflammation and vaccination site reaction), while she received vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) in left arm for Immunisation.  On 14-Oct-2019, the patient received a dose (0.5 mL) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ268AB, expiry date: Jun-2020) via intramuscular route in the right arm. On 14-Oct-2019, the patient received a dose of suspect PNEUMOVAX not produced by Sanofi Pasteur (lot S018140, expiry date: 30-Jun-2020) via intramuscular route in the right arm.  On an unknown date, the patient developed a non-serious injection site reaction described as redness,the redness on area was about 3 inches long and 2 inches wide and having pain (inflammation and vaccination site reaction), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOVAX.  Other relevant tests were not reported.  Final diagnosis was inflammation and vaccination site reaction.  It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 43 years old male patient who was vaccinated with 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) that had temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2019, patient received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number: UJ299AA, expiry date: 30Jun2020) via intramuscular in the Left Arm.   It was reported that vaccine pre-filled syringe that was shipped on Monday (11Nov2019) and received on 14Nov2019. The shipment experienced an extended time frame and was out of temperature compliance (no exact temperature was available).  It was a case of actual medication error due to incorrect product storage and Product shipment delay.  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
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; shipment of Fluzone QIV 0.5 mL pre-filled syringes was shipped on Monday (11Nov2019) and received on 14Nov2019, shipment experienced an extended time frame and was out of temperature compliance, NO AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 29 years old female patient who was vaccinated with 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) that had temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2019, patient received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number: UJ299AA, expiry date: 30Jun2020) via intramuscular in the right arm.   It was reported that vaccine pre-filled syringe that was shipped on Monday (11Nov2019) and received on 14Nov2019. The shipment experienced an extended time frame and was out of temperature compliance (no exact temperature was available).  It was a case of actual medication error due to incorrect product storage and Product shipment delay.  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
Sex: U
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient in the ER received an expired dose of Imovax vaccine, no AE; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received an expired dose (third dose in series, 1mg) of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) via an unknown route in an unknown administration site on an unknown date as post exposure immunization.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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.
Age: 42.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Arthralgia, Chills, Fatigue, Headache, Vomiting
Clinical narrative: joint pain; severe vomiting (5 times); headache; chills; SIck; fatigue; Initial information received on 25-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 42 years old female patient who experienced joint pain (arthralgia), severe vomiting (vomiting), headache (headache), chills (chills), sick (malaise) and fatigue (fatigue), while she received vaccines INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] or INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included flu vaccine (reported as Years ago she had a reaction to a flu vaccine that included hives). The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Nov-2019, the patient received a dose  of suspect INFLUENZA QUADRIVAL A-B VACCINE or INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: K3593 and expiry date not reported) via unknown route in the right deltoid.  On an unknown date, the patient woke up with pretty severe vomiting (vomiting) (5 times), she also had headache (headache) and later had chills (chills) and significant joint pain (arthralgia) in her legs, and had fatigue (fatigue). She was slowly improving, but had to call out of work sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE or INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   Lab data was not reported.  Final diagnosis was fatigue, malaise, chills, headache, vomiting and arthralgia.  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.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nasal congestion, Nausea, Parosmia
Clinical narrative: metallic chalky and bitter smell through his nose; nose has also been stuffy; headache; been nauseated; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old male patient had a metallic chalky and bitter smell through his nose (parosmia), nose has also been stuffy (nasal congestion), headache (headache) and had been nauseated (nausea), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Hepatitis C and Liver disorder. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient also takes a pain killer (name unknown).  On 11-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right shoulder.  On an unknown date, the patient had a metallic chalky and bitter smell through his nose (parosmia), nose has also been stuffy (nasal congestion), headache and had been nauseated (nausea) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.  Final diagnosis was parosmia, nasal congestion, headache and nausea.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Myalgia, Pain
Clinical narrative: kept her up throbbing; pretty significant muscle pain; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 23 years old female patient who experienced muscle pain (myalgia) and throbbing (Pain), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6657LA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid.  On an unknown date, patient experienced a non-serious pretty significant muscle pain (myalgia). It looks to be a perfect injection site in the right spot in the muscle. Nurse said she palpitated her injection site and there was nothing there and no redness. It looks to be a perfect injection site in the right spot in the muscle. It was reported that, it kept her up throbbing (Pain). At first, she had as expected, just typical soreness and she did not think anything of it and It seems to be worsening a bit. She never had this type of reaction before specifically to the flu. She had pain when trying to take off a shirt, when lift her arm up past her shoulder line, and when lying in bed (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab data was reported.  Final diagnosis was myalgia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for myalgia and throbbing.
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Cough, Dyspnoea, Injection site pain
Clinical narrative: did not feel well; Coughing; shortness of breath; Asthma has been acting up and feeling "under the weather", Asthma lately getting worse; pain during injection and flare-ups; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 48 years old female patient (162.56 cm and 68.027 kg) who experienced asthma has been acting up and feeling "under the weather", asthma lately getting worse, did not feel well, coughing, shortness of breath and pain during injection and flare-ups, while she received vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT].  The patient's past medical history included Allergic rhinitis, sinusitis and PE in lungs. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma.  Concomitant medications included SALBUTAMOL SULFATE (PROAIR) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA).  In Aug-2019, the patient started taking DUPIXENT (DUPILUMAB) 300 mg every two weeks under the skin (with an unknown batch number, 31-Dec-2021) for Dermatitis atopic.  On 31-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's asthma has been acting up and feeling "under the weather", asthma lately getting worse (asthma), did not feel well (malaise), coughing (cough), shortness of breath (dyspnoea) and pain during injection and flare-ups (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE and DUPILUMAB.  Other relevant tests not reported.  Final diagnosis was asthma, malaise, cough, dyspnoea and injection site pain.  Action taken with DUPILUMAB (DUPIXENT) was unknown.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: did not feel well; Coughing; shortness of breath; Asthma has been acting up and feeling "under the weather", Asthma lately getting worse; pain during injection and flare-ups; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 48 years old female patient (162.56 cm and 68.027 kg) who experienced asthma has been acting up and feeling "under the weather", asthma lately getting worse, did not feel well, coughing, shortness of breath and pain during injection and flare-ups, while she received vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT].  The patient's past medical history included Allergic rhinitis, sinusitis and PE in lungs. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma.  Concomitant medications included SALBUTAMOL SULFATE (PROAIR) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA).  In Aug-2019, the patient started taking DUPIXENT (DUPILUMAB) 300 mg every two weeks under the skin (with an unknown batch number, 31-Dec-2021) for Dermatitis atopic.  On 31-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's asthma has been acting up and feeling "under the weather", asthma lately getting worse (asthma), did not feel well (malaise), coughing (cough), shortness of breath (dyspnoea) and pain during injection and flare-ups (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE and DUPILUMAB.  Other relevant tests not reported.  Final diagnosis was asthma, malaise, cough, dyspnoea and injection site pain.  Action taken with DUPILUMAB (DUPIXENT) was unknown.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events.  Information on the batch number was requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Palpitations
Clinical narrative: She reported feeling like her heart was racing, nausea and dizziness immediately after vaccination was administered.  She was monitored by local EMT and there was no further treatment needed.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Death
Clinical narrative: INFANT DIED PROBABLY NOT RELATED TO IMMUNIZATION
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Headache, Neurological examination abnormal, VIth nerve paralysis
Clinical narrative: Severe headache 11/24/19, Aleve 2 tablets, mild headache 11/25/19 Aleve 1 tablet,  11/26/19 aware of double vision . saw regular ophthalmologist 11/27/19 for problem check due to sudden onset of double vision.  Spoke with family physician & both concluded I should be examined by neuro  ophthalmologist.  First appoint due to holiday was 12/3/19.  Diagnosis made during that visit of 6th nerve palsy
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling of eyelid
Clinical narrative: Pt had swollen eyelids a few hours after vaccine and continued today, pt also has aches from yesterday to today
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Ped Hep A given before minimum interval. due 12/11/19, accidently given early 12/3/19. Mom aware patient will require another dose.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Father brought patient in to Clinic to get dtap and mmr vaccine pt was given pediatric dosed Fluarix. Provider miss read consent form. Father stated pt had not received flu vaccines this season. Father stated they are against flu vaccines for personal reasons. Father denied allergic reactions to vaccines. Pt also received dtap and mmr all without complications. Patient was held in clinic for 45mins without complications.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Nausea
Clinical narrative: Client fell "passed out" in the main lobby after receiving vaccines. Laid client on floor. Elevated both feet on a chair. Put ice pack to  back of neck. Client was pale. In a few minutes, she felt better but was nauseous. Oriented x 3. Grandma stated that she hit her head. Client said the back of her head hurt but did not remember where she hit it. No obvious injury or bleeding. Pupils equal. Told to go to ED to be checked. Grandmother agreed to take client.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Client fell "passed out" in the main lobby after receiving vaccines. Laid client on floor. Elevated both feet on a chair. Put ice pack to  back of neck. Client was pale. In a few minutes, she felt better but was nauseous. Oriented x 3. Grandma stated that she hit her head. Client said the back of her head hurt but did not remember where she hit it. No obvious injury or bleeding. Pupils equal. Told to go to ED to be checked. Grandmother agreed to take client.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: CUSTOMER IS COMPLAING SHOULDER PAIN. SHE IS STILL HAVING SHOULDER PAIN AFTER GIVING INJECTION  IN 9/19. PAIN IS THERE EVEN NOW. CAME TO PHARMACY AND COMPLAINED TO PHARMACIST IN LAST WEEK OF NOVEMBER.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Dull, persistent headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 24th September 2019, less than a day after receiving Shingrix and an unknown time after starting Aspirin, the patient experienced headache. The patient was treated with acetylsalicylic acid (Aspirin) and paracetamol (Tylenol). On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient has had a dull, persistent headache since getting his 1st dose of Shingrix. The did not respond to aspirin and Tylenol. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Red raised golf ball sized lump at injection site. No fever. No pain.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Bed rest, Chills, Gait inability, Injection site erythema, Injection site pain
Clinical narrative: severe, uncontrolled shaking chills for 48 hours (to the point of not being able to hold a cup), severe diffuse myalgia that were incapacitating and required bedrest for 48 hours, severe pain at injection site with swelling from shoulder to elbow, redness, excruciating pain to touch for 72 hours, 10 + headache which recurred daily in form of severe migraines every day for 3 weeks, debilitating and requiring being supine and immobile most of the day, continued for 3 weeks, then complete laxity of hip joint, giving way, unable to walk. In all these have all resolved after a month and NONE of these were preexisting conditions or diagnoses, including no history of migraines or hip pain.  ( I am a PA and medical professional and have never experienced a reaction like this, nor have I ever had a patient in 40+ years have a reaction like this).  This WAS my first "senior" flu shot.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site swelling, Joint laxity, Migraine, Myalgia
Clinical narrative: severe, uncontrolled shaking chills for 48 hours (to the point of not being able to hold a cup), severe diffuse myalgia that were incapacitating and required bedrest for 48 hours, severe pain at injection site with swelling from shoulder to elbow, redness, excruciating pain to touch for 72 hours, 10 + headache which recurred daily in form of severe migraines every day for 3 weeks, debilitating and requiring being supine and immobile most of the day, continued for 3 weeks, then complete laxity of hip joint, giving way, unable to walk. In all these have all resolved after a month and NONE of these were preexisting conditions or diagnoses, including no history of migraines or hip pain.  ( I am a PA and medical professional and have never experienced a reaction like this, nor have I ever had a patient in 40+ years have a reaction like this).  This WAS my first "senior" flu shot.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Joint lock, Pain, Pyrexia, Skin warm
Clinical narrative: pt reports pain and fever for 8 hours, warmth and redness down to elbow for 1 week, and joints felt locked for 8 hours
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Aphasia, Coordination abnormal, Decreased eye contact, Pyrexia
Clinical narrative: high fever, loss of eye contact, loss of babbling, loss of coordination
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Bloody discharge, Burning sensation, Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: rash on chest and face started 11 days after vaccination, reported he had facial flushing, burning and itching significantly for 5 days and then it started to decrease. 3 weeks later still has some facial flushing but not as significant. Some numbness and tingling in left arm that comes and goes. About18 days after vaccination started having significant sinus drainage that turned dark bloody with clots. Took Benadryl routinely for 4-5 days.
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Paranasal sinus hypersecretion, Pruritus, Rash, Thrombosis
Clinical narrative: rash on chest and face started 11 days after vaccination, reported he had facial flushing, burning and itching significantly for 5 days and then it started to decrease. 3 weeks later still has some facial flushing but not as significant. Some numbness and tingling in left arm that comes and goes. About18 days after vaccination started having significant sinus drainage that turned dark bloody with clots. Took Benadryl routinely for 4-5 days.
Age: 79.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site reaction, Myalgia
Clinical narrative: Red rash 2-3 inches around injection site. Flu-like symptoms including nausea, headache, and chills.  Left arm muscle soreness.
Age: 79.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Nausea, Rash erythematous
Clinical narrative: Red rash 2-3 inches around injection site. Flu-like symptoms including nausea, headache, and chills.  Left arm muscle soreness.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Patient says he experienced his hands shaking uncontrollably to the point he could not hold anything with liquid. He also experienced chills the night of the injection.
Age: 57.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms including joint and muscle aches.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Pain in extremity, Tenderness
Clinical narrative: Pain in the left arm never went away after receiving flu shot.  The pain has increased throughout the upper arm.  Now there is constant general pain.  Sensitive to pressure.  Pain wakes me from sleep at night.  Some limited mobility with the arm
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Patient jerked while vaccine was being administered and did not receive full dose (no adverse events)
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Computerised tomogram, Musculoskeletal pain, X-ray therapy to joint
Clinical narrative: patient called this morning stating that her armpit/shoulder and down her side was in severe pain on scale 7 (level pain 1-10). She then called back and stated that she went the hospital and was examed/CAT scan to see if there were any issues.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Choking, Cyanosis, Dyspnoea, Gaze palsy
Clinical narrative: within one minute of receiving the influenza vaccine, patient had choking/gagging on secretions, emesis, alteration of consciousness with eyes rolling back in head.  she had an urticarial rash on both thighs and was having difficulty breathing with perioral cyanosis and pallor.   she did not have wheezing or stridor.   she was treated with epinephrine injection, oxygen and then oral diphenhydramine.  she recovered quickly and was observed for 2 hours without further adverse reaction.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site urticaria, Pallor, Retching, Urticaria
Clinical narrative: within one minute of receiving the influenza vaccine, patient had choking/gagging on secretions, emesis, alteration of consciousness with eyes rolling back in head.  she had an urticarial rash on both thighs and was having difficulty breathing with perioral cyanosis and pallor.   she did not have wheezing or stridor.   she was treated with epinephrine injection, oxygen and then oral diphenhydramine.  she recovered quickly and was observed for 2 hours without further adverse reaction.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: within one minute of receiving the influenza vaccine, patient had choking/gagging on secretions, emesis, alteration of consciousness with eyes rolling back in head.  she had an urticarial rash on both thighs and was having difficulty breathing with perioral cyanosis and pallor.   she did not have wheezing or stridor.   she was treated with epinephrine injection, oxygen and then oral diphenhydramine.  she recovered quickly and was observed for 2 hours without further adverse reaction.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discharge, Injection site swelling
Clinical narrative: Patients states that after about a week after the vaccination she started to have swelling as well as some discharge from the site of injection. After about two weeks she went to her primary doctor. He gave her an antibiotic (Cephalexin ) and a Medrol dose pack. She is currently doing better and being monitored
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Today employee stated that in the evening the day of receiving vaccine that he started to feel feverish. Employee reported having fever of 101.4 degrees for two days afterwards, fever then resolved. Employee states he took over the counter ibuprofen the day after the vaccination.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Impaired driving ability, Injection site erythema, Injection site nodule
Clinical narrative: The patient had no immediate adverse effects. The patient started to feel light-headed slightly before lunch and started to feel bad. She did not feel like she could drive herself home so she had someone come pick her up. Once at home, she changed and noticed that there was a red, slightly painful, and raised knot where she had got her shot the day before. She did not notice the knot this morning in the shower and felt fine going in to work. Once at home, she used a heating pad to loosen up the knot. She was advised to keep doing this and to take ibuprofen of Tylenol, whichever she can tolerate. If symptoms still persisted after a couple of days, she should go see the doctor.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The patient had no immediate adverse effects. The patient started to feel light-headed slightly before lunch and started to feel bad. She did not feel like she could drive herself home so she had someone come pick her up. Once at home, she changed and noticed that there was a red, slightly painful, and raised knot where she had got her shot the day before. She did not notice the knot this morning in the shower and felt fine going in to work. Once at home, she used a heating pad to loosen up the knot. She was advised to keep doing this and to take ibuprofen of Tylenol, whichever she can tolerate. If symptoms still persisted after a couple of days, she should go see the doctor.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient stated she has extreme arm soreness/weakness to date (12/03/2019).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: High fever (101), painfully swollen arm, unable to work in the 24 hours after vaccination.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Fatigue, Headache, Joint stiffness, Myalgia
Clinical narrative: Fever, headache, joint pain and stiffness, muscle pain and fatigue lasting more than 1 day.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Fever, headache, joint pain and stiffness, muscle pain and fatigue lasting more than 1 day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: patient stated she had a red, raised bump, painful, itchy rash on her right shoulder blade and a few spots on arm about a week after vaccination. the reaction resolved in a few weeks and she is completely better.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Pruritus, Skin discolouration, Swelling, Urticaria
Clinical narrative: Itching,  hives, red marks, swelling, and dark spots.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Injection site swelling, Limb discomfort, Rhinorrhoea
Clinical narrative: After vaccine arm felt heavy and there was swelling at vaccine site.  After 3 weeks, patient reports chest pain and runny nose.  Patient has not been to doctor to follow-up.    Patient has been using Bengay patches for pain but not helping.  Patient spoke to pharmacist today and reported problems; they encouraged him to file a report with VAERS.   Patient's chest pain continues, arm problems have improved but still has runny nose.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Loss of consciousness, Pneumonia, Upper respiratory tract infection
Clinical narrative: pt had sudden shortness of breath and passed out 11/01/19. Called 911 and was taken to hospital for treatment