chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Provider hospital summary "73-year-old female with the rheumatoid arthritis on Humira, who completed the COVID vaccine serious several months ago developed shortness of breath and cough and was tested positive for COVID-19 on 11/21/2021.  Patient was not able to get Regeneron. Patient later got worse at home and  presented with shortness of breath and generalized weakness and diarrhea on 11/26/2021. I think patient had acute respiratory failure as evidenced by ED note " Resp: 24, SpO2: 91 % (88% SpO2 when ambulating)".  Patient was given dexamethasone, she received 3 doses of remdesivir, her oxygen requirements decreased to room air on 11/29/2021 and patient is being discharged home.  She is still somewhat did has generalized weakness.  Physical therapy recommended that she gets outpatient PT OT, however I do not think patient can get out of the house with isolation requirements and without taxing effort due to her illness.  We will order home care with nurse and PT OT.  Patient will continue dexamethasone and cough medications at home as well as incentive spirometer. During the hospital stay patient was noted at times to have episodes of bradycardia down to 46, asymptomatic. Diarrhea resolved. BP medications had to be held due to hypotension"
Information has been received from a medical assistant referring to unknown number of unspecified patients of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant medications were not provided. On some unspecified dates the patients might have received an unknown number of doses of VAQTA (lot # M032492, expiration date 02-MAR-2018, dose, route and site of administration unknown) for prophylaxis. The vaccines were administrated after a temperature excursion to 29.29 degrees Fahrenheit for 111 hours. No adverse effect was reported in any patients. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA009633:
Patient started experiencing blurry vision while she was reading 13 mins status post injection and began feeling dizzy and sweaty. Her BP was taken immediately at 115/83 with P:97 and O2: 99%.. Patient placed in exam room and also started having left sided jaw pain described as if someone punched her in the face, but improved after 3-4 mins. Her dizziness returned after 2-3 mins, but then resolved after 3 mins. She  contacted her mom and was notified that she has had 3 major adverse reactions to vaccines as a child, but does not recall which ones with one causing a 10 day hospitalization. Patient also states that last year she had a severe reaction to the influenza vaccine where she was also hospitalized due to fainting. Her mother also told her she had a severe egg allergy up until the age of 12 and had never received the influenza vaccine. Patient did not know about her adverse reactions until she called her mother after getting the covid vaccine. Patient had vitals taken again after 20 mins with BP:118/81 and P:87. She was monitored for 40 mins and was discharged home to her mother. Patient advised to go to the ER if symptoms return.
Upon receiving second dose of DTaP that evening pt continued to cry for 6 hours straight and had a temp of 102F. She was seen at Urgent Care but no physical cause of distress could be determined except for vaccines received.  Upon receiving third dose of DTaP mom pre-medicated pt with Tylenol and continued this @ the clock following vaccines however, pt continued with inconsolable crying for 4 straight hours and ran a low grade temperature.  Person contacted and agreed this was an adverse effect listed on CDC vaccine website.  Mother instructed to continue with vaccine series and pre-medicate with Tylenol and hopefully pt will outgrow this reaction.
onset shaking 1030PM;fever during noc severe body aching;pain in palm of lt hand
This spontaneous case reported by an other healthcare professional, describes the occurrence of vaccination complication (minor viral symptoms) and vaccination complication (mild symptoms) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included allergy to chemicals (PEG2000). On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (minor viral symptoms) and vaccination complication (mild symptoms). At the time of the report, vaccination complication (minor viral symptoms) and vaccination complication (mild symptoms) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
we gave the patient a 4 days old  expired vaccine but patinet is fine have no symptoms
hives (12) each 10 to 20mm diameter;erythematous;locations: arms, legs, abd;
Urticaria started on trunk the afternoon after vaccine administered. Patient came to Dr. (PCP) after urticaria continued x 4 days.
After school, on the day that patient received the flu shot at school, he experienced a 20 min episode during which he heard voices "like in a crowded restaurant." Later that night, he experienced a similar episode lasting 10-15 seconds.
Within 2 hours of immunization patient had large golf ball sized lump on arm where injection. Very warm, itchy and painful.
flu like symptoms after the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The age at vaccination was not reported. Patient received the dose of Shingrix and had flu like symptoms. The reporter did not consent to follow up. The case was linked with US2021010484 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010484:same reporter US-GLAXOSMITHKLINE-US2021AMR011092:same patient, 2nd dose
hematuria; rash on both upper arms; headache; body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (hematuria), RASH (rash on both upper arms), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism since an unknown date. Concurrent medical conditions included Shellfish allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 02-Jan-2010 to an unknown date for Hypothyroidism.   On 30-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 28-Jan-2021, the patient experienced HEADACHE (headache). 28-Jan-2021, the patient experienced MYALGIA (body aches). On 29-Jan-2021, the patient experienced HAEMATURIA (hematuria). 29-Jan-2021, the patient experienced RASH (rash on both upper arms). On 29-Jan-2021, PYREXIA (fever) had resolved. On 30-Jan-2021, HAEMATURIA (hematuria) had resolved. On 12-Feb-2021, RASH (rash on both upper arms) had resolved. At the time of the report, HEADACHE (headache) and CHILLS (chills) outcome was unknown and MYALGIA (body aches) had resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events added,  event outcome updated, Product, reporter and patient info updated.
minor soreness; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor soreness) and FATIGUE (extremely exhausted) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 13-Mar-2021, the patient experienced FATIGUE (extremely exhausted). On an unknown date, the patient experienced PAIN (minor soreness). At the time of the report, PAIN (minor soreness) and FATIGUE (extremely exhausted) had not resolved.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. It was reported that, after second vaccine the patient had minor soreness but second day felt extremely exhausted. The reporter's causality for the events of soreness and exhausted was not provided.  The reporter assessed events of soreness and exhausted as possibly related to Moderna Covid-19 vaccine.  No treatment details were reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623056, MOD-2022-623065 (Patient Link).
clay colored stools, low abdominal pain and fever 4 days after received immunization. Elevated Liver function tests: AST 52* H 10-30 U/L  ; ALT 71* H 6-29 U/L
MMRV and varicella given on the same date and at the same time. Mother brought child into clinic on 7/15/17 with low grade fevers not over 99.9, controlled with TYLENOL.
pt exp partial sz DO & global regression; now w/mild mental retardation; onset 12 days p/MMR: sz result in lip smacking, clonic activity of the rt upper extremity & eye deviation to lt; EEG revealed temporal slowing & spikes; enlarging head
Administered a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 19th August 2022, the patient received Havrix. On 19th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The pharmacist reported that a patient was administered a dose of Havrix that had expired on 18th June 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Very large red patch starting two inches below injection site going down my arm 5 inches. The patch is roughly 3 inches wide.  Warm to tough and tender. Somewhat painful but not severe. If there is a place to attach photo to this report I will do that.
In the evening after receiving the vaccines, the baby demonstrated intermittent rhythmic suspiration/peroration of right arm. Later noted to have a temp of 102.
I am in the COVID 19 vaccine f/u survey group. The questionnaire just asks for reports to changes in health. They symptoms are consistent with ongoing chronic illnesses. Similar illness presentations have happened at least 6 times in the 5 years prior to getting the COVID vaccine. I received a call from the CDC study asking to submit this adverse rx report.
Patient with no adverse effect. Meant to give two separate vaccines of Varivax and MMR. Instead administered two doses of Varicella by giving Varivax and ProQuad. Knew I needed to give MMR but oversight on getting the correct vial
I had (slight) tinnitus ringing of the ears prior to the vaccine and it has gotten worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 07Jan2021 (unspecified if ongoing); "tinnitus ringing of the ears" (unspecified if ongoing), notes: I had (slight) tinnitus ringing of the ears prior to the vaccine. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I had (slight) tinnitus ringing of the ears prior to the vaccine and it has gotten worse".  Additional information: he had COVID-19 on 07Jan2021. He had (slight) tinnitus ringing of the ears prior to the vaccine and it had gotten worse. She wanted to get the second as soon as he could. He asked if the vaccine flare up tinnitus. He asked if they have any information on tinnitus and the vaccine. He wanted to get his second dose, but he wanted to find out more about this and he didn't want it to get worse or be permanent.  No follow-up attempts are possible. No further information is expected.
pt seen on floor in prone position per staff pt lost consciouness for 9 secs. staff who witness the accident said pt slid down on chair and fell face forward. vitals: 86/60 p-60 R-16 o2 98% offered food and fluids denied nausea vs bp 106/65  P-75 R 18 o2 98% RA t-98.1 at 337 pt verbalized no dizziness no headache able to move all extremetites without discomfort no vleedign on gums/mouth no change loc 347 BP104/63 P77 R18 o2 99% pt parents will accompany pt to visit primary doc. clininc for further eval.
headache in the left temple, headache increasing frequently; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and HEADACHE (headache in the left temple, headache increasing frequently) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 007M20A and 025520A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERTENSION (high blood pressure). In October 2021, the patient experienced HEADACHE (headache in the left temple, headache increasing frequently). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (high blood pressure) outcome was unknown and HEADACHE (headache in the left temple, headache increasing frequently) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) Increased.         Patient reports she has a family history of high blood pressure.   This case was linked to MOD-2021-420137, MOD-2021-420138 (Patient Link).
lt thigh red inc area size of softball;1st was size of silver dollar & grew in size;not painful;MD notified give APAP for discomfort;use ice/warm cloths
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA  11/29/2022 --  RECURRENCE OF SAME SYMPTOMS
The patient had near-syncope and confusion about 2 minutes after receiving a vaccine.  She is diabetic and hadn't eaten at all yet and thought it was more of a metabolic derangement.  She was sent to the ER.
Shingles; rash in one leg; Pain in leg; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. After receiving the second dose of COVID-19 vaccine last 10May2021, that's Pfizer COVID-19 vaccine. So, patient experienced pain in the leg, rash in one leg and had shingles. So 10May2021 was Monday, so he had pain in the leg Tuesday, Wednesday is rash in the leg, one leg and had shingles Thursday. The outcome of the events was unknown.  Information on lot number/batch number was requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Vaccine given around 9:15-9:30am on 10/18/18, That evening around 10 or 11pm the patient noticed chills and vomiting that evening, and then it resolved, starting Friday he also noticed blisters on his lips and it has not resolved. The injection site is also very bruised, which patient reports he noticed starting Friday or Saturday and was still bruised at time of reporting (10am on 10/23).
skin rash, to collar area, chest; This case was reported by a nurse via call center representative and described the occurrence of rash in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2020, the patient received the 2nd dose of Shingrix. On 20th January 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine on sunday and on monday developed skin rash, to collar area, chest. The patient tried to determine what in vaccine he/she may have reacted to.
Bell's palsy; This is a spontaneous report from a contactable (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and lot number: FA7484) dose 1 via an unspecified route of administration, administered in arm right on 21Jul2021 (age at vaccination: 46-years-old) as dose 1, single for COVID Prevention/ COVID-19 immunisation. Medical history was none. There were no concomitant medications. On 21Jul2021, the patient was received the first dose of the vaccine. Two days later on 23Jul2021, he had a facial droop, his mouth got numb. The patient had some slurred speech. The patient went to the ER on 26Jul2021 (Monday). The patient did not get admitted to the hospital, it was just an ER visit. The patient was diagnosed with Bells Palsy and given steroid and another pill to take and left the hospital on Monday. The patient stated that it was still ongoing but it was stabilized right now because of the medications he was given by the hospital but his right eye won't close and he can't smile and he has pressure behind his right ear. The patient was just trying to figure out what happened because wednesday he was normal, and then he got the shot and two days later he went to the hospital. The patient does have more appointments coming up, but he was wondering what information Pfizer has on this side effect. The outcome for the event was not recovered.
Redness and  Swollen left on the anterolateral thigh on the side of the injection pain on the area
On 10/10/02 pt noticed red spots on calf, by 10/12/02 pt had wide spread rash, physician on-call notified by pt andwas placed on medrol pk. Hosp admit on 10/15/02 for urticaria.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.