chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 87 yr old white male with a reported vitamin K allergy, history of coronary artery disease, four coronary artery bypass surgeries, type I diabetes mellitus, and an aneurysm who on the afternoon of 14Oct04 was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot 647636/0944N; also reported at 944N). Concomitant medication included warfarin sodium (Coumadin) (dose, duration, and indication not reported). Subsequently on 14Oct04, at 2000 hrs, the pt was seen in the ER at the hospital with left shoulder pain, nausea, chills, shaking and stated that "can't life my arm hurts so bad". The pt rated his pain a 10/10. It was reported that the pt's skin was pale, warm and dry, easy respiration. The pt was given diphenhydramine hydrochloride (Benadryl), 50mg PO to take at home and told to ice the shoulder. the following examination results were reported: 14Oct04: blood pressure measurement 148/88; vital sign measurement respiratory rate 18; total heartbeat count 76; temp measurement 96.2. It was also reported that on 18Oct04 the pt stated that his shoulder was still very sore. The pt was told to alternate ice 20 minutes and then next hour do heat for 20 minutes. It was also reported that at the time of vaccination the pt had actinic keratosis of the left cheek. The pt recovered on 19Oct04. No additional information is expected.
Patient received the first dose of the Pfizer vaccine September 2021 and 5 days later developed severe chest pain, pain  radiating down the left arm, and shortness of breath. Went to the ER for workup, echo, MRI, CT, labs, and EKG were all normal except there was a pericardial effusion found. It is believed the pericardial effusion was due to the vaccine.
Patient described feelings of anxiety and dizziness about 15 minutes post injection.  RN had patient lie down on cot for several minutes and perform deep breathing exercises.  After about 30 minutes of rest, laying flat, and deep breathing, patient stated she felt much better and was able to walk to her car and she can drive home. VS 1230: p102 pox100% bp140/90 r30 temp97.8 1240: p102 pox99% bp140/80 r24 temp97.7 1245: p93 pox97% bp130/70 r20 temp98
Received flu vaccine 9/23/13 felt immediate pain after vaccine. Went to ER 9/30/13 because pain didn't go away and had trouble lifting arm, c/o soreness in neck and tingling some in left arm but primary in shoulder. Was taking ibuprofen but upset stomach if take too much. Heat. ROM X-ray 10-25-13 will refer to ortho for follow up care.
Patient became light headed and passed out. He was moved to the floor when he came to, because he started shaking. Patient reported it was because he was scared that he couldn't see. He reported feeling much better after about 10 minutes, and said it was because he was very scared of needles.
Had Covid booster around 4 PM.  By 10 PM both arms and hands were numb and tingling.  Shot given in left arm.  Right arm worse than left arm.  Both hands tingling and extremely painful.  Continues at time of report, just not as painful as last night.
4 days post vax pt began to have sinus problems w/sl temp;no site rxn;bronchial cough;dx w/asthmatic bronchitis;benzonatate, Keflex;
Patient presented to vaccine clinic for Covid vaccine. (Patient received Moderna Vaccine).  She received her vaccine at 7:45 PM.  15 minutes after getting vaccination she developed symptoms of tingling around her mouth.  She informed staff of the symptoms.  Vital stable without any hypoxia. No lip, tongue or throat swelling.  No skin rash. No trouble breathing.  She was given 10 mg of cetirizine.  She did feel like she had hives in her throat and tingling sensation going to the back of her throat. EMS was called and she given 50mg of diphenhydramine and given 0.3mg of epinephrine. Symptoms immediately started to improve shortly after epinephrine was given.  She did develop some restlessness and tremor after epinephrine was given which did resolve. EMS arrive and transported her to the hospital.
10 year-old female patient administered a Fluzone High-Dose Quadrivalent, no AE; 10 year-old female patient administered 0.7 ml dose of Fluzone High-Dose Quadrivalent, no AE; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 year old female patient who received 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, vaccination and family history were not provided.  Patient did not received concomitant and no other vaccines.  On 11-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ541AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of report 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 holder's 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.
Received Hep-B Vaccine 27 Days after First dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Received Hep-B Vaccine 27 Days after First dose of Moderna COVID-19 Vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: HEP-B-VAX on 03-May-2021.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Received Hep-B Vaccine 27 Days after First dose of Moderna COVID-19 Vaccine). On 03-May-2021, INTENTIONAL PRODUCT USE ISSUE (Received Hep-B Vaccine 27 Days after First dose of Moderna COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Patient is a 34 year old male with a past medical history of asthma who presented to the vaccine site today for his first dose of the vaccine. He received his dose at about 1710 and went t o observation area for his 15 min wait. About 5 minutes into his wait he reports feeling lightheaded and feeling hot then had a syncopal episode with loss of consciousness and fell out of his chair. He hit the left side of his head on the floor. This writer her a loud thud and looked out to see him on floor. I immediately ran over to him. He was unresponsive to tactile and verbal stimuli. He finally regained consciousness with sternal rub. He was out for about 30-45 seconds.
Nine days after injection a round red flat slightly itchy lesion  about 3 in in diameter developed below the site of the injection called "Covid Arm"
Patient received COVID-19 vaccine (Pfizer) on:  1/5/2021      LOT EK9231 IM left arm 1/26/2021   LOT EL3248 IM right arm  on 2/19/2021 developed cough and congestion
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. The reporter stated that between 28-APR-2015 and 30-JUN-2015 (exact dates of administration were not provided), the patients were vaccinated with improperly stored doses of GARDASIL, dose 0.5 ml, intramuscularly, lot # K005881, expiration date 14-JAN-2017 (strength was not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Staph infection. I noticed the infection about a moth or so after vaccination. I went to Urgent Care where they cleaned the infection and prescribed antibiotics.
about 30 hours after first dose of covid 19 vaccine, the patient had a bad stomach aches and diarrhea for an hour. after that he went into anaphylatic shock-had itching, hives all over body, his tongue swelled up, and he couldnt talk. he went to the ER and received benadryl, decadron, and fluids
To first shot flu like response; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma, allergies" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulpher drugs" (unspecified if ongoing); "grasses" (unspecified if ongoing); "strawberries" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "Allergy:Ceftin"; Avalox, reaction(s): "Allergy:avalox"; Forteo, reaction(s): "Allergy:forteo"; Tymlos, reaction(s): "allergy:tymlos"; Amoxicillin, reaction(s): "Allergies:amoxicillin". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "To first shot flu like response".  Additional information: Patient received other medication in 2 weeks includes Stelara, Claritan, Albuterol, DHL by pure botanicals with slippery elm and marshmallow. Known allergies: Ceftin, avalox, penicillin, forteo, tymlos, amoxicillin, sulpher drugs, strawberries, grasses, etc. Other medical history: Asthma, allergies. COVID 19 Treatment: Paxlovid, start date 18Jun2022, stop date 22Jun2022, Lot number: Nd#00069-1085-30. Patient received Pfizer second dose on 15Mar2021 in left arm with lot number: EN6199. Patient received Pfizer third dose on 12Oct2021 on left arm with lot number: FF2587. To first shot flu like response. Other 2 shots no symptons. Pcr Tested positive for covid 17Jun pm. Treatment on paxlovid began am 18Jun. On paxlovid just heavy head and chest cold symptons first 3 days and symptons began easing. Felt fine and tested negative on rapid test on 24Jun. Rebound with same cold symptons and positive rapid test 30Jun. Rebound with heavy head/chest cold symptoms 3 days. bwgan to ease up slowly as struggled to keep lungs clear of secondary infection with steam etc. Tested positive on homevtest day, 5, 6 though Felt milder cold symptons day 5 and 6. Day 7 Tested negative on rapid test though still heavy chest and coughing.   No follow-up attempts are possible. No further information is expected.
Received vaccine at 12 noon 9/21/2016 around 6pm on 9/22/16. Patient developed vertigo, ataxia, dizziness, some upper resp symptom, nasal congestion. Took Meclizine 25-50 mg as of 10/26/16 still some dizziness.
Started with fatigue and headache about 3 hours after receiving vaccine. Slept for 14 hours straight. Woke up the next morning with fatigue, muscle/joint pain and extreme irritability. Later that evening, began shaking violently. Immediately took 400mg Motrin. Unable to walk or speak. Only able to moan to communicate with spouse. Violent chills. Numbness to arms, legs, and face. Tachycardia, vasoconstriction to hands and feet. Both hands and feet white and cold. Palpitations.  Event lasted about 15-20 minutes. After it was over, had severe fatigue, sweats, and excessive midline body heat. Hands and feet have remained cool but normal in color since then. Continuing to alternate Tylenol and Motrin and staying hydrated.  It took a couple of hours before being able to communicate in complete sentences.
lichen planus has blossomed all over with involvement of her fingernails, gums, and legs.; She also has an eye problem; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a patient  .   This case involves patient (gender unspecified) who had little redness on her gums (gingival erythema) and lichen planus has blossomed all over with involvement of her fingernails, gums, and legs (Lichen planus), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included lichen planus for many years and eye problem and is unable to take steroids due to the eye problem.  The patient's past vaccination(s) included flu shots in the past.    The patient's medical treatment(s) family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious eye problem (eye disorder) and lichen planus has blossomed all over with involvement of her fingernails, gums, and legs (Lichen planus), after the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of the report, the both events were unknown.
She was diagnosed with colitis at ER; Patient started with abdominal discomfort 4 days after receiving 2nd dose; Patient started with constipation; Patient started with diarrhea; Patient started with rectal bleeding; A spontaneous report was received from a reporter like a consumer concerning a 55 year old female patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like patient started with abdominal discomfort 4 days after receiving 2nd dose/ abdominal discomfort, patient started with constipation, patient started with diarrhea, patient started with rectal bleeding, 2 days later, abdominal pain returned, went to ER/ emergency care, white blood cell count was over 20,000.  The patient's medical history included blood pressure. Concomitant medications included blood pressure medication and fluoxetine hydrochloride.  On 11 March 2021, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position in the left arm for prophylaxis of COVID-19 infection. On 15Mar2021, she started with abdominal discomfort followed with constipation, diarrhea and rectal bleeding. On 17Mar2021,abdominal pain returned and she went to ER. Her white blood cell count was over 20,000. She was diagnosed with colitis at ER. Out of these events rectal bleeding, abdominal pain returned and went to ER were medically significant.  Laboratory details included white blood cell count.  Treatment information included metronidazole, levofloxacin.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events,  patient started with abdominal discomfort 4 days after receiving 2nd dose, patient started with constipation, patient started with diarrhea, patient started with rectal bleeding, 2 days later, abdominal pain returned, went to ER/ emergency care, white blood cell count was over 20,000 was considered as unknown.; Reporter's Comments: Little information about lab tests and other diagnostic procedures is available but all of the events are "unlisted" and "Possible Causality" related to the vaccine as there is a clear temporal relationship.
The decedent reported a continuous headache since receiving the vaccination. On March 3rd he suffered a cardiac arrest and was pronounced deceased.
Transient global amnesia and fall  the day after vaccination Elevated ESR 51 and CRP 3 Symptoms resolved spontaneously except for labs, still monitoring
Patient felt like he was going to faint.  Patient has had history of fainting with other vaccines in the past.  Patiient appears pale, mildly diaphoretic..  No apparent respiratory distress.   Patient moved to cardiac chair, legs elevated.  Cool washcloths applied to back of neck, cool water provided to drink. Patient felt better after 35 minutes and left hospital accompanied by father.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On 29-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L011080, expiration date 01-OCT-2016. Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
Presents with diarrhea, poor PO intake, AMS. Positive for Covid on 2/22/22. No remdesivir/dexamethasone. Dehyrdation resolved with IV fluids and supportive care.
broke out in whelps 24hrs p/over arms, legs back & chest;cont thru 2NOV95 taken to clinic & started on Atarax
hotspots on random parts of the body that lasted two days; very high temperature which made him delirious; Violent vomiting; very high temperature which made him delirious; bad headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (Pfizer Covid Vaccine Boost34- Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown. , Manufacturer unknown), for Covid-19 Immunization. The following information was reported: DELIRIUM (medically significant), PYREXIA (non-serious), outcome "unknown" and all described as "very high temperature which made him delirious"; VOMITING (non-serious), outcome "unknown", described as "Violent vomiting"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; RASH MACULAR (non-serious), outcome "recovered", described as "hotspots on random parts of the body that lasted two days". The patient underwent the following laboratory tests and procedures: body temperature: very high. No underlying conditions reported by the patient's wife. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported shooting and stabbing shoulder pain significantly impairing activities of daily living approximately 3 hours after administration. Patient denied swelling and redness. Patient reported symptom improvement after taking NSAID.
Information has been received from a physician concerning a female who on Oct 25 2005 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella Virus Vaccine live (upgrade process) (lot 651812/0769R). ten days following vaccination, on Nov 4 2005, the patient experienced a measles like rash and a fever. Additional information has been requested. This is in follow-up report(s) previously submitted on 12/21/2005.  Information has been received from a physician concerning a 12 month old child, with no known drug allergies, who on 25-OCT-2005, at 9:00am, was vaccinated with a first subcutaneous dose of PROQUAD (Merck) (Lot # 655812/0369R).  Concomitant vaccines administered at the same time a third intramuscular done of COMBAX (Lot# 652498/0643R), a fourth intramuscular dose of PREVNAR (Lot# A85856M) and a first intramuscular dose of FLUZONE (Lot# U1753AA).  It was noted that the patient had signs and symptoms of a mild upper respiratory infection at the time of vaccination.  "Ten days following vaccination.  On 06-NOV-2005, the patient experienced a measles like rash and a fever.  It was also reported that in the morning of 06-NOV-2005 the patient developed erythematous, papular lesions all over her chest and abdomen.  Subsequently the patient recovered.  Additional information is not expected.
Information has been received from a licensed practical nurse concerning a 78 year old retired white female with no known drug allergies who on Oct 13 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P), intramuscularly in the right deltoid. Concomitant therapy that day included a sixth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1411AA), intramuscularly in the left deltoid. The patient was seen on Oct 15 2004 with redness and pain in the right upper arm. The arm was swollen and warm to touch. Cellulitis was reported. The patient was treated with ciprofloxacin hydrochloride (Cipro) (500) (x 4 days). The reporter indicated that cellulitis was considered to be an other important medical event. There was no product quality complaint involved. The patient recovered. Follow up indicated that the cellulitis was not an was not an other important medical event. The nurse reported that 2 other female patients had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA03089, WAES0410USA03090) in the past two weeks. No further information is available.
This spontaneous report was received from a 60 year-old female patient, who was a medical assistant via a company representative, and refers to herself. The patient's pertinent medical history included osteoporosis and Raynaud's disease. No information about the patient's drug reactions/allergies and concomitant medications was reported. On 16-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). On 14-JUL-2015, 4 weeks after the vaccination with ZOSTAVAX, the patient experienced mild case of shingles. The patient sought medical attention and visited a doctor. She was prescribed prednisone (manufacturer unknown) and acyclovir as corrective treatment. The outcome of the events was reported as recovered on an unspecified date. The reporter did not provide the causality assessment. Additional information is not expected as there was no consent for further contact.
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provide
I received a Shingles vaccine on 5/11/21 at 1o:45am.  I had minor injection site pain and felt fine until about 11pm.  At 11pm I started to feel tired and achy.  I went to sleep and had a horrible nights sleep because I felt so poorly.  Headache, muscle aches, fatigue, more severe injection site pain. I woke up on 5/12/21 and felt like I had the flu with the same, aforementioned, reactions.  I took 2 ibuprofen at 8:35am and within 20 minutes, I felt fine, back to normal.  At 3pm the same symptoms were back, I took 1 ibuprofen but the symptoms remained.  I took another ibuprofen at 4pm because I had gotten a fever of 100.1.
Patient c/o tongue swelling & lips swelling. Pt was assessed by physician. Pt was given benadryl. Symptoms resolved.