chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Depressed level of consciousness, Dizziness, Electrocardiogram QT interval, Fatigue
Clinical narrative: Injection at 10:00 by 4:00 pm she was dizzy felt like she was going to pass out. At 4:30 she started to have uncontrollable muscle spasms that quickly spread to tics over her entire body below the neck. She complained of nausea, severe stomach pains, fatigue, and loss of appetite. Tics continued in her arms, legs, and abdomen several days.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Nausea, Streptococcus test, Tic, White blood cell count normal
Clinical narrative: Injection at 10:00 by 4:00 pm she was dizzy felt like she was going to pass out. At 4:30 she started to have uncontrollable muscle spasms that quickly spread to tics over her entire body below the neck. She complained of nausea, severe stomach pains, fatigue, and loss of appetite. Tics continued in her arms, legs, and abdomen several days.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Patient has a fever and the chicken pox rash developed a week after getting the vaccine
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: It's been 2 days of far of these symptoms- Major headache, Diarrhea, Stomachache and Gas, pain at the back of neck , fatigue, dizzy, foggy brain-can't focus, lower back pain, couldn't perform daily activities at home - cooking, taking care of family.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Flatulence, Headache, Loss of personal independence in daily activities
Clinical narrative: It's been 2 days of far of these symptoms- Major headache, Diarrhea, Stomachache and Gas, pain at the back of neck , fatigue, dizzy, foggy brain-can't focus, lower back pain, couldn't perform daily activities at home - cooking, taking care of family.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: It's been 2 days of far of these symptoms- Major headache, Diarrhea, Stomachache and Gas, pain at the back of neck , fatigue, dizzy, foggy brain-can't focus, lower back pain, couldn't perform daily activities at home - cooking, taking care of family.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncopal Episode, patient monitored and released once vitals were stable
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: My 2.5 WEEK old daughter was accidentally administered the Dtap instead of HepB vaccine. I do not know which manufacturer or other specifics at this time, only that it was the Dtap and it was not something I requested or that her pediatrician had intended for her to be vaccinated with.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; patient was "inadvertently administered an expired; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender.  The patient's medical history, historical drugs, concurrent conditions were not provided.    On 20-JUL-2020, the patient was "inadvertently" administered an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R017636, expiration date 20-JUN-2020 (Strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent.  No adverse symptoms were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Liver function test normal, Pruritus, Renal function test normal
Clinical narrative: Itchiness worsened; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus aggravated in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose in September 2019, refer case US2020135591).   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pruritus aggravated. The patient was treated with benadryl (nos) (Benadryl), antihistamine (Antihistaminic), corticosteroid nos (Corticosteroid (Trade Name Unknown)) and steroids nos (Steroids). On an unknown date, the outcome of the pruritus aggravated was recovering/resolving.   It was unknown if the reporter considered the pruritus aggravated to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and after that dose the itchiness worsened.  The patient consulted a physician who examined the patient and run tests liver, kidney as reported and no alternative explanations for the itchiness were found by the patient´s physician.  The pharmacist also reported that Benadryl and other antihistaminic drugs did not work for the itchiness which only improved after the administration of corticosteroids.  The patient was currently receiving steroids The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020135591:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 19th July 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient thought he/she have fever after getting the Shingrix vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain in extremity, Pyrexia
Clinical narrative: fever; arm soreness; 2nd dose received late; headache; This case was reported by a physician via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020134641).   On 16th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced headache. On 16th July 2020, the patient experienced pain in arm and drug dose administration interval too long. On 17th July 2020, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever and drug dose administration interval too long were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the headache, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose 2 years ago from reporting date. The patient experienced headache after vaccination.  The patient experienced arm soreness on day of vaccination which was not resolved till the time of reporting. The fever was started 12 to 18 hours after the vaccination. The patient reported a fever of 101.4 degree F following vaccination that lowered to 100.4 degree F. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020134641:same reporter
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Adacel exposed to 52.6 degree Fahrenheit for seven days and were administered to the patient/ No AE; pregnant female patient received Adacel vaccine at 28 Weeks of gestation/ No AE; Initial information was received on 20-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA188909, 2020SA189059, 2020SA189112 and 2020SA189085 (same reporter).  This case involves a 24 years old pregnant female patient who on 09-Jul-2020 at 28 weeks of gestation received a 0.5 mL dose of  vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA and expiry date 12-Apr-2022) via intramuscular route in the left arm for prophylactic vaccination and that vaccine got exposed to 52.6 degree Fahrenheit for seven days (exposure during pregnancy and product storage error)  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The patient received Adacel vaccine at 28 Weeks of gestation.  The date of last menstrual period was reported as 25-Dec-2019.  The estimated due date is 30-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were given to the patient.   It was of actual medication error due to incorrect product storage. It was also a case of vaccine exposure during pregnancy.    Case details: It was reported that the excursion was for seven days and vaccine got exposed to 52.6 degrees Fahrenheit from 08-Jul-2020 to 15-Jul-2020 that was administered to five patients since the excursion. Reporter wanted to know about the possible side effects.  Laboratory details were not reported.  The patient had no adverse reactions at the time of report.   Additionally, at time of reporting, the outcome of the pregnancy was unknown.   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: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Gait disturbance, Pain, Skin warm, Swelling
Clinical narrative: swelling, redness, warm to touch, pain. Started the morning of the 7/23/20, it caused patient to limp.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever for 24 hours, muscle pain for 48 hours, diarrhea for 48 hours, Tired feeling for 72 hours
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: Headache; fever; diarrhea on the day and night of the vaccine; all but diarrhea gone the next day.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood potassium decreased, Computerised tomogram abdomen, Computerised tomogram pelvis, Diarrhoea
Clinical narrative: Pt developed fever, abd pain, N/V/D, mild cellulitis at site. Seen in Urgent Care/ER 7/18/20 Started doxy BID - Neg test. Return to ER 7/22/20 for continued abd pain + diarrhea. pt currently in ER/UC
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt developed fever, abd pain, N/V/D, mild cellulitis at site. Seen in Urgent Care/ER 7/18/20 Started doxy BID - Neg test. Return to ER 7/22/20 for continued abd pain + diarrhea. pt currently in ER/UC
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: the patient was treated by a healthcare provider for shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. The pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, and route of administration not provided) on or about 21-MAY-2008 at a hospital, for the long-term prevention of shingles and zoster-related conditions. Subsequent on unspecified date, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's  use of  the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to 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 and other losses and damages.At the time of the report, the patient's outcome was not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: titers have come back negative; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient's titers have come back negative and the doctor wanted her to restart the series. The reporter consented to follow up. The health care professional was unaware of timing of previous vaccination but she thinks it was a while ago. She was not sure if patient was even fully vaccinated or not.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: High fever; Headache; Vomiting; This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for four patients. This is the first of four reports. A 16-year-old patient of an unspecified gender (reported as "both male and female patients affected but number of each sex is unknown") received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via intramuscular injection in arm one on an unspecified date at single dose for meningitis serogroup B vaccine and received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, injection), via intramuscular injection in arm two on the same day at an unspecified dose, single for vaccine. The patient medical history and concomitant medications were not reported. Nurse reported that 4 known patients that they had administered both meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) to experienced the same symptoms: high fever, headache and vomiting. The patients were each administered meningococcal group b rlp2086 injection in one arm and meningococcal vaccine a/c/y/w conj (dip tox) injection in the other arm at the same time. The outcome of the events was unknown (reported as "unknown other than usually resolved and cleared up in about 24 hours.").  Information about lot/batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279369 Same reporter,drug,event/Different patient;US-PFIZER INC-2020279391 Same reporter,drug,event/Different patient;US-PFIZER INC-2020279283 Same reporter,drug,event/Different patient
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: High fever; Headache; Vomiting; This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for 4 patients. This is 2nd of 4 reports. A 16-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via intramuscular on an unspecified date at single dose, administered in arm 1 for immunization and meningitis , meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via  intramuscular on an unspecified date at an unknown dose, administered in arm 2 for immunization. The patient medical history and concomitant medications were not reported. The nurse reported that the last 4 or 5 patients that they had administered both Trumenba and Menactra to experienced the same symptoms: high fever, headache and vomiting. The patients were each administered Trumenba injection in one arm and Menactra injection in the other arm at the same time. Caller was unable to verify if there was a 5th patient involved, so reports for 4 known patients provided. The affected patients were all 16 years of age at time of administration of these products. There were both male and female patients affected but number of each sex is unknown other than at least 1 of each sex. The outcome of the events was unknown (other than usually resolved and cleared up in about 24 hours).  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279270 Same reporter,drug,event/Different patient
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: High fever; Headache; Vomiting; This is a spontaneous report from a contactable Nurse via Pfizer Sales Representative. This Nurse reported same events for 4 patients. This is report 4 of 4. A 16-year-old patient received meningococcal group b rlp2086 (TRUMENBA, injection) on an unknown date via Intramuscular in one arm at single dose (Batch/lot number: Unknown) for Meningitis serogroup B vaccine and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Injection) via intramuscular injection in the other arm at the same time with trumenba at unknown dose for vaccine. The patient experienced the symptoms included high fever, headache and vomiting. Outcome of the events was unknown. Seriousness and causality between with events and trumenba and menactra were not provided.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279270 same reporter, same drug, same event, different patients.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pallor, Presyncope
Clinical narrative: Patient had vasovagal response approx 4-5 minutes after vaccines were administered while sitting on exam table. She was assisted to floor by NP. Patient was pale but opened eyes within a few seconds. She was briefly nauseated. She recovered quickly after sitting up and drinking water. Mom and patient remained in clinic for an additional 15 minutes and patient was back to baseline without complaints prior to ambulating out of clinic.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood glucose normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, Central nervous system lesion
Clinical narrative: Tingling, stiffness, tightness in leg mostly under knees
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Demyelination, Insomnia, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal normal
Clinical narrative: Tingling, stiffness, tightness in leg mostly under knees
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Musculoskeletal stiffness, Paraesthesia, Red blood cell sedimentation rate normal, Vitamin B12 normal
Clinical narrative: Tingling, stiffness, tightness in leg mostly under knees
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Discomfort, Pruritus, Rash, Scrotal dermatitis, Scrotal swelling
Clinical narrative: 2 weeks after administration of vaccines developed skin rash on lower abdomen and scrotum along with significant scrotal swelling. Patient was discomfort and itching that required a evaluation in our clinic. Avoid contact with immunocompromised people, Tylenol and motrin for the discomfort, topical Benadryl for the itching, cold compresses and elevation of scrotum, and to call back if signs and symptoms of infection. Outcome to be determined
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Fatigue, Haemorrhage subcutaneous, Immunoglobulin therapy, Increased tendency to bruise
Clinical narrative: Patient presented to hospital on 7/21 for evaluation of easy bruising and low platelets.  She received gardasil vaccination on 7/15/20 in MD office.  On Thursday, pinpoint spots on her skin from knees to feet were noticed.  On Friday, the spots got more prevalent and larger with a large bruise on her right inner thigh.  The pressure points also had an increased number of spots.  She felt shaky, tired, increased thirstiness, and dry blood in mucous.  Patient was admitted and has received 2 doses of IVIG (on 7/22 and 7/23).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Mucosal haemorrhage, Nervousness, Platelet count decreased, Thirst
Clinical narrative: Patient presented to hospital on 7/21 for evaluation of easy bruising and low platelets.  She received gardasil vaccination on 7/15/20 in MD office.  On Thursday, pinpoint spots on her skin from knees to feet were noticed.  On Friday, the spots got more prevalent and larger with a large bruise on her right inner thigh.  The pressure points also had an increased number of spots.  She felt shaky, tired, increased thirstiness, and dry blood in mucous.  Patient was admitted and has received 2 doses of IVIG (on 7/22 and 7/23).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: muscle pain at injection, lethargy
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Condition aggravated, Crohn's disease, Fatigue, Haematochezia
Clinical narrative: Fever, fatigue, upset stomach, sore itchy injection site, seemed to have triggered a Crohn's flare as I began to have blood in stool and extra couple days of fatigue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Fever, fatigue, upset stomach, sore itchy injection site, seemed to have triggered a Crohn's flare as I began to have blood in stool and extra couple days of fatigue.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Injection site erythema, Irritability, Vaccination site swelling
Clinical narrative: 2 inch area of swelling on left thigh at site of vaccine. Redness of area and extreme fussiness. Went to ER rectal temp there was 101. Symptoms improved overnight
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Chills, Dizziness, Dysphagia, Fatigue
Clinical narrative: On 7/22/20, around 8 pm pt came downstairs, was pale and developed chills, c/o leg pain/cramping. Pt drank some water and took tylenol, perked up a little, but still doesn't feel well today. No fever. Did not feel faint, felt a little lightheaded when she stood up from the couch. Slept well last night. Feels tired this morning, also has aches in her back and lower legs, some pain in arm at site. Walking fine today, color is much improved. Tylenol is helpful for the pain.  At end of phone call, pt notes also felt like her tongue was a bit swollen and had trouble swallowing last night.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Muscle spasms, Pain in extremity, Pallor, Swollen tongue
Clinical narrative: On 7/22/20, around 8 pm pt came downstairs, was pale and developed chills, c/o leg pain/cramping. Pt drank some water and took tylenol, perked up a little, but still doesn't feel well today. No fever. Did not feel faint, felt a little lightheaded when she stood up from the couch. Slept well last night. Feels tired this morning, also has aches in her back and lower legs, some pain in arm at site. Walking fine today, color is much improved. Tylenol is helpful for the pain.  At end of phone call, pt notes also felt like her tongue was a bit swollen and had trouble swallowing last night.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: tingling in arm starting 1 day after vaccine and not going away
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site bruising, Paraesthesia
Clinical narrative: tingling in arm starting 1 day after vaccine and not going away
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Loss of consciousness, Tinnitus, Tremor
Clinical narrative: Patient reportedly briefly lost consciousness, later recovered around 15-20 minutes later. Reported saying hear ringing in the ears, 'felt like she was going to faint' and slight shaking on the hands. Patient wore a mask, the room was small (confined) and the weather was slightly warmer than usual.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Antibody test positive
Clinical narrative: the patient had a positive titer on an unspecified date in 2018, then had a low titer on an unspecified date in 2020; This spontaneous report has been received from a physician referring to a female patient with unknown age. Information about current condition, medical history, concomitant therapy and drug reactions/allergies was not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient had a positive titer. On an unknown date in 2020, the patient had a low titer. The outcome and the causality was not reported.
Age: 0.17
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a medical assistant and refers to a 11-week-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 16-JUN-2020, the patient was inadvertently administered a dose of hepatitis a vaccine, inactivated (VAQTA) lot # S001832, expiration date 12-MAY-2020 (strength, exact dose and route of administration were not reported) for prophylaxis. No product quality complaint (PQC). No adverse events. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; expired vaccine administered; This spontaneous report was received from a medical assistant and refers to a 32-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 09-JUL-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S012250, expiry date 07-JUL-2020) (strength, route and site of administration were not provided) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Malaise, Pyrexia, Vomiting
Clinical narrative: feeling unwell; Stomach upset; vomiting; fever; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020 09:00, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell, upset stomach, vomiting and fever. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the upset stomach, vomiting and fever were unknown.   It was unknown if the reporter considered the feeling unwell, upset stomach, vomiting and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient was feeling unwell. The patient expereinced upset stomach though vomiting and fever of 99.3 degree F.  The reporter asked if this was a possibly a reaction to the shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Arm was sore/arm tenderness; Arm red; Fever; Arm warm to the touch; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020).   On 11th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 11th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, fever, skin warm and chills. On an unknown date, the outcome of the pain in arm and erythema of extremities were not recovered/not resolved and the outcome of the fever, skin warm and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, fever, skin warm and chills to be related to Shingrix.  Additional details were provided as follows: The reporter did not had lot number and expiration date. The patient received Shingrix and noticed that their arm was sore, red in color about the size of 3 quarters and was warm to the touch hours after injection. The patient also stated that the evening of receiving the second injection began having chills and confirmed they had a fever after checking their temperature.  The fever and chills, arm soreness, redness, and tender to the touch continued and fever and chills were gone but the sore arm and redness are still ongoing just not as bad.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Arm was sore/arm tenderness; Arm red; Fever; Arm warm to the touch; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020).   On 11th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 11th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, fever, skin warm and chills. On an unknown date, the outcome of the pain in arm and erythema of extremities were not recovered/not resolved and the outcome of the fever, skin warm and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, fever, skin warm and chills to be related to Shingrix.  Additional details were provided as follows: The reporter did not had lot number and expiration date. The patient received Shingrix and noticed that their arm was sore, red in color about the size of 3 quarters and was warm to the touch hours after injection. The patient also stated that the evening of receiving the second injection began having chills and confirmed they had a fever after checking their temperature.  The fever and chills, arm soreness, redness, and tender to the touch continued and fever and chills were gone but the sore arm and redness are still ongoing just not as bad.  The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site induration, Injection site nodule, Injection site pain, Limb discomfort
Clinical narrative: Upper arm almost down to her elbow became swollen; Typical soreness at site; Upper arm almost down to her elbow became swollen / very uncomfortable; Indurated nodule that protruded from the site; Injection site nodule; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA86AZ, expiry date 31st January 2022) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Bexsero (intramuscular). In July 2020, less than a week after receiving Bexsero, the patient experienced extensive swelling of vaccinated limb, injection site pain, arm discomfort, injection site induration and injection site nodule. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site pain was recovered/resolved and the outcome of the arm discomfort, injection site induration and injection site nodule were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, arm discomfort, injection site induration and injection site nodule to be related to Bexsero.  Additional details were provided as follows: After receiving Bexsero, the patient developed typical soreness at site for next couple days that was painful for the first 48 hours.  Then her upper arm almost down to her elbow became swollen, no erythema and no pallor but very uncomfortable.  The patient developed a 25-cent size indurated nodule that protruded from the site. It was firm.  The arm was still considered uncomfortable when she used it but it did decrease.  The reporter was consented to follow up. The batch number of Bexsero was reported as ABXAH6AZ, which was corrected to ABXA86AZ as per sales data sheet.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: fatigue, nausea, diarrhea,
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Loss of personal independence in daily activities, Pain, Rash
Clinical narrative: I developed a rash in my whole body with a very severe pain in my right side of my body. It is very hard for me to breath and do normar activities. The rash I don?t have anymore.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness postural, Nausea
Clinical narrative: EMPLOYEE STARTED FEELING DIZZY WHEN STANDING FROM A SITTING POSITION APPROXIMATELY 20 MINUTES AFTER RECEIVING VACCINATION. NAUSEA AND ABDOMINAL PAIN APPEARED APPROXIMATELY 45 MINUTES AFTER VACCINATION. B/P:122/80, PULSE 103. EMPLOYEE STATED HE FELT LIKE HE NEEDED TO VOMIT BUT NEVER DID. EMPLOYEE WAS THEN TAKEN TO AN URGENT CARE UPON RECOMMENDATION FROM POISON CONTROL.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Musculoskeletal pain, Myalgia
Clinical narrative: After 1st dose, no issue other than mild sore shoulder muscle. For this (reported) dose,. > 6 month after 1st dose. Shoulder pain more pronounced, and is lasting to this date. For 24 hours after dose, to 72 hours after dose (yesterday relative to this report) Unusual tiredness requiring work stoppage and naps. Muscle pain, whole body (No jaundice), Ibuprofen not effective. Severe headache not mitigated with regular 2x regular ibuprofen doses. No fever, No night sweats, No Jaundice. After 72 hours only symptom that have continued is shoulder pain. The only reason I am reporting this is that on 1st dose, I only experienced injection site (shoulder) pain for 24 hours, starting 12 hours after injection.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Two weeks after vaccination patient experienced side effect of lump and pain on and around the injection site.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Syncope
Clinical narrative: Patient came back after vaccination ~25 minutes later and stated that she had fainted. We called 911 and patient refused treatment, and MD cleared her to go home.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pain/tenderness/ red blotching  and swelling at injection site. Red area extended 6 inches below the injection site. General malaise, aching/  flu like symptoms continue after three days
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Rash macular
Clinical narrative: Pain/tenderness/ red blotching  and swelling at injection site. Red area extended 6 inches below the injection site. General malaise, aching/  flu like symptoms continue after three days
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cold sweat, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: Pain in left arm, sweating, faint , clammy, nausea, pain in all joints and muscles like the flu.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Pain in extremity, Syncope
Clinical narrative: Pain in left arm, sweating, faint , clammy, nausea, pain in all joints and muscles like the flu.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: syncope
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Pruritus, Rash erythematous, Swelling face, Urticaria
Clinical narrative: Hives began firming on Saturday around 9;10 pm. Skinbegan itching and white fluid filled hives were present across the mid stomach. Upon showing/ bathing they went down and then turned into small pink dots and went away. The next morning they began appearing again with a few on the stomach and on both arms about midway down as well as on neck and behind ears. Steroid lotion was applied after taking antihistamine tablets but this was brief relief. The hives grew to dark pink patches. Prednisone was prescribed and by morning all but a few hives had dissapeared but then by about 1 pm they returned in full force and pink patches covered the right side of the stomach and most of both arms. Legs were on effect a little on Sunday with a couple hives. Face effected on Sunday with hive. Swelling in cheaks on Wednesday despite all other hives nearly dissapearing leaving onkya few small red dots. Today, Thursday hives appear to be gone but cheaksstill pink
Age: 0.5
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Informed CMA who states she will talk with  her provider. Let her know Kinrix is for 4 to 6 yr olds and that Hep A is for 1 yr +
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Patient started experiencing itchy patches/rashes all over and a low grade fever.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Patient began feeling symptoms about two weeks or so since vaccine administration. Symptoms began with right submandibular lymph node swelling and tenderness followed by diffuse myalgias. Other lymph nodes in her neck also became swollen. She also had intermittent chills but no fevers. She has been controlling her muscle aches  with tylenol and advil. Symptoms started to subside for a couple days but now, for the past two days, her myalgias and overall malaise have recurred. In addition, she has mild swelling of the proximal metacarpal of the second digit of her right hand. Lymph nodes are slightly decreased in size since symptom onset and not as tender.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling
Clinical narrative: Patient began feeling symptoms about two weeks or so since vaccine administration. Symptoms began with right submandibular lymph node swelling and tenderness followed by diffuse myalgias. Other lymph nodes in her neck also became swollen. She also had intermittent chills but no fevers. She has been controlling her muscle aches  with tylenol and advil. Symptoms started to subside for a couple days but now, for the past two days, her myalgias and overall malaise have recurred. In addition, she has mild swelling of the proximal metacarpal of the second digit of her right hand. Lymph nodes are slightly decreased in size since symptom onset and not as tender.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, body aches,  extreme fatigue
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Patient experienced burning rash on stomach and thighs. Patient received a dose of steroid treatment at her doctor's office.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Blood test, Lymphadenopathy, Ultrasound scan
Clinical narrative: On  5/20/2020  in the morning, we noticed one side of his lymph nodes under his jaw had become majorly swollen.  (Unilateral Lymphadenitis).  A few days later, there was a defined large lump in his swollen lymph nodes (Dr.s think it became bacterially infected, but this is unknown).  We gave him antibiotics orally, then were admitted inpatient at Hospital for IV antibiotics, which he took for about a week, then we continued for another week or so with oral antibiotics.  His lymph nodes under one side remain very swollen to this day.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day 1-Patient had injection site reaction, with arm swelling (size of a tennis ball) when she woke from a nap , hot to touch and pain.   Day 2(07/18) the swelling was less at injection site but redness spread from deltoid to forearm.   Day 3 (07/19) Redness/ swelling subsided in upper arm but moved down to /worsening around elbow thru' the forearm -all the way down to the wrist. Pain better but still tender.  Day 4(07/20) -"not getting worse, redness / swelling from forearm to wrist started to resolve.  Day 5 (07/21) Swelling/ Redness significantly better. 70% of symptoms improved.  Day 7 (07/23) Swelling/pain/redness is gone.   Pharmacy followed up with family daily and recommended support treatment-- and daughter continued to apply ice, massage, moving of extremities and gave ibuprofen.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Day 1-Patient had injection site reaction, with arm swelling (size of a tennis ball) when she woke from a nap , hot to touch and pain.   Day 2(07/18) the swelling was less at injection site but redness spread from deltoid to forearm.   Day 3 (07/19) Redness/ swelling subsided in upper arm but moved down to /worsening around elbow thru' the forearm -all the way down to the wrist. Pain better but still tender.  Day 4(07/20) -"not getting worse, redness / swelling from forearm to wrist started to resolve.  Day 5 (07/21) Swelling/ Redness significantly better. 70% of symptoms improved.  Day 7 (07/23) Swelling/pain/redness is gone.   Pharmacy followed up with family daily and recommended support treatment-- and daughter continued to apply ice, massage, moving of extremities and gave ibuprofen.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: 48 hours after administration, patient experienced 2 red raised bumps about 2 inches aware from the injection site,
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Headache, Pain, Tremor
Clinical narrative: At around 6:30 PM on 7-22-20 - All of the sudden patient's body started shaking and he had a severe headache and body aches. When patient arrived at hospital his temperature was 102.8 degrees.
Age: 47.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bacterial test negative, Erythema, Fatigue, Headache, Incisional drainage
Clinical narrative: June 16 2020: 930 am Spoke with patient, right arm with oval redness about 1 and 1/2 inches. Slightly warm to the touch, painful. No fever. No blister/liquid. Using Neosporin ointment. No other over the counter meds. Started Fri, 6/12/20. Advised to follow up with MD if fever begins, or no improvement, advised not Usual occurrence after varicella immunization. He stated he had similar spot on his back a few years ago, had to be lancedX2. No culture done at that time. Also noticing a few red spots on his back and chest. June 17, 2020: 11 am Follow up phone call. Patient stated he began to have fever,101.4, around 4pm 7/16/20. Went to urgent care. Placed on Bactrim and Clindamycin. Area lanced. Told to go back for follow up 48 hrs. June 18, 2020: 1pm Phone conversation with Patient. Right arm less sore. Still fever 100, fatigue, sometimes headache. More spots all over body and in mouth. Will follow up w/urgent care physician. June 23, 2020 1215 Left message to call us back. June 25, 2020 Phone conversation with Patient. Had visit 6/19/20. Blood culture, Varicella Igg, Covid test done. Blood Culture neg for bacteria, non specific virus, Varicella negative, Covid negative per Patient. Said doctor thought it was Chicken Pox. Arm feeling better, no fever. Spots subsiding. July 9, 2020 2pm Drove wife to our office for immunizations. Spoke with Patient in parking lot as he was waiting in car with their children. Still has some discomfort if presses on site. Otherwise "back to normal." RN.
Age: 47.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Pain in extremity, Pyrexia, SARS-CoV-2 test negative, Skin warm
Clinical narrative: June 16 2020: 930 am Spoke with patient, right arm with oval redness about 1 and 1/2 inches. Slightly warm to the touch, painful. No fever. No blister/liquid. Using Neosporin ointment. No other over the counter meds. Started Fri, 6/12/20. Advised to follow up with MD if fever begins, or no improvement, advised not Usual occurrence after varicella immunization. He stated he had similar spot on his back a few years ago, had to be lancedX2. No culture done at that time. Also noticing a few red spots on his back and chest. June 17, 2020: 11 am Follow up phone call. Patient stated he began to have fever,101.4, around 4pm 7/16/20. Went to urgent care. Placed on Bactrim and Clindamycin. Area lanced. Told to go back for follow up 48 hrs. June 18, 2020: 1pm Phone conversation with Patient. Right arm less sore. Still fever 100, fatigue, sometimes headache. More spots all over body and in mouth. Will follow up w/urgent care physician. June 23, 2020 1215 Left message to call us back. June 25, 2020 Phone conversation with Patient. Had visit 6/19/20. Blood culture, Varicella Igg, Covid test done. Blood Culture neg for bacteria, non specific virus, Varicella negative, Covid negative per Patient. Said doctor thought it was Chicken Pox. Arm feeling better, no fever. Spots subsiding. July 9, 2020 2pm Drove wife to our office for immunizations. Spoke with Patient in parking lot as he was waiting in car with their children. Still has some discomfort if presses on site. Otherwise "back to normal." RN.