chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a field representative, refers to a female patient of unknown age. The patient's medical history was not reported. In approximately 2016, over a year ago, the patient was vaccinated with PNEUMOVAX 23 injection, at a dose 0.5 ml (Strength, frequency, anatomical location, lot/batch # and expiration date were not reported) intramuscularly for prevention of pneumococcal disease. There were no concomitant therapies reported. In approximately 2016, the day after the injection, the patient experienced pain at the injection site. There was no treatment given for the event of pain at the injection site. There was no product quality complaint involved. The outcome of the event, pain at the injection site was reported as recovered. The causality assessment was not provided.
Pt was leaving after 15 minute waiting period and passed out at the check out. Pt reported feeling fine and did not remember passing out.  Pt BP 113/71 hr 61. Pt BP dropped to 89/56 after 20 minutes. 1 liter of IV fluid given. Pt monitered an additional 30 minutes. Final BP 118/73 HR 69. Pt discharged home with sister.
Metallic taste; head ache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration, administered in arm right on 26Aug2021 17:00 (At the age of 58-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not received any other vaccine in four weeks. On 26Aug2021 17:15 the patient experienced metallic taste, head ache. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.   Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
UNPUNCTURED VACCINE STORED AT 35 F AND LATER ADMINISTERED TO PATIENTS; RECEIVED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced received expired vaccine. On SEP-2021, the patient experienced off label use. On an unspecified date, the patient experienced unpunctured vaccine stored at 35 f and later administered to subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unpunctured vaccine stored at 35 f and later administered to patients, received expired vaccine and off label use was not reported. This report was non-serious.   This report was associated with product quality complaint: 90000194295.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Numbness/Tingling on left side of face under eye and lips (primary) Started after injection, stopped and started up again 2/23/2021 Numbness/Tingling on left arm ER Visit 2/23/21 :  Covid tested (negative), Blood Work, EKG, Neurology Visit GOOD
Pt experienced right arm numbness and pain from site of injection to hand. The MD felt that it was due to carpal tunnel syndrome vs the Anthrax vaccine. The pt stated he had not had any problems with the previous 3 vaccinations. The pt is to follow-up with  a private physician on carpal tunnel. 07/28/2000:  Patient still experiencing pain from shoulder to elbow, diagnosed by two doctors as tendonitis and carpal tunnel.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with first dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported). Approximately one year after the first dose, the patient received second dose of ZOSTAVAX. No adverse symptoms were reported. Additional information has been requested.
Initially was experiencing the typical injection/inoculation site symptoms. After the second day discomfort continued for several more days, causing decreased range of motion, pain and localized tenderness. There was more tenderness at original site and some localized swelling. Treated by usual methods of cold and warm compress, OTC anti-inflammatory and rest, without any improvement. No signs of infection were noted local or systemic. Symptoms persisted for following 12 days without improvement, with some days being worse than others. Mild activity does cause some increase discomfort. Contacted dispensing medical facility and was advised to return for follow up. On their review was advised to file a report, they will be further researching and am to report any VAERS info and follow return in two weeks.
On 02/21/2023, I started with a sore throat and body aches that afternoon. In the evening, I developed a low-grade fever of 100.6 and little cough. I think the highest my fever got was 100.9 into the next day. I tested that day for COVID-19 and was negative. The next day, I tested again, and it was positive. I called my doctor's office who did a telephone visit pretty quickly with the nurse practitioner. They prescribed Paxlovid. After taking the Paxlovid, I felt a lot better after a day or two. I wasn't completely better, but my temperature went back to normal.
Vaccine mixed with incorrect diluent (sterile water instead of normal saline). Pt informed of error and offered revaccination. Pt reports no adverse reactions.
Dizziness, tightness in chest, labored breathing, tingling & numbness in hands & arms 2-3 hours post injection. Administered EPIPEN one time 11:17 am.
This 41 year old reported receipt of first Anthrax vaccine 26 Nov 2002 with complaints of burning, sore to his left arm, and site redness that lasted a couple of days.  His second AVA vaccine was given 23 Dec 2002 had similar complaints of site redness, soreness, however he experienced an acute onset of chest heaviness and shortness of breath while driving in traffic. He stated he had to pull off the road and calm himself down. He admitted to some nausea with radiating left arm, neck, jaw and substernal-left shoulder chest pain 5-6/10 pain scale. He described as a sharp pain 2 hours post vaccination with lasting 20+ minutes changing to a dull pain for next several hours. He remembers touching his AVA site noting increasing pain to chest so assumed it was radiating pain and not cardiac related. Position did not affect chest pain, but movement aggravated. No medical care was sought.  He received his third AVA vaccination 13 Jan 2003 with similar site burning, but worsening site redness and tenderness. Approximately 1-2 hours later he experienced reoccurring midsternal chest pain with shortness of breath 3/10 pain scale that was sharp and lasted about 30 -120 minutes. Position did not affect his pain, but rest did help resolve. Again, since he'd had similar chest pain with previous AVA, he again assumed vaccine related and non-cardiac in origin.  He did not seek medical care.  He received his fourth AVA vaccination 24 Nov 2003 with complaints of increasing site redness and tenderness (worse than previous 3 vaccinations) localized to deltoid region of left arm. He did not experience any chest pain.  He received his fifth AVA 01 Nov 2006 again to the left deltoid with immediate site burning, soreness, redness, and now immediate chest pain with shortness of breath. His appearance changed as patient asked if he was okay. He admitted to chest pain with shortness of breath but told patient he was fine as this had happened after previous AVA vaccines. He sat in the clinic for approximately 20 minutes until symptoms resolved. He quantified the pain on a 5/10 scale similar to initial chest pain following AVA #2 with radiating symptoms to neck, jaw, left arm, nausea w/o vomiting and mildly diaphoretic. No medical care was sought and no reoccurrence of symptoms since.
I started to have a low grade fever on June 5th and I saw my doctor due to maybe having prostate issues.  He prescribed my a antibiotic to take.   I am unsure if this is related to the vaccine or not.
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 23-OCT-2013 at 12:00 the patient was administered with a M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17: 14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch.  Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
Patient was only due for MCV4, Tdap and HPV.  There were three places to enter orders.  In an electric record database, on a charge ticket and consent form.  Orders were correct on two forms, but on the consent form, the varicella vaccine was circled to give by mistake instead of MCV4.  MA administered vaccines off of the consent form orders.
Two days post vax, the pt developed an erythemic upper arm; surrounding tissue was tender and right axillary lymph node was tender. On 6/8/00, the pt's uppper arm was still erythemic with induration. Tender axillary lymph node. Treated with ibuprofen, ice, and Benadryl.
New pt to this clinic on 6/16/03 complained of rash and fever onset 6/15/03. Stated got MMR and DTaP on 6/2/03 at another clinic. Had had titers at hospital on 5/13/03 where she is a volunteer. Positive immune to measles and varicella but not rubella. Here pt was afebrile (98.7) VSS, no lymphadenopathy or HSM. Eryth maculopapular rash on trunk and prox exterior.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 82 years old female (height 65 and weight: 148) patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
I got a massive runny rose and felt like I was chained to the KLEENEX box. I got a home COVID-19 test the first one I did that evening was negative, I tested the next morning, it was positive. I called the COVID-19 doctor's line, set up a video conference, they confirmed my positive test result. I was prescribed the PAXLOVID and started it immediately, I did get rebound COVID-19, I am now feeling more like myself and no long COVID-19 hangover.
Exacerbated gastroesophageal reflux disease and hypergastrinemia. Abdominal pain, cramping, discomfort, heartburn and acid regurgitation increased, as well as occurrence of new symptoms including sore throat, diarrhea and blood in the stool. Additionally, gastric polyps were diagnosed through endoscopic surgery. Patient was previously using sporadic histamine-2 blockers and occasional, low dose, short term proton-pump inhibitors to treat symptoms, which became ineffective. Patient was prescribed daily proton-pump inhibitors to manage symptoms.
Patient received the J&J vaccine on 7/15/2021 after receiving the first dose of  Moderna vaccine on 4/23/2021. Patient had no adverse reactions or side effects reported from the second vaccination.
This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 04-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type (HA). The temperature excursion (-14 Celsius degrees) lasted 56 hours. There was also a previous temperature excursion which lasted 2 hours and 48 minutes (captured in MARRS # 1602USA006365). No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Pt felt lightheaded and sweaty and heart rate dropped to 50 and blood pressure dropped to 70/30.  Paramedics were called 911 and arrived at 12:32 the episode happened at 12:30 by the time the paramedics arrived she was feeling better she had been put on the floor with her legs elevated on a chair and her blood pressure has come up since then she had refused to go to the hospital because she fell back to her normal.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration). No concomitant medications were reported. Reporter declined to provide patient identifiers for the 4th patient, stating that she already had a follow up form for them. No treatment  medications were reported.
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
8/14/21 pt was brought to ED for AMS and dyspnea; low O2 saturations; given O2 supplementation; had been at home with UTI and on IV ABX; positive for COVID; poor prognosis; on TPN; DNR; 8/27/21 dc'd to home with Home Care to follow patient since he does not quality for GIP hospice; patient died at home
Pt received MENACTRA vaccine in office (R arm). Upon arriving at home MOC stated 2 1/2" diameter redness around swollen/puffy area where vaccine was given. MOC gave BENADRYL, call office, advised to give Ibuprofen & ice site.
Weakness; difficult breathing; fatigue; Dizziness; general malaise; rapid heart rate; a sense of impending doom; This is a spontaneous report from a contactable consumer.   A 68-Year-old male consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in left arm on 04Feb2021 15.15 as SINGLE DOSE, for covid-19 immunization (age at vaccination: 68-Year-old). Medical history included Heart Failure, PAD, CAD and Fibromyalgia. Concomitant medications included alirocumab (PRALUENT), aspirin [acetylsalicylic acid, hydrocodone bitartrate, paracetamol (NORCO), perna caliculata extract (LYPRINOL), ca [calcium] and diphenhydramine hydrochloride (BENADRYL). Patient was allergic to food allergy, dairy products, sulfa drugs and soy. Patient not had Covid prior to vaccination. On 06Feb2021, the patient had weakness, difficult breathing, fatigue, dizziness, general malaise, rapid heart rate and a sense of impending doom. The events resulted in emergency room/department or urgent care. The patient has tested for covid 19, nasal swab on 06Feb2021, the test result was negative. The patient had not received any treatment for adverse events. The outcome of the events was reported as not recovered.
Pt was given dose of Rotateq after the age of 8 months, no known symptoms of adverse effect
Patient received 1 dose of Janssen Covid-19 vaccine in left arm. That evening it was determined that vaccine had been expired after its initial 1 puncture on 6-1-21. After original puncture vial had been stored under refrigeration and a time frame of 28 hours had past . Patient was contacted on 6-3-21 notifying him of the error. Patient stated that he was experiencing "normal" side effects, ie. drowsiness, headache and chills. Patient has previously had Covid-19 in December of last year. Advised patient to consult with MD on whether to re-vaccinate due to no studies available per Janssen's Medical Info center.
When doing minor routines, like washing dishes, pain in all my bones.  Doctor says it is muscle pain as bones hurt that don't have joints.  Started about 2 weeks after the second shot and continues to this day.  Doctor wanted me to report it to you IN CASE it is a reaction to Covid shots.   So pain since end of April.
Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everything  - chills, fever, arm soreness, headache. It all lasted about five or six hours. Then five days later, that night, on the 13th, I had fatigue again and on 14th - tired, headache, chills, and in the middle of the night on the 16th - 103 degrees  fever, throwing up, hallucinating, chills, muscle weakness and arm soreness ( I still have arm soreness - at the injection site)  and my wife had to call 9-1-1 and EMT's took me to  hospital and I was hospitalized for four days. Hospital.  I am recovering from the medications still but I have recovered from the health event from the vaccine.
Unusually high Blood sugar upon routine daily testing. The last several days since vaccine. No idea of related.
This spontaneous report as received from a healthcare worker via a company representative refers to 22 patients of unknown age and gender. The patients were vaccinated with first and second dose of VARIVAX (Merck) (dates, dose, route and lot # were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date "greater than 2 weeks"age, 56 patients had chicken pox due to vaccine failure (MARRS case # 1211USA001359, same reporter link). 23 patients had two doses of VARIVAX (of which 22 are covered by the current case). One of the 23 patients was reported to be pregnant (MARRS case # 1211USA001899, same reporter link). There was no correlation between lot number, age or provider. No treatment information was reported. The outcome of vaccine failure and chicken pox is unknown. The relatedness for vaccine failure and chicken pox was not reported for VARIVAX (Merck). Additional information has been requested.
Per pt, red swollen, hard lump x 3-4 days. Hot to touch.
patient contracted pneumonia a couple times already in life; patient contracted pneumonia a couple times already in life; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age (age: 50 units: unspecified) and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient contracted pneumonia a couple times already in life. The outcome of event was unknown.
After receiving pneumococcal and flu vaccines on Friday afternoon, 10/16/2009 patient awoke Saturday with fever and pain and swelling of left upper arm. Went to Hospital ER Saturday AM, 10/17/2009, and was admitted and discharged after weekend. MD diagnosed as cellulitis, per patient.
Patient started with c/o sinus symptoms @4/25-went to Urgent care and given zpack.  Traveled out of town.  called office on 5/18 stating was in airport getting ready to fly back.  Stated that never improved with zpack and was now SOB and coughing up blood.  She was advised to got to hospital as soon as could when arrived back.  Patient presented to ED on 4/22 and was diagnosed with bilateral PEs/pneumonia.  She was admitted on aBx and lovenox.  On  5/24 she had left sided CVA.  CTA showed right M! large vessel occlusion.  Tpa was not option and she was transferred to Health care and underwent emergent thrombolectomy.  Patient currently still hospitalized
15 month old male patient brought to ED with rash to the right flank/right abdomen red raise area in clusters (coalesced erythematous vesicular, extending from the lower back T9 region to the flank and abdomen does not cross midline, non-weeping and crusting at this time).  The diagnosis Herpes Zoster.  The patient received the following on 6 December 2019:  Vaccines Viral Varicella (Active) ADDITIONAL PROVIDER(S): - Varicella; Series #: 1; 0.5 mL; SC; Left Thigh; Mfg: Merck; Lot: S012037; EXP: 04/17/21  VIS given (Ver: 8/15/2019).  The patient was treated appropriately with acyclovir.   The literature shows that some patients may present with Herpes Zoster after the administration/exposure to the Varicella vaccine.
Cellulitis & Abscess Unspecified Sites  Left arm swollen - red: arm began to swell painful to touch or move after Flu Vaccine given; seen in ER