chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Neck Pain; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported for reporter's wife. The patient received Shingrix and experinced neck pain. The reporter did not want to provide any additional details on adverse events.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: painful to move arm; soreness in his left arm at sight at injection; feeling as if he has been hit by a train; Tiredness; Headache; feeling achy; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, 1 days after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, feeling abnormal, tiredness, headache and pain. On an unknown date, the outcome of the injected limb mobility decreased and feeling abnormal were unknown and the outcome of the injection site pain, tiredness, headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, feeling abnormal, tiredness, headache and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling as if he has been hit by a train and tiredness, headache, feeling achy, and soreness in his left arm at sight at injection and painful to move arm.  The reporter did not consent to follow up. The reporter was fine with receiving acknowledgment letter from GlaxoSmithKline.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful to move arm; soreness in his left arm at sight at injection; feeling as if he has been hit by a train; Tiredness; Headache; feeling achy; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, 1 days after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, feeling abnormal, tiredness, headache and pain. On an unknown date, the outcome of the injected limb mobility decreased and feeling abnormal were unknown and the outcome of the injection site pain, tiredness, headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, feeling abnormal, tiredness, headache and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling as if he has been hit by a train and tiredness, headache, feeling achy, and soreness in his left arm at sight at injection and painful to move arm.  The reporter did not consent to follow up. The reporter was fine with receiving acknowledgment letter from GlaxoSmithKline.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Keratitis, Ophthalmic herpes zoster, Rash
Clinical narrative: Occular shingles reactivation; Slight rash; Keratitis; This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date unknown) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had once before in the past).   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2019, 30 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), rash and keratitis. On an unknown date, the outcome of the ophthalmic herpes zoster, rash and keratitis were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash and keratitis to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix in the left deltoid. The reporter did not have expiry date of Shingrix vaccine. A month after vaccination, the patient had re-activation of ocular shingles. The ophthalmologist was the one that felt it was re-activation with a slight rash and the patient experienced keratitis. It had now resolved, but it took quite a few weeks, exact time was not known. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Associate gave me your information to contact you regarding several issues I have been experiencing since my flu shot was administered on October 3rd. On Friday, October 4th I began to feel fatigued and experienced some discomfort in my throat. On Saturday the throat discomfort, not exactly a sore throat but generally feeling like something was going on. This continued on Sunday the 6th and worsened on Monday the 7th. I continued feeling fatigued and having some discomfort in my throat through the remainder of the week including a fever and went home early on Tuesday, was off sick on Wednesday and then worked through Thursday and Friday. By Monday the 14th whatever was causing the issues in my throat moved to my chest turning into an upper respiratory infection and fever. I was off work two days that week and on vacation Thursday and Friday but remained very ill with fever, chills, coughing, but with no congestion I have had some issues catching my breath during coughing fits to the point where my husband was ready to call 911 in the middle of the night. About a week ago I noticed tenderness in the upper quadrant of my right arm. I thought that maybe I had strained a muscle. It got to the point where it hurt to press down to write something. A couple of days ago my husband noticed a bruise in the area where the tenderness is and it was then I realized that it was right below the area where the flu shot was given. It appears that what I am dealing with is indeed muscle pain and deep tissue bruising. Today I still have a terrible cough and have all but lost my voice. While I am susceptible to upper respiratory infections, bronchitis, and pneumonia none of the symptoms I've experienced in the last month are similar to those that I have experienced with any of the conditions I've had with those illness. In addition the fatigue is unbearable at times. I just haven't felt well since before getting the flu shot. I hope I provided what you might need so that the lot can be reported. I know several other people who are having same issues as I am however they're not here where I work so I'm not sure what's causing the similarities. Let me know if you have any questions.  Handwritten notes 11/7/19, RPh, Severe coughing spells, Arm bruise, tender to touch. Mild vertigo after flu. Under Tx. 5 days of work missed. Has had Rxn in the past, ill for an different.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injection site bruising, Injection site pain, Malaise, Oropharyngeal discomfort
Clinical narrative: Associate gave me your information to contact you regarding several issues I have been experiencing since my flu shot was administered on October 3rd. On Friday, October 4th I began to feel fatigued and experienced some discomfort in my throat. On Saturday the throat discomfort, not exactly a sore throat but generally feeling like something was going on. This continued on Sunday the 6th and worsened on Monday the 7th. I continued feeling fatigued and having some discomfort in my throat through the remainder of the week including a fever and went home early on Tuesday, was off sick on Wednesday and then worked through Thursday and Friday. By Monday the 14th whatever was causing the issues in my throat moved to my chest turning into an upper respiratory infection and fever. I was off work two days that week and on vacation Thursday and Friday but remained very ill with fever, chills, coughing, but with no congestion I have had some issues catching my breath during coughing fits to the point where my husband was ready to call 911 in the middle of the night. About a week ago I noticed tenderness in the upper quadrant of my right arm. I thought that maybe I had strained a muscle. It got to the point where it hurt to press down to write something. A couple of days ago my husband noticed a bruise in the area where the tenderness is and it was then I realized that it was right below the area where the flu shot was given. It appears that what I am dealing with is indeed muscle pain and deep tissue bruising. Today I still have a terrible cough and have all but lost my voice. While I am susceptible to upper respiratory infections, bronchitis, and pneumonia none of the symptoms I've experienced in the last month are similar to those that I have experienced with any of the conditions I've had with those illness. In addition the fatigue is unbearable at times. I just haven't felt well since before getting the flu shot. I hope I provided what you might need so that the lot can be reported. I know several other people who are having same issues as I am however they're not here where I work so I'm not sure what's causing the similarities. Let me know if you have any questions.  Handwritten notes 11/7/19, RPh, Severe coughing spells, Arm bruise, tender to touch. Mild vertigo after flu. Under Tx. 5 days of work missed. Has had Rxn in the past, ill for an different.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Associate gave me your information to contact you regarding several issues I have been experiencing since my flu shot was administered on October 3rd. On Friday, October 4th I began to feel fatigued and experienced some discomfort in my throat. On Saturday the throat discomfort, not exactly a sore throat but generally feeling like something was going on. This continued on Sunday the 6th and worsened on Monday the 7th. I continued feeling fatigued and having some discomfort in my throat through the remainder of the week including a fever and went home early on Tuesday, was off sick on Wednesday and then worked through Thursday and Friday. By Monday the 14th whatever was causing the issues in my throat moved to my chest turning into an upper respiratory infection and fever. I was off work two days that week and on vacation Thursday and Friday but remained very ill with fever, chills, coughing, but with no congestion I have had some issues catching my breath during coughing fits to the point where my husband was ready to call 911 in the middle of the night. About a week ago I noticed tenderness in the upper quadrant of my right arm. I thought that maybe I had strained a muscle. It got to the point where it hurt to press down to write something. A couple of days ago my husband noticed a bruise in the area where the tenderness is and it was then I realized that it was right below the area where the flu shot was given. It appears that what I am dealing with is indeed muscle pain and deep tissue bruising. Today I still have a terrible cough and have all but lost my voice. While I am susceptible to upper respiratory infections, bronchitis, and pneumonia none of the symptoms I've experienced in the last month are similar to those that I have experienced with any of the conditions I've had with those illness. In addition the fatigue is unbearable at times. I just haven't felt well since before getting the flu shot. I hope I provided what you might need so that the lot can be reported. I know several other people who are having same issues as I am however they're not here where I work so I'm not sure what's causing the similarities. Let me know if you have any questions.  Handwritten notes 11/7/19, RPh, Severe coughing spells, Arm bruise, tender to touch. Mild vertigo after flu. Under Tx. 5 days of work missed. Has had Rxn in the past, ill for an different.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Patient complained of 101 degree fever with chills approximately 6 hours after flu shot.  Also says that she is weak.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Acoustic stimulation tests abnormal, Deafness neurosensory, Deafness unilateral, Ear discomfort, Eustachian tube dysfunction
Clinical narrative: Sensation of fullness right ear with hearing loss and tinnitus. No ear pain, no dizziness.   31 Oct 14 Pt with URI 3-4 wks ago with subsequent sensation that the right ear is clogged. Is on ABX and has tried PSE and Flonase with no to minimal improvement. Mild HL, + Tinnitus: non pulsatile, no vertigo, No otolagia, No Otorrhea.  A/P:  Eustachian tube dysfunction of the right ear   Symptoms: TINNITUS, RIGHT EAR(H9311), SEN HEAR LOS,RT EAR,W UNRS,CNT(H9041).
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging brain normal, Tinnitus, Tympanometry abnormal, Upper respiratory tract infection
Clinical narrative: Sensation of fullness right ear with hearing loss and tinnitus. No ear pain, no dizziness.   31 Oct 14 Pt with URI 3-4 wks ago with subsequent sensation that the right ear is clogged. Is on ABX and has tried PSE and Flonase with no to minimal improvement. Mild HL, + Tinnitus: non pulsatile, no vertigo, No otolagia, No Otorrhea.  A/P:  Eustachian tube dysfunction of the right ear   Symptoms: TINNITUS, RIGHT EAR(H9311), SEN HEAR LOS,RT EAR,W UNRS,CNT(H9041).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: I went to get the flu vaccine and when i got it i thought i had picked up the regular dose flu vaccine and when i went to chart it the scanner would not pick up the bar so i checked it and saw that i had given the high dose. I immediately went in and told the patient and the doctor and she was fine with no harm would come to her. Dr. said she is just extra protected.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain onset 10/8/2019  in left posterior neck, running down his left scapula centered on his left shoulder. Pain extends down his left arm to his elbow and has pain, numbness, tingling to his left 4th and 5th fingers. Slowly improving.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Pain onset 10/8/2019  in left posterior neck, running down his left scapula centered on his left shoulder. Pain extends down his left arm to his elbow and has pain, numbness, tingling to his left 4th and 5th fingers. Slowly improving.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: On 11/7/2019, the patient called the pharmacy to ask what to do about her arm that has been hurting since getting Shingrix in September. The patient said that the pain was worst during the night when she is trying to sleep and sometimes has difficulty moving arm sometimes. I asked where the pain is located and she said in her muscle between her shoulder and elbow. I asked if she has any pain or soreness in her should and she reported no. She wanted an over the counter recommendation for the pain, I suggested Tylenol or Advil, but since the pain has been ongoing this long I suggested that she visit her primary care doctor.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Blood glucose normal, Blood pressure decreased, Confusional state, Dizziness postural, Eye movement disorder
Clinical narrative: My son received his flu shot (no other vaccinations done at this time) around 10:40 in our Pediatricians office during flu shot clinic.  About 10 minutes after receiving his shot we were in the elevator and heard a thump behind us.  I turned around and my son was having a grand mal seizure on the floor of the elevator.  He was stiff, shaking and eyes were open and rolled back in his head.  I am a nurse (BSN) and I have training in recognizing a seizure.  It lasted about 30-45 seconds before he started to come to.  He doesn't remember what happened and was confused for a short time afterwards.  My husband picked him up and ran back upstairs to the Peds office where he was diaphoretic but didn't feel overly warm tp the touch.  I asked them to check a Blood Sugar which was reported to be 100.  His Blood Pressure remained low for a while afterwards and was dizzy when sitting up.  They monitored his BP for about 30 minutes afterwards until it returned to his norm and was able to sit without feeling that he needed to lay back down.  He was sleepy the reminder of the afternoon and by evening he felt himself again.  He was 100% healthy prior to getting flu shot, has received flu shots in prior seasons without reaction.  He has never had a reaction to any vaccine he has received and is up to date on all vaccines.  He has never had a seizure prior to receiving this flu shot.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Fall, Generalised tonic-clonic seizure, Hyperhidrosis, Musculoskeletal stiffness, Somnolence
Clinical narrative: My son received his flu shot (no other vaccinations done at this time) around 10:40 in our Pediatricians office during flu shot clinic.  About 10 minutes after receiving his shot we were in the elevator and heard a thump behind us.  I turned around and my son was having a grand mal seizure on the floor of the elevator.  He was stiff, shaking and eyes were open and rolled back in his head.  I am a nurse (BSN) and I have training in recognizing a seizure.  It lasted about 30-45 seconds before he started to come to.  He doesn't remember what happened and was confused for a short time afterwards.  My husband picked him up and ran back upstairs to the Peds office where he was diaphoretic but didn't feel overly warm tp the touch.  I asked them to check a Blood Sugar which was reported to be 100.  His Blood Pressure remained low for a while afterwards and was dizzy when sitting up.  They monitored his BP for about 30 minutes afterwards until it returned to his norm and was able to sit without feeling that he needed to lay back down.  He was sleepy the reminder of the afternoon and by evening he felt himself again.  He was 100% healthy prior to getting flu shot, has received flu shots in prior seasons without reaction.  He has never had a reaction to any vaccine he has received and is up to date on all vaccines.  He has never had a seizure prior to receiving this flu shot.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Tremor
Clinical narrative: My son received his flu shot (no other vaccinations done at this time) around 10:40 in our Pediatricians office during flu shot clinic.  About 10 minutes after receiving his shot we were in the elevator and heard a thump behind us.  I turned around and my son was having a grand mal seizure on the floor of the elevator.  He was stiff, shaking and eyes were open and rolled back in his head.  I am a nurse (BSN) and I have training in recognizing a seizure.  It lasted about 30-45 seconds before he started to come to.  He doesn't remember what happened and was confused for a short time afterwards.  My husband picked him up and ran back upstairs to the Peds office where he was diaphoretic but didn't feel overly warm tp the touch.  I asked them to check a Blood Sugar which was reported to be 100.  His Blood Pressure remained low for a while afterwards and was dizzy when sitting up.  They monitored his BP for about 30 minutes afterwards until it returned to his norm and was able to sit without feeling that he needed to lay back down.  He was sleepy the reminder of the afternoon and by evening he felt himself again.  He was 100% healthy prior to getting flu shot, has received flu shots in prior seasons without reaction.  He has never had a reaction to any vaccine he has received and is up to date on all vaccines.  He has never had a seizure prior to receiving this flu shot.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Blood glucose normal, Eye movement disorder, Fall, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: My son received his flu shot (no other vaccinations done at this time) around 10:40 in our Pediatricians office during flu shot clinic.  About 10 minutes after receiving his shot we were in the elevator and heard a thump behind us.  I turned around and my son was having a grand mal seizure on the floor of the elevator.  He was stiff, shaking and eyes were open and rolled back in his head.  I am a nurse (BSN) and I have training in recognizing a seizure.  It lasted about 30-45 seconds before he started to come to.  He doesn't remember what happened and was confused for a short time afterwards.  My husband picked him up and ran back upstairs to the Peds office where he was diaphoretic but didn't feel overly warm tp the touch.  I asked them to check a Blood Sugar which was reported to be 100.  His Blood Pressure remained low for a while afterwards and was dizzy when sitting up.  They monitored his BP for about 30 minutes afterwards until it returned to his norm and was able to sit without feeling that he needed to lay back down.  He was sleepy the reminder of the afternoon and by evening he felt himself again.  He was 100% healthy prior to getting flu shot, has received flu shots in prior seasons without reaction.  He has never had a reaction to any vaccine he has received and is up to date on all vaccines.  He has never had a seizure prior to receiving this flu shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: starting yesterday, arm is swollen, red, warm and itchy at injection site
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: 5 days after receiving her Shingrix vaccination pt had Lt shoulder blade pain, trouble moving Lt arm, causing sharp stabbing pain.  Only relief is when pt is not moving at all.   Difficulty getting in and out of bed as well as dressing and raising arm above shoulder height.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Full blood count, Myalgia, Platelet count decreased, Pyrexia
Clinical narrative: 102 FEVER,CHILLS, WIDESPREAD MUSCLE PAIN X 3 DAYS
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Thrombocytopenia
Clinical narrative: 102 FEVER,CHILLS, WIDESPREAD MUSCLE PAIN X 3 DAYS
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Decreased appetite, Discomfort, Fatigue, Nausea
Clinical narrative: Initial side effects of nausea, loss of appetite and discomfort passed, but the side effect of severe long term fatigue remained. In bed for months. Still not back to baseline health yet.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal pain upper, Cough, Diarrhoea, Fatigue
Clinical narrative: Within 2 hours of receiving the flu vac she began to feel really exhausted. Within 2 days cold symptoms onsetted. Coughing, congestion, upset stomach, loose bowel movements, and gripping stomach pains. No fever. Saw her PCP at a regular scheduled appt on 10/28/2019. As of 11/16/2019 the gripping stomach pain and loose bowel movements continue and she is being followed by her PCP.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Respiratory tract congestion
Clinical narrative: Within 2 hours of receiving the flu vac she began to feel really exhausted. Within 2 days cold symptoms onsetted. Coughing, congestion, upset stomach, loose bowel movements, and gripping stomach pains. No fever. Saw her PCP at a regular scheduled appt on 10/28/2019. As of 11/16/2019 the gripping stomach pain and loose bowel movements continue and she is being followed by her PCP.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Fatigue, Flank pain
Clinical narrative: Fatigue on evening of vaccination, followed by severe, debilitating, bilateral,  nonradiating low back/flank pain the next morning and for at least the next 24 hours (at the time of reporting)
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Nausea, Pain, Vomiting
Clinical narrative: same night pt began to vomit , body aches and chills, localized redness at injection site, nausea
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Nausea, dizziness, fever (including sweating and shivers), headache, muscle and joint aches and pains, inability to sleep for 36 hours post-injection. Also soreness at the injection site on the left shoulder area for 72 hours post-injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, dizziness, fever (including sweating and shivers), headache, muscle and joint aches and pains, inability to sleep for 36 hours post-injection. Also soreness at the injection site on the left shoulder area for 72 hours post-injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: severe chills and body aches
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Patient was given the influenza vaccine in right arm. She  leaned over after being given the shot so I asked if she was ok. She said that she was lightheaded, and that she thought the vaccine might have gone into a nerve. She said that she has never passed out after receiving a vaccine, but that she did when giving blood. She was given water and she continued to keep her head on her knees. She then dropped the water and slumped. I caught her and her husband helped keep her from falling out of the chair. She woke up and took about 10 minutes before we helped her to lie down on a bench  for about 5-10 minutes after which she felt better and color returned to her face and she was able to continue with her shopping.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling abnormal, Feeling hot, Feeling of body temperature change, Hypersomnia
Clinical narrative: Patient started experiencing intense chills and aches early morning of November 6 (day following flu shot), approximately 4AM. Felt hot to the touch. Stayed home from school and slept for most of the day, alternating between feeling too hot or too cold. Seemed better in the evening, but then had trouble sleeping during night due to chills and aches. Morning of November 7, had 102.3 degree fever. Feels terrible, ache-y and hot, and is home from school a second day.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain, Pyrexia, Skin warm
Clinical narrative: Patient started experiencing intense chills and aches early morning of November 6 (day following flu shot), approximately 4AM. Felt hot to the touch. Stayed home from school and slept for most of the day, alternating between feeling too hot or too cold. Seemed better in the evening, but then had trouble sleeping during night due to chills and aches. Morning of November 7, had 102.3 degree fever. Feels terrible, ache-y and hot, and is home from school a second day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Faeces soft, Injection site pain, Injection site swelling, Nausea
Clinical narrative: "She comes in reporting gradually increasing swelling as well as pain to the right lateral triceps region following recent Shingrix vaccination administration 3 days ago. Beginning the next day she developed nausea with resultant vomiting as well as soften stools and slight bloated sensation. Reports 3-5 emesis episodes of 1st day with 2-4 today. denies any suspicious food exposure with no recent travel and other household/ family members with similar symptoms. No previous history of sensitivities to vaccines or other medications beyond anaphylactic like reaction to Dulcolax. She denies any other chest pains, abdominal pain, hematemesis, coffee-ground emesis, chest pain, difficulty breathing, lightheadedness or dizziness, diarrhea, hematochezia or melena"  Given prescriptions for cephalexin, promethazine, and ondansetron.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: "She comes in reporting gradually increasing swelling as well as pain to the right lateral triceps region following recent Shingrix vaccination administration 3 days ago. Beginning the next day she developed nausea with resultant vomiting as well as soften stools and slight bloated sensation. Reports 3-5 emesis episodes of 1st day with 2-4 today. denies any suspicious food exposure with no recent travel and other household/ family members with similar symptoms. No previous history of sensitivities to vaccines or other medications beyond anaphylactic like reaction to Dulcolax. She denies any other chest pains, abdominal pain, hematemesis, coffee-ground emesis, chest pain, difficulty breathing, lightheadedness or dizziness, diarrhea, hematochezia or melena"  Given prescriptions for cephalexin, promethazine, and ondansetron.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Given Meningococcal Conjugate . Had 2 doses previously on 09/01/2015 and 02/28/2019
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Visual impairment
Clinical narrative: Within 5 minutes of administration patient become dizzy and reported a darkening of vision.  The patient was given water and a granola bar and helped to the ground with feet elevated.  The patient never lost consciousness, but remained in an adverse state for about 10 minutes.  The patients blood pressure and pulse were taken once the student was helped to the floor and were 116/82 mm Hg and 56 bpm respectively.  The patient reported that his pulse is normally in the low 60s.  After about 10 minutes on the floor with the patient reporting that he was okay, he was helped to a chair and remained observed for about 15 minutes, and as the patient reported no further reaction he subsequently left the pharmacy.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Patient stated that 35 minutes after the influenza vaccine was administered her lips started tingling. she immediately took 25 mg of Benedryl , but the symptoms worsened and her tongue began to swell. She then drove to an Urgent Care facility and they administered Solumedrol and a 5 day course of prednisone. After approximately 1 hour all symptoms had dissipated.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Insomnia, Nausea, Pain, Product administered at inappropriate site
Clinical narrative: The vaccine was incorrectly given in the patient's shoulder joint, not in the deltoid muscle. The patient states that almost immediately she begin having pain that was abnormal for a typical vaccination.  She experienced severe pain, nausea (from pain), redness, and swelling. She states the pain was severe enough that she has not slept the past several nights. She sought treatment the day after from her MD office and was given a Toradol shot and advised to take Benadryl OTC. She says neither provided relief. She is been seen again by her physician later today.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: The vaccine was incorrectly given in the patient's shoulder joint, not in the deltoid muscle. The patient states that almost immediately she begin having pain that was abnormal for a typical vaccination.  She experienced severe pain, nausea (from pain), redness, and swelling. She states the pain was severe enough that she has not slept the past several nights. She sought treatment the day after from her MD office and was given a Toradol shot and advised to take Benadryl OTC. She says neither provided relief. She is been seen again by her physician later today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Asthenia, Body temperature increased, Fatigue, Feeling abnormal
Clinical narrative: Patient called on 11/6/19 with following symptoms:  She woke up 11/6/19 and felt awful she felt like she was going to pass out. She felt so weak. She checked her BP on an old machine 81/65 HR 120. She feels very fatigued and freezing so she tried to warm herself up by putting on a lot of clothes and using heating pad checked her temp was 100.3.  She had mild nausea, headache.  Has some nasal congestion could be allergies per pt. .  Residual URI with cough is almost gone.  Weakness is significant enough that she feels like she can't get up from the bed.  6 hours later, patient stable, headache, improved with Tylenol.  Still feeling weak.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nasal congestion, Nausea
Clinical narrative: Patient called on 11/6/19 with following symptoms:  She woke up 11/6/19 and felt awful she felt like she was going to pass out. She felt so weak. She checked her BP on an old machine 81/65 HR 120. She feels very fatigued and freezing so she tried to warm herself up by putting on a lot of clothes and using heating pad checked her temp was 100.3.  She had mild nausea, headache.  Has some nasal congestion could be allergies per pt. .  Residual URI with cough is almost gone.  Weakness is significant enough that she feels like she can't get up from the bed.  6 hours later, patient stable, headache, improved with Tylenol.  Still feeling weak.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, MMRV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Dtap was mixed with proquad and given to patient. Patient had no adverse event or signs or symptoms. CDC recommended waiting 28 days to repeat live vaccines and repeating the other one now.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received improperly stored varivax; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S005078 with expiration date 19-FEB-2021 or lot # R019237 with expiration date 04-JUL-2020 (exact dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent. The temperature excursion was from -14 °C to -10 °C (-9.74 C) for unknown period of time. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect was reported. The nurse was unable to determine which lot # was given to the patient.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: experiencing severe symptoms after her second Gardasil vaccine; from feeling miserable to feeling great; a case when homeopathic # Gardasil (highly diluted homeopathic remedy made of the vaccine); This spontaneous report as received from a reporter refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with dose 1 of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and also on an unknown date, the patient was vaccinated with dose 2 of the vaccine (dose, route of administration, lot number and expiration date were not reported for both doses).  On an unknown date, after her second quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) dose, the patient experienced severe symptoms. On an unknown date, she received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) reported as homeopathic remedy made of the vaccine (dose, route of administration, lot number and expiration date were not reported). The patient was also treated with other remedies (unspecified) for the side effects of the vaccine. It was reported that on an unknown day, she went from feeling miserable to feeling great (feeling abnormal). The outcome of events was unknown.  The reporter considered severe symptoms to be related to the vaccine. The relatedness of feeling abnormal was unknown.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.  On 10-OCT-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S012246, expiration date 10-FEB-2019 (strength, dose and route of administration were not provided) as prophylaxis (product storage error).   Administered dose of vaccine experienced the temperature excursion of 68 degrees Fahrenheit for 8 hours. Previous temperature excursion was reported as 57 degrees Fahrenheit for 2 hours. The data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient was administered an expired dose of MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2019, the patient was administered an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 milliliter subcutaneously (lot # N026828, expiry date 27-SEP-2019) for prophylaxis. No adverse effects were reported.  The outcome of the event was unknown.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effects; Received "VARIVAX and PROQUAD" instead of "VARIVAX and MMR II"; overdose ofthe VARIVAX vaccine; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-OCT-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/ one time, lot # S006018, expiration date reported as 20-FEB-2021, but upon internal validation established as 27-FEB-2021 (dose and route of administration were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml/ one time, lot # S008574, expiration date 16-SEP-2020 (dose and route of administration were not reported) (wrong product administered) both for prophylaxis instead of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # and expiration date were not reported). Other suspect therapies included and sterile diluent lot # R005478, expiration date 30-OCT-2020 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. It was reported that a medical assistant just picked up the wrong vaccine. It was additionally reported that on 22-OCT-2019, the patient received an overdose of varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, as a result of the patient receiving varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccines. There was no adverse event reported.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Slightly sore arm; Mild headache; Slight dizziness; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 29th October 2019, unknown after receiving Shingrix, the patient experienced pain in arm, headache and dizziness. On an unknown date, the outcome of the pain in arm, headache and dizziness were unknown.   It was unknown if the reporter considered the pain in arm, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient experienced sore arm, mild headache and slight dizziness on the day of reporting.
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling
Clinical narrative: Swelling in the right arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received approximately 1 year ago from day of reporting).   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 71 or 72 years. The patient received vaccine in unknown arm. The patient mentioned that she received a flu vaccine (unknown manufacturer) sometime last week and experienced swelling in the right arm. The VAERS details were reported for 1st dose of Shingrix. This case was 1 of the 3 cases, reported by same reporter. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: Hair is thinning; This case was reported by a consumer and described the occurrence of hair thinning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prednisone with an associated reaction of alopecia (about 2 years ago from the reporting date).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hair thinning. On an unknown date, the outcome of the hair thinning was unknown.   The reporter considered the hair thinning to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient asked was there a corticosteroid in Shingrix. The reason the patient asked was that the patient had noticed that hair was thinning and the only thing the patient could think of that might be causing it was Shingrix, as the patient was not taking any new medications.  The patient knew that when the patient was on Prednisone, it caused the patient's hair to thin for a while, but fortunately, about six months after the patient finished taking the Prednisone, the hair came back to the way it was before.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot to the touch at the injection site; Redness at the injection site; This case was reported by a consumer and described the occurrence of injection site warmth in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: On friday, the patient received shingles vaccination. The patient took the new 2 shot series. The patient seemed to be experiencing most of the side affects. The patient's main question was should it still be hot to the touch and should the redness at the injection site still be getting bigger at the reporting date.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Mechanical urticaria
Clinical narrative: hives and Urticaria at the injection site; Dermatographia on his chest and arms; This case was reported by a other health professional via call center representative and described the occurrence of injection site hives in a 12-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 59KC5, expiry date 11th June 2020) for prophylaxis.   On 24th October 2019, the patient received FluLaval Tetra 2019-2020 season .5 ml. On 25th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site hives and dermatographia. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site hives and dermatographia were resolved with sequelae.   It was unknown if the reporter considered the injection site hives and dermatographia to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The reporter stated that the patient after vaccination experienced hives and Urticaria at the injection site and Dermatographia on his chest and arms. The reporter stated that the patient was given benadryl during the day at school on 25th October 2019 and then again that evening. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold Sore; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2019, the patient received the 1st dose of Shingrix. On 30th October 2019, 3 days after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Past Sunday, before reporting date, the patient received 1st dose of Shingrix and on Wednesday, she developed cold sores. The reporter did not wish to provide any additional details.