chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had vaccine evening of 5/13 and did not notice side effects that night. Was very tired. Arm slightly hurt where vaccine was administered. On 5/14, woke up with headache and felt dizzy. Had very slight fever (~99 F). Felt better and worse off and on during day. By evening of 5/14, had fever of 101.9. Continued drinking water, took half tylenol dose. Felt very dizzy and a bit sick to my stomach. Fever gone by morning of 5/15. Still felt tired and had vivid dreams/ nightmares for few days after.
Got a severe case of Shingles a week after vaccine was given. I was told to report this to you by my allergist office.  Doctor's care said it might have had something to do with my immune system breaking down with shingles. My primary care physician seemed to think it was a coincident.
Urticaria all over entire body daily. tx with Zyrtec daily. However when tapering off Zyrtec x7 days, urticaria remains.
pt was in for a nurse visit. when checking the schedule to see what vaccine he was to get it stated MEN #2 (this is all that showed on the schedule). this normally means Menningitis or Menactra. It did not stated Menningitis B. pt was given Menactra. Provider received notification the next day that the patient was given this and noticed he should have received Bexero. When I went back with the provider to see what happened the only way you can see he was to get Bexero is if you hoover over the comment section of the schedule or open the appointment desk up.
~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness, anxiety He had taken 325mg of ASA 4x that day d/t right shoulder pain from previous injury
4 hrs after injection, area w/ injection became red and tender. By am, area of redness was the size of a grape fruit with a 1 inch red ring around this area. As the day progressed, redness spread from shoulder to wrist with swelling to twice the normal size. Seen by personal MD and treated with Augmentin 875bid and hot packs. Symptoms are resolving.
This spontaneous report as received from a licensed practitional nurse refers to one unspecified patient of unknown age and gender. The nurse reported that on 24-JUN-2014 the patient was vaccinated with improperly stored ZOSTAVAX (route and dose were not provided) lot # J014811, expiration date: 21-FEB-2015. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Two days after injection, both breasts became swollen and EXTREMELY painful. Lymph nodes in right side armpit were NOT swollen or painful (nor was anything else other than BOTH breasts. Injection site sore of course). Pain in both breasts got progressively worse (worst pain week of 12/16/21), and continues on now. Any light touch or bump to breast causes extreme pain. Unable to be topless (need sport bra or tight undershirt for compression), no weight or pressure at all can be put on breasts. Skin on breasts also has inflammation, looks like zits/pustules. This is abnormal. On day 15 of my cycle, I started bleeding. This is abnormal, and roughly 13 days early. Breasts still extremely painful. Also had additional per Additional information for Item 18: Also had additional periods after first two COVID vaccine doses (April 2020, May 2020), so it's not just making my cycle off schedule, I am having two periods a month. This has happened 4 times since getting the initial COVID vaccine (Pfizer).
Mom noticed some red spots on left thigh that seem tender.  These are new.  no associated fever. Had Prevnar and varicella in that thigh 10 days ago.
dose of expired TENIVAC was administered, with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA304012(CLUSTER).  This case involves a 74 years old male patient to whom dose of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine and pneumococcal vaccine for Influenza immunisation.  On 28-Sep-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection with lot 47183AA, expiry- 24-Sep-2023 via intramuscular route in the right deltoid or immunization (strength: unknown) expired tenivac was administered, with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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.
Patient came in on 5-28-22 to state that she have been nauseated and could not keep her balance and could only  attribute to the vaccine. She had the vaccine before but did not experience this reaction. Told patient to follow up with doctor if the symptoms continue or get worse.
fatigue; Pain at the sight of injection; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date not reported), via an unspecified route of administration, administered in the right arm on 08Mar2021 09:00 (at the age of 48-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included chronic bronchitis, penicillin allergy, and COVID-19. Concomitant medications included losartan (manufacturer unknown); cod liver oil (manufacturer unknown); and unspecified multivitamin, all taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, pain at the sight of injection, and headache on 09Mar2021 07:00. Patient was scheduled for 2nd dose on 30Mar2021. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient got a red itchy rash 8 days later that lasted for 1 week.
2 days p/vax pt lt arm from shoulder to elbow was red & swollen per pt;FMD inc routine steroids (pt has lupus) gave ATB & DPH;denied fever, rash, muscle aches;3 days p/start of rx, redness & swelling apparently subsided;pt gave hx to PHN;
Post vax, woke up with red and swollen arm with itching and rash on arm, slight fever and headache. Went to hospital and was given antibiotics and Benadryl with much improvement. Spent one night in hospital.
Numbness in both arms all the way to hands Vertigo minor  Panic attack  High anxiety  Crying  Hormonal Irritable
she tested positive for Covid. She has had 4 doses of the Pfizer vaccine; she tested positive for Covid. She has had 4 doses of the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The patient did not have COVID-19 prior to vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2023, outcome "recovering" and all described as "she tested positive for Covid. She has had 4 doses of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229460 same reporter/drug/ae, different patient.;
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo (room spinning when she tries to get up from bed).) and PALPITATIONS (occasional palpitations) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (Medical history was not provided). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK DF. On 18-Mar-2021, the patient experienced VERTIGO (Vertigo (room spinning when she tries to get up from bed).) and PALPITATIONS (occasional palpitations). At the time of the report, VERTIGO (Vertigo (room spinning when she tries to get up from bed).) had not resolved and PALPITATIONS (occasional palpitations) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report was received from a healthcare worker (an office manager) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-JAN-2017, the patient was vaccinated with an expired dose of VARIVAX subcutaneously (lot # K007976 with expiry date of 03-JUN-2017, site of administration was not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Some weeks after receiving 3rd dose ( prior two were Pfizer) I developed systemic aches and pain in multiple joints and muscles escaped over 2-4 weeks to 7/10 intensity interrupting sleep. Responded within 48 hrs to 15 mg prednisone.
severe pain in her arm; Difficulty lifting arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in her arm), LIMB DISCOMFORT (Difficulty lifting arm) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031521) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her arm), LIMB DISCOMFORT (Difficulty lifting arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (severe pain in her arm), LIMB DISCOMFORT (Difficulty lifting arm) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood thinner, blood pressure medication, thyroid medication and cholesterol medication
No adverse event; Patient received a bivalent dose as a second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent dose as a second dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a bivalent dose as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a bivalent dose as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a bivalent dose as a second dose).    No concomitant medication information was provided. No treatment medication were provided.
COUGH, DIFFICULTY BREATHING  ED Discharged 8/19/2021 (3 hours) Hospital ED  COVID-19 Clinical impression Cough  Chief complaint Chief Complaint Patient presents with ? Cough         History of Present Illness     Patient is a 46 y.o. male presenting to the ED with chief complaint of cough that started last night. Patient reports that he developed some chest tightness throughout the night. Reports he feels it more when he is coughing. Reports mild shortness of breath when coughing. No one else with similar symptoms. Denies any fevers or chills. Reports a slight headache, reports it is starting to get better which is normal for him to have in the morning. He had a difficult time sleeping last night.   ED to Hosp-Admission Current   8/23/2021 - present (4 days) Hospital  Type 2 diabetes mellitus (CMS/HCC)  COVID-19  Diabetic ketoacidosis associated with type 2 diabetes mellitus (CMS/HCC)  Acute respiratory insufficiency
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: said she felt awful and chest tightness later after vaccine and especially next day, too nyquil? and felt better.  I encouraged her to contact cardiologist.
Dizziness and nausea. Dizziness subsided after 30 minutes but nausea continued and she had to go home, couldn't finish her work shift.
Client and husband called health department to report adverse effect: she developed a head-to-toe red, itchy, unraised rash 2 days after her vaccination last Wednesday 1/27 and it is still ongoing (got worse but now improving). Instructed to consult her medical provider and call back for discussion on second dose eligibility
Patient presented with increased confusion, diagnosed with encephalopathy from Covid-19 infection aggravated by dementia. Supportive care with Vitamin C, Decadron, Lovenox, and Zinc. Discharged on Hospice.
Patient felt dizzy and confused. A hive was on left arm around injection site. Patient also felt hot.
Extreme left shoulder pain within hours of vaccination. Lost range of motion due to pain. 10 days later pain has not fully resolved.
Information has been received from a physician concerning a patient with a birth twin who was vaccinated subcutaneously on an unspecified date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot unknown).  Subsequently, the patient developed an elevated white blood cell count of 16.2.  Unspecified medical attention was sought.   No outcome was reported.  No product quality complaint was involved.  The physician also reported that the patient's twin experience an adverse event following vaccination.  Additional information has been requested.
Slept all day on 2-5-2021 low grade fever. Very wobbly had to have help getting out of bed and to the bathroom. Was better on 2-6 but still wobbly but not as bad.
This spontaneous report was received from a healthcare professional and refers to a 60 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAY-2016 at 16:05, the patient was vaccinated with a dose of ZOSTAVAX lot # L044528, expiration date was not reported, subcutaneously, in deltoid of the left upper arm (exact dose was not reported). On 27-MAY-2015 (reported as the next day), the patient broke out in varicella zoster. The patient asked the reporter if she could get shingles from the ZOSTAVAX and the reporter denied. The outcome of varicella zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as all relevant information has already been received.
Information has been received from a physician's assistant concerning their son who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (manufacturer unspecified). Concomitant therapy included a dose of influenza virus vaccine (unspecified) given on the same day in the same arm. Subsequently, a few days following the vaccinations, the patient developed chicken pox. The patient sought unspecified medical attention. Subsequently, the patient recovered from chicken pox. No product quality complaint was involved. Additional information is not expected.
got really sick/as sick as she's ever been; dizzy; immediately had a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick/as sick as she's ever been), DIZZINESS (dizzy) and VACCINATION SITE RASH (immediately had a rash at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE RASH (immediately had a rash at the injection site). On an unknown date, the patient experienced ILLNESS (got really sick/as sick as she's ever been) and DIZZINESS (dizzy). At the time of the report, ILLNESS (got really sick/as sick as she's ever been), DIZZINESS (dizzy) and VACCINATION SITE RASH (immediately had a rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, Myalgia, Fever, CHILLS/ FATIGUE Narrative:
Administration error: Labelling error of prefilled syringe led to administration of monovalent Pfizer COVID-19 vaccine rather than the intended bivalent COVID-19 product. No observable adverse effects ensued.
This spontaneous report was received from a 74 year old male consumer regarding himself without drug reactions/allergies or pertinent medical history. On 26-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose, duration and lot were not reported). Concomitant therapies included simvastatin (Manufacturer unknown), flunisolide(manufacturer unknown) and loratadine (manufacturer unknown). On 10-DEC-2013, the patient developed the shingles after receiving ZOSTAVAX. On unknown date, the patient saw medical attention. On unknown date, the patient received treatment with aciclovir (manufacturer unknown) 800mg/twice a daily and prednisone (manufacturer unknown). The patent did not performed lab diagnostics. The outcome of the patient developed the shingles after receiving ZOSTAVAX was reported as not recovered/not resolved. Additional information has been requested.
4AM pt awoke screaming x 1/2 hr, slept 15min & started screaming again-constantly on & off all day; @ 11AM mom noted t106 r; Sponge bath given to bring temp down; Mom called clinic to report incident;
Shaky, headache, brief heart flutter, queasy, tired, my joints ached, lower back hurt.
Itching at injection site with slight redness and swelling.  The Emergency Department physician was notified.  Benadryl 25mg was given by mouth at 12:25 AM.  Dr. then reported decreased swelling, no itching and that all symptoms were resolved.
This case was reported by a consumer via call center representative and described the occurrence of localized tingling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced localized tingling, numbness facial and pimples. On an unknown date, the outcome of the localized tingling, numbness facial and pimples were recovered/resolved. It was unknown if the reporter considered the localized tingling, numbness facial and pimples to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported  After receiving 1st dose of SHINGRIX, the patient reported tingling, numbness and pimples on the right side of her face from the temple to her lips. The call center representative informed the patient that she was misdirected to medical Information but the patient was hostile and stated that she would not give any additional information until her questions were answered. The patient was directed to the GRC for further guidance and reporting. No additional details could be provided. This case has been linked to the case US2019061250, reported by the same reporter.
Pt had progressive shortness of breath 4-5 days prior to vaccine administration that resulted in hospital admission and ICU transfer for hypoxic respiratory failure (possible secondary to pneumonia, acute HF exacerbation with fluid overload, etc.). Unclear if related to vaccine given patient's underlying comorbidities and progressive nature of the respiratory failure starting even prior to vaccine administration.
High grade fever consistent for 36 hours ranging from 100.7F to 103.5F despite alternation of acetaminophen and ibuprofen every 3 hours.  103.5 fever registered 27 hours after vaccine. Severe body aches, right axilla tenderness, nausea, diarrhea, multiple episodes of tunnel vision and tinnitus. Bilateral flank pain for 24 hours and severe headache.
Received my vaccine on 12/23, woke up 12/24 and was really tired as morning went on I got really cold and could not get warm, throat started to hurt, body aches and had low grade temp of 100.5, 12/25 felt the same but throat was really sore, 12/26 tested positive for Covid, 12/27 lost sense of taste and smell, 12/28 had horrible shortness of breath and burned when I breathed. 12/29 and 12/30--was very tired, body aches and generally did not feel well. 1/1 woke up and felt well, 1/2 had shortness of breath with activity and not feeling well in general. 1/3 had severe shortness of breath and tachycardia at rest--had to report to ER. 1/4-still had shortness of breath and burning while breathing and then had nausea, vomiting and diarrhea throughout the night. 1/5 went to er because I was so nausea and could not keep anything down and was having heart racing and chest pain. received fluids in er and nausea medications. 1/6, 1/7, 1/8 and 1/9 was very weak and still did not feel well, short of breath. 1/10 woke up and had lung burning, chest pain , shortness of breath and heart racing--was seen in ER for chest pain.  week of 1/10 was very tired and short of breath. finally returned to work 1/18---still am short of breath, heart races and tire easily
19th after patient received DTaP 7/16/07. Markedly swelling and red injection site 14 cm x 5 cm and tender on 7/18/07.