chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 min after immunization complained of nausea, light headed, dizziness patient monitored. Symptoms resolved. Patient said she was better
something like a connective tissue disease or lupus.; something like a connective tissue disease; ANA titer was drawn and it came back positive; rash; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 02Mar2021, as dose 2, single, for COVID-19 immunisation. Medical history included high levels of Epstein Barr in her body. She has not seen a rheumatologist yet. The patient's concomitant medications were not reported. Patient had no prior vaccinations within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021, as dose 1, single, for COVID-19 immunisation and experienced hematoma, itchy rash and got swelled up and got huge and had a bruise. The patient experienced rash after second dose (Mar2021). But it was not bad since she took Benadryl and Advil before the second dose. After the second dose in her right arm, the rash did show up sooner, within 24 to 48 hours after the shot. The rash after the second dose did not last as long and took about 5 to 7 days to recover. On an unspecified date in Apr2021, the patient went for her yearly checkup and had bloodwork and her ANA titer came out positive, a speckled pattern, which means something like a connective tissue disease or lupus (immunocompromised). The reporter stated she might have had this before the vaccine since she had high levels of Epstein Barr in her body previously. She has not seen a rheumatologist yet. It was reported that, she heard that people who are immunocompromised might not have protection against COVID19. She went to the doctor and asked if she can get the third dose booster. The outcome for rash was recovered while for other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101294311 same reporter/drug, different patient/event
Discharge Physician: MD Primary Care Clinician at Discharge: MD   Admission Date: 3/8/2023 Discharge Date: 3/12/2023 PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Acute cough [R05.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 79 y.o. female with a past medical history of atrial fibrillation with anticoagulation on apixaban, type 2 diabetes, hypertension, hyperlipidemia who presented with hypoxic respiratory failure secondary to COVID-19  She was recently exposed to COVID, however was fully vaccinated.  In the emergency department patient was afebrile, oxygen saturation was in the low 90s on room air, however with ambulation to the commode patient became hypoxic with an O2 saturation of 87%, she was placed on supplemental oxygen.   Chest x-ray and CT chest was performed which showed multiple areas of ill-defined ground-glass opacity throughout the lung parenchyma.  Patient received Decadron and albuterol, as well as Rocephin.  Due to concerns of hypoxia secondary to COVID-19, patient was admitted to hospitalist service for further workup, evaluation and management.  Dexamethasone/remdesivir was continued.  Urine cultures revealed greater than 100K CFU/mL Enterococcus faecalis.  She was given fosfomycin with improvement of her symptoms.  Her respiratory status improved and oxygen support was weaned to ambient air.  She is afebrile and hemodynamically stable.  She was discharged on 03/12/2023.
About 1.5 hrs after injection, patient reports she developed headache, felt her throat was closing up, and felt like she could not breathe. Used albuterol inhaler 4 times and got relief. Symptoms were subjective. EMS not called. Stable when seen by mom. Has hx of severe shot phobia.
3 to 4 days after vaccination, patient developed a rash over her whole body.  The rash resembled chicken pox.  She is currently being treated by her primary care physician with Prednisone 60mg.  She started the prednisone 4 days ago.
POST GIVING TDAP AND MMR VACCINES PATIENT COMPLAINED OF STRONG MEDICINE TASTE IN MOUTH.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in left arm and on 29Apr2021 as dose 2, single (Lot number: EW0171) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Negative, notes: thrilled to test negative for Covid on 31May on two different rapid tests; (03Jun2022) Positive, notes: By today, 03Jun2022, my rapid tests were solidly positive once again; (Jun2022) Negative, notes: Over the next few days I went between testing negative; (Jun2022) Positive, notes: having a faint positive line on rapid tests. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergies. The patient did not receive other medication in 2 weeks. The patient reported Covid rebound. The patient took Paxlovid and was thrilled to test negative for Covid on 31May2022 on two different rapid tests, after the patient finished course of Paxlovid. Over the next few days, the patient went between testing negative and having a faint positive line on rapid tests. Assumed it was clearing her system. By today, 3Jun2022, the patient rapid tests were solidly positive once again. The patient received Paxlovid for Treatment of COVID-19 on 26May2022 and stopped on 30May2022.
WITHIN 18 HRS FROM INJECTION / SYMPTOMS STARTED SATURDAY 01/09/2021 @ ~ 1400HRS DIARRHEA CHILLS LOW GRADE FEVER 99.8 JOINT PAIN JAW PAIN BODY ACHES HEADACHE NEAUSEAUS LIGHT HEADED  FATIGUE HYPOXIC ON EXERTION SYPMPTOM SUBSIDED ON SUNDAY 01/10/2021 @ ~ 1500HRS
woke up on 8/12/21 with " itchy rash over body" Denies any SOB, chest pain .  PT advised to go to urgent care for evaluation.
Mother of patient, call the clinic to report her daughter, pt after receiving the flu vaccine and the HPV #1 on 10/26/07 around 9:00am. 48hr later developed a fever of 103.6. Is treating the fever with Tylenol. Fever remains at 103 today this a.m.
Dizziness; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 016M20A,) for COVID-19 vaccination.     Concurrent medical conditions included Partial seizures since June 1970. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE SPRINKLE) for Partial seizures, CLORAZEPATE DIPOTASSIUM (TRANXENE) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Jan-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment drugs were reported.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Patient details was updated. Medical history date was updated.
I began to have arthralgias and joint swelling, My legs started swelling and I developed a rash on left leg. My PCP ran a battery of tests and indicated my A1c was elevated and I had inflammatory labs. I was referred to doctor, rheumatologist and I saw him in late April, early May. Doctor diagnosed me with psoriatic arthritis and told me I was in an immune flare. About 2 weeks or so later I had left leg swelling and the rash to left leg was hot and weepy. I was referred to vascular study and diagnosed with a posterior tibial DVT. My providers suggested I file this report.
He started coughing violently his whole body was shaking in his sleep. In the early hours on Monday morning, he was wheezing and coughing. By that point me and my husband were also sick, so we knew he had. I called the prevarication because of the wheezing his temperature was over 102, they had me bring him in to be checked to check his lungs. All day Monday he had a high fever. Lethargic. The doctor gave him a steroid. They also sent us home with a nebulizer and by Tuesday morning his fever had broken, his energy level had picked back up. He is still coughing and wheezing but he is fine. We still must do the nebulizer for a couple more days to help his breathing.
Headache, Myalgia, Fever, chills Temperature up to 102 degrees F Narrative:  Chills and high fevers.
10/29/21  Pt in clinic for flu like sxs.     Patient states over the past 2 days he has been experiencing flulike symptoms including cough, chills, body aches, fatigue and decreased appetite.  Patient states that he has not experienced decreased sense of smell or taste and denies difficulty breathing or shortness of breath or fevers.  Patient denies sinus pressure or congestion at this time.  He was previously vaccinated with the Materna vaccine and has not yet received a booster.  He denies contact with other individuals known to have Covid.  No other complaints today in clinic.
Shivers; Headache; This case was reported by a consumer via call center representative and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivers and headache. The patient was treated with cough cold preparations nos (Tylenol Plus Cold & Cough (Nos)). On an unknown date, the outcome of the shivers and headache were unknown.   It was unknown if the reporter considered the shivers and headache to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient receved Shingrix and experienced shivers and headache.
On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001CZ1A, 020B21A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it). At the time of the report, PAIN IN EXTREMITY (On second dose of the Moderna Covid19 Vaccine, her arm was sore if she touched it) outcome was unknown.            No Concomitant medication was reported.   This case was linked to MOD-2021-406211, MOD-2021-406226 (Patient Link).
About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so she received 50mg of Benadryl PO. About 10 minutes later she said that she thought it was helping. About 20 minutes after the benadryl she started having dizziness/lightheadedness, visual field narrowing, worsening throat swelling with frequent throat clearing, and tingling in her hands, epinephrine pen given L thigh. After 5 minutes without improvement Epinephrine pen given R thigh. No rash/hives noted. Vitals were stable the entire time with SpO2 of 100%, RR 18-22, HR 84-98, BP 100-138/60-86.
have a headache after getting the Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (have a headache after getting the Booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (have a headache after getting the Booster dose). At the time of the report, HEADACHE (have a headache after getting the Booster dose) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient wanted to know if it was okay to take sumatriptan which it is a migraine medication
Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Inflammation in rib cage cartilage. Severe body aches Exhaustion Profuse sweating
Extreme tiredness; Migraine; Vomiting; Nausea; Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed on an unknown date prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 22Apr2021 at 14:00, the patient experienced extreme tiredness, migraine, vomiting, nausea, body aches and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme tiredness, migraine, vomiting, nausea, body aches and chills was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
reported that an expired acthib was administered to a child, with no reported adverse event; Initial information received  on 29-Mar-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 3 years old male patient and reporter reported that an expired HIB (PRP/T) Vaccine [ACT-HIB] was administered to a child, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) for Immunisation; and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) for Immunisation.  On 29-Mar-2023, the patient received 0.3 ml (Dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ648ABA, Expiry date: 16-Mar-2023) (Strength- Standard) via intramuscular route in the left thigh for immunization.  On 29-Mar-2023, the reporter reported that an expired HIB (PRP/T) Vaccine was administered to a child, with no reported adverse event (expired product administered) (Latency: same day).  It was reported, She wanted to know what her next step will be. Frequency: 3 times ( 1st dose- 2 months old, 2nd dose- 4 months old, and 3rd dose- today.  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling, warmth, and erythema, with fluid collection per ultrasound to lower third of posterior arm 2 days post vaccination. Empiric antibiotic prescribed.
Chills; Muscle and joint aches; Joint aches; Upset stomach; Tired; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products that included sulphur drugs. Concomitant medications included Tylenol started on unknown date within 2 weeks of vaccination for unknown indication. The patient previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 27Feb2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received other vaccines within four weeks prior to the COVID-19 vaccine which are not specified. The patient experienced chills, muscle and joint aches, upset stomach and tiredness on 21Mar2021. The patient did not receive any treatment for events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events chills, muscle and joint aches, upset stomach and tiredness were not resolved.   Information about lot/batch number cannot be obtained. No further information is expected.
PA she saw, said that he had other patients who had the same. He didn't say they had shingles, he said they had the same symptoms.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (PA she saw, said that he had other patients who had the same. He didn't say they had shingles, he said they had the same symptoms.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (PA she saw, said that he had other patients who had the same. He didn't say they had shingles, he said they had the same symptoms.). At the time of the report, VACCINATION COMPLICATION (PA she saw, said that he had other patients who had the same. He didn't say they had shingles, he said they had the same symptoms.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-386895, MOD-2021-386953 (Patient Link).