chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased, Palpitations
Clinical narrative: heart has been racing consitenty over 105bps (usually 60).; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were received as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient had the second vaccine for shingles and heart has been racing consistently over 105bps (usually 60).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; pain; redness; fever; chills; swelling; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, erythema, fever, chills and swelling. On an unknown date, the outcome of the influenza-like symptoms, pain, erythema, fever, chills and swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, erythema, fever, chills and swelling to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. he patient received Shingrix  and experinced pain redness, swelling, and flu-like symptoms with fever and chills following Shingrix vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: flu like symptoms; pain; redness; fever; chills; swelling; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, erythema, fever, chills and swelling. On an unknown date, the outcome of the influenza-like symptoms, pain, erythema, fever, chills and swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, erythema, fever, chills and swelling to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. he patient received Shingrix  and experinced pain redness, swelling, and flu-like symptoms with fever and chills following Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: I am suffering most of the side affects from my shingle shot; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th February 2020, the patient received Shingles vaccine. In February 2020, less than a week after receiving Shingles vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient experienced most of the side effects from shingle shot and wanted to know how long these side effects might last.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Heart rate increased, Heart rate irregular, Sleep disorder
Clinical narrative: fast heart beat, 150; uncontrollable shivering; cold; I woke up later that night; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced heartbeats increased, shivers, cold and sleep disturbance. On an unknown date, the outcome of the heartbeats increased, cold and sleep disturbance were unknown and the outcome of the shivers was recovered/resolved.   It was unknown if the reporter considered the heartbeats increased, shivers, cold and sleep disturbance to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix and had uncontrollable shivering which went away but, patient woke up later that night with a fast heart beat 150 and had cold.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: most people have more side effects with the second dose; This case was reported by a consumer and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter stated that, most of the patient had more side effects after vaccination with 2nd dose of Shingrix. This case has been linked with case US2020AMR033844, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: fatigue; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 2 and 4 months after receiving Shingrix, the patient experienced fatigue and injection site pain. On an unknown date, the outcome of the fatigue and injection site pain were unknown.   It was unknown if the reporter considered the fatigue and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The patient received 1st dose of Shingrx was around late August-early September 2019. After that she felt some fatigue and soreness at the injection site.  This case has been linked with case US2020029074 and US2020AMR029706, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing in the ears; This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number B4TT5, expiry date 10th April 2022) for prophylaxis.   Co-suspect products included pneumococcal vaccine polysaccharide 23 valent (Pneumovax) for product used for unknown indication.   On 26th February 2020, the patient received the 1st dose of Shingrix (intramuscular) and Pneumovax at an unknown dose and frequency. On 26th February 2020, 3 hrs after receiving Shingrix, the patient experienced ringing in ears. The action taken with Pneumovax was unknown. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Pneumovax experienced ringing in the ears.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint stiffness, Pain in extremity
Clinical narrative: knees stiff; left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 13th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 22nd February 2020, the patient experienced stiff knees. On an unknown date, the outcome of the pain in arm and stiff knees were recovering/resolving.   It was unknown if the reporter considered the pain in arm and stiff knees to be related to Shingrix.  Additional details were provided as follows: The patinet received Shingrix and experienced pain in arm and stiff knees. Reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: Muscle twitching; This case was reported by a pharmacist via call center representative and described the occurrence of muscle twitching in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date unknown) for prophylaxis.   On 14th February 2020, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle twitching. On an unknown date, the outcome of the muscle twitching was unknown.   It was unknown if the reporter considered the muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing muscle twitching at the site of injection since the day of vaccination.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix. In December 2019, between 1 and 2 months after receiving Shingrix, the patient experienced pruritus. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and medication unknown (Anti-Itch Medication). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed some itching and felt it could be shingles. The patient was not able to see a doctor until 10th January 2019 and was prescribed valacyclovir which did not help.   He then saw a dermatologist on 27th January 2020 and was prescribed an anti-itch medication which helped a lot. He used it for 2 weeks and at the time of reporting, had been off of it for 2 weeks and the itching was almost gone.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: fever of 100.7 (F) and yesterday her temperature was 99.8 (F); Does not feel well (malaise); Pain in Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   On 26th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and malaise. On 26th February 2020, the patient experienced fever. On an unknown date, the outcome of the pain in arm, fever and malaise were recovering/resolving.   It was unknown if the reporter considered the pain in arm, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  After receiving Shingrix, the patient had pain in her arm. The patient had a fever of 100.7degrees Fahrenheit and on 26th February 2020, her temperature was 99.87 degrees Fahrenheit. The patient also stated that, she did not feel well (malaise) and would go to the doctor. She mentioned that, she had an autoimmune disorder. Reporter declined to provide more information for safety report.  Limited information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient received Shingrix and experienced sore arm. The reporter consented for follow up. This case has been linked with US2020036850, for 2nd dose.
Age: 0.08
Sex: F
Vaccine: TDAP
Symptoms: Crying, Pyrexia
Clinical narrative: fever of 100.5; was crying; This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-week-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than 2 months after receiving DTPa vaccine, the patient experienced fever and crying. On an unknown date, the outcome of the fever and crying were recovered/resolved.   The reporter considered the fever and crying to be related to DTPa vaccine.  Additional information was provided as follows: The reporter wanted to remain anonymous.  The patient received Diptheria Pertussis Tetanus and went into the hospital because she had a fever of 100.5 and was crying.   She did not complete the series.  The reporter anonymous and provided limited information. She also mentioned something about an outbreak of whooping cough at a school no further details and assume it was something she saw online or saw on the news. She was just using that as an example of why she was anti-vaccine.      Lab Comments: Lab test performed on unknown date.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Altered state of consciousness, Blood glucose normal, Disorientation, Dizziness, Drooling
Clinical narrative: Patient tolerated vaccine just fine at first but then proceeded to say he felt light headed. I raised the back of the bed up to a slight incline and raised his feet. Patient stated he was getting hot and more light headed to the point where he thought he was going to pass out. I did not leave his side, preparing myself for him to pass out. A couple seconds later he started to have seizure like activity, body completely shaking, eyes in the back of his head and spit coming out of his mouth. He started to slide down the bed. I was in there by myself so I yelled for help but the door was shut and I was unsure if anyone heard me so I kicked the door handle with my foot to open the door and yelled again. I was just getting ready to ease him to the floor because I could no longer hold him myself and staff came in and helped me. As she was running in, he stopped the seizure like activity and also stopped breathing for a couple seconds and then suddenly gasped for air. He finally started to open his eyes but then became very disoriented and started sweating profusely. Staff stayed by his side and I ran to grab his mother who was sitting in the car and I told Staff to find Dr. Dr. came in, we did a set of vitals 99/59 bp first time with heart rate of 51 and 111/60 second time with heart rate of 63. Also checked his glucose which was at 87 after giving him juice and water. Dr. stated he probably became very hypoglycemic which would explain the seizure like activity due to lack of oxygen to his brain. He felt much better after drinking some water and juice. Dr. let him leave after watching him for about 15-20 minutes.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Eye movement disorder, Feeling hot, Hyperhidrosis, Hypoglycaemia
Clinical narrative: Patient tolerated vaccine just fine at first but then proceeded to say he felt light headed. I raised the back of the bed up to a slight incline and raised his feet. Patient stated he was getting hot and more light headed to the point where he thought he was going to pass out. I did not leave his side, preparing myself for him to pass out. A couple seconds later he started to have seizure like activity, body completely shaking, eyes in the back of his head and spit coming out of his mouth. He started to slide down the bed. I was in there by myself so I yelled for help but the door was shut and I was unsure if anyone heard me so I kicked the door handle with my foot to open the door and yelled again. I was just getting ready to ease him to the floor because I could no longer hold him myself and staff came in and helped me. As she was running in, he stopped the seizure like activity and also stopped breathing for a couple seconds and then suddenly gasped for air. He finally started to open his eyes but then became very disoriented and started sweating profusely. Staff stayed by his side and I ran to grab his mother who was sitting in the car and I told Staff to find Dr. Dr. came in, we did a set of vitals 99/59 bp first time with heart rate of 51 and 111/60 second time with heart rate of 63. Also checked his glucose which was at 87 after giving him juice and water. Dr. stated he probably became very hypoglycemic which would explain the seizure like activity due to lack of oxygen to his brain. He felt much better after drinking some water and juice. Dr. let him leave after watching him for about 15-20 minutes.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Respiratory arrest, Seizure like phenomena, Tremor
Clinical narrative: Patient tolerated vaccine just fine at first but then proceeded to say he felt light headed. I raised the back of the bed up to a slight incline and raised his feet. Patient stated he was getting hot and more light headed to the point where he thought he was going to pass out. I did not leave his side, preparing myself for him to pass out. A couple seconds later he started to have seizure like activity, body completely shaking, eyes in the back of his head and spit coming out of his mouth. He started to slide down the bed. I was in there by myself so I yelled for help but the door was shut and I was unsure if anyone heard me so I kicked the door handle with my foot to open the door and yelled again. I was just getting ready to ease him to the floor because I could no longer hold him myself and staff came in and helped me. As she was running in, he stopped the seizure like activity and also stopped breathing for a couple seconds and then suddenly gasped for air. He finally started to open his eyes but then became very disoriented and started sweating profusely. Staff stayed by his side and I ran to grab his mother who was sitting in the car and I told Staff to find Dr. Dr. came in, we did a set of vitals 99/59 bp first time with heart rate of 51 and 111/60 second time with heart rate of 63. Also checked his glucose which was at 87 after giving him juice and water. Dr. stated he probably became very hypoglycemic which would explain the seizure like activity due to lack of oxygen to his brain. He felt much better after drinking some water and juice. Dr. let him leave after watching him for about 15-20 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Abdominal pain, Blood glucose normal, Drooling, Febrile convulsion, Gaze palsy
Clinical narrative: Febrile seizure around 6pm on March 12th, 9 days after MMR and Pediarix administration. Child stated his head and belly hurt and asked to go lay down. Temporal temperature 99.9 with sudden onset. Ten minutes later child vomited and a seizure with focal activity began. Body became flaccid, both eyes and head drifted to left with a head tick. Child was drooling profusely and unresponsive to commands for around 5-7 minutes.  Paramedics were called and arrived around ten minutes later after seizure activity had stopped.  Child was sleepy, tachycardic, still unresponsive to commands and not speaking. He was transported to pediatric emergency department for observation and testing. Blood glucose 99. Influenza and Strep tests negative. Red rash on face, trunk and arms.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Headache, Hypotonia, Influenza virus test negative, Posture abnormal, Rash erythematous
Clinical narrative: Febrile seizure around 6pm on March 12th, 9 days after MMR and Pediarix administration. Child stated his head and belly hurt and asked to go lay down. Temporal temperature 99.9 with sudden onset. Ten minutes later child vomited and a seizure with focal activity began. Body became flaccid, both eyes and head drifted to left with a head tick. Child was drooling profusely and unresponsive to commands for around 5-7 minutes.  Paramedics were called and arrived around ten minutes later after seizure activity had stopped.  Child was sleepy, tachycardic, still unresponsive to commands and not speaking. He was transported to pediatric emergency department for observation and testing. Blood glucose 99. Influenza and Strep tests negative. Red rash on face, trunk and arms.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Seizure, Somnolence, Streptococcus test negative, Tachycardia, Unresponsive to stimuli
Clinical narrative: Febrile seizure around 6pm on March 12th, 9 days after MMR and Pediarix administration. Child stated his head and belly hurt and asked to go lay down. Temporal temperature 99.9 with sudden onset. Ten minutes later child vomited and a seizure with focal activity began. Body became flaccid, both eyes and head drifted to left with a head tick. Child was drooling profusely and unresponsive to commands for around 5-7 minutes.  Paramedics were called and arrived around ten minutes later after seizure activity had stopped.  Child was sleepy, tachycardic, still unresponsive to commands and not speaking. He was transported to pediatric emergency department for observation and testing. Blood glucose 99. Influenza and Strep tests negative. Red rash on face, trunk and arms.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Vomiting
Clinical narrative: Febrile seizure around 6pm on March 12th, 9 days after MMR and Pediarix administration. Child stated his head and belly hurt and asked to go lay down. Temporal temperature 99.9 with sudden onset. Ten minutes later child vomited and a seizure with focal activity began. Body became flaccid, both eyes and head drifted to left with a head tick. Child was drooling profusely and unresponsive to commands for around 5-7 minutes.  Paramedics were called and arrived around ten minutes later after seizure activity had stopped.  Child was sleepy, tachycardic, still unresponsive to commands and not speaking. He was transported to pediatric emergency department for observation and testing. Blood glucose 99. Influenza and Strep tests negative. Red rash on face, trunk and arms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Body aches, chills, fever, headache at 1300 3/5. Had R shoulder pain after receiving.  In evening on 3/6 symptoms of fever chills, Headache , body ache resolved. Sunday 3/08 shoulder pain resolved when she woke up.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Vaccination site pain
Clinical narrative: PATIENTS ARM WAS LOCALLY SWOLLEN IMMEDIATELY AFTER THE VACCINATION, A FEW HOURS LATER HER WHOLE ARM WAS SWOLLEN AND UNABLE TO LIFT UP, THE AREA OF THE VACCINATION WAS SORE TO TOUCH, THIS CONTINUED UNTIL THE NEXT MORNING, CURRENT CONDITION IS UNKNOWN
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had a lot of pain after the first injection; This case was reported by a nurse and described the occurrence of 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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of vaccine and experienced lot of pain. The patient also received 2nd dose and wanted to administered tylenol but immunization coordinator who administered the vaccine told that if she receive tylenol before the pain in her arm  started, the strength of the vaccine would be weakened
Sex: M
Vaccine: DTP, DTP
Symptoms: Crying, Incomplete course of vaccination
Clinical narrative: he cried so he never finished the series; he cried so he never finished the series; This case was reported by a consumer via call center representative and described the occurrence of crying in a infant male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   Co-suspect products included DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP vaccine and the 2nd dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine and not applicable after receiving DTP vaccine, the patient experienced crying and incomplete course of vaccination. On an unknown date, the outcome of the crying was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the crying to be related to DTP vaccine.  Additional information was provided as follows: This case was reported by patient's mother. The age at vaccination was not reported. Till the time of reporting, the patient did not receive 2nd dose of DTP vaccine, which led to incomplete course of vaccination. The patient cried when he was baby, after receiving DTP vaccine so he never finished the series. This case is linked with US2020036876, reported by same reporter for same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Acarodermatitis, Acne, Chills, Feeling abnormal, Hyperaesthesia
Clinical narrative: One diagnoses was acne and the other scabies; One diagnoses was acne and the other scabies; feel raised spots; very sensitive to the touch/She also can't wear anything but natural fibers.; It has bothered her on and off; rash around her waist and on her nose; chills that day and it got progressively worse.; This case was reported by a consumer via call center representative and described the occurrence of acne in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 5th March 2019).   On 13th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) 5 ml. On 13th August 2019, less than a day after receiving Shingrix, the patient experienced chills. In October 2019, the patient experienced rash. On an unknown date, the patient experienced acne, scabies, raised rash, touch sensitivity increased and feeling abnormal. On an unknown date, the outcome of the acne, scabies, raised rash, touch sensitivity increased and feeling abnormal were unknown and the outcome of the chills was recovering/resolving and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the acne, scabies, chills, rash, raised rash, touch sensitivity increased and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix started to get chills that day and it got progressively worse.  On an unknown date between 1 and 3 months the patient experinced acne, scabies, rash, raised rash, touch sensitivity increased and feeling abnormal.  This lasted a couple of days but got better.  Then in October, she got a rash around her waist and on her nose. It had bothered her on and off since.  She compares it to the feeling of having a sunburn and raised spots and was very sensitive to the touch.  She also cannot wear anything but natural fibers.  She also had chills during this time but not as bad as when she first got the 2nd dose.  There was no fever associated with the chills. She had been to several doctors who said it was not related to the vaccine.  On an unknown date the patient was diagnosed with acne and scabies. Reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: One diagnoses was acne and the other scabies; One diagnoses was acne and the other scabies; feel raised spots; very sensitive to the touch/She also can't wear anything but natural fibers.; It has bothered her on and off; rash around her waist and on her nose; chills that day and it got progressively worse.; This case was reported by a consumer via call center representative and described the occurrence of acne in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 5th March 2019).   On 13th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) 5 ml. On 13th August 2019, less than a day after receiving Shingrix, the patient experienced chills. In October 2019, the patient experienced rash. On an unknown date, the patient experienced acne, scabies, raised rash, touch sensitivity increased and feeling abnormal. On an unknown date, the outcome of the acne, scabies, raised rash, touch sensitivity increased and feeling abnormal were unknown and the outcome of the chills was recovering/resolving and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the acne, scabies, chills, rash, raised rash, touch sensitivity increased and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix started to get chills that day and it got progressively worse.  On an unknown date between 1 and 3 months the patient experinced acne, scabies, rash, raised rash, touch sensitivity increased and feeling abnormal.  This lasted a couple of days but got better.  Then in October, she got a rash around her waist and on her nose. It had bothered her on and off since.  She compares it to the feeling of having a sunburn and raised spots and was very sensitive to the touch.  She also cannot wear anything but natural fibers.  She also had chills during this time but not as bad as when she first got the 2nd dose.  There was no fever associated with the chills. She had been to several doctors who said it was not related to the vaccine.  On an unknown date the patient was diagnosed with acne and scabies. Reporter did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Patient had limited mobility of arm and arm pain. Patient said that he had greatly improved over 2 to 3 weeks but some discomfort is still present.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: area below injection site is red and hot to the touch
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose was given instead of adult dose.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Contraindication to vaccination, Dermatitis allergic
Clinical narrative: - Pt has a severe egg allergy, which causes a full body rash - Pt developed severe allergic response to flu shot that was not immediately evident to providers since it was a skin allergyt.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema and erythema around injection site
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Patient presents to the ED the day after receiving her 2nd shingles vaccine. Patient has redness and swelling at the injection site which has been present for 5 hours and has been becoming more painful starting 2 hours before coming into ED. Patient reports pain radiating into neck and down her arm. Patient denies having a reaction to first dose. Patient's workup determined to also have cellulitis secondary to immunization. Patient was treated with diphenhydramine and started on ceftriaxone.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient presents to the ED the day after receiving her 2nd shingles vaccine. Patient has redness and swelling at the injection site which has been present for 5 hours and has been becoming more painful starting 2 hours before coming into ED. Patient reports pain radiating into neck and down her arm. Patient denies having a reaction to first dose. Patient's workup determined to also have cellulitis secondary to immunization. Patient was treated with diphenhydramine and started on ceftriaxone.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: 1-31-20 - RASH APPEARS ON UPPER BACK - SPREADS TO ALL BACK DOWN TO BUTTOX - FEB 11th - BEGAN CLOBATASOL (STEROID CREAM) - COUPLE DAYS RASH APPEARS ON CHEST FRONT + SIDES, BACK OF NECK AND ALL OF SCALP - Rx WON'T KEEP UP W/SPREAD NOW ON INSIDE THIGHS - ARMS & BACK OF HANDS RED RAISED SPOTS + WELTS - VERY ITCHY!! HORRIBLE & BLOTCHES ALL OVER (NOT HIVES) SO FAR CANNOT FIND APPROPRIATE TREATMENT TO STOP IT I USE CERAVE ITCH RELIEF CREAM 2x DAILY - HELPS A LITTLE! I'M VERY UPSET! - AFTER ONLINE RESEARCH, DID NOT SEE THIS AS SIDE EFFECT! BEFORE GETTING THE SHOT! SEE ONLINE SITE (OTHERS W/SIMILAR RASHES) SHINGRIX REVIEWS & RATINGS WEBSITE - SCROLL DN, READ ABOUT RASHES AFTER 4 DAYS OF SHOT! THERE ARE SEVERAL - DERMATOLOGIST DESCRIBED AS "DERMAL HYPERSENSITIVITY SYNDROM" SAID SHINGLES SHOT CAUSED IMMUNE SYSTEM TO OVER REACT?? I'VE HAD THIS FOR SIX WEEKS & COUNTING, CONTINUES TO GET WORSE
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: 1-31-20 - RASH APPEARS ON UPPER BACK - SPREADS TO ALL BACK DOWN TO BUTTOX - FEB 11th - BEGAN CLOBATASOL (STEROID CREAM) - COUPLE DAYS RASH APPEARS ON CHEST FRONT + SIDES, BACK OF NECK AND ALL OF SCALP - Rx WON'T KEEP UP W/SPREAD NOW ON INSIDE THIGHS - ARMS & BACK OF HANDS RED RAISED SPOTS + WELTS - VERY ITCHY!! HORRIBLE & BLOTCHES ALL OVER (NOT HIVES) SO FAR CANNOT FIND APPROPRIATE TREATMENT TO STOP IT I USE CERAVE ITCH RELIEF CREAM 2x DAILY - HELPS A LITTLE! I'M VERY UPSET! - AFTER ONLINE RESEARCH, DID NOT SEE THIS AS SIDE EFFECT! BEFORE GETTING THE SHOT! SEE ONLINE SITE (OTHERS W/SIMILAR RASHES) SHINGRIX REVIEWS & RATINGS WEBSITE - SCROLL DN, READ ABOUT RASHES AFTER 4 DAYS OF SHOT! THERE ARE SEVERAL - DERMATOLOGIST DESCRIBED AS "DERMAL HYPERSENSITIVITY SYNDROM" SAID SHINGLES SHOT CAUSED IMMUNE SYSTEM TO OVER REACT?? I'VE HAD THIS FOR SIX WEEKS & COUNTING, CONTINUES TO GET WORSE
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin normal, Blister, Dermatitis allergic, Erythema, Herpes zoster
Clinical narrative: 1-31-20 - RASH APPEARS ON UPPER BACK - SPREADS TO ALL BACK DOWN TO BUTTOX - FEB 11th - BEGAN CLOBATASOL (STEROID CREAM) - COUPLE DAYS RASH APPEARS ON CHEST FRONT + SIDES, BACK OF NECK AND ALL OF SCALP - Rx WON'T KEEP UP W/SPREAD NOW ON INSIDE THIGHS - ARMS & BACK OF HANDS RED RAISED SPOTS + WELTS - VERY ITCHY!! HORRIBLE & BLOTCHES ALL OVER (NOT HIVES) SO FAR CANNOT FIND APPROPRIATE TREATMENT TO STOP IT I USE CERAVE ITCH RELIEF CREAM 2x DAILY - HELPS A LITTLE! I'M VERY UPSET! - AFTER ONLINE RESEARCH, DID NOT SEE THIS AS SIDE EFFECT! BEFORE GETTING THE SHOT! SEE ONLINE SITE (OTHERS W/SIMILAR RASHES) SHINGRIX REVIEWS & RATINGS WEBSITE - SCROLL DN, READ ABOUT RASHES AFTER 4 DAYS OF SHOT! THERE ARE SEVERAL - DERMATOLOGIST DESCRIBED AS "DERMAL HYPERSENSITIVITY SYNDROM" SAID SHINGLES SHOT CAUSED IMMUNE SYSTEM TO OVER REACT?? I'VE HAD THIS FOR SIX WEEKS & COUNTING, CONTINUES TO GET WORSE
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pruritus, Rash, Urticaria
Clinical narrative: 1-31-20 - RASH APPEARS ON UPPER BACK - SPREADS TO ALL BACK DOWN TO BUTTOX - FEB 11th - BEGAN CLOBATASOL (STEROID CREAM) - COUPLE DAYS RASH APPEARS ON CHEST FRONT + SIDES, BACK OF NECK AND ALL OF SCALP - Rx WON'T KEEP UP W/SPREAD NOW ON INSIDE THIGHS - ARMS & BACK OF HANDS RED RAISED SPOTS + WELTS - VERY ITCHY!! HORRIBLE & BLOTCHES ALL OVER (NOT HIVES) SO FAR CANNOT FIND APPROPRIATE TREATMENT TO STOP IT I USE CERAVE ITCH RELIEF CREAM 2x DAILY - HELPS A LITTLE! I'M VERY UPSET! - AFTER ONLINE RESEARCH, DID NOT SEE THIS AS SIDE EFFECT! BEFORE GETTING THE SHOT! SEE ONLINE SITE (OTHERS W/SIMILAR RASHES) SHINGRIX REVIEWS & RATINGS WEBSITE - SCROLL DN, READ ABOUT RASHES AFTER 4 DAYS OF SHOT! THERE ARE SEVERAL - DERMATOLOGIST DESCRIBED AS "DERMAL HYPERSENSITIVITY SYNDROM" SAID SHINGLES SHOT CAUSED IMMUNE SYSTEM TO OVER REACT?? I'VE HAD THIS FOR SIX WEEKS & COUNTING, CONTINUES TO GET WORSE
Age: 1.42
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent 0.5 mL was administered in error when Hepatitis A vaccine was prescribed, no AE; Fluzone Quadrivalent 0.5 mL was administered in error when Hepatitis A vaccine was prescribed only 9 days after it's initial dose, no AE; Initial information received on 06-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 month old male patient who received the second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] within nine days of the first dose instead of HEPATITIS A VACCINE (wrong product administered and extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA TETANUS ACELLULAR PERTUSSIS, PNEUMOCOCCAL VACCINE and HIB VACCINE   On 26-Feb-2020, the patient received the first dose of INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 06-Mar-2020, the patient received the 0.5 mL second dose of INFLUENZA QUADRIVAL A-B VACCINE (lot number UT6695NA, expiry date 30-Jun-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 61 years old received Fluzone High-Dose/no AE; 61 years old received Fluzone High-Dose/no AE; Initial information was received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA062083 and 2020SA065020 via same reporter.  It was reported that 61 years old patient (unknown gender) was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (product administered to patient of inappropriate age),(overdose) on an unknown date for prophylactic vaccination [lot number, dosing details, expiry date, route and site of administration not reported]   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 62 years old received Fluzone High-Dose/no AE; 62 years old received Fluzone High-Dose/no AE; Initial information was received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA062083 and 2020SA065018 via same reporter.  It was reported that 62 years old patient(unknown gender) was vaccinated with  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE](product administered to patient of inappropriate age),(overdose) on an unknown date for prophylactic vaccination [lot number, dosing details, expiry date, route and site of administration not reported].   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, it was not reported whether adverse event was experienced 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Peripheral swelling
Clinical narrative: Pt is an medic with 8 recorded doses of AVA in his record.  He believes he may have received even more AVA doses in his 15 year career.  His last AVA dose was given 21 Feb 2020 in left deltoid.  He recalls that, with every AVA dose, including most recent, he experiences marked swelling in arm.  "Circumference expands by at least 4 inches."  Swelling seems to resolve over 2-3 days with NSAID use.   After swelling, however, he develops large firm lumps in deltoid.  He notes that left deltoid now feels like he has a "kneecap" in shoulder.  Firm lumps in deltoid are not painful and do not limit his activity in any way.  Immunization staff confirm that it is difficult to find viable IM injection site in left deltoid due to fibrosis.  [Immunization Healthcare team has written exemption from future AVA doses in pre-event setting.  AVA boosters may be considered only if >3 years from previous dose and if need validated.]
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Blood bicarbonate normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Blood urea normal, Chest X-ray normal, Pregnancy test negative, Pyrexia, Syncope
Clinical narrative: Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: White blood cell count increased
Clinical narrative: Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Blood test normal, Breath sounds abnormal, Chest X-ray normal, Confusional state, Electrocardiogram normal
Clinical narrative: Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Eye movement disorder, Fatigue, Head injury, Loss of consciousness, Malaise
Clinical narrative: Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Age: 16.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Memory impairment, Panic reaction, Pyrexia, Seizure
Clinical narrative: Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Decreased appetite, Headache
Clinical narrative: Pt c/o severe headache within an hour after receiving her vaccines, the headache lasted approximately 3 days. Pt had no appetite and was taking Tylenol extra strength, but not routinely. We did home treatment over the phone. We suggested Ibuprofen 600mg with food every 4-6 hours and suggested she stay hydrated. Pt was feeling better with first dose of Ibuprofen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient was given vaccine in office on 3/5/20.  She developed a painful rash on the right upper chest in the C4 dermatome consistent with shingles.  Patient's husband (who is an ER MD) directly observed the rash and patient sent us pictures of the rash which looked consistent with shingles rash.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: Patient came into the pharmacy 2 weeks after vaccination, and reports having pain on her left arm and having difficulties lifting the arm to a certain height which wasn't a problem she had before, she was counseled to try topical anesthetics, oral ibuprofen and apply topical ice but none of that has improved her pain. She went to her doctor and he performed x-rays with a referral for an orthopedic doctor for her left shoulder.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Product administered at inappropriate site, Tendonitis
Clinical narrative: Patient reported on 12/12/2019 that she has been having pain in the arm ever since she got the injection.  She went to her doctor and was told the injection was given in the wrong area and resulted in tendonitis.