chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Death, Paralysis
Clinical narrative: paralysis; Initial information was received on 10-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer/ non-healthcare professional via public post on the Sanofi flu shot campaign via social media.  This case involves two patients of an unknown demographics who suffered with paralysis, when they received INFLUENZA VACCINE.  The patients medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients suffered with serious paralysis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Case details: Reporter did not provided the product name, but since this was a public post on the Sanofi flu shot campaign, the Race for 200M it was assumed that the consumer was referring to the Sanofi flu vaccine. Reporter Commented that does company ever heard of French polio, one of the side effects of the flu shots, he/she  know of two people that got it and suffered paralysis and death. Wake up sheep.  Details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment (before death).  It was unknown if an autopsy was done. The cause of death was captured as paralysis.  Information on the batch number was requested.; Sender's Comments: A case was reported from Social Media, which involves two patients of unknown demographics who suffered with paralysis and death following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data and autopsy results are needed for complete assessment of the case. Based upon the reported information the role of the suspect product cannot be assessed. Missing data needed for further assessment of the case.; Reported Cause(s) of Death: paralysis
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient only received ACT-HIB portion and missed diluent (Dtap/IPV) portion of Pentacel/No AE; Initial information was received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.   This case involves a 3 years-old male patient who received only ACT-HIB portion and missed diluent (DTAP/IPV) [diphtheria, tetanus, acellular pertussis / Poliomyelitis vaccine(Inactivated)] portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: unknown, dosing details: fourth dose and expiry date 23-Apr-2021) via intramuscular route in the left deltoid on 09-Sep-2020 for prophylactic vaccination (product preparation issue).  For ACT-HIB vial batch number and expiry date was reported (lot UJ229AA and expiry date 21-Apr-2023) and not reported for DTaP/IPV portion.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to inappropriate reconstitution technique (latency was on same day).  It was also reported that they wanted to purchase the diluent or 0.4 percent NaCl (Sodium chloride) to mix with the powder that is left of the Pentacel dose and diluent in the Pentacel was the Dtap/IPV portion.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given Fluzone Quadrivalent instead of Fluzone High dose Quadrivalent, no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a male patient (age above 65 years old) who was vaccinated with a once dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 28-Sep-2020 for prophylactic vaccination (batch number and other dosing details were not reported).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to wrong vaccine administered (latency was same day).  The reporter wanted to know that how long they need to wait before administering the FLUZONE HIGH-DOSE QUADRIVALENT and if there are any adverse events to be aware of.  No adverse event reported to the patient 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.  There will be no information available on the batch number for this case.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Fibromyalgia, Injection site pain, Injection site swelling
Clinical narrative: had swelling, aching and intense burning on arm from the flu shot; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient).  This case involves a 76 years old female patient who was diagnosed with fibromyalgia with the symptom had swelling, aching and intense burning on arm from the flu shot (vaccination site inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patients medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On 29-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in the right deltoid for prophylactic vaccination.  On 30-Sep-2020, the patient diagnosed with a non-serious with fibromyalgia with the symptom had swelling, aching and intense burning on arm from the flu shot (vaccination site inflammation) one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details: Caller stated that she had the flu shot yesterday and she had swelling, aching and intense burning and has been using ice on and off consistently and states it scared her because she has never had this reaction. States her husband went at the same time and did not have any problems. Reporter contacted a pharmacist from another drug store who told her the burning may be the Fluad but caller looked on information and she did receive the Fluzone High Dose but no lot number was available. She stated that since she has been diagnosed with Fibromyalgia she has had to ice her arm for two weeks due to swelling from the flu shot.  Details of laboratory data were not reported.  Ice was used on and off consistently as a corrective treatment.  The outcome was unknown for the events of fibromyalgia and vaccination site inflammation.  There will be no information available on the batch number for this case
Age: 6.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 6 years old patient received FLUBLOK vaccine/No AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] pre-filled syringe (lot: UJ446AA, expiry date: 18-Mar-2021), via intramuscular route in left deltoid on 30-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was case of an actual medication error due to the inappropriate age at vaccine administration (latency same day).  It was reported that that a 6 year old received Flublok Quadrivalent which was not intended and the reporter wants to know if correct Fluzone Quadrivalent can still be given and if so then how long if at all time to wait before.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 year old patient was given FluBlok, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 year old patient (unknown gender) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  At the time of report no adverse event was reported.  Reporter called to ask if there were any warnings against giving FLUBLOK to patient under 18.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patients had been given the only the liquid component of the Pentacel vaccine with no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 6-month-old male patient who was given 0.5ml of the liquid component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6629AA and expiration date:02-May-2021) via unknown route in the left thigh for prophylactic vaccination on 28-Sep-2020 (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE 13V ; ROTAVIRUS VACCINE and INFLUENZA VACCINE for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency), as the only the liquid component of the Pentacel vaccine was given and not the powder part.  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: 11.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 11-years-old patient was inadvertently administered Flublok Quadrivalent/No AE; a 11-years-old patient was inadvertently administered Flublok Quadrivalent rather than Fluzone Quadrivalent/no AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA273042. (same reporter/15-years-old female patient)  This case involves a 11-years-old female patient who was inadvertently received a 0.5 mL suspect of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [prefilled syringe, lot number: UJ446AA and expiry date: 18-Mar-2021] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via an unknown route at an unknown administration site, on 01-Oct-2020, for prophylactic vaccination (product administered to patient of inappropriate age and wrong product administered). (Latency: at the same time of vaccination)  Medical history, medical treatment, vaccination and family history were not provided.  It was reported that, patient received no other vaccine as concomitant medication.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  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: 68.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Fluzone Quadrivalent and was supposed to get Fluzone High -Dose; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 68 year old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and was supposed to get INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 02-Oct-2020 (wrong product administered)  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 02-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered.(Latency: at the same time of vaccination).   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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dermatitis, Dizziness, Fall, Migraine
Clinical narrative: fell from the fainting; dizziness; headache which turned into a migraine; Nerve burning; itch; dermatitis; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a 62-years-old female patient who fell from the fainting (syncope), itch (pruritus), nerve burning (neuralgia), dermatitis, headache which turned into a migraine (migraine), dizziness, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's ongoing medical history included autoimmune disorder with small fiber neuropathy and skin irritation with two layers of the skin trying to destroy each other that causes irritation on the top of her skin.  The patient's past medical treatment, vaccination and family history were not provided.  On 28-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via unknown route in the left arm for prophylactic vaccination.  Concomitant medications included PREDNISONE (10 mg every day and has returned to the 10 mg dose after taking the 30 mg the day and symptoms were the worse), DUPILUMAB (DUPIXENT); HEPATITIS B VACCINE, HEPATITIS A VACCINE and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination on 02-Oct-2020.  On an unknown date, the patient developed a serious fainting (syncope) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  In Oct-2020, the patient developed a non-serious itch (pruritus), nerve burning (neuralgia), dermatitis, headache which turned into a migraine (migraine) (5 to 6 hours after DUPIXENT), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious dizziness unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The intensity of events itch, dermatitis and nerve burning was severe.  Laboratory details were not reported. e It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  Batch number has been requested for suspect product for this case.; Sender's Comments: A 62-years-old female patient who presented with syncope, pruritus, neuralgia, dermatitis, headache progressing to migraine, and dizziness following the vaccination with FLUZONE QUADRIVALENT. Time to onset is not known for syncope and compatible for other events. Medical history include small fiber neuropathy and skin irritation. Patient also had ongoing autoimmune disorder. Concomitant medication include PREDNISONE (symptoms were the worse after triple dose), DUPIXENT, HEPATITIS B VACCINE, HEPATITIS A VACCINE and SHINGRIX. Precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pruritus, Syncope
Clinical narrative: fell from the fainting; dizziness; headache which turned into a migraine; Nerve burning; itch; dermatitis; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a 62-years-old female patient who fell from the fainting (syncope), itch (pruritus), nerve burning (neuralgia), dermatitis, headache which turned into a migraine (migraine), dizziness, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's ongoing medical history included autoimmune disorder with small fiber neuropathy and skin irritation with two layers of the skin trying to destroy each other that causes irritation on the top of her skin.  The patient's past medical treatment, vaccination and family history were not provided.  On 28-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via unknown route in the left arm for prophylactic vaccination.  Concomitant medications included PREDNISONE (10 mg every day and has returned to the 10 mg dose after taking the 30 mg the day and symptoms were the worse), DUPILUMAB (DUPIXENT); HEPATITIS B VACCINE, HEPATITIS A VACCINE and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination on 02-Oct-2020.  On an unknown date, the patient developed a serious fainting (syncope) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  In Oct-2020, the patient developed a non-serious itch (pruritus), nerve burning (neuralgia), dermatitis, headache which turned into a migraine (migraine) (5 to 6 hours after DUPIXENT), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious dizziness unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The intensity of events itch, dermatitis and nerve burning was severe.  Laboratory details were not reported. e It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  Batch number has been requested for suspect product for this case.; Sender's Comments: A 62-years-old female patient who presented with syncope, pruritus, neuralgia, dermatitis, headache progressing to migraine, and dizziness following the vaccination with FLUZONE QUADRIVALENT. Time to onset is not known for syncope and compatible for other events. Medical history include small fiber neuropathy and skin irritation. Patient also had ongoing autoimmune disorder. Concomitant medication include PREDNISONE (symptoms were the worse after triple dose), DUPIXENT, HEPATITIS B VACCINE, HEPATITIS A VACCINE and SHINGRIX. Precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme swelling, painful, vruised, very red on his arm. I have pictures if necessary
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to site the same day of vaccine. Site continue to remain red and swelling three days after vaccine with redness and swelling spreading.  Mother giving child Tylenol and motrin. Child has follow up visit.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, Epilepsy, Laboratory test, Magnetic resonance imaging
Clinical narrative: patient had  new onset intractable seizures 11 days after administration
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: I told nurse I am allergic to neomycin. She said i would get preservative-free version. 11 days after the shot, i woke up unable to lift my arm higher than a few inches. Gives me a painful twinge when I try to use/lift my arm. This has happened to me before. When I reported it, I learned that my neomycin allergy was worth noting next time. Which I did.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Injection site pain, Lethargy
Clinical narrative: lethargy, head ache, soreness at site of infection
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Tired, mild fever, bad shivering/shakes, headache, body aches
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal, Product administered at inappropriate site
Clinical narrative: patient experienced pain in right shoulder and could not lift right arm above elbow
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Seasonal influenza vaccine administered to left shoulder resulting in moderately severe myalgia and limited ROM of the arm, worsening x2 days.  Unknown type of influenza vaccine, chose random one from the list in item 17 out of necessity.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT WAS ADMINISTERED MENVEO INSTEAD OF BEXSERO. PATIENT HAD NO REACTION, SHE WAS NOTIFIED IMMEDIATELY AND SHE WILL RETUN TO OFFICE TO GET RIGHT VACCINE.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group of patient was not provided but captured as adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix on past Monday afternoon of reporting day. After vaccination patient had soreness.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Friend that is a doctor indicated it was "cellulites"; Red mark / From the band aid where the vaccine was injected up her arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site cellulitis and injection site erythema. On an unknown date, the outcome of the injection site cellulitis and injection site erythema were unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The healthcare professional reported that 2 days after a Shingrix vaccine was administered to a patient there was a red mark extending from the band aid where the vaccine was injected up her arm.   The patient indicated physician stated that it was cellulites. They thought the patient got cellulites from the injection. The  healthcare professional wondering if this was a side effect that was like that, or part of a reaction of an infection?  No additional information could be collected from HCP.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Extreme fatigue; Muscle and joint pain; Joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 22nd March 2020) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd September 2020, 1 days after receiving Shingrix, the patient experienced fatigue, muscle pain and joint pain. On an unknown date, the outcome of the fatigue, muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the arm. The patient reported extreme fatigue, muscle and joint pain starting the day after receiving first dose. This was not resolved and continued to be bothersome. The patient was suggested to follow up with her health care provider. The reporter did not consent to follow up. No MD information was provided
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The batch number was updated from 57EX3 to 57EX2, as per sales data sheet. The patient received Shingrix and experienced pain at the injection site, it had been almost a month and the patient has not recovered The reporter consented to follow up. The HCP mentioned that patient would not be receiving dose 2 of the Shingrix due to adverse events after dose 1.  This AE was reported previously.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202988:FU1 deleted
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Incomplete course of vaccination, Pulmonary mycosis
Clinical narrative: episode of episode of lung fungal infection after the administration of the first dose of shingrix; was administered first dose of Shingrix on August 2018 / second dose was not yet administered; This case was reported by a pharmacist via call center representative and described the occurrence of pulmonary mycosis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pulmonary mycosis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pulmonary mycosis (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the pulmonary mycosis and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pulmonary mycosis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for 1st dose of vaccine. The age at vaccination was not applicable for 2nd dose of vaccine. This patient had a history of lung fungal infections. The patient had an episode of lung fungal infection after the administration of the first dose of Shingrix. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter gave consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: felt miserable for several days after; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media .  This case involves a 70 year old patient (unknown gender) who experienced felt miserable for several days (feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious felt miserable for several days (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Mom describes the under the injection site there was a huge hive or a whelt (1 inch). The site was also red.  Mom does not know when the reaction started until later in the evening when the child showed mom his arm.   Mom gave patient Benadryl and monitored the child.  Pt is doing better but arm is not completely clear yet.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Nausea, Tremor, Vomiting
Clinical narrative: Patient was shaky and vomited, felt nausea, temperature 99.1
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: 10/15/2020  At approximately 1000 Fluarix influenza vaccine was administered to the client during a mobile clinic at the Agency. It was explained to the nurse that the patient fainted but did not fall. He was place in a chair and the nurse was called summoned. Upon examination he was alert and oriented to self, time, and place; lips were pale; pulse regular, grade +2. He did not feel hot to the touch. He denied any pain or nausea. He was given one can of apple juice to drink. He stated he had eaten breakfast before coming to the clinic. After several minutes of monitoring, he denied any nausea and stated he was feeling slightly better, however his lip continued to be pale. He had a general appearance of not being well and RN felt he should be seen by a provider. He was carried by his mother to the clinic housed in the medical building. RN explained to the provider the events as they occurred and actions taken. Concern was also expressed about patient's continued appearance of ill health and this was the rationale for seeking additional evaluation. The provider agreed and accepted care.  At approximately 1445 patient's mother presented again to the mobile clinic with the patient. She stated she had taken the patient home after being evaluated in the clinic and had since vomited twice. she was concerned it was related to the influenza vaccine. When questioned the patient stated to the RN he was feeling better but did complain of a headache. Again, he was not hot to the touch but continued to look in ill health. It was strongly recommended to the mother that she take him to either an urgent care facility or Emergency Department for further evaluation as he was exhibiting headache, nausea and vomiting.  10/16/2020  @ 0810 - Spoke with mother to retrieve additional health information about the patient to complete the VAERS documentation. She states patient is much better today.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Fever of 99.3, felt shaky and nauseous
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Patient received flu-shot on 10/15/20 in the afternoon given by employee health staff while at work. Two hours after the administration, patient started feeling a burning and pin-prick sensation over the L deltoid region where she had received the shot but she did not examine it. Seven hours after administration that same day, she changed her clothes to take a shower and noticed the erythema and blisters to the region of the vaccine administration. She later had to put an ice-pack over it for comfort. The appearance of the skin lesions remains unchanged the next morning 10/16/20 when she presented to employee health clinic. In clinic, the exam of the L deltoid region showed 3 non-contiguous areas of erythema/purpura/edema, with the largest area measuring 9 cm X 3 cm. This largest area of erythema also has two overlying clear fluid-filled bullas, with the larger bulla measuring 4 cm X 2.2 cm and the smaller bulla measuring 1 cm X 1 cm.  Patient reports sensation of burning and pin-prick pain overlying the affected skin region that is worse with touch. Denies any shortness or breath or any other symptoms.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles, Paraesthesia, Purpura
Clinical narrative: Patient received flu-shot on 10/15/20 in the afternoon given by employee health staff while at work. Two hours after the administration, patient started feeling a burning and pin-prick sensation over the L deltoid region where she had received the shot but she did not examine it. Seven hours after administration that same day, she changed her clothes to take a shower and noticed the erythema and blisters to the region of the vaccine administration. She later had to put an ice-pack over it for comfort. The appearance of the skin lesions remains unchanged the next morning 10/16/20 when she presented to employee health clinic. In clinic, the exam of the L deltoid region showed 3 non-contiguous areas of erythema/purpura/edema, with the largest area measuring 9 cm X 3 cm. This largest area of erythema also has two overlying clear fluid-filled bullas, with the larger bulla measuring 4 cm X 2.2 cm and the smaller bulla measuring 1 cm X 1 cm.  Patient reports sensation of burning and pin-prick pain overlying the affected skin region that is worse with touch. Denies any shortness or breath or any other symptoms.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Seizure
Clinical narrative: Patient says she has a seizure that same day
Age: 32.0
Sex: F
Vaccine: FLU4, HEPA, HEPA, TDAP
Symptoms: Underdose
Clinical narrative: Gave 2 pediatric doses of Hepatitis A, instead of 1 adult dose
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Rash
Clinical narrative: 22 days following this vaccine there is a rash all over her body and she is being taken to the doctor about it.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Rash erythematous, Rash pruritic
Clinical narrative: Soreness at first, bruise at injection site October 9th. October 10th, soreness much increased, but could use arm; red rash appeared below injection site. October 11th, increased redness, warmth when touching red area; soreness slightly decreased.  October 12th, still large area of redness, but decreasing in color. October 13th to October 15th, redness much paler.  October 16th, redness appears more like a rash, with some itching and warmth again, but tolerable.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Soreness at first, bruise at injection site October 9th. October 10th, soreness much increased, but could use arm; red rash appeared below injection site. October 11th, increased redness, warmth when touching red area; soreness slightly decreased.  October 12th, still large area of redness, but decreasing in color. October 13th to October 15th, redness much paler.  October 16th, redness appears more like a rash, with some itching and warmth again, but tolerable.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccination: 14OCT2020 @ 12:30 PM.  Patient noted sore, reddened left tricep area, about 5cm in diameter at about 18:00 that evening.  On the morning of 15OCT2020 - Patient's entire left tricep area was sore, swollen  and reddened.  Patient presents at the Occupational Health Clinic on 16OCT2020 AM complaining of continued soreness and redness of the left tricep area. Left tricp - slight induration, erythematous, warm to the touch 12cm X 12cm, somewhat reduced in size from the previous evening. B/P 124/68, Pulse 92, Temp 98.5F. Referred to PA for further evaluation and documentation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: malaise, nausea, sore arm, extremely swollen arm, redness, fatigue
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: malaise, nausea, sore arm, extremely swollen arm, redness, fatigue
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Malaise, Muscular weakness, Oral herpes, Pain in extremity
Clinical narrative: Woke up the next morning and both right arm and right upper leg were extremely achy and felt weak. Extremely fatigued all day. General feeling of "just don't feel well" Had to take a nap and then still went to bed early. This morning (2 days after flu shot), had a hard time waking up with alarm. Already extremely fatigued. Achiness in right leg is less. Achniess in right arm is the same. Both still feel weak. Woke up with a cold sore. I'm not prone to frequent cold sores and haven't had a cold sore in over 2 years.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Somnolence
Clinical narrative: Woke up the next morning and both right arm and right upper leg were extremely achy and felt weak. Extremely fatigued all day. General feeling of "just don't feel well" Had to take a nap and then still went to bed early. This morning (2 days after flu shot), had a hard time waking up with alarm. Already extremely fatigued. Achiness in right leg is less. Achniess in right arm is the same. Both still feel weak. Woke up with a cold sore. I'm not prone to frequent cold sores and haven't had a cold sore in over 2 years.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pain in extremity
Clinical narrative: Started with extremely sore area some 2? away from injection site, which changed areas in the next 3 days until the painful area had traveled all around my arm. Also have bad headaches, nausea, general feeling of malaise.  This is the first time I?ve ever had a reaction to a vaccine and I?ve had many of those through the years.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Eye movement disorder, Loss of consciousness
Clinical narrative: After take out the needle her left hand jerk one and she ask for water, I turn around to ask my tech. give me the bottle of water but I saw her husband stand up to ward her so I turn right back and hold her head and tap her shoulder Are you ok for couple times ; her eyes ware rolling up and she was unconscious for couple second, she regain conscious after the bottle of water touch her lip.  we let her lay on the floor with her feet elevate for 15 minutes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyskinesia, Muscle rigidity
Clinical narrative: Became ridgid and had jerking muscular movements noted on 10/10/2019
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Injection site seemed high, person administering vaccine commented on how she had to use a lot of pressure to inject it.  Had shoulder pain immediately. Still having dull pain at rest and sharp pain with certain movements.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Skin Rash (arm); Hives (forehead)
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Injection site rash
Clinical narrative: RASH AROUND INJECTION SITE AND WHERE BAND-AID WAS APPLIED, HEADACHE, ACHING JOINTS
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Abdominal pain upper, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever, stomach pain, headache and arm where vaccines was given still hurting after 2 days.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: Intense headache; Shivering/chills; Horrible stomach ache / GI complants; Muscle cramps; Feeling horrible / Sick; I'm too weak; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (received 1st dose on unknown date, refer case US2020AMR202885).   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced headache, chills, stomach pain, muscle cramp, sickness and weakness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, chills, stomach pain, muscle cramp, sickness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, stomach pain, muscle cramp, sickness and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 12 hours later began an intense headache, shivering, chills, horrible stomachache, and muscle cramps. The patient was sick and feeling horrible. The patient treated with Tylenol and reporter asked should couple that with aspiring.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202885:same reporter
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise, Muscle spasms
Clinical narrative: Intense headache; Shivering/chills; Horrible stomach ache / GI complants; Muscle cramps; Feeling horrible / Sick; I'm too weak; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (received 1st dose on unknown date, refer case US2020AMR202885).   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced headache, chills, stomach pain, muscle cramp, sickness and weakness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, chills, stomach pain, muscle cramp, sickness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, stomach pain, muscle cramp, sickness and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 12 hours later began an intense headache, shivering, chills, horrible stomachache, and muscle cramps. The patient was sick and feeling horrible. The patient treated with Tylenol and reporter asked should couple that with aspiring.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202885:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: blister at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site blisters in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.  Additional details were reporter as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per a vaccine indication. The patient received a Shingrix injection at pharmacy on Wednesday even had a blister at injection site. No further information was provided. The reporter consented to follow up.