chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: PATIENT REPORTED A SEISURE INCIDENT AFTER RECEIVING PFIZER COVID VACCINE
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Fall, Fatigue, Impaired work ability, Malaise
Clinical narrative: the evening of 11/10/20 same day as vaccine, I was at the grocery store and couldn't even lift my daughter into the cart. A nice man had to stop and help me. Throughout the day i became increasingly achy all over especially in the arms and legs and felt very tired. While in the freezer section, my legs gave out and I fell to the ground. My entire body hurt so bad I was in tears. I sat there and spoke to my husband on the phone and somehow got the strength to get the few things needed and head home. That evening my body aches continued to worsen to the point i was in constant tears over how horrible I felt.   I ended up calling out sick and having to take unplanned PTO 11/11, 11/12, and 11/13. I continued to not feel well until that following Monday 11/16. i knew you could be sore from the shot, but this was something I had never experienced before. I honestly thought I got the flu from the vaccine. I did mention it to both my PCP and my daughters pediatrician when we were dealing with her HSP and the flu shot impact came up in the discussion.  When my daughter's pediatrician told me the added 2 new flu strands and possibly modified the formula that year for 2020 it was scary.  Ever since then, I continue to have regular body aches and exhaustion. I already had some sleep disturbances, but not sure if related, but seems to have gotten worse.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Sleep disorder
Clinical narrative: the evening of 11/10/20 same day as vaccine, I was at the grocery store and couldn't even lift my daughter into the cart. A nice man had to stop and help me. Throughout the day i became increasingly achy all over especially in the arms and legs and felt very tired. While in the freezer section, my legs gave out and I fell to the ground. My entire body hurt so bad I was in tears. I sat there and spoke to my husband on the phone and somehow got the strength to get the few things needed and head home. That evening my body aches continued to worsen to the point i was in constant tears over how horrible I felt.   I ended up calling out sick and having to take unplanned PTO 11/11, 11/12, and 11/13. I continued to not feel well until that following Monday 11/16. i knew you could be sore from the shot, but this was something I had never experienced before. I honestly thought I got the flu from the vaccine. I did mention it to both my PCP and my daughters pediatrician when we were dealing with her HSP and the flu shot impact came up in the discussion.  When my daughter's pediatrician told me the added 2 new flu strands and possibly modified the formula that year for 2020 it was scary.  Ever since then, I continue to have regular body aches and exhaustion. I already had some sleep disturbances, but not sure if related, but seems to have gotten worse.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neuropathy peripheral
Clinical narrative: About 1 week after shot, Joint pain increased, and my hands became very sensitive to cold(like an amped version of Raynaud?s Syndrome).  Feeling of tiredness in the chest.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Pt attempted to receive second dose of COVID vaccine at  location.  Upon review of record after updated with  information from outside, record revealed pt already completed pfizer vaccine two dose series at another location ( Stadium) At Stadium he received: EL9269 on 2/6/2021 EM9809 on 2/27/2021  At he came for "first dose" and received ER8791 on 4/22/2021  -Pt felt that based on what he heard on the news, he needed to get a booster dose.    He denies any reaction or side effects after receiving a third dose.   Pt teaching with patient to ensure that he understood that he already completed the series and that there is NO approved or recommended booster dose at this time.  Pt repeated back verbal understanding that he is not to try and get a fourth dose unless specifically recommended in the future.  Reinforced that patients will have the expected protection after the two authorized doses, and a third dose is NOT authorized or recommended at this time.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: I was notified by the school nurse, that this patient was have an itchy throat and a swollen tongue for over 30 minutes after vaccination.  I spoke to the patient. She said that her symptoms has not change in intensity during her wait. In consultation with the nurse, I decided to give a 50 mg Diphenhydramine dose and check on her progress after a few minutes.  After 10 to 15 minutes,  the patient said her symptoms seems to be lessening. But, the symptoms were still there.  EMS was called. They evaluated the patient and decided to take her to the closest hospital.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 8 mo patient received 3 doses of Haemophilus b Vaccine before 12 mo of age; This literature marketed report as received from the authors of a published literature article, titled as stated below, and refers to an 8-month-old patient of unknown gender. The patient was 33-week premature baby. There was no information about the patient's concomitant therapies or medical history provided.  On unknown dates, the patient was vaccinated with 3 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) injection (dose, route of administration, vaccination site, lot# and expiration date were not provided) for prophylaxis. It was considered to be an off-label use.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received their first dose of VARlVAX at the age of 5 years old; This spontaneous report was received from a pharmacist and refers to a 5-year-old patient (gender not reported). Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.      On 14-APR-2021, at the age of 5 years, the patient was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (oka/merck)(VARIVAX) (route of administration, lot# and expiry date not reported) for prophylaxis (product administered to patient of inappropriate age). The reporter stated that the patient's parents did not want to vaccinate the patient at the age of 12 to 15 months when the first dose was recommended.
Sex: U
Vaccine: HPV9
Symptoms: Death
Clinical narrative: there was a child who received the second dose of GARDASIL 9 vaccine and had to be rushed to Hospital in and later died; there was a child who received the second dose of GARDASIL 9 vaccine and had to be rushed to Hospital; This spontaneous report was received from a physician and his wife via a field represent, referring to a child of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On an unknown date, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) vaccine for prophylaxis.   On an unknown date, the patient had to be rushed to hospital (ill-defined disorder) and later died. It was unknown if an autopsy was performed. Furthermore, it was unknown if the patient had sought medical attention, laboratory diagnostic studies were performed or if received any treatment. The outcome of ill-defined disorder was unknown. The causality assessment was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller stated that the VARIVAX and MMR II that underwent multiple temperature excursions had been adminitered; This spontaneous report was received from a Medical assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 06-MAY-2021, the patients were inadvertently administered with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T020652 had been verified to be a valid number; expiration date 16-JUN-2022), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHa)) (M-M-R II) (lot number S035352 had been verified to be a valid number; expiration date 05-NOV-2021); both vaccines for prophylaxis (strengths, doses, frequencies, routes of administration, and anatomical locations were not reported). It was reported multiple temperature excursions: -14.03 degrees Celsius (C) for a time frame of 1 hour, 15 minutes and 0 seconds, -14.9  degrees C for a time frame of 0 hours, 9 minutes and 0 seconds, -10.3 degrees C for a time frame of 1 hour, 0 minutes and 0 seconds; and -6.3 degrees C for a time frame of 2 hours, 0 minutes and 0 seconds. It was reported that had previous temperature excursions were -14.03 degree C for a time frame of 1 hour, 15 minutes and 0 seconds and -14.9 degrees C for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that the call was due to data logger. No additional adverse events.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event reported; Temperature excursion on PROQUAD that was administered on 04/23/2021 to two patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 23-APR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) first time dose (route of administration was not reported), lot # T037957 rHA and expiration date 09-MAY-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 7.5 fahrenheit (°F) for 30 minutes on 22-APR-2021 and 6.0°F for 15 minutes on 23-APR-2021, for a total time out of range of 45 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of two reports from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: No addtional AE; finger flange broke off and the patient was unable to receive the full dose of GARDASIL 9.; finger flange broke off and the patient was unable to receive the full dose of GARDASIL 9.; This spontaneous report was received from a nurse who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date, the patient was vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location and strength were not provided; lot number T025370 for prophylaxis was confirmed to be valid, expiration 01-DEC-2022) for prophylaxis.  During the vaccination the finger flange has broke off and the patient was unable to receive the full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (syringe broken, incomplete dose administered). The patient has received about three quarter of the vaccine. There were no additional adverse events reported. The nurse kept syringe aside and would send its picture. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: had a reaction to Pnaumovax/ AE realized after the call.; This spontaneous report was received from a consumer via other company and refers to an 88-year-old female patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date in 2019, reported as about 2 years ago, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. Also on an unknown date in 2019, the patient experienced unspecified reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and want to know if the PFIZER BIONTECH COVID-19 vaccine has any active or inactive ingredients that are present in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of this reaction was not reported.  The reporter did not provide a causal assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and adverse event.
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: getting hives/rash one day after receiving the vaccine; getting hives/rash one day after receiving the vaccine; This spontaneous report was received from a pharmacist and refers to a currently 70-year-old male patient. His concurrent conditions included an allergies to penicillin and amoxicillin. His concomitant therapies included unspecified medications, mostly antipsychotic medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) reconstituted in sterile diluent (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for shingles prevention. On an unknown date (also reported as one day after receiving the vaccine), the patient experienced hives/rash. The outcome of the events was not reported.  The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; The vaccine that underwent a temperature excursion (2C to 8C (12.6C) for 480 hours) and was administered.; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was not reported.  On 05-MAY-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687290 was confirmed to be valid, expiration date 06-SEP-2022 (dose, route and site of administration were not reported) for prophylaxis. The temperature excursion was reported as "2 degrees Celsius (C) to 8 C (12.6 C) for 480 hours. There was no previous temperature excursion. No additional adverse event was reported. The call was because of a digital data logger.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck  devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion that occurred on MMR II; This spontaneous report was received from a medical assistant and refers to a 13-months-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAY-2021, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S035352, expiration date: 05-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On an unknown dates, the dose of the vaccine was exposed to temperature excursion at -14.03 Celsius degrees (C) for 1 hour 15 minutes, at -14.9 C for 9 minutes, at -10.3C for 1 hour and at -6.3C for 2 hours. There were previous temperature excursions at -14.03 for 1 hour 15 minutes and -14,9 C for 9 minutes. The call was due to digital data logger. No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's; underwent multiple temperature excursions; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 12-MAY-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), (lot # T020652 was verified to be valid, expiration date was not reported, however upon internal validation established to be 16-JUN-2022), and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S035352 was verified to be valid, expiration date was not reported, however upon internal validation established to be 05-NOV-2021), both for prophylaxis, (dose, route of administration and vaccination site were not provided for both).  The administered doses of vaccines experienced a temperature excursion of -14.03 Celsius degrees for 1 hour 15 minutes, -14.09 Celsius degrees for 9 minutes and -6.3 Celsius degrees for 2 hours. Data Logger was involved. The patient did not experience any additional adverse reactions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA003718: US-009507513-2105USA003706: US-009507513-2105USA003698: US-009507513-2105USA003695: US-009507513-2105USA003680: US-009507513-2105USA003672: US-009507513-2105USA003596: US-009507513-2105USA003554: US-009507513-2105USA003472:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's; The vaccine that underwent a temperature excursion (2C to 8C (12.6C) for 480 hours) and was administered.; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was not reported.  On 06-MAY-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687290 was confirmed to be valid, expiration date 06-SEP-2022 (dose, route and site of administration were not reported) for prophylaxis. The temperature excursion was reported as "2 degrees Celsius (C) to 8 C (12.6 C) for 480 hours. There was no previous temperature excursion. No additional adverse event was reported. The call was because of a digital data logger.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA003665:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; The vaccine that underwent a temperature excursion (2C to 8C (12.6C) for 480 hours) and was administered.; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was not reported.  On 07-MAY-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687290 was confirmed to be valid, expiration date 06-SEP-2022 (dose, route and site of administration were not reported) for prophylaxis. The temperature excursion was reported as "2 degrees Celsius (C) to 8 C (12.6 C) for 480 hours. There was no previous temperature excursion. No additional adverse event was reported. The call was because of a digital data logger.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA003665: US-009507513-2105USA003677:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAY-2021, the patient was vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T020652, expiration date: 16-JUN-2022 (formulation, strength, dose, frequency, route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S035352, expiration date: 05-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported), both for prophylaxis. On an unknown dates, the doses of the vaccines were exposed to temperature excursion at -14.03 Celsius degrees (C) for 1 hour 15 minutes, at -14.9 C for 9 minutes, at -10.3C for 1 hour and at -6.3C for 2 hours. There were previous temperature excursions at -14.03 for 1 hour 15 minutes and -14,9 C for 9 minutes.. The call was due to digital data logger. No additional adverse event was reported.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: no additional AE; concomitant administration of PROQUAD and VARIVAX to a patient. Caller states patient was meant to receive MMRII and VARIVAX; This spontaneous report was received from a licensed practical nurse and refers to a 15-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 14-MAY-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # S033952, expiration date 24-OCT-2021 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # T013539, expiration date 17-OCT-2021 (dose number, vaccination site and route of administration were not provided for both) for prophylaxis, although the patient was meant to receive varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 17-months-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAY-2021, the patient was vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T020652, expiration date: 16-JUN-2022 (formulation, strength, dose, frequency, route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S035352, expiration date: 05-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported), both for prophylaxis. On an unknown dates, the doses of the vaccines were exposed to temperature excursion at -14.03 Celsius degrees (C) for 1 hour 15 minutes, at -14.9 C for 9 minutes, at -10.3C for 1 hour and at -6.3C for 2 hours. There were previous temperature excursions at -14.03 for 1 hour 15 minutes and -14,9 C for 9 minutes.. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; An expired dose of PROQUAD was administered today; This spontaneous report was received from a physician concerning to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 17-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 1 injection (dosage regimen, route and anatomic site of administration were not provided) as prophylaxis. Lot # S027459 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 21-MAR-2021, but upon internal validation established as 02-MAR-2021.  It was also confirmed that there was no temperature excursion with the administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No further information was provided, no other adverse event (AE) was reported.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Rash erythematous
Clinical narrative: red, flushing rash on neck, arms and chest; This spontaneous report was received from a registered nurse referring to a 28 year old female patient.  The patient had no pertinent medical history or drug reactions/allergies.  Concomitant therapies included birth control pills.  On 09-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1687291, expiring on 11-SEP-2022, dose 1, intramuscularly, for HPV prophylaxis.    On the same day, several hours after vaccine, the patient developed a red, flushing rash on neck, arms, and chest (rash erythematous).  The patient did not seek medical attention.  No treatment was given for the event.  There were no laboratory tests performed.   The patient recovered from rash erythematous on 10-MAR-2021.   The reporter did not assess the causal relationship between therapy with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral infarction, Cerebral ischaemia, Cerebrovascular accident, Computerised tomogram, Laboratory test
Clinical narrative: Major Stroke as described below:    There is a large left MCA infarct with a hyperdense left MCA vessels sign consistent with a area of acute ischemia. There is medial uncal herniation compressing the left cerebral peduncle. There is compression of the left temporal horn. There is compression of the left lateral ventricle with left to right shift measuring approximately 9 mm. The basilar cisterns are patent. No intracranial hemorrhage.   Bone windows demonstrates no bony lytic or destructive changes   The orbital globes and retrobulbar structures appear grossly unremarkable. The visualized paranasal sinuses and mastoid air cells are well aerated. The bony calvarium is intact.   IMPRESSION: There is a large left MCA vascular territory acute ischemic change with uncal herniation and mild left to right transpleural seen shift described above without hemorrhage. Dense left MCA vessels sign. Results were discussed with doctor in the the ER at 10:45 PM
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Severe Pain and pressure in my head as I worry if I got a blood clot. A big and painful pimple under the arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Dizziness, Facial paralysis, Headache
Clinical narrative: I started having a headache the same day non stop, nausea and light dizziness, sensitivity to bright lights and a week after the vaccine I lost my sense of taste on my right side of my mouth. April 25th I woke up to my right side of my face paralyzed and rushed to the ER. I was diagnosed with Bell's Palsy
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Nausea, Photophobia
Clinical narrative: I started having a headache the same day non stop, nausea and light dizziness, sensitivity to bright lights and a week after the vaccine I lost my sense of taste on my right side of my mouth. April 25th I woke up to my right side of my face paralyzed and rushed to the ER. I was diagnosed with Bell's Palsy
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Adverse drug reaction, Blood pressure increased, Blood test, Computerised tomogram abdomen abnormal
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Dyspnoea, Gingival bleeding, Hypoaesthesia, Immune thrombocytopenia
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Mouth haemorrhage, Nephrolithiasis, Platelet count decreased, Sedative therapy
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cheilitis, Contusion, Gingival disorder, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Lip haemorrhage, Mouth haemorrhage, Oral disorder
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Purpura, Skin disorder
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, White blood cell count normal
Clinical narrative: Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted post vaccination, in the recovery area. Vaccination given at 3:03 pm. BP was 93/62. Patient has breakfast. but not lunch. After fainting, Pt got up immediately, and sat back on his chair. After about 30 minutes, Pt left for home.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Visual Snow - April 14 Floaters - April 17 Slightly numb hands/feet - Mid April Moving hands motion blur - Mid April  Still ongoing
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: A few days after receiving the first dose my knees started hurting as soon as I bent them. The symptoms have increased since then at first I thought it would go away and thought that maybe I just somehow hurt myself. However,  after I received the second dose the pain  has intensified I now can't sleep from the joint pain on my knees and it feels like there is something pressing on the back of my knees and the stiffness is terrible. I do not have great health insurance, thus I have been putting off seeing a doctor. Yet,  after last nights pain I have made an appointment and hope see one in July since there are no appointments available sooner.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Muscle twitching, Myalgia
Clinical narrative: Muscle aching and sometimes twitching. Dizziness of the head and stomach. Extreme nausea of head and stomach. Vomiting. Suppressed appetite. Great pain in head and stomach. Extreme fatigue and weakness. Symptoms peaked 24-36 hours after injection and were mostly gone after 3 days. Fatigue and weakness took a week to fully disappear.  Seemingly no lasting symptoms.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lip ulceration, Mouth ulceration, Pharyngeal ulceration, Tonsillar ulcer
Clinical narrative: Severe, numerous ulcers on tonsils, throat, roof of mouth and inner lips.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain, Pruritus, Rash erythematous, Subchorionic haematoma
Clinical narrative: A week after getting my first dose of the moderna Covid vaccine, I developed a sore arm near the injection site as well as a red rash (2 inch diameter). There is some minor itching. I was 11 weeks pregnant at the time of the vaccination and gave experienced a healthy pregnancy so far. At 10 weeks my obgyn did see a pretty small subchorionic hematoma and has had me on pelvic rest as it heals. My due date is Nov. 30th 2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: I have experienced a complete loss of appetite, with no fatigue or nausea. This has been ongoing for three days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Burning sensation, Computerised tomogram normal, Dizziness, Headache
Clinical narrative: Monday-Feeling like ants crawling under my skin.  Headache, present even with Tylenol Tuesday- Ant feeling subsided, headache and neckache.  Lightheadedness and loss of balance.  Went to ER Thursday 5/20- Lightheaded and loss of balance  Since 5/4, lightheadedness comes and goes.  Light and sound affect the ability to focus.  I have never felt like this before.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Photophobia, Vision blurred
Clinical narrative: Monday-Feeling like ants crawling under my skin.  Headache, present even with Tylenol Tuesday- Ant feeling subsided, headache and neckache.  Lightheadedness and loss of balance.  Went to ER Thursday 5/20- Lightheaded and loss of balance  Since 5/4, lightheadedness comes and goes.  Light and sound affect the ability to focus.  I have never felt like this before.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: HARD RED LUMP AT INJECTION SITE, RED AND PAINFUL
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Continuous sore upper arm, site of injection since vaccination.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED AFTER VACCINATION. PATIENT REGAINED CONSCIOUSNESS WITHIN 30 TO 60 SECONDS.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Lip swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Swelling of the lips, tongue, throat and feeling of heaviness in the lungs. No loss of ability to breathe. No urgent care or Epipen was used.  No long term effects.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Moderna COVID-19 Vaccine EUA, numbness in the arm and hand of the vaccination site, touch sensitivity around upper arm/area of vaccination site. Both lasted into the next 2 days (05/17-05/18) until fading throughout the day of 05/18.