chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very painful, very enlarged lymphnode in left armpit.; Very painful, very enlarged lymph node in left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 13Apr2021 at 17:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication included neora fit supplements from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 10:00, the patient experienced very painful and very enlarged lymph node in left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events very painful and very enlarged lymph node in left armpit was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shortness of breath, felt like something was sitting on my chest. Heart rate was 120bpm at rest. Felt very anxious was having problems breathing. Shaky and weakness all over body. Faint feeling and anxiety feeling.
Pt received initial Moderna vaccine at 1406 in left deltoid. Escorted to observation with RN for 30" wait time due to hx of multiple severe allergic reactions. At 1417 pt complained of "itchiness in throat" followed by subsequent throat tightening. Pulse 130, SaO2 98% on room air. Pt states she has history of postural orthostatic tachycardia syndrome and that she in not to receive epinephrine. No rash noted on body; no obvious airway swelling. Pt stated that she felt nauseous and began to vomit. Benadryl 50mg IM right deltoid given at 1424. Throat tightness initially not worsening and pulse down to 104 after emesis and Benadryl; SaO2 99% on room air. At 1427 pt states that she feels that tightness was starting to increase again. Decision made to call EMS. Call made at 1428. BP 146/102, pulse 110, SaO2 98 % on room air. EMS arrival at 1435. Report given to paramedics. Pt transferred out on stretcher, stable at 1440.
Patient with "not detected" PCR test upon admission to hospital, however, patient reported a positive antigen test for COVID at home that same day and was symptomatic for COVID infection, hypoxic, and received supportive care for COVID.  Provider d/c note:  "presented to ED on 9/28 with complaint of cough and SOB. Evaluation found her to have RLL infiltrate. She had a positive covid test at home on 9/26, but respiratory viral panel was negative for covid as well as other viruses. She required more than nasal cannula support and was transferred to progressive care for treatment inpatient. Treated with iv azithromycin and ceftriaxone for RLL infiltrate. As clinically behaved like acute covid and was hypoxic, she was treated with iv remdesivir and dexamethasone. She required 100 % fio2 for first day then was able to wean down FiO2 and from nonrebreather to nasal cannula at time of discharge. Eupoxic at rest on room air day of discharge. Home oxygen will be prescribed if walk test causes desats. Stable for discharge to home. Switched to oral ceftin for remainder of treatment for RLL pneumonia."
About a week after receiving the flu shot, got sick with the flu. It lasted about 4 days. Fever, malaise, severe sore throat. Now I am sick again about a month later. Bad cough, fever, malaise. Taking lots of vitamins and tylenol, which seem to help some. For year when I was not forced to take the flu shot, and did not take it, I never got these symptoms. I am a very active, healthy person in general. I was forced to take the shot because of my work. Please do not force health care workers to take this ineffective, miserable shot. It should be against our rights to demand this.
When the shot was given, the vaccine sprayed out of the syringe on to my arm and door of my car. When the nurse pulled back on the syringe the needle component stayed in my arm and more of the vaccine ran down my arm.  Needle was properly handled and locked once removed.
This spontaneous report as received from a female physician via a company representative of unknown age refers to herself. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX, subcutaneously (dose, lot# and expiration date were not reported) in arm. On an unknown date, the patient's arm got red and swollen from the injection site to the elbow. The outcome of events was reported as recovered on an unspecified date. The causality was not reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 11 year old female patient with nasal allergies. On 08-SEP-2014 the patient was vaccinated with GARDASIL (Lot # J010668 exp date: 29-APR-2016) dose 1, 0.5 ml, intramuscular. Concomitant therapies included (unspecified), tetanus toxoid and MENACTRA. The Nurse reported that on 08-SEP-2014, the patient received, toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA first, just prior to GARDASIL and did not experience any problem. Then on same date the patient received GARDASIL as third vaccine on this visit and right after receiving GARDASIL, patient complained of being lightheaded and so patient was asked to lie down on the examination bed. While patient was lying down, nurse reported that patient had a few jerky movement of her body. No additional information provided. The outcome of the patient had a few jerky movement of her body and patient complained of being lightheaded was unknown. The relatedness between adverse events and GARDASIL was unknown. Additional information has been requested.
About 5 days after vaccination, I started experiencing low grade fever. chest congestion,  exhaustion, digestive issues.  I went for a COVID test which was negative.  Symptoms have gradually diminished except for exhaustion which continues.
blanchable erythematous pruritic rash to back, chest, abdomen occurring 1 week after vaccine and lasting a week at time of visit.  Looks like hives but does not come and go.  No resp concerns.
On 04/18/2021, I got vasculitis on my legs. I had it for several weeks. It was continuing to spread and get worse. They put on prednisone. But it coming back again. So they put me on a second round of Prednisone again. It's an autoimmune reaction that I have had before with antibiotics. The doctor believes it's from the shot but they are calling it idiopathic. And I have not had it before since my last round of antibiotics. I have not recovered from the AEs. I am currently being monitored. I am currently on Prednisone. It is being managed by Prednisone. I feel like my immune system was triggered by the vaccine. I have never had vasculitis before without the antibiotics triggering it. I feel it's a reaction to the vaccine that caused my immune system to flare up. I would completely get the vaccine again. I just happened to have had an adverse reaction to it.
Per PCP, The patient developed a blotchy itching rash primarily on the trunk two days after receiving the immunization. The rash appears to be fading. Today he had some s/sx of possible Pityriasis rosea( I saw a possible herald patch). Treated with topical steroids.
Information has been received from a physician concerning a 14 year old female who on approximately 23-MAR-2007, was vaccinated intramuscularly with a first dose of Gardasil vaccine (yeast). On approximately 23-MAR-2007 the patient fainted. The patient did not seek medical attention. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/11/2007. Initial and follow-up information has been received from a physician concerning a 14 year old female who on 12-MAR-2007, at 16:30 was vaccinated intramuscular with a first dose of GARDASIL (lot #654510/0962F).  Concomitant therapy included ZYRTEC.  On 12-MAR-2007 the patient experienced syncope following vaccination.  The patient was given water and trail mix.  Te patient also experienced loss of consciousness for a few second.  She fell inito a chair in the waiting room and developed a bruise on her left stapula.  The patient was observed for 20 minutes.  On 12-MAR-2007 the patient recovered.  Additional information is not expected.
BLOOD CLOTS; This spontaneous report received from a consumer via media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event following vaccination with covid-19 vaccine (dose number series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that I know of a person that got the booster and died that night from blood clots. I have no reason to lie, everyone that works with this person knows what happened and why. It was the 3rd shot. This person was a supervisor, got his shot and didn't come back to work ever again. On an unspecified date, the patient experienced blood clots (dose number in series 2). On an unspecified date, the patient died from blood clots. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220224715-COVID-19 VACCINE AD26.COV2.S-blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOTS
Cough that won't go away, runny nose and no I do not have covid. These symptoms didn't persist until a WK after I have taken the vaccine.  Now I refuse to have the second shot.
pt recv vax; approx 6pm rash started all over body; itching, HA; rash is raised & appears blistered on hands & elbow areas;on f/u mom stated pt saw MD & felt rash was due to diarrhea med;
pt became very nauseated after vaccine. Pt also stated he did not eat today prior to vaccine. Pt BS checked and VS WNL. Watched by physician and monitored for 20 minutes then felt better.
Patient was given immunization at 7:30 am 1/12/16, by the afternoon arm was sore, by the evening movement was painful, by the next morning pain started moving down her arm. Swollen and redness.
9/7/13 12pm - pt had rash 2 inches south of injection site that was hot, not itchy, but red 9/7/13 12pm - Rph recommended hydrocortisone cream and see MD on Monday if not resolved.
Localized erythema 10 x 15 cm with pruritus and mild pain. No vesicles. No fevers or chills. Resolved over 5 - 7 days.
Presents for acute SOB, positive home COVID test same day. Admit for acute hypoxemic respiratory failure due to COVID & afib RVR. Tx: O2 via NC, decadron, remdesivir, abx, zinc. DC to rehab.
This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207) via an unspecified route of administration in the right arm 18Mar2021 at 08:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included colitis and possible lupus. The patient did not receive other medications within in two weeks of vaccination. The patient was allergic to biaxin. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 19Mar2021, the patient had chills, sweats, headaches, uneasy feelings and loss of appetite for four days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, sweats, headaches, uneasy feelings and loss of appetite was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Narrative:  Pt was a 78 year old male with pmmhx of chronic hyponatremia, CKDIII paroxysmal afib , COPD, HTN, DMII, HLD and chronic anemia presented to the ED via primary care office to "have his gallbladder removed" admitted to MICU for HAGMA 2/2 lactic acidosis and hyponatremia. After imaging and workup, pt was diagnosed with metastatic cancer and discharged with home hospice.
burning sensation on her tounge; breast tenderness; tongue; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. On 26th April 2019, 1 days after receiving Shingrix, the patient experienced burning sensation, breast tenderness and tongue discomfort. On an unknown date, the outcome of the burning sensation and breast tenderness were not recovered/not resolved and the outcome of the tongue discomfort was unknown.   It was unknown if the reporter considered the burning sensation, breast tenderness and tongue discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. The day after patient received the vaccine, she developed a burning sensation on her tongue and breast tenderness (both breast). The reporter consented to follow up. There is a discrepancy with respect to the outcome of the events burning sensation and breast tenderness and the event tongue discomfort. In the database the outcome is reported as not recovered for both events, however in provided source document it is recovering/resoling. The outcome of the both events retains as per the database structural field. And the event tongue discomfort is reported in the structural field in the database, however there is no mention about the event tongue discomfort in the source document. Retain as per reported.
Forearm rash, leg rash, ankle rash, foot rash, foot and ankle swelling
Information has been received from a Caucasian registered nurse for the pregnancy registry for HPV vaccine, concerning a 23 year old female with sulfonamide allergy who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660553/0070X, exp: 22-OCT-2010) 0.5ml, intramuscularly. There was no concomitant medication. The nurse reported that the patient received her first dose of HPV vaccine and then discovered that she was pregnant. On 28-JUL-2008, the patient had a urine pregnancy test that was negative, and on 06-AUG-2008 she had another pregnancy test that was positive. The patient's LMP was on 25-JUN-2008 and the EDD is on 01-Apr-2009. No adverse event was reported. The patient sought medical attention at the physician's office. Follow up information was received on 27-AUG-2008 from a registered nurse which reported that the patient's LMP was on 27-JUN-2008. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL SWELLING (right sided throat swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Reaction to food coloring. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (right sided throat swelling). At the time of the report, PHARYNGEAL SWELLING (right sided throat swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-073668.
VACCINATION DATE NOT DOCUMENTED ADMITTED TO HOSPITAL 7/7/2021 WITH CONGESTION AND COUGH AND HYPERGLYCEMIA  TYPE 2 DIABETES
itching at injection site for 3 days and counting. I will use a topical and systemic anti-histamine to relieve the itching
pt recvd vax; immed exp pain & stiffness in arm;cont 4-6 hrs;arm hurts mostly at noc & early am;found to have pain in arm due to hep vax;tx ibuprofen & ice & warm moist heat;no pain since 26sep94;
Under age vaccination.  Vaccinated with Pfizer Comirnaty Adult dose at age of 11 years and 3 months.
Chills, fatigue and sensation of fever following injection. Still having daily sensation of fever with increased fatigue.
Pericarditis - developed severe burning sensation in the center and across my chest, went to urgent care for a chest x ray and was diagnosed with mild pericarditis.
The next day a raised red spot the size of a quarter at the injection site. By Sunday the back of her arm was pink and still had the red spot. On Monday she went to see her doctor to verify it wasn't cellulitis. Dr told her to use ice and take BENADRYL - just a bad reaction.
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt had dizziness, confusio, drop in BP and HR. called 911 and transfered to ER; pt did not receive any medication only monitored; pt had an anxiety attack and vegal reaction per ER staff-Severe, Systemic: Hypotension-Severe, Additional Details: pt had low BP and HR in 50s
Abdominal pain in alternating locations.  Lower Right side of abdomen and center lower section of abdomen. 3 nights of pain were bad, then gradually better
Patient was sitting in the waiting area after receiving vaccine and complained of feeling swelling in her throat.  Patient was escorted to the urgent care department, and was given epinephrine 0.3 mg.  After being observed for a couple hours, developed no further symptoms and was able to discharge.
Sore arm. Severe body aches for 24 hrs, then fatigue for 6 hrs.
I felt the vaccine in my arm immediately, as in my left hand felt odd less than 15 minutes after...no big deal; the rest of the day I felt achy and took Tylenol twice in the evening, including before going to bed - the achy-ness started around 2pm (after a 9:30am shot). The next day I was normal.  8 days later, on 3/30/21, the vaccine site started itching and became swollen, warm and red and I was even achy and lethargic again. Much more mild than day-of vaccine. I took Advil and felt much better. Today (3/31/21) I feel a bit lethargic, aches are gone, vaccine site still slightly swollen and sore.
Severe excrutiating bilateral shoulder joint pain and swelling in overall body joints making daily activities like reaching, squatting, twisting jars off caps, and typing for work almost impossible. Dull headache. Inability to sleep from pain. Motrin and tylenol, hot baths, and heating pad applied for several weeks. 5 days of 2, 200 mg prednisone tablets prescribed 12/21/22 resulting in shoulder pain diminishing but the side effect was extreme dizziness by day 5. After the drug ceased, have some overall swelling still but not the extreme shoulder pain and can resume activity.
This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no drug reactions or allergies who on 27-AUG-2013, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number J003806). The pharmacist reported that on 28-AUG-2013, the patient developed an injection site of a red rash. The area was also  hard to the touch and there were blisters. The pharmacist instructed the patient to take BENADRYL. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for injection site reaction, blisters, area was also hard to the touch and red rash and ZOSTAVAX was unknown. Additional information has been requested.
Chest pain developed 12 hours following administration . Presented to hospital on 4/13/21 diagnosed with pulmonary embolus.
Immediately following administration of vaccine patient reported symptoms of light headedness, nausea and clamminess.
FLUBLOK was given to a 17 year old patient/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (Reference number- 00351502) was received from the other healthcare professional and transmitted to Sanofi on 09-Nov-2020.  This case involved a 17 year old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Relevant medical history, medical treatment, vaccination and family history were not provided.  No concomitant medication was reported.  On 09-Nov-2020, the patient received a dose of 0.5 ml once of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ509AA and expiry date: 05-Oct-2021) via intramuscular route in the left arm for prophylactic vaccination (product administered to patient of inappropriate age as 17 year old female patient received vaccine) (latency same day).  It was reported that the vaccine was grabbed by mistake from the refrigerator and the provider wanted to double check if they needed to watch out for anything in particular since it was given too early.  No adverse event was reported at the time of reporting.  Details of laboratory data not reported.    It was a case of actual medical error as the vaccine was given to a 17 year old patient.  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 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.
The second dose of Moderna COVID-19 vaccine was administered 6 days after the first dose.