chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting a couple days after vaccine #2, accessory breast tissue in my L axilla started to become swollen and tender.  No swollen or tender lymph nodes.  The L outer area of my L breast has also been tender.  I was 18 weeks on the day of vaccine #2 with minimal to no breast pain at that point.  No treatment has been needed.  My OB will be sending me for an ultrasounds if it has not dissipated at my 28 week visit (I?m currently 25 weeks).
Patient received COVID 19 vaccines on 07/27/2021, 08/24/2021 and the booster on 06/01/2022.  He claimed to have started experiencing symptoms of a stroke in July of 2022.  On November 28, 2022 after deteriorating health, he agreed to go to ER where he was diagnosed with a stroke and brain bleed.  The diagnosis was incorrect and determined to be lymphoma tumor on his brain, and subsequently lymphoma throughout his body.  He died on February 2, 2023.    Please refer to case number, patient, my wife.  Her process began with GBS on February 24, 2021.  She experienced renal failure in April, 2021, also diagnosed with lymphoma on June 2, 2021 and died on August 3, 2021.
Diarrhea since day after vaccine up to 10x daily for (currently) 18 days. Negative stool studies.
Skin around shot become red; Left shoulder swollen; Arm swollen; Hard to feel around shot; left shoulder, left arm and wrist feels warm inside; Itchy feeling on face; Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy feeling on face), DYSGEUSIA (Metallic taste), ERYTHEMA (Skin around shot become red), SWELLING (Left shoulder swollen) and PERIPHERAL SWELLING (Arm swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (Itchy feeling on face) and DYSGEUSIA (Metallic taste). On 03-Apr-2021, the patient experienced ERYTHEMA (Skin around shot become red), SWELLING (Left shoulder swollen), PERIPHERAL SWELLING (Arm swollen), MALAISE (Hard to feel around shot) and SKIN WARM (left shoulder, left arm and wrist feels warm inside). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-Mar-2021, PRURITUS (Itchy feeling on face) and DYSGEUSIA (Metallic taste) had resolved. At the time of the report, ERYTHEMA (Skin around shot become red), SWELLING (Left shoulder swollen), PERIPHERAL SWELLING (Arm swollen), MALAISE (Hard to feel around shot) and SKIN WARM (left shoulder, left arm and wrist feels warm inside) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs include: Blood pressure pill
This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored GARDASIL (lot number, dose, frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Dizziness, imbalance, vertigo like symptoms - when changing position from sitting to standing or bending. Symptoms were intense on 4/15/2021 - one week after receiving the vaccination. Since then the symptoms have become milder and infrequent.
Information has been received from a licensed visiting nurse concerning a 30 month old male patient with a history of jaundice at 3 weeks old who on 13-FEB-2009 was vaccinated with a dose of MMR II (lot #662559/1370X) and accidentally with a dose of MERUVAX II (Lot # 18154) instead of VARIVAX (Merck). There was no concomitant medication. At the time of reporting the child was fine. Additional information has been requested.
Headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and MYALGIA (Body aches) in a male patient of an unknown age 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 HEADACHE (Headaches) and MYALGIA (Body aches). At the time of the report, HEADACHE (Headaches) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were mentioned.  Patient experienced headaches, body aches for 48 hours.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received on 18-Nov-2021 contains no new information.
This is a spontaneous report from a contactable consumer (patient). A 43-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0151), at the age of 43, via an unspecified route of administration, left arm, on Apr 8, 2021, at 19:30, single dose, for COVID-19 immunisation. The patient did not have other medical history. The patient has no known allergies to medications, food or other products. The patient took other medication within two weeks of vaccination, which included vitamins (unspecified).  Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced a number of side effects since taking the vaccine. On Apr 9, 2021 at 15:30, initially it was just her arm that was very sore and stiffness in her neck. Approximately 24 hours after the vaccination, on Apr 9, 2021, she  broke out in hives on her chest. Following the hives, patient experienced a pins and needles sensation in various places throughout her body from an unknown date in Apr 2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. The outcome of the sore arm and hives on chest resolved at the time of report on Apr 12, 2021; while pins and needle sensation still ongoing. Patient's periodic stiffness/pain in neck: not resolved at the time of report. No follow-up attempts needed. No further information expected.
Patient received Pfizer for her 1st dose. Her second dose (administered 04/28/21) was given as Moderna.
approx 5 mins p/vax pt fell to ground; no LOC; pt appeared sl pale (stood up from chair) pt was always conscious; Bp was stable; pt put on table & observed for 30 mins; had no problems;
This spontaneous report was received from a Registered Nurse (R.N.) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of PEDVAXHIB (Lot # and doses were not reported) which was exposed to 8.8° C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating ever two hours (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS # 1607USA006260, 1607USA006261, and 1607USA006262). Additional information has been requested.
Headache, nausea, lethargy which continued for 2 1/2 days treated with pepto bismal and advil
Approximately 30hours after the patient received the vaccine the patient had an anaphylactic reaction.  The patient reported to an ED in another state and reported the ED physician told her he did not think it was related to the vaccine.  Patient following up with allergist on 12/31
Low grade fever, headache, fatigue. Sore throat, nausea. Taking MOTRIN prn.
Initial feeling of moderate deep pain at injection site, not dissimilar from the first injection.  On this second of two injections. Approximately 12 hours later, feelings of hyperpyrexia, chills, tachycardia, and moderate to extreme dizziness.  Increased with rising to go to bathroom.  Urine normal in amount and color.  Symptoms limited to feelings of fever, heart rate, and dizziness.  Now, at 28 hours post injection, Pulse of 90 seated, 120 on rising, dizzy on rising.  BP 118/78 P-95 seated.  BP 137/77 P-161 by home automated device.
Within 3 minutes of receiving vaccine, pt felt hot and like she was about to faint.   RPh gave patient cold towel to put on her head and bottle of cold water from cooler and patient felt better.  Husband accompanied patient home.  RPh followed up later with the patient at home and she was feeling "1000% better".
Headache, Fever, fatigue Narrative: missed work following the second dose due to the above symptoms
Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccinated with improperly stored doses (temperature: 35 F, time frame: 84 hours) of GARDASIL 9 (lot # M004116 with an expiry date: 12-OCT-2017 and lot # M007764, expiration date was not reported), dose and route of administration were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
12/18/21 presents to ED for "chest pain". PMHx of "CAD s/p CABG 3 months ago, HLD, atrial fibrillation, T2DM"
This spontaneous report as received from a physician assistant refers to a patient who was vaccinated with the first and second dose of GARDASIL on 01-NOV-2007 and 25-NOV-2008 respectively. On 23-AUG-2012 the patient was in the office to receive the third dose. No adverse effect reported. Additional information has been requested.
Patient is 17 years of age and received a vaccine that was indicated for use in ages 18 years and older
pain, redness and swelling at injection site ,muscle pain and joint pain. fatigue , headache, little chills,  and and body rash over torso and injected arm, and on face and forehead and top of head ,, the rash appeared subcutaneous and had pustules
I was sneezing, nose running, little cough, tired, and small fever. I tested positive for COVID-19 at home. I had a telehealth visit and was prescribed PAXLOVID. I was feeling better by the 24th. I was testing positive for about 2 weeks.
was scheduled to receive their third dose of ADACEL was accidentally given DAPTACEL instead with no adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old female patient who was scheduled to receive their third dose of adacel was accidentally given daptacel instead with no adverse event, on receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IODINATED GLYCEROL (IPOL [IODINATED GLYCEROL]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 10-Feb-2022, the patient received a dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation: unknown) with lot C5816AA via intramuscular route in the left deltoid asimmunization. The nurse practitioner stated that the patient that was scheduled to receive their third dose of ADACEL in the office on 10-FEB-2022 was accidentally given DAPTACEL instead (wrong product administered). Caller wanted to know if that vaccine would count as a valid Tdap dose or if the patient needed to be revaccinated with ADACEL. No adverse event was reported. Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event      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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Patient received a dose of high-dose flu, even though he was only 62 years of age. The patient had reported the incorrect date of birth at first, and so the vaccinator didn't realize he was only 62 until after the vaccine was administered.
Pt admitted to hospital on 2/12/22 d/t COVID-19 infection after experiencing SOB and lower back pain.  Dx w/ COVID-19 on 2/12/22.
Prolonged Nausea; vomiting; diarrhea; This is a spontaneous report from a contactable nurse (the patient, reported for self). This 39-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number: EL8982 & Expiration date: Not reported), via an unspecified route of administration in Left arm on 28Jan2021 at 8:00 (at age of 39-years-old) as single dose for COVID-19 immunization. Patient medical history includes Ulcerative colitis, Latent TB infection both from an unspecified date and unknown if ongoing. Patient concomitant medications include adalimumab (HUMIRA), Isoniazid, vitamin b6, iron, multivitamins used for used for unspecified indication from unknown date and unknown ongoing. Patient did not have any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 (5ays after vaccination), Patient experienced prolonged nausea, vomiting, diarrhea starting on day 5 after receipt of vaccine and continuing until present. Treatment received for events with Zofran given for prolonged nausea and vomiting. Post vaccination, the patient was not tested for COVID. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Discharge Provider: MD Primary Care Provider at Discharge: DO   Admission Date: 4/29/2023 Discharge Date: 05/02/2023    HOSPITAL PROBLEMS: 1. Acute metabolic encephalopathy 2. Subacute COVID infection 3. Abnormal UA   Stable medical conditions 4. Dementia 5. Hypothyroidism 6. Chronic constipation  PRESENTING PROBLEM: Confusion, weakness, fatigue. Recent Covid infection treated with Paxlovid.  HOSPITAL COURSE: Patient was admitted to the general medicine service for acute metabolic encephalopathy secondary to subacute COVID infection verses urinary tract infection.  She did not qualify for IV remdesivir, she had completed Paxlovid outpatient.  She was treated with supportive care including IV fluids.  She was initially given 1 dose of 1gram IV Rocephin for possible urinary tract infection, her initial sample was not enough to send for culture, repeat urine culture with no growth at time of discharge.  Blood cultures x2 with no growth at 48 hours at discharge.  IV fluids were discontinued and she was able to eat and drink on her own, no urinary complaints, and her confusion improved per family. Daughter had no acute concerns on day of discharge.   Patient worked with PT and OT who felt she would benefit from subacute rehab, her family agreed that she would benefit from a course of therapy.  She will be discharged to Facility
Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INTERCEPTED MEDICATION ERROR (Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCEPTED MEDICATION ERROR (Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCEPTED MEDICATION ERROR (Pharmacy was clearing him for another shot (Submitting AE with limited information - near miss), Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient was not immunocompromised.  Concomitant product use was not provided by the reporter.  Patient received his 1st dose on 07-Mar-2021, 2nd dose on 07-Apr-2021, 3rd dose on 29-Oct-2021, 4th dose on 16-Jun-2022. Patient was not eligible for a 3rd dose of the bivalent as he was not immunocompromised.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a consumer concerning her 67 year old husband with no medical history or allergies who on 19-JUN-2007 was vaccinated with 0.5 ml dose of ZOSTAVAX (Lot # 657767/0740U). Concomitant therapy included "tetanus" and unspecified medication. On 20-JUN-2007 the patient developed injection site reaction. The reaction was described as an oval-shaped red area about 6 inches in size. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. 3/25/2010 Additional information has been received from the physician who stated that the patient received vaccine at another facility. No further information is expected.
Fever, headache, body aches, fatigue and itching.  Started night of vaccine and still continues as of today Feb 4th.  Treating with Tylenol.
Within 5 minutes lips started to tingle, arm started to hurt & become red, hot & swollen. Arm remained red & swollen for 6 days and itched.
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (which had a lot # of R003739 and an expiration date of 16-MAR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: below 32F°/0°C (-1.2C) for 21 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. Sender's Comments: US-009507513-1807USA006219: US-009507513-1807USA006220: US-009507513-1807USA006221: US-009507513-1807USA006217: US-009507513-1807USA006218.
Pt reports lightheadedness, tongue swelling, and difficulty breathing after receiving her vaccine.  She denies itching/rash on skin, but reports "itchy/tingling" pharynx.  On exam, there was no wheezing, no rash.     Epipen administered to R thigh @ 11:36am  Pt transported to ED by EMS at 12:05pm  Vitals as follows:  11:25am HR- 63 RR- 20 BP- 109/73 SPO2- 98  11:30 am HR- 67 RR- 20 BP- 115/74 SPO2- 97  11:36am HR- 79 BP- 110/75 SPO2- 99  11:38am HR- 103 BP- 111/76 SPO2- 97  11:41am HR- 79 BP- 107/73 SPO2- 98  11:46am HR- 85 BP- 111/72 SPO2- 97  11:51am HR- 87 BP- 111/75 SPO2- 99  12:00pm HR- 79 BP- 136/76 SPO2- 99
Stiff arm immediately, Stiff neck left side 24 hours after,   Shingles presents 48 ours after injection on scalp left side from center line top to neck coving all of hair line with touch sensitivity. Rash begins on left side jaw, cheek and under chin 24 hours later.  Rash continues to spread to all of scalp, and behind ear and around back of neck.  Blisters follow and pain increases.  First suspected an allergic reaction but after no response to Benadryl and  increased pain sought medical care and was confirmed Shingles.  Treaded with Valacyclovir and has responded well to treatment.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-MAR-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-SEP-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
In the middle of the night after the booster I woke up with a sore arm and I was feeling woozy as I walked to the bathroom to get a cold cloth.  I fainted.  The next day I was weak day.  I didn?t have any other symptoms other than the sore arm.  Around October 10, 2022, I began to have a stomachache.  Then on October 17th I had a doctor?s appointment and my doctor suspected gall bladder.  I had a test, but no gallstones were found.  I have another test scheduled soon.  The pain began as a burning like heart burn and then I had tightness in my abdominal area.  I had gas and didn?t want to eat.  As of today, I am able to eat.
severe h/a;rigors ultimately dx w/sinusitis (probably chronic & unrelated to acute sx);