chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test abnormal, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: Important note: I filled out the VAERS form about an adverse reaction, ref # 2587887. They called and asked me to make a separate submission for this adverse reaction. This was patient's first adverse reaction as far as we know, and it was after the booster. He called on Feb. 5, 2022 and said he had a lot of chest pain and was resting. He'd tried to play sports that morning but was unable because he couldn't breathe well. He was still feeling lousy the next day and unable to attend service because of the pain. Honestly, it wasn't until I was praying that night that got through to me and told patient needed to get to the ER because he had pulmonary embolisms. I called patient and he went to the hospital where they did a CT scan and blood work and determined that yes, his lungs were full of clots. They gave him a prescription for eliquis and it took about a week for patient's pain to subside enough for normal activity. He remained on that rx for 6 months. You can read more about the further adverse reaction in the above case number. As far as we know, patient has still never had COVID-19, just four doses of vaccine. He went to Medical Center on the night of Feb 6, 2022, and it took until the morning of Feb 7, 2022 for the tests to be finalized and he was sent home. We then made an appt with his regular doctor to follow up.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Loss of personal independence in daily activities, Malaise, Pain, Pulmonary embolism
Clinical narrative: Important note: I filled out the VAERS form about an adverse reaction, ref # 2587887. They called and asked me to make a separate submission for this adverse reaction. This was patient's first adverse reaction as far as we know, and it was after the booster. He called on Feb. 5, 2022 and said he had a lot of chest pain and was resting. He'd tried to play sports that morning but was unable because he couldn't breathe well. He was still feeling lousy the next day and unable to attend service because of the pain. Honestly, it wasn't until I was praying that night that got through to me and told patient needed to get to the ER because he had pulmonary embolisms. I called patient and he went to the hospital where they did a CT scan and blood work and determined that yes, his lungs were full of clots. They gave him a prescription for eliquis and it took about a week for patient's pain to subside enough for normal activity. He remained on that rx for 6 months. You can read more about the further adverse reaction in the above case number. As far as we know, patient has still never had COVID-19, just four doses of vaccine. He went to Medical Center on the night of Feb 6, 2022, and it took until the morning of Feb 7, 2022 for the tests to be finalized and he was sent home. We then made an appt with his regular doctor to follow up.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Important note: I filled out the VAERS form about an adverse reaction, ref # 2587887. They called and asked me to make a separate submission for this adverse reaction. This was patient's first adverse reaction as far as we know, and it was after the booster. He called on Feb. 5, 2022 and said he had a lot of chest pain and was resting. He'd tried to play sports that morning but was unable because he couldn't breathe well. He was still feeling lousy the next day and unable to attend service because of the pain. Honestly, it wasn't until I was praying that night that got through to me and told patient needed to get to the ER because he had pulmonary embolisms. I called patient and he went to the hospital where they did a CT scan and blood work and determined that yes, his lungs were full of clots. They gave him a prescription for eliquis and it took about a week for patient's pain to subside enough for normal activity. He remained on that rx for 6 months. You can read more about the further adverse reaction in the above case number. As far as we know, patient has still never had COVID-19, just four doses of vaccine. He went to Medical Center on the night of Feb 6, 2022, and it took until the morning of Feb 7, 2022 for the tests to be finalized and he was sent home. We then made an appt with his regular doctor to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Compulsive handwashing, Fear of disease, Obsessive-compulsive symptom, Peripheral swelling
Clinical narrative: Within two weeks after vaccine, patient developed intermittent swelling of hands, as well as obsessive compulsive symptoms (frequent hand washing, fear of germs)
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscle swelling
Clinical narrative: The site of injection stayed sore and red. The muscle below began to get hot and swelled to the size of a baseball within 2 days of the injection. The area remained hot and swollen for about a week. The area was the middle of the bicep,  about 6 inches below the injection site.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Malaise, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: My symptoms started on May 09, 2022. I was coughing and had a runny nose. On Tuesday, May 10, 2022, I went to a clinic. They tested for COVID-19. The result was positive. I quarantined for five days. The symptoms stayed mild. I was still active.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Dizziness, Gastric disorder, Influenza like illness
Clinical narrative: 04/13/2023, I was feeling like I had the stomach flu. I was really dizzy, and I thought I was getting bronchitis and I went to the doctor. I was doing really well for a few years. I think my health is declining. It is reacting to the treatment that I take. I am chronic immunocompromised. I saw my doctor 4/19/2023. He just listened to my chest and said I do not have fluid in my lungs. I do not have pneumonia. He prescribed albuterol and said to call him in a few days or if I am feeling any worse.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: NONE Covid 19 vaccine EXPIRED 2/8/2023 GIVEN 3/20/2023
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, White blood cell count increased
Clinical narrative: Cellulitis, elevated WBC, no abcess
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Fatigue, Malaise
Clinical narrative: Months after receiving the last vaccine, I started feeling ill: fatigue, body aches, congestion, cough. I learned that I had been exposed to a COVID positive person, so I took a home test and it showed I was positive.  I stayed home until the 7th day after the onset of symptoms,  Then I wore a mask when out of the house for about 6 days more.  My symptoms did not disappear completely for about 2.5 weeks after the symptoms started.  I received no prescription medications.  I used over the counter decongestant, antihistamine and Tylenol to lessen the symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Months after receiving the last vaccine, I started feeling ill: fatigue, body aches, congestion, cough. I learned that I had been exposed to a COVID positive person, so I took a home test and it showed I was positive.  I stayed home until the 7th day after the onset of symptoms,  Then I wore a mask when out of the house for about 6 days more.  My symptoms did not disappear completely for about 2.5 weeks after the symptoms started.  I received no prescription medications.  I used over the counter decongestant, antihistamine and Tylenol to lessen the symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "EDS" (unspecified if ongoing); "POTS" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: strawberries" (unspecified if ongoing), notes: Known allergies: strawberries. The patient's concomitant medications were not reported. Past drug history included: Topamax, reaction(s): "Known allergies: topamax"; Edtas, reaction(s): "Known allergies: EDTAs". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 01Apr2023, she received Paxlovid for Treatment of COVID-19 and stopped on 06Apr2023. Vaccine administration time was reported as 02:30 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2 and the reported events covid-19, drug ineffective cannot be excluded.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Beta thalassemia minor" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN; PSEUDOEPHEDRINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. The other reported event (Interchange of vaccine products) is considered Related due to the nature of the event. ,Linked Report(s) : US-PFIZER INC-202300158002 same patient, different drug/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid rebound; Covid rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "atherosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) Positive, notes: Positive antigen test 15Apr2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Adverse event: Covid rebound. Positive antigen test 15Apr2023. Cough and congestion  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.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 02Apr2021 at 13:00 as dose 1, single (Lot number: 1805025), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 at 12:00 as dose 2 (booster), single (Lot number: 012F21A), in left arm and on 21May2022 at 12:00 as dose 3 (booster), single (Lot number: 049L2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction: "Known allergies: Celebrex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (09Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2023) Negative; (10Apr2023) Negative; (11Apr2023) Negative; (12Apr2023) Negative; (13Apr2023) Negative; (14Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment.  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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 09Apr2023 to 14Apr2023 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Interchange of vaccine products , Drug ineffective , Covid-19  and the use of suspect product cannot be fully excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1, dose 2, dose 4: Pfizer / Dose 3: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0158), in left arm and on 06May2021 as dose 2, single (Lot number: EW0171), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Livedo reticularis" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). Known allergies: Yes. Concomitant medication(s) included: FLONASE SENSIMIST ALLERGY RELIEF; VIT D [VITAMIN D NOS]; ZINC. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown", described as "Dose 1, dose 2, dose 4: Pfizer / Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2023) Negative; (07Apr2023) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: First Covid symptoms on 05Apr2023 and tested negative. Tested positive for Covid on 07Apr2023. Anti-viral details included COVID 19 Treatment was started Paxlovid (300mg; 100 mg Dose pack, lot number= GG1442) on 08Apr2023 and Finished last dose of Paxlovid (stop date) on 13Apr2023.
Sex: F
Vaccine: PNC20
Symptoms: Achromobacter infection, Bacterial disease carrier, Dyspnoea, Pneumonia
Clinical narrative: contracting pneumonia/the causative agent was the "Achromobacter xylosidans"; contracting pneumonia/the causative agent was the "Achromobacter xylosidans"; can't hardly breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization), ACHROMOBACTER INFECTION (hospitalization), outcome "unknown" and all described as "contracting pneumonia/the causative agent was the "Achromobacter xylosidans""; DYSPNOEA (non-serious), outcome "unknown", described as "can't hardly breathe". Events details: Caller is a patient. Caller said that she got Prevnar 13 and Prevnar 20 but still end up contracting pneumonia twice and they found a rare bacterium. Caller said that the bacteria they found was the "Achromobacter xylosidans sub specie" which was a blood resistant, and usually caused cystic fibrosis. Caller stated that she got pneumonia 1 year and 4 months ago, and was hospitalized for 9 and a half days, year later she contracted pneumonia again, they found that on her both Pneumonia the causative agent was the "Achromobacter xylosidans". Caller said that she is now considered as "colonizer", no cystic fibrosis, can't hardly breathe. Caller asked the reason why she got contracted pneumonia even though she got the Prevnar 13 and Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300160117 same patient/AE, different drug;
Sex: F
Vaccine: PNC13
Symptoms: Achromobacter infection, Bacterial disease carrier, Bacterial test positive, Dyspnoea, Pneumonia
Clinical narrative: Contracting pneumonia; bacteria they found was the ''Achromobacter xylosidans sub specie''; Can't hardly breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization), outcome "unknown", described as "Contracting pneumonia"; ACHROMOBACTER INFECTION (hospitalization), outcome "unknown", described as "bacteria they found was the ''Achromobacter xylosidans sub specie''"; DYSPNOEA (non-serious), outcome "unknown", described as "Can't hardly breathe".  Clinical course: Caller said that she got Prevnar 13 and Prevnar 20 but still end up contracting pneumonia twice and they found a rare bacterium. Caller said that the bacteria they found was the ''Achromobacter xylosidans sub specie'' which is a blood resistant, and usually cause cystic fibrosis. Caller stated that she got pneumonia 1 year and 4 months ago, and was hospitalized for 9 and a half days, year later she contracted pneumonia again, they found that on her both Pneumonia the causative agent was the ''Achromobacter xylosidans''. Caller said that she is now considered as ''colonizer'', no cystic fibrosis, can't hardly breathe. Caller asked the reason why she got contracted pneumonia even though she got the Prevnar 13 and Prevnar 20.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300159856 same patient/AE, different drug;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (201792). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "flu". The following information was reported: HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Additional information: Patient believed in the vaccine just a little worried about side effects cause she had side effects with both of vaccines she got the flu with the first and had a headache for 7 days and a fever with the second one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM5318) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown".
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight soreness at the injection site".  Additional information: Patient age was reported as 60 (unit not available). "I was reminded of the Pfizer vaccine I received last year. I experienced no side effects other than slight soreness at the injection site."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: my health issues got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "my health issues got worse".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Fatigue, General physical health deterioration, Hypersomnia, Malaise
Clinical narrative: I had my vaccination on 04/19/2022. My health had started to decline rapidly to include tremors. I started to seek medical attention in 09/2022. I had a physical and I brought my health concerns to my physician. I do speculate that I may have had COVID-19 in 2020 prior to lockdown. I became unwell and ended up sleeping for 7 weeks. I had extreme fatigue during this time and would only wake to use bathroom and eat. The doctor put an order in for a neurologist. I am working with the physician but I have run into road blocks. I have some testing scheduled. No one seems to be listening to be in regard to being it related to the vaccination. My tremors on the left side of my body with a slight shutter developing in the body. All my vaccinations have been on the left side. There are good days and really bad days in regard to my fatigue. If I physical exert myself the tremors increase in occurrence. I have been ruled out as having Parkinson's.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I had my vaccination on 04/19/2022. My health had started to decline rapidly to include tremors. I started to seek medical attention in 09/2022. I had a physical and I brought my health concerns to my physician. I do speculate that I may have had COVID-19 in 2020 prior to lockdown. I became unwell and ended up sleeping for 7 weeks. I had extreme fatigue during this time and would only wake to use bathroom and eat. The doctor put an order in for a neurologist. I am working with the physician but I have run into road blocks. I have some testing scheduled. No one seems to be listening to be in regard to being it related to the vaccination. My tremors on the left side of my body with a slight shutter developing in the body. All my vaccinations have been on the left side. There are good days and really bad days in regard to my fatigue. If I physical exert myself the tremors increase in occurrence. I have been ruled out as having Parkinson's.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiomyopathy, Electrocardiogram abnormal, Myocarditis
Clinical narrative: 4/11/2023 myocarditis, cardiomyopathy
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood potassium decreased, Blood test abnormal, Dehydration
Clinical narrative: For several days, I had upset stomach, diarrhea, nausea, and some vomiting. I couldn't eat or drink or anything, because I couldn't keep it down. On 5/27/2022, I called my PCP, and she told me that I should probably go to the ER. However, I did not go, because I hoped it would get better. It got worse over the weekend on 5/28/2022 and 5/29/2022, and I got weaker and weaker. I waited until 5/31/2022, I called my PCP again, and they insisted that I should go to the ER, so I went to the ER that morning. I underwent a COVID-19 test and bloodwork. They found that I was extremely dehydrated, so I was hooked up to intravenous fluids for about four hours. I tested negative for COVID-19. The bloodwork results also indicated a significant drop in potassium and the presence of a nonspecific virus of some type. I was then released and told to get Pedialyte and that I needed to rest and get rehydrated. I did this for about three weeks. It took about three or four weeks to regain my strength. I kept myself hydrated with Pedialyte and ate light meals. I also periodically got up and walked around to keep from getting lethargic. The nausea, diarrhea, and vomiting all ceased. I had a virtual visit with my PCP later on at about the end of June 2022, and although no specific virus had been detected in the bloodwork, my PCP suggested that my symptomology suggested norovirus. She said that it probably would have resolved itself sooner if I hadn't become dehydrated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fluid intake reduced, Hypophagia, Nausea, Norovirus infection
Clinical narrative: For several days, I had upset stomach, diarrhea, nausea, and some vomiting. I couldn't eat or drink or anything, because I couldn't keep it down. On 5/27/2022, I called my PCP, and she told me that I should probably go to the ER. However, I did not go, because I hoped it would get better. It got worse over the weekend on 5/28/2022 and 5/29/2022, and I got weaker and weaker. I waited until 5/31/2022, I called my PCP again, and they insisted that I should go to the ER, so I went to the ER that morning. I underwent a COVID-19 test and bloodwork. They found that I was extremely dehydrated, so I was hooked up to intravenous fluids for about four hours. I tested negative for COVID-19. The bloodwork results also indicated a significant drop in potassium and the presence of a nonspecific virus of some type. I was then released and told to get Pedialyte and that I needed to rest and get rehydrated. I did this for about three weeks. It took about three or four weeks to regain my strength. I kept myself hydrated with Pedialyte and ate light meals. I also periodically got up and walked around to keep from getting lethargic. The nausea, diarrhea, and vomiting all ceased. I had a virtual visit with my PCP later on at about the end of June 2022, and although no specific virus had been detected in the bloodwork, my PCP suggested that my symptomology suggested norovirus. She said that it probably would have resolved itself sooner if I hadn't become dehydrated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Viral infection, Vomiting
Clinical narrative: For several days, I had upset stomach, diarrhea, nausea, and some vomiting. I couldn't eat or drink or anything, because I couldn't keep it down. On 5/27/2022, I called my PCP, and she told me that I should probably go to the ER. However, I did not go, because I hoped it would get better. It got worse over the weekend on 5/28/2022 and 5/29/2022, and I got weaker and weaker. I waited until 5/31/2022, I called my PCP again, and they insisted that I should go to the ER, so I went to the ER that morning. I underwent a COVID-19 test and bloodwork. They found that I was extremely dehydrated, so I was hooked up to intravenous fluids for about four hours. I tested negative for COVID-19. The bloodwork results also indicated a significant drop in potassium and the presence of a nonspecific virus of some type. I was then released and told to get Pedialyte and that I needed to rest and get rehydrated. I did this for about three weeks. It took about three or four weeks to regain my strength. I kept myself hydrated with Pedialyte and ate light meals. I also periodically got up and walked around to keep from getting lethargic. The nausea, diarrhea, and vomiting all ceased. I had a virtual visit with my PCP later on at about the end of June 2022, and although no specific virus had been detected in the bloodwork, my PCP suggested that my symptomology suggested norovirus. She said that it probably would have resolved itself sooner if I hadn't become dehydrated.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Fibromyalgia, Gastroenteritis viral, Headache, Muscle spasms, Pain
Clinical narrative: fibromyalgia pain in entire body, muscle cramps, stomach flu, fever, headache
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: fibromyalgia pain in entire body, muscle cramps, stomach flu, fever, headache
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Arthralgia, Aspiration pleural cavity, Asthenia, Chest discomfort
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Cold sweat, Cough, Dyspnoea, Headache
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate increased, Hepatosplenomegaly, Hypervolaemia, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Lung opacity, Nausea, Oxygen saturation decreased, Pain, Pallor
Clinical narrative: DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.