chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax on 17AUG92 & 27AUG92 was seen by MD sx of swollen, faintly warm, non-tender arm which was also the inject arm; devel a samll lump @ the inject site; MD told to observe the area; 30AUG92 pt had recovered;
Horrible pains in both shoulders/ a friend in (State name) that hers lasted a month-Eben Pain spreaded to other joints; This is a spontaneous report from a contactable consumer. This contactable consumer reported for female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9267), via an unspecified route of administration administered in arm left on 18Feb2021 at single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9263), via an unspecified route of administration, administered in arm right on 21Jan2021 10:00 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included arthritis, HBP and chronic boreliosis, all from an unknown date and unknown if ongoing. The patient previously took NSAIDs, LEVAQUIN, latex and experienced hypersensitivity. Concomitant medications included Oxycodone 7.5 mg; Carvedilol 20 mg; Gabapentin 300. was reported that the No adverse effects first 4 days. The patient experienced horrible pain in both shoulders, samnitska m up dcery houf on 23Feb2021 06:00. Could not lift a cup of water, pull her pants up or shirt on. Because patient heard from a friend in a different state that hers lasted a month I was waiting. After three weeks, Eben Pain spreaded to other joints patient visited her family doctor. He prescribed Medrol- steroid pack and to stop Simvastatin. Pain subsided after 24 hours. The outcome of patient was recovered.   No follow-up attempts are possible; no further information are expected.
covid vaccine breakthrough case  dose 1 Pfizer  4/26/21  EW0161 dose 2 Pfizer  5/17/21  EW0179
Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; Little headache; Tired for a few days; A spontaneous report  was received from a consumer concerning a 77-year-old female patient who experienced slurring her words (dysarthria), became uncoordinated (coordination) abnormal and had symptoms like a stroke (cerebrovascular) accident, felt very nauseous (Nausea) and not feeling 100% (Malaise).  The patient's medical history was not provided. Relevant concomitant medications reported included Baby Aspirin and Vitamins NOS for unknown indication.  On 10 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 048AZIA) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient began slurring their words, became uncoordinated and had symptoms like a stroke. The patient was also very nauseous and went to the emergency room. The event, symptoms like a stroke was considered medically significant.  On, the same day, the patient was discharged. The patient still was not feeling 100% still.  No Treatment information were provided.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  On an unknown date, the outcome of the event, was slurring their words, became uncoordinated and had symptoms like a stroke, felt very nauseous and not feeling 100% resolved on 11MAR2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Watery eyes, dripping like they were running, and they were dark red and teared up constantly had to have a Kleenex all the time.  Had COVID in December 28, 2020
Severe body aches, feeling feverish (without elevated temp.), fatigue, headache, extreme arm pain at injection site, welt-appearance under injection site, redness and warmth at injection site. Treated with Tylenol (1000 mg) around-the-clock starting ~18hrs after injection.
"Per FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and local authority instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes".
I went on a trip 12/14/22, I wore a mask everywhere expect during dinner and when in the spa. I was congested, had a fever, fatigued was hoarse, coughing and slept one whole day. I lost my sense of taste while I was at the resort. I flew home 12/21/22, I got tested on 12/22/22 and it came back positive. I was prescribed PAXLOVID that I started taking immediately and I started feeling better after taking the medication for the five days.
I did not have an adverse reaction to the vaccine. On 12/16/2022 I started feeling symptoms of sore throat and congestion. On 12/18/2022 I tested positive for COVID-19 at the urgent care. I was advised to take regular cold like over the counter medication. As of today, I have a little brain fog and congestion.
ACTHIB with the wrong diluent and administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient for whom HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml dose and of standard strength suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with the wrong diluent, It was reconstituted with sterile water via unknown route in unknown administration site with unknown batch number & expiry date for Immunization with no reported adverse event (product preparation error) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
Started with headache Friday morning and small warm spot and gre. Bright reddish color Friday night through Sunday. Sunday evening it was pink. The following morning she reported in was a pale pink. Warm to the touch and tenderness.
12/17/2020 Vaccine L shoulder.  12/18 muscle aches, feverish, fatigue. @ night because itchy location on back; reddish and inflamed.  12/19 morning ecstatic  12/20 numbness on penis  12/21 lesions on gland penis; spots pigmented Referred to dermatology; prescribed topical steroid cream. Lesion numbness and itching subsided.
16 days after pt received VARIVAX #1, pt developed a low grade fever 100.1-101.8 degrees F and varicella-like rash. (rash is mild and generally on extremities only).
COVID; Postponed taking the oral typhoid capsule; A spontaneous report was received from a nurse practitioner on 15SEP2023 regarding a patient of unknown age and gender who had "COVID" (PT: COVID-19) and "postponed taking the oral typhoid capsule" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 07SEP2023, the patient took the first dose of Vivotif. Reportedly, the patient had COVID, hence postponed taking the second dose and took the dose on 15SEP2023.  The outcome of the event "COVID" was unknown at the time of this report while it was not applicable for "postponed taking the oral typhoid capsule".  The action taken with Vivotif with respect to the event "COVID" was dose interrupted and for event "postponed taking the oral typhoid capsule" it was not applicable.  No additional information was reported.  Company comment: It was reported that a patient received Vivotif and had COVID (COVID-19) due to which the patient postponed taking the oral typhoid capsule (inappropriate schedule of product administration). Considering the limited case information, the role of Vivotif  cannot be ruled out and the causality of COVID-19 is assessed as possible. Furthermore the causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vivotif and had COVID (COVID-19) due to which the patient postponed taking the oral typhoid capsule (inappropriate schedule of product administration). Considering the limited case information, the role of Vivotif  cannot be ruled out and the causality of COVID-19 is assessed as possible. Furthermore the causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
SICK REALLY BAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced sick really bad. The action taken with covid-19 vaccine was not applicable. The patient recovered from sick really bad on 31-MAY-2021. This report was non-serious. This report was associated with product quality complaint: 90000181659.
Pt experienced increased thirst, appetite and urination x 1 day. BS 259 at fasting and urinalysis and 4+ glucose. Pt was immediately sent to medical center ER for admission and work up. DC DX: new onset diabetes. Family HX: father type I diabetic.
I started to experience chest pain two weeks after receiving booster shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Dec2021 (Lot number: 33036BD) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). The patient did not take concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7533, Route of administration: Unspecified, Anatomical site: Left arm), administration date: 17Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0162, Route of administration: Unspecified, Anatomical site: Right arm), administration date: 08May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: CHEST PAIN (non-serious) with onset an unknown date in Jan2022, outcome "recovering", described as "I started to experience chest pain two weeks after receiving booster shot". Therapeutic measures were not taken as a result of chest pain.  Additional Information: The patient had no known allergies. 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Pt had a fever up to 104F within 24 hours of Prevnar vax.
This spontaneous report as received from a physician refers to a 4 years old male patient with allergy to penicillin and other allergies. The patient's medical history included an episode of asthma 1st time on 17-MAY-2011 and chickenpox disease at 10 months. The patient was vaccinated with dose 1 of MMR II (lot #, dose and route not reported) in 2008 and was then vaccinated subcutaneously with (lot # 0075AE exp 01-JAN-2014) dose 2 of MMR II on 30-JUL-2012. No other co-suspects were reported. Concomitant medications included ALLEGRA and ZYRTEC as needed but was not on these medications at the time of vaccination. On 30-JUL-2012 the patient had an anaphylaxis reaction (life threatening and disabling). The patient had a red rash all over that was from the face down and wheezing badly. The patient was given a nebulizer and 30mg of a steroid. The patient was in the office for 2-3 hours and recovered. The physician stated the patient had no allergy to eggs and received a flu vaccine twice without any problems. No lab diagnostic tests were performed. The outcome of anaphylaxis reaction was reported as recovered on 30-JUL-2012. The relatedness for anaphylaxis reaction was not provided for MMR II. Additional information has been requested.
Red or just skin colored hives that itch are occurring nightly. I also received two TB skin tests a week apart, with the second being done on 11/18/2014.
Initial report received from a physician on 08 September 2011. A 15-year-old female patient, with no medical history, fell and hit her face 5 minutes after receiving an intramuscular left deltoid injection of ADACEL (sanofi pasteur inc. lot number U4104BA/ sanofi pasteur ltd lot number C3962) on 07 September 2011. Per the reporter, the patient was sitting in a chair reading after vaccination when she fell and hit her face, resulting in a lip laceration and 2 broken teeth. After the fall it was noted that she had developed rigidity and "curled up backwards". She was taken to the emergency room and admitted for observation; outcome was unknown. Documents held by sender: None.
Pt claims nurse administered vaccine on triceps not deltoid initially there was some redness and swelling at injection site. Numbness, pain, weakness which extended from shoulder to fingers which continued until 2nd week in Nov. Had appointment with neurologist on 17 but further testing cancelled since pt had recovered. Had doctor visit today.
stuffy nose; flu-like symptoms; headache; muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "headache", "flu-like symptoms", "muscle ache", "stuffy nose"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "headache", "flu-like symptoms", "muscle ache", "stuffy nose". The following information was reported: NASAL CONGESTION (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered", described as "stuffy nose"; INFLUENZA LIKE ILLNESS (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered", described as "flu-like symptoms"; HEADACHE (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered"; MYALGIA (non-serious), 24 hrs after the suspect product(s) administration, outcome "recovered", described as "muscle ache".  Additional information: With each of the previous vaccines, the patient ended up showing flu-like symptoms (headache, muscle ache, stuffy nose, etc.) within 24 hours of receiving the vaccine. The symptoms went away within a day.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201363305 same patient/AE, different vaccine dose number;US-PFIZER INC-PV202200121275 same patient/AE, different vaccine dose number;
01/01/2021 The day after the vaccination when I was trying to raise my arm to the side and up. I could only go 90 degrees; I could not go any further. It resolved on its own, but it took like 5 or 6 months. I talked to my doctor about it in passing, but I did not think it was significant enough to go the doctor's office.
About 11:30 PM on 03/15/2021, started gasping for breath when laying down, sat up in lazy boy for a hour and half, beathing returned to normal.  About 3:30 PM on 3/16/2021, started gasping for breath again.  Called my daughter and she transported me to  Hospital.  They tested for covid - results negative.  They did a C-Scan of my chest and saw a blood clot in each lung.  While hooked to the monitors, they found I had Afib.  They also did an ultra-sound of my legs and found a small clot in each leg below the knees in a small vein.  I have never had any record of clots or Afib.  They transferred me to  Medical Center early on 3/17/2021.  They started a heparin drip to soften the clots.  In the afternoon of 3/17/2021, they performed a Suction Thrombectomy to remove the clots from my lungs.  On 3/19/2021, they put me on Eliquis Tab.  I was released from the hospital in the evening of 3/20/2021.
administered beyond the 12 hours use times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered beyond the 12 hours use times) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex and Depression. Concomitant products included HYDROXYZINE, BUSPIRONE and FLUTICASONE for an unknown indication.    On 21-Dec-2021 at 11:05 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered beyond the 12 hours use times). On 21-Dec-2021 at 11:05 AM, EXPIRED PRODUCT ADMINISTERED (administered beyond the 12 hours use times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A Moderna vial was taken out on 20 Dec 2021 near the end of the day. It was a little less than half full. The person in the morning came in and administered 5 patients beyond the 12 hours use times.  No treatment medications reported.   This case was linked to MOD-2021-430889 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up received contains Patient details, Medical history, Concomitant medications, Suspect product details updated.
pt recvd MMR vax as a child; Pt currently exhibited a lack of response to mumps; no further details were provided;
RN was giving patient INFANRIX pre-filled 0.5 ml injection. The pre-filled vaccine was being injected and shot back at the nurse. Per RN, the syringe appears to be defective.
vomiting, diarrhea.  D/C summary received for DOS 8/3-4/2007 for DX of Intussusception made at another facility. Infant had Air contrast barium enema which partially reduced the IS.  Taken to OR for open reduction of intussusception and appendectomy. D/C DX:  Intussusception.
Normal flu like symptoms; Chills; Sweats; Lethargy; Headache / persistent headache at back of head / persisting through second day; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Oct2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included Attention Deficit Hyperactivity Disorder (ADHD), possible perimenopause and possible cardiac arrhythmia (occasionally skipped heartbeats). The patient was allergic to penicillin and coconut. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks of vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) for immunization on 05Oct2021. Concomitant medications included methylphenidate (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA), ibuprofen (ADVIL) and paracetamol (TYLENOL) (as needed) and acetylsalicylic acid (ASPIRIN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 50-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. On 20Oct2021, on the day after vaccination, the patient experienced normal "flu like symptoms" including chills/sweats, lethargy and headache; persistent headache at back of head started the day after vaccine, was persisting through 21Oct2021, the second day and only somewhat eased with Advil/Tylenol. Consistent with mild to moderate adverse event and no medical intervention was necessary at that time. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the event headache; persistent headache at back of the head and included treatment with ibuprofen (ADVIL) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal "flu like symptoms" including chills/sweats, lethargy and headache; persistent headache at back of head started the day after vaccine and was persisting through second day was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
headaches; tinnitus; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headaches, and tinnitus on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
Case number PHEH2013US010556, is an initial spontaneous report received from a pharmacist on 09 May 2013. This report refers to an 82-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A11078) intramuscularly on 09 May 2013. After vaccination, a moment later, she experienced injection site blistered and a high raised rash that bled appeared. The events outcome was reported as ongoing. The causality and seriousness of the events was not reported.
Immunizations givens- baby crying/screaming- appeared to be holding breath- then baby became rigid/stiff-Dr. obtained and babe shaking and then postictal response. Seizure type activity lasted approx 1.5-2 minutes and postictal response approx 5 minutes. Face mask oxygen applied- babe O2 Sats 100% and HR 102-106. Ambulance called- O2 removed when ambulance arrived @ 10:00 a.m. Pt transported to Hospital.
Swelling on back of arm to top of elbow redness that went down arm (yesterday). 10-7-11 swelling & warmth still present on deltoid area to elbow - no redness.