chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Laboratory test
Clinical narrative: Patient returned to pharmacy to notify that he is still having joint pain that still persists on and off,  which started after receiving the J/J covid-19 vaccination. He also continue to have arm pain on the  arm he received the vaccine at. He has followed up with his MD and he had done labwork and  evaluated the patient's condition. Md advised that patient return to pharmacy to report persistant side effects.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Excruciating pain in shoulder blade and surrounding shoulder area front and back side of body. Eventually resulting in an outbreak of a rash. Diagnosed at urgent care 08-30-2021 as an outbreak of Shingles.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Herpes zoster, Hypertension, Rash
Clinical narrative: Excruciating pain in shoulder blade and surrounding shoulder area front and back side of body. Eventually resulting in an outbreak of a rash. Diagnosed at urgent care 08-30-2021 as an outbreak of Shingles.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal hernia, Abdominal pain, Back pain, Blood test, Computerised tomogram
Clinical narrative: Patient started experiencing abdominal pain and bloody diarrhea 6 days post vaccination. She went to emergency room and was diagnosed with colitis and doctor said it is likely unrelated to the vaccine but patient believes it was caused by the vaccine given the time frame.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Haematochezia, Haemorrhage, Inflammatory bowel disease, Keratitis
Clinical narrative: Patient started experiencing abdominal pain and bloody diarrhea 6 days post vaccination. She went to emergency room and was diagnosed with colitis and doctor said it is likely unrelated to the vaccine but patient believes it was caused by the vaccine given the time frame.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colitis, Diarrhoea haemorrhagic
Clinical narrative: Patient started experiencing abdominal pain and bloody diarrhea 6 days post vaccination. She went to emergency room and was diagnosed with colitis and doctor said it is likely unrelated to the vaccine but patient believes it was caused by the vaccine given the time frame.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest discomfort, Chest pain
Clinical narrative: Dose 1 Pfizer Covid vax age 16 immediately developed numbness toes and feet subsided 48 hrs later but then heart hurt signs and symptoms of pericarditis. Began on day 4 Monday . Seeing cardio again today .
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Dose 1 Pfizer Covid vax age 16 immediately developed numbness toes and feet subsided 48 hrs later but then heart hurt signs and symptoms of pericarditis. Began on day 4 Monday . Seeing cardio again today .
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Limb discomfort, Malaise, Nausea, Syncope
Clinical narrative: After the patient received the vaccine, she was feeling anxious and felt some heaviness in her arm. I advised that she sit in the chair in our clinical room since she was not feeling well. After sitting for approximately 5 minutes and feeling better, when she stood up and walked to the door, she started feeling nauseous and had syncope.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Herper Zoster (shingles) Left Eye and Left side of the face and head
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Visual impairment
Clinical narrative: Herper Zoster (shingles) Left Eye and Left side of the face and head
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia macrocytic, Asthenia, Cerebral thrombosis, Cerebrovascular accident, Dementia
Clinical narrative: July 2021= Acute Lacunar infraction in rt side of brain. Blood clot in brain caused a stroke, resulting in 6 months paralasys so far. Numb left side of face, constant headache and ringing, dizziness always forgetful and lack of energy. I cannot perform my daily duties anymore. My Dr says its called "Dead Brain". Onset of Dimentia.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Lacunar infarction, Loss of personal independence in daily activities
Clinical narrative: July 2021= Acute Lacunar infraction in rt side of brain. Blood clot in brain caused a stroke, resulting in 6 months paralasys so far. Numb left side of face, constant headache and ringing, dizziness always forgetful and lack of energy. I cannot perform my daily duties anymore. My Dr says its called "Dead Brain". Onset of Dimentia.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Paralysis, Tinnitus, Ultrasound scan abnormal
Clinical narrative: July 2021= Acute Lacunar infraction in rt side of brain. Blood clot in brain caused a stroke, resulting in 6 months paralasys so far. Numb left side of face, constant headache and ringing, dizziness always forgetful and lack of energy. I cannot perform my daily duties anymore. My Dr says its called "Dead Brain". Onset of Dimentia.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Cognitive disorder, Headache, Injection site pain
Clinical narrative: PATIENT EXPERIENCED PAIN IN HEAD EXTENDING INTO NECK, SHOOTING PAIN IN STOMACH, NAUSEA, AND SORENESS IN THE ARM OF INJECTION SITE.  ALSO HAD DIFFICULTY WITH COGNITIVE FUNCTION AND FELT INCAPACITATED.  WENT TO BED WITH SYMPTOMS WHICH DID NOT RESOLVE UNTIL 3PM ON SUNDAY, 08/29/2021. PATIENT FEELS OK NOW.  I INFORMED PATIENT TO REPORT TO HER PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: PATIENT EXPERIENCED PAIN IN HEAD EXTENDING INTO NECK, SHOOTING PAIN IN STOMACH, NAUSEA, AND SORENESS IN THE ARM OF INJECTION SITE.  ALSO HAD DIFFICULTY WITH COGNITIVE FUNCTION AND FELT INCAPACITATED.  WENT TO BED WITH SYMPTOMS WHICH DID NOT RESOLVE UNTIL 3PM ON SUNDAY, 08/29/2021. PATIENT FEELS OK NOW.  I INFORMED PATIENT TO REPORT TO HER PCP.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Throat irritation
Clinical narrative: Patient reported tongue going numb and throat scratchy about 5 minutes after vaccine administration. Gave patient 50mg of diphenhydramine by mouth with some water. Patient stayed 15 more minutes and reported no change, of which I made sure patient was okay to drive home. I instructed the patient to call if anything changed and we would check in the next day.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus, Throat tightness, Tremor
Clinical narrative: August 28: headache, feeling of throat closure August 29: felt shakey whenever i moved for a short period after waking up (only slept for 3 hours so that could be a result), felt nauseous (had a long car ride after eating that could also be a result) August 30 (today): chest feels tight and slight wheezing, also had an itchy neck for a short period of time.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: August 28: headache, feeling of throat closure August 29: felt shakey whenever i moved for a short period after waking up (only slept for 3 hours so that could be a result), felt nauseous (had a long car ride after eating that could also be a result) August 30 (today): chest feels tight and slight wheezing, also had an itchy neck for a short period of time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Strong heart pains a day after the vaccine, lasted approximately 4 hours
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: symptoms started 8/26/21 with congestion, runny nose, body aches and headache.  Covid positive 8/30/21   Symptoms improving 8/30/21
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: symptoms started 8/26/21 with congestion, runny nose, body aches and headache.  Covid positive 8/30/21   Symptoms improving 8/30/21
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Fatigue, Feeling abnormal, Herpes zoster
Clinical narrative: Shingles - lasted for 3 weeks. Fatigue, brain fog, acne has lasted for 3 months.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Muscle spasms, Tongue spasm
Clinical narrative: Had injection 2:30 pm 02/15/21; On 02/16/21 at about 11:30 am, muscle spasm in tongue (hurt like hell) 2/3 back from tip of tongue lasting a little over an hour.  IF it had lasted even a little longer, or pain had increased in the slightest, I would have headed to the emergency room.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in left arm at injection site. Pain has gotten worse on day 5.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Injection site joint movement impairment, Injection site reaction, Magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Bursitis and frozen shoulder in left arm where I received 2nd COVID vaccine shot. Unable to have full range of motion of left arm. Waited six months to see if it got better before going to Dr. in July and having an MRI. Received cortisone injections 8/19 and started physical therapy 8/30.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Experienced Tinnitus in the right ear - comes and goes
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargy
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epistaxis, Headache, Injection site bruising
Clinical narrative: Intense headache on top of the head, small bruise (first it was like a dot) on the left arm by injection site. Large bruise on the right hand, nasal bleeding.
Age: 80.0
Sex: U
Vaccine: CHOL, COVID19
Symptoms: Facial pain, Hyperaesthesia, Pain, Trigeminal neuralgia
Clinical narrative: Onset mid August 2021 6 months after civid 2 jab series, of typical right face/cheek trigeminal neuralgia  without dental or sinus etiology  persisting now 3 weeks nearly daily with textbook characteristics of shooting lancinating shooting facial pain triggered by lightly touching malar zygoma sea of right cheek.  Lasts. Few minutes area is sensitive but not tender.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menometrorrhagia, Thrombosis
Clinical narrative: I started my period very late that night into early the next morning and bled more than I have ever in my life and then it went to clots. Normally my cycle is like clockwork and never has anything like this happened to me in my life. I should have gotten my second shot today but won?t until I can have some explanation. I started my cycle again a few days ago. It isn?t as bad as the last but it?s not the same.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Palpitations, Paraesthesia
Clinical narrative: headache, diffuse/migratory paresthesias, 'brain fog', palpitations, dizziness
Sex: F
Vaccine: COVID19
Symptoms: Acne, Condition aggravated, Dilated pores, Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: I am not acne prone at all a pimple here and there even in high school. After the first dose of the covid vaccine I got a lot of acne. The second dose I got a lot of acne still have acne. My period around August 20, 2021, my period started early and was very heavy but short only a few days not a whole week. I have abnormal periods but this one was really weird. I have had vaccines before but never a vaccine that felt like period cramps throughout my body more than the usual sore muscles.  I haven't had another period yet so I can't say my periods have changed forever. My more acne prone skin hasn't gone away though. My nose pores are more prominent.
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Menstrual disorder
Clinical narrative: I am not acne prone at all a pimple here and there even in high school. After the first dose of the covid vaccine I got a lot of acne. The second dose I got a lot of acne still have acne. My period around August 20, 2021, my period started early and was very heavy but short only a few days not a whole week. I have abnormal periods but this one was really weird. I have had vaccines before but never a vaccine that felt like period cramps throughout my body more than the usual sore muscles.  I haven't had another period yet so I can't say my periods have changed forever. My more acne prone skin hasn't gone away though. My nose pores are more prominent.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came to Medical Group for second Pfizer vaccine dose. Patient received second dose at day 14 after initial dose, one full week prior to due date.  Patient was not schedule, came in as a walk-in patient through the Medical Group's mass vaccination line. Patient put the date he thought he received first dose on the the DHA 207 screening form. The technician on the computer didn't know that the patient was too early for second dose and proceeded to update the electronic medical record, and the patient was processed further into the vaccination line. Pt received their Pfizer vaccine and waited for 10-15 minutes in the waiting area for observation. Pt came to the Immunization clinic for the CDC COVID vaccination card, but couldn't remember when they received their first Pfizer dose. I looked the patient up in the EHR and discovered he received the second dose too early. RN and Medical Director notified of incident, patient notified at time of discovery. Pt instructed to self monitor and we would contact him in 24-48 hours to check on him.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient was very ill after her second dose and died two weeks later. Symptoms-fever, muscle aches, fatigue
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound foetal
Clinical narrative: POST VACCINE FIRST TRIMESTER MISCARRIAGE.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin positive, Ultrasound uterus abnormal
Clinical narrative: POST VACCINE FIRST TRIMESTER MISCARRIAGE.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling cold, Headache, Nausea, Photopsia
Clinical narrative: Patient received her second dose of pfizer vaccine and 10 to 15 minutes into the vaccine, she started seeing flashing lights with circle shapes but no other symptoms. Patient was awake, alert and oriented.  The flashing lights does not seem to go away so advised patient to lie down on the couch to allow blood flow to the head. Patient started feeling a little better, still alert, oriented and engaged in conversation. She is still seeing flashing lights that are like shooting stars. followed by headache. At this point, we elevated her leg up by putting pillows under the leg to allow more blood flow to the brain. Patient said she hydrated herself the day before and the morning of the vaccination and ate about an hour ago.  She said she is feeling better but feels cold, little nausea, headache and still seeing flashing lights. Patient took some tylenol at this point for the headache. Patient was observed for about 50 minutes total post vaccination, patient did not have any anaphylaxis type of reaction. She started feeling better and just wanted to rest on the couch so pharmacy team left patients home. Pharmacy  called about 20 minutes later to follow up and patient says no more headache but now she has diarrhea. Patient advised to make sure to keep herself hydrated and eat bland food- banana, rice etc. Patient also advised to call 911 or their PCP if symptoms gets worse and does not go away within the rest of the day.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Patient received her second dose of pfizer vaccine and 10 to 15 minutes into the vaccine, she started seeing flashing lights with circle shapes but no other symptoms. Patient was awake, alert and oriented.  The flashing lights does not seem to go away so advised patient to lie down on the couch to allow blood flow to the head. Patient started feeling a little better, still alert, oriented and engaged in conversation. She is still seeing flashing lights that are like shooting stars. followed by headache. At this point, we elevated her leg up by putting pillows under the leg to allow more blood flow to the brain. Patient said she hydrated herself the day before and the morning of the vaccination and ate about an hour ago.  She said she is feeling better but feels cold, little nausea, headache and still seeing flashing lights. Patient took some tylenol at this point for the headache. Patient was observed for about 50 minutes total post vaccination, patient did not have any anaphylaxis type of reaction. She started feeling better and just wanted to rest on the couch so pharmacy team left patients home. Pharmacy  called about 20 minutes later to follow up and patient says no more headache but now she has diarrhea. Patient advised to make sure to keep herself hydrated and eat bland food- banana, rice etc. Patient also advised to call 911 or their PCP if symptoms gets worse and does not go away within the rest of the day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Substernal chest pain a few hours after injection, lasting less than an hour. Patient does not recall much else as she reported this 3 months after incident.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Disturbance in attention, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: Very uncomfortable (7/10) kidney pain since injection, severely interferes with walking/standing and working/concentrating. Not muscular pain, is an internal organ sensation. Frequent urination, kidneys feel painfully full after drinking water, then painfully empty after urination. Have tried eating and drinking different amounts to alleviate, no progress. Drank electrolytes with no progress.  Did not drink coffee 8/30 to eliminate diarrhetic effect, no change. Tried mild exercise, no change. More minor side affects for entire duration after shot include fatigue, dizziness, brain fog, and headache.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Impaired work ability, Pollakiuria, Renal pain
Clinical narrative: Very uncomfortable (7/10) kidney pain since injection, severely interferes with walking/standing and working/concentrating. Not muscular pain, is an internal organ sensation. Frequent urination, kidneys feel painfully full after drinking water, then painfully empty after urination. Have tried eating and drinking different amounts to alleviate, no progress. Drank electrolytes with no progress.  Did not drink coffee 8/30 to eliminate diarrhetic effect, no change. Tried mild exercise, no change. More minor side affects for entire duration after shot include fatigue, dizziness, brain fog, and headache.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinittus experienced shorty after 1st injection. Ringing in the ears for a little over 4 months.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Dyspnoea, Epistaxis
Clinical narrative: A lot of fever, nosebleeds in several occasions, headache every day, diarrhea, dizziness, dilated pupils and cannot catch my breath and I lost my appetite.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mydriasis, Pyrexia
Clinical narrative: A lot of fever, nosebleeds in several occasions, headache every day, diarrhea, dizziness, dilated pupils and cannot catch my breath and I lost my appetite.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: suffered facial paralysis on the right side; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 13Aug2021 (at the age of 35-years-old) (Batch/Lot Number: FA7484) as dose 1, single for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced facial paralysis on the right side on 18Aug2021. The visited healthcare professional office for Emergency room/department or urgent care . Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. The patient did not have COVID prior and post vaccination. Patient received treatment with unspecified medicine. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.; Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) and HEAVY MENSTRUAL BLEEDING (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced MENSTRUATION DELAYED (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) and HEAVY MENSTRUAL BLEEDING (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.). On 19-Jul-2021, MENSTRUATION DELAYED (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) and HEAVY MENSTRUAL BLEEDING (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   No treatment information was provided by the reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller reports that a patient was administered a dose of PROQUAD on 30-JUL-2021 that experienced a termperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot number T034826 (rHA) expiration date 11-APR-2022 (route of administration were not provided) prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 9.12 degree fahrenheit (°F) for 1 hour and 6 minutes on an unknown date; another previous temperature excursions was reported of -6.5°F for 12 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller notes both patients asymptomatic. No additional AE's/PQC's; V ARlV AX was administered to (2) patients this morning, 8/9/2021.; This spontaneous report has been received from a nurse, referring to a 12 months old patient of unknown gender. Information about the patient's pertinent medical history, concomitant medications and previous drug reactions and allergies was not provided.  On 08-AUG-2021, a temperature excursion occurred for frozen products, involving varicella virus vaccine live (oka/merck)(VARIVAX). On 09-AUG-2021 (reported also as "this morning"), the patient was vaccinated with the improperly stored (product storage error) varicella virus vaccine live (oka/merck)(VARIVAX), at a dose reported as "1" (1 dosage form), lot number T029535 and expiration date on 01-SEP-2022 for prophylaxis (strength, frequency, route of administration and anatomical location were not provided).   The product was stored at a temperature of 6.134 F (Fahrenheit), for a timeframe of 30 Minutes, with no previous excursion. It was reported that the patient was asymptomatic.  This was one case of two from the same reporter.; Sender's Comments:  US-009507513-2108USA002868:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly Stored Vaccine/Administered/ Temperature (1.53°C); This spontaneous report has been received from a registered nurse concerning a patient whose age and gender was not reported. No information was provided regarding the patient's pertinent medical history, concomitant medication, previous drug reactions, or allergies.  On an unspecified date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1687292 and expiration date 25-AUG-2022, which was verified to be valid for prefilled syringe formulation) was improperly stored below 2 degrees Celsius (°C) at 1.53°C for 30 minutes (min); there were previous temperature excursions below 2°C on unspecified dates, 1.29°C, 1.43°C, and 1.38°C for 45 min each (product storage error).   On 07-AUG-2021, the patient was vaccinated with the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported).  No additional adverse events (AE) were reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA002930: US-009507513-2108USA002942:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no additional AE reported; A dose of GARDASIL 9 that experienced a temperature excursion was administered to a patient; This spontaneous report was received from a nurse practitioner referring to a patient of unspecified age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T029522, expiring on 13-MAR-2022, 0.5 milliliter for prophylaxis (route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of -4.8 degrees Celsius for 20 minutes. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 0.83
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE occurred; VAQTA inadvertently administered to a 10 and a half month old patient; This spontaneous report as received from a nurse referring to a 10 month old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 11-AUG-2021, the patient was inadvertently administered hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, lot # T037788, expiring on 30-APR-2022, for prophylaxis (dose, route and site of administration were not reported) too early, at 10 and a half month of age (product administered to patient of inappropriate age).  No adverse events occurred. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T037788; expirationdate: 30-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: no additional adverse events; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a medical assistant referring to a specific patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 09-AUG-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R029900, 1 dosage form (route and site of administration not reported), for prophylaxis.  The vaccine had expired on 23-JUL-2021.  No adverse events were reported.  The reporter stated that the dose was properly stored up through time of administration. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029900; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; VAQTA was administered on 21JAN2021 however it was documented to have been expired on 11JAN2021; This spontaneous report as received from a physician referring to a specific patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 21-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # "5032358" for prophylaxis (dose, route and site of administration, were not reported). The reporter called to verify the expiration date of hepatitis a vaccine, inactivated (VAQTA) since it was documented to had been expired on 11-JAN-2021 (expired vaccine used).  The reporter denied adverse events or product quality complains.   Upon internal validation, lot # "5032358" was evaluated and changed to the valid Lot #S032358 valid for hepatitis a vaccine, inactivated (VAQTA)formulation prefilled syringe, expiration date of 11-JAN-2021. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no adverse event; second dose should have been administered after the child turns 4; This spontaneous report was received from a office manager referring to a 14 month old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On18-MAY-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  lot S0239311, expiring on 04-DEC-2021, for prophylaxis (dose, route and site of administration were not reported).   04-AUG-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  lot # T028297, expiring on 16-FEB-2022, for prophylaxis (dose, route and site of administration were not reported).          Reporter stated this second dose should had been administered after the child turned 4 (inappropriate schedule of product administration).  No adverse event was reported.   Lot number S0239311 is an invalid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and does not match any Company product
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Scratch, Underdose
Clinical narrative: small scratch; less than recommended dose given due to patient moving during administration of initial vaccine; Information has been received from a Medical Assistant reporting on a 9-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 17-AUG-2021, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis (route of administration, lot number and expiration date were not reported). Medical assistant was calling to request information on hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) revaccination, after less than recommended dose given due to patient moving during administration of initial vaccine. The patient moved during vaccination and the needle left a "small scratch" on the patient's thigh. She states the physician was aware. Medical assistant verified the vaccine has been stored at recommended temperature and that the vaccine was not expired. The outcome of scratch was unknown.  The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported.; a dose of VARlVAX was administered after the expiration date.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.    On 18-AUG-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R035223 with expiration date of 04-DEC-2020 (internally verified), 0.5 ml, for prophylaxis (route of administration was not reported).  Caller stated the vaccine did not experience any temperature excursions. No additional events reported.  No additional information provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported; patient received 4 doses of GARDASIL 9; This spontaneous report was received from a nurse referring to a patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 17-AUG-2021, the patient was vaccinated with a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T027778, expiring on 27-FEB-2023, 0.5 milliliter dose, intramuscular for prophylaxis (extra dose administered). No adverse event were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T027778; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No additional adverse event reported; A 12 month old child was given PROQUAD instead of VARIVAX with the MMR II; A 12 month old child was given PROQUAD instead of VARIVAX; This spontaneous report has been received from a registered nurse concerning a 12 months old patient, gender not provided. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 24-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, for prophylaxis (lot number U006312 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 24-AUG-2022) instead of varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered); on the same date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, for prophylaxis (lot number S035355 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 05-NOV-2021) (inappropriate schedule of product administration) (strength, route of administration and anatomical location were not provided).   No adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE reported; A consumer received the first dose of GARDASIL-9 about 3 years ago. She has not received her second dose at this time; This spontaneous report has been received from a registered nurse (inconsistent information, also reported as a consumer) referring to a female patient of unspecified age. The patient's pertinent medical history, concomitant medications, previous drug reactions, and allergies were not reported.   Approximately in 2018 (reported as "about three years ago"), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, administered dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).         Up to 1-year period on an unspecified date in 2019 and by reporting time, the patient had not received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  No additional adverse events (AE) were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Pain in extremity, Pruritus
Clinical narrative: Itching under my skin in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles problem in year 2002 at the age of 57 years, it was first attack, from back of his/her head down to neck and to whole arm right side its so much pain and burning, the patient asked the best medicine and the sales lady gave cream (unspecified) but still patient felt pain so much itching but did not scratch it).  On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved.  It was unknown if the reporter considered the itchy skin to be related to Shingrix.  RERUN Additional details were reported as follows: This patient self reported the case. The age at vaccination was not reported. The patient received shingle shot in 2018 and since then, yearly felt itching under skin in arm just for 3 months. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR177031 and US2021AMR177044, reported by the same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: yearly i feel itching under my skin in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles problem in year 2002 at the age of 57 years, it was first attack, from back of his/her head down to neck and to whole arm right side its so much pain and burning, the patient asked the best medicine and the sales lady gave cream (unspecified) but still patient felt pain so much itching but did not scratch it).  On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved.  It was unknown if the reporter considered the itchy skin to be related to Shingrix.  Additional details were reported as follows: This patient self reported the case. The age at vaccination was not reported. The patient received shingle shot in 2018 and since then, yearly felt itching under skin in arm just for 3 months The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR177031 and US2021AMR177044, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shingle shots were more painful; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles by eye, it was very scary had to go to eye specialist 3 times, all good). Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case US2021AMR178265) and Covid-19 (received Covid shots on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got shingles shot and stated it was more painful than covid shots.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178265:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: arm sore; shot burning; felt nauseous; fever; headache; felt tired; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Family members had it and not a pretty site).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, burning sensation, nausea, fever, headache and tiredness. On an unknown date, the outcome of the pain in arm, burning sensation, nausea, fever, headache and tiredness were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation, nausea, fever, headache and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient just got the 2nd shingle shot and experienced burning and arm sore felt nauseous, fever, headache and felt tired. The patient reported that it had protected him/her so it was all worth it.  The patient's family members had it and it was not a pretty site.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: arm sore; shot burning; felt nauseous; fever; headache; felt tired; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Family members had it and not a pretty site).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, burning sensation, nausea, fever, headache and tiredness. On an unknown date, the outcome of the pain in arm, burning sensation, nausea, fever, headache and tiredness were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation, nausea, fever, headache and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient just got the 2nd shingle shot and experienced burning and arm sore felt nauseous, fever, headache and felt tired. The patient reported that it had protected him/her so it was all worth it.  The patient's family members had it and it was not a pretty site.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling abnormal, Incomplete course of vaccination, Influenza like illness, Pain
Clinical narrative: 102 temp; felt like I had a bad flu; aches; knocked my socks off. felt terrible; This case was reported by a consumer and described the occurrence of body temperature increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced body temperature increased, influenza-like symptoms, pain and feels awful. On an unknown date, the outcome of the body temperature increased, influenza-like symptoms and pain were unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the body temperature increased, influenza-like symptoms, pain and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient got the 1st shingle shots and had 102 temperature and felt like bad flu, aches etc and felt terrible for 4 days. The patient did not risk the 2nd one.  The patient called doctor and they said that was pretty common.