chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tumor; Hysterectomy; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM (Tumor) and HYSTERECTOMY (Hysterectomy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM (Tumor) (seriousness criterion medically significant), HYSTERECTOMY (Hysterectomy) (seriousness criterion medically significant) and PAIN (Pain). At the time of the report, NEOPLASM (Tumor) had not resolved and HYSTERECTOMY (Hysterectomy) and PAIN (Pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant Medication use information was not provided by reporter.  On unknown dates, the patient experienced tumor and sore from covid vaccine. On an unknown date patient had Hysterectomy.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira for the event(s) of tumor was no reasonable possibility and for sore from covid vaccine was not provided.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns an adult female patient, with no relevant medical history, who received a dose of mRNA-1273 and experienced the non  serious unexpected medically significant events of neoplasm and hysterectomy. Vaccination date and onset date of the events were not reported; hence latency and temporal association cannot be properly assessed. No further clinical information regarding have been provided for medical reviewing. Co-suspect product included Adalimumab. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with no relevant medical history, who received a dose of mRNA-1273 and experienced the non  serious unexpected medically significant events of neoplasm and hysterectomy. Vaccination date and onset date of the events were not reported; hence latency and temporal association cannot be properly assessed. No further clinical information regarding have been provided for medical reviewing. Co-suspect product included Adalimumab. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received PNEUMOVAX to (R) deltoid on 5-10-11. Called 5/12/11 with (R) arm redness, swelling, pain, heat. Advised to be seen in urgent care or emergency room (where she is out of town currently).
Fatigue Pain at injection site Fever Headache Joint pain Malaise Musclepain Dry Throat
Itch and rash full body most intense in thigh, knee, chest, wrist areas. Started around 8pm till now (11:26pm) with no sign of stopping. Feels like my skin is on fire. No medical professional has been contacted at this point
Patient presented to ER afternoon of 2/19/14 c/o bad (L) arm pain. Needed medication. C/o syncope and dizziness. Admitted for observation. Significant tenderness and weakness in arm. Patient has hx of leukemia.
localized redness/inflammation @ inj site 3-4" & swelling of lymph node axillae lt, mild h/a;sx gradually resolved by 10/11/99;
No adverse reaction First dose given on 3/9/2021 and second dose given on 3/29/2021 given to soon. No signs and symptoms.
Swollen at injection site one week after vaccine. Severe itching and soreness, and swole about 3 inches in diameter
After receiving the Varicella vaccine, the patient passed out. His eyes rolled to he back of his head, his body went limp, then his arm muscles tensed/seized up. Patient came to quickly and was speaking normally but had cold clammy skin. Patient was advised to remain seated. Within 5 minutes, patient passed out again with similar symptoms as previous. Again, he quickly came to and was speaking and acting normally. Paramedics arrived and patient was found to be stable with no more episodes. Patient was released from care.
Patient notated she is here to receive 1st dose of any COVID-19 vaccine. After billing insurance, rejected claim said "Duplicate/Paid Claim". Looked on and patient's profile showed that she received multiple doses of Pfizer at various locations in. Received on 4/3/21, 4/24/21, 5/17/21, 6/7/21.
This is a prospective pregnancy report. This 34-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV .5 ml on 20th October 2014. The subject received Flu Seasonal QIV at week 20 of the pregnancy and during the second trimester of pregnancy. On 20th October 2014, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: The estimated delivery date was unknown. No adverse events occurred as a result.
Large (2.5 inch), raised, red, painful bump/welt at injection site.
Hospitalized 7/7/22-7/11/22 AKI, hyperkalemia, weakness, decreased appetite, dehydration, UTI, sepsis, respiratory failure, PNA, cough, SOB, + fecal occult blood, anemia, malaise, c-diff,
This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or 15-SEP-2015, the patient was vaccinated with ZOSTAVAX by a physician for routine adult health maintenance for the prevention of shingles (route and lot number not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was further treated for continuing and worsening symptoms on or about 11-OCT-2016. She was prescribed famciclovir and mupirocin 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, pain and suffering and other damages. The outcome of the events were unknown. Additional information has been requested.
The evening of the vaccination I began to experience some achiness in my neck and shoulders.  Overnight I developed a crushing headache, fever, the achiness spread to my entire body and I felt nauseous.  I also had the sore arm which was totally expected given the intramuscular injection.  I went to work the following morning but had to leave early as the symptoms continued to increase to an unmanageable level.  The headache intensified and the fever rose.  I couldn't lift my head to do anything.  I am now on the second day post-vaccination and most of the symptoms still remain but at a much more manageable level.  I did not seek any medical treatment for the symptoms, living alone and being as sick as I was I couldn't have even if I needed to.
Low grade fevers, fatigue, arthralgias with joint swelling, anorexia, and weight loss, starting about 3 weeks after his first COVID19 (Pfizer) vaccine. Cultures were negative, but inflammatory markers were elevated (ESR, CRP, ferritin). He also developed pancytopenia. His appetite recovered with steroids but he has continued to have unexplained weight loss (55 pounds since May). Restaging scans and bone marrow biopsy showed no evidence of recurrent mantle cell lymphoma.
Fever, severe muscle pain, exhaustion, nausea.  I was unable to get out of bed or eat  for 2 days, I'm now post vaccination 10 day's & still feeling fatigue.
Itchy mouth, ears, throat, back, forearms and ankles. Warmth to skin and redness in face, and arms and swelling in the hands. difficulty swallowing .  Ringing in ears
Receives Covid 19 Booster vaccine of Pfizer at vaccine event on 03/23/2022, starts to have side effects 03/24/2022 the next morning of Fever (101.0), headache, chills, and body aches. Taken Tylenol to help alleviate pain and assist with fever. Will Continue to monitor for the next 48 hours.
Shingles in my eye after 1st shot; Shingles on face after 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 4th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, 2 weeks after receiving Shingles vaccine and an unknown time after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-APR-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received first shingles shot and two weeks later got shingles on his/her face and in eye. The patient was now afraid to get the second shot. The patient was still treated for shingles on my 4th refill of Valtrex . Additional Supportive Information: The follow-up would not possible as no contact details were available. Note:From the narrative Hashimoto's thyroiditis seems to be preexisting condition, hence considered as concurrent condition instead of adverse event.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of properly stored M-M-R II therapy type rHA, lot # N009800, expiration date 24-MAR-2019 (also reported as 24-FEB-2019) (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA003734:
No symptoms until 10pm when I started to experience achey joints, sensitive skin, and sore muscles. 12am is when I started to experience a fever and took my temperature which was 101'F. The fever and muscle aches lasted until the following morning. Around 12pm is when I began expecting some stomach discomfort/sharp pains on the upper left hand side of my stomach. It began to increase in intensity around 4pm when I began to get nauseous. 5-6pm is when I began vomitting, and decided to go to the ER after the pain reached a level 8-9 and my face and limbs felt numb. I was admitted to the emergency room at 11:30pm and was given a CT Scan where it was discovered I had appendicitis. Wednesday evening I underwent surgery, and was discharged Thursday 4/15. I am still experiencing a slight fever and soreness at the injection site on my left arm.
Patient completed covid vaccine series on 4/2/2021.  Patient reported for pre-procedure covid testing on 5/24/21.  Results of covid test returned positive on 5/25/21.
Headache, Myalgia, Fever, Diarrhea,  fatigue
NOT FEELING WELL; HAD FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced not feeling well. On 06-MAR-2021, the subject experienced fever. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.5 F, 100.5 F. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of not feeling well was not reported. This report was non-serious.  Additional information was received from patient on 17-MAR-2021 following information was updated and incorporated into case narrative: Reporter details (name of the reporter), additional event (not feeling well) was added.
52-year-old female presents with chest pain and episodes of palpitations feeling lightheaded which she describes as dizzy and feeling visual spots. Patient has been lightheaded with standing more recently. She was working here in the food service area when she began to feel the symptoms and came to the emergency department for evaluation. Patient has been seen in urgent care last week and placed on Augmentin for sinus infection. She has had diarrhea since being placed on the Augmentin recently. She had an echo with some wall motion abnormalities, albeit smaller are, in the septum. Due to this and risk factors, she was advised to have an ischemic eval - due to COVID precautions and inability to get her HR to a target for a CTA, she had a cardiac cath with essentially normal coronaries (one report did mention "nonobstructive CAD" but the cath report does not mention lesions or stenosis). She will follow with cardiology.
Diarrhea started next day and continues; DOSE 1: bivalent: False; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2023 at 16:00 as dose 1, single (Lot number: EW0191), in left arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Colorectal cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Jun2023 at 16:00, outcome "unknown", described as "DOSE 1: bivalent: False"; DIARRHOEA (non-serious) with onset 16Jun2023 at 14:00, outcome "not recovered", described as "Diarrhea started next day and continues". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient did not experience COVID prior to vaccination. Patient does not have any allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Approximately 15 min after flu shot, patient feeling hot, dizzy, thirsty and said her throat felt like it was swelling EPIPEN administered. EMTs took patient to hospital she was given oxygen observed and released same evening.
breakthrough COVID-19 infection and hospitalization Dexamethasone PO qday x10 days Remdesivir x5 days
left arm is very sore, painful to touch and difficult to move; left arm is very sore, painful to touch and difficult to move; fainted /vasovagal syncope episode; might have convulsed on the floor; out of breath; nausea; dizziness; This is a spontaneous report from a non-contactable consumer (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6199) at the age of 24 years old as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication received within 2 weeks of vaccination included levonorgestrel, ethinyl estradiol (reported as "Levonor-E Estrad"). Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:15, Few minutes after vaccination patient fainted and might have convulsed on the floor. Patient became conscious after a couple min. Patient had spouts of nausea and dizziness. 2 hr after dose (11Mar2021) patient was out of breath and went to a hospital. Doctors suppose that the incident was a vasovagal syncope episode. After 18 hr (12Mar2021) patient's left arm was very sore, painful to touch and difficult to move. The events resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient lost consciousness and appeared to seize. He came back to in approximately 10-15 seconds. EMS came and did not think he had a full seizure.
pt to hlth dept 15OCT97 24hr p/vax w/area of redness/warmth/induration measuring 5x10cm;T102.6;consulted w/pediatrician advised to apply warm compresses & given APAP for fever;pt seen by pediatrician 16OCT97 48hr p/vax w/swelling & redness;
Vaccine provider had difficulty pushing in flu shot to left deltoid using 23g 1" needle.  Then, when finally pushed with much needed pressure, I had immediate immense pain/burning/tingling up neck that lasted hours. Now having shoulder pain, decrease ROM in shoulder, getting worse.
Started with headache on the 4th of November; on the 5th of November started to be nauseated on and off throughout day. The 6th continued nausea plus stomach pains. The 7th was nausea. By Monday and Tuesday the 8th and 9th symptoms began to taper. Headache, nausea, pain abdo, dizziness, fever
Lemon size bruising and knot at the injection site of left arm. Breathing difficulties, cough, headache. Z-PAK and albuterol treatment.
Tdap vial was attached to a faulty needle. The injection leaked out through the vial/needle junction site. It appeared as though all of the vaccine dripped out from the junction site, however the patient may have received some of the Tdap vaccine through the tip of the needle. An additional Tdap vaccine was given 2 inches above the previous insertion site on the right deltoid.
Localized Swelling, Erythema, Tired, Dizzy, Achy  Reported to clinic for reaction monitoring, Swelling decreasing without medication, no sign of infections   Will report back to us with any changes, good or bad. Being monitored as outpatient with medical supervision.
11/26/21 presents to ED for "shortness of breath". PMHx of "adenocarcinoma of thyroid status post thyroidectomy, left renal cell carcinoma status post partial nephrectomy, coronary artery disease and end-stage renal disease"
Few hours after vacc. Pat started having arm stiffness followed by next day pain, heat and swelling  for 3 days. Applied arnacan medication to arm for relief. Felt achy day 2 .
Pulmonary embolism resulting in atrial fibrillation with rapid ventricular response. Hospital treatment  included IV anticoagulation, IV anti arrhythmic medications, and subsequent cardioversion.
food taste like metal or metalic like right eye stopped blinking i can't make it blink also it tears up,also right side of mouth can't move also,face drooping,fore head on right can't move went to doctor they said i have bell palsy never had this condition berfore h1n1 flu shot.  01/07/2010 ED records received. Service date 11/06/09. Assessment: (R) Bells Palsy. Patient presents with (R) facial droop, difficulty closing (R) eye.
shortness of breath; tiredness; urine turned dark; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and her sister. This is first of two reports (for her sister).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter's sister experienced shortness of breath, tiredness and her urine turned dark on an unknown date. She's trying to report everything and trying to find out what she could about this. She would like to know if these side effects were normal and related to the vaccine and if they have been reported. The events were reported as not serious. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247575 same report/drug/AE, different patient.
Right hand and wrist were very swollen,  couldn't make a fist and barely move wrist, would last most of the day...then got better. I'm still having the problem with the very swollen hand and wrist...I will have this problem for the rest of my life, *** * mostly severe *when it swells, hard to move fingers and wrist, *very seldom* when it swells, easier to bend**, when very swollen my hand feels very strange and scary.
First symptom was pain at the injections site. A few hours later I developed a dry cough, then a fever of 102.3, chills, arm pain became severe (couldn't touch the entire upper arm). Injection site then developed cellulitis.
I received a stroke on the morning of April 7, 2021 , 13 days after my second vaccine shot on March 25.
Severe headache; Fatigue; Chills; Mild nausea; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration Date: unknown) via an unspecified route of administration in left arm on 04Mar2021 (age at vaccination was 48 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Mar2021, few hours after vaccination, the patient experienced severe headache, fatigue, chills and mild nausea. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Woke up with extreme lower back pain.  Could barely stand.  At 10:30AM took Flexeril to relax muscles.  No relief until 5:30 PM.  Still hurts, but not as extreme.
m.d. stated mom brought child in on 4/15 complaining of lethargy & temp of 104 & not eating the day of vax. 4/16 pt unsteady & temp of 104. broke out with rash 4/17 over trunk & legs. 4/28 pt fine.
Reporter states vax splashed in pts eye & when titers were drawn pt found to be immune to mumps & rubella but not rubeola;