chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin weeping, Staphylococcus test negative, Ulcer haemorrhage
Clinical narrative: Event 1: Cold sore on outside of lip, noticed 02/13/2020 (approx.).  Ran its course 7 to 10 days, no treatment. Event 2: Peeling, bleeding inside both nostrils, noticed 03/06/2020 (approx.). Ran its course about 14 days, no treatment. Event 3: Peeling, burning, base of both nostrils, noticed end of May 2020. Treated with Eucerin. Event 4: (Major Flare 1) Outside weeping, then burning blister on outside of lip 06/05/2020; 06/07/2020 multiple bleeding sores (ulcers) above left eye and on both lips and sore under tongue. Treated with Abreva OTC and 1000 MG Lysine. Started on Valacyclovir 1 GM and Sulfameth/Trimethoprim 800/160 MG; ran its course until 06/16/2020. Event 5: (Major Flare 2): Weeping, then multiple bleeding sores (ulcers) on both lips 07/11/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 07/19/2020. Event 6 (Major Flare 3): Multiple bleeding sores (ulcers) on both lips 08/23/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 08/30/2020. Event 7 (Lesser Flare 4): Multiple bleeding smaller sores (ulcers) on both lips 09/21/2020. Treated with Valacyclovir 500 MG (current dosage) and Dexamethasone 0.5 MG/5ML elixir for internal mouth ulcer; current course in progress for 3 months; experiencing some inflammation on lips and reddish scar tissue where ulcers were appearing. Also treating lips and nostrils with EUCERIN for comfort.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: chills, fever, fatique, malaise, awful
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Rash pustular
Clinical narrative: 8 days after injection (9/17/2020)  developed rash on sides of face along hairline with small pustules, on 9/19/2020 his injection site on L thigh had a bright red spot around it approx  2.5 cm diameter.  The spots along the sides of his face and forehead seemed to be itchy as he would rub at them.  Dosed with Tylenol and Benadryl, and cool compress to site on leg.  The red spot around injection site became darker red over the next 2 days, then began to fade.  The rash spots on his face became dark red flat spots, and this was reported to the Dr office and had phone conversations with care givers. Also treated with cortisone cream.  The spots on his face faded around Oct. 3,2020, a little over 2 weeks after they appeared.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: The day after the vaccine was administered, the patient experienced high fever (103 degrees), body aches, tiredness, and heart rate over 90 bpm.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain
Clinical narrative: Patient felt immediate pain at the Lt deltoid site with the injection. She then noted she was having difficulty lifting her arm the next morning to get dressed. She experienced a dull constant ache and increase in pain with lifting her arm.  Physical Therapy started, Voltaren Gel QID, Ibuprofen
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Deafness unilateral, Headache, Pyrexia, Sudden hearing loss
Clinical narrative: 1st day after flu shot - headache, chills, fever (101.3 F)...late in the 1st day fever broke and then 2nd day after flu shot wake up with no hearing in my right ear (sudden hearing loss).
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pain
Clinical narrative: Shoulder pain mimicking a shoulder injury, shoulder pain with movement getting progressively worse over time after the shot. Pain prevalent when moving arm above shoulder level, using arm/hand to apply pressure, and when turning arm.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthritis, Mobility decreased, Pain
Clinical narrative: Transient arthritis day after pain, limited ROM
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Intense pain in the right from the elbow up to the shoulder.  Heat/ice provided little to no relief, patient could not lift arm more than a few inches.  Patient had very little range of motion without intense pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: After 1 day Mother came in on 11/6/20 for vaccine reaction No fever Right arm swollen. and redness. Cellulitis of right upper limb.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: 1-1 1/2 week after shot, arm started  to ached & stabbing pain certain movements hurt, like pulling off a shirt, or rotating  arm. Pain is still going on Also experience soreness in Rt shoulder blade & cont'd to rt side neck area. This has dimenses
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Injection site bruising, Injection site pain, Pain in extremity
Clinical narrative: oct 1 Left arm hurting. oct 2 - Bruise developed 3 in. down from injection site oct 3 - Pins & needle sensation developed  in both arms & legs.  oct 7 Burning sensation started around bruise area. oct 8 - upper back & left shoulder area  aching off & on Symptoms are still bothering me as of 11-1-2020 Left arm not hurting as much. A lot of burning sensation & pins & needles however in both arms & left shoulder area.  Pins & needles in legs subsided.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Paraesthesia
Clinical narrative: oct 1 Left arm hurting. oct 2 - Bruise developed 3 in. down from injection site oct 3 - Pins & needle sensation developed  in both arms & legs.  oct 7 Burning sensation started around bruise area. oct 8 - upper back & left shoulder area  aching off & on Symptoms are still bothering me as of 11-1-2020 Left arm not hurting as much. A lot of burning sensation & pins & needles however in both arms & left shoulder area.  Pins & needles in legs subsided.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth breathing, Nasal congestion, Throat tightness
Clinical narrative: Could not breathe my nose and the back of my throat plugged up had to breathe out of my mouth. Had to call the doctor got some fluticasone nose spray
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Oral herpes
Clinical narrative: Developed cold sore on lip with 5 pimples below it. Treated with Abreva. Cold sore resolved, but pimples still there and still treating with Abreva. No medical treatment to date. Pt did receive unknown name of Flu vax in early October.
Age: 70.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: CHILLS, FEVER AROUND 100 degrees TERRIBLE Headache lasted  all 3 Days SICK TO STOMACH - vomited SO SICK WAS Right down in bed 3 DAYS
Age: 70.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Vomiting
Clinical narrative: CHILLS, FEVER AROUND 100 degrees TERRIBLE Headache lasted  all 3 Days SICK TO STOMACH - vomited SO SICK WAS Right down in bed 3 DAYS
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site mass, Lymphadenopathy
Clinical narrative: swollen gland on left side. lump on left arm on vaccine site, total of about 7-10 days
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dyskinesia, Gait inability, Hot flush, Tremor
Clinical narrative: COLD CHILLS ACROSS SHOULDERS AND DOWN ARMS HOT FLASHES INTENCE JERKING AND SHAKEING UNCONTROLLABLE. SHAKEING OVER WHOLE BODY COLD CHILLS AND VOMITING COULD NOT WALK OR CONTROL ANYTHING
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: COLD CHILLS ACROSS SHOULDERS AND DOWN ARMS HOT FLASHES INTENCE JERKING AND SHAKEING UNCONTROLLABLE. SHAKEING OVER WHOLE BODY COLD CHILLS AND VOMITING COULD NOT WALK OR CONTROL ANYTHING
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: she gave a patient a dose of MMR II that was expired; This spontaneous report, as received from a nurse refers to a 64-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 30-OCT-2020, the patient was vaccinated with an expired dose of: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status: recombinant human albumin rHA), lot # R028003, expiration date: 01-OCT-2020, 0.5 milliliter (route of administration was not reported) for prophylaxis. No additional adverse event (AE) details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation. This case is regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified date in 2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) administered by her physician for long-term shingles and/or zoster-related conditions (prophylaxis). Subsequently, on unspecified date, the patient was treated by a healthcare provider at urgent care center for shingles. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX), the patient had and would continue to suffer ongoing injuries, included but not limited to medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; included but not limited to medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life and diminished quality of life. At the time of the report, the patient's outcome was not recovered, and the reporter considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Vasculitis
Clinical narrative: Vasculitis; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to pt's inoculation, the pt was treated for vasculitis. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of vasculitis was unknown. The reporter considered vasculitis to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received Shingrix. On 4th November 2020, 1 days after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was unknown.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Consumer stated that she received a dose of Shingrix and now had a low grade fever. The reporter did not consent to follow-up.; Sender's Comments:  DE-GLAXOSMITHKLINE-DE2020EME219261:Same atient 1st dose
Age: 8.0
Sex: F
Vaccine: FLU4, IPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient accidently received  IPOL already completed their series of IPV  NO AE; patient accidently received IPOL who already completed her series of IPV /NO AE; Initial information regarding an unsolicited valid serious case was received from a nurse via regulatory authority and transmitted to Sanofi on 05-OCT-2020.  This case is linked to case 2020SA278035 (same reporter).  This case involves a 8-years-2-month old female patient who accidently received once IPV (VERO) [IPOL] (strength: standard lot number: R1D973M, expiry date: 17-Jul-2021 via an intramuscular route in the left deltoid) and not the prescribed INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) on 05-Oct-2020 for prophylactic vaccination. Patient had already completed her series of IPV (extra dose administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.(latency: same day).  The clinic was thinking the IPOL was given due to inventory showing a missing IPOL that should be there. Nurse reporting that it was not sure if the IPOL was given but the inventory was leaning toward the IPOL being given. The clinic staff that administered the vaccine was not sure if IPOL or the flu vaccine was given.   At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4, FLUA3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient was billed for fluad and administered was Fluzone Quadrivalent/ No AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacistf.  This case involves a patient with unknown demographics who was billed for INFLUENZA VACCINE INACT SAG 3V [FLUAD] [batch number, expiry date and other dosing details are not applicable] and administered  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered. (Latency: at same time of vaccination)  At the time of report, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient received two doses of Fluzone High-Dose Quadrivalent within a few days of one another/no AE; patient received Fluzone High-Dose Quadrivalent instead of Tetanus vaccine on her previous visit/no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional (clinic supervisor) via Medical Information (Reference number- 00309537) and transmitted to Sanofi on 09-Oct-2020.  This case involves a 66-year-old female patient who accidentally received second dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of TETANUS TOXOID [TETANUS VACCINE] within a few days of one another from her first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. [wrong vaccine administered and extra dose administered].  Medical history, medical treatment, vaccination and family history were not provided. It was reported that, patient received no other vaccine as concomitant medication.   On 28-Sep-2020, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On 05-Oct-2020, patient was intended to receive TETANUS TOXOID [TETANUS VACCINE], but accidentally received 0.7 mL second dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Lot number: UJ516AA, expiry date: 30-Jun-2021] via intramuscular route at the left arm for prophylactic vaccination.   It was a case of actual medication error due to extra dose administered and wrong product administered. (latency on the same day of vaccination)  It was reported that, patient thought she got a TETANUS TOXOID [TETANUS VACCINE] on her previous visit and not realizing she got the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE instead, then the patient thought, that she still needed get her flu vaccine, and went back to the clinic with asking for and receiving the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE again. It was reported that, patient did not receive the Tetanus shot yet.    Product used: Used  First time product used: Yes  Still using product: No  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was inadvertently given two flu vaccines on their first administration/no AE; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional via Medical Information (with reference number :00311985).  This case involves a patient with unknown demographic who was inadvertently received two doses of influenza vaccine (lot and expiry date: not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination on their first administration (Extra dose administered).   Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  It was case of actual medication error due to extra dose administered (same day).  Reporter had a query regarding 2nd dose of flu vaccine as this was first season to receive flu.  At the time of reporting, patient had no adverse event.   Disclaimer: 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.      There will be no information available on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired doses of ADACEL with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2020SA287830 (same reporter).  This case involves a 11 year old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE).  On 15-Sep-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5519BA and expiry date: 12-sep-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: woman was given 2 Fluzone High Dose vaccines in 2 months with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 79 years old female patient who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] prefilled syringes in 2 months (lot: not reported, expiry date: not reported), via an unknown route and site, for prophylactic vaccination (extra dose administered) on 12-Oct-2020 (second dose).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the extra dose administered. (latency: unknown).  Caller said her store called her today to ask her to call Pasteur to check if there is any information on giving 2 Fluzone High Dose (HD) within 2 months. Caller said the patient got a Fluzone HD at their store yesterday and then called back later that night to tell them that she had received a Fluzone HD at another clinic 2 months ago too. She is feeling fine The caller did not have any details on patient or vaccine, she said she is not at that store.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will no information on the lot number for this case.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses of Fluzone High Dose within 10 minutes of each other/ No AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received a 0.7 ml two doses of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] injection (lot: UJ501AA, expiry date: 30-Jun-2021), via an unknown route and site, on an unknown date for prophylactic vaccination respectively (extra dose administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to extra dose administered. It was reported that patient received two doses of Fluzone High Dose within 10 minutes of each other in addition to Shingrix injection.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Influenza, Malaise
Clinical narrative: Flu; This spontaneous case was received on 02-Nov-2020 from other non-health professional (consumer) via the agency (reference number: SEQW20-04654) and concerned a 77-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date in late Oct-2019, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, route of administration, anatomical location and dose: not reported) for influenza prophylaxis. The batch number was not reported. The vaccine was one for seniors, recommended for age over 65.  On an unspecified date in 2019, within a couple of days after receiving influenza virus vaccine polyvalent, the patient became ill. The patient was sick for a month and had to see her physician who stated that she was dehydrated and had to be administered intravenous (IV) fluids.  On an unspecified date in Jan-2020, the patient was still sick and was diagnosed with the flu.   At the time of initial reporting on 02-Nov-2020, the patient had not recovered from the event and she was not the same since vaccination.  The reporter did not provide causality assessment.  The event of 'flu' was considered serious due to medically significance by a physician within agency.  This case is linked to 202005985 and 202005986 (the same reporter).  Company comment: A 77-year-old, female patient was vaccinated with influenza virus vaccine polyvalent. Within a couple of days after receiving influenza virus vaccine polyvalent, the patient became ill. Reportedly, on an unspecified date in Jan-2020, the patient was diagnosed with influenza. With information available, chronology is plausible and causality is assessed as possibly related.; Sender's Comments: A 77-year-old, female patient was vaccinated with influenza virus vaccine polyvalent. Within a couple of days after receiving influenza virus vaccine polyvalent, the patient became ill. Reportedly, on an unspecified date in Jan-2020, the patient was diagnosed with influenza. With information available, chronology is plausible and causality is assessed as possibly related.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Was diagnosed with the flu/the same thing happened to them; This spontaneous case was received on 02-Nov-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-04654) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed flu.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by a Physician within agency.  The case is linked to case 202005984 and 202005986 (the same reporter).  Company comment: The patient developed influenza on an unspecified date and an unknown amount of time after receiving suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as unassessable due to lack of information regarding onset latency.; Sender's Comments: The patient developed influenza on an unspecified date and an unknown amount of time after receiving suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as unassessable due to lack of information regarding onset latency.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Was diagnosed with the flu/the same thing happened to them; This spontaneous case  was received on 02-Nov-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04654) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed flu.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  The case is linked to case 202005984 and 202005985 (the same reporter).  Company comment: A patient of an unreported age and gender was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed influenza. Chronology needs more clarification. Causality is unassessable.; Sender's Comments: A patient of an unreported age and gender was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed influenza. Chronology needs more clarification. Causality is unassessable.
Age: 17.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Student nauseous, sweaty, and vomited. Episode last about 10 minutes, gave student water and cold compress.  Student sat in administration room for an additional ten minutes and stated that he felt better, did not feel nauseous anymore. Advised parent to follow up with doctor.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on outside of both knees that started the day after.  She can not think of anything that may have caused it.  She ruled out coming into contact with something.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: I went to bed earlier than usual the night I received the vaccine( Friday). The next day,(Saturday) I was tired and had muscle aches and pains, I didn't feel like doing much. Later in the evening I started to develop a headache and took some Advil.  On Sunday I was much better - not tired and no muscle aches.. Today (Monday) my wife pointed out that I had a few red blotches where I had the injection. Not sure when that started.  I did have some soreness around the injection site from Friday afternoon through Sunday afternoon.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: I went to bed earlier than usual the night I received the vaccine( Friday). The next day,(Saturday) I was tired and had muscle aches and pains, I didn't feel like doing much. Later in the evening I started to develop a headache and took some Advil.  On Sunday I was much better - not tired and no muscle aches.. Today (Monday) my wife pointed out that I had a few red blotches where I had the injection. Not sure when that started.  I did have some soreness around the injection site from Friday afternoon through Sunday afternoon.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Eczema
Clinical narrative: Patient developed what he termed eczema on his arms and legs 5 days post vaccination. Patient was counseled to contact his primary care provider to see if he should be evaluated and to ask if he should receive the influenza vaccine in the future.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was hospitalized with symptoms consistent with Guillian Barre syndrome.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient still reports of arm pain and soreness in left arm. She felt the shot was administered high on her left arm. No rash, burning or redness....Just arm soreness for 2 + weeks.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Initially pain/soreness in left arm. Throughout the night muscle aches, alternating hot/cold/chills.  Fever of 100.9 recorded at 6 am.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Irritability, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, temperature spike, generalized weakness, and irritability
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: we already discussed possible side effects that were to be expected BUT she stated she had slight fever (over 100.1 for over 72 hours) and nausea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pt has "severe" pain in her shoulder and arm which is unresolved following the vaccination
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Choking sensation, Dysphagia, Pain, Swelling
Clinical narrative: After having the vaccination, she had soreness, pain and swelling. Feels like she going to choke, hard to swallow which she didn't have before the vaccine.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports that she woke in the middle of the night after receiving the vaccine with very sore arm. Over the following 4 days, she reports that she had severe arm swelling (shoulder to elbow), elevated temp and severe headache. As patient already takes pain medicine and anti-inflammatory, she did not take any additional medications for these rxn(s). She did apply ice and heat to her arm.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: gave a Tdap instead of a Dtap  Advised mom to go to ER if adverse reactions. will follow up with mom for the next 2 days
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: PATIENT STARTED WITH ITCHY SKIN ON THURSDAY 11/5/20,  ITCHY SKIN PROGRESSED TO BLOTCHY SKIN DESCRIBED AS HIVES.  PATIENT WENT TO URGENT CARE CLINIC ON SATURDAY MORNING AND ORAL STEROIDS WERE PRESCRIBED.  PATIENT IS CURRENTLY TAKING ORAL PREDNISONE AND MONITORING THE RESOLUTION OF THE RASH
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Skin warm
Clinical narrative: Immediate itchiness lasted 4 days. Hot and red lasted 4 days. Large swelling lasted 4 days. The symptoms are ongoing.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Nausea, Urticaria
Clinical narrative: Hives / welts over most body areas,  fatigue nausea headache
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Hypersensitivity, Pruritus
Clinical narrative: Hives / welts over most body areas,  fatigue nausea headache
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Hives / welts over most body areas,  fatigue nausea headache
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Fatigue, Musculoskeletal chest pain
Clinical narrative: The same day I was feeling tired and it continued for 3-4 days.  I felt better for about 3-4 days again,  I relapsed with the muscle pain in chest and sometimes my extremities, sore throat, runny nose and extreme fatigue, more labored breathing upon exertion.  I am still very weak and right now, walk with weakness (I cannot walk down my basement stairs at this point -- hoping to improve).  As mentioned before, I don't know if this is a covid relapse or an adverse reaction.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Musculoskeletal pain, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: The same day I was feeling tired and it continued for 3-4 days.  I felt better for about 3-4 days again,  I relapsed with the muscle pain in chest and sometimes my extremities, sore throat, runny nose and extreme fatigue, more labored breathing upon exertion.  I am still very weak and right now, walk with weakness (I cannot walk down my basement stairs at this point -- hoping to improve).  As mentioned before, I don't know if this is a covid relapse or an adverse reaction.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Eye swelling, Injection site pain, Injection site urticaria
Clinical narrative: About 5 hours after getting the Flu shot, her face became red and her face and eyes were swollen ("she looked like she had been crying"). She felt dizzy but did not vomit. She also developed a large wheel that was tender at the injection site.  Mom gave her Ibuprofen and then a few hours later the symptoms gradually subsided. She had never had a reaction to the vaccine before. No hx of egg allergy.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: About 5 hours after getting the Flu shot, her face became red and her face and eyes were swollen ("she looked like she had been crying"). She felt dizzy but did not vomit. She also developed a large wheel that was tender at the injection site.  Mom gave her Ibuprofen and then a few hours later the symptoms gradually subsided. She had never had a reaction to the vaccine before. No hx of egg allergy.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cough, Hypoaesthesia oral, Nausea, Rash erythematous, Tongue pruritus
Clinical narrative: He received the vaccine along with the tdap around 2:30. At 5, he started coughing and feeling like throwing up. I went to check on him, he was completely red on his face, arms and stomach with raised bumps. He started feeling like his tongue was itchy and his lips were numb . Gave him Benadryl and too him to the ER, where they gave him methylprednisolone,  more Benedryl, famotidine and an epipen. He responded well but slept all weekend
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: it appears injection administerd high, now increased pain with shoulder movement
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dyspepsia, Headache
Clinical narrative: I felt fine until several hours later where I developed heartburn and an uneasy stomach. After 15 minutes I began vomiting and this happened 3 times. I also had diarrhea. This episode lasted about 45 minutes intotal. I went to bed and began to get the chills and very violent shakes. I had to turn on my heater as I was so cold. This lasted 3 hours. After I calmed down and only had a slight headache for the rest of the nite into the next day. I had a very low grade fever of 99. The next day I took 1 Tylenol and was able to eat and drink fine. No other symptoms to date.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: I felt fine until several hours later where I developed heartburn and an uneasy stomach. After 15 minutes I began vomiting and this happened 3 times. I also had diarrhea. This episode lasted about 45 minutes intotal. I went to bed and began to get the chills and very violent shakes. I had to turn on my heater as I was so cold. This lasted 3 hours. After I calmed down and only had a slight headache for the rest of the nite into the next day. I had a very low grade fever of 99. The next day I took 1 Tylenol and was able to eat and drink fine. No other symptoms to date.
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Administration site discolouration, Administration site swelling, Injection site erythema
Clinical narrative: Patient states has a "tennis sized" area of swelling and redness with an inch sized dark spot at the site of administration
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Decreased appetite, Diarrhoea, Erythema, Fatigue, Feeling jittery
Clinical narrative: Patient states has a "tennis sized" area of swelling and redness with an inch sized dark spot at the site of administration
Age: 74.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Patient states has a "tennis sized" area of swelling and redness with an inch sized dark spot at the site of administration
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Lymphadenopathy, Musculoskeletal chest pain, Neck pain, Pain in extremity
Clinical narrative: neck pain, glands swollen under jaw, rib pain and arm pain all on the side of the injection. She states that her mother had an adverse reaction several years ago that was similar but she couldn't move her arm for approx a month.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site muscle weakness, Injection site pain
Clinical narrative: Pain and weakness radiating  from injection site in left deltoid down into elbow that started the morning after shot and has continued until present (3.5 weeks later). Patient doesn't recall any pain or discomfort at time of administration and only slight discomfort that evening before bed. Patient claim there is a constant ache and the injection area still hurts on touching it.  Patient describes pain is much like that from a pulled muscle but does not recall any injury.  Pain and discomfort improves with Tylenol and ibuprofen, ice and heat doesn't seem to help. Patient will follow up with there regular doctor if it doesn't improve.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Chills; Fever of 100.6; Body Aches; Headache; redness and swelling and soreness below the injection site Lasted about 24 hours No treatment taken
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Chills; Fever of 100.6; Body Aches; Headache; redness and swelling and soreness below the injection site Lasted about 24 hours No treatment taken
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Patient had an episode of vomiting with a syncopal episode shortly after leaving  the clinic. Resolved with no further vomiting or syncopal episodes.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, headache, tired, fever, muscle aches all over.  These sysptoms lasted about 15 hours
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Myalgia, Pain, Sleep disorder
Clinical narrative: Flue vaccine, within one hour shoulder joint hurt terribly, deltoid muscle did not hurt, deltoid muscle never hurt (usually it is a little sore after 24 hours)  Rotator cuff muscles and joint very painful by the next morning.  Virtually no shoulder movement possible without bad pain.  No resolution after 2 weeks, went to Doctor.........thought I was getting better.  Pain wakes me up 2 times per night.  Should seems "frozen" every  morning, any rotation is very painful  Evenings allow for should movement, elevation of wrist above to chest height is very painful even at night
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Developed a rash.  Started chest and face and then spread throughout body.  Itching present.  No fever, cough, rhinorrhea, dyspnea.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Decreased appetite, Petechiae, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever for 3 days up to 102, intermittent. Decreased appetite. Petechial rash upper chest and back which cleared after 2 days. Slight runny nose 7 days later.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Redness wrapping around the circumference of pt's arm at level of elbow (band is about 6inches in width), itchy, fever of 100 degrees for 12hrs.   Pt took OTC Zyrtec and applied cool compress to site.  Symptoms are slowly resolving, not completely gone yet.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Hypoaesthesia
Clinical narrative: Patient had come to the drop off window and was complaining about side effects that she had after receiving her Shingles vaccine on 11/02/20. Patient was Spanish speaking, so flor translated her side effects to me. She stated that patient experienced severe Fatigue, fever, shivering, weakness and myalgia. She also stated that she felt pain in her shoulders, and numbness in legs. She was concerned as she perceived these side effects as something that was abnormal. She stated that she took Tylenol ,and the next day she felt a lot better, and the numbness in her feel has gotten a lot better as well improving on daily basis. I informed patient that what she was experiencing was the side effects that are associated with the shingles vaccine (as stated on facts & comparisons). I also advised her to make appointment with her doctor to do a follow up to make sure everything was ok with her to rule out any serious conditions.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient had come to the drop off window and was complaining about side effects that she had after receiving her Shingles vaccine on 11/02/20. Patient was Spanish speaking, so flor translated her side effects to me. She stated that patient experienced severe Fatigue, fever, shivering, weakness and myalgia. She also stated that she felt pain in her shoulders, and numbness in legs. She was concerned as she perceived these side effects as something that was abnormal. She stated that she took Tylenol ,and the next day she felt a lot better, and the numbness in her feel has gotten a lot better as well improving on daily basis. I informed patient that what she was experiencing was the side effects that are associated with the shingles vaccine (as stated on facts & comparisons). I also advised her to make appointment with her doctor to do a follow up to make sure everything was ok with her to rule out any serious conditions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Laboratory test, Ocular hyperaemia
Clinical narrative: red and swelling in my right eye.  I was given steroid eye drops and antiviral medication.