chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the covid 19 vaccine January 19th (Tuedsay) at 1:00pm. Started having lip and eye swelling around 6pm and by 9pm she went to the ER after her throat started swelling and she was having difficulty breathing. Says the ER MD gave her a shot benadryl. Also got a prescription of prednisone 20mg 2 tablets daily for 5 days which she has been taking. Swelling resolved but then her eye started to swell last night as well as her lips so she went to the Instacare. Said the doctor told her to stop all her medications but the metformin.  reports the last dose of humira was Sunday January 17th and she gets a dose every 3 weeks. Also had covid disease in November the week of Thanksgiving.  Spanish speaker. Had an official translator for this infomation.
no adverse event; patient was supposed to take the 2nd primary shot, but received Bivalent booster on 27DEC2022 (Lot# AS7168B MFG Expiration Date: 08Jun2023 ).; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was supposed to take the 2nd primary shot, but received Bivalent booster on 27DEC2022 (Lot# AS7168B MFG Expiration Date: 08Jun2023 ).) and NO ADVERSE EVENT (no adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was supposed to take the 2nd primary shot, but received Bivalent booster on 27DEC2022 (Lot# AS7168B MFG Expiration Date: 08Jun2023 ).). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was supposed to take the 2nd primary shot, but received Bivalent booster on 27DEC2022 (Lot# AS7168B MFG Expiration Date: 08Jun2023 ).) outcome was unknown and NO ADVERSE EVENT (no adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was supposed to take the 2nd primary shot, but received Bivalent booster on 27DEC2022 (Lot# AS7168B MFG Expiration Date: 08Jun2023 ).).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Right anterior thigh with bruising and patchy erythema 3x4cm raised lesion.
Pain, Redness, Swelling, Itching since  about four hours after the first vaccine dose. Very hard spot in arm injection site. Pain all night and most of day, hard to move right arm without pain. No other sickness or fever. Injection site however is hot, and remained such so far. Current time is about 72 hours since onset of reaction. I circled a pen around the spot after 48 hours so I could monitor it. It does not appear to have gotten larger thankfully, but itches a lot now at 72 hours. Redness does appear less bright, and the hard area appears to have softened slightly. This affected area is about a 2 to 2 and half inch diameter circle on right arm. The hotness extends to the entire upper arm basically and the pain the same. At times my lower arm aches.
Severe soreness in right arm. Difficult to move past parallel. Had to continue movement to loosen up.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02) via an unspecified route of administration in the right arm on 21Apr2021 at 16:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) and multivitamin (MANUFACTURER UNKNOWN) both were taken for an unknown indication from an unknown date and unknown if ongoing. On 22Apr2021 at 06:30, the patient experienced severe soreness in right arm, difficult to move past parallel where he had to continue movement to loosen up. He also reported that he never experienced such soreness after an immunization in his life. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe soreness in right arm and difficult to move past parallel, had to continue movement to loosen up was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
got shingles shot, then had shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles shot, then had shingles) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 The patient got the shingles shot and then had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
large lymph node under her vaccinated arm; A spontaneous report  was received from an HCP concerning an unmentioned age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced large lymph node under her vaccinated arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-JAN-2021, prior to the onset of the events, the patient received their first of the two planned dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 22-JAN-2021, the patient experienced large lymph node under her vaccinated arm. No lab details provided. No treatment information provided. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event large lymph node on vaccinated arm was unknown. Agent attempted callback, no answer. Filing with limited information.  The reporter assessed the event, [large lymph node on vaccinated arm] as listed to study drug.
*right arm sore the night of injection, resolved within 36hrs *dull headache behind eyebrows off & on starting 3-4 days post injection, still happening on day 9 post injection, have not taken anything to resolve it *red, raised, warm to touch, itchy hive on right, upper arm.  started 8 days after vaccine given, going on day 2 will use hydrocortisone cream
Started about 11:30am on April 16th, shortness of breath, heart rate in the 120s, chest pain, and headache I called my campus health services and they instructed me to go to the ER. I had a positive d dimer and was given a contrast CT scan which turned out negative for blood clots. Still experiencing the same symptoms as of 8:30pm April 17th.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 05 February 2013. A 27 year-old male subject with no significant past medical history was found to have acute pericarditis, unspecified 14 days after the subject had received on 19 November 2012: an injection of ACAM2000 (lot number, route and site of administration not reported). On 01 December 2012, the subject was diagnosed with acute myocardial infarction, unspecified site (reported as ICD-9 code 410.9 Unspecified site) and other and unspecified acute myocarditis. On 30 November 2012, the subject was diagnosed with other primary cardiomyopathies and non-specific myocarditis. Relevant laboratory data on 30 November 2012 included: an abnormal Troponin I recorded highest value of 16.75, an abnormal ECG and an abnormal Echocardiogram. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Mother called and stated on the day of vaccination the site was red and hot. The next night there was a raised rash that extended to just above elbow. Mother gave BENADRYL on own.
Sore arm and mild swelling at injection site, starting about 12 hours after vaccine administration, and lasting about 30 hours.. Mild headache, achy joints, fatigue starting about 20 hours after vaccine administration, and lasting about 24 hours.
Hospitalization due to COVID 19 on 9/8/2021. Reported per Janssen vaccine EUA.
Hard, painful lump immediately after vaccination. Within two days, the redness, induration, and pain spread to the elbow. Pain radiating from elbow to neck. Pain exacerbated by adducing and/or raising arm over the head. On 11/07/2022, visited primary care physician, explained event,  had an xray performed, and received an anti-inflammatory injection in her hip.
Patient had a syncope event after the meningococcal immunization.  I had administered the 3rd Covid dose and did the menactra.  We put him supine and obtained a set of vitals, mom went to get him a apple and juice. Vital WNL. I put a cold rag on his forehead while mom went to get something for him to eat. I stayed with him during that time. He was alert and oriented x3, his color was much better and we kept him here at the office until he knew he could stand and not feel weak.   We did not administer the other two immunizations that he was going to have today.
COVID Vaccine Breakthrough Case  Moderna Dose 1 7/15/21 Moderna Dose 2 8/17/21 COVID Positive 10/13/21 COVID Positive 10/15/21  10/15/21: -Patient is a 44yo female with medical history of Asthma, allergic rhinitis  , Anxiety/Depression , GERD , DMT2 ,HLD,  DVT/ PE , Iron deficiency anemia, Obesity, Former smoker.  -She is a transfer from ER for severe asthma exacerbation requiring intubation and sedation .  -She recieved 10mg IV decadron, duoneb treatment x 2, total 4g magnesium  -ER provider consulted pulmonary  -Latest VBG with PH 7.43, pCO2 39, pO2 41 . Otherwise rest of labs unremarkable  -Vitals remarkable for systolic BP 130-140 and diastolic BP 80s-100, HR 96-100, RR 20s, currently saturating > 95% on 60% FIO , tidal volume 400, PEEP 7 .  10/23/21: As noted patient was admitted for severe asthma exacerbation requiring intubation, was admitted to ICU started on Solu-Medrol, nebs, antibiotics pulmonary/critical care was consulted.  Was able to be extubated on 10/18 moved to medical floor, steroids titrated down, breathing treatments spaced out.  Patient was eventually weaned off oxygen to room air.  Will be discharged on a prednisone taper and complete course of empiric Levaquin.  Was also noted to be COVID-19 positive not completed course of remdesivir, has been vaccinated with Madonna vaccine on August 2021. During course of admission also was noted to have mild hydronephrosis some back/flank discomfort.  Urology evaluated patient cystoscopy with right ureteral stent placement on tele on/21, Flomax.  Acute symptoms resolved, stone has not passed yet however patient will follow-up with Urology on disposition for longitudinal management.  Otherwise patient on room air not requiring any supplemental oxygen on O2 walk.  All ED and RTC precautions have been provided to patient, endorses understanding and agreement with plan as outlined.  COVID precautions have also been provided to patient along with quarantine.  Small amount of analgesics for 2 days provided status post stent placement.  Was initially managed on heparin infusion bridge back to Coumadin INR therapeutic prior to disposition.  Will check INR in lab work on discharge follow-up with PCP.
was in bed / got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles and was in bed for almost two days.  The reporter asked was it too soon and said to wait a year.  The reporter asked was that why got so sick and should get the 2nd dose.
This case was reported by a pharmacist and described the occurrence of vaccination site abscess sterile in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown details). At an unspecified time after vaccination with ENGERIX B, the subject experienced vaccination site abscess sterile (described as "sterile-site abscess"). No further details were provided at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Vaccine against papilloma GARDASIL was in January 2017. My daughter received it and later in February she got Influenza B and later in May started to feel bad, diarrhea, stomach pain and L-sided pain. Labs were performed with elevated sed rate of 40 and C reactive protein. In August a colonoscopy and endoscopy were done and indicate inflamed bowels and possibly Crohn's disease. The same vaccine specifies patients have reported autoimmune diseases and thus is urgent that the vaccination and use stops and the company is forced to warn of the risks. I need you to provide guidance so that I can send evidence.
Client had history of fainting and refused to lie down. Mother had mild reactiion. Client felt tingling in throat after injection, had Benadryl 25mg in pocket, took it and immediately felt better. bp 115/74, hr 99, pox 98%
Acute pancreatitis.  Symptoms first appeared on 04/21/2021 Wednesday morning. Diagnosed with acute pancreatitis on Thursday 04/29/2021.
3 1/2 X 1 1/2 CM ERYTHEMA, RAISED AREA ON RIGHT UPPER ANTERIOR THIGH.
Arm pain/ throbbing in arm; Arm feels weak from elbow to shoulder; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain/ throbbing in arm), MUSCULAR WEAKNESS (Arm feels weak from elbow to shoulder) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain/ throbbing in arm), MUSCULAR WEAKNESS (Arm feels weak from elbow to shoulder) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm pain/ throbbing in arm), MUSCULAR WEAKNESS (Arm feels weak from elbow to shoulder) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported  No treatment medication was reported
Pt. developed varicella zoster after immunization. Adm IV acyclovir and isolation.
Left thigh large area of redness, swelling extended from front of left thigh, extending to the sides, tender to palpation.
Has not been able to work; Extreme brain fog; Extreme hair loss, Hair loss is continuing through today; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog), ALOPECIA (Extreme hair loss, Hair loss is continuing through today) and FATIGUE (Extreme fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog), ALOPECIA (Extreme hair loss, Hair loss is continuing through today) and FATIGUE (Extreme fatigue). At the time of the report, IMPAIRED WORK ABILITY (Has not been able to work), FEELING ABNORMAL (Extreme brain fog) and FATIGUE (Extreme fatigue) outcome was unknown and ALOPECIA (Extreme hair loss, Hair loss is continuing through today) had not resolved.            No Concomitant medication was reported. No treatment medications were reported. Patient reported that after second dose she felt extreme fatigue, extreme brain fog, extreme hair loss, reactions were so bad she had to drop out of her studies at school, her doctor may have thought she had a stroke but was not sure. Brought in an ambulance to the ER but not hospitalized.   This case was linked to MOD-2021-334639 (Patient Link).
Information has been received from a physician concerning a 74 year old male with no medical history who on 10-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 22-MAY-2007, the patient developed shingles and went to the emergency room and was released with a prescription for seven days of FAMVIR therapy.  On 30-MAY-2007, the went to the physician's office and was given an unknown antiviral medication.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing
Received 2nd Bivalent booster within 3 months of original bivalent booster
Information has been received from a licensed practical nurse concerning a 71 year old male with penicillin allergy and a history of diabetes mellitus and coronary artery disease who on 10/16/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651404/0352F). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). On 10/16/06, the pt experienced swelling and itching over the injection site after vaccination with Pneumococcal 23v polysaccharide vaccine. This was the pts second vaccination with Pneumococcal 23v polysaccharide vaccine. The pt was treated with antibiotics and antihistamines. Subsequently on an unspecified date, the pt recovered from swelling and itching over injection site. Swelling and itching over the injection site were considered to be other important medical events (OMIC). Additional information has been requested.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient received the Janssen covid vaccine on 31-MAR-2021 then travelled on 17-APR-2021. On 18-APR-2021, the patient went to get tested, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-MAY-2021, patient was tested again using a Polymerase chain reaction (PCR) test and it was found out that the patient was positive (confirmed covid-19 positive and confirmed clinical vaccination failure). It was reported that the patient was asymptomatic and did not exhibited any signs of a Covid 19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 positive was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178236.; Sender's Comments: V0:20210502752- COVID-19 VACCINE AD26.COV2.S-CONFIRMED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I had my vaccination on 10/15/2022. On 01/08/2023 I started to have a really bad shooting pain in back that went down right leg. This included weakness and numbness. I did a course of steroids and I finished that medication. It is still present on 01/18/2023. I am going to start physical therapy on 01/23/2023.
Fatigue, headache, body aches, chills, fever (101.9)  and nausea
visits on 2/16/20 positive for influenza B, admitted she has been having a productive cough of brown sputum, dyspnea, fever/chills, poor appetite, body aches since roughly 7-10 days ago which would be about the time of her 2ND COVID Vaccine. Also had visits on 2/23,3/01 for similar complaints. Tested negative for SARS COV-2 through PCR on 3/1/21. tested positive on 3/7/21 through PCR.
Vertigo; Tinnitus; Face tingling; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 07:00, the patient experienced vertigo, face tingling and tinnitus which was constant and has lasted 16 days now. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with unspecified anti-anxiety medications. The clinical outcome of the events vertigo, face tingling and tinnitus were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.