chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got flu shot and felt terrible for several days; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who got flu shot and felt terrible for several days (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got flu shot and felt terrible for several days (feeling abnormal).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Gaze palsy, Headache
Clinical narrative: overnight - headache, joint pain (hip), occasional hot flashes following morning/afternoon - achy feeling, continued, headache, occasional chills, slight temp 100.2 for brief period Felt better by 5pm on 12/13
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Pain
Clinical narrative: overnight - headache, joint pain (hip), occasional hot flashes following morning/afternoon - achy feeling, continued, headache, occasional chills, slight temp 100.2 for brief period Felt better by 5pm on 12/13
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Influenza like illness, Neuralgia, Pain
Clinical narrative: Patient had low grade fever and mild flu like symptoms achy and runny nose fatigue starting 4 hours after getting the shot and lasted 24 hours then 3 days post shot developed rash on left side under breast and armpit and back that was painful burning and stinging sensations as of 12/15 has mostly resolved still slight nerve pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient had low grade fever and mild flu like symptoms achy and runny nose fatigue starting 4 hours after getting the shot and lasted 24 hours then 3 days post shot developed rash on left side under breast and armpit and back that was painful burning and stinging sensations as of 12/15 has mostly resolved still slight nerve pain.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Soreness at injection site.  Fatigue and body ache with headache occurred approximately 10 hours post injection.  Subsided within two days.  Ibuprofen alleviated symptoms; however, they were acute and lingering.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Adverse events: Hives   Treatment: Ice and Oral Benadryl       Outcome: Minimal Hives in localized area
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema, Pain
Clinical narrative: Edema, erythema, pain, firm to touch
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Patient experienced mild numbness traveling from injection site up and down arm that subsided over 20 minutes.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Heplisav given to newborn
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Newborn patient received Heplisav
Age: 67.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever and fatigue
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: While after receiving the first shingles vaccine only resulted in a sore arm, this second dose resulted in chills, body aches, headache, nausea, as well as a sore arm.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Decreased appetite, Full blood count, Hypothermia, Nasal congestion
Clinical narrative: Seen in ER for episode of hypothermia day after influenza vaccine. Had rectal temperature of 96 after waking from nap w/ associated acrocyanosis. Mother noted decreased appetite, slight nasal congestion as well. Was well appearing + with normal temperature in ER (by the time was seeN)
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Urine analysis
Clinical narrative: Seen in ER for episode of hypothermia day after influenza vaccine. Had rectal temperature of 96 after waking from nap w/ associated acrocyanosis. Mother noted decreased appetite, slight nasal congestion as well. Was well appearing + with normal temperature in ER (by the time was seeN)
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Fever started on 12/15/20 of 102, runny nose, tired.
Sex: U
Vaccine: FLUX
Symptoms: Mechanical ventilation, Paralysis
Clinical narrative: paralyzed from the neck down for three years; ended up on a respirator; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and respiratory therapy. On an unknown date, the outcome of the paralysis was recovered/resolved and the outcome of the respiratory therapy was unknown.   The reporter considered the paralysis and respiratory therapy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at the vaccination was not reported. The patient only had one flu shot and ended up on a respirator, two hours from death. After waking up paralyzed from the neck down for three years. The physician stated one more flu shot and it would kill him/her.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site irritation, Pyrexia
Clinical narrative: prescriber advised that there could be some injection site irritation. She has some irritation; Fever; Chills; This is a spontaneous report from a contactable consumer (parent). A 24-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization.  Medical history included Type 1 diabetic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the injection on Tuesday and her prescriber advised that there could be some injection site irritation. She had some irritation, she also had fever and also had chills as well. The patient underwent lab tests and procedures which included body temperature: fever. The outcome of the events was unknown.   No follow-up attempts are needed. Information on Lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a social media consumer.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Past vaccination included flu shot every year.  Medical history, medical treatment, 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 (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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that from 1980 until 1992 patient was forced to get the flu shot every year. Every year patient would be down for at least a week, after I got the shot. Since 1992 patient have not gotten sick like that. Because patient stopped getting the shot.  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 not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got so sick; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient [age and gender unspecified] who got so sick, while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, 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) [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 got so sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient [age and gender unspecified] who got the flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, 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) [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 got the flu (influenza) (non-serious) within 30 days following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Expired product administered
Clinical narrative: Patient was due for 4 month vaccines. Per Mother's request he received 2 of the 4 month schedule vaccines. I had another nurse check vaccines to be given. We read Rotateq as Dec 20 20. Vaccines administered. When I went to enter Rotateq in the patient's chart I could not find the LOT number. I checked Roteq again and noted the date printed was 5 Dec 2020. I immediately let the patient's PCP know. I also went to my Supervisor and called the patient's Mother to inform her of the incident and that son would need to repeat Rotateq. I removed the vaccine from the refrigerator and wrote expired on it and gave it to my supervisor. I also filled out an unusual occurrence form. No harm came to the child but he will have to repeat  Rotateq.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: C/O Headache
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Haemorrhage, Swelling
Clinical narrative: pt reported swelling and some  bleeding
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Pt reported having a fever, chills, body aches for about 24 hrs after both doses. Onset of symptoms was about 6-8 hours after shot given
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Vaccine positive rechallenge
Clinical narrative: chills the evening of injection. took a single ibuprofen, which was sufficient to alleviate the symptom
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever, 101.4, headache, body aches Used acetaminophen to reduce aches and fever.  Fever came down by evening of 10/2/20 headache stopped 10/3/2020
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injections given on 12/14/2020. Severe redness and swelling around both injection sites started around 8:00AM on 12/15/2020. Skin warm to touch at that area. Patient seen in our office and placed on Keflex and Bactroban.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing
Clinical narrative: felt warm, hot and face and ears were red and flushed.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Diffuse mildly erythematous maculpapilar rash trunk, cheeks peri area and thighs
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiovascular disorder, Cerebrovascular accident, Herpes zoster, Hypoacusis
Clinical narrative: stroke; neuropathy; post herpetic neuralgia; cardiovascular event; vision problems; hearing problems; balance problems; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 10-AUG-2015, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, stroke, cardiovascular event, vision problems, hearing problems, balance problems and neuropathy. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered all events to be disabling and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the events of stroke and neuropathy were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Post herpetic neuralgia, Visual impairment
Clinical narrative: stroke; neuropathy; post herpetic neuralgia; cardiovascular event; vision problems; hearing problems; balance problems; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 10-AUG-2015, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, stroke, cardiovascular event, vision problems, hearing problems, balance problems and neuropathy. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered all events to be disabling and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the events of stroke and neuropathy were considered to be medically significant.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness, Migraine
Clinical narrative: the worst RA pain ever; flu-like symptoms; fever; migraine; achiness/ Worst RA pain ever; Feeling terrible all over; 2nd dose of Shingrix "a few days ago" / first Shingrix dose in December of 2019; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in December 2019, for tolerance refer case US2020239719). Concurrent medical conditions included rheumatoid arthritis, fibromyalgia, ehlers-danlos syndrome and crohn's disease.   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th November 2020, 5 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), influenza-like symptoms, fever, migraine, pain, feels awful and drug dose administration interval too long. Rechallenge with Shingrix was positive. On 1st December 2020, the outcome of the rheumatoid arthritis aggravated, influenza-like symptoms, fever, migraine, pain and feels awful were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   The reporter considered the rheumatoid arthritis aggravated, influenza-like symptoms, fever, migraine, pain and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient had her first Shingrix dose in December of 2019 but never went to get 2nd dose. The patient received her 2nd dose of Shingrix in arm, later than the recommended interval which led to lengthening of vaccination schedule. The patient stated that she started experiencing symptoms later same night. She reported that less than a day the patient experienced achiness, the worst rheumatoid arthritis pain ever, fever of 100.5 degrees F, flu-like symptoms and migraine. The patient went to the emergency room and they sent her home. The reporter did not consent to follow up. The patient declined to provide health care professional information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239719:same patient, 1st dose
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rheumatoid arthritis
Clinical narrative: the worst RA pain ever; flu-like symptoms; fever; migraine; achiness/ Worst RA pain ever; Feeling terrible all over; 2nd dose of Shingrix "a few days ago" / first Shingrix dose in December of 2019; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in December 2019, for tolerance refer case US2020239719). Concurrent medical conditions included rheumatoid arthritis, fibromyalgia, ehlers-danlos syndrome and crohn's disease.   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th November 2020, 5 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), influenza-like symptoms, fever, migraine, pain, feels awful and drug dose administration interval too long. Rechallenge with Shingrix was positive. On 1st December 2020, the outcome of the rheumatoid arthritis aggravated, influenza-like symptoms, fever, migraine, pain and feels awful were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   The reporter considered the rheumatoid arthritis aggravated, influenza-like symptoms, fever, migraine, pain and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient had her first Shingrix dose in December of 2019 but never went to get 2nd dose. The patient received her 2nd dose of Shingrix in arm, later than the recommended interval which led to lengthening of vaccination schedule. The patient stated that she started experiencing symptoms later same night. She reported that less than a day the patient experienced achiness, the worst rheumatoid arthritis pain ever, fever of 100.5 degrees F, flu-like symptoms and migraine. The patient went to the emergency room and they sent her home. The reporter did not consent to follow up. The patient declined to provide health care professional information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239719:same patient, 1st dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Peripheral swelling, Pulmonary oedema
Clinical narrative: Fluid in Lungs; foot Swelling; Difficulty breathing; This case was reported by a other health professional via call center representative and described the occurrence of pulmonary edema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number AL34K, expiry date 28th February 2022) for prophylaxis.   On 23rd November 2020 10:20, the patient received the 1st dose of Shingrix (intramuscular). On 23rd November 2020, less than a day after receiving Shingrix, the patient experienced pulmonary edema (serious criteria GSK medically significant), swelling of feet and difficulty breathing. On an unknown date, the outcome of the pulmonary edema, swelling of feet and difficulty breathing were unknown.   It was unknown if the reporter considered the pulmonary edema, swelling of feet and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in right deltoid and later that day she went to the emergency room for difficulty breathing, foot swelling and fluid in lungs. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: all got the shot all got the flu 100 percent failure; Initial information regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via Social Media and transmitted to Sanofi on 12-Nov-2020.  This case involves 72 patients with an unknown age who all got the INFLUENZA VACCINE all got the flu 100 percent failure (Influenza), while all patients received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications 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 unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, all patient got the flu 100 percent failure (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  There will be no information regarding the batch number for the case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves male patient (unknown demographics) who experienced got the flu (influenza), when vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination for influenza. The patient's medical history, past medical treatment, 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 and lot number not reported) via an unknown at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via The Agency (Reference number- 00348957) and transmitted to Sanofi on 06-Nov-2020.  This case involves a 2 years old female patient who experienced hives, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment, vaccination and family history were not provided. List of concomitant medication was reported as not applicable.  On 05-Nov-2020 at around 09:30, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7102MA, expiry date: 30-Jun-2021] via an intramuscular route at the left thigh for prophylactic vaccination.  On 05-Nov-2020 at around 15:30, the patient developed a non-serious hives (urticaria) 5 hours 30 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.   Parent was instructed to give the patient Benadryl [DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE] and to closely monitor.  Frequency and product use were reported as once.  First time product used and still using product were reported as no.  At the time of reporting, reporter was questioned regarding egg component in vaccine and if any other measures need to be taken following reaction.  At the time of reporting, the event outcome reported as unknown for hives.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: patient received her first dose of IMOVAX RABIES, was due for her second dose on 15nov2020, but missed it, no AE; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone via call center in the.  This case involves a 26 years old female patient who received her first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiration date not reported) via unknown route in unknown administration site for pre-exposure prophylactic vaccination on 06-Nov-2020 and she was due for her second dose on 15-Nov-2020, but she missed it (product dose omission issue).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was a case of actual medication error due to missed dose.  At the time of report no adverse event was reported.  Reporter asked does patient need to restart the dosing. Patient is employed with animal control and therefore needs the pre-exposure prophylaxis.  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 on the batch number for this case.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Low grade fever, overall achiness, lethargy - lasted 48 hours
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: NONE, PT just received two flu doses- OCT 06/2020 and DEC 15/2020
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus for 4 days after receiving vaccine
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Rash
Clinical narrative: Rash on trunk starting 24 hours after vaccine.  Pain at injection site.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Somnolence
Clinical narrative: Achy, sleepy feeling, flu like symptoms.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Crying, Decreased appetite, Measles, Pain, Pyrexia
Clinical narrative: Measles outbreak, fever, not eating, not drinking, pain, crying
Age: 1.58
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, horrible rash all over body
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Patient described having "extremely sore arm" lasting more than a couple of days. Pt stated that he is having increased pain and it is spreading to his neck/shoulder area.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Hyperhidrosis, Laboratory test normal, Presyncope
Clinical narrative: within 15 minutes progressive light-headedness leading to near-syncope and diaphoresis.  After 20 minutes symptoms subsided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral pruritus, Paraesthesia, Paraesthesia oral, Parosmia
Clinical narrative: Pt felt wave come over body @ 1218 starting in head and going down. Bad taste in mouth, tingling in body ,  legs, back , across stomach, BP 150/100 P 120@ 1219, EMS activated. BP 120/80, P 80 Pt alert and oriented, Pt declined transport and Benadryl. Symptoms come and go, pt feels better but then bad taste in mouth starts, shaking of hands, tingling starts again in stomach and back. @ 1300 pt requests Benadryl, 25 mg administered. Pt notified family by phone of circumstances and family in transit.@1324 BP 120/80, P 84, tongue tingling and pt  reports smelling chemical smell. @1345 Pt complained of mouth itching, EMS activated and will transport to Medical Center.  Pt oriented and transported at @13
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Tremor
Clinical narrative: Pt felt wave come over body @ 1218 starting in head and going down. Bad taste in mouth, tingling in body ,  legs, back , across stomach, BP 150/100 P 120@ 1219, EMS activated. BP 120/80, P 80 Pt alert and oriented, Pt declined transport and Benadryl. Symptoms come and go, pt feels better but then bad taste in mouth starts, shaking of hands, tingling starts again in stomach and back. @ 1300 pt requests Benadryl, 25 mg administered. Pt notified family by phone of circumstances and family in transit.@1324 BP 120/80, P 84, tongue tingling and pt  reports smelling chemical smell. @1345 Pt complained of mouth itching, EMS activated and will transport to Medical Center.  Pt oriented and transported at @13
Age: 51.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema
Clinical narrative: PINK/REDNESS SURROUNDING INJECTION SITE THE NEXT MORNING (DAY 2) AFTER INJECTION. PATIENT IS TAKING FEXOFENADINE DAILY AND TOOK A DOSE OF BENADRYL IN ADDITION AS A ONE TIME DOSE.  THE PINK/REDNESS SPREAD TO QUARTER SIZE THEN HALF-DOLLAR SIZE AND WAS INSTRUCTED TO SEE DR IF THE AREA SPREAD. PATIENT WENT TO ER TO GET PREDNISONE TAPER (DAY 5)
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Crying, Developmental regression
Clinical narrative: On September 16, 2019 I took my son, Patient to his 15 month check up. He received a DTaP shot at about 11:30am, we got home maybe 20-30 minutes later where I stood him in our living room and got settled. At about 12:00pm he started crying inconsolably, but wouldn?t move.  I said, ?come here,? but he just stood there, cries turning to screams. I grab his hand to get him to walk closer, but he falls over and does not get up.  I pick him up, trying to calm him, but he?s still crying uncontrollably.  I try to stand him in my lap, but he feels limp. I check everything on him, making sure he?s okay, seeing what I can do to help, nothing helps.  I have no clue what?s going on or how to help, so I call the doctors office - I can only hear some of what they are saying, but I try to tell the nurse what?s going on while he cries in the background, the nurse told me that soreness is to be expected and to give some Tylenol.  We?ve had shots before, but never any of this. Never crying like this, never going limp like this.  I finally calm him down and get him to sleep long enough for my husband to come home.  After weeks/months of research, talking to a family friend who had knowledge in this area, and a few nurse friends, I was able to discover that this was a hypotonic hypersensitive episode.   That afternoon and the following few days of that week, it?s as if Patient was re-learning how to walk. He was 15 months and had started walking at 11 months, so this was not a difficult task for him, but he was very clumsy, would stumble and fall several times a day. My husband and I both made comments to each other about him being very clumsy.  Patient also had/has a speech regression/delay which I am confident came after this. I only say this because I spent every day with him before and after and watched the regression and these are the things that I witnessed.  - Patient had been saying: Mama, Dada, Nose, Hair, had been practicing feeding himself, and when asked would point to a body part.  - 09/14/2019 he said ?sit down? his first 2 word sentence ever, (I was so proud, I documented it!) After his shot, he did not say the above words again until just a few months ago after months of speech therapy.  When I asked if he wanted to hold a utensil to help feed himself, he would act as if he were throwing a tantrum.  When his toys (that he has played with for months) would make a noise, he would flinch, when prior to the shot, he never did this.  He did not point to his body parts again for months as well, until speech therapy and months of me working with him again.   A few treatments that have helped are, of course, speech therapy (he began this in maybe February) and glutathione cream.  His doctor now has been amazing and very supportive and has said that he?s improved so much.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Defaecation urgency, Diarrhoea, Dizziness
Clinical narrative: Within 1 minute, patient complained of symptoms of lightheadedness, flushing, asked for water.  Symptoms persisted, reported vagal and "spacey", vitals were 117/91, HR 67,  O2 sat 99% on room air.  Reported chest heaviness, shortness of breath and within 5 minutes developed rigors and  urge to defecate. 911 called,  repeat vital 150/89 HR 113 O2sat 97%, continues to want to defecate.  1 loose BM, transferred to ED
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Flushing, Presyncope
Clinical narrative: Within 1 minute, patient complained of symptoms of lightheadedness, flushing, asked for water.  Symptoms persisted, reported vagal and "spacey", vitals were 117/91, HR 67,  O2 sat 99% on room air.  Reported chest heaviness, shortness of breath and within 5 minutes developed rigors and  urge to defecate. 911 called,  repeat vital 150/89 HR 113 O2sat 97%, continues to want to defecate.  1 loose BM, transferred to ED
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: pt had radiating pain from middle of left arm up to spine the first night following dose.  for the last 3 months, pt has reported having a coming and going pulsating pain around middle of left upper arm.  Pain is described to be more common in the morning upon wakening but distinctly different from her typical arthritis pain.  She has not seeked medical attention at this time
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 4 months shy of turning 18 and should not have received flublok yet. No adverse reactions are known, just the wrong vaccine given
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Gaze palsy, Heart rate increased, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Extreme soreness, unable to raise arm above elbow level; Extreme headache, wake every 2 hours throughout night. Considerable swelling at injection site.  Heart rate elevated from normal 55-60 to 90+ through at least noon the day following vaccine.  Skin hurts as when a fever is present, though no elevated temperature.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Sleep disorder
Clinical narrative: Extreme soreness, unable to raise arm above elbow level; Extreme headache, wake every 2 hours throughout night. Considerable swelling at injection site.  Heart rate elevated from normal 55-60 to 90+ through at least noon the day following vaccine.  Skin hurts as when a fever is present, though no elevated temperature.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pt. states the evening of vaccine her arm was very painful.  Difficult for her to sleep.  She had to take Motrin and arm hurt all the way up to shoulder/neck area.  Pt. states pain has gotten better but still has difficulty lifting arm up all the way.  Her range of motion is limited due to pain 1 week after administration.
Age: 77.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Diarrhoea, Malaise, Nausea, Pain, Pruritus
Clinical narrative: Morning after vaccine, I did not feel good. Had sores in mouth, low grade fever all day, aches and pain all over with nausea and diarrhea. Lasted for about a whole week. I went to dentist for sores in mouth (was prescribed mouthwash). The diarrhea finally subsided. When I saw a doctor, he gave me mouth was for the sores in mouth as well.  The initial  feeling of me not feeling well lasted for a week, but the sores and diarrhea lasted a lot longer.
Age: 77.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pyrexia, Stomatitis
Clinical narrative: Morning after vaccine, I did not feel good. Had sores in mouth, low grade fever all day, aches and pain all over with nausea and diarrhea. Lasted for about a whole week. I went to dentist for sores in mouth (was prescribed mouthwash). The diarrhea finally subsided. When I saw a doctor, he gave me mouth was for the sores in mouth as well.  The initial  feeling of me not feeling well lasted for a week, but the sores and diarrhea lasted a lot longer.
Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient received a flu shot at 12:10pm we spoke for several minutes before and after the shot. He then shopped the store and was getting ready to be rang out at the front registers when he felt faint and took a knew and fainted. Patient hit his right orbital on the floor. He regained consciousness immediately. During questioning he mentioned that he had not eaten at all that day which may have contributed to the fainting. He has had a variety of vaccines in the past without incident. He was checked out by the EMTs and they stated that his vitals where normal.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: lips swelled, resolved after 2 days
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Chills, Headache, Pain, Pyrexia
Clinical narrative: Swelling, rash, pain , headache, shivering all night, fever next day started in the afternoon. Rash spreading  Talked to a medical assistant and the dr. Pharmacist. Used Benadryl cream and liquid Benadryl. Advised to use my triamcinolone ointment, that helped the rash. Took 2 Tylenol at w different times. That helped. Fever gone on Friday, rash receding. No more side effects.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Swelling, rash, pain , headache, shivering all night, fever next day started in the afternoon. Rash spreading  Talked to a medical assistant and the dr. Pharmacist. Used Benadryl cream and liquid Benadryl. Advised to use my triamcinolone ointment, that helped the rash. Took 2 Tylenol at w different times. That helped. Fever gone on Friday, rash receding. No more side effects.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received the vaccine yesterday, had no issues until today. She reports symptoms of swelling, redness, and tenderness about 3 inches below the injection site.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Feeling abnormal, Flushing, Intensive care
Clinical narrative: rPfizer-BionNTech COVID-19 Vaccine EUA  5-7 minutes after the vaccine Associate stated she did not feel right, mentioned chest pain. "My chest feels funny. It feels like when you have really bad heartburn coming on". "I feel flushed like when you get contrast for a CT".  Pulse 90 BP 160/90 checked later 130/90
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure systolic increased, Chest discomfort, Chills, Cold sweat
Clinical narrative: rPfizer-BionNTech COVID-19 Vaccine EUA  5-7 minutes after the vaccine Associate stated she did not feel right, mentioned chest pain. "My chest feels funny. It feels like when you have really bad heartburn coming on". "I feel flushed like when you get contrast for a CT".  Pulse 90 BP 160/90 checked later 130/90
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Dyspnoea, Feeling abnormal, Intensive care, Pallor
Clinical narrative: rPfizer-BionNTech COVID-19 Vaccine EUA  5-7 minutes after the vaccine Associate stated she did not feel right, mentioned chest pain. "My chest feels funny. It feels like when you have really bad heartburn coming on". "I feel flushed like when you get contrast for a CT".  Pulse 90 BP 160/90 checked later 130/90
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pollakiuria, Sensory disturbance
Clinical narrative: rPfizer-BionNTech COVID-19 Vaccine EUA  5-7 minutes after the vaccine Associate stated she did not feel right, mentioned chest pain. "My chest feels funny. It feels like when you have really bad heartburn coming on". "I feel flushed like when you get contrast for a CT".  Pulse 90 BP 160/90 checked later 130/90
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Gianotti-Crosti syndrome, Otitis media, Rash, Upper respiratory tract infection
Clinical narrative: Developed a rash all over which started 2 days after vaccines and continued until clinic visit on 12/11/2020 which was diagnosed as Gianotti-Crosti syndrome.  Also had upper respiratory infection and serous otitis media diagnosed on 12/11/2020.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site paraesthesia
Clinical narrative: First day after, just seemed tender.  By Friday, I had smooth redness the size of an egg and felt like someone slugged me which also seemed fairly normal side effect.  Next day a little itching and tenderness and Sunday almost all the redness was gone except a few red blotches a little further away from the injection site.  Felt fine except a little light-headedness.  This morning the redness had grown to a about 6" diameter.  Still smooth.  Only a little tingling feeling. Headache, but not intense, and still a little light headedness but not dizzy.  Took 2 Benadryl 25mg  and called pharmacist who recommended I also ice it, and if become worse tomorrow to go to Urgent Care.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: First day after, just seemed tender.  By Friday, I had smooth redness the size of an egg and felt like someone slugged me which also seemed fairly normal side effect.  Next day a little itching and tenderness and Sunday almost all the redness was gone except a few red blotches a little further away from the injection site.  Felt fine except a little light-headedness.  This morning the redness had grown to a about 6" diameter.  Still smooth.  Only a little tingling feeling. Headache, but not intense, and still a little light headedness but not dizzy.  Took 2 Benadryl 25mg  and called pharmacist who recommended I also ice it, and if become worse tomorrow to go to Urgent Care.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Migraine, Tremor
Clinical narrative: a couple of hours after the injection patient started shivering. It continued all day with increasing intensity. by 8:00 pm the patient was feeling worn out and light headed wth considerable shaking. around 2:30 am the patient woke up with a migraine. the next moring the patient was still shiviring a little. Symptoms completley faded by mid evening 12/12/20.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: patient states that she has had shoulder pain since the vaccine. She states that the pain is mostly at night, but sometimes occurs during the day
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: I was fine the day of the vaccine. The day after, I had a large red circle on my arm that was hot and swollen for 2 weeks. Then, the swelling decreased and it became a large purple bruise that I still have 6 weeks later.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood prolactin increased, Fatigue, Poor quality sleep, Postictal state, Scan
Clinical narrative: 1 week of fatigue, poor sleep. Serious event (seizure activity lasting 1 min followed by 2 hour postictal state) occurred on 12/11/2020.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: 1 week of fatigue, poor sleep. Serious event (seizure activity lasting 1 min followed by 2 hour postictal state) occurred on 12/11/2020.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a 3rd Hep A.   She had received the 1st one on 09.20.2012 and the 2nd on 04.16.2013.  She was given a 3rd one on 04.12.2019- there was no adverse reaction noted .
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient became dizziness about a minute after vaccination
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Impaired work ability, Pain in extremity
Clinical narrative: A couple hours after receiving the shingles vaccine I started feeling very tired including mild fever, chills and backache so I went home to rest and ended up staying in bed asleep from about 3pm to 6am the next morning.  on the 15th, the next day, I felt better but still not great and my arm is still very sore but no swelling.  Decided to take a day off of work and continue to rest, drink plenty of liquids and Tylenol.  It is now almost 2pm and suspect I will return to normal capacity by tomorrow morning.