chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Headache, Malaise, Restlessness, Somnolence
Clinical narrative: Today she was feeling like sleeping, she just does not feel right.; feel lousy; had a feeling of unrest; Feeling of no energy; Headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 08Jan2025, outcome "not recovered", described as "Today she was feeling like sleeping, she just does not feel right."; ASTHENIA (non-serious) with onset Jan2025, outcome "not recovered", described as "Feeling of no energy"; HEADACHE (non-serious) with onset Jan2025, outcome "not recovered"; MALAISE (non-serious) with onset Jan2025, outcome "not recovered", described as "feel lousy"; RESTLESSNESS (non-serious) with onset Jan2025, outcome "unknown", described as "had a feeling of unrest".  Additional information: The patient stated that how if experiencing like no energy or headache, how long before that goes away. Patent stated in one or two days, she was going to be feeling herself, then. She is on her own then.  She just have to wait until it runs out. She felt very good before that and now she feels lousy, it doesn't matter, she just have to wait. She received dose of Prevnar 20 yesterday (07Jan2025) and now is feeling drowsy. She is calling reporting side effects. After transfer reporter clarified she was not drowsy. She clarified she has a feeling of no energy and a headache. Before she got the shot she was full of energy and doing things. Today (08Jan2025) she is feeling like sleeping, she just does not feel right. Difficult to understand caller, as she sounds muffled. Sounded like she stated had a feeling of unrest. Attempted to clarify statement, but she would not clarify further. Patient called and stated, "yesterday around 11:00 she had a prevnar 20 injection before that she was feeling fine today she feels lousy."
Sex: M
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre SYNDROME; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: GUILLAIN-BARRE SYNDROME (hospitalization), outcome "not recovered", described as "Guillian Barre SYNDROME". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body height, Echocardiogram, Electrocardiogram
Clinical narrative: diagnosed the myocarditis; This is a spontaneous report received from a Physician from medical information team.  A 14-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Lot number: FE3594) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 20Jan2022, outcome "recovered", described as "diagnosed the myocarditis". The patient was hospitalized for myocarditis (start date: 20Jan2022, discharge date: 21Jan2022, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (Jan2022) 564 pg/mL; Blood creatine phosphokinase MB: (Jan2022) 27.4 ng/ml; Body height: (unspecified date) 63.5, notes: inch 5 feet 3.5 inches; Echocardiogram: (Feb2022) Unknown results; Electrocardiogram: (Jan2022) inverted T waves and ST depression; testing: (unspecified date) diagnosed the myocarditis; N-terminal prohormone brain natriuretic peptide: (Jan2022) 242 pg/mL; Troponin I: (Jan2022) 9913 ng/L, notes: very elevated; Weight: (unspecified date) 183 lbs. Therapeutic measures were taken as a result of myocarditis, the patient was treated with Ibuprofen.; Sender's Comments: Given the compatible time association, the reasonable possibility that the event myocarditis is related to BNT162b2 (BNT162B2) administration cannot be excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin I, Weight
Clinical narrative: diagnosed the myocarditis; This is a spontaneous report received from a Physician from medical information team.  A 14-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Lot number: FE3594) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 20Jan2022, outcome "recovered", described as "diagnosed the myocarditis". The patient was hospitalized for myocarditis (start date: 20Jan2022, discharge date: 21Jan2022, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (Jan2022) 564 pg/mL; Blood creatine phosphokinase MB: (Jan2022) 27.4 ng/ml; Body height: (unspecified date) 63.5, notes: inch 5 feet 3.5 inches; Echocardiogram: (Feb2022) Unknown results; Electrocardiogram: (Jan2022) inverted T waves and ST depression; testing: (unspecified date) diagnosed the myocarditis; N-terminal prohormone brain natriuretic peptide: (Jan2022) 242 pg/mL; Troponin I: (Jan2022) 9913 ng/L, notes: very elevated; Weight: (unspecified date) 183 lbs. Therapeutic measures were taken as a result of myocarditis, the patient was treated with Ibuprofen.; Sender's Comments: Given the compatible time association, the reasonable possibility that the event myocarditis is related to BNT162b2 (BNT162B2) administration cannot be excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Sneezing
Clinical narrative: wet sneezes; coughing; tired; loss of taste and smell; loss of taste and smell; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2 (COMIRNATY), on 23Jan2021 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: SNEEZING (non-serious), outcome "unknown", described as "wet sneezes"; COUGH (non-serious), outcome "unknown", described as "coughing"; FATIGUE (non-serious), outcome "unknown", described as "tired"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "loss of taste and smell".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection
Clinical narrative: Then my husband and I contracted RSV in December 2024; Then my husband and I contracted RSV in December 2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset Dec2024, outcome "unknown" and all described as "Then my husband and I contracted RSV in December 2024". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500004123 same reporter/event, different patient/dose;
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Stillbirth
Clinical narrative: had a stillbirth two days after vaccination; This is a spontaneous report received from a Physician.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STILLBIRTH (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "had a stillbirth two days after vaccination". The pregnancy resulted in still birth.  Clinical course: The physician was informed that a pregnant patient who received the RSV vaccine had a stillbirth two days after vaccination. The patient received the vaccine at 37 weeks, outside the recommended window. The physician did not clarify if the patient had indeed received the Pfizer Abrysvo RSV Pref vaccine, simply stating that she had "received the RSV vaccine". Patient was a late entry into prenatal care.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: The pregnant patient who received the RSV vaccine had a stillbirth two days after vaccination.  Currently available data are insufficient to establish or exclude a causal relationship between stillbirth and ABRYSVO. More epidemiologic data and cumulative safety reports collected post marketing use are needed to indicate if there is the potential causal link between the vaccination and the event occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy, Hypothyroidism
Clinical narrative: Hypothyroidism; Cardiomyopathy; This is a spontaneous report received from an Other HCP.  A 46-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: HF9300) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose - Pfizer, lot number: EWO0170), administration date: 29Jul2021, for Covid-19 immunization; BNT162b2 (2nd dose - Pfizer, Lot number EWO169), administration date: 19Aug2021, for Covid-19 immunization; BNT162b2 (3rd dose - Pfizer, Lot number: FM0698), administration date: 25Feb2022, for Covid-19 immunization. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown"; CARDIOMYOPATHY (medically significant), outcome "unknown". Clinical course: recent diagnosis of hypothyroidism & cardiomyopathy.; Sender's Comments: There is not a reasonable possibility that the reported events hypothyroidism and cardiomyopathy was related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: F
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection
Clinical narrative: Then my husband and I contracted RSV in December 2024; Then my husband and I contracted RSV in December 2024; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset Dec2024, outcome "unknown" and all described as "Then my husband and I contracted RSV in December 2024". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500005918 same reporter/event, different patient/dose;
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash
Clinical narrative: small rash on leg above ankle; a new allergy to covid vaccine; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA277231 (Sanofi).  A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), in Jun2024 (ongoing) as 300 mg qow (every other day)) subcutaneous for nasal polyps. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2024, outcome "unknown", described as "a new allergy to covid vaccine"; RASH (non-serious) with onset 2024, outcome "unknown", described as "small rash on leg above ankle". The action taken for dupilumab was dosage not changed.  Additional information: Initial information received on 24Sep2024 (by Sanofi) regarding an unsolicited valid non-serious case received from a patient. In 2024 the patient developed the non-serious events (unknown latency) following the first dose intake of DUPILUMAB and of COVID-19 vaccine. Additional information was received on 20Nov2024 (by Sanofi) from the patient. Event of allergy to vaccine along with co-suspect COVID-19 VACCINE were added.   Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Cyanosis, Electroencephalogram normal, Influenza A virus test negative, Influenza B virus test negative, Irritability
Clinical narrative: My Daughter received her MMR Vaccine on 12/2/2024 and on 12/11/2024 she began acting "fussy" at about 1200. Pt was afebrile until approx. 1945 when she was found with emesis around her mouth, cyanotic, and seizing. She was taken to the ER. Her seizure lasted approx. 15 min. and required IV Ativan to stop. her O2 was 55% and HR was 218 upon arrive. She was flown to hospital. All test results were negative.  She did not have elevated WBC's and no source was found. Her EEG was negative and has since made a full recovery with no symptoms of the event
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: SARS-CoV-2 test negative, Seizure, Streptococcus test negative, Vomiting, White blood cell count normal
Clinical narrative: My Daughter received her MMR Vaccine on 12/2/2024 and on 12/11/2024 she began acting "fussy" at about 1200. Pt was afebrile until approx. 1945 when she was found with emesis around her mouth, cyanotic, and seizing. She was taken to the ER. Her seizure lasted approx. 15 min. and required IV Ativan to stop. her O2 was 55% and HR was 218 upon arrive. She was flown to hospital. All test results were negative.  She did not have elevated WBC's and no source was found. Her EEG was negative and has since made a full recovery with no symptoms of the event
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient stated that he had never had a RSV vaccine. Patient stated that he had attempted to have one at our facility in the past but was not able to due to insurance issues.  After the patient had left while going through his chart to add the vaccine it was discovered that he had a previous RSV vaccine two years ago here. Patient had no adverse effects at the visit and left the clinic in stable condition. Patient was notified about the issue, patient again stated "I did not have an RSV vaccine two years ago today was the first one". Advised patient of records on file and that provider would be making a report of the incident.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Fatigue, Pain, Vertigo
Clinical narrative: Patient had chills, dizziness, vertigo 2 hours after vaccine given. B/P lower at time of recheck, all other vital signs ok. B/P went up after drinking fluids, pt tired, achy
Age: 61.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient took one expired dose of Vivotif capsules. Patient reported no side effects or adverse events. The patient was provided non expired vaccine capsules and completed the course with no complications.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nausea, Pallor
Clinical narrative: Patient received both Pfizer covid and Flublok vaccinations in her left arm. After vaccinations were given, I stayed with the patient for five minutes, while I provided the same two vaccinations to her friend. She seemed fine and was speaking with us and did not report any issues. After I finished giving them the vaccines, I confirmed they were okay and went to help a  customer at the register because I was working alone. Her friend knocked on the door and asked for a bag for her friend to use if she had to vomit. I saw the patient, and she was sitting in the chair leaning back and was very pale. I told her  friend to stay close to her and keep an eye so that she would not fall if she fainted, and I got her some water and a piece of candy. She did not tell me that she fainted,  but her mother came into the store two days later to thank me for being there for her when she fainted. I kept a close eye on her and offered to check her blood pressure, which she declined. Once she ate the candy, pretzels and drank some water her coloring came back and she felt fine. She stayed in the vaccine room for 10 minutes or so before leaving while I checked on her in between customers at Will Call. She was shopping in the store after for about 30 minutes and told me she was feeling much better. Her mom said she usually faints when she gives blood.
Age: 38.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Hives from chest down to ankles including arms/hands.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Injection site erythema, Injection site swelling, Ocular discomfort
Clinical narrative: Patient reported to pharmacy two days after receiving shingrix vaccine with swelling and redness of the injection site, shoulder pain, trouble breathing in the morning, and left eye discomfort
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Urticaria
Clinical narrative: Facial flushing and Hives was given po 25 mg of benadryl
Age: 64.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Dyspnoea, Pyrexia, Respiratory tract congestion
Clinical narrative: pt  received the vaccine on 1/6/25 and had shortness of breath, congestion and fever the next day. She was not tested for the influenza, but was prescribed albuterol and benzonatate.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: patient came in on 01/09/2025 for a covid shot. received shot. The store cooperate contacted pharmacy on 1/10/2025 that patient had received the same type  covid shot on 11/25/2024. They were given to close together and pharmacist did not catch that she did not need another shot and patient did not remember getting the first shot. We notified the patient and she said she did not have any reaction other than the typical sore arm but the corporate office wanted us to report it.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt Rec'd 2nd dose of Arexvy. No Adr from 2nd dose were noted by patient.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had previously received Arexvy vaccine on January 6, 2024.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient previously received Arexvy vaccine on 1/6/2024.  Second dose not needed.  No side effects reported.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: Difficulty breathing,  hard time exhaling, felt I couldn't get enough air, 100 degrees fever, and the usual aches
Age: 4.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: 1/7/25 received vaccine, 1/8/25  mom noticed warmth, redness and swelling, took to the ER. 1/9/25 mom called for a follow up due to no improvement and low grade fever. 1/10/25 mom called said swelling and fever gone and feeling better canelled appt.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fungal infection, Infection parasitic
Clinical narrative: She has mold infections as well; Parasites/ongoing for 3 years prior to this last test; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 07Jan2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3(booster), single (Lot number: FH8028) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, batch/lot number EN6199, injection in the left arm), administration date: 05Mar2021, when the patient was 55-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, batch/lot number ER8732, injection in the left arm), administration date: 26Mar2021, when the patient was 55-year-old, for COVID-19 immunisation. The following information was reported: INFECTION PARASITIC (non-serious) with onset 2021, outcome "not recovered", described as "Parasites/ongoing for 3 years prior to this last test"; FUNGAL INFECTION (non-serious), outcome "not recovered", described as "She has mold infections as well". Therapeutic measures were not taken as a result of fungal infection.  Additional information: History: She was perfectly healthy and had nothing at all, she now has everything going on. Parasites: Said that she had Globurota and was diagnosed about a month ago. This was ongoing for 3 years prior to this last test. Never had it before the vaccine injury. Caller confirmed She had none of these reported symptoms before the vaccine injury. She reported this information to VAERS. She had symptoms after the 3rd dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500004660 same patient and reporter, different dose and event;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Blau syndrome, Environmental exposure, Gene mutation, Tooth loss
Clinical narrative: She has mold infections as well; Parasites/ongoing for 3 years prior to this last test; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 07Jan2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3(booster), single (Lot number: FH8028) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, batch/lot number EN6199, injection in the left arm), administration date: 05Mar2021, when the patient was 55-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, batch/lot number ER8732, injection in the left arm), administration date: 26Mar2021, when the patient was 55-year-old, for COVID-19 immunisation. The following information was reported: INFECTION PARASITIC (non-serious) with onset 2021, outcome "not recovered", described as "Parasites/ongoing for 3 years prior to this last test"; FUNGAL INFECTION (non-serious), outcome "not recovered", described as "She has mold infections as well". Therapeutic measures were not taken as a result of fungal infection.  Additional information: History: She was perfectly healthy and had nothing at all, she now has everything going on. Parasites: Said that she had Globurota and was diagnosed about a month ago. This was ongoing for 3 years prior to this last test. Never had it before the vaccine injury. Caller confirmed She had none of these reported symptoms before the vaccine injury. She reported this information to VAERS. She had symptoms after the 3rd dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500004660 same patient and reporter, different dose and event;
Age: 72.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: Pain in left arm started day after shot. Was fairly mild at that time, but grew increasingly more painful as days went by. Pain is at site of injection and moves down the arm affecting wrist and hand. Some days I cannot wear my watch. I have lost strength in the arm and have loss of motion. It is very painful to reach the arm out to the left or up in the air. It is painful to carry even my purse for any length of time. I can't find a comfortable position to put my arm when sleeping. I have to move it constantly and it wakes me right up if I turn and lie on it. I cannot reach back to the night stand for phone or light. Over the counter meds do not touch the pain, nor does topical ointments. It is now mid January and I had the shot on November 8. The pain has not diminished. I n fact, it is increasing. At times when I use it I have a wincing, shooting pain in the muscle. It has been more than two months.
Age: 72.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: Pain in left arm started day after shot. Was fairly mild at that time, but grew increasingly more painful as days went by. Pain is at site of injection and moves down the arm affecting wrist and hand. Some days I cannot wear my watch. I have lost strength in the arm and have loss of motion. It is very painful to reach the arm out to the left or up in the air. It is painful to carry even my purse for any length of time. I can't find a comfortable position to put my arm when sleeping. I have to move it constantly and it wakes me right up if I turn and lie on it. I cannot reach back to the night stand for phone or light. Over the counter meds do not touch the pain, nor does topical ointments. It is now mid January and I had the shot on November 8. The pain has not diminished. I n fact, it is increasing. At times when I use it I have a wincing, shooting pain in the muscle. It has been more than two months.
Age: 72.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pain in left arm started day after shot. Was fairly mild at that time, but grew increasingly more painful as days went by. Pain is at site of injection and moves down the arm affecting wrist and hand. Some days I cannot wear my watch. I have lost strength in the arm and have loss of motion. It is very painful to reach the arm out to the left or up in the air. It is painful to carry even my purse for any length of time. I can't find a comfortable position to put my arm when sleeping. I have to move it constantly and it wakes me right up if I turn and lie on it. I cannot reach back to the night stand for phone or light. Over the counter meds do not touch the pain, nor does topical ointments. It is now mid January and I had the shot on November 8. The pain has not diminished. I n fact, it is increasing. At times when I use it I have a wincing, shooting pain in the muscle. It has been more than two months.
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative, Immunisation
Clinical narrative: HCP called to report that she received a order from a doctor to revaccinate a patient with PNEUMOVAX 23 because they were not satisfied with their titer results stating the test is not showing immunity. The HCP could not confirm when the patient was; This spontaneous report was received from a pharmacist and refers to a currently 17 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) 0.5 mL (dose number, lot #, expiration date, route of administration, anatomical location not provided) as immunization for the prevention of pneumococcal disease.   On an unspecified date, the patient was ordered to be revaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), because the physician was not satisfied with the titer results stating that the test did not show immunity (antibody test negative). At the reporting time, the patient had not recovered from the event. It was reported that it was sought medical attention but no treatment was given; and that the last time the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) could not be confirmed.
Sex: M
Vaccine: UNK
Symptoms: Influenza, Palpitations, Ulcer haemorrhage
Clinical narrative: I had a very adverse reaction to Type A influenza with heart palpitation; I had a very adverse reaction to Type A influenza with bleeding ulcer; Subtype A influenza; This spontaneous case, initially received on 30-Dec-2024 was (with additional information received on same date), reported by a non-health professional and concerns an Elderly male patient.  Concomitant medication: Refer to the appropriate section.  Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: not reported and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 03-Jan-2024, the patient experienced Subtype A influenza (Hospitalized, outcome: Not Reported).  On an unknown date in Jan-2024, the patient experienced I had a very adverse reaction to Type A influenza with heart palpitation (Hospitalized, outcome: Not Reported), I had a very adverse reaction to Type A influenza with bleeding ulcer (Hospitalized, outcome: Not Reported).  I had a very adverse reaction to Type A influenza with heart palpitation and bleeding ulcer in January this year. I was hospitalized for 2 weeks and in rehab another 2 weeks. I do not want to have Type A influenza again this year.  The patient had trouble with it quite a bit, it gave him a real. The patient had to stay in the hospital. So, he wanted to know if there was a type A flu in the current flu vaccines, he thinks that, if he gets the type A included, it will help resist catching type A flu again. Yes, that time type A flu caused the symptoms, so he was hoping the vaccine will help. Last year it was not included in the vaccine so that's why he was in the hospital, from 3 January for two weeks. The patient did not have a reaction to the vaccine, patient had a subtype A influenza infection which caused the mentioned symptoms and hospitalization. Patient did not know the vaccine he took before hospitalization.  Fluad (TIV) action taken: Not Applicable  Reporter Assessment: The reporter assesses the events as serious, and causality was not reported.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, heart palpitations and ulcer bleeding are attributed to subtype A influenza infection (probable consequences of infection). Furthermore, causality for subtype A influenza infection assessed as not related (as reported), as the reaction/infection not attributed to vaccination.
Sex: M
Vaccine: HEP
Symptoms: Eye pain
Clinical narrative: Pain In and Around the Right Eye; Initial report received on 18-Dec-2024.    A consumer reported that he, a 30-year-old male, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced pain in and around his right eye.   Medical history was reported as an allergy to penicillin (PCN) that manifested as hyperventilation.   No concomitant medications were reported.    On approximately 26-Nov-2024 or 27-Nov-2024, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, and NDC number not available)] intramuscularly in the left arm. The patient stated that he has been having some pain in and around his right eye.  The pain started in his temple area and in his right eye.  The event was treated with unspecified oral steroids.  Reporter stated that his symptoms were ongoing. No further adverse effects were reported.  No other information was available.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: UNK
Symptoms: Malaise, Neuropathy peripheral, Pain, Sleep disorder
Clinical narrative: Neuropathy; Painful / #9 levels of pain; Became ill; This spontaneous case initially received on 06-Jan-2025, was reported by a non health professional and patient of unknown age/gender.  Administration of company suspect drug: On 31-Oct-2014, the patient received Fluad (TIV) for Indication not reported., dose Not reported route of administration in anatomical location Not reported, Lot number: No batch number available and would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 01-Nov-2024, the patient experienced Became ill (outcome: Not Reported). On Dec-2024, the patient experienced Neuropathy (Medically Significant, outcome: Not Reported). Associated symptoms included: Painful / #9 levels of pain.  On 31-Oct-2014, she had the Fluad shot for 65 and over at pharmacy, and became ill the next day, each day became worse so that the entire month of November I had never in the long life been so ill. Have had flu shots at my doctor's office or for years and no reaction. Contacted pharmacist at pharmacy and was told the company had increased the antigens several times over. This was the entire month of November, come December and I was now left with Neuropathy, so painful since the first part of December and I had this keeping me awake at night with very painful #9 levels of pain. If would like doctors name and I am happy to provide these shots should be accompanied with information about the increase.  Fluad (TIV) action taken: Not Applicable  Reporter´s assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Plausible temporal relationship for illness (next day of vaccination). Causal association cannot be completely ruled out for neuropathy in view of insufficient information (onset date, temporality, relevant medical history).
Age: 59.0
Sex: M
Vaccine: HEPA, PNC20
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Muscular weakness, Tracheostomy
Clinical narrative: Patient developed acute onset of severe muscle weakness 10 days after vaccination. Determined to be severe Guillain-Barre Syndrome requiring mechanical ventilation, tracheostomy, etc.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Other Relevant
Age: 81.0
Sex: M
Vaccine: COVID19-2, TDAP
Symptoms: Herpes zoster, Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; 10040555:SHINGLES; Narrative: Other Relevant HX: 80 y/o male patient presented to urgent care with rash to left buttock noted this morning 11/9/2022. Other: treated for shingles
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Reported Symptoms: 10012727:DIARRHEA; Narrative: Patient received influenza vaccine 1/5/24 and reported diarrhea on 1/111/24. Other Relevant HX: other: DIARRHEA
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cough, Dyspnoea, Hypertension, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10020772:HYPERTENSION; Narrative: Patient received COVID and Flu Shot on 2/9/24. Presented to ED on 2/10 "reporting a few days of cough, chest congestion, and sore throat. (+) mild sob starting today. denies fevers/chills. States he received covid and flu shots yesterday." On arrival in the ER pt had a BP of 199/90 with a pulse of 105. He was admitted after he was to have tachycardia & abn troponin of 0.04. Discharged diagnosis "Uncontrolled HTN/Abnormal Troponins". Patient was restarted on Metorpolol which he had self-d/c'ed a year earlier. Other Relevant HX: Other:
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Tachycardia, Troponin abnormal
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10020772:HYPERTENSION; Narrative: Patient received COVID and Flu Shot on 2/9/24. Presented to ED on 2/10 "reporting a few days of cough, chest congestion, and sore throat. (+) mild sob starting today. denies fevers/chills. States he received covid and flu shots yesterday." On arrival in the ER pt had a BP of 199/90 with a pulse of 105. He was admitted after he was to have tachycardia & abn troponin of 0.04. Discharged diagnosis "Uncontrolled HTN/Abnormal Troponins". Patient was restarted on Metorpolol which he had self-d/c'ed a year earlier. Other Relevant HX: Other:
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Musculoskeletal discomfort, Myalgia, Pain
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10040617:SHOULDER PAIN; Narrative: On July 10th, I received my second dose of Shingle vaccine in my left shoulder. Since that time, my shoulder is continually in pain, generally a level 8 pain, but often, and increasing in occurrences I will move my shoulder and it sends shooting pain through my arm. For instance, just yesterday I went to pick up a grocery sack with 2 loafs of bread, the pain was beyond measurable and I was unable to lift it. I am rotate my shoulder in a 360 degree motion. I believe that the nurse may have hit a nerve or the Bursa sack as the injection was very high on the joint Left shoulder pain - Shingrix shot 7/10/24 -8/10 left shoulder pain in the subacromial area with exacerbations lifting away from the body and with external rotation -He also reports some tingling in the left hand first through third fingers. Mild neck discomfort. Wonders if he could have some weakness but pain is also shutting him down. Other Relevant HX: Other: shoulder pain
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10040617:SHOULDER PAIN; Narrative: On July 10th, I received my second dose of Shingle vaccine in my left shoulder. Since that time, my shoulder is continually in pain, generally a level 8 pain, but often, and increasing in occurrences I will move my shoulder and it sends shooting pain through my arm. For instance, just yesterday I went to pick up a grocery sack with 2 loafs of bread, the pain was beyond measurable and I was unable to lift it. I am rotate my shoulder in a 360 degree motion. I believe that the nurse may have hit a nerve or the Bursa sack as the injection was very high on the joint Left shoulder pain - Shingrix shot 7/10/24 -8/10 left shoulder pain in the subacromial area with exacerbations lifting away from the body and with external rotation -He also reports some tingling in the left hand first through third fingers. Mild neck discomfort. Wonders if he could have some weakness but pain is also shutting him down. Other Relevant HX: Other: shoulder pain
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Erythema, Injection site rash, Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: arrives with complaint of getting random areas on body that are red and itchy, hive like in appearance since receiving the Zoster Recom # 2 on 6/10/24. He has taken po benadryl with good effect. He denies difficulty breathing or swallowing, throat tightness. Last night his significant other also noted a "bull's eye rash" to back of left upper arm. States they had been in a field recently but he did not see any ticks on his body. He denies new joint pain, he normally has left hand pain from arthritis. States he has been treated for lyme in the past. Other Relevant HX: Other: URTICARIA
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose normal, Blood pressure increased, Dizziness, Dysstasia
Clinical narrative: Reported Symptoms: 10047340:VERTIGO; Narrative: Resulted in admission to the medical center for vertigo. Other Relevant HX: 80 year old MALE with hx of hypertension, diabetes, COPD and hypothyroidism who presents to the ER with severe headache, dizziness and difficulty with balance. Patient's wife provided most the hx, she reports patient has been tired/fatigued since returning from vacation a few days ago. Today, he had an appointment with his PCP where her received his COVID booster. He then went to a few stores with is wife and returned home. He was resting and around 1630 he developed severe headache and room spinning. He had trouble standing and his wife called her son to bring him to the hospital. He needed assitance to walk into the hospital. Blood pressure was elevated to 162/80 and blood glucose was 152. NIHSS was 0. Patient was able to stand and take a few steps. Wife stated his balance was close to baseline. He was excluded from tPA due to non disabling symptoms. Pfizer Monovalent (Comirnaty) Administered: COVID-19 (PFIZER), MRNA, LNP-5, PF, TRIS-SUCROSE, 30 MCG/0.3 ML (Ages 12+ YEARS) Date Administered: Jul 05, 2024 11:00   Series: Booster Manufacturer: PFIZER, INC Lot : HF9301 Exp Date: Jan 30, 205 Admin Route/Site: INTRAMUSCULAR/RIGHT DELTOID Dosage: 0.3mL Vaccine Information Statement: COVID-19 MRNA VACCINE (12+ YRS)
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, NIH stroke scale, Vertigo
Clinical narrative: Reported Symptoms: 10047340:VERTIGO; Narrative: Resulted in admission to the medical center for vertigo. Other Relevant HX: 80 year old MALE with hx of hypertension, diabetes, COPD and hypothyroidism who presents to the ER with severe headache, dizziness and difficulty with balance. Patient's wife provided most the hx, she reports patient has been tired/fatigued since returning from vacation a few days ago. Today, he had an appointment with his PCP where her received his COVID booster. He then went to a few stores with is wife and returned home. He was resting and around 1630 he developed severe headache and room spinning. He had trouble standing and his wife called her son to bring him to the hospital. He needed assitance to walk into the hospital. Blood pressure was elevated to 162/80 and blood glucose was 152. NIHSS was 0. Patient was able to stand and take a few steps. Wife stated his balance was close to baseline. He was excluded from tPA due to non disabling symptoms. Pfizer Monovalent (Comirnaty) Administered: COVID-19 (PFIZER), MRNA, LNP-5, PF, TRIS-SUCROSE, 30 MCG/0.3 ML (Ages 12+ YEARS) Date Administered: Jul 05, 2024 11:00   Series: Booster Manufacturer: PFIZER, INC Lot : HF9301 Exp Date: Jan 30, 205 Admin Route/Site: INTRAMUSCULAR/RIGHT DELTOID Dosage: 0.3mL Vaccine Information Statement: COVID-19 MRNA VACCINE (12+ YRS)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Anaphylaxis which did not require intervention Other Relevant HX: Other: ANAPHYLAXIS
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Monoplegia, Vomiting
Clinical narrative: Reported Symptoms: 10021097:HYPOTENSION; 10033814:PARALYSYS LEG; 10047700:VOMITING; Narrative: Pt. had to be admitted to the hospital and later discharged to rehab facility Other Relevant HX: Other: paralysis of right leg
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: WEAKNESS
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Nurse called and reported that she received a dose of VARIVAX in 1999 and a dose in 2017 and that her titers for varicella are still negative. Dates the titers were drawn were not provided. Nurse did not provide additional information and stated that; This spontaneous report was received from nurse and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 1999, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection and second dose on 2017, both administered for prophylaxis (strength, doses, lot #, expiry dates, and routes of administration were not provided).  The patient stated that her titers for varicella were still negative (antibody test negative). Dates the titers were drawn were not provided.   The causal relationship between antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.   Nurse did not provide additional information.  Additional information is not expected.