chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Obsessive-compulsive disorder, Paraesthesia, Post-traumatic stress disorder
Clinical narrative: She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate, Sinus disorder, Streptococcus test
Clinical narrative: She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Erythema of left upper arm around injection site, tenderness and itching around injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to metals, Furuncle, Infection, Pruritus, Rash vesicular
Clinical narrative: Chicken pox like symptoms, pimple-like boils, VERY itchy, lumpy under skin even on muscles, scaling, slight infection and no healing where spots were scratched.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scratch, Skin exfoliation, Skin mass, Skin test positive
Clinical narrative: Chicken pox like symptoms, pimple-like boils, VERY itchy, lumpy under skin even on muscles, scaling, slight infection and no healing where spots were scratched.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Secretion discharge, Skin ulcer, Varicella
Clinical narrative: Chicken pox like symptoms, pimple-like boils, VERY itchy, lumpy under skin even on muscles, scaling, slight infection and no healing where spots were scratched.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash starting 2 days after vaccine and persisting several days. No response to Benadryl. Prednisone prescribed 3/26/19 (date of report).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Monoplegia, Neuralgic amyotrophy
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of arm paralysis in a 56-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received SHINGRIX (intramuscular). On an unknown date, 56 days after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant) and parsonage-turner syndrome. On an unknown date, the outcome of the arm paralysis and parsonage-turner syndrome were not recovered/not resolved. It was unknown if the reporter considered the arm paralysis and parsonage-turner syndrome to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 56 or 57 years old. The patient received SHINGRIX on left arm. It was reported that approximately eight weeks after receiving SHINGRIX, the patient experienced parsonage turner syndrome. The physician reported that the patient was paralyzed in her left arm. He claimed that her arm would recover but it would take approximately a year. He also claimed that her reaction was an immunologic reaction and had nothing to do with the actual needle and that the condition could happen with any of the vaccine. The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Diarrhoea, Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: No fever. On Saturday evening 01-26 after shot my left arm was slightly red and swollen. Still uncomfortable 01-27. Then at 3:30 AM Monday (01-28) I woke with really awful diarrhea and throwing up. Episodes would last 15-20 minutes or so, then repeat in about 1 1/2 to 2 hours. Could not take even water called Dr. about 3:30 pm 01-29 and he sent me to emergency room for fluids and nausea shot. Last in 2 days. Better 02-01.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: No fever. On Saturday evening 01-26 after shot my left arm was slightly red and swollen. Still uncomfortable 01-27. Then at 3:30 AM Monday (01-28) I woke with really awful diarrhea and throwing up. Episodes would last 15-20 minutes or so, then repeat in about 1 1/2 to 2 hours. Could not take even water called Dr. about 3:30 pm 01-29 and he sent me to emergency room for fluids and nausea shot. Last in 2 days. Better 02-01.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Pain, Urticaria
Clinical narrative: Arm at injection site swelled up. Turn red and blue. Painful for 5 days. Developed hives for 5 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest X-ray, Full blood count, Herpes zoster, Pneumonia
Clinical narrative: The shot was on Mon 2/25, by Friday I was very weak and coughing up green sputum. On Sun March 3, I started erupting shingles lesions - look LEVAQUIN for pneumonia.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Productive cough, Sputum discoloured
Clinical narrative: The shot was on Mon 2/25, by Friday I was very weak and coughing up green sputum. On Sun March 3, I started erupting shingles lesions - look LEVAQUIN for pneumonia.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Pt came in for a adult Hep B vaccine for her work and seen the provider, after she finished seeing the provider I gave her the Adult hep B vaccine and then documented the vaccine at which time I then seen that the pt had already had the 3 required doses of Hep B as a child.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Diarrhoea, Erythema, Headache, Lethargy
Clinical narrative: Arm swelled, 3 inch raised red bump that now has turned to a purple bruise- no biggie. Nausea, headache, lethargy and EXPLOSIVE diarrhea...big deal. It?s been 4 days now.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Arm swelled, 3 inch raised red bump that now has turned to a purple bruise- no biggie. Nausea, headache, lethargy and EXPLOSIVE diarrhea...big deal. It?s been 4 days now.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Decreased eye contact, Diarrhoea, Ear infection, Faeces discoloured, Irritability
Clinical narrative: Itchy, bleeding rash covering body with small red spots, loss of vocabulary (10 words to 0, but I could tell he was frustrated trying to speak like he used to), ear infections, throwing up, white stool, diarrhea, lack of eye contact, disrupted sleeping schedule, irritability. My son was completely different the same day, and continued to worsen for nearly a month. I started juicing with heavy metal binders like cilantro and parsley, within days he was returning to his healthy state.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Purpura, Rash erythematous, Rash generalised, Rash pruritic, Sleep disorder
Clinical narrative: Itchy, bleeding rash covering body with small red spots, loss of vocabulary (10 words to 0, but I could tell he was frustrated trying to speak like he used to), ear infections, throwing up, white stool, diarrhea, lack of eye contact, disrupted sleeping schedule, irritability. My son was completely different the same day, and continued to worsen for nearly a month. I started juicing with heavy metal binders like cilantro and parsley, within days he was returning to his healthy state.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Itchy, bleeding rash covering body with small red spots, loss of vocabulary (10 words to 0, but I could tell he was frustrated trying to speak like he used to), ear infections, throwing up, white stool, diarrhea, lack of eye contact, disrupted sleeping schedule, irritability. My son was completely different the same day, and continued to worsen for nearly a month. I started juicing with heavy metal binders like cilantro and parsley, within days he was returning to his healthy state.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: 3-20-19 Mom called at 4 PM stating pt had been complaining of pain in arm where she got shot since vaccination. Mom had not looked at arm until now and states there is no swelling or redness. Mom encouraged to make contact with PCP if symptoms persist. No use of mobility. 3-22-19 Mom called again and states pt still C/O arm pain but mom has not followed up with MD. Questioned about prior injury or symptoms, over use etc. Pt is a cheerleader. 03-26-19 I called mom to follow up on pt and she states that pt hasn't complained since our last conversation on 3-22-19. Pt refused to go to ER for check per mom. Mom cut our conversation short stating she was "watching children and had to go". Again encouraged to follow up with PCP.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Activated partial thromboplastin time, Angiogram cerebral, Arteriogram carotid, Chest X-ray, Computerised tomogram head
Clinical narrative: Bells Palsy diagnosed on 09/19/18 (3 weeks after vaccination). Ear discomfort for approximately 10 days prior to 09/19/18. Severe headache for approximately 4 days prior to 09/19/18.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Ear discomfort, Electrocardiogram, Facial paralysis, Full blood count, Headache
Clinical narrative: Bells Palsy diagnosed on 09/19/18 (3 weeks after vaccination). Ear discomfort for approximately 10 days prior to 09/19/18. Severe headache for approximately 4 days prior to 09/19/18.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging brain, Prothrombin time, Troponin I
Clinical narrative: Bells Palsy diagnosed on 09/19/18 (3 weeks after vaccination). Ear discomfort for approximately 10 days prior to 09/19/18. Severe headache for approximately 4 days prior to 09/19/18.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphonia, Dysphonia, Full blood count, Hypersensitivity, Laryngitis
Clinical narrative: 03/18/2019: INITIAL OFFICE VISIT: Chief Complaint(s): Sore throat  All over body rash Hoarseness, lost voice HPI: Notes Pt presents today for an acute visit. Dermatology c/o rash  generalized, upper extremities, lower extremities, trunk, groin , itchy, spreading, raised lesions, hives since yesterday morning, was spreading, has been taking benadryl with some relief, woke up this morning with hoarseness, and sore throat, voice is improving now. Itching is much better, voice is raspy, denies feeling ill or achy or fever, chills, abdominal pain, nausea, vomiting, diarrhea. ENT Denies : COUGH. Denies : EAR PAIN. Denies : EYE SYMPTOMS. Denies : HEADACHE. HOARSENESS  laryngitis, improving since this morning, denies difficulty swallowing. Treatment: Rash and other nonspecific skin eruption  Notes: Discussed various etiologies, most likely allergic reaction. Will start prednisone taper and Benadryl x 5 days. To go to ED with any worsening of symptoms. Advised patient to stay away from hot showers as much as possible, Keep well moisturized, may need to follow up with dermatologist if persistent. Acute laryngitis Notes: Most likely viral vs due to postnasal drip, symptomatic treatment advised. Symptoms are improving. Rapid strep negative. PATIENT RE-EVALUATED ON 03/21/2019: Symptoms mostly resolved PATIENT RE-EVALUATED ON 3/26/2019 TO ENSURE RESOLVEMENT OF ABOVE SYMPTOMS All symptoms resolved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pruritus, Rash generalised, Skin lesion, Streptococcus test negative
Clinical narrative: 03/18/2019: INITIAL OFFICE VISIT: Chief Complaint(s): Sore throat  All over body rash Hoarseness, lost voice HPI: Notes Pt presents today for an acute visit. Dermatology c/o rash  generalized, upper extremities, lower extremities, trunk, groin , itchy, spreading, raised lesions, hives since yesterday morning, was spreading, has been taking benadryl with some relief, woke up this morning with hoarseness, and sore throat, voice is improving now. Itching is much better, voice is raspy, denies feeling ill or achy or fever, chills, abdominal pain, nausea, vomiting, diarrhea. ENT Denies : COUGH. Denies : EAR PAIN. Denies : EYE SYMPTOMS. Denies : HEADACHE. HOARSENESS  laryngitis, improving since this morning, denies difficulty swallowing. Treatment: Rash and other nonspecific skin eruption  Notes: Discussed various etiologies, most likely allergic reaction. Will start prednisone taper and Benadryl x 5 days. To go to ED with any worsening of symptoms. Advised patient to stay away from hot showers as much as possible, Keep well moisturized, may need to follow up with dermatologist if persistent. Acute laryngitis Notes: Most likely viral vs due to postnasal drip, symptomatic treatment advised. Symptoms are improving. Rapid strep negative. PATIENT RE-EVALUATED ON 03/21/2019: Symptoms mostly resolved PATIENT RE-EVALUATED ON 3/26/2019 TO ENSURE RESOLVEMENT OF ABOVE SYMPTOMS All symptoms resolved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 03/18/2019: INITIAL OFFICE VISIT: Chief Complaint(s): Sore throat  All over body rash Hoarseness, lost voice HPI: Notes Pt presents today for an acute visit. Dermatology c/o rash  generalized, upper extremities, lower extremities, trunk, groin , itchy, spreading, raised lesions, hives since yesterday morning, was spreading, has been taking benadryl with some relief, woke up this morning with hoarseness, and sore throat, voice is improving now. Itching is much better, voice is raspy, denies feeling ill or achy or fever, chills, abdominal pain, nausea, vomiting, diarrhea. ENT Denies : COUGH. Denies : EAR PAIN. Denies : EYE SYMPTOMS. Denies : HEADACHE. HOARSENESS  laryngitis, improving since this morning, denies difficulty swallowing. Treatment: Rash and other nonspecific skin eruption  Notes: Discussed various etiologies, most likely allergic reaction. Will start prednisone taper and Benadryl x 5 days. To go to ED with any worsening of symptoms. Advised patient to stay away from hot showers as much as possible, Keep well moisturized, may need to follow up with dermatologist if persistent. Acute laryngitis Notes: Most likely viral vs due to postnasal drip, symptomatic treatment advised. Symptoms are improving. Rapid strep negative. PATIENT RE-EVALUATED ON 03/21/2019: Symptoms mostly resolved PATIENT RE-EVALUATED ON 3/26/2019 TO ENSURE RESOLVEMENT OF ABOVE SYMPTOMS All symptoms resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Low grade fever, 7 PM day of vaccination. Soreness and lump at vaccination site. Next morning, 2-28-19 had a severe headache, nausea, ached, shivered, generally felt awful for 48 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site mass, Vaccination site pain
Clinical narrative: Low grade fever, 7 PM day of vaccination. Soreness and lump at vaccination site. Next morning, 2-28-19 had a severe headache, nausea, ached, shivered, generally felt awful for 48 hours.
Age: 37.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No current symptoms. After administration, it was noted that vaccine was closer than 28 days from first injection in series. This is being reported in advance in case adverse reactions occur.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Vaccination site pain, Vomiting
Clinical narrative: Shot given while standing up. Patient was still at the doctor's office when reaction occurred. Patient had similar reaction as his brother. Within 2 minutes, patient started feeling dizzy, then ended up vomiting, and had headache. Patient moved to another room to lay down. Patient given water and apple juice.  Patient stayed in the room for 15-20 minutes if not more. Everything subsided; patient felt better and enough to get up on his own and walk. Left doctor's office after about 1 hour. The site of vaccination sore until the next day. Did not take any meds or did any treatment at home.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Loss of consciousness, Tinnitus, Vomiting
Clinical narrative: Patient was still at the doctor's office when reaction occurred. Patient had similar reaction as his brother, passing out and then vomited. Patient felt better after getting sick. His reaction was not as long but happened quicker. Patient did not have to lay down. Mom put cold paper towels on his forehead.  Patient had ringing in his ears for about 5 minutes. Patient had pain at site of injection and upper part of arm at night and next day. Patient took no medicine and did not do any treatment at home. Patient left doctor's office after 1 hour and was fine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Malaise, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient developed a 6 cm diameter red, swollen area around site of vaccination. It was also warm to the touch. He also suffered fatigue and malaise for approximately 36 hours following the injection. He spent that 36 hours in bed, unable to get up and function normally. On 03/26/19 he was seen in our office and still had a 3-4 cm red, slightly raised area around the site of the injection. The fatigue and malaise were gone.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Peripheral swelling, Skin discolouration, Skin tightness, Skin warm
Clinical narrative: I'm actually not sure if the Dtap was INFANRIX or the other- I don't have that information. About 24 hours after injection, the patient complained of pain when bending her leg, and hives were noticed later that evening. Her whole thigh was enlarged, hot, and tight to the touch. We went to Urgent Care and BENADRYL/monitoring was recommended. Swelling finally subsided by 3/22/2019 but discoloration remains.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: I'm actually not sure if the Dtap was INFANRIX or the other- I don't have that information. About 24 hours after injection, the patient complained of pain when bending her leg, and hives were noticed later that evening. Her whole thigh was enlarged, hot, and tight to the touch. We went to Urgent Care and BENADRYL/monitoring was recommended. Swelling finally subsided by 3/22/2019 but discoloration remains.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema annulare, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to clinic with parent about 48 hours after administration requesting provider/nursing to advise. It is unclear when exactly the reaction started. SubQ site did not have any visible abnormalities. Both IM injection sites were red, swollen, and warm. R deltoid is documented at 6cm annular erythema, no induration. Left deltoid IM inj site documented at 4cm annular with erythema- no induration. Provider visualized. RN and provider educated parent on localized reaction to vaccination. Ice/Cold therapy and NSAIDs recommended for swelling and pain reduction. Return to clinic if not improved.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was given his vaccines and he walked over to his seat nearer his mother, when he fainted, around 09:45, 5 min after he was vaccinated. He was unconscious for approximately a minute, he then woke up and was startled that we were all standing around him. He had no recollection of  fainting. His BP was 108/70, HR 44. He was alert and oriented. He claimed that he has fainted before when he has had to get his blood drawn. His VS did not change from his earlier assessment. He is noted to have a slow HR from his previous visit. His provider did come into the injection room to see him.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Neck pain, Neuralgia, Paraesthesia
Clinical narrative: I did have some flu like symptoms the following day after the initial vaccine but then I also felt tremendous electric pain in my neck and shoulder on the side the shot was given to me (left upper arm). The pain has consistently gotten extremely bad. It feels like nerve pain. It does sometime dissipate but it's gotten progressively worse over the last 2.5 months to the point where I have had an X-ray of the neck and cervical spine and now I have an appointment to see a Neurologist.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal X-ray normal
Clinical narrative: I did have some flu like symptoms the following day after the initial vaccine but then I also felt tremendous electric pain in my neck and shoulder on the side the shot was given to me (left upper arm). The pain has consistently gotten extremely bad. It feels like nerve pain. It does sometime dissipate but it's gotten progressively worse over the last 2.5 months to the point where I have had an X-ray of the neck and cervical spine and now I have an appointment to see a Neurologist.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Hyperaesthesia, Injection site rash, Malaise
Clinical narrative: Hi I finally got my first SHINGRIX vaccine on Wednesday 3/20. I got the expected sore arm and local redness and swelling. I also got fatigue and malaise. What I did not expect was a rash all along my shoulders, neck itching and sensitivity on my upper back like open sores. The rash is gone. The itching persists on my back and is sensitive.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash, Swelling
Clinical narrative: Hi I finally got my first SHINGRIX vaccine on Wednesday 3/20. I got the expected sore arm and local redness and swelling. I also got fatigue and malaise. What I did not expect was a rash all along my shoulders, neck itching and sensitivity on my upper back like open sores. The rash is gone. The itching persists on my back and is sensitive.
Sex: F
Vaccine: HIBV
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a female nurse practitioner of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-FEB-2019, the nurse practitioner, while trying to prepare a dose of LIQUID PEDVAXHIB, lot # R004964, expiration date 26-NOV-2020 (dose and indication were not reported), got some of it in her eyes. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a health professional referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-JUN-2018, the patient was vaccinated with the first dose of VAQTA intramuscularly (dosage schedule, anatomical location, lot number and expiration date were not reported), indicated for prophylaxis. Then on 27-AUG-2018, the patient received the second dose (inappropriate schedule of product administration).
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 14-MAR-2019, the patient was vaccinated with a dose of ROTATEQ orally, lot# R034700, expiration date 16-JUN-2020 (exact dose and frequency were not reported) for prophylaxis. On an unknown day in March 2019 (reported as about 8 hours later) the patient experienced fever "of 102" which resolved on an unknown date in March 2019 (reported as within 24 hours). The relatedness between the event and ROTATEQ was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA010123.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine yesterday from the reporting date and had common side effects such as headache and fever. The patient asked whether to take a fever reducer or cold medicine to counteract these side effects. The patient denied permission to contact their physician and said the patient would call their local pharmacy regarding the same issue. Further the patient told that the patient did not like to give too much information on the internet, and the patient already given more information than the patient was comfortable giving.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, injection site erythema, injection site swelling and sleepiness. On 24th January 2019, the outcome of the influenza-like symptoms, general body pain, injection site erythema, injection site swelling and sleepiness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, injection site erythema, injection site swelling and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, when the patient woke up, she had flu like symptoms and felt achy all over. The patient was very sleepy and slept all day. The patient states that the injection site was red and swollen as well. After the call was concluded, the representative realized that they did not get injection site information. Attempt was made to reach out to patient to obtain this information. The patient did not consent to follow up.
Age: 1.0
Sex: M
Vaccine: MMRV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 12 months old male patient who received vaccines ADACEL instead of DAPTACEL which was ordered (lot number, expiry date, dose, dose in series, route and site of administration was not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD. On 18-Mar-2019, the patient received a dose of suspect DAPTACEL (lot number: U5979AA and expiry date: 13-Jun-2020) via intramuscular route in right vastus lateralis. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was not reported if any adverse event occurred or not. 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 and Module VI of the 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. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 7 months old male patient who received 0.5 ml third dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE (Liquid: lot: UJ100AB, Expiry date Jun-2020) via unknown route in the left thigh on 13-Feb-2019. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the patient was administered with just the diluent-DTAP IPV portion and the lyophilized powdered-ACTHIB portion was not administered. No side effects 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 and Module VI of the 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. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer). This case involves unknown age and gender patient who experienced allergy to tetanus vaccines and toxoid, while he/she received vaccine TETANUS TOXOID. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus vaccines and toxoid (allergy to vaccine) <with unknown latency following the administration of TETANUS TOXOID. Other relevant tests included No lab data. Final diagnosis was allergy to tetanus vaccines and toxoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus vaccines and toxoid. List of documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Hives on face; red face splotches.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Post VARIVAX varicella; rash.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Got PPSV23, same day entire left arm red, no pain, no fever.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Hot flush, Lethargy
Clinical narrative: Patient reports, "I had a reaction to the flu shot I received on Tuesday (12/11/2018). I got the shot at 9:15 AM and by 3 or 4 PM was starting to feel week. I developed a fever and fluctuated between having cold chills and hot flashes until early Wednesday morning when the fever finally broke. I felt lethargic on Wednesday and had a persistent headache throughout the day so stayed home from work. I feel entirely normal now but wanted to report my reaction since it is the first time I've ever responded in any way to a vaccine".
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient reports, "I had a reaction to the flu shot I received on Tuesday (12/11/2018). I got the shot at 9:15 AM and by 3 or 4 PM was starting to feel week. I developed a fever and fluctuated between having cold chills and hot flashes until early Wednesday morning when the fever finally broke. I felt lethargic on Wednesday and had a persistent headache throughout the day so stayed home from work. I feel entirely normal now but wanted to report my reaction since it is the first time I've ever responded in any way to a vaccine".
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills and body aches which lasted about 8 hours. Fatigue is ongoing, so far it's 13 hours since it started.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Palpitations
Clinical narrative: About 12 hrs. after shot, violent shaking chills, followed by racing, pounding heart and intense headache, lasting for hours. Chills changed to fever. The racing, pounding heart was the scariest part. All this led to no sleep that night. Next day, headache is still with me, along with exhausting fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: About 12 hrs. after shot, violent shaking chills, followed by racing, pounding heart and intense headache, lasting for hours. Chills changed to fever. The racing, pounding heart was the scariest part. All this led to no sleep that night. Next day, headache is still with me, along with exhausting fatigue.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Somnolence
Clinical narrative: Chronic Sleepiness during the day! I feel like I just want to lay down and go to sleep while at work since the injection date. Lost all my energy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash pustular, Rash vesicular
Clinical narrative: Severe chicken pox-like rash covering entire body, some of the rash progressed to pustule-like sores. Severe itching noted with child, mild fever of 100.7 F.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain in extremity
Clinical narrative: Patient stated she had chills, weakness, and a sore arm for 3 days after receiving the vaccine.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Hallucination, Panic attack
Clinical narrative: Hallucinations and panic attack lasting 24 hours.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: PATIENT COMPLAINED OF BEING TIRED, HAVING ENTIRE BODY ACHE, AND CHILLS AFTER GETTING SHOT ON 3/24/10. SHE HAD TAKEN IBUPROFEN AND FELT TEMPORORAY RELIEF. SHE CONTINUES TO EXPERIENCE SYMPTOMS WHEN SHE CALLED PHARMACY ON 3/25/19. HER DR WAS CONTACTED AND WILL CALL PATIENT TO FOLLOW UP AND POSSIBLY SCHEDULE CHECK UP.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Paraesthesia, Rash
Clinical narrative: PATIENT REPORTS: SEVERE HEADACHE LASTING SEVERAL DAYS, HOT/RED/BURNING RASH ON ARM OF INJECTION THAT TURNED PURPLE (NO RAISED LESIONS ON THE ARM), FEELING "PINS AND NEEDLES" ALL OVER HER BODY, RAISED RASH WITH BLISTERS ON NECK - PER PATIENT HER PHYSICIAN DIAGNOSED HER WITH SHINGLES IN THAT AREA; PATIENT STATES THE RASH IS STILL NOT CLEARED UP (11 DAYS LATER) AND IS STILL RED AND ITCHY.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular, Skin discolouration, Skin warm
Clinical narrative: PATIENT REPORTS: SEVERE HEADACHE LASTING SEVERAL DAYS, HOT/RED/BURNING RASH ON ARM OF INJECTION THAT TURNED PURPLE (NO RAISED LESIONS ON THE ARM), FEELING "PINS AND NEEDLES" ALL OVER HER BODY, RAISED RASH WITH BLISTERS ON NECK - PER PATIENT HER PHYSICIAN DIAGNOSED HER WITH SHINGLES IN THAT AREA; PATIENT STATES THE RASH IS STILL NOT CLEARED UP (11 DAYS LATER) AND IS STILL RED AND ITCHY.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently given Adult dose of HepA instead of pediatric.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: Red swollen painful injection site as large as patient's right palm. Hot to touch. Patient had itchy sensation all over the body. Patient took BENADRYL with some relief.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Developmental delay, Injection site erythema, Injection site papule, Lethargy, Rash erythematous
Clinical narrative: Father, reports patient seemed emotionless, lethargic for about 8 days. She seemed to stop making developmental progress for about 3 weeks and seemed to make less sounds. She also had some diffuse red spots that are now resolving. She has now been back to her baseline, seems alert and dad says she seems to be making good developmental progress. Her exam today was unremarkable with normal tone and alertness. She has a single faint red papule on her left lower leg.
Age: 1.33
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently given Adult dose HepA instead on Pediatric.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Flushing, Hypoaesthesia
Clinical narrative: Client received MMR as part of a measles outreach clinic due to measles outbreak. Client reported that within 30 minutes she started coughing, felt shortness of breath, jaw became numb and face and chest started to flush.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently given Adult HepA instead on Pediatric dose.
Age: 0.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Musculoskeletal disorder
Clinical narrative: The patient came to pharmacy 2 days later complaining of pain, redness, and swelling at the injection site. Pt said she felt a knot where the injection was given. Could not sleep on the left side of her body. Had limited use of her arm due to pain. Thought the injection was given too high in the arm and worried that she has tendon damage.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: The patient came to pharmacy 2 days later complaining of pain, redness, and swelling at the injection site. Pt said she felt a knot where the injection was given. Could not sleep on the left side of her body. Had limited use of her arm due to pain. Thought the injection was given too high in the arm and worried that she has tendon damage.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently given Adult dose HepA instead of Pediatric.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: No adverse effect.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient reports feeling feverish the night after receiving his vaccine, however never checked his temperature. The patient reports feeling muscle pain in his legs and lower back starting the day after receiving the vaccine. The patient was still able to perform his daily activities by going to work despite these symptoms.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning a male patient of unknown age. Patient's historical condition, concurrent conditions, concomitant medication, previously drug reactions and allergies were not reported. On an unknown date, while receiving a dose of varicella virus vaccine live (Oka/Merck) subcutaneously for prophylaxis, lot number R024265 with expiration date 26-AUG-2020 (strength and anatomical location were not reported) the patient moved his arm and only a partial dose of the vaccine was administered (Incomplete dose administered). The outcome of the incomplete dose administered was unknown. The causal relationship between the incomplete dose administered and the varicella virus vaccine live (Oka/Merck) was not provided. No adverse effects were reported in the patient.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. In an unspecified date in 2006, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, also reported as (2 months after the first dose), the patient received the second dose of GARDASIL 9. On an unknown date, also reported as (2 weeks early), the patient was administered the third dose of GARDASIL 9 (inappropriate schedule of product administration). The outcome of the event inappropriate schedule of product administration was not reported.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Apparent death, Hypersensitivity, Loss of consciousness, Road traffic accident
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (consumer) on 15-Mar-2019, concerning a 74-year-old, elderly, female patient. On 12-Mar-2019, in the morning, the patient was administered FLUAD TIV [batch number: 250798, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported] for influenza prophylaxis. On the same day after vaccination, the patient rested for more than 15 minutes, then she had a medical consultation with her doctor, at the same clinic, between 10:00 and 11:30 am (reported as patient could not remember the exact time). After that, the patient left the clinic, and while driving, she passed out and had an accident with the car, around 12 pm (12:29 PM as per the accident report) (reported as almost died). The patient went to an emergency room and received 2 antihistamines (unspecified). Her medical report states that, she had a major allergy reaction', but she was not hospitalized. On 14-Mar-2019, the patient felt better and had recovered from the events. The reporter assessed the case as non-serious.; Reporter's Comments: A 74-year-old, female patient experienced loss of consciousness, hypersensitivity, road traffic accident and near death experience, on the same day after administration of FLUAD TIV. Considering the plausible temporal relationship between vaccination and reported events and lack of any underlying conditions or alternative more plausible causes, the company assessed the events (loss of consciousness and hypersensitivity) as possibly related to suspect vaccine. Despite temporal association between vaccination and events of road traffic accident and near death experience, the course of events suggests that the reported loss of consciousness and hypersensitivity as more plausible explanation for the events. Hence, the company assessed the causality as not related to suspect vaccine. The company assessed the events loss of consciousness and near death experience as serious (medically significant).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: R shoulder stinging pain upon administration. Pain in injection site radiating to neck, elbow, wrist, fingers, lasting 4 weeks so far.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: R shoulder stinging pain upon administration. Pain in injection site radiating to neck, elbow, wrist, fingers, lasting 4 weeks so far.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Two days after receiving her PNEUMOVAX injection, patient's left arm became red below the injection site and sore at the injection site. Patient went to physician who prescribed an antibiotic.