chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Joint swelling
Clinical narrative: Swelling and slight redness in Right Leg that extends to knee. Patient refused to take motrin  Recommended cold pack for discomfort and swelling.   Referred to doctor for evaluation.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever started the  night  of vaccine administration, and continued for 3 days, readings of 100-101. then 9 days post-vaccine papular erythematous rash appeared. Approximately 50  appeared  on trunk then spread. Self -resolved after 48hrs and them self resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Monday night after I received the shot and my arm was in severe pain. The next night I was asleep and a woke with chills, cough, and nausea. I vomited twice. and fever and arm pain. 10-5am
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Monday night after I received the shot and my arm was in severe pain. The next night I was asleep and a woke with chills, cough, and nausea. I vomited twice. and fever and arm pain. 10-5am
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Drainage, Rash, Rash macular, Rash pruritic
Clinical narrative: 48 hours after injection, patient began developing a blister like rash on his right arm. It slowly spread throughout his right chest wall and abdomen and his left leg over the course of a week.  Draining and very itchy.  Is slowly resolving with small areas of pinpoint dots on skin remining at this point.  Patient was advised use of benadryl and hydrocortisone cream which he did use.  Also used "Technu" cream and medicated Gold Bond.  If noteworthy, patient stating that he had "a very severe" case of the chicken pox as a child, requiring hospitalization.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain
Clinical narrative: Shoulder pain when lifting up arm and moving arm around.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Pain in extremity
Clinical narrative: arm pain, severe fatigue, body aches (flu like), malaise
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Soreness at injection site; Headache for 12 hours; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and injection site pain. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccination indication. The patient experienced Headache for 12 hours and soreness at injection site.
Sex: U
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Pain
Clinical narrative: persisent, very mild soreness / very minor soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient got the second Shingrix vaccination about a month ago and was still feeling some very minor soreness after 4 weeks. The patient was just wondering if there was any known side effect from the Singrix vaccination that might cause persistent, very mild soreness for an extended period of time after the second vaccination. The patient wanted to know how long soreness may persist after Shingrix vaccination.
Sex: U
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Asthenia, Exercise tolerance decreased, Injection site pain, Injection site reaction
Clinical narrative: persisent, very mild soreness / very minor soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient got the second Shingrix vaccination about a month ago and was still feeling some very minor soreness after 4 weeks. The patient was just wondering if there was any known side effect from the Singrix vaccination that might cause persistent, very mild soreness for an extended period of time after the second vaccination. The patient wanted to know how long soreness may persist after Shingrix vaccination.
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Dizziness / Lightheadedness; Passed out for 10 minutes.; This case was reported by a consumer via other manufacturer and described the occurrence of passed out in a 56-year-old male 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, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. On an unknown date, the outcome of the passed out was recovered/resolved and the outcome of the dizziness was unknown.   It was unknown if the reporter considered the passed out and dizziness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:   The age at vaccination was not reported. The patient had a bad reaction to his flu shot including dizziness, lightheadedness, and he passed out for 10 minutes.
Sex: U
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; Initial information regarding this unsolicited valid non-serious social media case received from a consumer and transmitted to Sanofi on 12-Oct-2020.  This case is linked to cases 2020SA294157, 2020SA294158 and 2020SA294166 (same source).  This case involved a patient of unknown demographics who experienced got the INFLUENZA VACCINE runny nose (rhinorrhoea).  Relevant medical history, medical treatment, vaccination details, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient runny nose (rhinorrhoea), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was runny nose.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: had bad body aches for a day; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to: 2020SA294158, 2020SA294157 and 2020SA294125.  This case involves a patient of unknown demographics who had bad body aches for a day (pain), after receiving INFLUENZA VACCINE.  The patient's concurrent condition included being allergic to eggs. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date (many years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had bad body aches for a day (pain) (non serious) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the patient was recovered from the event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Cough, Dyspnoea, Dysstasia, Gait disturbance
Clinical narrative: flu from the shot; sick; chills; Very high fever; body aches; could hardly stand; could hardly stand to walk back in drs office; congestion; runny nose; cough; couldn't breathe; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who had flu from the shot (influenza) characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), while the patient received INFLUENZA VACCINE.  Medical history and family history were unknown.   The patient had received flu vaccine (reported 9 to 10 years ago).  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient had flu from the shot (influenza) which was characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise, Nasal congestion, Pain, Pyrexia
Clinical narrative: flu from the shot; sick; chills; Very high fever; body aches; could hardly stand; could hardly stand to walk back in drs office; congestion; runny nose; cough; couldn't breathe; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who had flu from the shot (influenza) characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), while the patient received INFLUENZA VACCINE.  Medical history and family history were unknown.   The patient had received flu vaccine (reported 9 to 10 years ago).  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient had flu from the shot (influenza) which was characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: flu from the shot; sick; chills; Very high fever; body aches; could hardly stand; could hardly stand to walk back in drs office; congestion; runny nose; cough; couldn't breathe; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who had flu from the shot (influenza) characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), while the patient received INFLUENZA VACCINE.  Medical history and family history were unknown.   The patient had received flu vaccine (reported 9 to 10 years ago).  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient had flu from the shot (influenza) which was characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient got FluBlok on 01-Oct-2020 and by mistake a second dose on 09-Oct-2020, no AE; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00353175).  This case is linked to case 2020SA318070 (same reporter).  This case involves a 60 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] twice by mistake (Extra dose administered).  Medical history, medical treatment(s), past vaccination(s) and family history was not provided.  The patient did not receive concomitant medications.   On 01-Oct-2020, the patient received a first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported, prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination.  On 09-Oct-2020, the patient received a 0.5 ml second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2009, expiry date: 30-Jun-2021, prefilled syringe) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered.  The reporter asked if they should expect any side effects or were there any concerns if a patient got 2 doses of FLUBLOK.  At the time of report, patient was not experiencing any side effects or any symptoms.  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: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old was administered a dose of Flublok Quadrivalent/no AE; Initial information was regarding an unsolicited valid non-serious case was received on 10-Nov-2020 from a Other Healthcare Professional (Practice manager) via Medical Information (Reference number- 00353491) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 16-year-old male patient who received 0.5 mL dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ446AA, expiry date 08-Mar-2021) via an intramuscular route at the right deltoid on 16-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENACTRA) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency was on same day).  At the time of report, 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: F
Vaccine: FLU4
Symptoms: Device connection issue, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: Leakage of the vaccine from between the needle and the syringe tip due to the needle not being secure on the syringe with no AE; The needle was not on tight and the vaccine rolled down the arm of the consumer with no AE; Patient getting a dose less than the 0.5 ml due to leakage of the vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information (MI) (Reference number- 00360254) and transmitted to Sanofi on 16-Nov-2020.  This case involves a 47 years old female patient who got a dose less than the 0.5 mL of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled syringe, lot UT7115LA and expiration date: 30-Jun-2021) via intramuscular route in the right arm for prophylactic vaccination (underdose). This occurred due to leakage of the vaccine from between the needle and the syringe tip due to the needle not being secure on the syringe (device connection issue) as the needle was not on tight and the vaccine rolled down the arm of the patient (exposure via skin contact) on unknown date.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to exposure via skin contact and vaccine underdose (latency on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 88.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthritis, Back pain, Chest pain, Condition aggravated, Fall
Clinical narrative: Resident stated her hands and right elbow felt like they were numb, tingly, and like her arthritis was "flaring up," approx 4 days after flu shot. Continued to get worse, and resident developed painful, red rash on 10/14/20, to her right arm. Was sent to the clinic, and received diagnosis of Shingles. Pain continued to get worse, rash spread, resident had falls, and ended up hospitalized from 10/16/20-10/18/20 for chest pain and fainting. Continues to have Shingles pain to right arm, chest, and back ever since.
Age: 88.0
Sex: F
Vaccine: FLUR4
Symptoms: Herpes zoster, Hypoaesthesia, Laboratory test, Pain in extremity, Paraesthesia
Clinical narrative: Resident stated her hands and right elbow felt like they were numb, tingly, and like her arthritis was "flaring up," approx 4 days after flu shot. Continued to get worse, and resident developed painful, red rash on 10/14/20, to her right arm. Was sent to the clinic, and received diagnosis of Shingles. Pain continued to get worse, rash spread, resident had falls, and ended up hospitalized from 10/16/20-10/18/20 for chest pain and fainting. Continues to have Shingles pain to right arm, chest, and back ever since.
Age: 88.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash, Rash erythematous, Syncope
Clinical narrative: Resident stated her hands and right elbow felt like they were numb, tingly, and like her arthritis was "flaring up," approx 4 days after flu shot. Continued to get worse, and resident developed painful, red rash on 10/14/20, to her right arm. Was sent to the clinic, and received diagnosis of Shingles. Pain continued to get worse, rash spread, resident had falls, and ended up hospitalized from 10/16/20-10/18/20 for chest pain and fainting. Continues to have Shingles pain to right arm, chest, and back ever since.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: I suffered several side effects after receiving both doses of the shingrix. These included: low grade fever, chills, muscle aches, shivering, headache and nausea
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Insomnia
Clinical narrative: Freezing, fever, headache, joint pain in hands and wrists, terrible body aches,  fatigue, inability to sleep.  Treated with Tylenol.  I'm on day 2 and still suffering
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Freezing, fever, headache, joint pain in hands and wrists, terrible body aches,  fatigue, inability to sleep.  Treated with Tylenol.  I'm on day 2 and still suffering
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Started with chills right before bed, developed a fever overnight, woke up with headache, dizziness, nausea and fever. All symptoms continued through the day. Fever got up to 102.2. Woke up today (12/3/2020) with most symptoms gone except the dizziness
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Dysphagia, Ear pain, Headache
Clinical narrative: Monday night-muscle aches, dry heaves, headache, weakness; Tuesday-flat on bed-slept all day; Turned to dry cough/cold/headache (no fever); Wednesday evening-around 8 again severe throat-difficult to swallow; phlegm; cough;  ear aches on both ears (no breathing issues or chest pains and no fever at any time)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Myalgia, Nasopharyngitis, Productive cough, Retching
Clinical narrative: Monday night-muscle aches, dry heaves, headache, weakness; Tuesday-flat on bed-slept all day; Turned to dry cough/cold/headache (no fever); Wednesday evening-around 8 again severe throat-difficult to swallow; phlegm; cough;  ear aches on both ears (no breathing issues or chest pains and no fever at any time)
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and minor swelling at site. Not hot to the touch and no streaking.   Watched patient for extra amount of time about 30 mins after reaction. Swelling and redness had started to decrease, no trouble breathing noted. Reviewed with mom what to watch for and what steps to take for reaction- mom stated understanding.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Feeling hot, Nausea
Clinical narrative: shivering, nausea, dizziness, sensation of cold despite no reason to be so, body was hot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Received vaccine in the morning, mom reports "knot and redness" starting that afternoon that worsened and starting itching over the next 48 hours. Improving today.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flubolk was given to someone under the age of 18, for which it is not licensed for. We had instructed the visiting  association that the clinic was for ages 19 and older but that information did not get to this particular nurse. Attempted to contact family to inform them, but no call back.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hard heated small pancake sized red mark around the vaccine with minor itching and no swelling. stayed flat and resolved in a couple of days
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Rash at injection site and down the left arm. Rash also present on right shoulder and right side of neck. Itching is present with rash. Paient was given hydrocortisone cream and told to return if rash does not subside.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Two hours after receiving the flu vaccine the patient developed hives and fever of 102.00. The patient's mother gave her benedrayl and tylenol and then came to my office today. I performed an exam and the patient had hives around her mouth and eyes as well as the upper part of her neck. I prescibed hydroizine to the patient for the hives.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Peripheral swelling
Clinical narrative: PATIENT REPORTED SWOLLEN ARM, PAIN AND ITCHING AT INJECTION SITE,
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient had a doctor's visit yesterday and complained that she has been having soreness and pain on left shoulder about two days after the first dose of Shingix.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Feeling abnormal, Headache, Injection site erythema, Injection site swelling
Clinical narrative: The day after the vaccine was given, she woke up feeling achy, headache, stomach ache and not feeling good all day.  Later that evening she felt better.  The next day she felt fine.  Today, she woke and is feeling like she did the day after vaccine.  Plus at the site of the injection it is red and swollen, warm to the touch.  She went back to the Pharmacy that gave her the injection and the pharmacist told her to call us and report the adverse event.  I told her to also call her PCP and let them know.  She asked if there was anything she could do to feel better.  I gave her the number to the CDC.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: The day after the vaccine was given, she woke up feeling achy, headache, stomach ache and not feeling good all day.  Later that evening she felt better.  The next day she felt fine.  Today, she woke and is feeling like she did the day after vaccine.  Plus at the site of the injection it is red and swollen, warm to the touch.  She went back to the Pharmacy that gave her the injection and the pharmacist told her to call us and report the adverse event.  I told her to also call her PCP and let them know.  She asked if there was anything she could do to feel better.  I gave her the number to the CDC.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Nurse called to report temperature excursion for MMR-II, PROQUAD, and VARIVAX, given vaccine during improperly stored; This spontaneous report was received from a nurse referring to a 13-month-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (route of administration was not reported), lot# T000344, expiration date 05-JAN-2022 for prophylaxis (product storage error).         The vaccine was exposed to the following temperature excursions: -13.9 degrees Celsius (C) to -14.7 C; -14 to -10 C, with an average of -13.9 C for 30 minutes; -14 C to -10 C, with an average of -14.2 C for 15 minutes; -14 C to -10 C, with an average of -14.7 C for 20 minutes and -14 C to -10 C, with an average of -14.6 C for 5 minutes. There were no previous temperature excursions. The call was due to digital data logger.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No adverse event; Improperly stored vaccine; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R034547, which was confirmed to be a valid lot number, expiration date: 09-JUN-2021) at a dose of 0.5 milliliter for prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion 46.9 degrees Fahrenheit (F) for 15 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Headache
Clinical narrative: his headaches returned. The headaches were "quite severe"; This spontaneous report was received from a physician assistant, via a company representative, referring to a male patient in a college-aged with multiple unknown medical problems after concussion. The patient's medical history included a concussion and chronic headaches which were under control (possibly due to an unknown medical intervention). The patient's concomitant medications and drug reactions/allergies were unknown by reporter.    On an unspecified date around 3 to 4 years ago, in 2016 or 2017, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown). Around the same vaccination time, after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration, the patient's headache returned and were quite severe. He sought medical attention and began using onabotulinumtoxinA (BOTOX) as treatment.  At reporting time, the outcome of headache was unknown. The causality assessment was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; Brain fog due to flu; Brain fog; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 30-year-old female 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 vaccination failure (serious criteria GSK medically significant), influenza and foggy feeling in head. On an unknown date, the outcome of the vaccination failure, influenza and foggy feeling in head were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and foggy feeling in head to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced brain fog due to flu. This case was considered as suspected vaccination failure as time to onset, laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: suspected vaccination failure; had 2 flu shots and the flu both times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure'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 vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:   The age at vaccination was not reported. The patient had flu shot and the had flu, he or she was staying away from this shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset, laboratory confirmation test were unknown at the time of reporting. This case was linked with case US2020AMR236391, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR236391:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: caught the flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to 2020SA294125, 2020SA294157, 2020SA294158.  This case involves a patient of unknown demographics who caught the flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (in the early sixties), the patient caught the flu (influenza) (non serious) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Anxiety, Asthenia, Muscular weakness
Clinical narrative: I feel my legs muscles to weak and a lot anxiety attacks; Initial information regarding this unsolicited valid non-serious social media case received from a consumer and transmitted to Sanofi on 18-Oct-2020.  This case is linked to cases 2020SA294157, 2020SA294158 and 2020SA294166 (same source).  This case involved a patient of unknown demographics who experienced got the INFLUENZA VACCINE patient feel my legs muscles to weak and a lot anxiety attacks (anxiety).  Relevant medical history, medical treatment, vaccination details, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient patient feel my legs muscles to weak and a lot anxiety attacks (anxiety), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was patient feel my legs muscles to weak and a lot anxiety attacks.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Ageusia, Weight decreased
Clinical narrative: losing weight; loss my sense of taste; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient of unknown age and gender who experienced losing weight (Weight decreased) and loss my sense of taste (Ageusia), while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for vaccination.  On an unknown  date (unknown latency), the patient developed a non-serious losing weight (weight decreased) and loss my sense of taste (ageusia)following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Final diagnosis was loss my sense of taste and losing weight.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for losing weight and for loss my sense of taste.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills, weakness, fatigue
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Erythema, Urticaria
Clinical narrative: Patient experienced redness and hives to face, bilateral arms, and chest, scratchy throat and swelling to throat prior to Emergency Department arrival.  On assessment the provider noted redness and hives to face, chest, lungs clear, airway clear, no sob, +slight chest pain.  The patient was given 125mg solumedrol and 50mg bendadryl IV by EMS enroute to the Emergency Department.  The patient was treated with steroids, epinephrine, and antihistamines in the ED.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN, INFLAMMED LEG AT INJECTION SITE. TREATMENT WAS KEFLEX & PREDNISONE. OUTCOME IS PENDING.
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Burning sensation, Computerised tomogram head normal, Hypoaesthesia, Immunoglobulin therapy, Insomnia
Clinical narrative: Pain and numbness, weakness of bilateral extremities.  Presented with numbness and burning of bilateral lower extremities which began 4 days after receiving flu vaccine and progressively worsened.  Hospital admission- CT head and brain MRI was unremarkable except for possible sinusitis with mucosal thickening that was incidentally noted.  She was treated for possible sinus infection during admission as well.  She had a cervical MRI showing increased T2 of C6-C7.  This was thought to be transverse myelitis triggered by her flu shot and she was treated by neurologist with steroids and IVIG treatment.  She is on gabapentin 100 mg 3 times daily to be decreased after 2 weeks to twice daily and eventually stopped once paresthesias resolve and Klonopin at night for insomnia.  She developed urinary incontinence during her stay and lumbar MRI was unremarkable, treated with Diflucan for possible yeast adenitis/vulvitis.
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Myelitis transverse, Pain in extremity
Clinical narrative: Pain and numbness, weakness of bilateral extremities.  Presented with numbness and burning of bilateral lower extremities which began 4 days after receiving flu vaccine and progressively worsened.  Hospital admission- CT head and brain MRI was unremarkable except for possible sinusitis with mucosal thickening that was incidentally noted.  She was treated for possible sinus infection during admission as well.  She had a cervical MRI showing increased T2 of C6-C7.  This was thought to be transverse myelitis triggered by her flu shot and she was treated by neurologist with steroids and IVIG treatment.  She is on gabapentin 100 mg 3 times daily to be decreased after 2 weeks to twice daily and eventually stopped once paresthesias resolve and Klonopin at night for insomnia.  She developed urinary incontinence during her stay and lumbar MRI was unremarkable, treated with Diflucan for possible yeast adenitis/vulvitis.
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Paraesthesia, Urinary incontinence
Clinical narrative: Pain and numbness, weakness of bilateral extremities.  Presented with numbness and burning of bilateral lower extremities which began 4 days after receiving flu vaccine and progressively worsened.  Hospital admission- CT head and brain MRI was unremarkable except for possible sinusitis with mucosal thickening that was incidentally noted.  She was treated for possible sinus infection during admission as well.  She had a cervical MRI showing increased T2 of C6-C7.  This was thought to be transverse myelitis triggered by her flu shot and she was treated by neurologist with steroids and IVIG treatment.  She is on gabapentin 100 mg 3 times daily to be decreased after 2 weeks to twice daily and eventually stopped once paresthesias resolve and Klonopin at night for insomnia.  She developed urinary incontinence during her stay and lumbar MRI was unremarkable, treated with Diflucan for possible yeast adenitis/vulvitis.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Fall, Impaired work ability, Injection site pain
Clinical narrative: 11/04/2020 06:20 am patient, went to bathroom and felt light-headed. Experienced vertigo upon getting a glass of water and fell to the floor, spilling water all over self. Patient proceeded to get ready for work. Called into work and stayed home. Did not take temp. Felt 'fine' but 'no business going to work'. Took it 'easy', rested, low energy and did not push self, even though felt better. Patient pushed water, protein. No rash, raised, etc at injection site. Patient refused to have flu shot during the same date of shingrix shot.   After first injection site of the shingrix in the left arm, soreness right at injection site (1st week of August 2020). Soreness lasted approximately 2 weeks.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: 11/04/2020 06:20 am patient, went to bathroom and felt light-headed. Experienced vertigo upon getting a glass of water and fell to the floor, spilling water all over self. Patient proceeded to get ready for work. Called into work and stayed home. Did not take temp. Felt 'fine' but 'no business going to work'. Took it 'easy', rested, low energy and did not push self, even though felt better. Patient pushed water, protein. No rash, raised, etc at injection site. Patient refused to have flu shot during the same date of shingrix shot.   After first injection site of the shingrix in the left arm, soreness right at injection site (1st week of August 2020). Soreness lasted approximately 2 weeks.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematochezia
Clinical narrative: 11/26/2020-11/28/2020, bloody stools throughout the day. Bloody stools did not continue on and after 11/29/2020. Follow-up phone call with Nurse Practitioner;medical test ordered for colonoscopy and blood work to be scheduled.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain of skin
Clinical narrative: Patient called and indicated that she has red patches that are sore when touched on the arm of injection but lower than injection site
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Outbound call made 10/30/2020, spoke with Consumer. States that patient/patient's parents have not reported any adverse events after receiving a 3rd dose of MMRII.; Customer below called this morning to report off label use of MMRII Vaccine, vaccine was administered to patient 12 years of age whom had previously received 2 doses as per recommended schedule.; This spontaneous report has been received from the patient's parents referring to a 12 years old male patient (gender unknown). Information about concomitant medication, pertinent medical history, drug reactions or allergies was unknown.  On an unknown date (it was also reported as when the patient was 12 months), the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route lot number, expiration date and indication were not reported) for prophylaxis. When the patient was 4 years old, the second dose of the vaccine was received as per recommended schedule. On 23-OCT-2020, the patient was vaccinated with a third dose off label use of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (frequency, route lot number, expiration date were not reported) for prophylaxis (extra dose administered). The patient's parents had not reported any adverse events after receiving the third dose of the vaccine. His parents would like to know if there were any recorded adverse events from any similar situations.