chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired Act HIB, no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 months old female patient who was vaccinated with an expired dose of vaccine hib (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included hepatitis A vaccine (Hepatitis A); measles vaccine, mumps vaccine, rubella vaccine (MMR); pneumococcal conjugate vaccine (Pneumococcal Vaccine); and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 26-Nov-2019, the patient received an expired Booster dose (4th dose) of the suspect vaccine hib (PRP/T) vaccine lot UI913AA, exp date: 22 Nov 2019 (Diluent lot# UI913AAA, exp; 11/14/2019) via intramuscular route in the left thigh.  It was a case of expired vaccine used.  At the time of the report, no adverse event was reported.   Disclaimer: 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.  No further relevant information was reported.
Age: 16.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient Flublock Quadrivalent instead of the Fluzone Quadrivalent, no AE; Patient Flublock Quadrivalent instead of the Fluzone Quadrivalent, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked with case 2019SA309785  This case involves a 16 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE instead of the INFLUENZA QUADRIVAL A-B VACCINE (wrong product administered), while he received vaccine influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot-QFAA1916 , exp date: 30 June 2020, via unknown route in the right arm.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong product administered.  At the time of the report, no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Arthritis, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports soreness of right and left arms after injection that has not resolved. He has trouble extending his arms and lifting arms to put on clothing. He plans to consult his primary care provider to see if he is experiencing inflammation of the joint from vaccinations or if it is a side effect/progression of his medical conditions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Appetite disorder, Arthralgia, Chills, Dizziness
Clinical narrative: I felt fine for the rest of the day after the shot.  That night, went to bed and woke about 2:30 AM with extreme body ache, shaking chills, upset stomach, and dizziness.  The body ache and chills were severe!  EVERYTHING seemed to ache, but particularly my hips. At 8 AM I contacted my doctor to advise her that I thought I was experiencing adverse symptoms to a Shingrix shot received the day before.  She advised me to take 1000 mg Tylenol  in 3 separate doses.  Also suggested that if a cough started I should come in promptly, as I might have simultaneously contracted a virus and could receive treatment for flu.  I followed  her advice.  No cough appeared.  Just lethargy, aches, chills.   The strong adverse symptoms continued for the entire day.  No amount of layered clothing or electrical warmers could ease the chills.  I spent a good share of the day in bed, a new experience for me!   It was a LONG DAY and  I went to sleep early evening.  Slept well.  Next morning, I woke feeling like I have felt most of my life: well, strong, energetic.  Apetite not so good, but chills, aches, dizziness, stomach upset were gone.  A 24 hour NASTY experience!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Tremor
Clinical narrative: I felt fine for the rest of the day after the shot.  That night, went to bed and woke about 2:30 AM with extreme body ache, shaking chills, upset stomach, and dizziness.  The body ache and chills were severe!  EVERYTHING seemed to ache, but particularly my hips. At 8 AM I contacted my doctor to advise her that I thought I was experiencing adverse symptoms to a Shingrix shot received the day before.  She advised me to take 1000 mg Tylenol  in 3 separate doses.  Also suggested that if a cough started I should come in promptly, as I might have simultaneously contracted a virus and could receive treatment for flu.  I followed  her advice.  No cough appeared.  Just lethargy, aches, chills.   The strong adverse symptoms continued for the entire day.  No amount of layered clothing or electrical warmers could ease the chills.  I spent a good share of the day in bed, a new experience for me!   It was a LONG DAY and  I went to sleep early evening.  Slept well.  Next morning, I woke feeling like I have felt most of my life: well, strong, energetic.  Apetite not so good, but chills, aches, dizziness, stomach upset were gone.  A 24 hour NASTY experience!
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Discomfort, Joint range of motion decreased, Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: Extreme pain and soreness in left arm following Tdap vaccination for at least a week, pain causing sleep disturbances and inability to use arm. After about a week the extreme pain subsided to a moderate pain that only became severe when using the arm, lifting the arm, etc. Still experiencing pain, discomfort, and reduced range of motion over a month after recieving the vaccination. I can't lift left arm more than 45 degrees to the side or across the body without significant pain. Treatments so far: I took  OTC antiinflammatories for several days (that didn't really help). After three weeks of pain  I eventually visited an orthoped who prescribed a topical antiinflammatory and physical therapy, to be followed up by an MRI if the physical therapy does not resolve the issues.  I have had one session of PT so far.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Sleep disorder
Clinical narrative: Extreme pain and soreness in left arm following Tdap vaccination for at least a week, pain causing sleep disturbances and inability to use arm. After about a week the extreme pain subsided to a moderate pain that only became severe when using the arm, lifting the arm, etc. Still experiencing pain, discomfort, and reduced range of motion over a month after recieving the vaccination. I can't lift left arm more than 45 degrees to the side or across the body without significant pain. Treatments so far: I took  OTC antiinflammatories for several days (that didn't really help). After three weeks of pain  I eventually visited an orthoped who prescribed a topical antiinflammatory and physical therapy, to be followed up by an MRI if the physical therapy does not resolve the issues.  I have had one session of PT so far.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, X-ray
Clinical narrative: Patient developed busitis at the arm of injection.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Fine motor skill dysfunction, Seizure like phenomena, Speech disorder, Visual impairment
Clinical narrative: Following day after patient received vaccination, patient returned to the pharmacy and stated after the shot (approx 30 min after), pt reported that he had difficult seeing, talking, and his motor skills were impaired. Pt was home at time of incident. Pt spouse called 911 and pt was taken to emergency room. MD took several test too rule out seizure and stroke. Pt states he was at ER for approx 3-4 hours, and steadily improved at ER. Pt was released from ER for seizure-like symptom.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Rash, Swelling face, Swelling of eyelid
Clinical narrative: Woke up next morning (12/12/19) w/swollen face & eyelids. Rash. Otherwise felt fine; no SOB Just to head area. Spoke w/Mom again 12/13/19. Swelling & rash resolving Patient woke up w/a bad headache 4AM 12/13/19. Better w/OTC med
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: The patient stated that his entire left arm was red and swollen from the immunization
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dehydration, Fatigue, Injection site reaction, Pyrexia, Rash papular
Clinical narrative: Patient presented to clinic 12/12 with fever and rash.  His fever started 12/10 with Tmax 102F and lasted 3 days total.  The rash started in the evening 12/11 on the left thigh and spread to the groin, b/l legs, and trunk rapidly over the next 12 hours.  In clinic, patient was dehydrated and tired appearing but not toxic.  The rash was a diffuse papular rash with coalescence on the L lateral thigh.  He followed up in clinic 12/13 and had no further fever in the previous 16 hours.  He was eating and drinking better and the rash was starting to improve.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Malaise, Pyrexia
Clinical narrative: Chills, fevers, stomach upset, weakness for last 3 days. Still not well.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Culture throat negative, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Mother called same day and reports the child went home and slept for several hours and reported feeling weak and like her legs were heavy. Mother assumed it was normal side effects. The next morning she passed out while getting ready for school, had a terrible sore throat and again complained of legs feeling heavy, light headed and very tired. Mother monitored her, gave her juice and peanut butter and stayed home from school with her. She was tired and slept all day, continuing to complain of sore throat, achey and spacey says mother. This provider was called Tuesday night(12/10/19) and the father reports the child was not acting normal and was glassey eyed, staring off into space and passed out again. They were instructed to take her to the ER. Mother reports the ER physican performed lab work , Strept and Flu test and were told everything was normal and it could be a virus and or possible reaction to flu vaccine.  Wednesday morning,  mother reports  she slept for hours and reported feeling exhausted, no fever during the entire time. Thursday, mother reports she was still weak and just wanted to sleep and lay around. Today she returned to the office for follow up from the ER visit. Patient and mother reports she is feeling some better, no sore throat, no fever, no cough, earache, vomiting or diarrhea. The patients reports continued feelings of being tired and just wants to lay around but not as bad as the first few days after the immunization.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Glassy eyes, Influenza virus test negative, Laboratory test normal, Limb discomfort, Loss of consciousness
Clinical narrative: Mother called same day and reports the child went home and slept for several hours and reported feeling weak and like her legs were heavy. Mother assumed it was normal side effects. The next morning she passed out while getting ready for school, had a terrible sore throat and again complained of legs feeling heavy, light headed and very tired. Mother monitored her, gave her juice and peanut butter and stayed home from school with her. She was tired and slept all day, continuing to complain of sore throat, achey and spacey says mother. This provider was called Tuesday night(12/10/19) and the father reports the child was not acting normal and was glassey eyed, staring off into space and passed out again. They were instructed to take her to the ER. Mother reports the ER physican performed lab work , Strept and Flu test and were told everything was normal and it could be a virus and or possible reaction to flu vaccine.  Wednesday morning,  mother reports  she slept for hours and reported feeling exhausted, no fever during the entire time. Thursday, mother reports she was still weak and just wanted to sleep and lay around. Today she returned to the office for follow up from the ER visit. Patient and mother reports she is feeling some better, no sore throat, no fever, no cough, earache, vomiting or diarrhea. The patients reports continued feelings of being tired and just wants to lay around but not as bad as the first few days after the immunization.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Somnolence, Staring, Streptococcus test negative
Clinical narrative: Mother called same day and reports the child went home and slept for several hours and reported feeling weak and like her legs were heavy. Mother assumed it was normal side effects. The next morning she passed out while getting ready for school, had a terrible sore throat and again complained of legs feeling heavy, light headed and very tired. Mother monitored her, gave her juice and peanut butter and stayed home from school with her. She was tired and slept all day, continuing to complain of sore throat, achey and spacey says mother. This provider was called Tuesday night(12/10/19) and the father reports the child was not acting normal and was glassey eyed, staring off into space and passed out again. They were instructed to take her to the ER. Mother reports the ER physican performed lab work , Strept and Flu test and were told everything was normal and it could be a virus and or possible reaction to flu vaccine.  Wednesday morning,  mother reports  she slept for hours and reported feeling exhausted, no fever during the entire time. Thursday, mother reports she was still weak and just wanted to sleep and lay around. Today she returned to the office for follow up from the ER visit. Patient and mother reports she is feeling some better, no sore throat, no fever, no cough, earache, vomiting or diarrhea. The patients reports continued feelings of being tired and just wants to lay around but not as bad as the first few days after the immunization.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram, Fall, Hypoaesthesia, Intervertebral disc protrusion, Laboratory test normal
Clinical narrative: I had a shot while in good health Wed afternoon at 4pm.  I had a sore arm that night.  I awakened to void at 6 am Thursday morning.--and felt perfectly normal in and out and in again,  of bed.   There was the sudden onset about 655 AM  (while still in bed) of rapidly progressive right leg numbness and weakness.  It started in upper buttock/thigh and quickly went all the way down to the toes within mere minutes.  There wasn't much for pain, just a leg that instantly stopped working. I tried to get out of bed, and fell,  later fainted in the kitchen.  I was transported to the ER, where stroke protocol ruled out stroke.  Guillen Barre was felt unlikely.   Labs, brain MR were fine.  After a back MRI, the ER doctor suggested a tiny S1 disc herniation contacting the left S1 nerve was the cause of this complete loss of leg function across the L4-S1 nerve roots.?.   While I can accept this is possible, pain really hasn't been an issue. I can put on my right sock, no problem which hasn't been the case with past sciatica spells   I just want to document this event as it seems so weird, and I am seeing a neurologist as the sciatica diagnosis seems "shaky."    I am a physician and fully accept this may not relate to the flu shot, but the timing and course is so bizarre. As of today(Friday), I am now using a cane to assist walking.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: I had a shot while in good health Wed afternoon at 4pm.  I had a sore arm that night.  I awakened to void at 6 am Thursday morning.--and felt perfectly normal in and out and in again,  of bed.   There was the sudden onset about 655 AM  (while still in bed) of rapidly progressive right leg numbness and weakness.  It started in upper buttock/thigh and quickly went all the way down to the toes within mere minutes.  There wasn't much for pain, just a leg that instantly stopped working. I tried to get out of bed, and fell,  later fainted in the kitchen.  I was transported to the ER, where stroke protocol ruled out stroke.  Guillen Barre was felt unlikely.   Labs, brain MR were fine.  After a back MRI, the ER doctor suggested a tiny S1 disc herniation contacting the left S1 nerve was the cause of this complete loss of leg function across the L4-S1 nerve roots.?.   While I can accept this is possible, pain really hasn't been an issue. I can put on my right sock, no problem which hasn't been the case with past sciatica spells   I just want to document this event as it seems so weird, and I am seeing a neurologist as the sciatica diagnosis seems "shaky."    I am a physician and fully accept this may not relate to the flu shot, but the timing and course is so bizarre. As of today(Friday), I am now using a cane to assist walking.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Walking aid user
Clinical narrative: I had a shot while in good health Wed afternoon at 4pm.  I had a sore arm that night.  I awakened to void at 6 am Thursday morning.--and felt perfectly normal in and out and in again,  of bed.   There was the sudden onset about 655 AM  (while still in bed) of rapidly progressive right leg numbness and weakness.  It started in upper buttock/thigh and quickly went all the way down to the toes within mere minutes.  There wasn't much for pain, just a leg that instantly stopped working. I tried to get out of bed, and fell,  later fainted in the kitchen.  I was transported to the ER, where stroke protocol ruled out stroke.  Guillen Barre was felt unlikely.   Labs, brain MR were fine.  After a back MRI, the ER doctor suggested a tiny S1 disc herniation contacting the left S1 nerve was the cause of this complete loss of leg function across the L4-S1 nerve roots.?.   While I can accept this is possible, pain really hasn't been an issue. I can put on my right sock, no problem which hasn't been the case with past sciatica spells   I just want to document this event as it seems so weird, and I am seeing a neurologist as the sciatica diagnosis seems "shaky."    I am a physician and fully accept this may not relate to the flu shot, but the timing and course is so bizarre. As of today(Friday), I am now using a cane to assist walking.
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Child developed hives 10 minutes after vaccination. He has hx of eggs & nuts allergy & was sent to ER.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient was given MenB vaccine instead of meningococcal ACYW. Patient is not on schedule for school vaccinations. patient's parents contacted.
Sex: F
Vaccine: HPV9
Symptoms: Anogenital warts, Human herpesvirus 6 infection, Papilloma viral infection, Smear cervix
Clinical narrative: Patient diagnosed with hpv 6 and hpv11; This spontaneous report was received from a company representative refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions or allergies and concomitant therapies were reported as unknown. On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, lot # and expiration date unknown) intramuscularly for prevention of human papilloma virus. It was unknown if the patient received a two-dose series or three-dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date in November 2019 (within the past month) the patient was diagnosed with Human Papilloma Virus 6 and 11 (papilloma viral infection). On an unknown date, the patient underwent Papanicolaou test (PAP smear test) (results were not provided). The patient had an unknown procedure to scrape her genital warts as a treatment for papilloma viral infection. The outcome of papilloma viral infection was reported as not recovered.   The causality assessment of the event with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Facial paralysis, Pain
Clinical narrative: Acute Bell's Palsy; Information has been received from a lawyer referring to a male patient (pt) of unknown age. The pt's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 14-FEB-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving the vaccine, the pt suffered left facial paralysis, sharp pain and inability to close his left eye completely. The pt was diagnosed with Acute Bell's Palsy. As a further proximate result, the pt has suffered and will continue to suffer physical limitations, mental and emotional distress, sustained severe progressive and permanent personal injuries, as well as significant medical expenses, pain and suffering, and other damages. The outcome of the event was not recovered and it was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Acute Bell's Palsy was considered a medically significant and disabling event.
Age: 71.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Headache, Hypersomnia, Product dose omission
Clinical narrative: headache back of neck; Slept for 14 hours; This case was reported by a consumer via other manufacturer and described the occurrence of occipital headache in a 71-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included treprostinil (Orenitram) for pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season and Orenitram at an unknown dose and frequency. In November 2019, less than a month after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced occipital headache and sleep excessive. On an unknown date, the outcome of the occipital headache and sleep excessive were unknown.   It was unknown if the reporter considered the occipital headache and sleep excessive to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient had flu shot and slept for 14 hours and missed one dose. The patient occasionally got headache back of the neck. He had minimal health improvement since starting PO Orenitram. The orenitram dose was not changed due to the events of therapeutic response decreased, headache and hypersomnia. Action taken with Flu dose due to the events of therapeutic response decreased, headache and hypersomnia was not reported. At the time of reporting, the outcome of the events of therapeutic response decreased, headache and hypersomnia were unknown. The reporter assessed the causal relationship between the PO Orenitram and the event of therapeutic response decreased as possible. The reporter did not provide causality for the events of headache and hypersomnia.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Got Guillain-Barre; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu trivalent vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist was inquiring about Shingrix, if there was data that it could cause Guillain-Barre as a patient received a flu shot 10 years ago and got Guillain-Barre.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pain of skin
Clinical narrative: feels awful; chills; flu-like symptoms; skin hurts; This case was reported by a consumer via sales rep and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 2nd December 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 3rd December 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced feels awful, chills, influenza-like symptoms and skin pain. On an unknown date, the outcome of the feels awful, chills, influenza-like symptoms and skin pain were unknown.   It was unknown if the reporter considered the feels awful, chills, influenza-like symptoms and skin pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the GlaxoSmithKline employee. The patient received a dose Shingrix shot along with the flu shot, the day before reporting at her primary care physician's office and at the time of reporting, she feels awful, has chills, flu-like symptoms, (no fever) and her skin hurts.
Sex: F
Vaccine: PNC13
Symptoms: Arthropathy, Hypoaesthesia, Mobility decreased, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Lingering numbing pain limiting the movement of her arm; Lingering numbing pain limiting the movement of her arm; Joint issues; discomfort; This is a spontaneous report from a contactable pharmacist. An 84-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# CD0208, Exp date Jan2022, NDC 0005197102), intramuscular in the arm, in Oct2019, at 0.5 ml single, for immunisation. Medical history included ongoing joint disorder (since several years). Concomitant medications were none. The patient experienced lingering numbing pain limiting the movement of her arm, joint issues and discomfort all in 2019 with outcome of unknown.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pneumonia
Clinical narrative: She had not had all of the doses of Prevnar/The child had dose on 02Sep2009. She had another dose 17Nov2011; Child is ill with pneumonia; Child is ill with pneumonia; The child had dose on 02Sep2009. She had another dose 17Nov2011; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse reported that 2-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: F25578) as the second dose, via an unspecified route of administration into thigh on 17Nov2011 at single dose for immunization, received pneumococcal 7-val conj vac (dipht crm197 protein) (PREVNAR) as the first dose, via an unspecified route of administration into thigh on 02Sep2009 at single dose for immunization. There were no medical history and concomitant medications. The child had first dose on 02Sep2009, she had another dose on 17Nov2011. It was reported that previously were using paper charts. The product was documented as Prevnar. They were unsure if it was Prevnar 7 or Prevnar 13. She had not had all of the doses of Prevnar. She was not a regular check up kid. On 03Dec2019, the child was ill with pneumonia. The child went to the immediate care on 03Dec2019. Then she was admitted to the hospital on 03Dec2019 due to pneumonia. The doctor was concerned because the child had pneumonia. If she was properly vaccinated with Prevnar 13, she might not be sick right now. She had not had any recent shots. The organism she was ill with would have been covered if fully immunized. There was no record of recent vaccines. The outcome of pneumonia was not resolved.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal conjugate vaccines  in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Discomfort, Injection site reaction, Rash erythematous, Skin exfoliation
Clinical narrative: Skin begin to peel; pinkish rash on the left deltoid and the upper left arm; Feel discomfort; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 67-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration in the left deltoid on 05Sep2019 at the age of 66 years at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2019, the patient began to feel discomfort following administration. Three to four days later, patient notice pinkish rash on the left deltoid and the upper left arm. Slowly faded away. The rash lasted through 17Sep2019 at which time the skin began to peel. There was no damage to the skin. Patient treated himself with ALLEVE and Prednisone for minor discomfort. The outcome of the event of pinkish rash on the left deltoid and the upper left arm was recovered on 17Sep2019 while unknown for the other events. The information on the batch number has been requested.
Age: 25.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Fatigue, Joint range of motion decreased, Pain, Peripheral swelling
Clinical narrative: Left arm red, swollen, tender, warm to the touch, fever, fatigue, decreased range of motion, pain.
Age: 25.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Left arm red, swollen, tender, warm to the touch, fever, fatigue, decreased range of motion, pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Slept 10 hours the night I had the vaccine then had flu-like symptoms for approximately 24 hours,- aches, fever, headache, chills.  Very sore arm as with the first shot as well.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Slept 10 hours the night I had the vaccine then had flu-like symptoms for approximately 24 hours,- aches, fever, headache, chills.  Very sore arm as with the first shot as well.
Age: 22.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site bruising, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Patient started experiencing right arm pain, difficulty moving arm, intermittent paresthesias in right arm et hand, faint bruising to posterior aspect of right upper arm the evening after the injections were administered.
Age: 57.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Asthenia, Guillain-Barre syndrome, Myalgia
Clinical narrative: ascending paralysis, myalgia, weakness
Age: 57.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Gait inability, Gastroenteritis viral, Guillain-Barre syndrome, Immediate post-injection reaction, Neuropathy peripheral
Clinical narrative: ascending paralysis, myalgia, weakness
Age: 57.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Asthenia, Guillain-Barre syndrome, Myalgia
Clinical narrative: Guillain Barre: patient experienced stomach flu like symptoms for two weeks immediately following the flu shot which then transitioned into neuropathy. patient is now out of hospital but is unable to walk. nerve damage is unknown.
Age: 57.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Gait inability, Gastroenteritis viral, Guillain-Barre syndrome, Immediate post-injection reaction, Neuropathy peripheral
Clinical narrative: Guillain Barre: patient experienced stomach flu like symptoms for two weeks immediately following the flu shot which then transitioned into neuropathy. patient is now out of hospital but is unable to walk. nerve damage is unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 4yo female with adverse reaction to vaccines -left thigh is warm and well perfused with swollen area about 7cm in diameter and annular in appearance on anterior L thigh with puncture mark from one shot far from lesion - slightly dusky and tender/warm in center - no fluctuance.  FROM.  unknown if it was Kinrix or Proquad. Likely local reaction or perhaps extravasation of punctured vein. Dexamethasone 10mg given PO as well as 25mg Benadryl. Will have mother apply ice TID and use benadryl and will see back in 3 days or sooner PRN
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: 4yo female with adverse reaction to vaccines -left thigh is warm and well perfused with swollen area about 7cm in diameter and annular in appearance on anterior L thigh with puncture mark from one shot far from lesion - slightly dusky and tender/warm in center - no fluctuance.  FROM.  unknown if it was Kinrix or Proquad. Likely local reaction or perhaps extravasation of punctured vein. Dexamethasone 10mg given PO as well as 25mg Benadryl. Will have mother apply ice TID and use benadryl and will see back in 3 days or sooner PRN
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Somnolence
Clinical narrative: Rash with redness surrounding immunization sites to bilateral thighs within 5 min of vaccination today. No dyspnea. No oral edema. No distress. Vitals stable.  Benadryl dose administered as below with 10 minutes of vaccination, within 5 minutes of noticed rash. 10 min Update: No spreading rash or hives. No other associated symptoms. 20 min Update: No spreading rash or hives. No other associated symptoms. 30 min Update: Rash improved. Lightened in color and smaller in size. Patient drowsy with benadryl dose, but easily awakened. Vitals stable. Cardio/Pulm exam WNL. No oral edema of new rash. No other associated symptoms.  Four vaccines given today. Flu and prevnar vaccines given previously with no side effects. New vaccines today include MMR and VZV.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient presented to the pharmacy 12/13/19 with a rash on the left arm and said it was very painful, she had been seen by her medical provider but was advised by provider to let us know so we could report it to VAERS.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Emotional distress, Feeling abnormal, Feeling cold, Injection site pain
Clinical narrative: That evening of administration from 8pm to 4am the next day, the patient reports she started to feel extremely cold and shaking, she was upset and crying and felt all over strange. Her arm also hurt in the shoulder, left upper arm muscle for a month she says.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: That evening of administration from 8pm to 4am the next day, the patient reports she started to feel extremely cold and shaking, she was upset and crying and felt all over strange. Her arm also hurt in the shoulder, left upper arm muscle for a month she says.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pyrexia, Swelling
Clinical narrative: FEVER, SWELLING AND ITCHING OF INJECTION SITE
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Flushing, Injection site pain, Insomnia, Joint stiffness
Clinical narrative: Several hours after immunization arm was tender, with muscle ache (as if exercised a lot.). This progressed to severe pain and limited movement due to  pain. Difficult to move arm away from "hanging" position without extreme pain.  Difficult to undress at the end of day due to limited range of motion.  By 10 pm area appeared edematous with pinkish splotches, from shoulder to elbow. Next a.m., flushed facial skin, low grade temp (99.6F).   Malaise.  Extreme pain of right upper arm. Little relief from analgesic (ibuprofen).  No change in arm appearance or feeling until Thursday, when arm symptoms started to subside.  Thursday afternoon, noted achiness in knees,  progressing to overall pain in legs, mainly around joints. Pain did not allow for sleep, as bilateral calves and knee areas felt "tight", almost burning.  More motrin, better this morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased, Muscle tightness, Myalgia
Clinical narrative: Several hours after immunization arm was tender, with muscle ache (as if exercised a lot.). This progressed to severe pain and limited movement due to  pain. Difficult to move arm away from "hanging" position without extreme pain.  Difficult to undress at the end of day due to limited range of motion.  By 10 pm area appeared edematous with pinkish splotches, from shoulder to elbow. Next a.m., flushed facial skin, low grade temp (99.6F).   Malaise.  Extreme pain of right upper arm. Little relief from analgesic (ibuprofen).  No change in arm appearance or feeling until Thursday, when arm symptoms started to subside.  Thursday afternoon, noted achiness in knees,  progressing to overall pain in legs, mainly around joints. Pain did not allow for sleep, as bilateral calves and knee areas felt "tight", almost burning.  More motrin, better this morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Several hours after immunization arm was tender, with muscle ache (as if exercised a lot.). This progressed to severe pain and limited movement due to  pain. Difficult to move arm away from "hanging" position without extreme pain.  Difficult to undress at the end of day due to limited range of motion.  By 10 pm area appeared edematous with pinkish splotches, from shoulder to elbow. Next a.m., flushed facial skin, low grade temp (99.6F).   Malaise.  Extreme pain of right upper arm. Little relief from analgesic (ibuprofen).  No change in arm appearance or feeling until Thursday, when arm symptoms started to subside.  Thursday afternoon, noted achiness in knees,  progressing to overall pain in legs, mainly around joints. Pain did not allow for sleep, as bilateral calves and knee areas felt "tight", almost burning.  More motrin, better this morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Several hours after immunization arm was tender, with muscle ache (as if exercised a lot.). This progressed to severe pain and limited movement due to  pain. Difficult to move arm away from "hanging" position without extreme pain.  Difficult to undress at the end of day due to limited range of motion.  By 10 pm area appeared edematous with pinkish splotches, from shoulder to elbow. Next a.m., flushed facial skin, low grade temp (99.6F).   Malaise.  Extreme pain of right upper arm. Little relief from analgesic (ibuprofen).  No change in arm appearance or feeling until Thursday, when arm symptoms started to subside.  Thursday afternoon, noted achiness in knees,  progressing to overall pain in legs, mainly around joints. Pain did not allow for sleep, as bilateral calves and knee areas felt "tight", almost burning.  More motrin, better this morning.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient has had persisting right upper arm pain since vaccine administration
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Patient was due for Dtap, HIB, IPV. she was given the DTAP and IPV portion of the of the pentacel vaccine. it was not mixed with the HIB powder.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 6 hrs after vaccination, patient experienced swelling and itchiness at the injection site.   The swelling was approximately 4 inches in diameter.  Patient took benadryl and used hydrocortizone cream and a cold pack.  The symptoms did not resolve, and did not worsen.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient had 3-4 linear vescicles with red base appear on upper posterior deltoid about 2 days after injection to opposit (left) arm.  Resolved on own; however, slightly reddened area still visible at 2 month revaccination.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: Patient received only the diluent for the oral dose of rota virus
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Urticaria
Clinical narrative: Patient developed hives the same day vaccines were given. lasted approximately 24 hours
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Case of shingles developed early December, 2019
Age: 89.0
Sex: M
Vaccine: FLUA3
Symptoms: Blood test, Computerised tomogram head, Depression, Eating disorder, Eye discharge
Clinical narrative: 13:18:04 checked into pharmacy For Flu shot. Sat on bench waiting For Wife to pick up a Few groceries. About 14:00 P.M. Grandson stopped to talk to me, he noticed L side of face drooping. I checked out groceries at 14:30:03 pm. Went to restaurant to eat. Sat across from my husband Noticed L side of Face drooping. Checked for signs of stroke None Noted, walking, talking ok, NO ARM weakness, no slurred speech, Eating & drinking OK. Arrived home checked again for stroke symptoms, NONe, gave him a 325 mg. aspirin, watched him closely aLL day. Night. In morning Looked worse, could not drink without straw. Took him to Hospital ER. While checking in they said a nurse had a Flu shot & got Bell's palsy. Seen Dr. and another Dr., stated Bell's Palsy, very rare but happens. Ordered Lab drawn & brain scan. Put him on Valacyclovir HCL 1 gram t. 21 tabs -1- tab every 8hrs for -7- days & Prednisone 20 mg tabs -3- tabs a day For -7- days & eye drops, said ENT Dr. usually takes care of this. We had an appointment with Dr. Nov 7th said okay to wait untill then. Dr. said Full blown Bell's Palsy, added Prednisone packet For -6- more days. Could not close L eye, continue with eye drops, showed me how to tape eye shut at Not time. Noticed eye getting red & yellowish green drainage so took him to Ophthalmologist Dr, changed meds and showed me how to tape eye the right way, stated, can get ulcer in cornia. Eye has to be checked every 4-6 wks. Patient has difficulty seein eating, has to drink with a straw. I took him to his Family Dr., have seen Dr. three times, Dr 2 times, have appointment 01-14-2020 Have heard of three others plus patient got Bells Palsy after getting the Flu shot. My husband is depressed over it.
Age: 89.0
Sex: M
Vaccine: FLUA3
Symptoms: Eyelid function disorder, Facial paralysis, Ocular hyperaemia, Visual impairment
Clinical narrative: 13:18:04 checked into pharmacy For Flu shot. Sat on bench waiting For Wife to pick up a Few groceries. About 14:00 P.M. Grandson stopped to talk to me, he noticed L side of face drooping. I checked out groceries at 14:30:03 pm. Went to restaurant to eat. Sat across from my husband Noticed L side of Face drooping. Checked for signs of stroke None Noted, walking, talking ok, NO ARM weakness, no slurred speech, Eating & drinking OK. Arrived home checked again for stroke symptoms, NONe, gave him a 325 mg. aspirin, watched him closely aLL day. Night. In morning Looked worse, could not drink without straw. Took him to Hospital ER. While checking in they said a nurse had a Flu shot & got Bell's palsy. Seen Dr. and another Dr., stated Bell's Palsy, very rare but happens. Ordered Lab drawn & brain scan. Put him on Valacyclovir HCL 1 gram t. 21 tabs -1- tab every 8hrs for -7- days & Prednisone 20 mg tabs -3- tabs a day For -7- days & eye drops, said ENT Dr. usually takes care of this. We had an appointment with Dr. Nov 7th said okay to wait untill then. Dr. said Full blown Bell's Palsy, added Prednisone packet For -6- more days. Could not close L eye, continue with eye drops, showed me how to tape eye shut at Not time. Noticed eye getting red & yellowish green drainage so took him to Ophthalmologist Dr, changed meds and showed me how to tape eye the right way, stated, can get ulcer in cornia. Eye has to be checked every 4-6 wks. Patient has difficulty seein eating, has to drink with a straw. I took him to his Family Dr., have seen Dr. three times, Dr 2 times, have appointment 01-14-2020 Have heard of three others plus patient got Bells Palsy after getting the Flu shot. My husband is depressed over it.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Tremor
Clinical narrative: EXTREME ITCHING: 1. UPPER + LOWER BACK 2. LEFT LEG 3. INTERNAL TREMERS (WHOLE BODY) 4. BROKE OUT IN A RASH (WHOLE BODY) LAST MEDICATION TAKEN ON 11-28-2019 AT FIRST I DIDN'T THINK MUCH OF THE ITHCING, BUT GOT STEADILY WORSE TRIED BENADRYL ON MY OWN, DID NOTHING THINGS GOT WORSE, I DECIDED IT WAS TIME TO SEE A DOCTOR. WENT TO WALK IN TYPE CLINIC. WAS PRESCRIBED: 1. HYDROXYZINE (ATATAX) 2. METHYLPREDNISOLONE (MEDROL DOSEPACK) 3. INJECTION OF CORTAZONE AT THE CLINIC THINGS STARTED GETTING BETTER AFTER ABOUT A WEEK THIS WAS PRETTY BAD. I HOPE YOU CHECK THIS OUT, SO NO ONE ELSE GOES THREW THIS, IF POSSIBLE
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: the patient developed a "swelling of the arm by the injection site"; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date in November 2019 (reported as last week), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 dose, lot # R012360, expiration date: 15-JAN-2020 (injection site and route of administration were not provided) for prophylaxis. On an unknown date in November 2019, he developed a swelling of the arm by the injection site. The nurse noted that she had not seen this patient back at the office.   The outcome of injection site swelling was unknown. The relatedness between the event and the suspect therapy was not reported.