chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL given to a 9 year old female /No AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional (medical assistant).  This case involves a 9 years old female patient who received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]lot C5688AA, expiry date 26-Nov-21 via intramuscular route in the left deltoid for prophylactic vaccination on 11-Sep-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  No adverse event symptoms 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: 27.0
Sex: F
Vaccine: DT, HPVX
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: a patient was administered DIPTHERIA and TETANUS (DT) vaccine which was expired/No AE; patient was supposed to receive Adacel but received a DIPTHERIA and TETANUS (DT) standard dose accidently/No AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 27-years-old female patient who received a 0.5mL dose of an expired DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE lot C5511AA, expiry date 30-Aug-20 via intramuscular route in the left deltoid for prophylactic vaccination on 04-Sep-2020 accidently instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Human papilloma virus (HPV) VACCINE for prophylactic vaccination on 04-Sep-2020.  It was case of an actual medication error due to wrong vaccine administered and expired vaccine used (latency seven days).  Nurse states the non-pregnant consumer was supposed to receive Adacel but received an expired  DIPHTHERIA TETANUS [DT] standard dose.  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.
Sex: U
Vaccine: FLUR4, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 140 team members was administered Fluzone High-dose quadrivalent instead of FLUBLOK, No AE; the office staff members gave Fluzone High-dose quadrivalent to people under age, No AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves (140 team members) patients who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE QUADRIVALENT HIGH DOSE] (batch number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency).  At the time of 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: FLUX
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Hypertension, Palpitations
Clinical narrative: anaphylactic reaction; blood pressure went up; dizzy; could not breathe; heart raced; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a (patient) consumer/non-healthcare professional.  This case involves a 80 years old female patient whose blood pressure went up (blood pressure increased) was dizzy (dizziness) and she could not breathe (dyspnoea) and her heart raced (palpitations), and it was resulted into anaphylactic reaction, while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient's blood pressure went up (blood pressure increased) was dizzy (dizziness) and she could not breathe (dyspnoea) and her heart raced (palpitations), and it was resulted into anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE.   These events were assessed as medically significant.   Relevant laboratory test results included: On an unknown date, the blood pressure was increased.  The patient cannot take ibuprofen, lidocaine and cortisone.  The event outcome was reported as unknown for anaphylactic reaction.  Information on the batch number was requested; Sender's Comments: This case concerns a 80 years old female patient who experienced anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE  produced by unknown manufacturer.  Medical history concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine could not be assessed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered with Quadracel past expiration date, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional .  This case involves a 4 year old female patient who was administered with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] past expiration date (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5500CA, expiry date: 16-Aug-2020) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  At the time of 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.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood pressure increased, Burning sensation, Malaise, Noninfective encephalitis
Clinical narrative: inflammation in her brain; burning; stinging, pinching; spike in blood pressures; joint pain, extreme pain in hips when walking; ill/sick; Seriousness criteria- Medically significant.  Initial information was received on 14-Sep-2020 regarding an unsolicited valid serious case from a consumer.  This case involves a 67 years old female patient who experienced inflammation in her brain (non-infective encephalitis), burning (burning sensation), stinging, pinching  (pain), spike in blood pressures (blood pressure increased), joint pain, extreme pain in hips when walking (arthralgia), extreme pain in hips when walking and ill/sick (malaise), while she received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number UJ25388 and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  The patient became ill/sick (malaise) on 28-Sep-2019 (in same month) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  On an unknown date, the patient developed a serious inflammation in her brain (noninfective encephalitis), burning (burning sensation), stinging, pinching (pain), spike in blood pressures (blood pressure increased) and joint pain, extreme pain in hips when walking (arthralgia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was not reported if the patient received a corrective treatment.  The patient was not recovered from any of the event.; Sender's Comments: This case involves a 67 years old female patient who experienced noninfective encephalitis, burning sensation, pain, arthralgia and malaise after vaccination with FLUZONE. The time to onset is unknown. Additional information patient's medical history, medical condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: inflammation in her brain; burning; stinging, pinching; spike in blood pressures; joint pain, extreme pain in hips when walking; ill/sick; Seriousness criteria- Medically significant.  Initial information was received on 14-Sep-2020 regarding an unsolicited valid serious case from a consumer.  This case involves a 67 years old female patient who experienced inflammation in her brain (non-infective encephalitis), burning (burning sensation), stinging, pinching  (pain), spike in blood pressures (blood pressure increased), joint pain, extreme pain in hips when walking (arthralgia), extreme pain in hips when walking and ill/sick (malaise), while she received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  In September 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number UJ25388 and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  The patient became ill/sick (malaise) on 28-Sep-2019 (in same month) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  On an unknown date, the patient developed a serious inflammation in her brain (noninfective encephalitis), burning (burning sensation), stinging, pinching (pain), spike in blood pressures (blood pressure increased) and joint pain, extreme pain in hips when walking (arthralgia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was not reported if the patient received a corrective treatment.  The patient was not recovered from any of the event.; Sender's Comments: This case involves a 67 years old female patient who experienced noninfective encephalitis, burning sensation, pain, arthralgia and malaise after vaccination with FLUZONE. The time to onset is unknown. Additional information patient's medical history, medical condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel given to a patient over 64 years of age, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a physician via phone.  This case is linked to case 2020SA25090 (same reporter).  This case involves male patient (age over 64-year-old) who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  No adverse event reported at the time of reporting.  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.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Exposure via skin contact, Injection site extravasation, Muscle tightness, No adverse event
Clinical narrative: consumer tighten up his arm muscle, and some of the product run down his arm from his injection site/NO AE; consumer tighten up his arm muscle, and some of the product run down his arm from his injection site/NO AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 58 year old male patient who received dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, out of which some ran down his arm from his injection site because of tightening up during the injection.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ428AA, expiry date- 30-June-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose and Exposure via skin contact (latency same day).  Caller states she had a consumer, that was tightening up during the injection and when she finished some ran down his arm from his injection site. States she didn't notice anything wrong with the needle nor the syringe and the needle retracted the way it should have. States she had seen this before when a consumer tightens up during injection.  At the time of 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.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Food allergy, Rash
Clinical narrative: Rash; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 44-year-old female patient who experienced rash, while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided. At the time of the event, the patient had ongoing egg allergy.  On 12-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6092BA and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination..  On an unknown date, the patient developed a non-serious rash few days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event (reported as lasted for few weeks).  There will be no information available on the batch number for this case.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Erythema, Fatigue, Myalgia
Clinical narrative: Patient described that on 9/12/2020 (day after vaccine administration) left arm was red and swollen. She has experienced congestion, cough, muscle aches, diarrhea, and general fatigue since 9/12/2020. She is still experiencing these symptoms 9/21/2020.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Respiratory tract congestion
Clinical narrative: Patient described that on 9/12/2020 (day after vaccine administration) left arm was red and swollen. She has experienced congestion, cough, muscle aches, diarrhea, and general fatigue since 9/12/2020. She is still experiencing these symptoms 9/21/2020.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling of eyelid
Clinical narrative: HE CAME IN THE MORNING FOR HIS APPOINTMENT, IN WHICH WE GAVE HIM A FLU SHOT.  MOM CALLED IN THE AFTERNOON  TO SAY THAT HE STARTED HAVING SWELLING AROUND THE EYES.  SHE ALSO NOTED THAT IT WAS HIS FIRST FLUSHOT, BUT ALSO HAD SOME AVOCADO THAT DAY.  MOM HAS A KNOWN ALLERGY TO AVOCADO, AND WASN'T SURE IF THIS WAS ALSO THE CASE FOR HIM.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: large raised red rash, 6 inch by 6 inch area around injection site.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Immediately after she had walked out of the vaccine room, she had experienced severe muscle pain in the injection site. Once home that night, she could hardly lift her arm above her head. As days progress, the pain started to radiate throughout her left arm at different sites, as well as her left lower back.  After a few days, she was able to lift her arm above her head but she cannot lift her elbow . 2 weeks still, she is experiencing pain and cannot lift her elbow.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Pain of skin, Swelling face
Clinical narrative: swelling to right lower jaw area and tender to touch
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Dad reported that she woke up with a rash all over her body
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: PATIENT HAS A SWELLING  CLOSE TO THE INJECTION SITE,  IN THE UPPER RIGHT ARM CLOSE TO THE ARMPIT. NO FEVER, RASH, PAIN OR ITCHING. PATIENT IS CURRENTLY USING COLD PACKS TO REDUCE THE SWELLING. THE SIZE OF THE SWOLLEN PART IS DECREASING.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: on 9-16-20 about 30 minutes after the injection, injection site started itching, burning and turning red. from that time, arm began to swell at the injection site and swelling and redness progressed over the next 48 hours down to elbow and underneath arm. patient went to clinic for treatment on 9-17-20 in the am and was given triamcinolone cream 0.1% to apply twice a day  and prednisone tablets 20mg twice a day for 3 days. and benadryl 25mg every 6 hours as needed. pt used all these medications and symptoms began to resolve on 9-19-20 and gradually improved until now. no swelling now, injection site is just bruised looking.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: - Red rash at site of injection on day 2 after first injection - muscle pain/stiffness 3 hours after first injection and up to day 3 - low grade fever 10 hours after injection and continuously until day 3 - headache 6 hours after injection and on and off until day 2
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: - Red rash at site of injection on day 2 after first injection - muscle pain/stiffness 3 hours after first injection and up to day 3 - low grade fever 10 hours after injection and continuously until day 3 - headache 6 hours after injection and on and off until day 2
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Eye discharge, Eye irritation, Eye swelling, Fatigue, Fluorescence angiogram
Clinical narrative: Had strong flu-like event night of 9/14 - 9/15. Recovery (Tired, achy) 9/15.   Woke up with HSV- eye symptoms  in/around right eye 9/16 (Swelling, Irritation, weeping, Redness of sclera, ulcerations near eye and at opening of right nostril)   Went to clinic (noted above), and was prescribed Viroptic (trifluridine) drops.  Will pickup prescription 09/22 . Currently symptoms have lessened slightly (Swelling less pronounced,  irritation lessened slightly).
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Influenza like illness, Ocular hyperaemia, Pain, Ulcer
Clinical narrative: Had strong flu-like event night of 9/14 - 9/15. Recovery (Tired, achy) 9/15.   Woke up with HSV- eye symptoms  in/around right eye 9/16 (Swelling, Irritation, weeping, Redness of sclera, ulcerations near eye and at opening of right nostril)   Went to clinic (noted above), and was prescribed Viroptic (trifluridine) drops.  Will pickup prescription 09/22 . Currently symptoms have lessened slightly (Swelling less pronounced,  irritation lessened slightly).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had a painful, red, warm to touch reaction on her right arm right below the injection site that extened to her elbow.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Eye swelling, Lip swelling, Rash
Clinical narrative: Giant bumps on head, swollen eye and lips
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Muscle spasms
Clinical narrative: Pain and Spasms of the lower back
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Chest discomfort, Dyspnoea, Erythema, Fatigue, Injection site erythema
Clinical narrative: The day after receiving the pneumonia vaccine patient experienced redness, extreme pain and excess swelling.  Patient also experienced fatigue and a heaviness in his chest accompanied by a difficulty breathing.  Patient took benedryl, which improved the chest pressure and breathing so that the patient didn't feel the need to go to the doctors.  Patient also used hydrocortisone cream that helped with the redness.   Monday morning the injection site was still red and inflamed and painful.  Patient reports no chest pressure or breathing difficulty and improvement of local symptoms.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site inflammation, Injection site pain, Pain, Swelling
Clinical narrative: The day after receiving the pneumonia vaccine patient experienced redness, extreme pain and excess swelling.  Patient also experienced fatigue and a heaviness in his chest accompanied by a difficulty breathing.  Patient took benedryl, which improved the chest pressure and breathing so that the patient didn't feel the need to go to the doctors.  Patient also used hydrocortisone cream that helped with the redness.   Monday morning the injection site was still red and inflamed and painful.  Patient reports no chest pressure or breathing difficulty and improvement of local symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient was given her first Shingrix injection. She experienced redness and swelling around the injection site along with mild fever and general body ache about 1 to 2 days later. Patient was advised to use OTC care and contact her physician if symptoms do not resolve in 1 to 2 days.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Influenza like illness, Nausea
Clinical narrative: Pt reports that he woke up Saturday morning after the flu shot w/severe dizziness and nausea that lasted the entire day. He then woke up Sunday am w/ mild Flu like Symptoms that lasted the entire day. As of Monday 9/21/2020 he is feeling at baseline. Patient is very concerned about severe dizziness.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Swelling face
Clinical narrative: Swelling and pain at injection site and down left arm. Body aches in legs. Right cheek, directly under the right eye swollen, down to mouth. Swelling continued for 3 days.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Loss of personal independence in daily activities, Weight increased
Clinical narrative: The outcome is permanet Restricted Breathing - Cannot Do Treadmill Anymore - Have gained WT since.
Age: 56.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: W/IN 3 DAYS, RED, SWELLING & INFLAMMATION ~ 3" DIAMETER PT CAME AFTER 7 DAYS, SIZE INCREASED TO 8-12". HAD TRIED ICE, HYDROCORTISONE & ADVIL.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Confusional state, Dehydration, Diarrhoea
Clinical narrative: had Shingrix 9-3-2020. Now having diarrhea + confusion started "sometime during hs". instructed daughter to take her to Dr. called pt family back @ 1300 unable to reach Dr. "pt is improving" no diarrhea after immodium states "I think he was dehydrated (1600) spoke with staff @ Dr. instructed to take to ED (1615) spoke with patients daughter taking pt to ED still confused + unsteady on feet.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Fatigue, Malaise, Urticaria
Clinical narrative: Hives all over her chest Felt sick, tired, no fever, light headed.  Started next day and started feeling better 3 days later.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Abdominal discomfort, Eye swelling, Lip swelling, Swelling face, Vomiting
Clinical narrative: CHILD RECEIVED TdaP, MENACTRA, INFLUENZA VACCINE. GOT UP, HAD SIGNIFICANT ABDOMINAL DISCOMFORT, VOMITED FORCEABLY, DEVELOPED SWELLING IN CHEEKS, LIPS, EYES. GIVEN ORAL BENADRYL WITH SOME RESOLUTION. SENT TO ED FOR FURTHER CARE
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: hives breakout whole body
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Tiredness Muscle Pain Headache Shivering fever Stiff Neck Weak Dizzy Hot to touch
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia, Skin warm
Clinical narrative: Tiredness Muscle Pain Headache Shivering fever Stiff Neck Weak Dizzy Hot to touch
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Disorientation, Fall
Clinical narrative: Patient slumped to floor in vaccination waiting room. Parents caught her and no head injury. Patient laid on floor and was disoriented for 30 seconds. Heart rate and breathing rate within normal limits. After patient disorientation passed, she drank water and was monitored in waiting rom for an additional 15 minutes and no return of syncope symptoms. No EMS called to location. Patient has had history of fainting but not after a vaccine until now.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Oral herpes, Pruritus
Clinical narrative: AT THis TiMe, "FeveR BlisTeRs" on LeGs. 18 wATeR FiLLeD BLisTeRs, Very ITcHy FROM 08/24/20. STiLL occuRING, NOT AS FREeQUeNTLy. I GET FLU SHoT EVeRy year. THis is THe FIRST TIMe THIS HAPPeNeD. My WiFe, Rec'D SAMe SHOT FoR THe FIRST TIMe. HeR CONDITIoN HAS BeeN MucH Less Irritating, SeveRe THAN MINe. We've TReATeD THe BLISTeRS + ITCH WITH CORTIZONe CReAM + BeneDRyL TABLeTs. BoTH HAVe HeLPeD. THANK YOU FOR YOUR INVALUABLE WORK. Be SAFE
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Incision site rash, Injection site pain, Neck pain, Pain, Rash
Clinical narrative: Rash around incision from hip surgery and on botton of feet Stinging going thru-arms, hands and feet also aching arm up thru neck where shot was given Dr. prescribed Antibiotics for a week seem to help
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous, Tenderness
Clinical narrative: 2.25 X 2.25 in erythematous rash with halo reaction around. Slight itchy. Started w/ a small red mark went to sleep + woke up today enlarged. Not overly painful unless deep pressure. No induration. Had done ice prior to exam. Area marked. Gave 10ML benadryl. Recommended Q6-8hr, ice, ibuprofen if area of redness increasing or not improving then to call.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pruritus, Feeling hot, Lip pruritus, Lip swelling, Pruritus
Clinical narrative: Symptoms: Itching hands, head, lips, ears, swelling of the lips,  feeling hot, Treatment: took Benadryl and Pepcid at home and received Benadryl and  solu-medrol  at Urgent care Timeline: went to Urgent Care 1 and 1/2 hours after event started
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Child developed a generalized erythematous maculopapular rash 9 days after immunizations were given. Child had no fevers, no cough, no emesis or diarrhea. He has been eating well, playful. No sick contacts at home. Observation recommended, supportive care. Explained to parents, it was probable adverse event due MMR vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: The patient reported a raised, red 6 inch welt that is hot to the touch. She descrived it as "on fire" and stated benadryl has not given her any relief. She did say it has not improved or gotten worse since Friday.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Confusional state, Decreased activity, Dysstasia, Injection site pain, Pain
Clinical narrative: The first day there was site soreness.  Days two and three has substantially worse affects.  I was unable to stand on day one and had a fever of 103.  Day two there was confusion, i wasn't able to read, entire body ached and a fever of 101.  Day 4 my fever finally broke and I was able to function at a depressed level.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Reading disorder
Clinical narrative: The first day there was site soreness.  Days two and three has substantially worse affects.  I was unable to stand on day one and had a fever of 103.  Day two there was confusion, i wasn't able to read, entire body ached and a fever of 101.  Day 4 my fever finally broke and I was able to function at a depressed level.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Skin abrasion
Clinical narrative: Per report, pt developed redness and pruritus on injection site (left deltoid) on 9/18. Patient scratched itchy site.  Later,  noted superficial abrasion on her skin. On 9/19, developed erythema and edema on affected site and pain of left upper arm. Presented to urgent care on 9/19. Treated w/ Keflex 50o mg 3 times a day for 1 week.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Patient said he felt the soreness right away when the vaccine was given and that he can "feel" the place where the needle was inserted.
Age: 81.0
Sex: M
Vaccine: FLUA4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: AT NIGHT AFTER PATIENT EAT ICE CREAM HE VOMIT  AND HAD DIARREHEA PATIENT CONTACTED MD BY PHONE  AND HE TOLD HIM TO USE LIQUID DIET AND IMMODIUM TODAY IS THE FIRST DAY HE CAN EATS 09/21/2020
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Pt reports muscle pain all over his body that developed 2 days after receiving his first dose of Shingrix. He notes that his pain was most severe in his legs and hips, pain lasted for 1 month but is now resolved. He reports taking OTC ibuprofen to relieve the pain but it was not effective.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Headache, Neurological examination normal
Clinical narrative: On Wednesday, an hour after recieving  flu vaccine right sided headache occured.  Head ache felt like a jolt of pain at the top right of head that would come and go.  Pain would be precipitated by  sometimes touching top of head and hair, sound and would also be painful with no stimulus at all.  Occured for 4 days. On the weekend it became more intense and frequent.  Went to  the emergency room and was given Reglan, Torodol,  and IV fluids.  Headache still present but less frequent. Purchased an ingested CBD oil before bed on Saturday and frequency of pain became significantly less.  By Monday the pain did not come back.
Age: 62.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash, Urticaria
Clinical narrative: Rash/Hives
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: Chills, fever, body aches, vomiting.  Both shots.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Contusion, Dry skin, Injection site pain
Clinical narrative: Patient reported "normal" sore pain at the injection site for 2-3 days after the injection. 2-3 days after that, black brusing appeared and stayed through the day the incident was reported (9/21/2020). Patient stated the area was very dry, after being questioned/examined by multiple pharmacists it was presumed a localized topical reaction. No intense pain or swelling reported.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Exactly 7 days after vaccine with Shingrix vial(10-pk )kit I developed shingles on 8/25/20.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Laboratory test abnormal, Malaise, Platelet count decreased
Clinical narrative: Patient received influenza immunization on 9/15/20, patient  reports to vomiting few hours later after having received the flu vaccine. Patient  reported to medical office on 9/17/20 and described the reactions as, possible allergic reaction with nerve sensitivities, feels like "burning" on back, arms, and legs. As per medical provider, possible neuritis from the flu shot (unsure). On 9/18/20, patient reported to hospital, after being referred by provider at medical office, with joint pains and malaise since receiving the flu vaccine. Patient was advised upon admission evaluation for observation in the hospital for symptomatic relief and for follow-up on blood work but patient declined and signed out against medical advice.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: Patient received influenza immunization on 9/15/20, patient  reports to vomiting few hours later after having received the flu vaccine. Patient  reported to medical office on 9/17/20 and described the reactions as, possible allergic reaction with nerve sensitivities, feels like "burning" on back, arms, and legs. As per medical provider, possible neuritis from the flu shot (unsure). On 9/18/20, patient reported to hospital, after being referred by provider at medical office, with joint pains and malaise since receiving the flu vaccine. Patient was advised upon admission evaluation for observation in the hospital for symptomatic relief and for follow-up on blood work but patient declined and signed out against medical advice.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Ocular hyperaemia
Clinical narrative: in words' of patient, "Bell's palsy-like reaction", right side of face was "frozen", left eye was extremely red, patient was prescribed steroid eye drops and antibiotics, symptoms lasted over 2 weeks, all issues appear to be resolved
Age: 51.0
Sex: F
Vaccine: FLUC4, TDAP, VARZOS
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Administered vaccines to patient, she said she didn't feel well and asked for some water. I went to go get her a glass of water and she passed out briefly per her husband. Came back and got pt cold wet cloths, a cold pack, and a coke. She sat for about 20 minutes and then she was able to leave on her own accord.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoacusis
Clinical narrative: Patient woke up the following morning with diminished hearing in bilateral ears. Tried claritin without improvement. Plan to send to audiology for additional evaluation.
Age: 81.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: redness on arm of injection site
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: Patient is claiming that she got cellulitis from the flu shot and that the vaccine was administered below the deltoid muscle and that she ended up in urgent care and got prescribed antibiotics for the cellulitis. She claims that she got the cellulitis 6 days post administration of the vaccines.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Dizziness, Dyspnoea, Hypersensitivity, Hyperventilation
Clinical narrative: within a few seconds of administering MMR, noted Pt. saying it was burning- noted small blistering started to appear directly below where imm was administered. Ice applied- denied initially any issues with breathing- as time progressed, states she was dizzy- laid on floor immediately and elevated feet- V/S were taken and other nurses in room to help with documentation and med administration- states B/P was on the low side, decision made to admin. 1 ml of Benadryl to help allergic reaction admin.  this was done at 11:44 AM. rash became worse- more of a " large hive", states she started hyperventilating and was having some s/s of anxiety and states it was starting to feel like " she just climbed a mountain and was having issues breathing about 12:11PM- 911 was called to be in route- prior to giving epinephrine. admin. 0.5 ml and paramedics and fire arrived to assess and decision  to transport to hospital at 12:43 PM
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Hypotension, Injection site pain, Injection site vesicles, Rash, Urticaria
Clinical narrative: within a few seconds of administering MMR, noted Pt. saying it was burning- noted small blistering started to appear directly below where imm was administered. Ice applied- denied initially any issues with breathing- as time progressed, states she was dizzy- laid on floor immediately and elevated feet- V/S were taken and other nurses in room to help with documentation and med administration- states B/P was on the low side, decision made to admin. 1 ml of Benadryl to help allergic reaction admin.  this was done at 11:44 AM. rash became worse- more of a " large hive", states she started hyperventilating and was having some s/s of anxiety and states it was starting to feel like " she just climbed a mountain and was having issues breathing about 12:11PM- 911 was called to be in route- prior to giving epinephrine. admin. 0.5 ml and paramedics and fire arrived to assess and decision  to transport to hospital at 12:43 PM
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint effusion, Joint range of motion decreased, Pain, Tendonitis
Clinical narrative:  Chronic right shoulder pain Comment: Unknown etiology. Consider side effect to pneumovax vaccine and or secondary frozen shoulder versus tendonitis, bursitis or rotator cuff pathology. Xray pending. Will likely refer to PT. Plan: XR SHOULDER 3 VW RIGHT
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: X-ray limb abnormal
Clinical narrative:  Chronic right shoulder pain Comment: Unknown etiology. Consider side effect to pneumovax vaccine and or secondary frozen shoulder versus tendonitis, bursitis or rotator cuff pathology. Xray pending. Will likely refer to PT. Plan: XR SHOULDER 3 VW RIGHT
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: swollen, sore, red arm
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Head injury, Syncope
Clinical narrative: Patient received the flu vaccine at approximately 12:19PM. Stayed seated in the vaccination area for a while to recover. Patient fainted and hit the back of his head on a shelf in store aisle when getting up to go home at 12:30PM. Pharmacy and store staff did initial evaluation and paramedics came and fully checked patient for signs of a concussion as well as need for stitches or other medical treatment.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Hives and redness for 2 days.  Needed Benadryl
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, SARS-CoV-2 test negative, Tremor
Clinical narrative: Patient developed shakiness, chills, and headache apx. 12 hours after the flu vaccine.  They overall improved.  No s/s of anaphylactic reaction.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: 10 minutes after injection developed bright red hives from chest to thighs, across abdomen and back, inside of arms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Pyrexia
Clinical narrative: Injection site rash, mild fever and flu like symptoms. Rash still present on the 3rd day but not painful or itchy
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Loss of consciousness, Pyrexia
Clinical narrative: Patient experienced a slight fever. She could not sit up or walk without passing out. She stated that she passed out once. On 9.17.20 she said she felt ok, but weak. On 9.18.20 she said she was still feeling very weak.
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient got shot on 9-18-20.  He stopped in on 9-21-20 to report still very painful and having some difficulty moving it
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site pain, Injection site reaction
Clinical narrative: Patient had a low muscle mass and appears that a blood vessel may have been nicked by the needle. After pulling the needle out of arm after injection, notice the blood seeped out from the injection site spurted out at more force than the usual trickle.  The site of injection swelled into a little welt with a slight blue hue.  The patient reported mild pain locally at the site of the injection immediately after.  No further complaints or reports from the patient since that time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Patient had a low muscle mass and appears that a blood vessel may have been nicked by the needle. After pulling the needle out of arm after injection, notice the blood seeped out from the injection site spurted out at more force than the usual trickle.  The site of injection swelled into a little welt with a slight blue hue.  The patient reported mild pain locally at the site of the injection immediately after.  No further complaints or reports from the patient since that time.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Fatigue, Headache, Nausea
Clinical narrative: The day after the vaccines was given, she felt some abdominal pain, nausea, severe fatigue, headache.  This lasted for over 5 days, and at the time of this report she is still having some abdominal pain and nausea
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient described reaction manifested as red circle at the site of injection that is mildly painful and warm to the touch. Patient did not endorse any signs of inflammation, not fever or trouble breathing at any point since onset of reaction.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Patient fainted after given shot. Father said this has happened before last year after getting flu shot. Called 911 and the paramedics came but father declined services.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Patient also received: MMR lot S032036 in the right deltoid, IM  She developed redness (mild), swelling and significant pain within  24 hours.  treated as cellulitis.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: Patient received HPV, MCV4 and flu vaccine shortly after 10am on 9/18/2020, patients mother called RN  around 12pm the same day stating that she has concerns about potential allergic reaction to vaccines. Patients mother states that patient has one hive to the left side of patients lip. No other signs or symptoms of reactions. patients mother states that patients reaction resolved after taking one dose of Benadryl. Denies SOB/ difficulty breathing or worsening symptoms.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: After administering the vaccine the patient's arm began to swell around injection site. The swelling continued till it was about the size of a golf ball and hard to the touch. Gave the patient two Benadryl 25 mg capsules and an ice pack. The patient said it itched initially. After sometime the swelling came back down and itching stopped.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Tingling in left hand pinky, left forearm and elbow area immediately after injection.  Left shoulder soreness within one hour after injection.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness on left arm and swelling,
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Patient passed out while driving home and got into a car accident
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Rash
Clinical narrative: Patient developed a rash all over that evening and her eyes reddened.  She went to the hospital, and the Dr prescriber her steroids, Pepcid and OTC Benadryl.   The Dr told her it may get worse before better and to keep an eye on it.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Patient had pain in her arm, red, hot swelling in the right arm the next morning at 8am.  Shot was descriibed as irritating, raised and hot to the touch x 36 hours.   Patient noticed two spots under left breast that looked like bug bites beginning two days ago on 9/19/2020.  She believes it is shingles.  Patient states she has had shingles twice in the past.