chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following COVID-19 mRNA Vaccine: A case series and incidence rate determination.     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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant information were reported. Treatment information was not provided.  All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine with the majority occurring within 3 days (range 1-13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived.  Myocarditis was a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose was not known at this time.  Company Comment: This is a literature study case concerning a 44-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant and AESI) event of Myocarditis. The event occurred approximately with unknown latency after a dose of Moderna COVID 19 vaccine.  The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-380819, MOD-2021-380876, MOD-2021-380878 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature study case concerning a 44-year-old, male patient with unknown medical history, who experienced the unexpected serious (medically significant and AESI) event of Myocarditis. The event occurred approximately with unknown latency after a dose of Moderna COVID 19 vaccine.  The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Vaccine Breakthrough   COVID + 8/1/21.  Symptomatic COVID + test in ED for respiratory distress.  Discharged to home.
Narrative: Pt was a 69 yo M with PMH of DJD, CKD, HLD, DM2, and HTN presenting to ER with NSTEMI, altered mental status, possible head bleed, and GI bleed. Pt was transferred to another hospital, where he expired.
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable in the Janssen given as an alternative 9.15.2021
Severe vertigo, nausea, light headedness at night. Lasts 30 mins. Room spins, etc
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; 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, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received treatment for covid. No known allergies. He was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. He was previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ADVERSE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced adverse symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse symptoms was not reported. This report was non-serious.
Patient reports experiencing significant dizziness since receiving his first Covid vaccination 3/11/21. He has difficulty walking, he's unsteady on his feet, and he's experiencing vertigo-like symptoms. His symptoms have progressively worsened to the point of attempting to schedule an MRI but having concerns of stroke (slurred speech, facial droop) and was advised to go to the ER. Stroke-like symptoms resolved and MRI showed findings suspicious for CNS lymphoma vs a demyelinating process. Prior to the vaccination, he was very active and able to work in his wood shop.
COVID-19 (PFIZER Monovalent ) ordered instead patient received  COVID-19  (Pfizer Bivalent).  Patient had no adverse reaction from the vaccine.
red bumps covered joints, then hands became severely swollen, couldn't open doors, tie shoes, write my name. after that my joints became sore and swollen and my mouth was covered in sores to the point where I could not eat. I was later diagnosed with rheumatoid arthritis and possibly lupus. I also suffered from chronic fatigue. in 2011 my husband and I started trying for our second child. we later found out I had unexplained secondary infertility and are still struggling and spending countless dollars trying to conceive. this past year I was diagnosed with trigeminal neuralgia. I was being treated for the rheumatism with several medications and injections however those meds are on hold while trying to conceive. I have also had to take several infertility medications, none of which have worked.
Was driving home after waiting my 15 minutes. Throat started to close up, tingling sensation throughout entire body, rush of heat, dizziness, increased heart rate. Made it back to the site (closest medical professionals near me) where my throat still felt swollen but I could breathe. Chest hurt and was still dizzy. Was given 50mg Benadryl & 20mg Pepsid. It seemed to come and go in waves but I still went to the ER. ER doc said what he saw I was experiencing was anxiety. Pharmacist who had been with me the whole time could tell that my neck and throat had been swollen but had gone down with the Benadryl. ER administered anti nausea meds and a steroid shot. Also prescribed steroids for a few days. Received the shot at 6:45, initial reaction occurred around 7:10, went to the ER around 8:45
rash that was about 3 inches across and in a circle at the injection site; pain at the injection site in her left arm; extreme fatigue; in her left arm where she received the injection, when she bends her arm a certain way, like a 90 degree angle at the elbow, her arm locks there; left arm is immobile for a time; third dose was on 03Sep2021; third dose was on 03Sep2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administrated in left arm on 03Sep2021, as DOSE 3, SINGLE (BOOSTER) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/ Lot Number: EM9809), via an unspecified route of administration, on 03Feb2021, as DOSE 1, SINGLE for COVID-19 immunization and experienced Sore arm; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, on 24Feb2021, as DOSE 2, SINGLE for COVID-19 immunization and experienced Sore arm. On an unspecified date, the patient experienced rash that was about 3 inches across and in a circle at the injection site, pain at the injection site in her left arm, extreme fatigue, in her left arm where she received the injection, when she bends her arm a certain way, like a 90-degree angle at the elbow, her arm locks there, left arm is immobile for a time. On 03Sep2021, the patient had received third dose. The outcome for all the events was not recovered.  The third Covid 19 vaccine lot number is in the formal field as the side effects associated with the third dose are the reason for her call. She declines to provide any additional information. No further information is provided or obtained.  Follow up (01Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent via telephonic follow-up activity that included: Consumer mailing address was added.  Follow-Up (07Oct2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer via Company Representative referring to a 67 year old female patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 12-APR-2017, the patient was vaccinated with PNEUMOVAX 23 for prevention pneumococcal infection (route of administration, lot number, expiration date, dose and anatomical location were not provided). Following this, on 13-APR-2017, the patient experienced "localized swelling" around the injection site (unspecified arm) "severe pain" and "fluid on the bottom of her arm". On 13-APR-2017 the patient sought medical attention and was given unspecified steroids as treatment for the mentioned events. At the time of reporting, the patient was recovering from "localized swelling" and "severe pain" but still experienced "fluid on the bottom of her arm". Additionally, the reporter did not provided causal relationship between the events and vaccination with PNEUMOVAX 23. There was not product quality complaint involved. Additional information is not expected since there are no contact details.
Chills, fever, body aches, fatigue, injection site pain and swelling, bright red patches on the right arm
DIZZINESS POST MODERNA VACCINE  1017 AM 72/31 43  16  100% O2 SAT ON RA   DIAPHORETIC, COOL, CLAMMY,   PLACED ON FLOOR IN SUPINE POSITION   WITH HIS LEGS ELEVATED   CLIENT STATED THAT MOST OF HIS DIZZINESS RESOLVED IMMEDIATELY.  HE STATED HE IS ATHLETIC AND HAS A LOW BLOOD PRESSURE AND HEART RATE NORMALLY.  EVENTUALLY SAT UP , STOOD WITH MILD DIZZINESS.   HE THEN SAT IN A CHAIR ,DRINKING A BOTTLE OF WATER.   1025 92/47 53/20    AT 1059  90/57 47    PATIENT SITTING IN CHAIR MILDLY DIZZY  , NAD, MAEW, STEADY GAIT    MEDICATION  ZOLOFT, ZYRTEC DENIES ANY ALLERGIES
Patient is a 66 year old male with a past medical history significant for metastatic throat cancer to lung, hypertension, hyperlipidemia, who came to the emergency department complaining of fever and intractable coughing. According to the patient, he developed worsening coughing than his baseline a few days ago and reports he feels like the mucus is stuck in his throat. He states yesterday he became nauseous and vomited. After vomiting, he checked his temperature which was 101. He denies any body aches however he admits he just hasn't felt right for the last few days. He denies any headaches, chest pain, shortness of breath, abdominal pain, diarrhea, loss of taste or smell, or contact with anyone sick however he does report having no appetite. He also complains that his throat hurts from coughing so much so he is having a hard time swallowing.
muscle ache; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot/batch no: unspecified) via unspecified route, as a 1st dose, single dose on 23May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient has experienced muscle aches within the past few days. She worked out and was not sure that if that was from working out or the vaccine. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.
2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose.   No concomitant medications was provided by the reporter. It was unknown if patient  had any Allergies to medications, food and other products or patient was diagnosed or tested positive for COVID-19. It was unknown if the patient had chronic or long-standing health condition and if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.  The Vial was initially stored in refrigerator 30-MAr-2022 and Dose administered after 30-day Use By Date or after manufacturer date of expiry Vial did not undergo any temperature excursions. Expired Vaccine was administered on 23-Apr-2022.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-555023 (Patient Link).
Information has been received from a physician concerning a 15 year old female who on 20-AUG-1995 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 24-NOV-1998, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 22-NOV-2009, the patient experienced mumps (thought the date diagnosed was reported as 01-DEC-2009). The patient was afebrile and did not have parotitis. The outcome for mumps was not reported. Follow-up information was received from a physician who reported that the patient experienced mumps on 15-NOV-2009 (previously reported as 22-NOV-2009) and was diagnosed on 18-NOV-2009 (previously reported as 01-DEC-2009). It was reported that the patient had left parotitis and as other symptoms sore throat. On 18-NOV-2009, the following labs were taken: serum immunoglobulin M test which showed < 1:10, serum immunoglobulin G test which showed 2.27 and serum amylase test which 352. This is one of several reports from the same source. No further information is available.
Agitation, wheezing, shortness of breath at 1700. Albuterol/ATROVENT treatment given -> initially pale, developed hives/erythema by completion at treatment (1715). Received Epinephrine 0.15 mg IM x 1 at 1745 (vomited ORAPRED).
Had vaccine on 3/19/21. Had slight reaction at injection site and was sore for a few days, but felt fine until today. On 3/31/21 I woke up with the injection site swollen, painful and red.  My arm feels like it did the first day of getting my vaccine.
Information has been received from a medical assistant(also reported as office manager) referring to a 16 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 18-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Throwing up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Right on 24Feb2021 15:00 (at the age of 67-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included cancer, hypertension and diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Patient did not receive any other medications in 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. On 25Feb2021 at 12:00 AM, patient experienced throwing up. There was no treatment for the event. The clinical outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
Patient has severe itching and blistering down both legs that started a day after receiving vaccine and has still not resolved as of 3 weeks later.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna/ Dose #6: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), on 13Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "chronic cough" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE, start date: 19Mar2020, stop date: 06Mar2023; FLUTICASONE, start date: 19Mar2020, stop date: 25Feb2023. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone", notes: Known allergies: prednisone; Mucinex-d, reaction(s): "Known allergies: Mucinex-d", notes: Known allergies: Mucinex-d. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna/ Dose #6: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Mar2023) Negative, notes: tested negative 1 day after finishing of Paxlovid treatment; (05Mar2023) Positive, notes: On the 4th day after completing treatment mild symptoms re occurred and  tested positive again; (Mar2023) Negative, notes: tested negative the following 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Feb2023 to 01Mar2023.  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.
Cellulitis or similar skin infection. Mild itching on day 3 since vaccine administered which increased and on day 7 noticed a red hot inflamed patch near where vaccine was administered. On day 8 spoke with a dr, sent a picture and described symptoms, whom immediately diagnosed the condition as cellulitis and prescribed antibiotics and told me if it gets bigger to seek an antibiotic iv. Wanting a second opinion, I saw a dr in person afternoon of day 8. He was not convinced it was cellulitis and told me only to take antibiotics if the patch doubled in size. By that evening it had doubled and was spreading down the back of my arm and towards my elbow. I began antibiotics. Day 9 morning the infection has spread to a wider area but the color is less bright. This is where I am currently and am hoping continuing antibiotics will heal this quickly. I have never had anything like this before.