chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 hours post vaccine my top teeth became very sensitive pressure feeling. After 1 500 mg Tylenol the pain let up but still tight & sensitive to liquids.; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 at 14:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) taken for unknown indication taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 13:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021 at 14:00 24 hours post vaccine heavy feeling, chills, she took Tylenol 500mg and she started to sweat & feel much better.0n 26May2021 48 hours post vaccine her top teeth became very sensitive pressure feeling. She took 500 mg Tylenol the pain let up but still tight & sensitive to liquids. Therapeutic measures were taken as a result of the events chills, sensitive teeth with Tylenol 500mg. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events heavy feeling, chills, top teeth became very sensitive pressure feeling and the pain let up but still tight & sensitive to liquids were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
This spontaneous case reported by a consumer, describes the occurrence of muscle spasms (cramping), electrolyte imbalances and pyrexia (she experienced fever) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced muscle spasms (cramping), electrolyte imbalances and pyrexia (she experienced fever). At the time of the report, muscle spasms (cramping), electrolyte imbalances and pyrexia (she experienced fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
little bit tired; besides just sore site injection and little bit tired; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm (Anatomical site of administration: patient stated, the upper left arm) on 02Apr2021 (Age at vaccination: 50-year-old) as DOSE 1, SINGLE for COVID-19 immunization at Rite Aid; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication (taken Ibuprofen after but nothing). The patient medical and concomitant medication history were report-ed. It was reported that patient not on any medication. In Apr2021, it was reported that, patient did not have any side effect on the first shot, besides just sore site injection and little bit tired. Patient was little worried that this was like permanent thing that patient have to deal with now. The event was not treated. The outcome of the event was unknown.   No follow up attempts are needed. No further information expected.
Leg swelling from hip to knee - double in size. Child would not walk for several days. 3 days later a hive-like rash on bilateral buttocks and legs. Then a bruise around injection site - more than what is common. 5-7 days for resolution of sx. Child remains anxious about future immuniztions.
Approximately 17 hours following vaccination, recipient experienced fever, chills, shortness of breath, nausea, diarrhea.
2.5 hrs post vax pt became extremely fussy, crying, not eating & unable to be soothed; Seen by MD who said had URI;
Lip swelling, earlobe swelling and eyelids, vomited. Some drop in BP. Seizure - post-ictal.  8/31/09 ER / hospital records received DOS 8/17/09 to 8/18/09. Assessment: Mild anaphylactoid reaction with vasovagal changes and secondary generalized seizure. Post ictal phase. Presented with altered mental status post seizure and mild anaphylactoid reaction. Had c/o abdominal pains, nausea, headaches. Vomiting, lip and eye swelling. Stiffened up, went limp, stopped breathing. Cyanotic. Not verbal, aphasic for 2 1/2 hours in ER. Admitted for observation. Babinski on right.  10/1/09 ICD-9 Codes received: 999.4, 780.39, 780.79, 789.00 787.01, 784.0, 782.3, 780.2, 780.97, E947.9
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, and previous drug reactions and allergies were not provided. The sterile diluent (MERCK STERILE DILUENT) was considered a concomitant therapy.  On 10-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy type: rHA), lot number S006833 and expiration date 02-SEP-2020 for prophylaxis. (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) was reported to be properly stored.  The vaccine was stored at 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit) for a timeframe of 25 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
this is 1 of 4 pt, out of 35pt, to devel an inj site rxn characterized by redness & itching, immed p/vax;
Anaphylaxis with throat swelling treated with Epinephrine at 10:20am and diphenhydramine at 10:23am.  Transported to ER
I am sending this email to document my experience that I just went through after taking the TBT and MMR vaccine. On Wed May 5th I took the TB test and went back on Friday to have it read. I was informed by the nurse that I needed to take the MMR also because my results from the first one was negative, and also that the rules had changed so in order to be in compliance with Hospital policy I needed to have another one. I said that I did not want to because it had made me sick the first time, and I also informed my boss that I did not want to do this because it had made  me sick , he said that I had to because it is required, the nurse said that it will probably make me sick and I said how so, she said just feel a little weird and my arm would get a bit stiff and sore. Ok, so as to be in compliance, I took the shot and signed the required forms, on the way home that Friday, I could barely see the stripes in the road to drive, over the next 72 hours my eyes hurt so badly I could barely open them, it hurt too bad to cry, for the next 3 days and nights I was extremely sick with high fever and severe chills, my hands and legs swold to where I could not make a fist or close my hands. My gums were huge and I could not eat, it hurt to bad to chew, I have been bed ridden since Friday and today is the first day that I have been able to make it outside of my home and to work, I did not want to be sick and neither did I want to have to take time off of work. I am not happy with the results of this and I am stating it in writing that I do not wish to take any more MMR shots. I am not pleased that I have to risk my health and life to be in compliance or loose my job because of it. I have notified my family and I am also sending this email in strict confidence to you. Please tell me what my rights are when compliance risk my health and life.
Pt started having a red rash and warmness at the site of injection 2 days after and low grade fever resolving with Tylenol.
Booster; body aches; soreness at the injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "soreness at the injection site"; FATIGUE (non-serious) with onset 23Nov2021, outcome "recovering", described as "fatigue".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Local swelling, redness, warmth of arm started several hours after injection - swelling of upper arm, elbow, proximal forearm.  Seen in ER - dx with cellulitis vs. allergic rxn and treated with keflex and orapred
mixed the DTaP/IPV component but did not mix the Acthib portion of this vaccine and administered to a patient, no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown demographics who received a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ071AA, expiry date: 13-Jun-2020, route and site of administration were not reported) which was reconstituted incorrectly on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was a case of actual medication error due to inappropriate reconstitution technique. It was reported patient received a dose of Pentacel but did not mix the powder. Only administered the liquid portion from the vial. Mixed the DTaP/IPV component but did not mix the Acthib portion of this vaccine.  At the time of reporting, no adverse event was reported.  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.  Documents held by sender: none.
Initial report received from healthcare professional on 17 NOVEMBER 2014. A 54-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UI207AA, Expiry date 30-JUN-2015, intramuscular in left deltoid) on 12 NOVEMBER 2014. The patient's  illness at the time of vaccination and medical history were unknown. The patient received many doses of FLUZONE QIV. It was reported that on 12 NOVEMBER 2014, 5 hours after receiving FLUZONE QIV, the patient could not move her left arm. On the next day she had 25% improvement, 2 days later she had 80% improvement and 2.5 days later she had 100% improvement but there was minimal pain. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovering. Documents held by sender: none.
arm soreness, fatigue Narrative:  Developed arm soreness and fatigue following vaccine administration. Resolved by 1/1/21.
pt recv vax;devel drainage at inject site with skin "abraidment"; skin was hot & red; following day c/o muscle pain;
Case previously recorded as MA2009-3832. Initial case report received from a physician via Novartis Pharma, on 06 NOV 2009. A 6-month-old patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102042P1) i.m., on a not reported date. No adverse events was reported. MedCom reference no.: NA09-007771.
Patient hospitalized on 4/1/2021 for heart catheterization, was diagnosed with Severe (+3-4) degenerative mitral valve regurgitation. Patient hospitalized on 5/5/2021 for hypomagnesemia and severe mitral valve prolapse. Patient presented to the ED on 5/20/2021 and was subsequently hospitalized for severe sepsis without septic shock. These visits are within 6 weeks of receiving COVID vaccination.
Hot, hard red lump inder imjection site.  Baby has tun low fever.  Administered Tylenol.
This spontaneous report was received from a registered nurse who referred to a 20-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-JUL-2018, the patient was vaccinated with the first dose of PROQUAD, recombinant human albumin (rHA), lot # N025926, expiration date 18-MAR-2019 (strength, dose and route of administration were not reported), for prophylaxis (drug administered to patient of inappropriate age). On 07-AUG-2018, the patient was vaccinated with the second dose of PROQUAD, recombinant human albumin (rHA), lot # R003294, expiration date 31-JUL-2019 (strength, dose and route of administration were not reported), for prophylaxis (inappropriate schedule of drug administration). A sterile diluent was used for reconstitution of the vaccines. No adverse events were reported.
Sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (Sinus infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, FELODIPINE, SIMVASTATIN and ALLOPURINOL for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient experienced sinus infection with no symptoms which was diagnosed during a routine check up the ear, nose and throat.   Treatment included Antibiotics.
Pt c/o bodyache,headache and feeling lowe grade fever but did not check temp. Pt concerned its due to possible s/e of covid 19 vaccine Pfizer that she got on 07/27/21.  Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. Advised to monitor her sx  but  pt requested f/u MD appt for these mentioned concerns .
Initial and follow up information has been received from a director of nursing at a nursing facility concerning a 86 year old female patient with dementia, asthma, and insulin-dependent diabetes mellitus who on 3/26/05 at 10:45 PM was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The patient had no acute illness at the time of vaccination. The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. On 3/29/05, the patient developed a non-productive cough and hoarseness. On 3/31/05, the patient developed fever (laboratory value not provided), wheezing, and was diagnosed with an upper respiratory infection (previously reported as respiratory distress). The patient was treated at the nursing facility with nebulizer treatments, unspecified medications and oxygen. An influenza swab taken was negative. As of 4/8/05, the patient recovered from the upper respiratory infection. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
This spontaneous report received from a public health nursing supervisor on 23-FEB-2015 who indicated that there were 7 doses of PROQUAD (Merck) (lot # K005644, expiration date 17-OCT-2015) affected by temperature excursion and administered to unspecified patients of unknown ages and genders on unknown dates (dose and route were not reported). No Patient identification information provided for this specific lot number. The nurse also stated that there had been no reports of adverse events following administration of the vaccine and there was no need for revaccination. This is one of several reports from the same source. Additional information has been requested.
My Son went to the doctor for shots on December 11 2018.  He got DTP/DTap /HIB/PCV/and Influenza (flu shot).  This was his first time getting the flu shot. Research says it takes 2 weeks for the flu shot to start to take effect. Approx 3 weeks later we found our Son unresponsive on 1/3/2019.
12/19 positive on an at home COVID-19 test. 12/20 televisit with doctor. 12/21 runny nose, scratchy throat. Televisit with doctor again, who prescribed PAXLOIVD. Symptoms got worse over next couple of days. 12/24 oxygen level down to 92% and fever at 102. 12/25 about 2:20 AM coughing badly. Felt good otherwise, no fever. Oxygen level 97%. Cough lingered until 12/29. Recovered on 12/30.
A couple weeks after the first booster I started having hives. I saw a doctor and he gave me prednisone cream and oral medication. It started at 50 mg and then tapered down. This medication didn?t help so he advices me to see an allergy specialist. Which I didn?t do because I started to recover. Over the time of 3 month the hives weren?t as bad, but they never completely went away.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 05-APR-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown) (lot# reported as No14633 which was verified as not valid and expiration date reported as 07-NOV-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
moderate sore arm,  muscle pain, headache, shivering, nausea, vomiting.
Eye stroke/ Occular vein occlusion -left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GUAIFENESIN taken for fibromyalgia (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: FL247, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 15Jan2021, for Covid-19 immunization. The following information was reported: OCULAR VASCULAR DISORDER (medically significant) with onset Jul2021, outcome "not recovered", described as "Eye stroke/ Occular vein occlusion -left eye". The patient underwent the following laboratory tests and procedures: eye test: (Jul2021) eye stroke, notes: Test: Eye stroke. Date: Jul2021. Result: eye test. Therapeutic measures were taken as a result of ocular vascular disorder. Clinical course: "Eye stroke - Jul2021. Ocular vein occlusion - left eye. Back of eye - Have to get injections in my left eye."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Temperature 102.2. Pulse 156, Respiratory rate 36. Seizures with postitial period/post-apneic. Decreased range of motion to RU/LE. (Clarifications) Pt experienced decrease range of motion to right upper and lower extremities after the seizures and this resolved by the following day.
History of Present Illness Patient is a  57-year-old female presents today for acute visit related to a rash. Patient was seen here in clinic 3 days ago and she received both nursing works in the pneumonia shot in her left arm. Since that time she has noted redness and pain spreading down towards her elbow. She denies any itchiness. She denies any fevers chills or systemic symptoms at this time. 1 Cellulitis, unspecified: - Will give bactrim DS BID for 10 days for cellulitis. - No signs or symptoms of systemic infection at this time or abscess. - Return precautions given including fever, worsening redness or other concerns.
When the technician was administering the vaccine the syringe was faulty and leaked out instead of going into the patients right arm. the patient was revaccinated in the right arm with the proper 0.5ml dose in order to ensure appropriate vaccination.
This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter gave consent to follow up.