chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Friend got a shingles vx, got shingles the next month/Suspected vaccination failure; Got terrible shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's comment: This case was reported by a patient's friend via interactive digital media. The patient got a Shingles vaccine and then got terrible shingles the next month Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccination and still got Shingles/Suspected vaccination failure; Got Shingles,Still bothered 6 years later; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received the dose of Shingles vaccine and still got shingles and reported that he/she still bothered 6 years later. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Pain, Vaccination failure
Clinical narrative: got shingles months after her vaccine, death/Suspected vaccination failure; Shingles led to her death, demise; Horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), shingles (serious criteria death) and pain. On an unknown date, the outcome of the vaccination failure and shingles were fatal and the outcome of the pain was unknown. The reported cause of death was shingles and vaccination failure.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter reported that the patient got shingles a couple months after her Shingles vaccine which led to her death a few months later. She had horrible pain. The reporter stated that he/she was done with these so-called vaccines that did not prevent disease but the CDC (Centers for Disease Control and Prevention) wants them to believe that there some unmeasurable best protection as his/her mother also received Shingles vaccine a few months before she was demise due to shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Shingles; Vaccination failure
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Laboratory test abnormal, Myalgia
Clinical narrative: Polymyalgia/ran tests that pointed to polymyalgia; Achiness around injection site; Shoulder pain; pain in arm/pain  then moved to my right arm; This case was reported by a consumer and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high (was on Spironolactone for high blood pressure), female pattern hair thinning (was on Minoxidil 0.5 tablet for female pattern hair thinning) and polymyalgia rheumatica (was on Prednisone for polymyalgia rheumatica). Concomitant products included spironolactone and minoxidil.   On 9th December 2022, the patient received the 1st dose of Shingles vaccine (intramuscular). On 18th December 2022, 9 days after receiving Shingles vaccine, the patient experienced injection site pain, shoulder pain and pain in arm. On an unknown date, the patient experienced polymyalgia. The patient was treated with prednisone. On an unknown date, the outcome of the injection site pain, shoulder pain, pain in arm and polymyalgia were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, pain in arm and polymyalgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's comments: The patient received a dose of Shingles vaccine in left arm and had achiness around the injection site on her left arm which the spread up into her left shoulder and then moved to her right arm and shoulder. The patient did not have to go to the hospital but saw her physician who ran tests that pointed to polymyalgia and prescribed prednisone which had worked to stop the pain. The patient was in the process of tapering off the prednisone.  The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Polymyalgia/ran tests that pointed to polymyalgia; Achiness around injection site; Shoulder pain; pain in arm/pain  then moved to my right arm; This case was reported by a consumer and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high (was on Spironolactone for high blood pressure), female pattern hair thinning (was on Minoxidil 0.5 tablet for female pattern hair thinning) and polymyalgia rheumatica (was on Prednisone for polymyalgia rheumatica). Concomitant products included spironolactone and minoxidil.   On 9th December 2022, the patient received the 1st dose of Shingles vaccine (intramuscular). On 18th December 2022, 9 days after receiving Shingles vaccine, the patient experienced injection site pain, shoulder pain and pain in arm. On an unknown date, the patient experienced polymyalgia. The patient was treated with prednisone. On an unknown date, the outcome of the injection site pain, shoulder pain, pain in arm and polymyalgia were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, pain in arm and polymyalgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's comments: The patient received a dose of Shingles vaccine in left arm and had achiness around the injection site on her left arm which the spread up into her left shoulder and then moved to her right arm and shoulder. The patient did not have to go to the hospital but saw her physician who ran tests that pointed to polymyalgia and prescribed prednisone which had worked to stop the pain. The patient was in the process of tapering off the prednisone.  The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: HCP recommends Shingrix to patients less than 50 years old who have had a case of Shingles; This case was reported by a physician via sales rep and described the occurrence of off label use in unapproved indication in an unspecified numbers of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use in unapproved indication. On an unknown date, the outcome of the off label use in unapproved indication was unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Additional Supportive Information: The health care professional (HCP) recommended Shingrix vaccination to patients who were less than 50 years old who have had a case of Shingles, which led to off label use in unapproved indication.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter had called to inquired for data related to expiration of Twinrix.  Additional Supportive Information: The patient was administered with Twinrix vaccine, which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: was painful, has horrible reactions; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Feb-2023 Reporter's Comments: The patient self-reported the case via interactive digital media. Reporter's daughter got it, but reporter had just been given the vaccine against that disease which by the way was very painful and had horrible reactions.  The patient received information about the disease and when his/her daughter started with symptoms on her lower back, he/she immediately suspected that it was shingles, indeed the doctor confirmed it and gave her a very good medicine with a lot of care. The reporter said thank god nothing else happened.  Her recovery lasted a month.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Feb-2023 Reporter's Comments: The patient received vaccine and he/she had a fever for 2 weeks, that was the reaction in his/her body. The reporter hopes everyone was fine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is swollen; arm is sore; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th February 2023, the patient received the 2nd dose of Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the 2nd shingles vaccine on Friday.  The patient's arm was swollen and sore.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Was scarcely even sore from shots; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's cousin had shingles (on face)).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The case  was received from the patient via interactive digital media. The patient had received the Shingles vaccine and was scared even sore from shots and did not changed his/her routine. The patient reporter that his/her cousin had on his/her face, so why to take a chance. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: Made arm red; arm hurt; head hurt; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema of extremities, pain in arm and headache. On an unknown date, the outcome of the erythema of extremities, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: The case  was received from the patient via interactive digital media. The reporter stated that there was an injection for this problem and they just gave it to me.  The reporter stated that strong it made his/her arm red and hurt for 4 days, more apart for 2 days head hurt but the physician told him/her that it was worth it because the pain of the injection was nothing compared to the pain of the sores that came out of the shingles so that's his/her story. The injection was called zoster.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shingles shot and soon after got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:01-MAR-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter knew people (patients) who got the shingles shot and soon after got the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: Just getting over them; Terrible pain; Felt terrible; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after starting Valacyclovir, the patient experienced shingles, pain and feels awful. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, pain and feels awful were unknown.   It was unknown if the reporter considered the shingles, pain and feels awful to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-MAR-2023 Reporter's Comment:  This case was reported by a patient via interactive digital media. The patient had the first shingle shot in 2019 and Just getting over them terrible pain. The patient started on valacyovir an antiviral on the 3rd day.  The patient I felt terrible the whole time he/she was on them, 3 pills a day for 7 days. The follow-up could not be possible as no contact details were available.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Haematoma, Immunisation reaction, Pain, Pruritus
Clinical narrative: 4 year old female presenting to the ER s/p vaccine shot reaction. Patient received her vaccine injection on her left thigh and started noticing a hematoma developing. Patient does have a fever and has been give OTC medication. Patient also has had intermittent diarrhea, no episodes of vomiting.  Hematoma is described as itchy and moderate in pain. No fever.  No vomiting. All other systems reviewed and negative except as otherwise indicated above.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: 4 year old female presenting to the ER s/p vaccine shot reaction. Patient received her vaccine injection on her left thigh and started noticing a hematoma developing. Patient does have a fever and has been give OTC medication. Patient also has had intermittent diarrhea, no episodes of vomiting.  Hematoma is described as itchy and moderate in pain. No fever.  No vomiting. All other systems reviewed and negative except as otherwise indicated above.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Blood test, Cardiac monitoring, Electrocardiogram, Syncope
Clinical narrative: I had syncopal episodes and was very weak, administered IV fluids received 3 hours of heart monitoring, blood pressure and blood sugar. Went to cardiologist 12 lead EKG, 2 week heart monitor Zio-patch. Decreases blood pressure medication, blood work drawn, one week later had blood work repeated.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Therapy change
Clinical narrative: I had syncopal episodes and was very weak, administered IV fluids received 3 hours of heart monitoring, blood pressure and blood sugar. Went to cardiologist 12 lead EKG, 2 week heart monitor Zio-patch. Decreases blood pressure medication, blood work drawn, one week later had blood work repeated.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt says he received the shingrix shot on 2/20/2023. On 3/3/2023 he reported that he was still experiencing a minor rash. He says there were no lifestyle changes or any new meds taken since the shot. He tried Benadryl once and it seemed to get better, said he would try another dose to see if it would help. Advised pt to contact MD to see if they recommend him getting the second dose of shingrix.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Sterile Diluent was expired at the time of administration. Lot# T018894, Exp# 03/02/2023 Merck Vaccines was contacted. Revaccination not recommended.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Fatigue, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: After receiving my 4th dose I contracted COVID-19 infection. My COVID-19 infection symptoms started on 02/21/2023 in the evening with sore throat, fatigue, low of energy and nasal drip. I had a bad head and chest congestion. I took over the counter medication such as SUDAFED and multi symptom cold medication. I tested with a COVID-19 home test on  02/26/2023 which was positive. I also called nurse's hotline the same day. They advised me to take cough drop, use humidifier and drink plenty of liquids. I drank hot tea with honey. I tested negative for COVID-19 infection on 03/03/2023.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: After receiving my 4th dose I contracted COVID-19 infection. My COVID-19 infection symptoms started on 02/21/2023 in the evening with sore throat, fatigue, low of energy and nasal drip. I had a bad head and chest congestion. I took over the counter medication such as SUDAFED and multi symptom cold medication. I tested with a COVID-19 home test on  02/26/2023 which was positive. I also called nurse's hotline the same day. They advised me to take cough drop, use humidifier and drink plenty of liquids. I drank hot tea with honey. I tested negative for COVID-19 infection on 03/03/2023.
Age: 54.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: left arm red swelling with warmth, no itchness, no pain. Patient noticed the sx this morning (03/08/23)
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Sterile Diluent Lot# T018894, Exp# 03/02/2023 Merck Vaccines was notified. No recommendation for revaccination.
Age: 27.0
Sex: F
Vaccine: PNC20
Symptoms: Blood glucose normal, Blood pressure decreased, Cold sweat, Dizziness, Malaise
Clinical narrative: Patient went to lab to have her labs drawn. The lab called at 3:36pm and reported patient was not feeling well. This nurse and MA went to the lab and patient was sitting in the atrium with her mother. Patient reported she was feeling light headed and nauseous. Reported she had vaccines in FM and that the Pneumo vaccine made her have the same reaction last time (patient had PCV23 in past).   Patient was pale and clammy. BP was faint at 90/70, HR 75 SPO2 99%RA. Denied any vision changes. Patient reported she took her blood sugar and was 101. Patient was advised to sit with me and was given water. At about 3:44 patient reported she was feeling a bit better. Patient appeared to have more color in her face.   Patient was given more water and advised that labs did not need to be drawn today. Lab Supervisor came out to check on patient. Patient was given a cool wash cloth to put on neck and forehead. At about 3:55p patient said she was feeling better and was able to stand without issue. Reported that she wanted to do her UA, but would come back for labs. BP was taken again and was 110/82. I walked with patient back to the lab and advised staff what had happened. Reported that patient did not fall (I was unsure). Patient was able to complete UA. Lab techs advised that they could call me back if patient had any further issue.
Age: 27.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Pallor, Urine analysis
Clinical narrative: Patient went to lab to have her labs drawn. The lab called at 3:36pm and reported patient was not feeling well. This nurse and MA went to the lab and patient was sitting in the atrium with her mother. Patient reported she was feeling light headed and nauseous. Reported she had vaccines in FM and that the Pneumo vaccine made her have the same reaction last time (patient had PCV23 in past).   Patient was pale and clammy. BP was faint at 90/70, HR 75 SPO2 99%RA. Denied any vision changes. Patient reported she took her blood sugar and was 101. Patient was advised to sit with me and was given water. At about 3:44 patient reported she was feeling a bit better. Patient appeared to have more color in her face.   Patient was given more water and advised that labs did not need to be drawn today. Lab Supervisor came out to check on patient. Patient was given a cool wash cloth to put on neck and forehead. At about 3:55p patient said she was feeling better and was able to stand without issue. Reported that she wanted to do her UA, but would come back for labs. BP was taken again and was 110/82. I walked with patient back to the lab and advised staff what had happened. Reported that patient did not fall (I was unsure). Patient was able to complete UA. Lab techs advised that they could call me back if patient had any further issue.
Age: 60.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Incorrect product formulation administered
Clinical narrative: The Pfizer Monovalent was given in place of the Bivalent.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient 4 y/o. Checked in around 4:00 pm to get Moderna 6m - 5y bivalent booster. LVN, called patient in her station and prepared vaccine appropriately. The nurse asked all proper questions before administering. Patient sat in mothers lap and was calm. As soon as vaccinator initiated vaccine, the patient jerked and grabbed the vaccine out of nurses hand to take out the left arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: itching  and redness
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test abnormal, Musculoskeletal stiffness, Rheumatoid arthritis, Tendon pain
Clinical narrative: First shot was March 2021.  2nd shot was April 2021.  In July 2021 and continuing, started having severe rotator cuff pain.  Steroid injections and physical therapy did not help.  Next was stiffness in alternating hands.  3rd shot was November 2021In May 2022, I was finally diagnosed with RA.  Had final shot in September 2022.  Never had any RA symptoms/problems, prior to getting the covid vaccination.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow abnormal, Haematocrit decreased, Lymphoplasmacytoid lymphoma/immunocytoma, Normocytic anaemia
Clinical narrative: 3 month after receiving first covid vaccine, patient developed new chronic normocytic anemia, and was monitored over the next year and ultimately found to have lymphoplasmacytic lymphoma
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: No reaction to the vaccine. I got COVID several months later, with basically minor symptoms (low grade fever, tiredness for a couple days, sore throat).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Angiogram, Blood test, CSF protein increased, Computerised tomogram
Clinical narrative: Weakness and numbness in legs, loss of use of legs , transverse myelitis ,loss of bowel control, urinary incontinence , numerous pulmonary embolisms, dvt?s,  numbness in hands and arms, spinal cord inflammation,  Vision issues  Ivig no help. Steroids - temporary relief but no help. ,
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Electromyogram, Hypoaesthesia, Immunoglobulin therapy, Laboratory test
Clinical narrative: Weakness and numbness in legs, loss of use of legs , transverse myelitis ,loss of bowel control, urinary incontinence , numerous pulmonary embolisms, dvt?s,  numbness in hands and arms, spinal cord inflammation,  Vision issues  Ivig no help. Steroids - temporary relief but no help. ,
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Weakness and numbness in legs, loss of use of legs , transverse myelitis ,loss of bowel control, urinary incontinence , numerous pulmonary embolisms, dvt?s,  numbness in hands and arms, spinal cord inflammation,  Vision issues  Ivig no help. Steroids - temporary relief but no help. ,
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse, Positron emission tomogram, Pulmonary embolism, Urinary incontinence, Visual impairment
Clinical narrative: Weakness and numbness in legs, loss of use of legs , transverse myelitis ,loss of bowel control, urinary incontinence , numerous pulmonary embolisms, dvt?s,  numbness in hands and arms, spinal cord inflammation,  Vision issues  Ivig no help. Steroids - temporary relief but no help. ,
Age: 53.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pain, Periarthritis, X-ray abnormal
Clinical narrative: I noticed pain in the upper arm for weeks after the vaccinations, particularly when lifting the arm horizontally or above my head. On May 27, 2022, I contacted Dr. He thought that "the pain is related to the immune system's response to the vaccinations." and recommended "over the counter Voltaren Gel (anti-inflammatory)". I used this but did not notice an improvement. While my arm was pain free at rest, certain extreme motions continued to be painful, e.g., holding my arm horizontally or moving it behind my back. On Dec 15, 2022, I visited an orthopedic specialist and was diagnosed with adhesive capsulitis (frozen shoulder). On Jan 9, 2023, I began physical therapy to restore the range of motion of my left shoulder.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bone pain, Brain fog, Fatigue, Mobility decreased, Pyrexia
Clinical narrative: 2/16/203 Vaccine given: 2/17/2023 The patient says she had a fever, Bones hurt, unable to get out of Bed. Symptoms continued. 2/19/2023 fatigue, Brain fog (hard to describe) until 3/4/2023. 3/7/2023 - stiff fatigue but starting to ease up with symptoms.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Fever, Breathing spells, tylenol 4-6 Hrs to treat fever. Administered shots on Monday (3.6.23), dad noticed today (3/8/23) 10cm 5x5
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness in her left injection site arm; Little fatigue/felt tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness in her left injection site arm) and FATIGUE (Little fatigue/felt tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 031M20A, 052E11A and 046L21A) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Soreness in her left injection site arm) and FATIGUE (Little fatigue/felt tired). At the time of the report, VACCINATION SITE PAIN (Soreness in her left injection site arm) outcome was unknown and FATIGUE (Little fatigue/felt tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided.   This case was linked to MOD-2023-713925.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrophy, Brachial plexopathy, Cervical spinal stenosis, Electromyogram abnormal, Grip strength decreased
Clinical narrative: On 10/24/21, patient received booster injection into L arm of Moderna's SARS Co-V 2 immunizatio; on 10/30/21, severe pain developed over R scapula radiating down tricep, along elbow, posterior side of forearm to dorsal slide of hand; October 31-Nov 3, 2021:loss of all grip strength in R pain; continued pain; November 1 woke up with R fingers swollen 200% and contracted; November 2 slight improvement in pain, dorsal slide of R hand 5 degrees colder than L hand as (pt) measured by IR thermometer; November 4: fingers still contracted, very limited grip strength returning; November 15, still unable to straighten fingers, swelling somewhat improved; no grip strength; Dec 20 Persistent pain & slight improvement
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Intervertebral disc degeneration, Intervertebral disc protrusion, Intervertebral disc space narrowing, Magnetic resonance imaging spinal abnormal, Mobility decreased
Clinical narrative: On 10/24/21, patient received booster injection into L arm of Moderna's SARS Co-V 2 immunizatio; on 10/30/21, severe pain developed over R scapula radiating down tricep, along elbow, posterior side of forearm to dorsal slide of hand; October 31-Nov 3, 2021:loss of all grip strength in R pain; continued pain; November 1 woke up with R fingers swollen 200% and contracted; November 2 slight improvement in pain, dorsal slide of R hand 5 degrees colder than L hand as (pt) measured by IR thermometer; November 4: fingers still contracted, very limited grip strength returning; November 15, still unable to straighten fingers, swelling somewhat improved; no grip strength; Dec 20 Persistent pain & slight improvement
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Mononeuropathy, Muscular weakness, Musculoskeletal pain, Neuralgic amyotrophy, Pain
Clinical narrative: On 10/24/21, patient received booster injection into L arm of Moderna's SARS Co-V 2 immunizatio; on 10/30/21, severe pain developed over R scapula radiating down tricep, along elbow, posterior side of forearm to dorsal slide of hand; October 31-Nov 3, 2021:loss of all grip strength in R pain; continued pain; November 1 woke up with R fingers swollen 200% and contracted; November 2 slight improvement in pain, dorsal slide of R hand 5 degrees colder than L hand as (pt) measured by IR thermometer; November 4: fingers still contracted, very limited grip strength returning; November 15, still unable to straighten fingers, swelling somewhat improved; no grip strength; Dec 20 Persistent pain & slight improvement
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Peripheral swelling, Spinal deformity, Spinal flattening
Clinical narrative: On 10/24/21, patient received booster injection into L arm of Moderna's SARS Co-V 2 immunizatio; on 10/30/21, severe pain developed over R scapula radiating down tricep, along elbow, posterior side of forearm to dorsal slide of hand; October 31-Nov 3, 2021:loss of all grip strength in R pain; continued pain; November 1 woke up with R fingers swollen 200% and contracted; November 2 slight improvement in pain, dorsal slide of R hand 5 degrees colder than L hand as (pt) measured by IR thermometer; November 4: fingers still contracted, very limited grip strength returning; November 15, still unable to straighten fingers, swelling somewhat improved; no grip strength; Dec 20 Persistent pain & slight improvement
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray limb normal
Clinical narrative: On 10/24/21, patient received booster injection into L arm of Moderna's SARS Co-V 2 immunizatio; on 10/30/21, severe pain developed over R scapula radiating down tricep, along elbow, posterior side of forearm to dorsal slide of hand; October 31-Nov 3, 2021:loss of all grip strength in R pain; continued pain; November 1 woke up with R fingers swollen 200% and contracted; November 2 slight improvement in pain, dorsal slide of R hand 5 degrees colder than L hand as (pt) measured by IR thermometer; November 4: fingers still contracted, very limited grip strength returning; November 15, still unable to straighten fingers, swelling somewhat improved; no grip strength; Dec 20 Persistent pain & slight improvement
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Cardiac disorder, Chest discomfort, Dizziness, Imaging procedure
Clinical narrative: The day after did not feel well, chest discomfort, dizzy, light headed etc. Ended up in ER a month later with cardiac issues, initially misdiagnosed by one medical facility. I was in and out of their ERs 7 times between July and December. Was told at ER during multiple visits my cardiac issues were either Covid or the Vaccine. In December after that medical facility failed to properly diagnose my cardiac issues I sought second opinion at another medical facility. Yesterday, my primary at the second facility confirmed with me that my cardiac issues were most likely vaccine or Covid related but suspect the vaccine more than Covid. There is now substantial medical evidence of these mRNA vaccines giving healthy athletic men like myself myocarditis and reoccurring paricarditis which is what I have been diagnosed with now.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Laboratory test, Malaise, Myocarditis, Pericarditis
Clinical narrative: The day after did not feel well, chest discomfort, dizzy, light headed etc. Ended up in ER a month later with cardiac issues, initially misdiagnosed by one medical facility. I was in and out of their ERs 7 times between July and December. Was told at ER during multiple visits my cardiac issues were either Covid or the Vaccine. In December after that medical facility failed to properly diagnose my cardiac issues I sought second opinion at another medical facility. Yesterday, my primary at the second facility confirmed with me that my cardiac issues were most likely vaccine or Covid related but suspect the vaccine more than Covid. There is now substantial medical evidence of these mRNA vaccines giving healthy athletic men like myself myocarditis and reoccurring paricarditis which is what I have been diagnosed with now.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: feeling anaphylactic/had a rash and itchiness increased and heightened sense of itch/ extreme hives; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for COVID-19 immunization. The patient's relevant medical history included: "oligodendroglioma", start date: 2020 (unspecified if ongoing), notes: healing. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization.The following information was reported: ANAPHYLACTIC REACTION (life threatening) with onset Oct2022, outcome "unknown", described as "feeling anaphylactic/had a rash and itchiness increased and heightened sense of itch/ extreme hives". The events "feeling anaphylactic/had a rash and itchiness increased and heightened sense of itch/ extreme hives" required physician office visit and emergency room visit.  Therapeutic measures were taken as a result of anaphylactic reaction. Clinical information: It was stated that the patient had heightened sense of itching had a horrific reaction to the Pfizer Booster in Oct2022 for the Pfizer bivalent vaccine. It was elaborated that she had a rash, heightened sense of itch, and extreme hives over the last three days and it was delayed onset.  The patient had two emergency room visits, three dermatology urgent care and primary care and allergy appointments so it was kind of severe. It was also stated that there were emergency room trips because she was feeling anaphylactic and was getting worse from when she initially saw her primary care doctor. She went again to the emergency room for the second time because she needed an epinephrine shot at that time.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300092498 Same patient/drug, different dose and different event;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: feeling anaphylactic/had a rash and itchiness increased and heightened sense of itch/ extreme hives; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for COVID-19 immunization. The patient's relevant medical history included: "oligodendroglioma", start date: 2020 (unspecified if ongoing), notes: healing. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization.The following information was reported: ANAPHYLACTIC REACTION (life threatening) with onset Oct2022, outcome "unknown", described as "feeling anaphylactic/had a rash and itchiness increased and heightened sense of itch/ extreme hives". The events "feeling anaphylactic/had a rash and itchiness increased and heightened sense of itch/ extreme hives" required physician office visit and emergency room visit.  Therapeutic measures were taken as a result of anaphylactic reaction. Clinical information: It was stated that the patient had heightened sense of itching had a horrific reaction to the Pfizer Booster in Oct2022 for the Pfizer bivalent vaccine. It was elaborated that she had a rash, heightened sense of itch, and extreme hives over the last three days and it was delayed onset.  The patient had two emergency room visits, three dermatology urgent care and primary care and allergy appointments so it was kind of severe. It was also stated that there were emergency room trips because she was feeling anaphylactic and was getting worse from when she initially saw her primary care doctor. She went again to the emergency room for the second time because she needed an epinephrine shot at that time.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300092498 Same patient/drug, different dose and different event;
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: The person administrating the shot, that it hurt and did not feel like any of the others I had taken; They had given me an expired dosage of COVID -19 vaccination; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The person administrating the shot, that it hurt and did not feel like any of the others I had taken) and EXPIRED PRODUCT ADMINISTERED (They had given me an expired dosage of COVID -19 vaccination) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Dec-2022, the patient experienced VACCINATION SITE PAIN (The person administrating the shot, that it hurt and did not feel like any of the others I had taken) and EXPIRED PRODUCT ADMINISTERED (They had given me an expired dosage of COVID -19 vaccination). At the time of the report, VACCINATION SITE PAIN (The person administrating the shot, that it hurt and did not feel like any of the others I had taken) and EXPIRED PRODUCT ADMINISTERED (They had given me an expired dosage of COVID -19 vaccination) outcome was unknown.            No concomitant medications were reported. Patient received booster dosage. Patient was wondered  each day that what effect this expired vaccine would have on patient body.  No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Heart rate increased, Insomnia, Myalgia
Clinical narrative: Patient received Shingrix vaccination @ 5 pm on 1/30/23.  At 9 pm, patient experienced pounding in bed, and increased heartrate, muscle pain, and insomnia.  Pt reported adverse effects to manufacturer on 1/31/23.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: chickenpox like bumps on both legs and feet; Itchy bumps on both legs and feet; Sharp, shooting pain on head; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2023, the patient received the 1st dose of Shingrix (intramuscular). In February 2023, less than 2 weeks after receiving Shingrix, the patient experienced varicella-like rash, itchy rash and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the varicella-like rash and headache were unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash, itchy rash and headache to be related to Shingrix.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The patient received a dose of Shingrix in left arm and days after receiving vaccine, she experienced itchy bumps, chicken pox like bumps on both legs and feet and sharp, shooting pain on left side of head for which she was taking Tylenol. Medical information (MI) phone number and website package insert were provided. The reporter did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Rash pruritic, Rash vesicular
Clinical narrative: chickenpox like bumps on both legs and feet; Itchy bumps on both legs and feet; Sharp, shooting pain on head; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2023, the patient received the 1st dose of Shingrix (intramuscular). In February 2023, less than 2 weeks after receiving Shingrix, the patient experienced varicella-like rash, itchy rash and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the varicella-like rash and headache were unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash, itchy rash and headache to be related to Shingrix.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The patient received a dose of Shingrix in left arm and days after receiving vaccine, she experienced itchy bumps, chicken pox like bumps on both legs and feet and sharp, shooting pain on left side of head for which she was taking Tylenol. Medical information (MI) phone number and website package insert were provided. The reporter did not consent to follow-up.