chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain, Peripheral swelling
Clinical narrative: painful and swollen armpits; painful and swollen armpits; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Arm Right on 17Jul2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. There were no concomitant medications. On 08Aug2021 patient experienced painful and swollen armpits, worse after the second shot. Patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: painful and swollen armpits; painful and swollen armpits; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Arm Right on 17Jul2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. There were no concomitant medications. On 08Aug2021 patient experienced painful and swollen armpits, worse after the second shot. Patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pain of skin, Rash, Sensitive skin
Clinical narrative: weird rash; some fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 39; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced weird rash. On an unspecified date in Mar2021, patient experienced some fatigue. Patient stated that rash keeps changing and progressively getting worse and can't even wear a shirt over it because it's so hypersensitive. Patient stated that rash hurts so bad, it's burning and stinging to such an uncomfortable level, and it keeps changing colors and shape and now spreading to new areas. Patient also mentioned that she noticed that Moderna patients who got their vaccine experienced rashes 10 days after the shot. Therapeutic measures taken as a result of event rash included ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  can't even wear a shirt over it because it's so hypersensitive, rash hurts so bad, it's burning and stinging, spreading to new areas
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Vaccination site erythema
Clinical narrative: weird rash; some fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 39; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced weird rash. On an unspecified date in Mar2021, patient experienced some fatigue. Patient stated that rash keeps changing and progressively getting worse and can't even wear a shirt over it because it's so hypersensitive. Patient stated that rash hurts so bad, it's burning and stinging to such an uncomfortable level, and it keeps changing colors and shape and now spreading to new areas. Patient also mentioned that she noticed that Moderna patients who got their vaccine experienced rashes 10 days after the shot. Therapeutic measures taken as a result of event rash included ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  can't even wear a shirt over it because it's so hypersensitive, rash hurts so bad, it's burning and stinging, spreading to new areas
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Rash
Clinical narrative: weird rash; some fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 39; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced weird rash. On an unspecified date in Mar2021, patient experienced some fatigue. Patient stated that rash keeps changing and progressively getting worse and can't even wear a shirt over it because it's so hypersensitive. Patient stated that rash hurts so bad, it's burning and stinging to such an uncomfortable level, and it keeps changing colors and shape and now spreading to new areas. Patient also mentioned that she noticed that Moderna patients who got their vaccine experienced rashes 10 days after the shot. Therapeutic measures taken as a result of event rash included ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  can't even wear a shirt over it because it's so hypersensitive, rash hurts so bad, it's burning and stinging, spreading to new areas
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Lichen planus, Skin exfoliation, Squamous cell carcinoma of skin, Thermal burn
Clinical narrative: Prior to receiving the vaccine I had never had skin issues. If I had a skin injury it healed quickly. After the vaccine I had a minor burn on my hand and shortly afterward I noticed a scaly patches along the  path of the burn. I also had a squamous cell carcinoma removed from my leg and it also developed a hard scaly patches around it. I saw the dermatologist who did a biopsy and it was Lichen Planus which is an rare autoimmune disease. It has continued to appear on my arms and legs.  I need to know if other recipients of the vaccine have reported developing Lichen planus. I also need to know if I get the booster will it worsen the current status.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Employee given expired flu vaccination.  Expiration date of 06/30/21.  No signs or symptoms reported thus far.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Antinuclear antibody positive, Biopsy skin abnormal, Blood test abnormal, Double stranded DNA antibody positive
Clinical narrative: I had a reaction to the first dose, which including mild fever, severe fatigue, itching, swelling and pain at injection site, that last approx 5 days. Withing 3 weeks of my second dise, I broke out in a severe rash that was so painful, I had difficulty sleeping. When I told the dermatologist the date of my 2bd dose, he suspected the possibility of lupus, based on family history and symptoms. My internist agreed, a biopsy and other labs were done, and Systemic Lupus Erythematosus was confirmed. I have been ill since the onset of the rash. I have started medication, and I'm told I will need immunosuppressive drugs.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Insomnia, Malaise, Rash, Red blood cell sedimentation rate increased
Clinical narrative: I had a reaction to the first dose, which including mild fever, severe fatigue, itching, swelling and pain at injection site, that last approx 5 days. Withing 3 weeks of my second dise, I broke out in a severe rash that was so painful, I had difficulty sleeping. When I told the dermatologist the date of my 2bd dose, he suspected the possibility of lupus, based on family history and symptoms. My internist agreed, a biopsy and other labs were done, and Systemic Lupus Erythematosus was confirmed. I have been ill since the onset of the rash. I have started medication, and I'm told I will need immunosuppressive drugs.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus, Urine analysis abnormal
Clinical narrative: I had a reaction to the first dose, which including mild fever, severe fatigue, itching, swelling and pain at injection site, that last approx 5 days. Withing 3 weeks of my second dise, I broke out in a severe rash that was so painful, I had difficulty sleeping. When I told the dermatologist the date of my 2bd dose, he suspected the possibility of lupus, based on family history and symptoms. My internist agreed, a biopsy and other labs were done, and Systemic Lupus Erythematosus was confirmed. I have been ill since the onset of the rash. I have started medication, and I'm told I will need immunosuppressive drugs.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Nausea, Vertigo
Clinical narrative: Nausea, fatigue, dizziness, vertigo - spent so much time hunched over toilet puking i had to take a hot bath & lay on a heating pad for the back pain
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood test, Pregnancy test, Smear cervix
Clinical narrative: stopped menstruating. Haven?t had a period since having the vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Employee given expired flu vaccination.  Expiration date of 06/30/21.  No signs or symptoms reported thus far.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Oral herpes
Clinical narrative: Twenty minutes after receiving the test I started having sever menstrual bleeding. I had already had my menstrual for the month and have never had two in one month. I also have never had a cold sore in my mouth and after the vaccine I have two that appeared twenty four hours after the first shot.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: I was on the last day of my mensuration when I got the vaccine. However instead of ending my menstrual started again heavy. It had since alternated between spotting and heavy bleeding but there hasn't been a day since the vaccine that I haven't been menstruating to some degree. This makes 5.5 weeks straight (including the first week of my normal menstruation before the vaccine).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional
Clinical narrative: Pt developed dyspnea on exertion and atypical chest pain following dose #1, lasting approx. 15 days-- seemed to be improving on its own by the time she got dose #2
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Breast tenderness, Decreased appetite, Joint swelling
Clinical narrative: Left calf, knee and ankle swollen, foot turned purple, stomachache because painful to touch and bloated and lost appetite, prior to that I had severe neck pain
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Peripheral swelling, Skin discolouration
Clinical narrative: Left calf, knee and ankle swollen, foot turned purple, stomachache because painful to touch and bloated and lost appetite, prior to that I had severe neck pain
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Face injury, Fall, Loss of consciousness, Skin laceration, Syncope
Clinical narrative: Patient had just recieved her first dose of her COVID 19 Pfizer vaccine and was waiting 15 minutes in the pharmacy waiting area where she experienced syncope and fell down from the chair she was sitting and got a cut on her forehead from the fall onto the floor.  Patient was unconscious for about 30 seconds.  As the pharmacist on duty I quickly responded to the patient's side as she regained consciousness. EMS was called and quickly responded and took the patient with them under their care.  Patient had filled out vaccine consent form prior to getting vaccine, counseled on possible side effects and how to manage those side effects, as well as counseled to remain in the pharmacy waiting are for 15 minutes after receiving the vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Covid Arm, small red patch around injection site, no pain or swelling just red and sometimes slightly itchy.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine 4 days past beyond use date 9/4/21  No adverse outcomes or symptoms reported by patient
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Headaches in the front of head. back of eyes hurt when looking from corner of eyes. Everyday for the last few days. Never happened to me before.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine beyond use date of 9/4/21
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographia
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dizziness, Eye pain, Neck pain
Clinical narrative: Extremely dizzy, neck pain, eye pain/crying
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Chills, Fatigue, Feeling hot
Clinical narrative: On the second day after the administration of the second dose of the vaccine I began to feel tired (day 1 and 2) fever (day 2) pain in the bones (day 2) chills (day 2) intense heat in the sole of the right foot that even today (day 2 and 3) and low back pain (day 2 and 3).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: On the second day after the administration of the second dose of the vaccine I began to feel tired (day 1 and 2) fever (day 2) pain in the bones (day 2) chills (day 2) intense heat in the sole of the right foot that even today (day 2 and 3) and low back pain (day 2 and 3).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond use date of 09/04/2021
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Cardiac failure, Chest discomfort, Dyspnoea
Clinical narrative: Patient states she has never has heart problems before, she started having shortness of breath and sensation of heaviness on her chest and was hospitalized from 09/13-09/20/2021; now she has new onset and diagnosis of heart failure and atrial fibrillation, she wanted to report in VAERS in case it was related to the vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Blood clots on lungs/Pulmonary embolism; Inappropriate route of administration; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots on lungs/Pulmonary embolism) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 31-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of administration). On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots on lungs/Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Sep-2021 due to PULMONARY EMBOLISM. On 31-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of administration) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots on lungs/Pulmonary embolism) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       Concomitant medications include 1 daily dose of unknown Blood pressure meds.  No treatment medications are reported.  Company comment- This case concerns a  69 year-old male patient, who experienced the unexpected event s of Inappropriate route of product administration and Pulmonary embolism. The event of Pulmonary embolism occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  69 year-old male patient, who experienced the unexpected event s of Inappropriate route of product administration and Pulmonary embolism. The event of Pulmonary embolism occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Red welts on the face (rash) body itching, sensation from the inside of my body to the outside (inside my body).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Injection site pain
Clinical narrative: Arm pain at injection site has lasted for over a month  Periods have changed - heavier, more painful, longer
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Laboratory test
Clinical narrative: Headache
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Facial paralysis, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: bad headaches and left side partial face paralysis/numbness /tingling
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: The nurse is reporting that unknown number of patients received improperly stored V ARlV AX since 7/25/2021; No further information is available; wrong route of administration; This spontaneous report as received from a nurse referring to an unknown number of patients of unknown age and gender.The patients' medical history, concomitant medications, drug allergies, or reactions were not reported.  On 25-JUL-2021, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022, for prophylaxis (dose, frequency, strength, and route of administration, were not reported). The vaccine was expose to a temperature of 37.94 Fahrenheit degrees for 100 hours, no previously temperature excursion were reported (product storage error). No additional adverse events were reported.  Follow-up information was received from a nurse on 20-SEP-2021. This case was previously non-valid due to the lack of patient's identifier. The patient was 4-year-old male. On 03-AUG-2021, the patient vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) intramuscularly (Drug administered via inappropriate route), in the left tigh, lot number: T002847, expiration date: 23-JAN-2021. The digital data logger was involved. The varicella virus vaccine live (oka/merck)(VARIVAX) was removed immediately after contacting the company. Parent were being notified and this dose of varicella virus vaccine live (oka/merck)(VARIVAX) would be repeated with new vaccine stock.; Sender's Comments:  US-009507513-2109USA005394:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Improperly stored vaccine was administered to this patient on 8/24/2021.; This spontaneous report was received from a nurse, referring to 6 months old male patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 24-AUG-2021, the patient was administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose, route were not reported; lot# 1742470 has been verified to be a valid lot number, expiration date 16-MAR-2022) for prophylaxis that had undergone a temperature excursion (product storage error). No additional adverse events were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006895: US-009507513-2108USA007324:
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: pt developed a rash after the administration of Varivax; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient had no known allergies. His medical history and concomitant therapies were not provided.   On 20-NOV-2018, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not provided) as immunization. On the same day, the patient experienced rash. The outcome of the event was reported as recovered.   Causality assessment was not provided.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: A patient received improperly stored vaccine; This spontaneous report was received from nurse referring to a 6-months-old patient of unknown gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On 03-SEP-2021, the patient received a dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot # 1691301, expiration date 12-DEC-2021) orally for prophylaxis.  Temperature was 14.2 C during a time frame of 3 hours and 15 minutes, previous temperature excursion reported was 17.5 C for 8 hours.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: no adverse event; Patient received half of the dose; This spontaneous report was received from an administrator via company representative, concerning a 4-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 09-SEP-2021, the patient was vaccinated with half dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (frequency, route of administration, anatomical location, vaccination, scheme, lot number and expiration date were not reported) (incorrect dose administered). No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: The vaccine gave me shingles; I had the shingles shot when there was just one and still got shingles; Neuralgia; This spontaneous report as received, via GlaxoSmithKline, from a female patient of unknown age, concerning herself. The patient also posted on an unspecified social media page regarding herself. The patient had familiy history of shingles, her son was not vaccinated against shingles. No information was reported regarding the patient's concurrent conditions or concomitant medications.  On an unspecified date (reported as "several years ago",  and also reported as "about a year ago"), the patient was vaccinated with zoster vaccine live(ZOSTAVAX) or varicella zoster vaccine rge (cho)(SHINGRIX) for prophylaxis, she did not remember exactly which vaccine she got. (dose, frequency, route, lot number and expiration date were not provided). The patient reported that she only got one shot. On an unspecified date, a couple of days after the first shot (also reported as "five years ago"), even though she got the vaccine to stop it (vaccination failure), she got a shingles outbreak on her breast and back and around  her neck and hairline, which made her miserable. The patient reported that the vaccine gave her shingles and 12 years of unspeakable pain. The patient's pharmacist told her that the vaccine had a little bit of chicken pox in it.  By the time of the report, the patient still had rash with her and she had side effect of neuralgia around her right scapula, since an unspecified date. She takes acetaminophen (TYLENOL) 3 times a day. She reported that she did not think neuralgia would ever leave her. The outcome of vaccination failure was reported as "resolved". The patient had not recovered from neuralgia and shingles.   Upon internal review, the vaccination failure was determined to be related to suspect vaccines. The patient considered the shingles related to zoster vaccine live(ZOSTAVAX) or varicella zoster vaccine rge (cho)(SHINGRIX). No assessment was provided between the neuralgia and zoster vaccine live(ZOSTAVAX) or varicella zoster vaccine rge (cho)(SHINGRIX).
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The caller reports PROQUAD vaccine was administered 19AUG2021 following a supported temperature excursion on 28JUN2021; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 13-month-old male patient. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T031603 has been verified to be valid, expiration date reported and established as 15-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.
Sex: M
Vaccine: VARZOS
Symptoms: Drug effect less than expected
Clinical narrative: SHINGRIX provides better protection against Shingles than ZOSTAVAX.; This spontaneous report was received from a male patient of unknown age referring to himself. The patient's concurrent condition, pertinent medical history and concomitant medication were not reported.  In 2018 (reported as approximately 2-3 years ago), the patient received one dose of a shingles vaccine that he believed was zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) shot in the arm for prevention of shingles (prophylaxis), however, the patient could not confirm the brand name of the vaccine at the time of the call.   On 21-JUL-2021, the patient received first dose of varicella zoster vaccine rge (cho) (SHINGRIX). The patient decided to receive varicella zoster vaccine rge (cho) (SHINGRIX) in addition to his vaccination with zoster vaccine live (ZOSTAVAX) due to the fact that "varicella zoster vaccine rge (cho) (SHINGRIX) provided better protection against shingles than zoster vaccine live (ZOSTAVAX)" (drug effect less than expected). The outcome was not reported. The causality assessment was related.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No further AE.; ROTATEQ experienced a temperature excursion and was then administered to a patient; This spontaneous report was received from a Medical assistant referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), dose:2 milliliters, orally, lot number: 174813 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ).Lot number 174813 does not match any Company product as confirmed by Lot Verification team; expiration date:25-MAR-2022 for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 34.8 Fahrenheit degrees for 1 hour and 20 minutes and 35.6 Fahrenheit degrees  for 1 hour and 30 minutes.No previous temperature excursion was reported There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; temperature excursion for one vial of VARlVAX; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 17-SEP-2021, the patient was going to be vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U010398, expiration date 01-APR-2023 (route of administration not provided) for prophylaxis, however, the vaccine was stored at room temperature (72 degrees Fahrenheit) for 1 hour and 25 minutes. Due to this, the vaccine was not administered. No adverse event was reported.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 17-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or around 06-SEP-2013, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently,  the patient was treated by a healthcare provider for the following injuries resulting from patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. At the reporting time, the outcome of shingles was not provided. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: lmpropely stored vaccine administered; This spontaneous report was received from a nurse referring to a 4 years old male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 04-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022,  (number of previous doses was reported as 1; frequency and strength were not reported) intramuscularly in left thigh for prophylaxis (product storage error). The digital data logger was involved to capture the temperature excursion.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; expired V AQT A was administered; This spontaneous report was received from a medical assistant and refers to a 3-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 10-JUN-2021, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T008698 was verified to be valid with expiration date 04-JUN-2021) for prophylaxis (exact dose, dose number, route of administration and anatomical location were not reported). No additional adverse events were reported. The outcome of expired vaccine used was unknown.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-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; Sender's Comments:  US-009507513-2109USA005216:
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AEs reported; expired VAQTA was administered; This spontaneous report was received from a medical assistant and refers to a 15 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 23-AUG-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) lot # T008698, expiration date 04-JUN-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The administered vaccine was not involved in a temperature excursion. No adverse events (AEs) were reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T008698; expirationdate: 04-JUN-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; Sender's Comments:  US-009507513-2109USA005193: US-009507513-2109USA005135:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; RECOMBIVAX HB that underwent a temperature was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-AUG-2021, the patient was vaccinated with improperly stored dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 84.0 degrees Fahrenheit for 2 hours and 45 minutes. There was no previous temperature excursion reported. No additional adverse event was reported.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: temperature excursion / temperature: 37.94 F; Route: IM; This spontaneous report was received from a licensed practical nurse and refers to a 15 months old male patient. There was no information regarding his medical history, concurrent conditions nor concomitant therapies provided.  On 16-AUG-2021, the patient was vaccinated in a public health clinic by the reporter (described also as a trained operator) with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose, intramuscularly into the left thigh, lot # T002847, expiration date 23-JAN-2022 (exact dose was not provided) for prophylaxis; the vaccine was purchased with public funds (product storage error, incorrect route of product administration). The administered vaccine was stored in a temperature of 37.94 degree Fahrenheit (F) for 100 hours. No previous temperature excursion was reported. Digital data logger was involved. No prescription drug treatment for the experience was required.  The reporter stated that the improperly stored vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified and the vaccination would be repeated with new vaccine stock.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE information reported; The patient went to her local CVS to receive the PNEUMOVAX 23 vaccine on 20Sep2021 at 2:46pm. She was inadvertently given PREVNAR 13.; This spontaneous report was received from a 68-year-old female patient reporting on herself.  The patient's historical vaccines included varicella zoster vaccine live (oka/merck) (ZOSTAVAX) and pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13). There was no information about her concurrent conditions, concomitant therapies or medical history provided.  On 20-SEP-2021 at 14:46, the patient was supposed to received dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) but was inadvertently given pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (wrong vaccine administered). There was no additional adverse event reported.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: temperature excursion / temperature 37.94 F; Route: IM; This spontaneous report was received from a licensed practical nurse and refers to a 15 months old male patient. There was no information regarding his medical history, concurrent conditions nor concomitant therapies provided.  On 23-JUL-2021, the patient was vaccinated in a public health clinic by the reporter (described also as a trained operator) with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose, intramuscularly into the left thigh, lot # T002847, expiration date 23-JAN-2022 (exact dose was not provided) for prophylaxis; the vaccine was purchased with public funds (product storage error, incorrect route of product administration). The administered vaccine was stored in a temperature of 37.94 degree Fahrenheit (F) for 100 hours. No previous temperature excursion was reported. Digital data logger was involved. No prescription drug treatment for the experience was required.  The reporter stated that the improperly stored vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified and the vaccination would be repeated with new vaccine stock.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; patient received an expired MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 20-SEP-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter, once, lot # S029457 was confirmed to be valid, expiration date 19-SEP-2021, for prophylaxis (route and site of administration were not reported). No additional adverse event was provided.
Age: 1.83
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a nurse practitioner, referring to a 22-month-old male patient at the time of vaccination (also reported 2-year-old). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 17-AUG-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). It was reported that the call was due to data logger. It was reported, the patient would be repeated with new vaccine stock.; Sender's Comments:  US-009507513-2108USA006311:
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; temperature excursion / temperature: 37.94 F; Route: IM; This spontaneous report as received from a licensed practical nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history, concomitant medications, drug allergies, or reactions were not reported.    Since 25-JUL-2021, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022, for prophylaxis (dose, strength, and route of administration, were not reported). The vaccine was expose to a temperature of 37.94 Fahrenheit degrees for 100 hours as detected by a digital data logger; no previously temperature excursion were reported. No additional adverse events were reported.  Follow-up information has been received on 20-SEP-2021 from the licensed practical nurse.   The patient's demographics were updated as the following: 14-month old female patient.   On 22-JUL-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) intramuscularly in the left tight.   The reporter stated that the improperly stored vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified, and the vaccination would be repeated with new vaccine stock.  This case is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up, it was determined that the case is now valid.; Sender's Comments:  US-009507513-2108USA006311:
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; his 4- month-old daughter was administered with GARDASIL 9 vaccine/ administered to the infant; This spontaneous report was received from the patient's father, and refers to a 4-month-old female patient. The patient's concurrent conditions included drug hypersensitivity. The patient's medical history included injection site erythema. Information regarding the patient's concomitant medications was reported as none.   On 14-SEP-2021 (reported as "7 days ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) at a dose of 0.5 mL, intramuscular, in the thigh muscle for prophylaxis (strength, lot number and expiration date were not reported).  It was stated that she was only supposed to get her 4-month-old shots and then the pediatric office informed him that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) was administered to the infant by accident.  On 14-SEP-2021, the patient had redness and swelling at the injection site (vaccination site erythema and vaccination site swelling). The patient sought medical attention and no treatment was provided. At the reporting time, the patient had not recovered form the vaccination site swelling and vaccination site erythema.   The reporter did not provide the causality assessment between the events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) and consider the events vaccination site erythema and vaccination site swelling not to be cancer or overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot is very powerful, if you get shingles you'll be way worst with the pain it causes; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient's doctor recently gave him/her the shingle vaccine, that shot was very powerful, but the patient heard if anyone get shingles, he/she would be way worst with the pain it causes. The follow-up would not possible as no contact details were available.