chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 3 years old patient was inadvertently administered Menactra instead of Hib vaccine , no AE; 3 years old patient was inadvertently administered Menactra, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 3 years old female patient who was inadvertently administered a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6596AA, expiry date: 24-May-2021) via an unknown route at an unknown administration site instead of the HAEMOPHILUS TYPE B (HIB) VACCINE on 16-Sep-2020 for prophylactic vaccination (wrong product administered) (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS); POLIO VACCINE INACT (POLIOMYELITIS VACCINE INACTIVATED) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency-same day).  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: 101.9 fever, headache, sore arm
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Bone pain, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: She received Gardasil 9 vaccine on 9/17/20, felt typical soreness in her left upper arm for the next 3 days, but on the 4th day, she developed "severe pain" in her left lateral upper arm. She is an avid athlete, but a few days prior to vaccination, she threw out her back and was taking a break from her usual work-out. On 9/21/20, she did lift a heavy desk up some stairs, and her severe pain started some time after this activity. She presented urgently to hospital on 9/26 and was advised to increase ibuprofen to 800mg PO TID with food.  The pain is located "right on the deltoid attachment and feels like stabbing into the bone," not like a muscle strain. The pain radiates down into her left fingers and she struggles to lift her left arm above 90 degrees. She feels the pain has stabilized now, but it's adversely affecting her life. Denies swelling, bruising, or erythema of left shoulder or upper arm, and there is no worsening of pain when she palpates the left upper arm. She can't lift weights or sleep through the night due to the pain. This lack of sleep "is frustrating as a grad student." It wakes her up around 5am despite taking Advil q6 hours and Acetaminophen qHS. The pain is the worst in the early mornings. Advil does reduce her pain, but doesn't eliminate it, and unfortunately, it's now upsetting her stomach.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: She received Gardasil 9 vaccine on 9/17/20, felt typical soreness in her left upper arm for the next 3 days, but on the 4th day, she developed "severe pain" in her left lateral upper arm. She is an avid athlete, but a few days prior to vaccination, she threw out her back and was taking a break from her usual work-out. On 9/21/20, she did lift a heavy desk up some stairs, and her severe pain started some time after this activity. She presented urgently to hospital on 9/26 and was advised to increase ibuprofen to 800mg PO TID with food.  The pain is located "right on the deltoid attachment and feels like stabbing into the bone," not like a muscle strain. The pain radiates down into her left fingers and she struggles to lift her left arm above 90 degrees. She feels the pain has stabilized now, but it's adversely affecting her life. Denies swelling, bruising, or erythema of left shoulder or upper arm, and there is no worsening of pain when she palpates the left upper arm. She can't lift weights or sleep through the night due to the pain. This lack of sleep "is frustrating as a grad student." It wakes her up around 5am despite taking Advil q6 hours and Acetaminophen qHS. The pain is the worst in the early mornings. Advil does reduce her pain, but doesn't eliminate it, and unfortunately, it's now upsetting her stomach.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: tingling , numbness, burning in ring and pinkie finger of left hand
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Client received Dtap inadvertently and should have received Tdap. No adverse reactions noted. Notified parent about incident and aware of vaccine error.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Body temperature increased, Cough, Eye irritation, Fatigue
Clinical narrative: Please read portal message below from bottom to top to see time course of symptoms/signs.  Message ( 09/29/20 (Tue Sep 29) 08:11 Am - Portal message You unfortunately had many side effects from the flu shot. It should subside over time. Over the counter meds to alleviate your symptoms is all that we can do at this point. I am glad your COVID test was negative.   ( 09/29/20 (Tue Sep 29) 08:05 Am - Portal message from) Hi, COVID-19 test came back negative. :) Temp remains elevated, between, 100-101F. Tylenol/ibuprofen bring it to 99-100F. Lethargy remains moderate, occasional headaches, but not as severe; cough is gradually increasing in frequency but not persistent/severe. It has been 11 days since I first started feeling ill. Hoping I'll turn the corner in the next few. Thanks,   ( 09/24/20 (Thr Sep 24) 10:54 Am - Portal message   You can go ahead and get a covid test to be sure. Urgent care can do that for you.  ( 09/24/20 (Thr Sep 24) 10:49 Am - Portal message from) Hey, Here we are 3 days later. My temp has been in the 99-100.0 range most of the last 3 days. I do not feel horrible, but I'm not well. Pain in back is better (1or2 out of 10); headaches less consistent but still bothersome (3-5 but not constant). The reason I write is that this is day 7 since my Friday morning flu shot, and my temp is going in the wrong direction. 100.2 a few hours ago. 100.3 a few minutes ago. Likely due to temp, overall fatigue, malaise, eyes burning a little. I will take some tylenol. My big question is whether I should do more/different. My temp is nearly at the point I need to report to UB as having COVID sx and then be mandated to get a COVID test (and be quarantined for 2 weeks - I'm not going anywhere now, but...). Should I just go ahead and do that? Thanks,    ( 09/21/20 (Mon Sep 21) 12:04 PM - Portal message  Sorry to hear. Symptomatic care for you. Some patients get more symptoms than others. You can continue to do what you have been.   ( 09/21/20 (Mon Sep 21) 11:36 Am - Portal message from) Hey, Within hours of getting my flu shot this past Friday, I began to have headaches. Pretty bad on Saturday (up to 6/10), forcing me to lay down for a couple of hours (which I don't normally do). Because they were worse when I bent over, I figured just sinuses and took Sudafed. Still going today though, and yesterday and today my lower back has been hurting (4/10). As my chart shows, my temp is typically 97.6-98F. However, it's been running between 98.6 and 99 over the past 2 days. Not a fever, but a bit higher than usual. Anyway, I'm not terribly concerned, but I wanted to check in and ask you if I should do anything other than continue with Sudafed and acet/ibuprofen - which seem somewhat helpful. Thanks,
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Lethargy, Malaise, SARS-CoV-2 test negative
Clinical narrative: Please read portal message below from bottom to top to see time course of symptoms/signs.  Message ( 09/29/20 (Tue Sep 29) 08:11 Am - Portal message You unfortunately had many side effects from the flu shot. It should subside over time. Over the counter meds to alleviate your symptoms is all that we can do at this point. I am glad your COVID test was negative.   ( 09/29/20 (Tue Sep 29) 08:05 Am - Portal message from) Hi, COVID-19 test came back negative. :) Temp remains elevated, between, 100-101F. Tylenol/ibuprofen bring it to 99-100F. Lethargy remains moderate, occasional headaches, but not as severe; cough is gradually increasing in frequency but not persistent/severe. It has been 11 days since I first started feeling ill. Hoping I'll turn the corner in the next few. Thanks,   ( 09/24/20 (Thr Sep 24) 10:54 Am - Portal message   You can go ahead and get a covid test to be sure. Urgent care can do that for you.  ( 09/24/20 (Thr Sep 24) 10:49 Am - Portal message from) Hey, Here we are 3 days later. My temp has been in the 99-100.0 range most of the last 3 days. I do not feel horrible, but I'm not well. Pain in back is better (1or2 out of 10); headaches less consistent but still bothersome (3-5 but not constant). The reason I write is that this is day 7 since my Friday morning flu shot, and my temp is going in the wrong direction. 100.2 a few hours ago. 100.3 a few minutes ago. Likely due to temp, overall fatigue, malaise, eyes burning a little. I will take some tylenol. My big question is whether I should do more/different. My temp is nearly at the point I need to report to UB as having COVID sx and then be mandated to get a COVID test (and be quarantined for 2 weeks - I'm not going anywhere now, but...). Should I just go ahead and do that? Thanks,    ( 09/21/20 (Mon Sep 21) 12:04 PM - Portal message  Sorry to hear. Symptomatic care for you. Some patients get more symptoms than others. You can continue to do what you have been.   ( 09/21/20 (Mon Sep 21) 11:36 Am - Portal message from) Hey, Within hours of getting my flu shot this past Friday, I began to have headaches. Pretty bad on Saturday (up to 6/10), forcing me to lay down for a couple of hours (which I don't normally do). Because they were worse when I bent over, I figured just sinuses and took Sudafed. Still going today though, and yesterday and today my lower back has been hurting (4/10). As my chart shows, my temp is typically 97.6-98F. However, it's been running between 98.6 and 99 over the past 2 days. Not a fever, but a bit higher than usual. Anyway, I'm not terribly concerned, but I wanted to check in and ask you if I should do anything other than continue with Sudafed and acet/ibuprofen - which seem somewhat helpful. Thanks,
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt became dizzy and passed out a few seconds after the HPV vaccine was administered IM into her RA. Pt was monitored for 15 mins after passing out. I checked her blood pressure and it was at 106/68 She had no other side effects to  report. Patient was released home to mom.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: After vaccine was administered patient felt extremely lightheaded and dizzy; brought water and ice chips, she took deep breaths and felt better within about 10 minutes. Followed up on 09/29/20 - patient said she feels back to normal and it was just that 30 minutes after the vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Neuropathy peripheral, Sensory disturbance
Clinical narrative: persistent sensory issues after HPV vaccine. Likely peripheral nerve issue but will report as adverse event. No treatment but will delay second dose until next year 2021.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient received flublok quad which is only fda approved for 18 and older, this patient is only 14  years of age
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Low grade fever and sore arm
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received flublok quad that is only fda approved for 18 years and up.  the patient is 14 years of age
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient called on 9/18/20 to make appointment for 2nd shot. I saw he got 1st shot on 6/20/20 and he was due for the 2nd. As I was navigating his Rx history if he was due for any other shot, I discovered he already received the Shingrix series from 2018 (1st shot 10/2/18 and 2nd shot 12/02/18). I asked him what made him come in for the shot back in 6/20/20, he replied his Dr recommended to get the shot. I asked if he remembers that what he received in 2018, he said he remembers that he got the shingrix and he said he told his doctor on 2018 and 2020 his doctor asked him to get it again. I advised patient not to get the 2nd shot and I said I will inform his primary doctor. I spoke to the office on 9/18/20 and the doctor was informed. On 9/21/20, Md informed to fax his certifcate of immunizations from 2018 and 2020, office manager looked his profile and said in their record it states that patient informed he received the shot on 2018 but they listed it as Zostavax the old shingles vaccine and not the new one. They fixed the record and said they will inform the patient. I myself also informed the patient that his Dr will call him and also convinced we wouldn't need another shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gastrointestinal disorder, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: pain from the injection site; redness at the injection site; swelling also at the injection site; Fatigue; GI symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 22nd September 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix at Left deltoid almost immediately had pain from the injection site, along with redness at the injection site. The patient also had swelling also at the injection site, along with fatigue and GI symptoms. The patient stated that she was calling to report this because the instructions said to report any adverse events . The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: pain from the injection site; redness at the injection site; swelling also at the injection site; Fatigue; GI symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 22nd September 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix at Left deltoid almost immediately had pain from the injection site, along with redness at the injection site. The patient also had swelling also at the injection site, along with fatigue and GI symptoms. The patient stated that she was calling to report this because the instructions said to report any adverse events . The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Headache, Myalgia
Clinical narrative: Left arm was Swollen to her elbow; Muscle Pain; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 68-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, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, muscle pain, fatigue and headache. On an unknown date, the outcome of the extensive swelling of vaccinated limb, muscle pain, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, muscle pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix in left arm. After vaccination patient had fatigue,  Headache, Muscle Pain, and her left arm was Swollen to her elbow. The reporter did not consent to follow up. All information was not available
Sex: U
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Joint swelling, Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: swelling of hands and feet; swelling of joint; itchy hives; rash all over body; itchy hives; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 4-year-old patient who experienced swelling of hands and feet (peripheral swelling), itchy hives, rash all over body, and swelling of joint (joint swelling), while he/she received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD].  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and received a dose of suspect PROQUAD not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious swelling of hands and feet (peripheral swelling), itchy hives (pruritus and urticaria), rash all over body (rash), and swelling of joint (joint swelling), (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and PROQUAD. On 11-Sep-2020, the patient was seen for the 4 year physical and well check by doctor. On 13-Sep-2020 the Patient was seen for reported events.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient was recovering from the all events.  There will be no information available on the batch number for this case.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: First Shingrix shot on 5/28/20 caused pain within a couple hours in vaccination arm, shoulder and neck which eventually went away.  After the 2nd shot in the series on 8/20/20, this pain returned worse and still has not subsided as of 9/29/20.  Patient is seeing Dr. for treatment.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives almost immediately after getting flu shot
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic shock, Rash
Clinical narrative: PER IMMUNIZING PHARMACIST'S ACCOUNT, PT HAD WHAT SEEMED TO BE ANAPHYLACTIC SHOCK AFTERWARDS. SHE WAS LAYING ON THE FLOOR. WHEN APPROACHED SHE WAS BREATHING AND RESPONSIVE. RPH NOTICED RASH ON BOTH ARMS AND EPINEPHRINE WAS ADMINISTERED. PARAMEDICS ARRIVED SHORTLY AFTER AND PT STOOD UP ON HER OWN HOLDING PARAMEDIC'S HAND.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation
Clinical narrative: Patient stated that on the morning of 9/24/20 wit a burning sensation in her left axilla, arm, clavicle on neck. On 9/25 she reported that her left clavicle and side of her neck still had the burning sensation.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Headache, Injection site erythema, Injection site induration
Clinical narrative: Received vaccine during my shift at the hospital; 12 hours after receiving the vaccine, when I woke up to go back to work, the site was pink, swollen, itchy and I felt ill: scratchy throat, headache, nausea, cold chills. No fever so I went to work. For the next 2 days, the site got redder, and larger and the skin felt hard and very hot. I took benedryl and slept with an ice pack on the site. Finally after about 4 days, the redness started to go away and I was feeling better. To note, the flu vaccine was given more towards the back of my arm in the fat and not in my deltoid muscle as it should have been.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Malaise, Nausea
Clinical narrative: Received vaccine during my shift at the hospital; 12 hours after receiving the vaccine, when I woke up to go back to work, the site was pink, swollen, itchy and I felt ill: scratchy throat, headache, nausea, cold chills. No fever so I went to work. For the next 2 days, the site got redder, and larger and the skin felt hard and very hot. I took benedryl and slept with an ice pack on the site. Finally after about 4 days, the redness started to go away and I was feeling better. To note, the flu vaccine was given more towards the back of my arm in the fat and not in my deltoid muscle as it should have been.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal discomfort, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Received vaccine during my shift at the hospital; 12 hours after receiving the vaccine, when I woke up to go back to work, the site was pink, swollen, itchy and I felt ill: scratchy throat, headache, nausea, cold chills. No fever so I went to work. For the next 2 days, the site got redder, and larger and the skin felt hard and very hot. I took benedryl and slept with an ice pack on the site. Finally after about 4 days, the redness started to go away and I was feeling better. To note, the flu vaccine was given more towards the back of my arm in the fat and not in my deltoid muscle as it should have been.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Body temperature increased, Dizziness, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Inflammation at the injection site with induration, erythema, and tenderness. Throbbing pain at the injection site. Lightheadedness intermittently. Increased temp with highest being 99.9 with Tylenol onboard.  Pt also had the pneumococcal vaccine administered in the right shoulder but has no localized reactions at that site.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain
Clinical narrative: Inflammation at the injection site with induration, erythema, and tenderness. Throbbing pain at the injection site. Lightheadedness intermittently. Increased temp with highest being 99.9 with Tylenol onboard.  Pt also had the pneumococcal vaccine administered in the right shoulder but has no localized reactions at that site.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Swelling
Clinical narrative: Swelling redness, red patches
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Nausea, headache, muscle pain, shivering.  Had to stay in bed all day, I was very weak. No fever. Next day I felt better,, but a day later still not feeling well, although symptoms were milder. Third day I was ok.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Headache, Palpitations
Clinical narrative: dizziness, headache, appeared weak, palpitations
Age: 57.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Myalgia, Nausea, Pain in extremity
Clinical narrative: Sore left arm, slight nausea, muscle soreness, feeling weak
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Pt developed hives at the injection site 18 hours post vaccination.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Pain in left shoulder since injection and knot in the injection site.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEPA, MEN, PPV
Symptoms: Cough, Decreased appetite, Fear, Injection site erythema, Injection site swelling
Clinical narrative: My son began getting a fever, raised red bump at injection site (warm to touch), loss of appetite, runny nose, coughing. We brought him in 5 days later after the fever continued and symptoms did not alleviate. They said it was a virus and dismissed that the symptoms could have started from the shots and said it was not from the shots. My son lost weight and had an oral aversion in fear of not breathing from plugged nose and/or runny nose. He had a loss of appetite and that first night and slept long periods unlike his normal breastfeeding habits. Had to pump milk to feed him because he was so lethargic for 2-3 days. I just realized you can report these since they doctors office did not take our concerns seriously. Now these vaccines are not valid from improper storage.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEPA, MEN, PPV
Symptoms: Injection site warmth, Lethargy, Nasal discomfort, Poor feeding infant, Product storage error
Clinical narrative: My son began getting a fever, raised red bump at injection site (warm to touch), loss of appetite, runny nose, coughing. We brought him in 5 days later after the fever continued and symptoms did not alleviate. They said it was a virus and dismissed that the symptoms could have started from the shots and said it was not from the shots. My son lost weight and had an oral aversion in fear of not breathing from plugged nose and/or runny nose. He had a loss of appetite and that first night and slept long periods unlike his normal breastfeeding habits. Had to pump milk to feed him because he was so lethargic for 2-3 days. I just realized you can report these since they doctors office did not take our concerns seriously. Now these vaccines are not valid from improper storage.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEPA, MEN, PPV
Symptoms: Pyrexia, Rhinorrhoea, Weight decreased
Clinical narrative: My son began getting a fever, raised red bump at injection site (warm to touch), loss of appetite, runny nose, coughing. We brought him in 5 days later after the fever continued and symptoms did not alleviate. They said it was a virus and dismissed that the symptoms could have started from the shots and said it was not from the shots. My son lost weight and had an oral aversion in fear of not breathing from plugged nose and/or runny nose. He had a loss of appetite and that first night and slept long periods unlike his normal breastfeeding habits. Had to pump milk to feed him because he was so lethargic for 2-3 days. I just realized you can report these since they doctors office did not take our concerns seriously. Now these vaccines are not valid from improper storage.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Febrile seizure
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: After full administration dose of vaccine, the prefilled glass handle broke. There was no damage to patient or administering nurse.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging brain, Paraesthesia, Paraesthesia oral
Clinical narrative: Numbness, parathesia left fingers and left face, lips to hairline, did not include eyelid, no drooping
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound Doppler
Clinical narrative: Numbness, parathesia left fingers and left face, lips to hairline, did not include eyelid, no drooping
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; dose of VARIVAX was administered during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-SEP-2020, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously, 0.5 ml, lot# T008129, expiration date 06-MAR-2022 (strength was not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 7.8 Fahrenheit degrees (F) for 6 hours and 46 minutes. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE/PQC reported; temperature excursion thet occured in August/Rotateq given on 31-AUG-2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender (MRN: 14681979). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-AUG-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, orally, lot # S014947, expiry date: 10-DEC-2020 for prophylaxis (dose number was not provided). No adverse events were reported. Administered dose of vaccine experienced the temperature excursions of above 47 degrees Fahrenheit for 31 hours and 45 minutes and below 36 degrees Fahrenheit for 2 hours and 5 minutes. There were no information concerning previous excursions. Data logger was involved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Fatigue, Headache, Injection site erythema, Pain in extremity
Clinical narrative: arrhythmia; fatigue; headache; fever with temperature of 100.8; site of injection was red; arm pain; This case was reported by a other health professional via call center representative and described the occurrence of arrhythmia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th August 2020, 1 days after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), fatigue, headache, fever, injection site erythema and pain in arm. On 12th August 2020, the outcome of the arrhythmia, fatigue, headache and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the arrhythmia, fatigue, headache, fever, injection site erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and the next day, she had left arm pain and site of injection was red and the arm pain and the redness lasted for 6 days.  The patient also had fever with temperature of 100.8 degree F, headache, fatigue, and arrhythmia which lasted the whole of 11th August 2020 and by 12th August 2020 it resolved. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: arrhythmia; fatigue; headache; fever with temperature of 100.8; site of injection was red; arm pain; This case was reported by a other health professional via call center representative and described the occurrence of arrhythmia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th August 2020, 1 days after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), fatigue, headache, fever, injection site erythema and pain in arm. On 12th August 2020, the outcome of the arrhythmia, fatigue, headache and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the arrhythmia, fatigue, headache, fever, injection site erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and the next day, she had left arm pain and site of injection was red and the arm pain and the redness lasted for 6 days.  The patient also had fever with temperature of 100.8 degree F, headache, fatigue, and arrhythmia which lasted the whole of 11th August 2020 and by 12th August 2020 it resolved. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling cold, Injection site pain, Pyrexia
Clinical narrative: fever; stomach upset; injection site pain; chills; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, less than a day after receiving Shingrix, the patient experienced upset stomach, injection site pain, chills and fever. On an unknown date, the outcome of the upset stomach, injection site pain and chills were recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, injection site pain, chills and fever to be related to Shingrix.  Additional details were reported as follows: Reporter was patient's wife. The patient received 1st dose of Shingrix and later on same day, experienced fever, chills, injection site pain, and stomach upset. Reporter stated that the chills, injection site pain, and stomach upset lasted 3 to 4 days and then resolved, but patient currently still had a fever. The reporter consented to follow-up but did not for healthcare professional.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 2nd dose of Shingrix. On 23rd September 2020, 1 days after receiving Shingrix, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was not recovered/not resolved.   It was unknown if the reporter considered the flu symptoms to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The patient was vaccinated with dose of Shingrix at afternoon. The patient experienced flu symptoms. Patient ended call abruptly before any additional information could be gathered. No additional information provided. The reporter did not consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: swelling was very large on the arm/swelling at the injection site is common; This is a spontaneous report from a contactable physician via a sales representative. A patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) on unknown date at single dose for immunisation on the arm. Medical history and concomitant drugs were not provided. This patient had an adverse event. The patient came back to see doctor and the swelling was very large on the arm. The reporter witnessed the adverse event with doctor and kind of went through the swelling at the injection site is common. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Eye swelling
Clinical narrative: Left eye had swollen up; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 2-month-old male patient (age at vaccination: 9 weeks) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number: CM1132; Expiration date: 31May2022), intramuscularly on the left thigh on 23Jul2020 at 0.5 mL, single to vaccinate/immunize against pneumonia. The patient had no relevant medical history and concomitant medications. On 23Jul2020, approximately four hours after the vaccination, the patient's left eye had swollen up. The outcome of the event, 'left eye had swollen up', was recovered in Jul2020.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year patient received Flublok Quadrivalent, no AE; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old patient who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date.  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency same day).   At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms, she was complaining that she was freezing when in fact she had a fever; flu-like symptoms, she was complaining that she was freezing when in fact she had a fever; Initial information regarding an unsolicited valid non-serious case received from a consumer and transmitted to Sanofi on 25-Sep-2020.  The case involved a 81 years old female patient who experienced flu-like symptoms, she was complaining that she was freezing when in fact she had a fever (Influenza like illness and Pyrexia), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date not reported) via unknown route in unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu-like symptoms, she was complaining that she was freezing when in fact she had a fever (Influenza like illness, Pyrexia) (after an hour or two, as reported) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Other relevant tests were not reported.  Final diagnosis was flu-like symptoms, she was complaining that she was freezing when in fact she had a fever.   The patient received paracetamol (Tylenol) as a corrective treatment.  At the time of reporting, the event outcome ported as unknown for the reported events.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Ultrasound scan
Clinical narrative: Patient said her Left arm is very painful and she can not lift it.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled up and doctor at hospital gave her antibiotics
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Tremor
Clinical narrative: patient  experienced loss of consciousness last approximately 10 seconds, some shaking of arms noted last approximately 1-2 seconds. Patient regained consciousness with out intervention.  Given juice and monitored for additonal 20 minutes with no further reaction noted.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Crying, Irritability, Lethargy, Pyrexia, Rash
Clinical narrative: three days of very high fever 103.4 and higher and lethargy 2 full weeks of extreme irritability, constantly crying and thrashing body around as if in severe pain red bumpy rash covering entire torso and upper thigh area
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: three days of very high fever 103.4 and higher and lethargy 2 full weeks of extreme irritability, constantly crying and thrashing body around as if in severe pain red bumpy rash covering entire torso and upper thigh area
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Facial discomfort, Fatigue, Influenza like illness, Periorbital swelling, Pruritus
Clinical narrative: Sunday I just felt tired and slightly flu-ish which is common but my face did feel sunburned. On Monday, my face was more itchy and I took Benadryl. On Tues morning, I woke up and my face was swollen, especially around my eyes and the itching was worse.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling face
Clinical narrative: Sunday I just felt tired and slightly flu-ish which is common but my face did feel sunburned. On Monday, my face was more itchy and I took Benadryl. On Tues morning, I woke up and my face was swollen, especially around my eyes and the itching was worse.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: Hives a few days after receiving vaccine.  Currently seeking medical care with medrol dose pack and benadryl.   Seqirus is manufacturer of vaccine.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Rash all over chest-looked like sunburn or sun poisoning.  Last time I had a rash like that it was following surgery and Darvocet Rx.  I noticed the rash when I went to get ready for bed.  No fever or other symptoms.  I still have it today but appears less red, splotchy, bumpy.  I will answer no for recovered as I still have the rash the following day.  I called my doctor's office to notify them.  Not requested to be seen at this time.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Rash papular, Rash pruritic
Clinical narrative: intensely pruritic papular rash developed on back, chest, breasts, legs and arms the next after receiving vaccination. Pruritus became worse. She went to urgent care on 9/26 and was prescribed prednisone taper. no improvement so she came to report on 9/29.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Soon after receiving flu shot her arm starting aching and she had limited range of motion, progressing to a stabbing sharp pain and extreme difficulty in moving her arm.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: C-reactive protein, Differential white blood cell count, Erythema, Eye swelling, Full blood count
Clinical narrative: 12 months vaccines 6/10/20, 24 hours after with fussiness--99 temp, Friday with tmax 103 with rash about 48 hours post vaccines-red.  Treated with Benadryl.  Saturday with rash swelling and red (not urticarial-not itchy per mom.  +eye swelling.   No joint swelling with mild swelling hands/feet. Taken to ER with CBCd, CRP, and CMP.  Mild leukopenia and thrombocytopenia.  CRP 1.2.  Otherwise normal. Home Saturday and fever lasted x5 days.    Rash resolved in 2 weeks.  No fevers in interim.  No school.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Leukopenia, Metabolic function test, Peripheral swelling, Platelet count decreased
Clinical narrative: 12 months vaccines 6/10/20, 24 hours after with fussiness--99 temp, Friday with tmax 103 with rash about 48 hours post vaccines-red.  Treated with Benadryl.  Saturday with rash swelling and red (not urticarial-not itchy per mom.  +eye swelling.   No joint swelling with mild swelling hands/feet. Taken to ER with CBCd, CRP, and CMP.  Mild leukopenia and thrombocytopenia.  CRP 1.2.  Otherwise normal. Home Saturday and fever lasted x5 days.    Rash resolved in 2 weeks.  No fevers in interim.  No school.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Swelling, Thrombocytopenia, White blood cell count decreased
Clinical narrative: 12 months vaccines 6/10/20, 24 hours after with fussiness--99 temp, Friday with tmax 103 with rash about 48 hours post vaccines-red.  Treated with Benadryl.  Saturday with rash swelling and red (not urticarial-not itchy per mom.  +eye swelling.   No joint swelling with mild swelling hands/feet. Taken to ER with CBCd, CRP, and CMP.  Mild leukopenia and thrombocytopenia.  CRP 1.2.  Otherwise normal. Home Saturday and fever lasted x5 days.    Rash resolved in 2 weeks.  No fevers in interim.  No school.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, extreme fatigue, sore arm, headache
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Pain, Skin warm
Clinical narrative: LARGE WARM, INDURATED PAINFUL LOCAL REACTION. PAIN STARTED IN THE EVENING FOLLOWING, ERYTHEMA AND WARMTH STARTED SMALL WITHIN ONE DAY AND HAS RAPIDLY INCREASED IN SIZE. TODAY DEVELOPED  PAIN.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness, redness and swelling in the arm where given, fever of 99.8, extreme tiredness, muscle aches. Took a hot shower and aspirin. Mostly clear by the next morning.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Soreness, redness and swelling in the arm where given, fever of 99.8, extreme tiredness, muscle aches. Took a hot shower and aspirin. Mostly clear by the next morning.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Instant swelling and bubbling of skin (approximately 1/2" high) at injection site, induration >3"; ice applied within 1 minute of injection. Swelling continued to expand to 4" diameter induration over the next 15minutes while continuously applying ice to site. No other ADEs noted.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: SWELLING, HOT TO TOUCH, ARM PAIN.