chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm (injection site) burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, blood pressure high and seafood allergy (Shrimp). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 03Apr2021 around 09:30, the patient experienced left arm (injection site) burning sensation for about an hour or two. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event left arm (injection site) burning sensation recovered on 03Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt experienced a lump on right arm where the vaccine was given. Pt had it cut it out because it was large and growing. Pt has other lumps as well. It was dx as as cyst.
Within 12 hours of vax administration pt developed an injection site reaction characterized by redness, pain, warmth and itching.
Saturday early morning began with fever over 100, severe headache, every joint and muscle in body ached, sore throat, stuffy sinuses, very tired   -  fever finally broke around 3 PM on same day, headache and body aches continued until late evening.  Everything better by 6 AM following morning (Sunday) except for still being tired.  Back to normal Monday.
temp up to 105 took motrin & APAp & bath before temp dropped;2Am-430AM short febrile sz about 8-10 seconds long;
Developed a fever with dizziness and nausea. Also had really deep chills that started in extremities and worked way up towards chest. Extremely fatigued for a couple days.
pt recv vax 18APR96 & 22APR96 pt exp a fever of 104.9R (105.3 by ear);tx w/Ibuprofen & APAP;pt recovered w/in 24hr;
I had a headache, and body aches. I took a COVID-19 test and it came back positive.  The same day I went to an urgent care clinic and I took another COVID-19 test there that came back positive. They prescribed Paxlovid. Within the next week I developed nasal congestion, breathing problems and I did not feel well. The following week I did a telephone visit and my doctor prescribed me an inhaler. I am still having trouble breathing.  The other symptoms subsided after 2 weeks.
Hospitalized (11/1/21);  COVID-19 positive (11/1/21); fully vaccinated  Discharge Provider: MD Primary Care Provider: DO Admission Date: 11/2/2021 Discharge Date: 11/4/2021 PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is a 69 y.o. male  with pmhx of OSA on cpap, CAD s/p CABG and recent PCI in May on asa and plavix, HFpEF on torsemide, T2DM not on insulin, hx amyloidosis, HTN. He presented to the hospital for chief complaint of worsening SOB and chest discomfort. He was admitted for Elevated troponins and chest discomfort in the setting of dehydration and a COVID positive test.  Came from ER with chest discomfort and shortness of breath.  Patient was recently found to be COVID positive.  He is fully vaccinated but has not received a booster yet.  Chest angiogram thorax did reveal a right middle lobe pneumonia and was negative for PE.  Case was discussed with Cardiology given elevated troponin. They recommended heparin drip and transfer to another facility.  There was discussion about possible AFib, patient was given multiple IV Cardizem doses at facility before transfer to other facility.  At other facility, cardiology was consulted and thought this was only demand ischemia with his unchanged unremarkable EKGs and TEE. Troponins were elevated on admission but plateaud and in the context of the overall picture, were not concerning in their opinion.  Patient was admitted for elevated oxygen requirements and had a few episodes of hypoxia dropping into 87%, usually overnight. However this was determined to be 2/2 to not being on a CPAP machine and during periods of exertion. His saturations improved considerably afterwards and he continued to saturate in the mid to low 90s on room air. After two days of improved oxygen saturations, it was determined the patient would be best served by the COVID at home program. We discussed the patients care and plans moving forward to which they agreed. All questions were answered to the best of our ability with the given data. The patient was discharged in stable condition
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 31-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Sep2023 to 12Sep2023.  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-202300305693 Same patient, different product, different event;
Initial pain and swelling.  2-3 hours later post nasil drip followed that evening by sore throat.  Increased the next day with a slight nose bleed at night.  Some light-headed-ness and dizziness. Health facility provided cold medication (OTC).  Also two spots on chest they said may symbolize bacteria infection.
Pt received Flu shot 10/14/15 in right arm. By 10/15/15 swelling and a lump noted with pain and itch per pt. Pt went to E.D. - MD who looked stated was a reaction even though it was 3-4 inches away from injection site. Pt. states minor limited rxn. Swelling and rash decreasing each day.
Pt began feeling warm from head to toe, and dizzy. All vitals were stable and within 20min client stated that she was feeling normal again.
Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication or treatment were reported by the reporter.  Company Comment: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.   This case was linked to MOD-2021-102410 (Patient Link).; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Severe pain in arm that vaccine was injected in, with little relief from Ibuprofen and aspirin. Worse at night when laying down, no relief from ice pack.  Some relief from prescription muscle relaxant I had available on hand.
Pt was administered FLUARIX Quad on 11/13/13. On 12/5/13 was still complaining of stiff arm no warm or redness at site.
I did have COVID before in June and symptoms are very similar to that I am experiencing right now; Fever; Chills; Body aches, muscle aches pretty much everything, joint ache; Body aches, muscle aches pretty much everything, joint ache; Headache; Body aches, muscle aches pretty much everything, joint ache; This is a spontaneous report received from a contactable consumer (patient- caregiver). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9263, Expiration date: Unknown), via an unspecified route yesterday on 20Feb2021 at 12:45, as a single dose for covid-19 immunization. Medical history included covid in Jun2020 with symptoms that were very similar to what patient was experiencing right now and got 2 moles removed. Concomitant medications included birth control, fish oil, vitamin D, multivitamin, green tea and pota. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 21Feb2021 today morning since 14:00, patient experienced fever, headaches, body aches, muscle aches pretty much everything, joint ache, chills, and wanted to know this is normal, how long it will last and what she should do with these side effects. Treatment received as a result of events included Tylenol. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
A report has been received from an office manager concerning a 3 year old, female patient who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) was administered on 13-Jan-2014. The office manager reported that they gave EXPIRED FLUMIST QUADRIVALENT to patient which occurred on 13-Jan-2014. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Patient had low grade fever for 2 days after the vaccination. Injection site was swollen and warm to the touch. Area of swelling was approximately 3"x4" in size. Area was reddish-pink in color. Tender pain at touch of site.
Initial report was received on 13 October 2011 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 09 January 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A 55 year-old female patient, who had no illness at the time of vaccination had received FLUZONE Intradermal, lot number UT4163AA (route and site of administration not reported) on 04 October 2011 and an unspecified amount of time later, experienced soreness and redness at the injection site. The patient was treated with a ROCEPHIN shot for the "infection". No further information was available at the time of the report. The patient's outcome was reported as recovered. This report involves a cluster of unknown patients (exact number not reported). Upon follow-up information identifiers were reported for only one patient. According to the reporter, "no other patient had adverse reactions that they are aware of". Documents held by sender: none.
cramping with a lot of pain; I was spot bleeding; By April 24th I was cramping with a lot of pain and bleeding.; I was supposed to start my period April 27/28; nauseous; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ew0161), dose 1 via an unspecified route of admin-istration, administered in Arm Left on 16Apr2021 at 15:15 (at the age of 35-years-old) as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included semaglutide (OZEMPIC), ethinylestradiol, norethisterone acetate (AUROVELA 1.5/30) taken for unspecified indication from unknown date. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 17:00 (in less than 24 hours after receiving the vaccine), the patient was started with the event of spot bleeding, by april 24th, was cramping with a lot of pain and bleeding, She reported that she does not usually have painful cramps and have been randomly nauseous since getting her vaccine shot. she was supposed to start her period april 27/28. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. All the seriousness criteria was reported as no'.  It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was provided as 28Apr2021. Outcome of the events were unknown.  Information about Lot/Batch number was available. Additional information has been requested.
Pruritic Rash every night all over  Relieved by combination of Benadryl 50 mg, Claritin and pepcid
sore arm; red swollen; red swollen; painfull; Flu-like symptoms; Dose: 3rd; the undiluted vial was administered to a patient with 0.3 mL; the undiluted vial was administered to a patient with 0.3 mL; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 83 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Oct2021 11:45 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 83 years as dose 3 (booster), 0.3 ml single 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; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 28Oct2021 11:45, outcome "unknown", described as "Dose: 3rd"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 28Oct2021, outcome "unknown" and all described as "the undiluted vial was administered to a patient with 0.3 mL"; PAIN IN EXTREMITY (non-serious) with onset 29Oct2021, outcome "unknown", described as "sore arm"; ERYTHEMA (non-serious), SWELLING (non-serious) all with onset 29Oct2021, outcome "unknown" and all described as "red swollen"; PAIN (non-serious) with onset 29Oct2021, outcome "unknown", described as "painfull"; INFLUENZA LIKE ILLNESS (non-serious) with onset 29Oct2021, outcome "unknown", described as "Flu-like symptoms".  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). The patient had provided information regarding the reported adverse event(s) with the use of the product, the Pfizer product had a causal effect to the adverse event. NDC number of COVID-19 Vaccine: 59267100001. It was unknown that prior vaccinations within 4 weeks. It was unknown that there was specific relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Severe diarrhea; This is a spontaneous report received from a contactable consumer reported for herself. A 91-year-old female patient (non-pregnant) received first dose bnt162b2 (batch/lot number: unknown, brand: Pfizer, Solution for injection) via unspecified route of administration in left arm on 27Jan2021 at 12:15 PM at single for covid-19 immunisation at hospital facility. The patient did not have any allergies to food or other products and relevant medical history was reported as none. The patient concomitant medications were not reported. The patient did not receive any other vaccines 4 weeks prior to administration of COVID vaccine and any other medications within 2 weeks of administration of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 at 17:00, the patient experienced severe diarrhea. The patient did not receive any treatment for the same. No seriousness criteria reported. Outcome of the event diarrhea was reported as recovering.   Information about batch/lot number is not available. Follow-up attempts have been completed and no further information is expected.
administered ACTHIB with an expired diluent with no reported adverse event; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age/gender patient who involved in administered haemophilus type b (HIB) (PRP/T) vaccine [ACT-HIB] with an expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received 0.5 ml total dose of suspect haemophilus type b (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ667ABA, expiry date: 15-May-2023) with an expired diluent (Lot Number:U7261AA, expiration date: 07-Apr-2023) (strength, route, administration site: Unknown) for Immunization (immunization) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event administered acthib with an expired diluent with no reported adverse event.  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.
On Day 1 -9/10/21  following my first dose of Pfizer I experienced tingling and numbness down my right arm that reached to my fingers but I didn't think much of it due to a similar sensation I had in the past from a rhomboid injury.   On Day 3 - 9/13/21  I began to experience twitching under my right eye. On Day 4 - 9/14/21  The twitching continued but progressed into tingling and numbness on the right side of my face.  I also developed a rash on both of my cheeks. On Day 5 - 9/15/21 The symptoms continued to be present and I began to feel the tingling in numbness in my right arm again so I was advised to go to Urgent Care where it was confirmed that I was experiencing inflammatory neuropathy and likely a result from the vaccine. I was prescribed Prednisone at 20 mg to be taken twice orally for 3 days.  Symptoms began to subside following my first dose but fully returned by the end of my prescription. On day 10 - 9/20/21  I went to see a neurologist, because my symptoms were still ongoing.  By this time the spasms and numbness and tingling in my legs had not yet presented itself.  Dr diagnosed me with an autoimmune inflammatory response to the vaccine. On day 11 - 9/21/21  My symptoms progressed to the top of my head on the right side and both of my legs, very faintly on the left leg and predominantly more noticeable on the right leg and eventually only noticeable on the right leg.  It felt as if my legs were asleep and the right leg felt very weak as if I could fall at any moment. I also started to experience involuntary muscle spasms in my right leg and throughout the right side of my body (upper body and ribcage).   The symptoms have been ongoing to date 9/27/21
About fifty minutes after shot I experienced a metallic taste in my mouth (my mouth was very dry), mild swelling in my throat, and mild difficulty swallowing.  The symptoms subsided after thirty minutes.  My throat was sore for two days.  I did not require medical attention.
Pt recvd vax 7MAR94 & mom noted pt's arm shaking like an old person-states, not all the time, but when pt raises them up; cont to do this off & on today;
injection site swelling; side was swollen; This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Contrast dye with an associated reaction of urticaria (Injected contrast dye for a kidney test and she had hives after the test). Concurrent medical conditions included epinephrine (Allergic to Epinephrine), drug allergy (Allergic to Tetracycline, Vicodin, and contrast dye) and food allergy (allergic to seafood particularly seafood).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injection site swelling and swelling. On an unknown date, the outcome of the injection site swelling and swelling were unknown.   It was unknown if the reporter considered the injection site swelling and swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported.  Caller stated she was also allergic to Epinephrine, Tetracycline, Vicodin, and contrast dye. Caller stated that she was allergic to seafood particularly seafood. The patient received the shingles vaccine and she had a reaction a day after receiving it and she had injection site swelling and her side was swollen.  Caller would like to know if it would be safe for her to take the Pfizer COVID vaccine. Caller would like to know if these allergies would cause a problem with her receiving the Pfizer COVID vaccine. Caller stated she was injected with contrast dye for a kidney test and she had hives after the test. Caller took a list of ingredients to an HCP to compare ingredients to medications she was allergic to and saw if there were any ingredients that were the same that could cause a potential interaction.  Caller would like to know if the Covid vaccine would be safe to take. No further information was reported.
Violent entire body chills approximately 12 hrs after vaccine.  Chills lasted an hour with 3 blankets and heating pad. Then switched to fever for next 8 hours. Fever recorded 102 the only time I checked. Nausea, body aches, plugged nose making it slightly difficult to breathe, headache, and exhaustion. Unable to sleep through the night due to fever, aches, and breathIng discomfort.  Slept off and on all following day.  Able to eat minimally at dinner next day.  Strong taste of food, ie chicken soup seemed way strong. Third day tired but appetite slightly returning and other side effects seem subsided.
urticarial like nickel size papules in fingers of both hands;also fever & vomited about 4 days;had a rash x 1wk;
Patient reports small red bumps around injection site. Patient denies SOB, chest pain, or any anaphylactic type reactions. Patient advised to monitor symptoms for 1 week and report to PCP if any worsening of symptoms.