chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: During vaccination, the needle went in and the patient moved away/needle came out, small teardrop amount of the vaccine had dripped from arm, no AE; During vaccination, the needle went in and the patient moved away/needle came out, small teardrop amount of the vaccine had dripped from arm, no AE; Initial information received on 31-Jul-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a 4 year old male patient who was administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and the needle went in, the patient moved away and the needle came out, it was noted a small teardrop amount of the vaccine had dripped from his arm (Underdose and Exposure via skin contact).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.    Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 30-Jul-2020, the patient received a fifth Booster dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5688AA, expiry 26-Nov-2021) once via unknown 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  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: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: at 10:30 pm (08/10/2020) patient felt her finger tingling and at 3:00 am (08/11/2020) woke up with her both  hands swollen. Mom then gave her 1 tablet of Allegra, called clinic this morning to inform PCP and was told to come in for evaluation. PCP prescribe  hydrocortisone topical ointment, 2.5%, 1 app, applied topically, hydroxyzine tablet, hydrochloride 10 mg, prednisone tablet, 20 mg, 1 tab(s), orally, once a day.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: On 8-10-2020 there was a mistake made with this patient's vaccinations. The orders for the vaccines were not put into software at the time they were given, however the patient's report had been printed out and put on the doctor's desk. I could see Patient needed a Tdap (no mistake there) and the Meningococcal vaccine. There are two different Meningococcal vaccines, Bexsero and Menveo and bexsero was given when it was supposed to be menveo. I heard the doctor say bexsero and so did my co- worker, I then had her verify that I had the right vaccines and  gave them to the patient. There were no adverse reactions and the doctor said that the mistake will not harm the patient in any way
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received both IPOL and Quadracel inadvertently.  She did not have any negative side effects from this.  Parents were informed to monitor child and contact the office if she was having any type of reaction.
Sex: M
Vaccine: PPV, UNK
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: no additional AE; When the nurse pushed down on the plunger to administer the vaccine to the patient via IM injection in the deltoid, the syringe came loose from the needle hub and the vaccine spilled out of the syringe and down the patient's arm.; Patient was informed he likely did not receive the vaccination, and declined to receive another dose.; the vaccine spilled out of the syringe and down the patient's arm; the needle hub and the vaccine spilled out of the syringe and down the patient's arm.; This spontaneous report was received from a clinic supervisor via a company representative referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.      On 28-JUL-2020, a nurse went to administer pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  (0.5 milliliter, lot # S036495 with expiration date not reported, but upon internal validation established as 13-SEP-2021; frequency was not reported) intramuscularly (IM) in the deltoid for prophylaxis. The nurse expelled air from the syringe and attached the needle for administration. When the nurse pushed down on the plunger to administer the vaccine to the patient , the syringe came loose from the needle hub and the vaccine spilled out of the syringe and down the patient's arm. The patient was informed he likely did not receive the vaccination, and declined to receive another dose(syringe issue, incorrect dose administered, exposure via skin contact and accidental exposure to product). No adverse event was reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA001646:
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Can fatigue caused/it possible to still be tired six days after getting that injection?; This case was reported by a physician via call center representative and described the occurrence of fatigue in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported fatigue caused by the injection of Shringrix last 1week. The patient asked if it was possible to still be tired six days after getting that injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reactions of redness; Injection site reactions of redness, swelling; Injection site reactions of redness, swelling and warm to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fish allergy.   On 4th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with prednisone. Shingrix was discontinued. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient.  The patient asked if the Shingrix vaccine conatin fish. The patient had her first dose of Shingrix and experienced injection site reactions of redness, swelling and warm to touch. The physician prescribed Prednisone. Follow up was delayed due to the outbreak of the COVID-19 pandemic.  The patient was followed up for her 2nd dose with her HCP and he indicated not to get the 2nd dose. The patient would follow up with HCP.  The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received the liquid portion of the Pentacel vaccine but not the powder, No AE; Initial information received on 28-Jul-2020 regarding an unsolicited valid non-serious case from other healthcare professional via consumer/ non-health care professional.  This case involves a sex-month-old female patient who was given only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, [PENTACEL] (would be the third dose in the series ,batch number for Carton: UJ224AAA, Pentacel liquid vial lot: UJ314AA,Expration: 23-Apr-2020) vaccine but not the powder via an intramuscular route in an right thigh for prophylactic vaccination on 27-Jul-2020.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received concomitant medications that included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  Potential PTC:No  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.  Follow up information received on the 28-Jul-2020 from consumer/ non-health care professional  Batch number, Date of vaccination, patient's age and route and site of administration and conmeds were added.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired dose of Menactra, no adverse event; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case involves a 16 year old patient (gender was not reported) who was vaccinated with a 0.5 ml second dose (booster) once of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (single-dose vial, lot U6208AD and expiration date 08-Jul-2020) via an intramuscular route in the right arm for prophylactic vaccination on 20-Jul-2020.  The patient received first dose of Menactra vaccine in the past on an unknown date.  The patient's medical history, past medical treatment and family history were not provided.  The patient was concomitantly vaccinated with a dose of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for prophylactic vaccination (batch number and other dosing details were not reported).  It was an actual medication error case due to expired vaccine used (expired product administered).  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Episodes of syncope; Initial information was received on 03-Aug-2020 regarding an unsolicited valid serious case received from an other health professional.  This case involves a 17-years-old female patient who experienced episodes of syncope (syncope), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccine was received.   On 31-Jul-2020, the patient received a 0.5 mL once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE injection (lot U6596AB and expiry date 24-May-2021) via unknown route in the left arm for prophylactic vaccination.  On 31-Jul-2020, the patient developed a serious episodes of syncope (syncope) immediately on same day after the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant.  Case details: Reporter stated that, they had three episodes of syncope right after administration of Menactra with three different patients from the same batch of Menactra.  The patient was doing well at the time of report.  Details of laboratory data were not reported.  Final diagnosis was syncope.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient was recovered from the event of syncope. It was reported patient was doing well.; Sender's Comments: This case involves a 17-years-old female patient who experienced syncope on same following vaccination with MENACTRA vaccine. The time to onset was compatible. However, detailed additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, concurrent conditions, laboratory data were not reported. Based upon the reported information, the role of the vaccine cannot be assessed. Missing data needed for further assessment of the case.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: Patient states that she has experienced dry cough, muscle pain in stomach area, hot and cold spells and a headache. She did not state taking anything for these reactions.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Malaise, SARS-CoV-2 test negative
Clinical narrative: temperature and ill for a couple days. COVID test done but negative
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Erythema, Rash
Clinical narrative: I had vomiting, dizziness, diarhhea, hot shivers, rashy-redness in arm near site of injection, almost down to elbow. The shivers started first, the rest peaked about 3:00am.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: I had vomiting, dizziness, diarhhea, hot shivers, rashy-redness in arm near site of injection, almost down to elbow. The shivers started first, the rest peaked about 3:00am.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Nausea, Vision blurred, Vomiting
Clinical narrative: Approximately 3 hours after receiving the vaccine, patient had a sudden onset of severe dizziness, blurry vision, nausea, vomiting and fatigue.  She contacted our office and was advised supportive care with OTC pain relievers and anti-emetics.  Her symptoms began to resolve after 6 hours.  Patient was contacted the next morning and reported complete resolution.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effect reported; MMR II and Sterile Diluent was given to a patient that was expired; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 31-JUL-2020, the patient was vaccinated  an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) 0.5 milliliter, lot # R019979 with expiration date 11-JUL-2020 which was diluted with an expired sterile diluent, 0.5 milliliter, lot number reported as N03021 with expiration date 20-JUL-2020 (frequency, route and anatomical location were not provided for any suspect therapy) and were administered for prophylaxis. The reporter stated that the vials were throw in the biohazard box. No additional adverse effect reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Severe Rash on left arm and left torso / Rash was very itchy; This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th April 2020, 1 days after receiving Shingrix, the patient experienced itchy rash. On 6th April 2020, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had severe rash on left arm and left torso which was the same side as the injection. The rash was very itchy and lasted for one day. The reporter did not consent to follow up. The reporter wanted to know if this was an allergic reaction because the patient was due for her next Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: adverse event for patient had symptoms listed on the website; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fever and adverse event. On an unknown date, the outcome of the headache and fever were recovered/resolved and the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had headache and fever had for 2 days. The reporter asked how long the symptoms would last and ruled in for adverse event.  No patient demographics, LOT or EXP provided other than the patient being a female. The HCP information not obtained.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Neuropathy peripheral
Clinical narrative: neuropathy; loss of balance; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathy in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date unknown) for prophylaxis.   Concurrent medical conditions included low back pain.   On 31st May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and loss of balance. On an unknown date, the outcome of the neuropathy and loss of balance were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy and loss of balance to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced loss of balance and neuropathy. The patient received some treatment for lower back pain in March 2020 and the patient did not know if the adverse events reported started after the lower back pain treatment. The reporter was consented to follow up.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received vaccine at 0830 am in the right thigh area and then at about 0835 area was red and was about 10 mm red, pt had mild itching to area at about 0840 area was red and 40 mm red and still mild itching and warm to the touch. Nurse did assess trunk area and there was no other redness no soa or any other signs area was localized, nurse did call PAC assessed pt and said she was ok to go home and to give tylenol and benadryl childrens to help with the discomfort and to return  for any new or worsening symptoms. Nurse did draw a line around reddened area and pt was discharged at 0855 and redness and itching did not get any worse.
Age: 13.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Drug dispensed to wrong patient, Injection site pain
Clinical narrative: Pt recieved Meningococcal MCV4 and Menogoccal B in error. Doses were for her older sister. No adverse reaction noted 45 minutes after injections.  C/O soreness at injections sites.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: patients adverse reaction were severe itching and facial swelling. hives on trunk and limbs
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 101.4, vomiting, arms and legs aching. Symtpoms lasted for about two days and then resolved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever (99.9) for ~8 hours. Tylenol took care of it. Right arm very sore for 3 days and also was slightly red at injection site.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Feeling abnormal, Musculoskeletal stiffness, Nodule, Peripheral swelling
Clinical narrative: Patient was given the vaccine and after 15 mins I check on her and her arm started to get a swollen knot area. It was itchy, there was reddness, swelling and her fingers felt tight on this arm. There was no breathing issues or heart racing. Pt was given an ice pack and Benadryl 25 mg orally once. Pt was advised to stay for a little while to make sure she wouldn't get worse. After about another 15-20 mins I checked on pt again. She started feeling "off", she felt "fuzzy", just not right. Pt was also getting sleepy (due to the Benadryl).  Pt was advised to lay down. After another 15 mins we checked on her again. The swelling and redness were going down. She was starting to feel better. After speaking with Dr. again, pt was okay to go home. Advised if breathing or heart racing issues to go to the ED. Pt was taken home by her mother.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Somnolence, Swelling
Clinical narrative: Patient was given the vaccine and after 15 mins I check on her and her arm started to get a swollen knot area. It was itchy, there was reddness, swelling and her fingers felt tight on this arm. There was no breathing issues or heart racing. Pt was given an ice pack and Benadryl 25 mg orally once. Pt was advised to stay for a little while to make sure she wouldn't get worse. After about another 15-20 mins I checked on pt again. She started feeling "off", she felt "fuzzy", just not right. Pt was also getting sleepy (due to the Benadryl).  Pt was advised to lay down. After another 15 mins we checked on her again. The swelling and redness were going down. She was starting to feel better. After speaking with Dr. again, pt was okay to go home. Advised if breathing or heart racing issues to go to the ED. Pt was taken home by her mother.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: Shaking, vomiting
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: pain, redness, swelling at the injection site, pt reported chills/fever on following day (but she also tested positive for COVID-19 on the day she reported symptoms)
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pain, redness, swelling at the injection site, pt reported chills/fever on following day (but she also tested positive for COVID-19 on the day she reported symptoms)
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Fatigue, Feeling cold, Fluid intake reduced
Clinical narrative: severe chills that I felt frozen, extreme muscle ache and fatigue. when I left work I had to turn the heat on in my home to 80 degrees. After three hours of sleep and waking up I finally turned off. I slept the entire day of 08/10/20. my feet felt cold and my body ached, I could not keep warm and had a comforter and sheets and no a/c running. I had no appetite and little desire for drinking fluids.  This wiped me out like I was sick. When I reported it to a friend she said that some of her relatives have experienced the same paralyzing sickness like I described after taking the flu shot for this season.  This is the second flu shot in my life time. My first flu shot was 09/2014 from pharmacy and I was fine.  I grew up with all of my vaccines and in a medical household.  I can tell you this year is not a normal reaction, I never have adverse reactions to vaccines and medications.  I am still recovering as I type. I originally requested a day off from work on monday and I am glad that i am off today and tomorrow as well because it will take that long to get my strength back and the body aches and chills to go away.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain, Peripheral coldness
Clinical narrative: severe chills that I felt frozen, extreme muscle ache and fatigue. when I left work I had to turn the heat on in my home to 80 degrees. After three hours of sleep and waking up I finally turned off. I slept the entire day of 08/10/20. my feet felt cold and my body ached, I could not keep warm and had a comforter and sheets and no a/c running. I had no appetite and little desire for drinking fluids.  This wiped me out like I was sick. When I reported it to a friend she said that some of her relatives have experienced the same paralyzing sickness like I described after taking the flu shot for this season.  This is the second flu shot in my life time. My first flu shot was 09/2014 from pharmacy and I was fine.  I grew up with all of my vaccines and in a medical household.  I can tell you this year is not a normal reaction, I never have adverse reactions to vaccines and medications.  I am still recovering as I type. I originally requested a day off from work on monday and I am glad that i am off today and tomorrow as well because it will take that long to get my strength back and the body aches and chills to go away.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives to legs MOSTLY right left and left wrist ( 1 ) and left mid arm(1)
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Differential white blood cell count, Fontanelle bulging, Full blood count normal, Human herpes virus 6 serology, Polymerase chain reaction
Clinical narrative: Patient developed bulging fontanelle five days after vaccine (8/10/20).  She also had developed a fever on day of vaccination and a rash soon after the fever.  Fever and rash were gone by the time she was seen in clinic.  The bulging fontanelle was still present per parents the following day (8/11/20) when provider called family.  She was otherwise acting normal without any other signs of increased intracranial pressure.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Patient developed bulging fontanelle five days after vaccine (8/10/20).  She also had developed a fever on day of vaccination and a rash soon after the fever.  Fever and rash were gone by the time she was seen in clinic.  The bulging fontanelle was still present per parents the following day (8/11/20) when provider called family.  She was otherwise acting normal without any other signs of increased intracranial pressure.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site; body aches, headache, tired, upset digestive system,  lasted approximately 72 hours
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swelling and redness at injection site; body aches, headache, tired, upset digestive system,  lasted approximately 72 hours
Age: 11.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse events.; Nurse reports an 11 year old patient was inadvertently administered PEDVAXHIB  instead of MENVEO (unknown manufacturer); This spontaneous report was received from a registered nurse, referring to a 11-year old male patient. The patient's medical history, concomitant medication and concurrent condition were not provided.     On 03-AUG-2020, the patient was inadvertently administered haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S031500, expiration date 21-APR-2022; strength, dose and route were unknown) for prophylaxis instead of meningococcal acyw conj vaccine (crm197) (MENVEO) (wrong vaccine administered). No additional adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash, Herpes zoster, Rash
Clinical narrative: suffered a rash on the right side of his lower back, wrapped around his right groin and down his buttocks and was diagnosed with shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about his medical history, concurrent conditions and concomitant therapies was provided. On or about 20-AUG-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a rash on the right side of his lower back, wrapped around his right groin and down his buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 10-SEP-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a health department for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 22-APR-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: neuropathic pain; herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 06-JUL-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a medical group for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): herpes zoster and neuropathic pain. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 21-OCT-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for multiple outbreaks of herpes zoster, resulting from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not reported. The reporter considered the event of multiple outbreaks of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; report expired V ARlV AX was inadvertently administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant  therapies were not reported.  On 04-AUG-2020, the patient was inadvertently  vaccinated with an expired varicella virus vaccine live (oka/merck)(VARIVAX) lot # R021098, 23-JUL-2020 (dose, route and vaccination site  were not reported), for prophylaxis.  No additional adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Electrocardiogram abnormal
Clinical narrative: unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Initial information was received on 04 August 2020 via medical records ( the case is medically confirmed). As per the records the patient underwent vaccination for herpes zoster 3 dose schedule. The patient was also receiving Vaccine zostervirus (shingles) recombinant, subunit adjuvanted no sooner than 07 September 2018 and no longer than 06 December 2018.
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain; Immobility of the right arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix, Boostrix and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingrix and Boostrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix and Boostrix.  Additional detaails were provided as follows: The age at vaccination was not reported. The patient received  Boostrix, Shingrix, and a pneumonia vaccine on the same day. The reporter stated that, after vaccination with Boostrix, Shingrix, and a pneumonia vaccine, the patient had pain in right arm and immobility of right arm. The reporter did not sure which vaccine caused the adverse events. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site scab, Injection site vesicles, Injection site warmth
Clinical narrative: Mom contacted me 8/7 re: redness/warmth left leg when got shot last week. She sent me a picture which was very localized with 3-4 small blister like lesions visible. Not seeming to bother. Reviewed note and had received varicella only in that leg. Mom reached back out on 8/8 with mild erythema on ovoid area that width wise cover about 1/3 of anterior thigh. Blistering still present and at medial aspect of erythema. Still not bothering.  8/11/2020: 2cm redness blister at injection site scabbed over
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Full blood count, Inflammatory marker increased, Injection site erythema
Clinical narrative: Patient experienced redness in arm of injection site that progressed into diffuse joint and body pain, dry cough, fever, elevated inflammatory markers, and elevated LFT.  Symptoms continued to a lesser degree until early May 2020. Reaction has resolved without injury.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test increased, Metabolic function test, Pain, Pyrexia
Clinical narrative: Patient experienced redness in arm of injection site that progressed into diffuse joint and body pain, dry cough, fever, elevated inflammatory markers, and elevated LFT.  Symptoms continued to a lesser degree until early May 2020. Reaction has resolved without injury.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Onset of diarrhea and fever shortly after vaccine administration. Child has had diarrhea for 6 weeks--slowly improving.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Antiphospholipid antibodies negative, Arthralgia, Joint lock
Clinical narrative: hand locked up, burning in joint (knee caps and toes)
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Approx 90 minutes after receiving the vaccine, the patient was eating sandwich and noticed his eyes felt swollen bilaterally. He also noted his right sclera was reddened. He denied pain or itching. He had no other rash, no N/V/D, no abdominal pain, no swelling or redness at site of vaccine, no tongue or mouth swelling, no shortness of breath or difficulty swallowing. He was seen immediately for a visit and given Benadryl 50mg PO & Prednisone 60mg PO. His vitals were stable and his exam was normal other than the eye swelling and redness. He was observed for about 45 minutes, during which there was no improvement or worsening of his symptoms. Rx for Zyrtec, Pepcid, & Prednisone was sent to his preferred pharmacy. He was sent home with his mother and instructed to seek emergent care if any new s/sx developed or if his s/sx worsened.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia
Clinical narrative: Pt called on call service with "severe joint pain" throughout entire body.  OTC product instructions given via Dr.
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Abdominal pain, Cardiac flutter, Computerised tomogram, Condition aggravated, Laboratory test
Clinical narrative: Heart fluttering Abdominal pains  3 internal infections septic and hospitalized Kidney Cancer / surgery/ hospitalized
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Magnetic resonance imaging, Renal cancer, Sepsis, Surgery, Ultrasound scan
Clinical narrative: Heart fluttering Abdominal pains  3 internal infections septic and hospitalized Kidney Cancer / surgery/ hospitalized
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PEDVAX HIB was improperly stored and administered; This spontaneous report as received from a nurse, who refers to a patient of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 29-JUL-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S031500, expiration date 21-APR-2020, for prophylaxis (formulation, strength, dose number, dose, route of administration and frequency were not reported). Digital data logger was involved. The vaccines was stored at the temperature reported as 50 degrees of Fahrenheit (F) for1 hour and 46 minutes. There was no previous temperature excursion. No additional adverse event was reported. No product quality complaint (PQC) involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307: US-009507513-2008USA000367:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a study coordinator concerning a 12 month old patient of unknown gender. Information on pertinent medical history and drug reactions/allergies was not reported.   On 17-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, dose number, route of administration and location of administration were not reported) (lot # S0077963, expiration date 02-AUG-2021), administered for prophylaxis. The vaccine was reconstituted on a properly stored sterile diluent.   The vaccine was exposed to a temperature of -14 degrees Celsius (C) to -10 C (-12.8 C) for a time frame of 46 minutes as recorded by a digital data logger. There were no previous temperature excursions. No adverse symptoms were reported.   This is one of multiple reports from the same reporter.  Lot number S0077963 is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  US-009507513-2008USA000587: US-009507513-2008USA000665:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Product storage error
Clinical narrative: mmediately after administration lhe patient had some redness and swelling at lhe insertion site; Immediately after administration The patient had some redness and swelling at lhe insertion site; The patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a study coordinator referring to a 1 year old female patient. There were no pertinent medical history, concurrent conditions nor drug allergies/drug reactions.  On 15-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot  S007963, expiration date 02-AUG-2021 for immunisation (strength, dose, frequency and route of administration were not provided).    The improperly stored suspect vaccine had a temperature of -14 degrees Celsius (°C)  to -10°C  ( average -12 .8°C) during 46 minutes. There was no previous temperature excursion and the Merck sterile diluent used to reconstitute the vaccine was properly stored.   On 15-JUL-2020, immediately after administration the patient had some redness (injection site erythema ) and swelling at the injection site.   It was reported that the patient's mother sought medical attention by contacting the physician office and paracetamol (TYLENOL) was provided as treatement.   The outcome of injection site swelling and injection site erythema was reported as recovered on the same day. The call was made because of a data logger.  The causality between the events and varicella virus vaccine live (Oka/Merck)(VARIVAX) was not provided.   Lot number S007963 is an invalid lot number for varicella virus vaccine live (Oka/Merck)(VARIVAX).  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2008USA000665:01664542 US-009507513-2008USA000429: