chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 100; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On 16th October 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Age group of patient was captured as adult as per indication of product. The patient received Shingrix vaccine yesterday from the day of reporting and had a fever of 100 Degree Fahrenheit on the day of reporting.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: mild injection site swelling more than just wheel and flare; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to case 2020SA272580 (same reporter).  This case involves a patient who experienced mild injection site swelling more than just wheel and flare (vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history included DT containing vaccines that sometimes caused limb swelling, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious mild injection site swelling more than just wheel and flare (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu three times; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient who experienced flu three times (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu three times (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on lot number for this case.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Chills, Decreased appetite, Headache, Pain in extremity, Pyrexia
Clinical narrative: arms are still sore; fever; chills; extreme head ache; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (patient) via public post on the flu shot campaign via social media.   This case involves patient of unknown demographics whose stated that his/her arms are still sore (pain in extremity), fever (pyrexia), chills and extreme head ache (headache), while he/she received vaccines PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) and dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious adverse events as his/her arms are still sore (pain in extremity), fever (pyrexia), chills and extreme head ache (headache) on an unknown latency following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Case details: Patient stated that he/she  just has his/her flu shot and a pneumonia shot and his/her arms are still sore after three days and had fever and chills and extreme head ache. He/she was  just now able to eat something light. Patient further stated that this was the worst reaction he/she have ever had.   Details of laboratory data were not reported.    It was not reported if the patient received a corrective treatment.  The patient was not Recovered from the event of  pain in extremity and outcome was unknown for other events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: arms sore and hurt; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from the patient via social media.  This case is linked to case 2020SA294125 (same reporter).  This case involves an unknown demographic patient whose arms were sore and hurting (pain in extremity), while the patient received vaccines INFLUENZA VACCINE, PNEUMOCOCCAL VACCINE and VARICELLA ZOSTER VACCINE RGE (CHO) [SHINGRIX].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, a dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur and a dose of suspect SHINGRIX not produced by Sanofi Pasteur (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient's arms were sore and hurting (pain in extremity), on the same night following the administration of INFLUENZA VACCINE, PNEUMOCOCCAL VACCINE and SHINGRIX.  The patient was not sick.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Blood test normal, Decreased appetite, Feeling of body temperature change, Influenza like illness, Malaise
Clinical narrative: general flu like; loss of appetite; shaking on and off; tingling in arms; muscle weakness; general malaise; nausea; muscles aching of left arm left leg; feeling cold then hot; weight loss; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 66-years-old female patient who experienced feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm left leg (myalgia), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  The patient had a bat in her room and woke up with a scratch on her neck. She was unsure if she was bitten by the bat.  Concomitant medication included HyperRab.   The patient received first, second, third and fourth dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an intramuscular route in an arm NOS (not otherwise specified) for prophylactic vaccination on 24-Aug-2020, 27-Aug-2020, 31-Aug-2020 and 07-Sep-2020 respectively.   In Aug-2020, the patient developed a non-serious feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm and left leg (myalgia) 3 days after each of the 1st, 2nd and 3rd dose of RABIES (HDC) VACCINE.  The patient experienced the symptoms again 10 days after her 4th vaccine that lasted for 7 days.  Relevant laboratory test: blood work and X-rays results came back normal.  The patient had to go to the emergency room (ER) twice due to these symptoms.  The ER gave her fluids.  At the time of this report, the patient had not recovered from events.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Muscular weakness, Myalgia, Nausea, Paraesthesia, Tremor
Clinical narrative: general flu like; loss of appetite; shaking on and off; tingling in arms; muscle weakness; general malaise; nausea; muscles aching of left arm left leg; feeling cold then hot; weight loss; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 66-years-old female patient who experienced feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm left leg (myalgia), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  The patient had a bat in her room and woke up with a scratch on her neck. She was unsure if she was bitten by the bat.  Concomitant medication included HyperRab.   The patient received first, second, third and fourth dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an intramuscular route in an arm NOS (not otherwise specified) for prophylactic vaccination on 24-Aug-2020, 27-Aug-2020, 31-Aug-2020 and 07-Sep-2020 respectively.   In Aug-2020, the patient developed a non-serious feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm and left leg (myalgia) 3 days after each of the 1st, 2nd and 3rd dose of RABIES (HDC) VACCINE.  The patient experienced the symptoms again 10 days after her 4th vaccine that lasted for 7 days.  Relevant laboratory test: blood work and X-rays results came back normal.  The patient had to go to the emergency room (ER) twice due to these symptoms.  The ER gave her fluids.  At the time of this report, the patient had not recovered from events.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: RAB
Symptoms: Weight decreased, X-ray normal
Clinical narrative: general flu like; loss of appetite; shaking on and off; tingling in arms; muscle weakness; general malaise; nausea; muscles aching of left arm left leg; feeling cold then hot; weight loss; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 66-years-old female patient who experienced feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm left leg (myalgia), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  The patient had a bat in her room and woke up with a scratch on her neck. She was unsure if she was bitten by the bat.  Concomitant medication included HyperRab.   The patient received first, second, third and fourth dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an intramuscular route in an arm NOS (not otherwise specified) for prophylactic vaccination on 24-Aug-2020, 27-Aug-2020, 31-Aug-2020 and 07-Sep-2020 respectively.   In Aug-2020, the patient developed a non-serious feeling cold then hot (Feeling of body temperature change), weight loss (weight decreased), general flu like symptoms (influenza like illness), loss of appetite (decreased appetite), shaking on and off (tremor), tingling in arms (paraesthesia), muscle weakness (muscular weakness), general malaise (malaise), nausea, muscles aching of left arm and left leg (myalgia) 3 days after each of the 1st, 2nd and 3rd dose of RABIES (HDC) VACCINE.  The patient experienced the symptoms again 10 days after her 4th vaccine that lasted for 7 days.  Relevant laboratory test: blood work and X-rays results came back normal.  The patient had to go to the emergency room (ER) twice due to these symptoms.  The ER gave her fluids.  At the time of this report, the patient had not recovered from events.  There will be no information available on the batch number for this case.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Vaccine positive rechallenge, Viral infection, Vomiting
Clinical narrative: almost flu like symptoms; just threw up and had virus one right after another; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves a 72 years old male patient who experienced almost flu like symptoms (influenza like illness) and just threw up and had virus one right after another (vomiting), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination (s), family history and concomitant medications were not provided. At the time of the event, the patient had ongoing food allergy.  On 23-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious almost flu like symptoms (influenza like illness) and just threw up and had virus one right after another (vomiting) on an unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details:  Reporter would like to know if either of the Flu vaccines are egg free because her husband is allergic to eggs and if FLUBLOK QUADRIVALENT is egg free. She mentioned her husband reacted to FLUZONE HIGH DOSE. Caller further reported her husband reacted to a flu vaccine in the past. He received the FLUZONE HIGH DOSE and experienced, almost flu like symptoms, he just threw up and had virus one right after another. Finally, someone brought up the egg content in the FLUZONE HIGH DOSE. He can only eat eggs once a week otherwise he is sick.  Details of laboratory data were not reported.     It was not reported if the patient received a corrective treatment.  The outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Chest pain, Electrocardiogram normal, Headache, Laboratory test normal
Clinical narrative: Arm was sore, eventually leading to both arms being painful.  Headache, pounding heart and chest pains.  Blood pressure raised to 207/156
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Palpitations
Clinical narrative: Arm was sore, eventually leading to both arms being painful.  Headache, pounding heart and chest pains.  Blood pressure raised to 207/156
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Neck pain
Clinical narrative: neck and shoulder pain
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Per phone call from mother, patient passed out in the front yard of their home after receiving vaccines. Nurse advised her on the actions to be taken and if concerns continue to have patient see her PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Rash
Clinical narrative: Hives, scratchy throat, shivering, weak, tired, sweating, rash
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation, Urticaria
Clinical narrative: Hives, scratchy throat, shivering, weak, tired, sweating, rash
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bartonella test negative, Borrelia test negative, C-reactive protein normal
Clinical narrative: Saturday, October 3, 2020  Flucelvax given 13:00 IM Left arm  Monday, Oct 5 Extreme fatigue in evening  Tuesday, Oct 6 Awakes with drenched pillow, has myalgias and chills in the morning at work, some relief with apap.  Returns home with extreme chills, no fever.  Begins isolation at home.  Wednesday, Oct 7 Chills and sweats.  Covid tests at hospital collected  Thursday, Oct  Chills and night sweats.  Friday, Oct 8 Chills and night sweats 2 neg Covid tests resulted.  Saturday Multiple night sweats, drenching and requiring 3-4 changes of clothes.  Discovered painful left axillary lymph nodes in morning.  Rides bike  Sunday 10/11/20 Night sweats, changing clothes, functional during the day  Monday 10/12/20 Night sweats Sees Dr in afternoon.  Tuesday 10/13/20 Night sweats  Wednesday 10/14/20 Night sweats decreasing,  only one change by morning Attempts to have blood test, refused at lab because covid test was also ordered - employee states that tests cannot be drawn until covid done and negative.  He states that he has 2 negative test posted in the last week, but is still denied.  Confirmed by Dr that this is not lab policy. Gets CXR in the evening at hospital  and starts Zpak at beditime.  Thursday 10/15/20 Awakes in am- no night sweats! Has blood drawn at lab.  Friday 10/16/20 Feeling better, no night sweats.  Continues Zpak.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest X-ray normal, Chills, Fatigue, Full blood count normal, Hepatic enzyme increased
Clinical narrative: Saturday, October 3, 2020  Flucelvax given 13:00 IM Left arm  Monday, Oct 5 Extreme fatigue in evening  Tuesday, Oct 6 Awakes with drenched pillow, has myalgias and chills in the morning at work, some relief with apap.  Returns home with extreme chills, no fever.  Begins isolation at home.  Wednesday, Oct 7 Chills and sweats.  Covid tests at hospital collected  Thursday, Oct  Chills and night sweats.  Friday, Oct 8 Chills and night sweats 2 neg Covid tests resulted.  Saturday Multiple night sweats, drenching and requiring 3-4 changes of clothes.  Discovered painful left axillary lymph nodes in morning.  Rides bike  Sunday 10/11/20 Night sweats, changing clothes, functional during the day  Monday 10/12/20 Night sweats Sees Dr in afternoon.  Tuesday 10/13/20 Night sweats  Wednesday 10/14/20 Night sweats decreasing,  only one change by morning Attempts to have blood test, refused at lab because covid test was also ordered - employee states that tests cannot be drawn until covid done and negative.  He states that he has 2 negative test posted in the last week, but is still denied.  Confirmed by Dr that this is not lab policy. Gets CXR in the evening at hospital  and starts Zpak at beditime.  Thursday 10/15/20 Awakes in am- no night sweats! Has blood drawn at lab.  Friday 10/16/20 Feeling better, no night sweats.  Continues Zpak.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Lymph node pain, Myalgia, Night sweats, Red blood cell sedimentation rate normal
Clinical narrative: Saturday, October 3, 2020  Flucelvax given 13:00 IM Left arm  Monday, Oct 5 Extreme fatigue in evening  Tuesday, Oct 6 Awakes with drenched pillow, has myalgias and chills in the morning at work, some relief with apap.  Returns home with extreme chills, no fever.  Begins isolation at home.  Wednesday, Oct 7 Chills and sweats.  Covid tests at hospital collected  Thursday, Oct  Chills and night sweats.  Friday, Oct 8 Chills and night sweats 2 neg Covid tests resulted.  Saturday Multiple night sweats, drenching and requiring 3-4 changes of clothes.  Discovered painful left axillary lymph nodes in morning.  Rides bike  Sunday 10/11/20 Night sweats, changing clothes, functional during the day  Monday 10/12/20 Night sweats Sees Dr in afternoon.  Tuesday 10/13/20 Night sweats  Wednesday 10/14/20 Night sweats decreasing,  only one change by morning Attempts to have blood test, refused at lab because covid test was also ordered - employee states that tests cannot be drawn until covid done and negative.  He states that he has 2 negative test posted in the last week, but is still denied.  Confirmed by Dr that this is not lab policy. Gets CXR in the evening at hospital  and starts Zpak at beditime.  Thursday 10/15/20 Awakes in am- no night sweats! Has blood drawn at lab.  Friday 10/16/20 Feeling better, no night sweats.  Continues Zpak.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Saturday, October 3, 2020  Flucelvax given 13:00 IM Left arm  Monday, Oct 5 Extreme fatigue in evening  Tuesday, Oct 6 Awakes with drenched pillow, has myalgias and chills in the morning at work, some relief with apap.  Returns home with extreme chills, no fever.  Begins isolation at home.  Wednesday, Oct 7 Chills and sweats.  Covid tests at hospital collected  Thursday, Oct  Chills and night sweats.  Friday, Oct 8 Chills and night sweats 2 neg Covid tests resulted.  Saturday Multiple night sweats, drenching and requiring 3-4 changes of clothes.  Discovered painful left axillary lymph nodes in morning.  Rides bike  Sunday 10/11/20 Night sweats, changing clothes, functional during the day  Monday 10/12/20 Night sweats Sees Dr in afternoon.  Tuesday 10/13/20 Night sweats  Wednesday 10/14/20 Night sweats decreasing,  only one change by morning Attempts to have blood test, refused at lab because covid test was also ordered - employee states that tests cannot be drawn until covid done and negative.  He states that he has 2 negative test posted in the last week, but is still denied.  Confirmed by Dr that this is not lab policy. Gets CXR in the evening at hospital  and starts Zpak at beditime.  Thursday 10/15/20 Awakes in am- no night sweats! Has blood drawn at lab.  Friday 10/16/20 Feeling better, no night sweats.  Continues Zpak.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, UNK
Symptoms: Eczema, Rash
Clinical narrative: Patient returned on 10/12/20 for follow up. It was at that  time the patients mother notified the provider of an "eczema like" rash that formed on the childs right arm as a straight line from his shoulder down his arm. Mom states the rash formed within a day or two after receiving the vaccines.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports prolonged pain/discomfort in shoulder which began immediately after  the shot was administered. They report a decrease in range of motion. Both symptoms persist now, even 3 weeks after the vaccination was received.
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Amenorrhoea, Autoimmune thyroiditis, Dairy intolerance, Gluten sensitivity
Clinical narrative: she was diagnosed with Hashimoto disease/ monthly periods and hair loss/ damaged thyroid; ovary failure; This spontaneous report was received from a 17-year-old female patient who reported on herself via a company representative. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 14-AUG-2009, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and subsequently received next doses as follows: 19-OCT-2009 and 15-FEB-2010 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported for any of them); all for prophylaxis. On an unknown date, she experienced damaged thyroid, "no dairy or gluten", estrogen at menopausal levels, no monthly periods and hair loss (reported as the reporter did not know when the adverse signs and symptoms first started). Then, on an unknown date in August 2015, the patient was diagnosed with Hashimoto's disease and ovary failure. It was reported that it took a long time to get to a diagnosis. The outcome of the events was not reported.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of Hashimoto's disease was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Hormone level abnormal, Ovarian failure, Thyroid disorder
Clinical narrative: she was diagnosed with Hashimoto disease/ monthly periods and hair loss/ damaged thyroid; ovary failure; This spontaneous report was received from a 17-year-old female patient who reported on herself via a company representative. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 14-AUG-2009, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and subsequently received next doses as follows: 19-OCT-2009 and 15-FEB-2010 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported for any of them); all for prophylaxis. On an unknown date, she experienced damaged thyroid, "no dairy or gluten", estrogen at menopausal levels, no monthly periods and hair loss (reported as the reporter did not know when the adverse signs and symptoms first started). Then, on an unknown date in August 2015, the patient was diagnosed with Hashimoto's disease and ovary failure. It was reported that it took a long time to get to a diagnosis. The outcome of the events was not reported.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of Hashimoto's disease was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: intermittent hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult 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 hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient got intermittent hives for a week after the first shot of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Retching
Clinical narrative: Nauseated not; Wretching; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 2nd dose of Shingrix. On 17th October 2020, less than a day after receiving Shingrix, the patient experienced nausea and retching. On an unknown date, the outcome of the nausea and retching were not recovered/not resolved.   It was unknown if the reporter considered the nausea and retching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had got second Shingrix vaccination on the morning of reporting date and was nauseated and wretched then.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: swelling the size of a golf ball at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   On 6th October 2020, the patient received Kinrix. In October 2020, less than a week after receiving Kinrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling to be related to Kinrix.  Additional details were reported as follows: The patient received the Kinrix on Left arm and experienced swelling the size of a golf ball at injection site.  It resolved within 2-3 days. The reporter consented to follow up. This case has been linked with US2020203016 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203016:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Hyperaesthesia, Hypersensitivity, Pain, Swelling
Clinical narrative: slight swelling; hypersensitivity reaction; intense pain sensation / of pain and agony; very sensitive to touch; pain is now radiating to the middle of her back; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix. In September 2020, 3 weeks after receiving Shingrix, the patient experienced local swelling, hypersensitivity, pain, touch sensitivity increased and back pain. The patient was treated with ibuprofen (Advil) and lidocaine (Lidocaine Cream). On an unknown date, the outcome of the local swelling, hypersensitivity, pain and back pain were not recovered/not resolved and the outcome of the touch sensitivity increased was unknown.   It was unknown if the reporter considered the local swelling, hypersensitivity, pain, touch sensitivity increased and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine probably in her left arm (she was not sure).  About 3 weeks later the patient started to experience hypersensitivity reaction like the skin on the right shoulder blade was very sensitive to touch and she cannot wear any clothes as the cloth inflicted intense pain sensation. The patient stated there was slight swelling in the area and the hypersensitivity to pain radiated to the middle of her back and moved slightly to the left side. The stated this was slightly better than before. The patient's physician advised her to use lidocaine topical cream and Advil, but patient stated that it did not help. The patient was in a lot of pain and agony because of this. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination, Product administered at inappropriate site
Clinical narrative: she and her husband have both been "sick; not yet completed the 2 dose vaccine series; She administered it intramuscularly /  into his buttock; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 28th March 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness, vaccine administered at inappropriate site and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's wife who was a nurse. The reporter does not have a record of the lot/expiry details for the first dose. Nurse said that she was very experienced, and she had been a nurse for 45 years and had given thousands of shots. The patient received 1st dose of Shingrix (intramuscularly) and was administered into his buttock, which led to vaccine administered at inappropriate site. Till the time of reporting, the patient had not yet completed the 2 dose of Shingrix vaccine series as the nurse did not had another vial of adjuvant to prepare a dose for patient, which led to incomplete course of vaccination.  Nurse stated that the patient had been sick recently. The reporter did not ask for MD contact information. This case had been linked with US2020AMR206531 and US2020204772, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206531:Wife's case US-GLAXOSMITHKLINE-US2020204772:Wife's case
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: swelling in his elbow; Swelling extended to patient forearm; This case was reported by a nurse via call center representative and described the occurrence of swollen joints in a 26-year-old male patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Twinrix. On 10th October 2020, 5 days after receiving Twinrix, the patient experienced swollen joints and swelling arm. On an unknown date, the outcome of the swollen joints was not recovered/not resolved and the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swollen joints and swelling arm to be related to Twinrix.  Additional details were reported as follows: On 10th October 2020, the patient experienced swelling in his elbow. Swelling in the patients AC (as reported) and back of elbow extended to the forearm. The patient had not consulted a physician, diagnosis was not available and outcome reported as ongoing.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Laboratory test abnormal, Ophthalmic herpes zoster, Rash
Clinical narrative: diagnosed as ocular shingles; rash occur in her right eye; remaining irritation in her right eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had a long history of ocular shingles over the last 7 years.).   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), rash and eye irritation. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the rash and eye irritation were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash and eye irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 66 or 67 years. The patient received 1st dose of shingrix in September 2020 and had rash in eye which was diagnosed as ocular shingles. The patient was treated with Valtrex and rash was resolved and reappeared after stopping Valtrex. The patient had some remaining irritation in eye, which she mentioned as better than that she had rash, shingles after first shingrix vaccine. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 8 inch round red circle on her left arm (the site of injection); circle was warm, not hot, warmer than her skin; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, 5 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On 4th September 2020, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Then 5 days later, the patient developed an 8 inch round red circle on her left arm (the site of injection). The circle was warm, not hot but warmer than her skin. It went away by 4th September 2020. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: at the injection site, her upper left arm has been "swollen"; injection site / pink; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 64 or 65 years. The patient received Shingrix at upper left arm. At the injection site, the patient's upper left arm had swollen and pink for two to three days. The reporter stated she just wanted to know if it was okay. The reporter was provided with Medical Disclaimer and information from the product information in content. The caller was offered product information material to be mailed to her. The reporter did not consent to follow up. No health care provider information was given.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching / believes it is due to administering the Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   The reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported the case about the patient who was a pharmacist. The patient had been experiencing some itching and believed it was due to administration of the Shingrix vaccine. The itching was ongoing till the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: patient got GB from the flu shot; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a female patient(age not reported) who experienced GB (unevaluable event), while she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed non-serious GB (unevaluable event) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. it was assumed that the consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old was given Quadracel, no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 years old male patient who was vaccinated with 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number C5763AA and expiration date:26-Aug-2022) via intramuscular route in the left deltoid for prophylactic vaccination on 08-Sep-2020 (PT:product administered to patient of inappropriate age).  Medical history was not reported.  No concomitant medication as given to patient.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency)..  No adverse event reported at the time of reporting.  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: 47.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: pain/numbness in left arm/thumb about 3 days after injection
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia, Tachycardia, Tachypnoea
Clinical narrative: tachypnea, tachycardia, fever, lethargy lasting approx 12 hours
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shortly after she experienced injection pain, swelling and redness. She claims to present with these symptoms and visited our pharmacy. She was advised to take OTC Benadryl. The arm did not improve so she went to urgent care. She was advised to go to the ER with cellulitis. She was given IV antibiotics and discharged with oral antibiotics
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, Blood creatine phosphokinase, Chest X-ray, Diarrhoea, Differential white blood cell count
Clinical narrative: Trouble breathing then eyes swollen, extremely red, eyeballs filled with gunk, difficulty seeing, then vomiting, diarrhea, tachycardia, difficulty swallowing,..in that order.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Electrocardiogram, Eye discharge, Eye swelling
Clinical narrative: Trouble breathing then eyes swollen, extremely red, eyeballs filled with gunk, difficulty seeing, then vomiting, diarrhea, tachycardia, difficulty swallowing,..in that order.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, International normalised ratio, Liver function test, Metabolic function test, Ocular hyperaemia
Clinical narrative: Trouble breathing then eyes swollen, extremely red, eyeballs filled with gunk, difficulty seeing, then vomiting, diarrhea, tachycardia, difficulty swallowing,..in that order.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia, Troponin, Visual impairment, Vomiting
Clinical narrative: Trouble breathing then eyes swollen, extremely red, eyeballs filled with gunk, difficulty seeing, then vomiting, diarrhea, tachycardia, difficulty swallowing,..in that order.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Gaze palsy, Myalgia, Nausea
Clinical narrative: Shortness of breath, headache,  muscle aches, joint aches, nausea
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Within a few hours of receiving the vaccination I started to feel dizzy and light headed, my arms and legs also began to feel weak which was accompanied by a severe headache later that evening. The following day my symptoms seemed to have gotten worst I had a fever along with joint pain and muscle spasms by mid afternoon I started to have chest pains and heart palpitations within next few hours my symptoms continued to get worst they were accompanied with swelling of my lips and an even more rapid heartbeat. I remember going upstairs to sit down and before I made it to the couch I had passed out, I do not recall the length of time but by the time I came to the ambulance was at our home. They completed the regular first responders assessment and advised me that If I continue have cheat pain, to feel light headed or weak that I should go to the hospital. I then made an initial appointment with hospital which at that point I was scheduled for follow up x-rays and examinations. I had never received the flu shot prior, and I had never had any medical issues, on any medication and neither does my family have any history of any medical complications. I exercise 4 to 5 times per week and live and maintain a healthy lifestyle and diet, I do not consume alcohol or smoke. In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Lip swelling, Loss of consciousness, Muscle spasms, Muscular weakness
Clinical narrative: Within a few hours of receiving the vaccination I started to feel dizzy and light headed, my arms and legs also began to feel weak which was accompanied by a severe headache later that evening. The following day my symptoms seemed to have gotten worst I had a fever along with joint pain and muscle spasms by mid afternoon I started to have chest pains and heart palpitations within next few hours my symptoms continued to get worst they were accompanied with swelling of my lips and an even more rapid heartbeat. I remember going upstairs to sit down and before I made it to the couch I had passed out, I do not recall the length of time but by the time I came to the ambulance was at our home. They completed the regular first responders assessment and advised me that If I continue have cheat pain, to feel light headed or weak that I should go to the hospital. I then made an initial appointment with hospital which at that point I was scheduled for follow up x-rays and examinations. I had never received the flu shot prior, and I had never had any medical issues, on any medication and neither does my family have any history of any medical complications. I exercise 4 to 5 times per week and live and maintain a healthy lifestyle and diet, I do not consume alcohol or smoke. In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.