chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medication was not provided.  It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up.  Treatment information was not provided.
Within 15 minutes of Yellow Fever administration, patient experienced a significant Raynaud's phenomenon reaction to left hand. This was arm in which vaccine was administered. Patient did have a bilateral Raynaud's phenomenon to both hands, however only left hand displayed significant vasospastic responses with bluing color to palmar surface of hand and fingers. Patient was escorted to Emergency Room secondary to increased anxiety and feeling lightheaded.  Patient remained in ER for observation, lab tests to return, and was released to return home. No further signs/symptoms presented since.
Patient received COVID-19 vaccine (unknown which manufacturer or lot) and began noticing swelling in her cheeks and nose nearly immediately. She denies any SOB. Symptoms self resolved in about half an hour and she is currently feeling fine. She does have swelling if she takes Naprosyn containing products. Patient reports vaccine was given on 1/22/21 and second dose is scheduled for 2/15/21 and is not sure if this will be contraindication for her second dose.
Knot at injection site; Nausea; Headache; Neck pain; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE MASS (Knot at injection site), NAUSEA (Nausea), HEADACHE (Headache) and NECK PAIN (Neck pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046321A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INJECTION SITE MASS (Knot at injection site), NAUSEA (Nausea), HEADACHE (Headache) and NECK PAIN (Neck pain). At the time of the report, INJECTION SITE MASS (Knot at injection site), NAUSEA (Nausea), HEADACHE (Headache) and NECK PAIN (Neck pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication no treatment provided  Upon in internal review on 21 May 2021, the age was corrected to an unknown age.
Developed pericarditis. I?ve never had any heart issues in my life and haven?t been sick at all in many months. I had no colds or diarrhea or anything in over 6 months.
WEAKNESS - GENERALIZED GENERALIZED BODY ACHES SORE THROAT ALLERGIC REACTION
Vaccine was stored for greater than the recommended time post puncture of vial, vial was potentially stored for up to 28 days post puncture. No adverse effects, no illness
Tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 26Jan2021,14:45 (lot number: EL3247), at the age of 51-years via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient did not receive other vaccines within four weeks. The patient had no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was tested after the vaccination for COVID-19. The patient experienced tested positive for COVID-19 on 04Feb2021. The adverse events required doctor or other healthcare professional office/clinic visit. The patient did not received treatment. The patient underwent COVID-19 (Nasal Swab) test on 04Feb2021 which was positive. The consumer assessed the events as non-serious. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Left thigh 7x18 cm area of erythema, warm to touch, no abscess, no fever, no lymphadenopathy,
Patient up to date with COVID vaccinations who admitted with positive COVID test.  Provider d/c note:  "42 YO male with history of meduloblastoma (resection 1991 with VP shunt placement) admitted with acute intermittent confusion and blurred vision in setting of covid infection without hypoxia.  Patient placed on empiric levetiracitam for suspected complex partial seizures.  MRI showed meningeal enhancement on the left and cortical edema in the right occipital lobe (no recent MRI for comparison).  LP showed elevated protein only, with no nucleated cells.  No clinical or lab evidence of meningitis.  Neurology and ID consulted, considered high-dose IV steroid for covid cerebritis, though elected 60mg daily 5-day course given mild and improving symptoms.  No confusion episodes since starting Keppra. Problem list: Suspected partial complex seizure              -continue levetiracetam, follow-up with Neurology             -EEG negative, though no events during study Acute encephalopathy, blurred vision (chronic left visual field loss)             -consider Covid cerebritis, though with no lab evidence of acute inflammation             -prednisone 60mg daily to complete 5d course             -Follow with Neurology locally, will discuss follow-up MRI COVID infection             -respiratory and constitutional symptoms resolved, not requiring any specific treatment Chronic hearing loss History of medulloblastoma s/p resection and VP shunt             -shunt study unremarkable, case reviewed with Neurosurgery".
Severe muscle (deltoid) pain, weakness, unable to lift over head or lie on arm, 7 days after immunization. On-going. Referred to PCP.
Active Hospital Problems   Diagnosis ? Principal Problem: Unable to ambulate  ? Thrombocytopenia  ? Hypomagnesemia ? Frequent falls ? COVID-19 ? Normocytic normochromic anemia ? Elevated serum creatinine ? Alzheimer disease ? General weakness ? Fall ? Mixed hyperlipidemia ? Essential hypertension ? Coronary artery disease involving native coronary artery of native heart with angina pectoris   Resolved Hospital Problems No resolved problems to display.     o Labs reviewed o Next steps per discharge planning, needs 24-hour care at discharge o Titrated following, Zyprexa when necessary low-dose - PT/OT evaluation and treatment as needed - Activity progression as tolerated  - Nutritional assessment with optimal diet - DVT prophylaxis assessment -Bowel program as needed - Case management evaluation and discharge planning support
Swelling on the side of left tricep, felt hard and warm 20mm x 28mm.
Paresthesia starting in feet, moving up legs, also in left arm. Over the last several weeks, mostly in feet and lower legs but occasional throughout the body. No treatment provided besides waiting to resolve. Currently in 5th week of experiencing symptoms.
Information has been received from a CMA concerning a baby who was vaccinated po with a dose of ROTATEQ (date and dose not provided). It was reported that the baby coughed and spit up the dose of ROTATEQ while it was being administered. Outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Redness, swelling and pain at left deltoid site (site of injection).  Noted on 5/16/15 symptoms progressed with growing area of redness, new onset of pruritis on arm 5/19/15; then 5/22/15 rash to same area.  PREVNAR (not a choice on next page), Manufacturer: Wyeth Pharmaceuticals (Subsidiary of Pfizer; Lot #L62072    NDC: 0005-1971-01
This literature report (initial receipt 10-FEB-2011) concerns a 15 year old male patient with no medical history. On an unknown date, the patient received influenza vaccine. On the same day, the patient also received HepA vaccine. Seven (7) days post vaccination, the patient experienced new onset nonfebrile seizures. The event outcome was unknown. Reporter's comments: The reporter considered events to be serious. Case correction (16-Aug-2012): After internal review, it was noted that the company causality for the event was inadvertently captured. This has been corrected.
Pt reported swelling sensation of her "glands" (in anterior cervical, lymph nodes and a rash around her neck. None was noted on exam. Pt given BENADRYL 25 mg PO / 10 min later pt reported she was better. Wanted to leave before 1 hr completed and signed out.
Weakness, Dizziness, Mild Nausea - 20 Mins after injection - feeling (mild) of throat closing VP (Briefly)
MEMBER WAS FEELING NAUSEATED, DIZZY, AND LIGHTHEADED. EMT'S WERE CALLED AND PATIENT WAS TRANSPORTED TO THE HOSPITAL.
He felt very cold, shivering, felt too cold to walk. He was in a warm room at school at the time. His rectal temperature at about 3:45 PM was 101*. At 4:30 PM it was 103.2*. It was 99* at 10:00 PM. By the next morning, there was no fever and no more symptoms. In addition, his arm hurt badly enough immediately after getting the flu shot that he didn't use it for the rest of the first day.
Sore arm immediately, Slightly lightheaded for about 1-2 hours after shot, headache around 6pm, severe heartburn around 10pm after I took Sertraline.
Itching at injection site started about nine days afer second dose.  No noticeable itching after first dose (012M20A) administered  at local facility,  site on Feb 3, 2021.  Slight redness of about 1 sq. in at injection site and also similar redness about 2 inches away.
On 11/Oct/2006, a report was received, via a company representative, concerning an 81-year-old female vaccinee (initials VB, DOB 10/05/1925). No details were provided regarding the vaccinee's medical history or concomitant medications. On 08/Oct/2006 the vaccinee received 0.5ml Fluvirin (batch number 69427), intramuscularly. On the same day, 08/Oct/2006, the vaccinee experienced a swollen arm, which was described as a cellulitis type swelling, from her shoulder to elbow. The swelling improved with Benadryl, but there is still some swelling. The vaccinee takes the flu shot every year and has not had this reaction before. Follow-up information will be sought. Follow up information was received on 21/May/2007 from a healthcare professional. No details were provided regarding the vaccinee's medical history or concomitant medications. The vaccinee received Fluvirin on 08/Oct/2006, one day later (09/Oct/2006) the vaccinee developed abnormal swelling from the wrist to the shoulder. The event was treated with Benadryl and resolved in approximately 1 week. The reporter considered the event to be serious, medically significant as it caused pain and stiffness to the affected arm. No further information is expected.
First shot  Lot# ER 8732    administered 04/03/2021 Death
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. On an unknown date, the patients might have been vaccinated with GARDASIL (dose not reported) that was exposed to temperatures below 36 degrees F for an unknown amount of time. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
General soreness and illness the next day.  From that day until January 24th, 2022, I was generally ill feeling, tired and didn't feel like I was at 100%.  More like a malaise making me feel like I was at 70% wellness.
Mother called 2 1/2 hrs post immunization, stating pt developing red rash on trunk. Described with like hives.
Fever - 10-18-13 through 10-20-13 (varied). Chills 10-18-13 about 1/2 hr. Severe bone pain throughout body - some degree for 3 days - started 10-18-13. Nausea started 10-18-13 ended 10-21-13. Headache started 10-18-13 through 10-21-13.
Client state feeling dizzy, blurry vision, and difficulty hearing. Ice pack applied over client left arm. Client were ask to take deep breath, and drink some sip of water.
The day after the vaccination I started getting a sore right TMJ. I waited a week to see if it would go away, but it didn't. I then took aleve and ibuprofen for about two days which decreased the TMJ pain and it did not return. It was then that I noticed that I had a tender swollen lymph node under the right side of my chin. I assume that the swollen lymph node was the cause of the TMJ pain.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended by her physician for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 11-JUL-2016, the patient was admitted at a hospital for the development of zoster and was prescribed VALTREX. On 12-JUL-2016 the patient was diagnosed by the physician with herpes zoster, or shingles. The patient was prescribed VALTREX, and zolpidem for the management of her shingles related symptoms. As a direct and proximate result of the defective ZOSTAVAX, 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 is unknown. Additional information has been requested.
Pt presented after 30 min wait post vaccine with bilateral hives to arms, stomach, chest, and neck.  pt states has has a h/o hives of unknown origin.  Pt DID take a Zyrtec today as per her normal for allergies.  Pt given 50 mg of PO liquid benadryl with some relief post additional 30 min wait pt had increased itching to head and thighs.  Earlier Hives did resolve, pt refused ambulette transport will go to Urgent care with her friend that came with her.  Pt denies SOB, or chest pain, LSCTA, VSS at time of leaving vax site.
ankle swelling; foot swelling; shooting pains in feet; rashes on her back; This case was reported by a physician via sales rep and described the occurrence of ankle swelling in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced ankle swelling, swelling of feet, foot pain and rash. The patient was treated with furosemide (Lasix) and gabapentin. On an unknown date, the outcome of the ankle swelling, swelling of feet and foot pain were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the ankle swelling, swelling of feet, foot pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The reporter reported that the Shingrix was given to patient by a different provider so only information available from patient was that she received 1 dose of Shingrix and the patient started to saw doctor in March 2022 and explained that she experienced foot and ankle swelling and shooting pains in feet and that it was on going since receiving the vaccine and complained of rashes on back. The physician did prescribe Lasix and Gabapentin to the patient. The doctor could not determine if adverse events were related to the Shingrix vaccine. The reporter agreed to follow up from GlaxoSmithKline.
Woke up the morning after the vaccine with a cough, a fuzzy head, muscle aches, chills, and a low fever. Slept off and on until the afternoon. Started feeling a little better in the evening. Slept fine that night. Went to work the next day and still had an occasional cough.
Local reaction where VCZ given, about 2" diameter, red, swollen, tender lump.  On 4/4, redness & tenderness decreased, but still has lump.
Received extra dose of Hep B vac on 3/13/23. No adverse effects reported
Fever over 100 onset 10 hours after injection, maintained 34 hours.  Chills, body aches, severe headache, nausea, dizziness, fatigue 40 hours.  Stomach upset manifested 48 hours after and lasted 12.  Elevated heart rate for 24 hours.
CHILLS FOR 4 HOURS; NOT FEELING WELL; FEVER OF 102 F; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was processed along with additional information received on 10-MAR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular,  and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 10-MAR-2021, the subject experienced fever of 102 F. On 10-MAR-2021, the subject experienced chills for 4 hours. On 10-MAR-2021, the subject experienced not feeling well. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 102 F, and chills for 4 hours, and the outcome of not feeling well was not reported. This report was non-serious.
Pt complained of dyspnea and facial urticaria. Pt treated with po diphenhydramine.
TEMP OF 103F CHILLS AND FEVER NAUSEA ACHING JOINTS SEVERE HEAD ACHES
Initial report received from consumer on 27 October 2014. A 'patient' (age and gender was not reported0, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD (lot number, and expiration date, route and site of vaccination was not reported) on an unspecified date. It was reported that the patient had experienced adverse event on an unspecified date. The details of lab investigation and corrective treatment were not reported. The outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Pain throughout whole right arm with tingling in forearm to fingers throbbing pain. Unable to sleep.
Moderna Covid-19 vaccination: Patient called and reported circle spots starting on 02/26 that itched and slowly it started spreading across her chest, upper back and shoulders, rash got worse and she went to on 3/4, dr. gave her predisone. Pt reports taking benadryl and putting cortisone cream on rash and that it did nothing to help it. Pt still reports have the circle like spots on her, but they do not itch like they did before.
Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.
Left arm feels weak; Burning sensation at the center of her back; Swollen left arm; Rash at injection site; Soreness at the injection site; Fatigue; A  spontaneous report was received from a consumer who is a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, vaccination site pain, arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness.  The  patient's medical history was not provided . No relevant concomitant medications were reported.  On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown, route of administration:unknown)  in the left arm for prophylaxis of COVID-19 infection.   On 15-Jan-2021, the patient experienced fatigue and vaccination site pain. On 25-Jan-2021, the patient experienced arm swelling, vaccination site erythema and burning sensation on the back. On 05-Feb-2021, the patient experienced muscular weakness.  Treatment details include Benadryl and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events fatigue and  vaccination site pain was considered to be recovered/resolved.  The outcome for the events arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a male subject aged between 40 and 49 years old who was vaccinated with TWINRIX, (GlaxoSmithKline).  There was no relevant medical history and no concomitant medications or vaccines.  On unspecified dates the subject received 1st dose, 2nd dose, 3rd dose of TWINRIX (details unknown).  In April 2009, at an unknown time after vaccination with TWINRIX the subject experienced decreased therapeutic response with low titers.
severe leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe leg pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe leg pain). At the time of the report, PAIN IN EXTREMITY (severe leg pain) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
UNEXPECTED THERAPEUTIC BENEFIT FOR SINUS AND ALLERGIES; SLEEPY; TIRED; This spontaneous report received from a patient via a company representative concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinusitis, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unexpected therapeutic benefit for sinus and allergies, sleepy, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, and tired, and the outcome of unexpected therapeutic benefit for sinus and allergies was not reported. This report was non-serious.
After a day or two my heart started to feel tight. I?ve experience anxiety and panic in the past but never in my chest. My breathing is normal. Heart rate normal. But i can?t shake this tight chest. I?m gonna see a doctor if it doesn?t get better.
pneumonia 15 given to a 12 year old.  No adverse reactions noted in clinic.  Mother states that child was ok on 07/20/2023