chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Severe continual heartburn for about a week IMMEDIATELY following the vaccine, tingling and numbness on the left side of my body (some in leg, lots in my arm, but largely in my face) that persisted on and off for several months. No weakness or pain or loss of mobility, just numbness and tingling. This was after my second dose, the first one did not seem to have side effects. I also had increased incidence of acne and boils for months afterward as well. None of these things (except a much milder version of the heartburn) were a problem for me before or since, and I have had no side effects aside from any vaccine before other than the usual soreness of injection site and tiredness. I have virtually no allergies that I know of, only an extremely mild rash from amoxicillin
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated
Clinical narrative: Initially mild asthmas exacerbation that escalated into a severe exacerbation requiring steroid shot, oral steroids, breathing treatments every 2 hours, with other medications such as cough syrup, guaifenesin, and decongestant. May still require hospitalization as I am not through with this yet.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Until now headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jul2021 17:45 (Lot number: EWO196) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "known allergies: Drug" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies: Codeine". The following information was reported: HEADACHE (non-serious) with onset 23Jul2021 12:00, outcome "not recovered", described as "Until now headache". Therapeutic measures were not taken as a result of headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Interchange of vaccine products, Off label use, Pain, Swelling
Clinical narrative: swelling in the left armpit; Little pain when touching the area; hot and with little pain,; I had the area of the vaccine swollen; recieved first and second dose of moderna and third dose of comirnaty; recieved first and second dose of moderna and third dose of comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:45 (Lot number: FD0809) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; AMLODIPINE BESYLATE. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 031B21A, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 07Apr2021, when the patient was 60 years old; Moderna (Dose Number: 1, Batch/Lot No: 013A21, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 60 years old. The following information was reported: OFF LABEL USE (non-serious) with onset 12Nov2021, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Nov2021, outcome "unknown" and all described as "recieved first and second dose of moderna and third dose of comirnaty"; SWELLING (non-serious) with onset 13Nov2021, outcome "recovering", described as "swelling in the left armpit"; PAIN (non-serious) with onset 13Nov2021, outcome "recovering", described as "Little pain when touching the area"; FEELING HOT (non-serious) with onset 12Nov2021, outcome "recovering", described as "hot and with little pain,"; VACCINATION SITE SWELLING (non-serious) with onset 12Nov2021, outcome "recovering", described as "I had the area of the vaccine swollen". Therapeutic measures were taken as a result of swelling, pain, feeling hot, vaccination site swelling.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. Facility type vaccine : Pharmacy or perfumery. Adverse event: swelling in the left armpit with a little pain when touching the area. I noticed this on 13Nov2021, when I started to touch the area. I don't know If I had it before and I didn't notice it then as I had not touched myself there. By 12Nov2021 I had the area of the vaccine swollen, hot and with little pain, but only if I touched myself there. AE treatment : continued taking Panadol.  No follow-up attempts are possible. No further information was expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling in the left armpit; Little pain when touching the area; hot and with little pain,; I had the area of the vaccine swollen; recieved first and second dose of moderna and third dose of comirnaty; recieved first and second dose of moderna and third dose of comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:45 (Lot number: FD0809) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; AMLODIPINE BESYLATE. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 031B21A, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 07Apr2021, when the patient was 60 years old; Moderna (Dose Number: 1, Batch/Lot No: 013A21, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 60 years old. The following information was reported: OFF LABEL USE (non-serious) with onset 12Nov2021, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Nov2021, outcome "unknown" and all described as "recieved first and second dose of moderna and third dose of comirnaty"; SWELLING (non-serious) with onset 13Nov2021, outcome "recovering", described as "swelling in the left armpit"; PAIN (non-serious) with onset 13Nov2021, outcome "recovering", described as "Little pain when touching the area"; FEELING HOT (non-serious) with onset 12Nov2021, outcome "recovering", described as "hot and with little pain,"; VACCINATION SITE SWELLING (non-serious) with onset 12Nov2021, outcome "recovering", described as "I had the area of the vaccine swollen". Therapeutic measures were taken as a result of swelling, pain, feeling hot, vaccination site swelling.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. Facility type vaccine : Pharmacy or perfumery. Adverse event: swelling in the left armpit with a little pain when touching the area. I noticed this on 13Nov2021, when I started to touch the area. I don't know If I had it before and I didn't notice it then as I had not touched myself there. By 12Nov2021 I had the area of the vaccine swollen, hot and with little pain, but only if I touched myself there. AE treatment : continued taking Panadol.  No follow-up attempts are possible. No further information was expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jun2021 13:30 (Lot number: EW0181) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Congenital hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Gastritis" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing); "Herniated discs in the lumbar area" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FIORICET; XYZAL; NORFLEX [ORPHENADRINE CITRATE]. The following information was reported: HEADACHE (non-serious) with onset 26Jun2021 14:30, outcome "recovered" (Jun2021), described as "Mild headache". Therapeutic measures were taken as a result of headache.  Additional information: The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Synthroid 175mg, Fioricet, xyzal, norflex within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date : 27Jun2021. The patient was treated with two Tylenol. The patient had COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: pain in injection arm.  Fever and fatigue for 48 hours past booster.  Far worse than a case of covid.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthropathy, Autoimmune disorder, Back pain, Bone disorder
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Colonoscopy, Contusion, Dizziness, Dyspnoea
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Eye pain, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival pain, Guillain-Barre syndrome, Headache, Hormone level abnormal, Laboratory test
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Multi-organ disorder, Muscle spasms, Myalgia
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Neuralgia, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Panic attack, Polyarthritis, Skin ulcer, Sluggishness
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Speech disorder, Swelling, Thrombosis, Toothache
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Trigeminal nerve disorder, Vision blurred
Clinical narrative: Organ swelling, generalized pain, extreme tiredness, dizziness, blurred vision, pain in the chest, back, legs, arms, head, gums, teeth, jaw, eyes, nose, throat, ears, neck, anxiety, panic attacks, disorder hormonal, guillan-barre symptoms, COVID symptoms, bruises, clots, cramps, spasms, shortness of breath, not being able to walk and talk well, brain fog, sluggishness, drowsiness, swollen lymph nodes throughout the body, abscesses, peripheral nerve pain, trigeminal nerves, muscle aches, joints, bones, generalized arthritis, autoimmune symptoms.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Since receiving the vaccine, I have suffered constant tinnitus which ranges from mild and tolerable (on good days) to  overwhelmingly irritating and intolerable (on bad days).  The sound is similar to the high pitches that you are asked to listen for during a hearing test, except the sound is at a constant pitch and never subsides.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received their second GARDASIL 9 four months after the first dose and then the third dose two months after the second dose.; Information has been received from a registered nurse, via a vaccine field representative who called to request information on behalf of a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unspecified dates, the patient was vaccinated with the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (administration routes, anatomical locations, lot numbers and expiration dates were not provided) for prophylaxis.   It was reported that the patient received their second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) four months after the first dose and then the third dose two months after the second dose (inappropriate schedule of product administration).  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse on 16-FEB-2022, referring to the 25-year-old female patient.  Patient's demographics were updated.  On 06-JUL-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) then, on 07-SEP-2021, the patient missed scheduled appointment for second dose of the vaccine so, the injection was given on 01-NOV-2021 (when she went to the office for an unrelated problem visit). Information regarding administration routes, anatomical locations, lot numbers and expiration dates was not provided for both first and second doses that were administered for prophylaxis. On 03-JAN-2022 (2 months after second dose, instead of 4 months), the patient received the third and last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route in her left deltoid (lot # 1775809, expiration date reported as 17-AUG-2021 but upon internal validation established as 18-AUG-2023) (inappropriate schedule of product administration). As corrective action, all the staff was informed again on correct schedule (0, 2, 6 months) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The vaccine was used according to the instruction leaflet and was not available for return/evaluation. The current location of vaccine was sharps container. The vaccine was purchased with private funds and the patient was vaccinated at a private doctor's office/hospital.   This case is now considered valid since patient's identifiers were provided.
Sex: M
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events reported; Nurse reported administration of an expired dose of MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T000892, expiration date 08-JAN-2022, dose of 0.5 milliliter (route was not reported) for prophylaxis; along with sterile diluent, lot # T001631, expiration date 11-JUN-2022, dose of 0.5 milliliter (route was not reported) for prophylaxis. The vaccine did not undergo a temperature excursion. No further adverse events were reported.  Follow-up information has been received  from a registered nurse on 22-FEB-2022 through the filled-out questionary.  Reporter clarified the identity of the patient vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), it was set to be a 27-year-old male patient. Additionally, the anatomical injection site was reported as left deltoid.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AE reported; administered the RECOMBIVAX HB to a 17 year old patient instead of the VAQTA; patient was already fully vaccinated with the RECOMBIVAX HB; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-JAN-2022, the patient was vaccinated with hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) 5 microgram (mcg)/0.5 ml, 0.5 ml, lot # U005271 with expiration date on 21-NOV-2022 (route of administration was not reported), for prophylaxis. The reporter stated that she administered the hepatitis B vaccine (recombinant) (RECOMBIVAX HB) instead of the hepatitis A vaccine, inactivated (VAQTA) (wrong product administered). The patient was already fully vaccinated with the hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (extra dose administered). On the same day, after the error was discovered, the hepatitis A vaccine, inactivated (VAQTA) (25 units (U)/0.5ml, 0.5 ml, lot # U024504 with expiration date on 15-OCT-2022, for prophylaxis; route of administration not reported) was administered in the patient's opposite arm. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired MMRll; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 17-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot# S039309, expiration date: 04-DEC-2021 (dose, site and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 14-JAN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), at a dose of 0.5 milliliter (ml) (lot number U016975, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 24-NOV-2022), as prophylaxis (route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of -14.1C during a time frame of 12 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller stated the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 18-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U022321, expiration date reported and validated as 15-JUL-2023) as prophylaxis, after a temperature excursion (product storage error).  The vaccine experienced a temperature excursion of minus (-) 14.1 degrees Celsius (C) for 12 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further information provided. No additional adverse events reported; Caller reports that a patient was administered an expired ROTATEQ today; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 25-JAN-2022, the patient was vaccinated with one (1) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (concentration, vaccination scheme frequency, route of administration, and anatomical site of application were not reported; lot number 1742457 that was verified to be a valid lot number with an expiration date reported as 16-JAN-2022, but upon internal validation established as 06-JAN-2022) (expired product administered) as prophylaxis.  Additionally, it was reported that the dose was properly stored through the time of administration. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a nurse, concerning to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On an unknown date, the with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) underwent a temperature excursion of -14.1 grades Celsius (C) for a timeframe of 12 minutes (product storage error). There were no previous temperature excursions.  Consequently, on 25-JAN-2022, the patient was vaccinated with the inappropriate storage  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD)  at a dose of 0.5 milliliters (mL) (lot number U016975 has been verified to be a valid lot number, expiration date reported and established as 24-NOV-2022) as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).
Age: 24.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy, Pain, Vaccination site pain
Clinical narrative: not 100% sure I got pregnant before or after I got the vaccine; Patient is unable to provide brand name of HPV vaccine that she received.; Patient reports pain as a soreness and only experienced the soreness for half a day; This spontaneous prospective pregnancy report was received from a 24-year-old female patient who referred to herself. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On 15-OCT-2021 and on 17-DEC-2021, the patient was vaccinated with retrospectively the first and the second dose of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) intramuscular injection (strength, dose, lot #, expiration date, route and site of administration were not provided) for prophylaxis. The patient was unable to provide the brand name of human papilloma virus (HPV) vaccine that she received (Product origin unknown).  On 17-DEC-2021, patient experienced minor pain after the administration of HPV vaccine, which lasted for half a day (Pain). There was no treatment given for the event.  On 21-JAN-2022, the patient discovered that she is pregnant (Exposure during pregnancy). Patient was informed that she might be 5 weeks pregnant, but it was impossible to confirm if she was pregnant or not during her second dose of vaccination as she was not sure she got pregnant before or after she got the vaccine. Her last menstrual period (LMP) date was 21-DEC-2021 and estimated date of delivery (EDD) was 27-SEP-2022 (all dates calculated based on gestation age at the time of the report). The pregnancy outcome was pending. Fetal outcome was unknown at the time of the report.  The outcome of pain was reported as resolved on 17-DEC-2021. The outcome of other events was unknown.  The causality assessment between the events and suspected vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JAN-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).   The reported stated that the vaccine was improperly stored (temperature -14.1 Celsius degrees for 12 minutes). There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccine was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-JAN-2022, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # U022321, expiration date: 15-JUL-2023 (route of administration was not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of -14.1 degrees Celsius for 12 minutes. There were no previous temperature excursions reported. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 20-JAN-2022, the patient was vaccinated with improperly stored (temperature -14.1 Celsius degrees, time frame: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023 (route of administration were not provided) for prophylaxis, (Product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; PEDVAXHIB was administered subcutaneously on two different patients, who are twins; This spontaneous report was received from a medical assistant and refers to a 15-month-old twin of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 25-JAN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U012705, expiration date: 16-SEP-2023 administered subcutaneously for prophylaxis (intramuscular formulation administered by other route). No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA007760:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; The vaccine was administered after a temperature excursion/ Temperature: -14.1 degree Celsius, time frame: 12 minutes; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 18-JAN-2022, the patient was vaccinated with improperly stored (temperature: -14.1 degree Celsius, timeframe: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #: U022321, expiration date: 15-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (product storage error). There was no additional adverse event reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired VARlVAX; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 24-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T002848, expiration date: 23-JAN-2022 (route of administration was not provided) for prophylaxis (expired vaccine used). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; The vaccine was administerd after a temperature excursion/Temperature: -14.1 degree Celsius, time frame: 12 minutes.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 19-JAN-2022, the patient was vaccinated with improperly stored (temperature: -14.1 degree Celsius, time frame: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #: U022321, expiration date: 15-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (product storage error). There was no additional adverse event reported (No adverse event).
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Mobility decreased
Clinical narrative: she experienced fatigue; "couldn't move"; This spontaneous report was received from a 73-year-old female patient who was referring to herself. The patient's concurrent conditions, medical history, concomitant therapies and allergies/drug reactions were not provided.  On an unknown date in January 2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, site of administration, route of administration, lot #, expiration date were not provided) for prophylaxis.  On unspecified date in January 2022 (it was unclear of the exact timing, but either the day after or the 2nd day after the administration), the patient experienced fatigue and "could not move". This lasted for abut 3/4 of a day before she recovered and felt normal again. The outcome of fatigue and "could not move" was reported as recovered on an unknown date.   The causal relationship between fatigue, "could not move" and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; PEDVAXHIB was administered subcutaneously on two different patients, who are twins; This spontaneous report was received from a medical assistant and refers to a 15-month-old twin of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 25-JAN-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, lot #U012705, expiration date: 16-SEP-2023 administered subcutaneously for prophylaxis (intramuscular formulation administered by other route). No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA007587:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: no adverse event; expired vaccine administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions and allergies and concomitant medications were not provided.  On 24-JAN-2022, the patient started therapy with expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose 0.5 milliliter, lot #T002842, expiration date: 23-JAN-2022, administered for prophylaxis (strength and route of administration were not provided). The vaccine was reconstituted with sterile diluent (STERILE DILUENT)(dose 0,5 ml; lot # T014299, valid expiry date 28-NOV-2022) administered on the same day.  There was no previous temperature excursion. No adverse effects were reported.
Age: 34.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Varivax received four days earlier; This spontaneous report was received from a pharmacist and refers to a 34-year-old of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, frequency, lot #, expiry date, and route of administration were not provided). On 27-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, frequency, lot #, expiry date, and route of administration were not provided).   The patient was supposed to wait with the administration of virus vaccine live (oka/merck) (VARIVAX) until 31-JAN-2021. The patient did not wait and received it on 27-JAN-2022, which was 4 days earlier than it was supposed to be (inappropriate schedule of vaccine administered). The patient did not experience any other adverse reaction.    This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA008274:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no known side effects; an expired dose of VARIVAX was accidently administered to a patient; This spontaneous report as received from a medical assistant refers to a 4-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-JAN-2022, the patient was accidently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: S038701, expiration date: 01-DEC-2021) 0.5 mL subcutaneously (also reported as intramuscularly, conflicting information) in the private doctor's office/hospital. No temperature excursion occurred. No adverse event was reported. No treatment was given.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: vaccine administered after temperature excursion; No additional AEs or PQC reported; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 27-JAN-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number: 1821811, expiration date: 27-JUL-2022, 2 ml, orally for prophylaxis (incorrect product storage).  The vaccine experienced temperature excursion of 35 degree of Fahrenheit for 1 hour and 24 minutes. The previous temperature excursion was not detected. No additional adverse event was provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; patient received an expired PROQUAD; This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 28-JAN-2022, the patient was vaccinated with an expired 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD), lot # T019420, expiry date 02-DEC-2021 (exact dose, route and site of administration were not reported) for prophylaxis (expired product administered). No additional adverse events were reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Product was administered to patient after temperature excursions; This spontaneous report was received from a medical assistant, and refers to a 12 month old patient of unspecified gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 28-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # U008180, expiration date: 12-MAR-2023, for prophylaxis. On unspecified dates, the doses of varicella virus vaccine live (oka/merck)(VARIVAX)underwent temperature excursions of 7.4 Fahrenheit degrees (°F) for 0 Hours 25 Minutes 0 Seconds; 6.4 °F for 0 Hours 20 Minutes 0 Seconds; 5.9°F for 0 Hours 15 Minutes 0 Seconds; 31.3 °F for 10 Hours 28 Minutes 0 Seconds;  Between range of 6°F to 14°F; No exact temperature was provided; for 1 Hour 15 Minutes 0 Seconds and 11 °F for 4 Hours 6 Minutes 0 Seconds.  No adverse events were reported.  This is one of seven cases received from the same source.; Sender's Comments:  US-009507513-2202USA000523: US-009507513-2202USA000416: US-009507513-2202USA000290: US-009507513-2202USA000275: US-009507513-2202USA000257: US-009507513-2202USA000100:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Product was administered to patient after temperature excursions; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unspecified gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 21-JAN-2022, the patient was vaccinated with a reported once dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (concentration, exact dose, route of administration and anatomical site of application were not reported; lot number U008180 that was verified to be a valid lot number with an expiration date reported and established as 12-MAR-2023) as prophylaxis after temperature excursions (product storage error).  The temperature excursions were reported as following: 7.4 degrees Fahrenheit (°F) with a time frame of 25 minutes, 6.4 degrees Fahrenheit (°F) with a time frame of 20 minutes and 5.9 degrees Fahrenheit (°F) with a time frame of 15 minutes. It was stated that the vaccine experienced a previous temperature excursion that were reported as: 31.3 degrees Fahrenheit (°F) with a time frame of 10 hours 28 minutes; a range between 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) with no exact temperature provided but with a time frame of 1 hour 15 minutes and then 11 degrees Fahrenheit (°F) with a time frame of 6 minutes.  No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. This patient was reported as patient number three out of seven.; Sender's Comments:  US-009507513-2202USA000100: US-009507513-2202USA000257: US-009507513-2202USA000275: US-009507513-2202USA000290: US-009507513-2202USA000324:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: No additional AEs; Patient received GARDASIL 9 vaccinations of 21-JUN-2012, 14-MAR-2013, 14-JAN-2021 and 12-MAY-2021. Patient was 15 years old when series began.; Patient received GARDASIL 9 vaccinations of 21-JUN-2012, 14-MAR-2013, 14-JAN-2021 and 12-MAY-2021. Patient was 15 years old when series began.; This spontaneous report was received from a registered nurse and refers to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2012, the patient was administered first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. Subsequent doses of the vaccine were administered on 14-MAR-2013, 14-JAN-2021 (inappropriate schedule of product administration) and 12-MAY-2021 (extra dose administered). No additional adverse event (AE) reported.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a first dose of ROT ATEQ was administered to a patient at 28 weeks old prior to realizing it was not indicated to be given after 12 weeks of age; This spontaneous report as received from a physician refers to a 30-week-old (reported as 28-week-old, but calculated as 30-week-old based on date of birth) patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 31-JAN-2022, prior to realizing that the first dose was not indicated to be given after 12 weeks of age, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # 1742078, expiry date 06-JUL-2022, 2 ml by mouth, for prophylaxis (product administered to patient of inappropriate age).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; dose of Improperly Stored VARIVAX has been administered to a patient; This spontaneous report as received from a registered nurse refers to a 12-month-old patient. No information regarding the patient's concurrent conditions, medical history, drug allergies and concomitant medications were provided.  On 25-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # U020238, expiration date 25-JUN-2023, dose: 0,5 milliliter (formulation, injection site and route of administration were not provided) for prophylaxis.  The the vaccine was stored in inappropriate range of temperature. Temperature and time frame: 6 F (Fahrenheit) degrees up to 14 F degrees (13.8F) for 1 hour 45 minutes and 0 seconds; 14 F degrees up to 46 F degrees (14.4 F) for 0 hours 25 minutes and 0 seconds (product storage error temperature too high). There was no previous temperature excursion. No additional adverse event was reported.