chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information was received from a health care professional on 08 October 2008. A 32 year old female patient with a history of depression, hypothyroidism, and one previous pregnancy resulting in a full term delivery received an intramuscular booster dose of ADACEL in the right deltoid on 26 September 2008 (lot number C2998BA). The patient was "two to five weeks pregnant". It was not reported whether the patient was two to five weeks pregnant at the time of the report or at the time of vaccination. The patient's date of her last menstrual period was unknown. The patient's estimated due date was reported as "30 June 2009 to 10 June 2009". The patient did not experience any adverse events at the time of the report. No further information was provided. Follow-up information received on 22 December 2008 from a physician. The patient has past obstetrical history of one previous pregnancy that resulted in one live birth with no congenital anomalies. The patient was reported to have miscarried, the current pregnancy on 26 November 2008 at seven weeks gestation. It was not reported whether the patient had any other adverse events since being vaccinated with ADACEL on 26 September 2008. No other information was provided. Documents held by sender: none.
central retinal vascular occlusion.  Complete blindness in left eye 15 hours after vaccination.  Partial sight returned 3 hours later.  Still severe blurry in left eye.  Five days after vaccination received "Avastin (Bevacizumab) intravitreal" injection in eye.  Scheduled to return for additional Bevacizumab injection every 28 days until resolved, or determined to be untreatable.
03/14/2021, A few hours after the vaccine-there was ringing in my ear, tinnitus. In the past, I had it years ago.  It happened and it was not as pronounced.  This one is different because it did not seem to go away as frequently. It does quiet down. There are times when it does not matter if I am distracted, I can still hear it. When it's loud it's loud. It has not affected my sleep. 05/24/2021, I mentioned the tinnitus to my doctor when I had a follow up appointment for my blood pressure. Doctor told me I am not a candidate for hearing aids right now. He mentioned there was something that could cancel noise and suggested to try to be distracted and avoid anything that triggers it. I have not recovered from the AEs. I continue to have the ringing in my ear daily.
28 y/o patient calls at 4:30 PM on 11JUL12 reporting positional, pleuritic pain rt rib cage with deep breathing "I can't take a deep breath." Patient received his primary SPV, AVA#1 and Typhoid IM vaccines on 05JUL12- day #6 s/p SPV. Pain began on Saturday 07JUL12 around mid day while patient was sitting in car (no previous physical exertion). Pain progressed throughout day till it was an "8-9"/10 by Saturday evening. Describes pain as "constant, sharp, worse when breathing in, difficulty to exhale and a lot worse when lying down." Pain does not radiate to left chest, to jaw, throat or left arm. No diaphoresis. No sweating. No N, V. No pallor. Patient's pleuritic rt rib cage pain & SOB exacerbated again morning of 11JUL12, while patient was attempting to do his usual 2-mile run in PT. Patient could not finish run due to SOB & sharp pleuritic pain rt rib cage. Denies sensation of deep pressure in center of chest. States that pustule on left upper arm at SPV injection site is about the size of a dime. Denies red streaking, significant erythema or left axillary LAD. NP advises patient to get buddy to drive him to ER Immediately for further evaluation to r/o post-smallpox vaccine myopericarditis. Initial EKG in ER with ST elevation, otherwise normal. Normal CXRAY. Bedside echo ER with no evidence of pericardia effusion. Cardiac enzymes, ESR, CMP, CBC all WNL, with exception of elevated CRP. (SEE LABS / DIAGNOSTICS BELOW). Patient released from ER w/o limitations and instructed to f/u with Cardiology. Seen by Cardiology on 13JUL12. EKG and echocardiogram repeated (13JUL12). (SEE BELOW) VITALS BP: 120/76, HR: 72, T: 97.5 degrees F, HT: 72 in, WT: 170 lbs. BMI: 23.06, BSA: 1.988 square meters. A/P Last updated at 13 Jul 2012 1329 EDT 1. Chest pain: Pt with symptoms of CP increasing with exertion/laying breathing in the setting of recent vaccination. All of which is consistent with pericarditis. The location of his pain is a bit atypical on the other hand. He does not have an audible friction rub and none was reported in the typed portion of the ER note. Both his current and ER EKGs show subtle PR and ST changes, but they appear to be localized and not diffuse as is typical of pericarditis. Lastly there is no evidence of pericardial effusion on his echo. In the end the patient fails to meet the strict definition of pericarditis, however, that being said I feel that there is enough information to treat him with high dose NSAIDs and colchicine. He may in fact have pleuritis, but will likely benefit from pericarditis therapy. 2. Visit for: screening exam cardiovascular disorders Procedures(s): -ECG Interpretation And Report Only x 1 Medication(s): -Colchicine--PO 0.6MG TAB - TI PO BID #180 RFO Qt: 180 Rf: 0 Start Date: 07/12/2012. Disposition Last updated at 13 Jul 2012 1330 EDT. Released w/o Limitations Follow up: as needed with PCM.
sore arm; couldn't sleep on that arm for a day or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INSOMNIA (couldn't sleep on that arm for a day or so) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and INSOMNIA (couldn't sleep on that arm for a day or so). At the time of the report, PAIN IN EXTREMITY (sore arm) and INSOMNIA (couldn't sleep on that arm for a day or so) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-067813 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067813:2nd dose
Breakthrough case admission after 3 vaccines Pfizer 3/27/21 Lot# ER8730;  Pfizer 4/17/21 Lot# ER8730;  PFizer 11/24/21 Lot# FJ1620
Client presented to nurse requesting explanation of redness on left arm. She also expressed concern about the use of sterile needles in clinic environment. RN observed client's left deltoid area, where she had received flu vaccination two days earlier on 11/12/02. Site was notable for an erythematous area that was warm to touch. There was not swelling or discharge. Area was approximately 1.5" below injection site, and approximately 2"x4" wide with an irregular border. Client denied pain or discomfort and stated "I'm not so worried about my arm, but whether or not you used sterile needles." Nurse explained use of Universal Precautions to client. Client was advised that she could have a local reaction to vaccine. She reported that she didn't think it was necessary to see a doctor, and just needed to be assured that sterile technique and Universal precautions were used. Nurse offered reassurance, education and counseling to client. Client was advised to apply cold compresses to site and return for observation tomorrow. Client appeared to be without distress when she left. Client presented to nurse this day for observation of injection site on left deltoid. Client reports she applied cold compresses last night that provided some relief. Client also stated she thought site looked less red and denied pain or discomfort. RN observed client's left deltoid area. Site was found to be cool to touch, redness was present but diminished and more diffuse. No swelling or discharge was noted. Area now appearing as pink band with irregular border, beginning approximately 1.5" below injection site and approximately 3"x5" wide from lateral aspect to posterior aspect of left upper arm. Client denied pain or discomfort. Client requested reassurance again from nurse regarding sterile technique. Nurse provided education regarding Universal Precautions and the transmission of HIV virus. Client stated she was relieved and felt better and appeared without distress when she left.
Around injection site red, swollen, hot to touch. Starting to bruise, tender to touch, 6 cm around of redness.
Cough; So much pain above her shoulder blade/her arm hurts a lot, not at the inject, above the soulder blade; Body ache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (So much pain above her shoulder blade), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event ( No reported medical history.).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), PAIN (So much pain above her shoulder blade), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, COUGH (Cough), PAIN (So much pain above her shoulder blade), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.    Reporter did not allow further contact
Left arm and back later that day, hurt slight puffy, heating pad applied 20 min. Next day blotchy, tender, redness lower left triceps area, left upper back with 2 blisters almost burn like.
After the vaccine the patient fainted in the vaccine waiting area roughly 5 minutes after the vaccine. The patient was unconcious for rougly 10 seconds then woke up. The patient had no other symptoms or concerns. When fainting the pharmacist on duty was beside the patient and helped them to the floor to put them in the recovery position and ensure their head did not hit the ground. After recovering the patient was attended to by EMTs who were suspecting a vasovagal reaction.
Case number PHEH213US010540, is an initial spontaneous report received from a medical assistant on 09 May 2013. This report refers to a 15-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11072 and expiry date: Jun 2014) at dose of 0.5 ml, intramuscularly on 14 Mar 2013, which was stored below 36F. The vaccine reached 34.5F multiple times since 07 Feb 2013 for collective total times of 9-hours and 20-minutes. No adverse event was reported following this administration error.
Gout flare up with aches in joints in left foot and ankle. Treated with Colchicine (Mitigare) for 4 days.
Information has been received from a certified medical assistant concerning a female who on 13-FEB-2009 was vaccinated with the first 0.5 ml dose of GARDASIL.  At the same visit the patient was vaccinated with the second dose of VARIVAX.  No additional information was provided for the first dose of VARIVAX.  Concomitant vaccine included diphtheria toxoid/tetanus toxoid.  After receiving the first dose of GARDASIL the patient fainted and got injured on her head.  CAT scan has been performed.  The patient recovered on unspecified dates.  The patient sought unspecified medical attention.  Additional information has been requested.
I got the shots and have it now/ Suspected Vaccination Failure; I got the shots and have it now.; very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immune system disorder (low immune system because of rheumatoid arthritis medication).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shots and have it now/ Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shots and have it now.) and pain (Verbatim: very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 6 Jul 2023 This case was reported by a consumer via interactive digital media . The patient got the shots and had shingles now. It was on his/her back and very painful.  The patient had a low immune system because of rheumatoid arthritis medication. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Pt recvd vax & devel scarlantina-like rash w/small portion petechiae on trunk, arms & legs; pt also devel itching; pt taking DPH;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "RA" (unspecified if ongoing); "OA" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Discoid Lupus" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: CT dye" (unspecified if ongoing); "Known allergies: tomatoes" (unspecified if ongoing); "Known allergies: onions" (unspecified if ongoing); "Known allergies: pork" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Biaxin, reaction(s): "Known allergies: Biaxin".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Presented for decreasing LOC that progressed to unresponsiveness after 1st Covid vaccine that day-- >CTH w/cerebellar hemorrhage, intubated, transferred to hospital
Flu like symptoms, extreme headache, sensitivity to light, nausea, generalized weakness (unable to lift self off of bathroom floor or lift arms for a couple minutes).
pt stated that on 2/2/2021 he developed and SOB, choking sensation and fatigue.  On 2/3/2021 he went to the ER for these symptoms.  His O2 level was 98.  He as given EKG, XRAY, tested for pneumonia, heart condition and Covid.  All test came back negative. He was diagnosed w/ Acute Bronchitis and prescribed an Inhaler and Mucinex.  .  On 2/4/2021 pt went to his ENT Dr.  where he was scoped for possible cancer reoccurrence.  The triage of head and neck was negative for any illness.  He was told to continue the Inhaler and Mucinex.  On 2/5/2021 he went to his PCP and was told there was nothing they could do for him.  Told him to wait about 10 days to see if his symptoms subsided, if not he was going to refer him to a Pulmonologist.  From 2/5 to 2/19  the shortness of breath and choking sensation continued but the fatigue had subsided.  On 2/19 pt woke up w/ severe SOB and choking sensation so pt went back to the ER.  They performed another EKG, CT of neck and lungs, Covid Test, blood work, O2 level was 99 with wheezing symptoms. All test were negative but pt still had SOB.  Pt was released and referred to ENT Doctor once again on 2/25 w/ Dr. which they will do another scope where they will go further down.  Pt thinks his next option maybe a referral to a Pulmonologist.
; Lightheadedness and headache; BP: 148/70 Temp by forehead monitor: 98F; HR: 84 RR: 14; Plan: Patient stayed in exit area for 30min instead of 15min. Patient felt safe to walk out of facility by herself after 30min.
ITCHY RASH; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included Caesarean section and concurrent conditions included nephrotic syndrome, asthma, and penicillin allergy, and other pre-existing medical conditions included the patient is currently breast-feeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported. On 31-MAY-2021, the subject experienced itchy rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchy rash was not reported. This report was non-serious.
NauseaVomiting Chills, Stomach Cramps, Flare up of Crohns Narrative:  States was taken to ER due to adverse effects of vomiting, nausea, chills, stomach cramps and bleeding-had a flare up of Crohns
administered a non-approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA7232, expiry date 9th August 2023) for prophylaxis.   On 9th January 2023, the patient received Menveo. On 9th January 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: Nurse Practitioner (NP) called to inquire if how do they proceed. Reporter asked did this person need to be revaccinated. NP reported on 9th January 2023, a patient was inadvertently administered the Lyophilized component of Menveo without approved diluent.  NP assumes it was with a non-approved diluent because they still had the Menveo Liquid component on hand. NP stated unsure what the vaccine was reconstituted with because NP had not spoken to the nurse about further details this morning. The reporter did not consent to follow-up. Additional Supportive Information: the patient was inadvertently administered the Lyophilized component of Menveo without approved diluent, which led to Wrong solution used in drug reconstitution.
Pain in arm immediately after injection, blacked out after 2 mins after injection, felt faint, shaking, very sweaty for about 15 mins after injection. Symptoms receded and felt better about 30 mins after.
Unusual fatigue; uncoordination; confusion; extremely painful and excruciating headache - felt like my brain was going to explode; excessive thirst; nausea; body aches; high body temperature; shaking/trembling; felt hot and cold (chills?): short term memory loss.
Chest tightness, shortness of breath, tasted metal, light headed, hives/rash, nausea Started immediately after injection
pt recv vax;pt had been crying continuously,turned blue & stopped breathing;grand dad blew in pt's face & pt started breathing;inc T but no oth episodes of apnea;to er; pt tx for inc T;
early Saturday morning 19DEC98 began to break out & itch & throat began to swell, eyes red & watery called MD 21DEC98 sx better, throat not swollen but rash still present & itching;went to ER 21DDEC98 & recv pred inj & pred pills & atarax;
Received 2nd vaccine on Wednesday 4/14/21, felt fine (a little tired) until Thursday evening and then had severe abdominal cramps and felt really bloated. Couldn't get comfortable to lie down to sleep; Severe abdominal cramps; Felt really bloated; Stomach felt acidic; Couldn't get comfortable to lie down to sleep; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and thyroid. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and multi vitamin, all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6202) via an unspecified route of administration in the left arm on 17Mar2021 at 14:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 18:00, the patient experienced received 2nd vaccine on wednesday 14Apr2021, felt fine (a little tired) until and thursday evening and then had severe abdominal cramps and felt really bloated, could not get comfortable to lie down to sleep. Stomach felt acidic and really hard. No temperature, the patient took an acetylsalicylic acid (ASPIRIN). Next morning, the patient was still feeling very very bloated but not in as much pain, still enough to call in to work. Felt acidic and bloated and somewhat painful all day. Got a co-worker to bring her tums and baking soda which helped relieve the pressure. felt much better Saturday and Sunday. The patient was under the impression that though she might have nausea, she would not have that sort of cramping and abdominal pain more than 24 hours after the vaccine was injected, was not sure if she should go to the hospital - if it was an allergic reaction - in looking online it looked like it is listed as an allergic reaction, yet it should have been within hours after the vaccine? Please make clearer. 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 taken as a result of the events abdominal cramps which treatment included acetylsalicylic acid (ASPIRIN), tums and baking soda. The clinical outcome of the events felt fine (a little tired), severe abdominal cramps and felt really bloated, couldn't get comfortable to lie down to sleep comfortable to lie down to sleep, stomach felt acidic and really hard was recovered on unknown date on Apr2021.   No follow-up attempts are needed. No further information is expected.