chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was ill; Based on information previously received on 16-Oct-2020, the following information [non-case classification deleted from general tab] has amended.  Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a patient (unknown age and gender) who had ill, while he/she received vaccine INFLUENZA VACCINE. Patient stated that at least she should be able to tell if she got COVID-19.  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 ill (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided, since this is a public post on the Sanofi flu shot campaign The Race for 200M it was assumed that the consumer is 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: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Emotional disorder, Fatigue, Feeling abnormal
Clinical narrative: not feeling well; felt dizzy; Fatigue/quite tired; she was upset that she doe not have energy and is quite tired; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/other non-professional.  This case involves a 66-year-old female patient who was not feeling well (malaise), felt dizzy (dizziness), fatigue/quite tired (fatigue) and was upset that she did not have energy (asthenia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date were not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 02-Oct-2020, the patient was not feeling well (malaise), felt dizzy (dizziness), fatigue/quite tired (fatigue) and was upset that she did not have energy (asthenia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that the patient did not believe in flu vaccines, but she was advised this year to get it due to Coronavirus Disease [COVID]. She did not want the high dose vaccine, due to due to the mercury, formaldehyde and the quadruple whammy of the vaccine. She wanted the regular one only. The dizziness was more when she was lying down and while getting up. When she was moving around she was okay, but she did feel a little spacey. She mentioned the dizziness was more on her right side; the side she got her Fluzone vaccine.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for all the events at the time of report.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: not feeling well; felt dizzy; Fatigue/quite tired; she was upset that she doe not have energy and is quite tired; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/other non-professional.  This case involves a 66-year-old female patient who was not feeling well (malaise), felt dizzy (dizziness), fatigue/quite tired (fatigue) and was upset that she did not have energy (asthenia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date were not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 02-Oct-2020, the patient was not feeling well (malaise), felt dizzy (dizziness), fatigue/quite tired (fatigue) and was upset that she did not have energy (asthenia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that the patient did not believe in flu vaccines, but she was advised this year to get it due to Coronavirus Disease [COVID]. She did not want the high dose vaccine, due to due to the mercury, formaldehyde and the quadruple whammy of the vaccine. She wanted the regular one only. The dizziness was more when she was lying down and while getting up. When she was moving around she was okay, but she did feel a little spacey. She mentioned the dizziness was more on her right side; the side she got her Fluzone vaccine.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for all the events at the time of report.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pruritus
Clinical narrative: Itching/Redness to upper torso
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Basophil percentage, Blood albumin increased, Blood alkaline phosphatase normal, Blood bilirubin decreased, Blood calcium normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity decreased, Blood potassium normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Differential white blood cell count, Eosinophil count normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Eosinophil percentage decreased, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal, Lymphocyte count normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Metabolic function test abnormal, Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pericarditis, Platelet count normal, Protein total normal, Red blood cell count normal, Red cell distribution width normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Troponin T normal, White blood cell count normal
Clinical narrative: Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: PATIENT HAD HIVES ON RIGHT ARM, NECK AND FACE.  PT CONTACTED DR AND TOOK BENADRYL ON 10/27/20. PT TAKING CLARITIN ON 10/28/20.    THE HIVES RESOLVED EXCEPT NEAR HER RIGHT EYE.  THE REDNESS ON ARM AND NECK HAS LESSENED BUT THE SKIN IS STILL ITCHY
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Exercise tolerance decreased, Injection site pain, Injection site swelling
Clinical narrative: The day after the vaccine was given tip of left clavicle was swollen and tender.  could not do workout for eight days.  History of clavicle surgery in 2010 and 22012.  Antibiotics were given first visit to clinic, steroid injection and oral steroids given at second visit on 10.17.20.  On 10/28/20, states that he has been referred to orthopedist.  Pain is no longer felt while at rest.  Continuing to use rest and ice.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PT HAVING BREAK OUTS ON THE BODY SPECIFICALLY 2 SPOTS ON LEFT LEG AND FOREHEAD
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: REDNESS AND TENDERNESS AT SITE
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Nasal congestion, Vomiting
Clinical narrative: PATIENT REPORTED SHE HAD A 100.6 TEMP 4 HOURS AFTER VACCINATION, SHE ALSO STATED SHE THREW UP AND WAS CONGESTED. NO TREATMENT WAS SOUGHT BUT ALL SYMPTOMS WERE RESOLVED WITHIN 24 HOURS.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient reported extensive bruising with vaccination and wanted it documented.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, muscle aches, fatigue, nausea, fever of 99.8. Resolved by evening of Oct 27. Took Tylenol to help with aches and fever.
Age: 57.0
Sex: M
Vaccine: FLUA4
Symptoms: Bursitis, Injection site pain, Injection site reaction, Muscle strain
Clinical narrative: Patient had a pain at the site of injection . Had to go to Dr ( PCP) who prescribed him Prednisone tab to resolve that , what MD suspected was bursitis caused by the needle. Followed up with patient second time today 10/28 . He said he has no pain and Presnisone worked. When I spoke to clinical nurse on 10/26/20 , she said that it was not allergic reaction but probably muscular tear caused by needle , leading to bursitis.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenopia, Erythema of eyelid, Eyelid pain, Headache, Swelling of eyelid
Clinical narrative: Noticed swollen, heavy, red eyelid on left eye  accompanied by a headache within 6 hours of receiving vaccine. Took one tablet (recommended dosage) of Benadryl 30 minutes later. Swelling, pain, headache, and redness had all decreased within 12 hours, at which point I took another Benadryl tablet for good measure. 27 hours after the vaccination, symptoms seem to have subsided.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Swelling
Clinical narrative: On 9/17/2020 the patient called and said she was having swelling and Rt shoulder pain down to her wrist after her shot was given on 9/16/2020.. the Clinical manager spoke with her after speaking with the doctor and told her to use heat or ice for the swelling and tylenol or advil for the pain. Patient called back 9/22/2020  and said she was fine and the pain and swelling where gone.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No adverse event; patient received his first GARDASIL 9 vaccine on 10 JAN 2019 and his second one on 14 OCT 2020. He was on the two dose series.; This spontaneous report was received from a nurse practitioner, referring to a 13 year old male patient.  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 10-JAN-2019, he received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml lot# 1621929, expiration date: 06-DEC-2021 for prophylaxis. On 14-OCT-2020, the patient received the second dose. He was on the two dose series. However, no adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: PROQUAD given to a 14 years old.; This spontaneous report was received from a consumer and refers to a 14-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, at age of 14-year-old, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml (lot #, expiration date, route and site of administration were not provided) for prophylaxis (Inappropriate age at vaccine administration).
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Disturbance in attention, Drug ineffective, Pain in extremity, Sleep disorder
Clinical narrative: arm pain is vomit induding / The pain is so overwhelming; It constantly feels like my elbow and arm is being hammered on by a mallet.; I can't sleep; I can't concentrate; I can't think straight; drug ineffective; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen unknown for pain.   On 7th October 2020, the patient received Shingrix. In October 2020, the patient started ibuprofen at an unknown dose and frequency. In October 2020, less than 2 weeks after receiving Shingrix and not applicable after starting ibuprofen, the patient experienced pain in arm, pain in elbow, sleep disturbance, concentration loss, abnormal thinking and drug ineffective. The patient was treated with ibuprofen, paracetamol (Tylenol), non-drug therapy (Ice Pack (No Medication)) and non-drug therapy (Hot Compresses). The action taken with ibuprofen was unknown. On an unknown date, the outcome of the pain in arm, pain in elbow, sleep disturbance, concentration loss, abnormal thinking and drug ineffective were unknown.   It was unknown if the reporter considered the pain in arm, pain in elbow, sleep disturbance, concentration loss and abnormal thinking to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The arm pain was vomit inducing. It constantly feels like elbow and arm was being hammered on by a mallet.  The patient cannot think straight, cannot sleep, cannot concentrate.  The pain was so overwhelming. The patient taken tylenol, ibuprofen, oil, rubbed oil on my arm, taken gummies, and have taken other pain medication. Nothing has helped.  The patient has iced to the arm, put heat on it, wrapped it, did some stretching, rested it nothing has even begun to this pain. The patient has been going through this pain for over 10 days. This side effect was so painful, so sad.
Sex: F
Vaccine: VARZOS
Symptoms: Thinking abnormal
Clinical narrative: arm pain is vomit induding / The pain is so overwhelming; It constantly feels like my elbow and arm is being hammered on by a mallet.; I can't sleep; I can't concentrate; I can't think straight; drug ineffective; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen unknown for pain.   On 7th October 2020, the patient received Shingrix. In October 2020, the patient started ibuprofen at an unknown dose and frequency. In October 2020, less than 2 weeks after receiving Shingrix and not applicable after starting ibuprofen, the patient experienced pain in arm, pain in elbow, sleep disturbance, concentration loss, abnormal thinking and drug ineffective. The patient was treated with ibuprofen, paracetamol (Tylenol), non-drug therapy (Ice Pack (No Medication)) and non-drug therapy (Hot Compresses). The action taken with ibuprofen was unknown. On an unknown date, the outcome of the pain in arm, pain in elbow, sleep disturbance, concentration loss, abnormal thinking and drug ineffective were unknown.   It was unknown if the reporter considered the pain in arm, pain in elbow, sleep disturbance, concentration loss and abnormal thinking to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The arm pain was vomit inducing. It constantly feels like elbow and arm was being hammered on by a mallet.  The patient cannot think straight, cannot sleep, cannot concentrate.  The pain was so overwhelming. The patient taken tylenol, ibuprofen, oil, rubbed oil on my arm, taken gummies, and have taken other pain medication. Nothing has helped.  The patient has iced to the arm, put heat on it, wrapped it, did some stretching, rested it nothing has even begun to this pain. The patient has been going through this pain for over 10 days. This side effect was so painful, so sad.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received his first Shingrix vaccination in his left arm approximately two months before the date of reporting and experienced redness and soreness at the injection site. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020211996.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211996:same reporter, 2nd dose
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: redness at the injection site; soreness, pain at the injection site; terrible pain beyond my leg/terrible pain behind the knee that went down to her foot\Soreness; PAIN BEHIND KNEE; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020 12:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2020 05:00, 5 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site pain, leg pain and knee pain. The patient was treated with non-drug therapy (Hot Compresses). On 12th October 2020, the outcome of the injection site erythema, injection site pain, leg pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, leg pain and knee pain to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine around noon. At 5 pm after vaccination, the patient experienced terrible pain behind the knee that went down to her foot it lasted for a couple of days.  She also reports experiencing soreness, pain and redness at the injection site. All symptoms became mild and resolved on 12th October 2020. The patient used hot pot, EMU machine and massages to help relieve the symptoms.  The patient states health care professional did not know about the event but was told by patient's daughter to report it. The patient was due for the 2nd dose in December and plans on getting it.  The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: FLUR4, PNC13, TDAP, FLUR4, PNC13, TDAP
Symptoms: Chills, Erythema, Induration, Limb mass, Pain
Clinical narrative: Cellulitis; Fever; Body aches; Chills; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; have very sore arms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: DF1306, NDC number: 0005-1971-02, Expiry Date: 31Aug2022), via an unspecified route of administration on 14Oct2020 at 0.5 ml, single in left deltoid for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL, manufacturer: Sanofi, lot number: U6807BB, NDC number: 49281-400-20, Expiry Date: 10Sep2022) via an unspecified route of administration on 14Oct2020 in right deltoid at unknown dose for immunization, influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT, manufacturer: Sanofi, lot number: UJ497AA, NDC number: 49281-720-10, Expiry Date: 03May2021), via an unspecified route of administration on 14Oct2020 at 0.5 ml in left deltoid for immunization. Medical history included inflammatory arthritis, inflammatory bowel disease, arthritis, nasal allergy/nasal drip allergy, and anxiety. Concomitant medication included loratadine for nasal allergy, sertraline hcl for anxiety, tofacitinib citrate (XELJANZ), methotrexate, folic acid, celecoxib (CELEBREX) for arthritis. Patient received other concomitant therapy. Patient had 3 vaccines on this past Wednesday in Oct2020, and proceeded to get what may be cellulitis and patient was not self-diagnosing herself but she had fever and body aches and chills and had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading. So, she marked off her arm with a sharpie and at present it was starting to get better. She marked it because it was just not looking good and then she woke up this morning and then the fever broke, she felt tremendously better than she did the night before, but still had very sore arms. She had what was no longer a golf ball size, may be just, actually it was probably still a golf ball sized lump in her right arm and two smaller lumps in her left arm. Those seemed to be doing fine other than mild to touch, soreness but the right arm just completely went, that was the wrong one. The left arm went down significantly but the right arm still had a pretty good sized hard lump. No treatment received in response to adverse events. The outcome of fever was recovered on 16Oct2020, outcome of the other events was unknown.
Age: 50.0
Sex: F
Vaccine: FLUR4, PNC13, TDAP, FLUR4, PNC13, TDAP
Symptoms: Pain in extremity, Pyrexia, Skin warm, Tenderness
Clinical narrative: Cellulitis; Fever; Body aches; Chills; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; have very sore arms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: DF1306, NDC number: 0005-1971-02, Expiry Date: 31Aug2022), via an unspecified route of administration on 14Oct2020 at 0.5 ml, single in left deltoid for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL, manufacturer: Sanofi, lot number: U6807BB, NDC number: 49281-400-20, Expiry Date: 10Sep2022) via an unspecified route of administration on 14Oct2020 in right deltoid at unknown dose for immunization, influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT, manufacturer: Sanofi, lot number: UJ497AA, NDC number: 49281-720-10, Expiry Date: 03May2021), via an unspecified route of administration on 14Oct2020 at 0.5 ml in left deltoid for immunization. Medical history included inflammatory arthritis, inflammatory bowel disease, arthritis, nasal allergy/nasal drip allergy, and anxiety. Concomitant medication included loratadine for nasal allergy, sertraline hcl for anxiety, tofacitinib citrate (XELJANZ), methotrexate, folic acid, celecoxib (CELEBREX) for arthritis. Patient received other concomitant therapy. Patient had 3 vaccines on this past Wednesday in Oct2020, and proceeded to get what may be cellulitis and patient was not self-diagnosing herself but she had fever and body aches and chills and had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading. So, she marked off her arm with a sharpie and at present it was starting to get better. She marked it because it was just not looking good and then she woke up this morning and then the fever broke, she felt tremendously better than she did the night before, but still had very sore arms. She had what was no longer a golf ball size, may be just, actually it was probably still a golf ball sized lump in her right arm and two smaller lumps in her left arm. Those seemed to be doing fine other than mild to touch, soreness but the right arm just completely went, that was the wrong one. The left arm went down significantly but the right arm still had a pretty good sized hard lump. No treatment received in response to adverse events. The outcome of fever was recovered on 16Oct2020, outcome of the other events was unknown.
Age: 50.0
Sex: F
Vaccine: FLUR4, PNC13, TDAP, FLUR4, PNC13, TDAP
Symptoms: Cellulitis, Chills, Erythema, Limb mass, Pain
Clinical narrative: Cellulitis; Fever; Body aches; Chills; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; have very sore arms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: DF1306, NDC number: 0005-1971-02, Expiry Date: 31Aug2022), via an unspecified route of administration on 14Oct2020 at 0.5 ml, single in left deltoid for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL, manufacturer: Sanofi, lot number: U6807BB, NDC number: 49281-400-20, Expiry Date: 10Sep2022) via an unspecified route of administration on 14Oct2020 in right deltoid at unknown dose for immunization, influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT, manufacturer: Sanofi, lot number: UJ497AA, NDC number: 49281-720-10, Expiry Date: 03May2021), via an unspecified route of administration on 14Oct2020 at 0.5 ml in left deltoid for immunization. Medical history included inflammatory arthritis, inflammatory bowel disease, arthritis, nasal allergy/nasal drip allergy, and anxiety. Concomitant medication included loratadine for nasal allergy, sertraline hcl for anxiety, tofacitinib citrate (XELJANZ), methotrexate, folic acid, celecoxib (CELEBREX) for arthritis. Patient received other concomitant therapy. Patient had 3 vaccines on this past Wednesday in Oct2020, and proceeded to get what may be cellulitis and patient was not self-diagnosing herself but she had fever and body aches and chills and had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading. So, she marked off her arm with a sharpie and at present it was starting to get better. She marked it because it was just not looking good and then she woke up this morning and then the fever broke, she felt tremendously better than she did the night before, but still had very sore arms. She had what was no longer a golf ball size, may be just, actually it was probably still a golf ball sized lump in her right arm and two smaller lumps in her left arm. Those seemed to be doing fine other than mild to touch, soreness but the right arm just completely went, that was the wrong one. The left arm went down significantly but the right arm still had a pretty good sized hard lump. No treatment received in response to adverse events. The outcome of fever was recovered on 16Oct2020, outcome of the other events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Inflammation
Clinical narrative: isolated inflammatory response; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.    This patient of unspecified age and gender received (yesterday)pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose in the left arm in Oct2020 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced isolated inflammatory response in Oct2020 with outcome of unknown. It resulted in an emergency room visit, day off of work and taking meds to control the symptoms experienced.  No follow-up attempts are needed. Information about lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site pain
Clinical narrative: headache and pain at injection site; headache and pain at injection site; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative.  A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and pain at injection site on an unspecified date with outcome of recovered.  No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza, Pneumonia, Sepsis
Clinical narrative: flu; pneumonia; sepsis; Initial information received on 24-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case is linked to cases 2020SA302174 (same reporter).  This case involves a patient (unknown demographics) who experienced flu (influenza), pneumonia and sepsis, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE (reported as It was 90 days of misery).  On an unknown date, the patient developed a serious pneumonia and sepsis unknown latency following the administration of INFLUENZA VACCINE (reported as It was 90 days of misery). Both the event was assessed as medically significant   All the events were leading to death.  Case details: Patient got the shot and the downhill trend.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  It is unknown if an autopsy was done.   The causes of death were reported as influenza, pneumonia and sepsis.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who died due to influenza, pneumonia and sepsis after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: flu; pneumonia; sepsis
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 month old male patient received a expired dose of Pentacel, no AE.; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four month old male patient who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PALIVIZUMAB (SYNAGIS).  On 14-Oct-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ061AA, U6137AA and expiry date: 04-Oct-2020, 04-Oct-2020) via an intramuscular route at an unknown administration site (reported left) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: 63-year-old female patient was given DAPTACEL instead of ADACEL, no AE; 63-year-old female patient was given DAPTACEL, no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 63 year old female patient who received 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], (Wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 14-Oct-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date: 10-Jun-2021) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Gait disturbance, Pyrexia
Clinical narrative: shivers, feverish, left leg adversely affected (trouble walking)
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Injection site streaking
Clinical narrative: Starting the day after the injection, the patient noticed an expanding rash around the injection site and streaking towards her axilla. The rash was approximately 2 " in diameter at its max, the streaking was about 2" beyond that. The rash started resolving in about 24 hours.
Age: 29.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Oedema, Pyrexia
Clinical narrative: Fever, redness, edema, cellulitis. Treated with clindamycin, daptomycin, lancing and packing. Symptoms improved in about a week.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: pt had rash on both arms
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Patient experienced facial swelling and tingling approximately 8 hours after receiving the vaccine.  The symptoms were resolved on 16 October 2020 (two days later).
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: She called me this morning and said she started feeling muscle soreness the night of the immunization. She says both of her arms are hurting and below her buttocks. She takes some Advil and the soreness does away enough for her to perform her daily activities but the pain comes back. I asked her to follow up with her primary care in case it was related to her statin.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Chest pain, Chills, Myalgia
Clinical narrative: first night after fever, chills, aching muscles, etc. second night after extreme pain in lower right back, position sensitive, some pain with deep breaths third day and night developed cough, still aching muscles, still some pain with deep breaths, lower right back pain improving. having sharp central chest pain when trying to sleep on left side, can't lay on left side. present 7th day, still have productive cough, still feel weak and achy, still can not lay down on left side with out causing sharp pain in central chest area.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Painful respiration, Productive cough, Pyrexia, Sleep disorder
Clinical narrative: first night after fever, chills, aching muscles, etc. second night after extreme pain in lower right back, position sensitive, some pain with deep breaths third day and night developed cough, still aching muscles, still some pain with deep breaths, lower right back pain improving. having sharp central chest pain when trying to sleep on left side, can't lay on left side. present 7th day, still have productive cough, still feel weak and achy, still can not lay down on left side with out causing sharp pain in central chest area.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Starting within an hour of vaccination, I had major soreness in upper arm and had difficulty lifting arm.  This is normal for me for the 2 days after vaccination but my pain is still consistent on 10/28 - 18 days after the injection.  Pain moving, pushing, pulling, lifting, twisting across upper arm directly below tip of shoulder bone that affects everything I do.  I tried taking the NP recommended does of 600mg 3x a day of ibuprofen for 5 days and did not feel any change besides a slight dulling of the pain.  Today, 10/28, I began the NP prescribed Prednisone which I will take for 5 days.  I had no pain before this injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Syncope
Clinical narrative: Patient reported feeling tired and dizzy this morning. She reported that she took her temperature and it was 99 degrees Fahrenheit. She reports that she fainted this morning, but is feeling better now. She reports that symptoms have improved. Advised patient to make her primary care physician aware. Will continue to monitor. Advised patient to call us back with additional questions or if symptoms persist.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Laboratory test, Petechiae, Purpura
Clinical narrative: 24 hours after his vaccination, patient had two patches of petechiae and purpura on his anterior thighs. His CBC, CMP, and sed rate were normal. There is no history of trauma. He is well with no other symptoms. No prior similar reactions or rashes.   While I haven't seen this type of non-ITP associated rash before, he is completely well and because of the timing of his flu shot, thought I should make the report.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Pyrexia, Tremor
Clinical narrative: VERY COLD WITH SHAKING FOR ABOUT TWENTY MINUTES.  FEVER AT 100.1 WHICH WAS GONE BY MORNING. THE NEXT NIGHT FEVER AT 99.1 NO OTHER PROBLEMS
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: The patient started with a rash on her torso, abdomen, legs and arms. Her mother will just monitor her symptoms.
Age: 37.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Migraine, Visual impairment
Clinical narrative: Developed an ocular migraine which lasted for 15 minutes.  I have never had one before in my life, but I saw a vibrating line of colors in the right side of my vision which persisted with either eye closed.  My sister had had one of these before and described it, so I knew what to search for, and the illustrations I saw online matched what I experienced.  I use a computer for my work and was unable to see the keys I had entered as I typed them.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Headache, Injection site discomfort, Myalgia
Clinical narrative: Soreness on sight, muscle aches,headache and chills into fever. Next day, today, dizzy.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Soreness on sight, muscle aches,headache and chills into fever. Next day, today, dizzy.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash, Rash macular, Skin warm
Clinical narrative: received vaccine as usual. One hour later I began to itch. 3-4 hours later I noticed significant itching, splotchy rashes over body, heat, and incremental growth of rash as time progressed. By midnight I was covered top of feet to scalp, sans toe/fingernails, genitals, and mouth. Horrible itchy and slight heat remains however now not as red. Used Hydrocortizone 2%, Gold Bond eczema cream, and absorbine Jr. No history of allergies, so did not have any related meds in home. No respiratory issues. Site never red or warm. I have pictures documenting some of the past 24 hrs.   Fluzone UT7081KA, expires 6/30/2021, L deltoid <-- yesterday's flu shot information provided by occupational health at saint Mary's regional medical center employee
Sex: F
Vaccine: UNK
Symptoms: Cardiac flutter, Injection site pain, Injection site pruritus, Muscle tightness, Pruritus
Clinical narrative: Received Flu shot. Few hours after shot started having hives, itching, tightness in back. heart fluttering and left arm pain. Still itching from shot inside and out .
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Received Flu shot. Few hours after shot started having hives, itching, tightness in back. heart fluttering and left arm pain. Still itching from shot inside and out .
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a local reaction to the Kinrix. He had a red swollen, warm area around the injection site. He was instructed to use a cold compress.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Hypoaesthesia oral, Mouth swelling, Paraesthesia, Swelling
Clinical narrative: event -extensive swelling limited to face - down to neck, mouth and tongue numbness, warm and tingly, increased bp  treatment - Benadryl once daily, steroids twice daily for 1 week outcome - 100% improvement (took 3-4 days)
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: event -extensive swelling limited to face - down to neck, mouth and tongue numbness, warm and tingly, increased bp  treatment - Benadryl once daily, steroids twice daily for 1 week outcome - 100% improvement (took 3-4 days)
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness and severe headache
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Limb discomfort, Nasal congestion
Clinical narrative: Sore left arm still 3 days later.  Swollen eyes (especially left eye) and congestion.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient states that 4 to 5 days after receiving his vaccine he developed a painful spot on the right side of his back, Today he is calling stating that this has now developed into a rash and is very painful. The rash goes in a line across the right side of his back from where the painful point began, Patient is contacting his provider to seek treatment for rash/SE.
Age: 68.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Skin infection
Clinical narrative: Patient claims shot was given in the fatty tissue which caused a skin infection and a hospitalization.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood test abnormal, Chills, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: The patient stated that 12 hours after the flu shot she started getting a fever. The fever then continued for 11 days. During their time she also experience vomiting, headaches, shakinen, chills and the fever ran 99 to 102.4. Her doctor gave her a COVID 19 test it came back negative. Blood test showed SA elevated numbers.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Tremor, Vomiting
Clinical narrative: The patient stated that 12 hours after the flu shot she started getting a fever. The fever then continued for 11 days. During their time she also experience vomiting, headaches, shakinen, chills and the fever ran 99 to 102.4. Her doctor gave her a COVID 19 test it came back negative. Blood test showed SA elevated numbers.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Immediate post-injection reaction, Swelling
Clinical narrative: Swelling immediately, vaccine "travelled" lower in arm. Probably Not IM but SQ Treated for infection & allergic RXN for 3cm erythemous swelling which began quickly