chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        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 UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Patient received Additional Booster Dose.  Concomitant medication list was not provided.  It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: added patient demographic details.
Broke out in a rash and bumps on arm, used Neosporin for the pain. Also had a headache. Contacted PCP and the assistant informed her that it happens sometimes and to keep an eye on it.
Gross Hematuria, increased proteinuria  and reduced kidney function 2 days following second covid vaccine  dose  Suspect patient has IgA nephropathy as an underlying kidney disease although not biopsy proven.
Day one was the same reaction to doses 1 and 2 (fatigue, enlarged lymph nodes, muscle and joint pain). Day two I woke feeling very disoriented (9:00am).  Within an hour I could barely move due to pain and dizziness.  By the afternoon my vision was impacted.  By late afternoon I was incoherent.  I could not place words, names or the people around me.  My family called the advice nurse and I was put to bed for the night.   Day three I was the same as day two and had no short term memory.  I spent the day under adult supervision, on the couch. Day four all symptoms except for the fatigue and short term memory problem had resolved completely. As of today I am still struggling to recall certain words, experiencing a significant amount of brain fog.  My shoulder and hip joints have worsened from a point of stability reached in December 2020 following a severe accident in July 2019.  My gait and strength have worsened and I am now in physical therapy to strengthen all four joints.
Patient presented with angioedema.  He stated the day after his second shot, he had what appeared to be 2 cold sores, one on each corner of his mouth.  He says each day the swelling has gotten worse.  (Presenting  from vaccine almost 6 weeks ago) He was advised to seek medical advice, to which he declined.  He was then advised that if he would not do that, he should take benadryl and ibuprofen.
Red, raised area approx 2.5x1.5, painful and very warm to the touch. Sought medical advice and was advised to ice the area and take anti-inflammatory meds for pain and swelling relief.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 88 year-old female patient of unspecified ethnicity received PREVNAR 13 via an unspecified route of administration, on 09Feb2016 at 0.5 ml single for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced creatinine level increased to 16- 17 on 14Mar2016. The outcome of the event was unknown. The physician confirmed that the event took place after received the vaccine. The physician asked if it could be a relationship between the event and product. Follow-up (11MAY2016): Follow-up attempts are completed. No further information is expected.
patient developed significant swelling and pain of the left deltoid, fever, chills, and fatigue.
Information has been received from a registered nurse concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis. The pts outcome was unknown. Additional information has been requested.
PT REPORTS A FULL FEELING IN HER THROAT - PT IS AN MD AND DESCRIBES IT AS GLOBUS
Huge bruise on her right arm; some of the solution ran down her right arm; Possibly administered subcutaneously; Right arm was sore; Felt uneasy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), FEELING ABNORMAL (Felt uneasy), CONTUSION (Huge bruise on her right arm), ACCIDENTAL UNDERDOSE (some of the solution ran down her right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Possibly administered subcutaneously) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Sulfa drugs), Thyroid disorder and Blood pressure abnormal.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore), FEELING ABNORMAL (Felt uneasy), ACCIDENTAL UNDERDOSE (some of the solution ran down her right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Possibly administered subcutaneously). On 03-Nov-2021, the patient experienced CONTUSION (Huge bruise on her right arm). On 01-Nov-2021, ACCIDENTAL UNDERDOSE (some of the solution ran down her right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Possibly administered subcutaneously) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore), FEELING ABNORMAL (Felt uneasy) and CONTUSION (Huge bruise on her right arm) outcome was unknown.            Concomitant medications include thyroid medications and blood pressure medication. No treatment medications provided.   This case was linked to MOD-2021-374481, MOD-2021-374535 (Patient Link).
Patient had prolonged non-bloody diarrhea following Rotavirus vaccine.  Diarrhea lasted three weeks.  Child received supportive care at home and did not need any hospitalization.
Fever  100-101 starting 12 hours after injection.  Body aches, headache , fatigue.  Flu like symptoms.  Started 11pm 2/3 and ended the morning of 2/5/2020
metallic taste in his mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021366175 (Pfizer).  A 61-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 10:15 (Lot number: EP7533) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "He just has one kidney" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DYSGEUSIA (non-serious) with onset 31Mar2021 12:30, outcome "not recovered", described as "metallic taste in his mouth".  Additional Information: The patient received first dose about 4 hours ago. He was having a metallic taste in his mouth and did not know if that was normal. He would like to find out if there were reports of anyone else having this symptom. Patient did not see it in the literature. He did not wish to provide an email address. There was no prescriber. He just has one kidney but does not take any medication for it. This was prior to receiving the vaccine. When he went to get it, it looked like somebody else used his name and address to get his shot. (Health network name). Vaccine supplemental form. No previous additional vaccines administered on same Date of the Pfizer suspect. NO ER or physician's office required Prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations.  Follow Up(31Mar2021): Updated information included: Vaccination administration site, time, vaccine facility type, event onset time, event outcome.  No follow-up attempts are possible. No further information is expected.
myasthenic crisis, with worsening neck weakness, proximal muscle weakness and dyspnea, beginning 24hr prior to presentation.   Treatment required  IVIG, PLEX, brief intubation for respiratory support and eventual Rituximab dosing.
No adverse events from vaccine.  Tested positive for Covid 19 on April 30, 2022.
8 days after I got the first Moderna vaccine my arm started to hurt again (pain had been gone for 5 days) and I have an oval shaped red mark around the injection site.  It hurts, is itchy and the spot is hot.
Diarrhea for 24 hrs occurring 24 hrs p/the inject; responded to Immodiuim immediately;
Received call from patient stating her eyes were almost swollen shut, she also stated had gotten tightness in throat after receiving first dose of vaccine but she did not seek medical care.  Advised patient to call emergency
swelling & tenderness both knees 22JUL98;swelling, tenderness lt elbow 22JUL98;redness above lt ankle;taking DPH for several days;ER visit 23JUL98 & given DPH;
This case was reported by a consumer and described the occurrence of scar tissue in a 53-year-old male subject who was vaccinated with FLUARIX 2012-13 season (GlaxoSmithKline), FLUARIX 2013-14 season. A physician or other health care professional has not verified this report. On 12 October 2012, the subject received a dose of FLUARIX (administration site and route unknown, batch number not provided). On 13 October 2012, 1 day after vaccination with FLUARIX, the subject experienced eye pruritus and erythema around eyes. Some scar tissue remained around eyes. In October 2013, the subject received a dose of FLUARIX (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with FLUARIX, the subject experienced some itchiness about the eyes and some redness but not as bad as after previous dose. The subject was treated with BENADRYL but it didn't help. At the time of reporting, scar tissue was unresolved, eye pruritus and redness around eyes were improved.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203962 same patient/product, different dose/event;
Day 2 - Had a bad headache but that went away by day 3.  Day 4 I started to notice a tenderness in my right thigh and a rash started to appear.  The entire front of my thigh is very tender.  Plus my body just seems to feel achy.
After waiting 15 minutes patient started sneezing he looked good we let him leave. Mom called us back face started swelling up she gave him oral BENADRYL. He returned to clinic around 2:30 we gave him BENADRYL IM. He was admitted into the hospital for 23 hour observation in the ICU department.
hair is falling out; autoimmune response or systemic inflammation/severe inflammation response; can't go to work; has been injured; he can't walk; can't get out of bed/can't raise arm above his head; pain; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair is falling out), INFLAMMATION (autoimmune response or systemic inflammation/severe inflammation response), IMPAIRED WORK ABILITY (can't go to work), INJURY (has been injured) and GAIT INABILITY (he can't walk) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair is falling out), INFLAMMATION (autoimmune response or systemic inflammation/severe inflammation response), IMPAIRED WORK ABILITY (can't go to work), INJURY (has been injured), GAIT INABILITY (he can't walk), MOBILITY DECREASED (can't get out of bed/can't raise arm above his head) and PAIN (pain). The patient was treated with METHOTREXATE for Adverse event, at an unspecified dose and frequency and LEFLUNOMIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, ALOPECIA (hair is falling out), IMPAIRED WORK ABILITY (can't go to work), INJURY (has been injured), GAIT INABILITY (he can't walk), MOBILITY DECREASED (can't get out of bed/can't raise arm above his head) and PAIN (pain) outcome was unknown and INFLAMMATION (autoimmune response or systemic inflammation/severe inflammation response) had not resolved.            No  Concomitant medications were provided. Treatment medications includes Steroids and monoclonal antibody were reported.  Lab investigations includes lupus and Lyme disease test was reported.  Patients needs to take chemo drug   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant follow-up Follow up received and contains: Updated Vaccine Information, Treatment information, Events and Outcome of the events and narrative.
Lightheaded, L sided chest pain, Feeling cold flushing, feet tingling Tx: vs, monitored - taken to ED in ED at 3:35pm - motrin/tylenol, Fluids Rest 1/21 allergic and adverse reaction not allergic 1/26- 2ND dose given- no adverse reactions
while sitting right arm went numb, then couldn't get words out to speak and was confused;  was taken to hospital and given tests (MRI, CT scan, COVID test, echocardiogram, chest X-ray);  numbness went away first day, MRI showed TIA/mini strokes on left side of brain and insula part of brain;  had aphasia for two days; admitted to hospital for observation and released after 3 days; given Lipitor and aspirin and heparin shots for treatment; no lasting effects from stroke; doctor says cholesterol, blood pressure and family history normal;
I was pregnant with my third child at the time of vaccination. This was my third pregnancy, with no prior miscarriages. My last menstrual cycle was on 9/10/21. I was 5.5 weeks pregnant at the time of my second vaccine dosage. My estimated due date was June 17, 2022. When I went in for an ultrasound on November 29, 2021, it was determined that my baby stopped growing around 6 weeks of age- which would have been a few days after receiving the COVID vaccine. My body did not recognize the miscarriage and did not pass the baby until 13 weeks of pregnancy, even though the baby had stopped growing at 6 weeks. We have now been trying for 8 months to get pregnant again with no success yet.
Patient was sitting in the waiting area as directed to do so for 15 minutes after the shot.  Patient starting to feel dizzy a few minutes later but did not inform the pharmacy staff.  He told his girlfriend that he wanted to go outside to get some fresh air and proceeded with the girlfriend and after about 15 feet, he fell down but his girlfriend caught him so no injuries.  He remained on the floor for about 10 minutes, drank some water and then was helped to one of the chairs in the waiting area.  He refused us in calling the ambulance.  After another 15 minutes, he felt better and left.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.  Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Could not keep sodium levels up, gastrointestinal problems, throwing up every feed, kidney function diminished, regression, slow growth, lung function diminished, uncontrollable seizures starting immediately after.
Started getting headach and low-grade Fever. At about 3:30 I started getting a stabbing pain in my right lung under my breast whenever I took a deep breath. I attempted to wait it out and went to my primary care physician on 9/19/13 to find out more. Due to my breathing being shallow to avoid pain, I fainted and had to go to the ER. ER Doctor diagnosed me with Pleurisy.
1348 weak p/vax;1350 dizzy c/o diaphoretic, pale conscious answering questions appropriately-BP 100/70, 76P, R12; 2sec nailbed capillary refill-placed supine 1355; c/o tingling of hands;  1410 BP 90/70; poss hypoglycemic attack; arm sore
FEVER; FELT WEAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The 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 patient experienced fever, and felt weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt weak was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 5 year old male, who on an unknown date, was vaccinated in the thigh with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced pain, cellulitis and swelling in the thigh of the leg that received the vaccine. The patient's status was unknown. No product quality complaint was involved. This information is one of several reports from the same source. Additional information has been requested.
Throwing up; Stomach was upset; Nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced vomiting, upset stomach and nausea. On an unknown date, the outcome of the vomiting, upset stomach and nausea were recovered/resolved.   It was unknown if the reporter considered the vomiting, upset stomach and nausea to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient received Shingrix and was throwing up on the 1st night and her stomach was upset for 1 week. The events resolved after 1 week.  Due to that experience, the patient did not get the 2nd dose.  The reporter consented to follow up even though she did not have the exact date of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186600:Same reporter, same Suspect product, same AE, different dose (1st dose) invalid
I've had a raised red bump at the injection site since my 2nd injection. It's not painful but it has not gone down at all since my 2nd shot.; I've had a raised red bump at the injection site since my 2nd injection. It's not painful but it has not gone down at all since my 2nd shot.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and ankylosing spondylitis. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ustekinumab (STELARA) every 3 months and medroxyprogesterone acetate (DEPO PROVERA) every 3 months; both for unknown indications from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 26Feb2021 at 11:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. On 19Mar2021 at 12:00, the patient had a raised red bump at the injection site since second injection and it was not painful but it had not gone down at all since her second shot. The patient did not receive any treatments for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event raised red bump at the injection site was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Patient with previously negative HIV 4th generation test, with a false positive HIV 4th generation test on 7/21/21.
Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient presented to this RN due to complaints of feeling like she would pass out. She was holding her head in a wheelchair and appeared quite uncomfortable. She was safely transported to a recliner to elevate legs. She was laying in a flat position. Mask taken off due to complaints of "having a hard time breathing." Patient complained of LEFT sided chest pain; unable to determine if this pain is acute or chronic. Patient slow to respond and unable to describe symptoms well. Patient slow to respond to questioning. Patient with mildly stuttered speech. Eventually patient admitted to dizziness.   Given the nature of presentation, First responder called and arrived quickly.   Vitals at 1200:   135/112, semi-Fowler's position, right arm 84 bpm, apical, regular 95%, room air  Patient denied swelling, throat tightness. No rash.   Patient sat up in chair to help with breathing.   Vitals at 1212:  Heart rate 101 bpm. No apparent respiratory distress. NP briefly auscultated prior to immediate transport to Emergency Department. Per NP, patient with =1/6 systolic murmur and tachycardic, on auscultation. Per NP Patient's LS clear and equal bilaterally, bases mildly diminished.    Patient transported to Emergency Department via wheelchair with First Responder.