chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had tick bourn illness. Patient had allergic reaction to unspecified drug.  The patient's past medical history included Chronic fatigue syndrome. Concurrent medical conditions included Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR), PREGABALIN, TRAZODONE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC), DOXYCYCLINE and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 12-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. 1 week after the treatment with paxlovid patient experienced rebound symptoms and was tested positive for covid-19 as on 19-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. 1 week after the treatment with paxlovid patient experienced rebound symptoms and was tested positive for covid-19 as on 19-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Swelling pain and redness at injection site right arm; Swelling pain and redness at injection site right arm; Swelling pain and redness at injection site right arm; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age (Age: 65; Unit: Unknown) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number unknown), via an unspecified route of administration in right arm in 2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling pain and redness at injection site right arm on an unspecified date. The outcome of the events was unknown.  No follow up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Day 2 - Sore arm, fatigue Day 6 - fatigue Day 7 - extreme fatigue Day 8 - 100.2 temp, aches, chills, stomach ache, mild diarrhea Day 9 - fatigue, mild diarrhea, but no temp, aches, or chills
My entire right arm went numb, I got dizzy/everything turned bright, and I nearly lost consciousness. I thought I was having a stroke. Rushed to the hospital and testing came back normal. I looked at the side effects on the Clinic site and it listed bodily/limb numbing as a side effect. Nobody told me about this effect and it?s not clearly detailed.
expired dose of DAPTACEL being administered with no adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient to whom expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] being administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 21-Sep-2022, the patient was administered an expired dose 0.5 ml (dose 4) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5765BA; Expiration: 28-AUG-2022) via intramuscular route in the right arm for immunization with no adverse event (expired product administered)(latency on same day).  Action taken: not applicable.  Outcome : Unknown.   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 the 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.
Body aches; Fever; Nausea; Restlessness; This is a spontaneous report from a contactable nurse (patient). A 34-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: not reported), dose 2 via an unspecified route of administration, administered in Left Arm on 06Mar2021 18:00 (at the age of 34-years-old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2, dose 1 via an unspecified route of administration, administered on 13Feb2021 18:00 (at the age of 34-years-old) as 1st dose, single dose for COVID-19 immunization. Patient did not take any other vaccine in four weeks. Patient had no Covid prior vaccination. Patient was not tested for COVID post vaccination. On 07Mar2021 03:00, the patient experienced body aches, fever, nausea, restlessness. Patient had not tested Covid post vaccination. No treatment received for adverse events. Patient was unable to locate or read the details of Lot. Patient was not recovered from events.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Patient reports her symptoms started on 2/16/2021 with fevers, generalized weakness, mild disorientation, and dizziness when she presented to the ER.
Approx 15 mins after receiving flu vaccine pt states left arm felt cold, fingers left hand numb, nausea, dizziness, slight headache.
I received my first vaccination yesterday in my car, a 1999 Miata.  If you would allow folks to exit very low cars, it would let us avoid a virtually straight down shot angle.  My injection was in the very top of the bicep muscle and it is still quite swollen.
severe leg weakness lasting about 24 hours, difficulty walking, difficulty walking up stairs. Lethargy lasting about 10 days
Received TC from pt. stating "that her arm was hurting with a knot and fever present.  Started 5/14/08.  She has been using cortisone cream on it.  Plans f/u with ER or provider increased discomfort.
Fully vaccinated patient tested COVID-19- PCR  positive pre-procedure. She is asymptomatic and has no known new exposures.
Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Premature ovarian failure.  Pregnant at age 18 and had my son full-term, with no complications.  I have no infertility in my family. In my 20's I was diagnosed as POF while trying to get pregnant after this vaccine at age 24yr old when it came out. AMH level 0.28. Never able to get pregnant again and carry to term with fertility meds. Multiple ectopic pregnancies though. De quervain's diagnosis in the right wrist started in mid 30's and ANA level was always high.
Patient was a high functioning 97-year-old female with a history of CLL diagnosed 1 year ago on no treatment prior to arrival, chronic stable thrombocytopenia, chronic kidney disease, past history of breast cancer and bladder cancer in remission, transfusion dependent anemia of chronic disease, covid 19 vaccination on 3/5/2021, who presented to the emergency room on 3/25/2021 unresponsive found by the family and emergency services was called.  The paramedics found her temperature to be 101.6 and her room air sat was 87%.  In the ER CT of the head revealed acute subarachnoid hemorrhage.  There was no trauma.  CT the abdomen and pelvis showed lymphadenopathy and splenomegaly consistent with her known CLL and new bilateral lung infiltrates.  Patient's white blood cell count was 124,000 consistent with her known CLL.  Patient prior was high functioning and still drove herself to her doctor's appointments.  The day prior she told her son she was feeling slightly nauseous and ill and went to bed early.  She was admitted with a subarachnoid hemorrhage which was felt to be spontaneous and not traumatic.  She was not on any anticoagulation prior to arrival. She was also admitted with severe sepsis felt possibly due to aspiration pneumonia or pneumonia in general and she did have fever and bilateral infiltrates on imaging. covid 19 and influenza neg.  The decision was made to place her on comfort care after discussion with family.  She ultimately expired on 3/28 At 14:48 PM in the presence of her family
Chills; Episode with teeth chattering; 100.2 degree fever; back of her neck was dripping with water; Episode with shaking; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), CHILLS (Episode with teeth chattering), PYREXIA (100.2 degree fever) and HYPERHIDROSIS (back of her neck was dripping with water) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (Fatigue). On 18-Feb-2021, the patient experienced CHILLS (Episode with teeth chattering), PYREXIA (100.2 degree fever), HYPERHIDROSIS (back of her neck was dripping with water) and TREMOR (Episode with shaking). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), CHILLS (Episode with teeth chattering), PYREXIA (100.2 degree fever), HYPERHIDROSIS (back of her neck was dripping with water) and TREMOR (Episode with shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I was observed for 15 minutes and then shuttled back to vehicle.  Approximately 30+ minutes after shot, I started to feel something weird in my throat area.  I decided to go through a drive through to get a bite to eat and something to drink.  While waiting in line, I could tell it was becoming more difficult to swallow.  Was hoping the drink would help.  I tried to take a bite of the chicken nugget, but about choked and had to spit it out.  I live approximately an hour from where the vaccination was administered and my goal was to just head home.  While driving on Road, I was talking with a friend.  I told my friend what I was experiencing in my throat area and that I needed to hang up to concentrate on what was going on.  I unbuckled my seat belt and pulled by coat and sweater out from throat area, wondering if they were compressing on it.  That did not help and I could tell something was just not right.  I was having a hard time swallowing.  I then googled possible side effects from the COVID vaccination and that is when I read about anaphylaxis reactions.  I was torn on what to do since by this time I was approximately 30 minutes from the testing site and just wanted to get closer to home.  There really were no medical facilities along my route home.  My friend called back to check on me.  Explained the situation and my friend suggested I stop at a gas station to get Benadryl.  I then drove to Town and took a 2 Benadryl tablets.  I also knew this town had a fire department and ambulance service in case things started to turn South.  I sat in my car for about 20 minutes to assess the situation.  I finally felt like I could make it the rest of the way home.  I had already put my family on notice in case things got worse.  By the time I made it to Town, my swallowing was less difficult.  My nurse friend recommended I continue to take Benadryl every 6 hours for 24 hours and then to take a Claritin.  That is what I did.  I did not report this to my PCP, but in hindsight... I probably should have.  It was quite alarming and truly a very scary feeling to experience this, especially while driving.  It kind of still feels like there is a lump in the back of my throat when I swallow, but that is something I can deal with.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning an adult male. Neither medical history nor concomitant medication were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/98;SAT-100%; Dr at bedside to evaluate pt. 1300- No repiratory distress;VS- 143/83; 104; 100%; 16; MD advised pt to take 25-50mg of benadryl every 6 hrs for 24 hr Narrative:  Patient with flushed skin; VSS; denies difficulty breathing; advised by Dr to take 25-50mg benadryl every 6hrs and follow up if any change in or worsening of symptoms. Ambulated from clinic with husband. No assistance needed.
Patient inadvertently received the 5-11 year old dose instead of age group appropriate dose.  Parent notified.
First event was unusual exhaustion. It progressed the next day and started to have appetite loss, acid reflux, sensitive skin, totally dry, cracked lips, some coughing up phlegm. I started to get some pain in my abdomen. After six days, I called my doctors office. A girl said or maybe reaction to flu. You should be on the road to recovery. Oct.17th, I could not get in to the doctor and was told to go to ER if it got worse or call them on Monday. I went to ER, they took urine sample and said I had a urinary tract infection. Gave me antibiotic. Oct 20, saw person at doctor's office. She took another urine sample and would go from there. By that time, it was diminishing. Nov. 6th, I did not sleep well and Nov. 7th, developed the same symptoms as Oct. 8th. By 5 days, I saw my family doctor. It was again subsiding a bit. She took urine, blood and sent me for xrays. They called and said Dr. wants me to go for an Ultra Sound Nov. 20th and see her on Dec. 3rd.
Headache, nauseous, swelling, pain, small lump, rash, dizziness
Pharmacy was notified pt was experiencing nausea and needed to come up front. Went to front of store and saw pt propped in chair surrounded by 4 to 5 other people. Her eyes were closed. Was notified pt was unconscious (pt was breathing and EMS already ready been dispatched). Pt seemed sweaty and heat, so cold drinks and wet paper towels were applied to skin. We were able to get pt to the floor, but by that time pt was coming to though still lethargic. Orientation questions like name, place, who she was with were asked, which she was able to answer. First responders arrived, and asked pt if she was able to sit up/stand up. Pt was able to sit up-right, however you could still tell she was lethargic, so discouraged pt from rising. Shortly after the ambulance arrived, pt was carried away on a stretcher by EMS.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patients were vaccinated with VARIVAX (dose, lot number and route were not provided) that was stored improperly. No adverse effects were reported. This is one of two cases from the same source. Additional information has been requested.
NI also got extremely ILL for 2 days. Diarrhea, throwing up, fever, chills, weak I got sick 8 hours after the injection which was on a Thursday morning when I received the shot. That evening I got very sick and it lasted until 10pm Sat. night.
13:40 patient complained of bilateral numbness of fingers and toes BP 180/125, HR 129, 100% spO2.  Patient was monitored for 35 minutes and released home. Last set of vitals: BP 161/114, HR 80, 100% spO2. Patient referred to follow up with PCP. All symptoms had resolved at time of release.
5 chicken pox sores on torso 6 days after injection.  Told was normal by doctor office over the phone and could last 7-10 days.  I started noticing all minor cuts, scrapes ,wounds etc and pox not healing as normal.  Still never a fever.  9/6 diagnosed with cellulitis and impetigo.  Started on KEFLEX, BACTRIM, Bactroban cream and bleach baths.
Redness at injection site (Wednesday-Thursday), swelling at injection site (Wednesday-Thursday), muscle pain (Wednesday-today), hives on left arm (Wednesday-Thursday), headache (Thursday-today), nausea (Thursday-today), vomiting (today) , diarrhea (today)
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022 at 18:00, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: 4 days after taking the full course of Paxlovid, most of my COVID symptoms returned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Eye conjunctivitis and redness without itching or swelling or discharge every 3 weeks in left eye.
her left arm red; her left arm hot; her left arm hard; her left arm swollen; her left arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her left arm red), PARAESTHESIA (her left arm hot), LIMB DISCOMFORT (her left arm hard), PERIPHERAL SWELLING (her left arm swollen) and PRURITUS (her left arm itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESTRADIOL, BIOTIN (BIOTINE BAYER), AMLODIPINE, HYDROCHLOROTHIAZIDE, ATORVASTATIN and SERTRALINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ERYTHEMA (her left arm red), PARAESTHESIA (her left arm hot), LIMB DISCOMFORT (her left arm hard), PERIPHERAL SWELLING (her left arm swollen) and PRURITUS (her left arm itchy). At the time of the report, ERYTHEMA (her left arm red), PARAESTHESIA (her left arm hot), LIMB DISCOMFORT (her left arm hard), PERIPHERAL SWELLING (her left arm swollen) and PRURITUS (her left arm itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
pt recv vax in school & that noc woke up sick, T102, fever would come & go for 24hr;also breathing difficulty w/exhalation & arm & axilla swelled;pt seen @ clinic by MD;c/o SOB, glands in axilla were enlarged & tender w/high fever;sore arm;
black marks from the shoulder to the elbow; This is a spontaneous report from a contactable consumer (patient).   A 78-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose of vaccine on 06Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. On Mar2021 (reported as "at the third day after the second dose"), patient experienced black marks from the shoulder to the elbow with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving her shots pt c/o shortness of breath. She recovered on her own before paramedics arrived.
rash began around 130PM 3FEB97 & mom called around 930PM pt had red blotches & itching;no resp distress;advised to go to ER;mom did not go to ER but gave DPH & APAP;advised to call 911 if resp distress occurred;rash began again;pt exp wheal