chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Came down with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with covid) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with covid). At the time of the report, COVID-19 (Came down with covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported. The patient stated that got the regeneron antibody infusion treatment which was composed of 4 shots. The patient stated that was unsure of the waiting time after the antibody infusion whether it is 30 days or 90 days. and a nurse even told him that he may need to be restarted on the vaccination series.
Pt Rcd Pneumococcal vaccine in the ER on 6/18/09 in the Lt posterior arm.  Left posterior arm noted with red raised erthema, swollen and very warm to touch 15cm in length x 14 cm in width area. Pt states area is painful to touch.  Dr. made aware. Benadryl 12.5mg iv x1 given. Benadryl 12.5mg po q6hrs prn ordered.
Patient seen for initial allergist appointment 2/16/23 per the request of the COVID Medical Exemption committee at patient's employer. While there, Dr. "elected to proceed with vaccination using antihistamine pretreatment with the Pfizer bivalent booster vaccine given recent immunity developed from multiple infections."   Dr. states that, "in his expert opinion, patient should be considered up-to-date on her COVID-19 vaccination as of 2/16/23" although patient did not receive any primary doses. Employer requires that employees complete primary series of vaccines or apply and be approved for a religious or medical exemption. Currently, the Medical Committee is discussing whether patient would be required to obtain 2nd dose of vaccine (per CDC guidelines/employer policy) OR if Dr.'s physician statement of patient's "fully vaccinated status" will suffice.
After his vaccination, patient was waiting 15 minutes in waiting room. Patient knocked on door and said he didn't feel well. I closed door and turned to grab epi-pen and diphenhydramine. When I turned back around, patient fell on the floor and was unresponsive. I asked my technician to call 911. Patient regained consciousness in about 10 seconds and I told him an ambulance was coming. I observed his breathing to be normal. He sat up against the wall in a cold sweat and told me this has happened to him one time when he donated blood. The ambulance and paramedic arrived very promptly. They took him to the ambulance.
This spontaneous report was received from a pharmacist and refers to a 71 year old male patient with allergy to azithromycin. The patient had no medical history. On 18-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot# M038351, expiration date: 06-DEC-2017 (dose and route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) lot# reported as M044950, expiration date: 30-MAY-2019 (dose and route of administration were not reported). The patient's had no concomitant therapies. On 20-APR-2017, the patient experienced spotted blisters throughout his body, but mainly on face and legs. No treatment for the event was commenced. No laboratory diagnostic tests were performed. The outcome of the event was reported as not recovered. The causality between the event and ZOSTAVAX was not provided. Product quality complaint was not involved. Additional information has been requested.
Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.
Patient states that they are "feeling bad" that they are experiencing muscle aches, chills and a head ache but is afebrile. The patient was advised to take Tylenol 1000mg three times daily.
Information has been received from a nurse in a doctor's office concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient's hands and feet swelled and had itchiness at the injection site. The patient refused to come in for the second vaccine.  The patient recovered.  Unspecified medical attention was sought.
Lg (12cm x 8cm) wheal -erythematous area on left buttock.
Myalgia, Arthralgia, NauseaVomiting, arm pain, fatigue and chills Narrative:
Pt had numbness in his arm where flu shot was given, few minutes after he left the pharmacy- he called his doctor and the doctor explained to him it is a common reaction to the shot. Then pt was fine an hour after that.
Immunized 03/29. Developed pain and swelling at site, same day with progressive redness
Covid19 breakthrough.  1st vaccine received on 03/10/2021.  99 y/o with PMHX of HTN, HLD, CKD stage 3, peripheral neuropathy and recent fall with pelvic fracture presents to ED from SNF with c/o uncontrolled pain and oral thrush.  Pt afebrile, CXR -no acute process and requiring O2 at 2L NC.  Pt receiving IV hydration and pain management.
Patient reported dizziness, brought back to observation room, vital signs b/p: 202/104, pulse: 92, began to be jittery and stated she felt her throat closing and having trouble to breathe. 1535 administered epi pen 0.3 mg to left thigh, b/p: 210/122, pulse; 129, 911 called, also put her on oxygen, 1542 911 services got here and took over care and transferred patient out to nearest emergency room.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient reports she was diagnosed as having a vasovagal syncope to the pfizer covid vaccine at the ER
Inflammation and pain in arm pit, left arm, after second vaccine; Inflammation and pain in arm pit, left arm, after second vaccine; This is a spontaneous report from a contactable consumer(patient). A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO158) via an unspecified route of administration, administered in left arm on 11May2021 at 08:30 as DOSE 2, SINGLE for COVID-19 immunization(age at vaccination 25 years old). The patients medical history included melanoma from Feb2019 to Apr2019 she stated that it was diagnosed about 2 years ago, in Feb2019 and the Melanoma was fully removed by Apr2019. The patient's concomitant medications was not reported. The patient previously took contraceptives from an unknown date and for an unspecified reason. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration, administered in left arm on 20Apr2021 at 08:30 as DOSE 1, SINGLE for COVID-19 immunization. No additional vaccines administered on same date of the Pfizer Suspect. No emergency room visit and physician office visit was reported. The patient did not receive any vaccine 4 weeks prior vaccination. On 12May2021 the patient experienced inflammation and pain in arm pit, left arm, after second vaccine. Additional Context: Caller is calling about the Pfizer Covid 19 vaccine. she experienced an inflammation and pain, in the arm pit, of the arm that she got her vaccine. Caller stated she read online that it was a common side effect, and 15 percent of people experienced swelling of the lymph notes. Caller reported that she has a history of melanoma, and she wanted to know if she should call her Oncologist. Caller asked should she be concerned or is there any action that she would need to take? Caller agrees to complete a safety report. The outcome of the event was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Swelling, warm, redness, temperature of 100.5 F. Tx: Cool compress. Child continues to play, and is acting normal and is walking with no problem.
Half an hour after the dose was administered, I began to feel numbness and pain in my arm, as the hours passed the pain intensified to the point of not being able to mobilize the arm in a normal way. body began to feel that it was very uncomfortable to fall asleep. At dawn I woke up with a lot of pain in the rib cage, however I went to work, being at my place of work I began to feel without strength to stand, with a lot of headache and chills. I left the workplace and came home to bed and from there, fever and general discomfort in my body. Until today I am still resting, it should be noted that today I have not had a fever, the pain in my arm is less but the pain in the body continues.
One week after my blood sugar values began increasing to between 200-300 ng/dl after 2 in the morning..  was consistent for 6 days thus far. It bothered me so that I contacted my Endocrinologist for help
Information has been received from a nurse concerning an 8 week old patient without any pertinent medical history who at approximately 11:00 in the morning of 15-APR-2009 was vaccinated with a 0.5 ml/0.5 mcg dose of RECOMBIVAX HB. Concomitant therapy included a dose of PENTACEL. In the afternoon of 15-APR-2009 the patient was found to be dead. It was reported that the patient sought medical attention before death. Additional information has been requested.  9/4/09 Autopsy Received DOD 4/14/09 - Sudden Infant Death Syndrome. Manner of death natural. Addtional information abstracted: Found supine and unresponsive on mattress. Grossly unremarkable 2 month (10 and 3/7th weeks) old male infant. Pulmonary edema. Rare epicardial and pleural and scattered thymic petechia. Simian crease of left palm.
arm soreness; swelling; lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), SWELLING (swelling), PYREXIA (fever) and LYMPHADENOPATHY (lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a, 046b21a and 008b21-2a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), SWELLING (swelling) and LYMPHADENOPATHY (lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 12-Jan-2022 for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) on 13-Jan-2022 for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), SWELLING (swelling), PYREXIA (fever) and LYMPHADENOPATHY (lymph nodes swelled in her armpit/swelled lymph nodes on her neck and groin/lymph nodes are getting swelled again) outcome was unknown.            No Concomitant medications were provided.  Patient took anti inflammatory and felt better. Patient experienced fever on the 12th and 13th Jan 2022.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received contains NNI.
Felt like fever but its normal 98.6F; Shoulder hurts; Gave her chills; headache; Arm hurt where she got the vaccine left arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt like fever but its normal 98.6F), ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Lot number ET7534, 1st dose, intramuscular route) on 22-Mar-2021, Pfizer Biontech Covid-19 vaccine (Lot number EW0151, 2nd dose) on 12-Apr-2021, Pfizer Biontech Covid-19 vaccine (Lot number 300308D and booster dose) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine, Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 05-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2022, the patient experienced FEELING ABNORMAL (Felt like fever but its normal 98.6F). 05-Jun-2022, the patient experienced ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm). At the time of the report, FEELING ABNORMAL (Felt like fever but its normal 98.6F), ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive (Positive) Positive. On 05-Jun-2022, Body temperature: 98.6 (normal) 98.6 F which was normal.         Patient had no allergy or acute or chronic condition at time of vaccination. Patient weight was 177.  No concomitant medication was reported by reporter.  Patient got 2nd booster.  Events did not cause patient to seek medical care. Patient had experienced similar event in past for one Pfizer.  No treatment medication was reported by reporter.
PRESSURE ON CHEST; COULD NOT GET OUT OF BED; TIREDNESS; This spontaneous report received from a patient concerned a 33 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, non smoker, and allergic to aspirin, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced could not get out of bed. On 13-APR-2021, the subject experienced tiredness. On 14-APR-2021, the subject experienced pressure on chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and the outcome of pressure on chest and could not get out of bed was not reported. This report was non-serious. This parent/child case is linked to 20210436123.
Patient admitted and treated for respiratory insufficiency, CHF, hypotension, AKI, metabolic acidosis, and hyperuricemia
Admit w/ SOB x2 weeks, dx with COVID pna. Fully vaccinated 4/2021. Steroids, bipap/O2, zinc, singulair, vit-c., tocilizumab, remdesivir. Intubated 8/11. Eventually improved, weaned to RA and discharged home.
unable to move arme due to increase in pain; Arm was very painful at rest; my arm still throbs; Terrified of what the second one WILL DO to me.; arm swollen; Arm was hot; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision (removed lymph node from other side).   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection. The patient was treated with ibuprofen and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Shingrix, the patient had warm or hot and swollen arm at least 2 inches from injection site for 4 weeks. The patient reported that, the arm was very painful at rest and almost unable to move due to increase in pain. The patient reported that, at the time for 2nd shot, the arm was still throbs, especially after doing normal movement and would needed to had shot in same arm as, the he or she had lymph nodes removed from other side. The patient had treatment with ice and ibuprofen, which minimally hepled. The patient did not have shingles, but was terrified for what the 2nd dose would did to him or her.
got the 2nd shot- am still having itching issues; This is a spontaneous report from a contactable consumer (Patient).   A female patient of unknown age (reported as age: 80; unit: unknown) received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6208 and expiry date was not reported), via an unspecified route of administration into left arm on 25Mar2021 as dose 2, single as COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included: known allergies to sulfa, penicillin and Macrobid. Concomitant medications were not reported. The patient did not receive any vaccine in four weeks of Covid-19 shot. The patient received other unspecified medications in two weeks of Covid-19 shot. The patient was neither diagnosed with covid prior vaccination nor tested for covid post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EM9809) via an unspecified route of administration into left arm on 25Feb2021 at 01:45 PM as dose 1, single for Covid-19 immunization. 5 days after 1st dose started to itch on torso on 02Mar2021 and started to abate till got the 2nd shot and was still having itching issues since an unspecified date. The patient was treated with topical creams and outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Heart Palpitations, chest pain, tachycardia, hypertension, chest spasms and bruising. Heart attack like symptoms. Body aches and Covid-like symptoms.
Pt recvd DTP/HIB/MMR 24APR & devel swelling lt arm; area of redness & swelling about 4" around inject site; Seen by MD was told should not get DTP in future;
I had soreness at the injection site for two days. On 12/01/2022, I started not feeling well with a cough, upper respiratory issues and gastro issues. On 12/02/2022, I tested positive for COVID-19 with a home test. I had a telehealth visit with a provider on 12/03/2022 and got a prescription for Paxlovid. On day two of taking Paxlovid I was feeling better. I rebound the following week as I was warned.
Information has been received from a pharmacist concerning a 4 year old male pt whose mother reported the pt was vaccinated "at the suggested age" (exact date not reported) with a dose of MMR II. The pt was diagnosed with autism after receiving MMR II. Unspecified medical attention was sought and treatment was required. The pt has been treated through the state health program for speech and language development, behavior and occupational therapy and other therapies. Autism was reported to be disabling. Additional info has been requested.
BLOOD IN STOOL; RASH ON FANNY; CHILLS; FEVER; HEADACHE; BODY ACHES; BACK ACHE; This spontaneous report received from a parent concerned a 23 year old, white, and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the patient had body aches, chills, fever, headache and backache (low back pain). On 12-APR-2021, Monday, she felt better but experienced backache again on 13-APR-2021, Tuesday and felt better later that day. On 14-APR-2021, at night she had weird rash on fanny and also had lower back pain. On 15-APR-2021 morning, she had blood in stool and again experienced backache (pain in the lower back).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 13-APR-2021, and had not recovered from back ache, rash on fanny, and blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432632-Covid-19 vaccine ad26.cov2.s -Blood in stool. This event(s) is considered unassessable. 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).
patient received expired dose of Act-HIB/No AE; Initial information received on 29-Jun-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 15 months old male patient (also reported as 13 months old) was vaccinated with a 0.5ml dose of HIB (PRP/T) VACCINE [ACT-HIB] which was already expired (lot UJ112AAC and expiry date: 21-JUN-2020) via unknown route in left arm on 29-Jun-2020 for prophylactic vaccination (expired product administered).  Medical history,medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL CONJUGATE VACCINE (PCV).  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  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.