chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Body temperature increased, Cardiac monitoring abnormal, Fatigue
Clinical narrative: Day after: ached in every joint, bad headache, fatigued, temperature of about 100. Two days after: fatigued and bad headache. Then, Just after midnight on the 3rd day I went into atrial fibrillation (I have a Kardia Mobil  unit that can detect heart arrhythmias). I had two more readings of afib over the next hour or so and then fell asleep reading.  When I awoke  a couple of hrs. later had a "normal" reading but, after falling back asleep, I awoke about 9 am and had a reading of "normal sinus rhythm with premature ventricular contractions (pvc)".  I have been having either pvc's or "sinus rhythm with supraventricular ectopy" readings on and off daily ever since (two and a half weeks).  I contacted my cardiologist and he said continue on the same medications as see what happens.  I have an appointment on June 14 to discuss this.  Could it be related to this second booster?
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ventricular extrasystoles
Clinical narrative: Day after: ached in every joint, bad headache, fatigued, temperature of about 100. Two days after: fatigued and bad headache. Then, Just after midnight on the 3rd day I went into atrial fibrillation (I have a Kardia Mobil  unit that can detect heart arrhythmias). I had two more readings of afib over the next hour or so and then fell asleep reading.  When I awoke  a couple of hrs. later had a "normal" reading but, after falling back asleep, I awoke about 9 am and had a reading of "normal sinus rhythm with premature ventricular contractions (pvc)".  I have been having either pvc's or "sinus rhythm with supraventricular ectopy" readings on and off daily ever since (two and a half weeks).  I contacted my cardiologist and he said continue on the same medications as see what happens.  I have an appointment on June 14 to discuss this.  Could it be related to this second booster?
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: From onset for about 24 hours extreme fatigue, also even though temp was 98.6, the feeling that of having a fever.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PAID NURSE AT PHARMACY DID NOT DILUTE VACCINE PRIOR TO ADMINISTERING ORANGE CAP PFIZER TO 8 YEAR OLD CHILD. CHILD IS WITHOUT NOTICEABLE SIDE EFFECTS AT TIME OF DISCOVERY.
Age: 50.0
Sex: F
Vaccine: COVID19, TDAP, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Syncope, Wrong product administered
Clinical narrative: PT GIVEN BOOSTRIX VACCINE DUE TO INCORRECT ENTRY TO PHARMACY SYSTEM. PT CONFIRMED DESIRE TO RECEIVE BOOSTRIX DURING PRE-ADMINISTRATION PERIOD WITH PHARMACIST, BUT REALIZED THIS IS NOT WHAT SHE WANTED AFTER ADMINISTRATION. ROUGHLY 2 HOURS AFTER VACCINATION, PT REPORTED LEFT ARM SHOULDER-TO-WRIST PAIN/FAINT NUMBNESS. PT CALLED HER DOCTOR AND TOOK 2 TYLENOL AS ADVISED BY DOCTOR. VACCINES WERE APPROPRIATELY SPACED IN LEFT ARM DURING ADMINISTRATION BY PHARMACIST.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block complete, Bradycardia, Cardiac pacemaker insertion, Electrocardiogram ambulatory abnormal, Heart rate irregular
Clinical narrative: began with irregular heart beats that progressed over several months to the point he needed a pacemaker placed 4 months later because of complete heart block
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Rash, Seasonal allergy
Clinical narrative: pt reported seasonal allergies and an allergy to the shingles vaccine causing a rash, no other info. pt reported new medications dorzolamide, timolol maleate, latanoprost.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Epistaxis, Hypoaesthesia, Musculoskeletal disorder
Clinical narrative: In 2021, I was experiencing whole body weakness and numbness. This started in a program. May 18, 2021, I had the Janssen vaccine, I didn't notice any adverse effects, I'm 100% disable. I had not realize the extent of my numbness and weakness, until I went to shop. I turned left, my right arm hit a shopping cart, I was not able to control my arm, this happened three separate trips. I had began having body weakness in 2021, for three major nose bleeds. I went to ER for the nose bleeds. This left me very weak, the weakness and numbness affected my whole body, I knew the doctors knew what was wrong but did nothing to stop the weakness and numbness. October 26, 2021 I dad the booster. The weakness and numbness, did not stop. I have it now, but its not as bad. I'm on antibiotics. I don't know what to do to stop the numbness and weakness. Yes the booster made it worse. This was the injection of Janssen 043a218 May 18, 2021 and Janssen 1822871 on October 26, 2021. I had numbness and whole body weakness prior to the vaccines, everything worsen. All I've been given is antibiotics. They work for sometime before I have to go to the ER. yes I did tell my provider - and asked him why he's overlooking my health condition. He was humiliated, by my request for better medical care.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: April 15th my husband and I had our old folks' Covid booster shots. We took our shots at store. I did not want to use this store but we had much difficulty finding a place where the old folks' booster was provided. The lady stuck a round patch on my arm then needled the shot through the patch. Seemed the patch was rubber or latex. All the other vaccinations I received were just a simple prick after an alcohol wipe - no patch - almost no pain - but this shot hurt. I was surprised that it hurt. It hurt more than a shot should hurt when I was pricked. I had asked why the round rubber patch. I thought it odd that a needle would go through a rubber patch then into my arm. Now - over a month later - my arm at the location of the shot has developed a lingering soreness. It is too much soreness to ignore and seems to be increasing rather than decreasing. That is not right. I had little reaction to the prior three shots for covid. I think that a tiny dab of the plastic or latex of the patch was shoved into my arm. I think that is why my arm is sore where the needle went in. From the internet: The bandage is circular, with an adhesive membrane. A nurse cleans the patient?s arm, applies the Barrier Bandage, and then administers the shot right through the bandage. It then acts immediately as a band-aid to catch and conceal any fluids from the broken skin. ?The Barrier Bandage is constructed of a self-sealing, non-coring, elastomeric membrane. which is another way of saying once the needle passes through the barrier, it reseals preventing any fluid from coming out,? person said. Person is with Inject-Safe? Barrier Bandages. Overall person said the product is a safer, quicker, and more affordable way to administer a vaccine. I VERY STRONGLY DISAGREE AND BELIEVE THAT ALTHOUGH MOST WILL NOT HAVE PLASTIC STUCK Into THEIR ARM - THIS IS NOT GOOD AND NOT RIGHT AND MY ARM STILL HURTS 05/27/22
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dehydration, Dyspnoea, Fatigue
Clinical narrative: I am reasonably health. However, since injected the Pfitzer 2nd Booster at facility on May 10, 2022. I have experienced the following side effects that does not seem to go away: Nausea, shortness of breath, loss of appetite, soreness in my legs while walking; unusual cramps and tightness in my ankle and calf muscles causing slowness while walking. Fatigue; tiredness during the day. Little coughs (but not bad). Smell and taste Pinesol especially after drinking lemonade or coke products. Taste buds are off, feels something is on my tongue that doesn't go away. Sometimes chewing foods thick and clumpy to chew. Crave smoothies and water (dehydration). Did Covid Patient Test results negative.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Mastication disorder, Muscle spasms, Muscle tightness, Nausea
Clinical narrative: I am reasonably health. However, since injected the Pfitzer 2nd Booster at facility on May 10, 2022. I have experienced the following side effects that does not seem to go away: Nausea, shortness of breath, loss of appetite, soreness in my legs while walking; unusual cramps and tightness in my ankle and calf muscles causing slowness while walking. Fatigue; tiredness during the day. Little coughs (but not bad). Smell and taste Pinesol especially after drinking lemonade or coke products. Taste buds are off, feels something is on my tongue that doesn't go away. Sometimes chewing foods thick and clumpy to chew. Crave smoothies and water (dehydration). Did Covid Patient Test results negative.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Parosmia, SARS-CoV-2 test negative, Taste disorder, Tongue disorder
Clinical narrative: I am reasonably health. However, since injected the Pfitzer 2nd Booster at facility on May 10, 2022. I have experienced the following side effects that does not seem to go away: Nausea, shortness of breath, loss of appetite, soreness in my legs while walking; unusual cramps and tightness in my ankle and calf muscles causing slowness while walking. Fatigue; tiredness during the day. Little coughs (but not bad). Smell and taste Pinesol especially after drinking lemonade or coke products. Taste buds are off, feels something is on my tongue that doesn't go away. Sometimes chewing foods thick and clumpy to chew. Crave smoothies and water (dehydration). Did Covid Patient Test results negative.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electromyogram abnormal, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: AFTER 2 WEEKS OF SECOND DOSE OF MODERNA BOOSTER SHOT, MY ENTIRE BODY STARTED FEELING EXTREMELY WEAK AND FATIGUE, ALL BODY MUSCLES GOT TENSED. MY HANDS STARTED STIFFED INCLUDING FEET. I COULD NOT ABLE TO WALK AT ALL SO I WENT TO HOSPITAL EMMERGENCY DEPARTMENT TO RUN THE BLOOD WORK AND REST OF THE TESTS TO FIND OUT . I HAVE ALL THE REPORT IN MY POSSESION TO JUSTIFY THE CAUSE OF THE ROOT WAS BOOSTER SHOT OF MODERNA 2ND SHOT. I DEVELOPED GUILLAIN-BARRE SYNDROME.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal, Lumbar puncture abnormal, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: AFTER 2 WEEKS OF SECOND DOSE OF MODERNA BOOSTER SHOT, MY ENTIRE BODY STARTED FEELING EXTREMELY WEAK AND FATIGUE, ALL BODY MUSCLES GOT TENSED. MY HANDS STARTED STIFFED INCLUDING FEET. I COULD NOT ABLE TO WALK AT ALL SO I WENT TO HOSPITAL EMMERGENCY DEPARTMENT TO RUN THE BLOOD WORK AND REST OF THE TESTS TO FIND OUT . I HAVE ALL THE REPORT IN MY POSSESION TO JUSTIFY THE CAUSE OF THE ROOT WAS BOOSTER SHOT OF MODERNA 2ND SHOT. I DEVELOPED GUILLAIN-BARRE SYNDROME.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: AFTER 2 WEEKS OF SECOND DOSE OF MODERNA BOOSTER SHOT, MY ENTIRE BODY STARTED FEELING EXTREMELY WEAK AND FATIGUE, ALL BODY MUSCLES GOT TENSED. MY HANDS STARTED STIFFED INCLUDING FEET. I COULD NOT ABLE TO WALK AT ALL SO I WENT TO HOSPITAL EMMERGENCY DEPARTMENT TO RUN THE BLOOD WORK AND REST OF THE TESTS TO FIND OUT . I HAVE ALL THE REPORT IN MY POSSESION TO JUSTIFY THE CAUSE OF THE ROOT WAS BOOSTER SHOT OF MODERNA 2ND SHOT. I DEVELOPED GUILLAIN-BARRE SYNDROME.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchiolitis, Chest X-ray abnormal, Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: After waiting to see if my breathing got better, which it did not, so on October 25th, 2021 I went to see Dr. who was my doctor at the time, for my breathing and she sent me for a chest x-ray. That evening she called me to set up an appointment for a Pulmonary Test with Dr. The x-ray showed the lungs are hyperinflated and apical pleural thickening. Now with my breathing problem, mostly when I'm bending and doing things fast is when I feel at my worst. Seems like something heavy is on my chest. Now I make an appt. on February 4, 2022 with Dr. a Pulmonologist. He sets an appt. for a CT. Scan of the chest on February 17, 2022 and a Pulmonary Test on February 24, 2022. The result of the CT Scan showed that my Lungs had clusters of small centrilobular pulmonary nodules with tree-in-bud morphology associated with thickening of the peribronchial vascular insterstitium were identified throughout the lungs bilaterally, likely related to chronic bronchiolitis.  Subpleural soft tissue density pulmonary nodule in the right lower lobe measures 4 mm.   Dr. no longer seemed it necessary for any other follow-ups and suggested I see a Cardiologist. I set up an appointment for Dr. from the Heart facility, on July , 2022.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung hyperinflation, Pleural thickening, Pulmonary function test abnormal, Pulmonary mass
Clinical narrative: After waiting to see if my breathing got better, which it did not, so on October 25th, 2021 I went to see Dr. who was my doctor at the time, for my breathing and she sent me for a chest x-ray. That evening she called me to set up an appointment for a Pulmonary Test with Dr. The x-ray showed the lungs are hyperinflated and apical pleural thickening. Now with my breathing problem, mostly when I'm bending and doing things fast is when I feel at my worst. Seems like something heavy is on my chest. Now I make an appt. on February 4, 2022 with Dr. a Pulmonologist. He sets an appt. for a CT. Scan of the chest on February 17, 2022 and a Pulmonary Test on February 24, 2022. The result of the CT Scan showed that my Lungs had clusters of small centrilobular pulmonary nodules with tree-in-bud morphology associated with thickening of the peribronchial vascular insterstitium were identified throughout the lungs bilaterally, likely related to chronic bronchiolitis.  Subpleural soft tissue density pulmonary nodule in the right lower lobe measures 4 mm.   Dr. no longer seemed it necessary for any other follow-ups and suggested I see a Cardiologist. I set up an appointment for Dr. from the Heart facility, on July , 2022.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Limb discomfort, Pain
Clinical narrative: Immediately after injection, pt felt odd heaviness pain in upper arm/shoulder. This intensified through the night and by bedtime pain 10/10 - tylenol helped some but not much. Had a spell of numbness & tingling in hand x1 last night. (None today). No weakness. No fever. Some bodyaches. Today pain 5/10 in upper arm. Feels better with meds and if arm is splinted. Exam normal apart from intense pain throughout deltoid and mild-med pain in brachioradialis area. strength 5/5. Strong distal pulse. Skin cool but color normal with rash. ROM of deltoid, but with pain
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Paraesthesia, Rash
Clinical narrative: Immediately after injection, pt felt odd heaviness pain in upper arm/shoulder. This intensified through the night and by bedtime pain 10/10 - tylenol helped some but not much. Had a spell of numbness & tingling in hand x1 last night. (None today). No weakness. No fever. Some bodyaches. Today pain 5/10 in upper arm. Feels better with meds and if arm is splinted. Exam normal apart from intense pain throughout deltoid and mild-med pain in brachioradialis area. strength 5/5. Strong distal pulse. Skin cool but color normal with rash. ROM of deltoid, but with pain
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema
Clinical narrative: eczema that has not gone away for almost 1 yr. Started 6-7 wks after last Pfizer dose. Never used medications took no supplements regularly, none new. While I understand under emergency release no culpability is assigned however if ever another mass vaccine is reqst, I would definitely pass & stand w the never vacciners. Adverse effects must be identified b4 releasing on gen. population. Many I  know in immediate community across country have skin problems after the vaccine while the official rpts say the skin issues go away in 2 wks, that is not true for many of  us and you all need to fess up bc there will not be a willing public w/o full admission I've lost trust in the whole sys, bc instead of protecting ppl, it set up top protect hospital sys. That says the sys is NOT to bust enough. Allergy testing: both food and environment (definitely not food) Continuous dermatology (which I NEVER had ANY problems!) Quality of life issue! In addition to the many reporting skin problems to the vaccine, given general environmental allergy, I took the time to find where to report (not well advertised) and I'm send many more have to and should but have not reported or know where to report.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Agonal respiration, Death, Decreased appetite, Depressed level of consciousness, Diarrhoea
Clinical narrative: Resident noted as having lethargy, difficulty in arousing from sleep & napping periods. No reports of pain or discomfort from resident. Resident c/o sleepy and wanted to rest. Appetite - poor; c/o nausea loose stool. Agonal breathing, pallor, no pulse note 5/28/22 in AM. Pronounced @ 9:33/AM
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pallor, Pulse absent, Somnolence
Clinical narrative: Resident noted as having lethargy, difficulty in arousing from sleep & napping periods. No reports of pain or discomfort from resident. Resident c/o sleepy and wanted to rest. Appetite - poor; c/o nausea loose stool. Agonal breathing, pallor, no pulse note 5/28/22 in AM. Pronounced @ 9:33/AM
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, COVID-19, Cardiac failure congestive, Condition aggravated, Intervertebral discitis
Clinical narrative: kidney infection, acute renal failure, CHF, and diskitis following booster; requiring 5 day hospital admission, followed by 2 weeks in rehab facility, and 6 weeks of IV antibiotics. Also vaccine failure with Covid infection following booster.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Kidney infection, Vaccination failure
Clinical narrative: kidney infection, acute renal failure, CHF, and diskitis following booster; requiring 5 day hospital admission, followed by 2 weeks in rehab facility, and 6 weeks of IV antibiotics. Also vaccine failure with Covid infection following booster.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019f21a) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy, Asthma, Respiratory infection, Allergy, GERD, Drug allergy (Topiramate), Drug allergy (carbamazepine) and Drug allergy (phenytoin). Concomitant products included MONTELUKAST from 01-Jan-2022 to an unknown date, LEVETIRACETAM from 01-Jan-2022 to an unknown date, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) from 01-Jan-2022 to an unknown date, OLOPATADINE from 01-Jan-2022 to an unknown date, ALBUTEROL SULFATE from 01-Jan-2022 to an unknown date, FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) from 21-May-2022 to 25-May-2022 and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 01-Jan-2022 to 20-May-2022 for an unknown indication.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            COMPANY COMMENT: This is an spontaneous case concerning a 37-year-old female patient with medical history of Epilepsy, Asthma, Respiratory infection, Allergy, GERD, Drug allergy (Topiramate), Drug allergy (carbamazepine) and Drug allergy (phenytoin), Concomitant products included MONTELUKAST, LEVETIRACETAM, TIOTROPIUM BROMIDE MONOHYDRATE, OLOPATADINE, ALBUTEROL SULFATE, FORMOTEROL FUMARATE, MOMETASONE FUROATE, BUDESONIDE, FORMOTEROL FUMARATE, PAXLOVID from 21-May-2022 to 25-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 212 days after 3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 37-year-old female patient with medical history of Epilepsy, Asthma, Respiratory infection, Allergy, GERD, Drug allergy (Topiramate), Drug allergy (carbamazepine) and Drug allergy (phenytoin), Concomitant products included MONTELUKAST, LEVETIRACETAM, TIOTROPIUM BROMIDE MONOHYDRATE, OLOPATADINE, ALBUTEROL SULFATE, FORMOTEROL FUMARATE, MOMETASONE FUROATE, BUDESONIDE, FORMOTEROL FUMARATE, PAXLOVID from 21-May-2022 to 25-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 212 days after 3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Erythema, Pruritus, Pyrexia, Rash
Clinical narrative: torso rash again. Rash progressed anyway. Still red.; I suppressed fever; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: ER8732 Location of injection: Arm Left) on 24-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: ER8729 Location of injection: Arm Left) on 14-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Batch/lot number: FJ1620, in Arm Left, dose number 3) on 29-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE on 29-Nov-2021. Past adverse reactions to the above products included Itching with PFIZER BIONTECH COVID-19 VACCINE; No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE; and Red rash with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (pollens), Osteoporosis (no medicines yet) and Allergy (thimerosal).    On 28-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Fever, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) had not resolved and PYREXIA (I suppressed fever) outcome was unknown.            The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Calcium and Vit D supplements within 2 weeks of vaccination.   The patient had a 4th shot (2nd booster) on May 28, 2022 (Moderna) - torso rash again even though patient suppressed fever with NSAIDs this time. Took Zyrtec. Rash progressed anyway. Still red. Even though not a serious effect, it can be serious because will lead to vaccine hesitancy or reluctance in the future for me.   Pharmacist advised for next time to start antihistamine a few days before vaccine to allow more time for antihistamine to work. Patient will not be going through this 4 times a year given that the 4th dose has debatable benefit anyway, patent want to known patient would get this rash again, patient would have skipped the 4th dose and waited until fall.   The patient did not diagnose with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Device Date: 31May2022
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Skin warm, Sleep disorder
Clinical narrative: torso rash again. Rash progressed anyway. Still red.; I suppressed fever; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: ER8732 Location of injection: Arm Left) on 24-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: ER8729 Location of injection: Arm Left) on 14-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Batch/lot number: FJ1620, in Arm Left, dose number 3) on 29-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE on 29-Nov-2021. Past adverse reactions to the above products included Itching with PFIZER BIONTECH COVID-19 VACCINE; No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE; and Red rash with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (pollens), Osteoporosis (no medicines yet) and Allergy (thimerosal).    On 28-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Fever, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) had not resolved and PYREXIA (I suppressed fever) outcome was unknown.            The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Calcium and Vit D supplements within 2 weeks of vaccination.   The patient had a 4th shot (2nd booster) on May 28, 2022 (Moderna) - torso rash again even though patient suppressed fever with NSAIDs this time. Took Zyrtec. Rash progressed anyway. Still red. Even though not a serious effect, it can be serious because will lead to vaccine hesitancy or reluctance in the future for me.   Pharmacist advised for next time to start antihistamine a few days before vaccine to allow more time for antihistamine to work. Patient will not be going through this 4 times a year given that the 4th dose has debatable benefit anyway, patent want to known patient would get this rash again, patient would have skipped the 4th dose and waited until fall.   The patient did not diagnose with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Device Date: 31May2022
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: torso rash again. Rash progressed anyway. Still red.; I suppressed fever; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: ER8732 Location of injection: Arm Left) on 24-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: ER8729 Location of injection: Arm Left) on 14-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Batch/lot number: FJ1620, in Arm Left, dose number 3) on 29-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE on 29-Nov-2021. Past adverse reactions to the above products included Itching with PFIZER BIONTECH COVID-19 VACCINE; No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE; and Red rash with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (pollens), Osteoporosis (no medicines yet) and Allergy (thimerosal).    On 28-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) and PYREXIA (I suppressed fever). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Fever, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (torso rash again. Rash progressed anyway. Still red.) had not resolved and PYREXIA (I suppressed fever) outcome was unknown.            The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Calcium and Vit D supplements within 2 weeks of vaccination.   The patient had a 4th shot (2nd booster) on May 28, 2022 (Moderna) - torso rash again even though patient suppressed fever with NSAIDs this time. Took Zyrtec. Rash progressed anyway. Still red. Even though not a serious effect, it can be serious because will lead to vaccine hesitancy or reluctance in the future for me.   Pharmacist advised for next time to start antihistamine a few days before vaccine to allow more time for antihistamine to work. Patient will not be going through this 4 times a year given that the 4th dose has debatable benefit anyway, patent want to known patient would get this rash again, patient would have skipped the 4th dose and waited until fall.   The patient did not diagnose with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. Device Date: 31May2022
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pain, Somnolence
Clinical narrative: experienced a very bad reaction; Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021); This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (experienced a very bad reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003a21a, 006b21a and 037832b) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (Patient is allergic to Pollen dust).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021)). On an unknown date, the patient experienced IMMUNISATION REACTION (experienced a very bad reaction). At the time of the report, IMMUNISATION REACTION (experienced a very bad reaction) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021)) outcome was unknown.            No concomitant medication was reported. It was reported that patient had no COVID + test or diagnosis. No other vaccines were administered to the patient within 1 month prior to Moderna COVID-19 vaccine. It was confirmed that AE did not cause patient to seek medical care so far, patient never experienced a similar event in the past and symptoms had not really improved. Treatment included: Pain medication which had its own side effects and patient could stand it only for a few days.   This case was linked to MOD-2022-581044 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: experienced a very bad reaction; Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021); This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (experienced a very bad reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003a21a, 006b21a and 037832b) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (Patient is allergic to Pollen dust).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021)). On an unknown date, the patient experienced IMMUNISATION REACTION (experienced a very bad reaction). At the time of the report, IMMUNISATION REACTION (experienced a very bad reaction) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (2nd dose April 14 2021 and 1st booster dose Sep 9 2021)) outcome was unknown.            No concomitant medication was reported. It was reported that patient had no COVID + test or diagnosis. No other vaccines were administered to the patient within 1 month prior to Moderna COVID-19 vaccine. It was confirmed that AE did not cause patient to seek medical care so far, patient never experienced a similar event in the past and symptoms had not really improved. Treatment included: Pain medication which had its own side effects and patient could stand it only for a few days.   This case was linked to MOD-2022-581044 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Heart rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: exhausted; Because of her tachycardia, her heart rate skyrockets when she's sick; Friday felt lousy/ Just felt awful; Had a stomach ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: Tachycardia History of heart rate goes through the roof when sick. Racing heart beat. She's had this for a few years at least, a long time.; "Kidney stone removed", start date: 12Apr2022 (unspecified if ongoing), notes: Verbatim: Had Kidney stone removed 12Apr2022. Concomitant medication(s) included: MUCINEX DM. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 3, Manufacturer: Pfizer, Date: 04Oct2021, NDC: Unknown, LOT: 30145BA, EXP: Unknown), administration date: 04Oct2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 02Apr2021, NDC: Unknown, LOT: EP87534, EXP: 31Jul2021), administration date: 02Apr2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer , Date: 12Mar2021, NDC: Unknown, LOT: EN6202, EXP: 30Jun2021), administration date: 12Mar2021, when the patient was 57-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "exhausted"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Because of her tachycardia, her heart rate skyrockets when she's sick"; MALAISE (non-serious), outcome "unknown", described as "Friday felt lousy/ Just felt awful"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Had a stomach ache". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Fatigue, Heart rate, Heart rate increased, Malaise
Clinical narrative: exhausted; Because of her tachycardia, her heart rate skyrockets when she's sick; Friday felt lousy/ Just felt awful; Had a stomach ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: Tachycardia History of heart rate goes through the roof when sick. Racing heart beat. She's had this for a few years at least, a long time.; "Kidney stone removed", start date: 12Apr2022 (unspecified if ongoing), notes: Verbatim: Had Kidney stone removed 12Apr2022. Concomitant medication(s) included: MUCINEX DM. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 3, Manufacturer: Pfizer, Date: 04Oct2021, NDC: Unknown, LOT: 30145BA, EXP: Unknown), administration date: 04Oct2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 02Apr2021, NDC: Unknown, LOT: EP87534, EXP: 31Jul2021), administration date: 02Apr2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer , Date: 12Mar2021, NDC: Unknown, LOT: EN6202, EXP: 30Jun2021), administration date: 12Mar2021, when the patient was 57-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "exhausted"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Because of her tachycardia, her heart rate skyrockets when she's sick"; MALAISE (non-serious), outcome "unknown", described as "Friday felt lousy/ Just felt awful"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Had a stomach ache". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test
Clinical narrative: exhausted; Because of her tachycardia, her heart rate skyrockets when she's sick; Friday felt lousy/ Just felt awful; Had a stomach ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: Tachycardia History of heart rate goes through the roof when sick. Racing heart beat. She's had this for a few years at least, a long time.; "Kidney stone removed", start date: 12Apr2022 (unspecified if ongoing), notes: Verbatim: Had Kidney stone removed 12Apr2022. Concomitant medication(s) included: MUCINEX DM. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 3, Manufacturer: Pfizer, Date: 04Oct2021, NDC: Unknown, LOT: 30145BA, EXP: Unknown), administration date: 04Oct2021, when the patient was 58-year-old, for COVID-19 Immunization; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 02Apr2021, NDC: Unknown, LOT: EP87534, EXP: 31Jul2021), administration date: 02Apr2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer , Date: 12Mar2021, NDC: Unknown, LOT: EN6202, EXP: 30Jun2021), administration date: 12Mar2021, when the patient was 57-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "exhausted"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Because of her tachycardia, her heart rate skyrockets when she's sick"; MALAISE (non-serious), outcome "unknown", described as "Friday felt lousy/ Just felt awful"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Had a stomach ache". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid+
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Pruritus, Urticaria
Clinical narrative: Full body hives.  Itchy, painful, brusing
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: covid+
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in lower leg and hands
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site muscle weakness, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Muscle atrophy
Clinical narrative: Left arm severe weakness from shoulder to hands  and fingers .  Unable to use left upper extremity as before covid vaccine.  Left arm pain with muscle loss and tingling.  Inset followed 2nd vaccine dosage given 012422.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Left arm severe weakness from shoulder to hands  and fingers .  Unable to use left upper extremity as before covid vaccine.  Left arm pain with muscle loss and tingling.  Inset followed 2nd vaccine dosage given 012422.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid+
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID+
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid+
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Pyrexia, Toothache
Clinical narrative: Fever, chills,  and toothache
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Exercise tolerance decreased, Fatigue
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, myalgias, fatigue and malaise for 72 hours. Followed by severe asthenia, headache and nausea with anorexia for next 5 days. Currently persistent generalized weakness unable to exercise
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, myalgias, fatigue and malaise for 72 hours. Followed by severe asthenia, headache and nausea with anorexia for next 5 days. Currently persistent generalized weakness unable to exercise
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, myalgias, fatigue and malaise for 72 hours. Followed by severe asthenia, headache and nausea with anorexia for next 5 days. Currently persistent generalized weakness unable to exercise
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: patient received an extra dose of VARIVAX on 1-MAY-2022; low or undetectable antibody levels after vaccination with VARIVAX; This spontaneous report was received from a registered nurse and refers to a 15-year-old male patient. Information regarding his concomitant medications, concurrent conditions and medical history was not reported.  On an unknown date, the patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 23-APR-2022, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml), administered subcutaneously, lot # U020244, expiration date: 28-JUN-2023 (anatomical location was not reported). On an unknown date in 2022, after the second vaccination, the patient had low or undetectable antibody levels. On 01-MAY-2022 (described also as approximately one week after receiving the second dose), due to low or undetectable antibody levels, the patient received third dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, administered subcutaneously, lot # U020244, expiration date: 28-JUN-2023 (anatomical location was not reported) (extra dose administered). The outcome of the low or undetectable antibody levels was unknown.  The causality assessment between the event and the suspect vaccine was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Medical assistant calling with MIR related to a patient that received both PROQUAD and VARIVAX on the same day; Medical assistant calling with MIR related to a patient that received both PROQUAD and VARIVAX on the same day; No additional AE information; This spontaneous report was received from a medical assistant 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 an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, site of administration reported as leg, lot number: U025202, expiration date: 13-AUG-2023 and Measles, Mumps, Rubella and Varicella (Oka-Merck) site of administration reported as leg, Virus Vaccine Live (rHA)(PROQUAD) subcutaneous injection lot number T037955, expiration date: 09-MAY-2022 (strength, dose, dose number, route of administration for both suspect vaccines were not reported) for prophylaxis (inappropriate schedule of product administration, overdose). It was reported that each suspect vaccine was given in a different leg. No additional adverse information was reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the additional two doses "due to COVID."; This spontaneous report was received from a pharmacist and refers to a female in her 30's.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, approximately 2 years ago, the patient was vaccinated with one dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered to prevent human papillomavirus (HPV) (exact dose, lot #, expiry date and route of administration were not provided).  On an unknown date, the patient did not receive the additional two doses "due to COVID." At the time of reporting, the outcome of the event was not reported.  The causal relationship between the event and the suspect therapy was not provided.