chrisvoncsefalvay/vaers-outcomes huggingface dataset:
63 Y male with a past medical history of h/o HTN, HLD, h/o genital herpes (suppressive acyclovir), and recent COVID + (symptoms onset 12/27, positive 12/30) who presents with new hypoxia (81% on RA at home), admitted for COVID PNA. Symptom onset on 12/27. COVID positive on 12/30. Last fever on 1/4 (subjective); afebrile throughout admission. Patient is vaccinated w/ Moderna since 4/2021; has yet to receive booster. CXR and CT chest both showing bilateral diffuse scattered opacities, c/w COVID. 1/5 Overnight, patient acutely decompensated and supplemental O2 needs rapidly escalated from 6LNC to HFNC 60L FiO2 95%. D/w pulmonary, given TOCI x1 on 1/6 and increased steroids to solumedrol 125mg BID. Pt w/ slightly improved oxygenation when prone but continued to have persistent high O2 supplementation requirements so given second dose of TOCI on 1/9. Patient completed course of Remdesivir from 1/5-1/9. Patient was noted to have increased cough with slight end expiratory wheezing so scheduled Combivent q6h starting 1/10. Weaning O2 support requirements with significant improvement starting 1/11 and was on RA w/ SpO2 at rest but required 2L with activity/exertion. Primary Procedures: None. Secondary Procedures: None. Reason for Hospital Admission (Admitting Diagnosis): CORONAVIRUS COVID-19 DISEASE.
Severe headache, chills and fever, very weak,dizzy, cough,  and  water diarrhea, nausea no vomiting.
Headache with no fever; Coughing; muscle pains; chest discomfort; mucus; Diarrhea; mouth was like glue; got a weird smell and it was a nauseating smell; burning in her stomach; burning in her stomach,and she had some reflux; burning in her mouth; leg muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in right deltoid (Right shoulder) on 24Aug2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not had any medical history and family history. The concomitant medication(s) included oxycodone (OXYCODONE) 5 mg taken 4 times daily taken for an unspecified indication started 7 years ago and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: PAG780), via an unspecified route of administration, administered in left shoulder on 03Aug2021 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced sore arm and hot flashes that lasted a couple of days. The patient did not had any prior vaccination within a four weeks. On 24Aug2021, the patient experienced had some burning in her stomach and she had some reflux anyway and then, some burning in her mouth, and then it was gone. She went home and had some leg muscle aches and chills. She wants to know, her chills lasted for two days. Two days after she got a weird smell and it was a nauseating smell. It could have been the mucus. She clarified as a day later at 2 in the morning Thursday the 26Aug2021. Then everything went away, now yesterday. On 29Aug2021, the patient mouth was like glue. On an unspecified date, the patient reported headache with no fever. All subsided after a few days yesterday the night of the 30Aug2021 and she had a mouth breather and she will take a drink of water and it will be gone. She woke up on Monday night and it was like glue. On 01Sep2021, the patient had diarrhea and on unspecified date, she reported muscle pains, coughing, mucus, chest discomfort, and just sore. Patient reported going for a covid test tomorrow be-cause maybe it was covid. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event for burning in her stomach,and she had some reflux, burning in her mouth, Chills, got a weird smell and it was a nauseating smell, was recovered on Aug2021 and, headache was recovered on 30Aug2021 and outcome of rest all events were unknown.
1st dose / 29Oct2020 / not received a 2nd dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th october 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Parent states 2 days p/DTP inject was given 31MAY91, pt became very weak, perspiring & slow to respond; sx lasted approx 30 mins-no fever or convulsions; was taken to ER; no further problems;
Vertigo woke up 5:00am do to vertigo (Tuesday AM after Monday vaccine) lasted 48+ hours dr. provided rx Meclizine unknown if that helped reduce time of vertigo took it at 1:00pm  on second day (Wednesday).
Pt developed shortness of breath, extreme fatigue, low blood pressure, episodic low grade fever, hypoxia, quickening of the heart (up to 90), tremors, pale, clamminess, cold, sweating, weakness, and cough. Doc 198136 states the following: Hypersensitivity to environmental allergens, developed food allergies. A follow up report received 8/1/2000 adds: Pt states that symptoms had sudden onset. She was seen that day (5/19/2000) by her physician who ordered several tests all of which were WNL. In late June-early July, she was hospitalized as symptoms worsened. More tests were performed including CXR, echocardiogram and blood tests for oxygen content of her blood. Admitting diagnosis was hypoxia. She consulted with a pulmonary-critical care specialist after discharge from the hospital. Again, all tests were negative or WNL. Pt states she obtained a copy of the package insert from SmithKline and that "all my symptoms are there." She plans follow-up with PCP later this week to discuss this. Currently her health status is slowly improving. Her breathing has become easier and she is able to cook for herself. She continues to sleep a lot and feel fatigued.
Given expired dose of Boostrix as above. on 2/14/20 mom notified me staff has endorsed intermittent dizziness. I told her I do not believe it's related.
Warm heavy sensation to both feet, tingling to both calves, tingling to right and left hand
4/2/12 - c/o not feeling well. Afebrile. Had approximate 25-35 red, raised pustules on abd, back, chest & legs. 4/4/12 lesion scabbing. Remain afebrile.
bitterness in mouth; tonsils is very white; arm is reddish tender; Arm is painful; Arm is reddish; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitterness in mouth), TONSILLITIS (tonsils is very white), TENDERNESS (arm is reddish tender ), PAIN IN EXTREMITY (Arm is painful) and ERYTHEMA (Arm is reddish ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01AB21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PANTOPRAZOLE, LOSARTAN and DEXLANSOPRAZOLE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DYSGEUSIA (bitterness in mouth), TONSILLITIS (tonsils is very white), TENDERNESS (arm is reddish tender ), PAIN IN EXTREMITY (Arm is painful) and ERYTHEMA (Arm is reddish ). At the time of the report, DYSGEUSIA (bitterness in mouth), TONSILLITIS (tonsils is very white), TENDERNESS (arm is reddish tender ), PAIN IN EXTREMITY (Arm is painful) and ERYTHEMA (Arm is reddish ) outcome was unknown. Not Provided          Treatment details included cold compress. Action taken with mRNA-1273 in response to events were not applicable.
Persistent high pitched crying for 6 hrs, severe irritability x 4days, fever (>101) for 3 days. Repeat doctor visits x 2, ER visit x 7.
Within 2 hours of vaccination Pt experienced generalized ache ness that lasted 3 days. Itching was significant enough to require antihistamines. No respiratory involvement, angioedema or other S/ Sx. Pt also reported area of redness, swelling and warmth at site of yellow fever injection, lasting 3 days
Numbness left side of face/swollen face/drooping.  Followed by numbness on entire left side of body, weakness and some minor motor-skill impairments (on the left side).  Fever,aches and chills the following day.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M041212, expiry date 21-JUN-2019, lot# M034780, expiry date 15-APR-2019, lot# M032650, expiry date 31-MAR-2019, lot# M030380 expiry date 01-FEB-2019 for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Initial case received on 07 September 2010 from a healthcare professional. An 8 year old female patient received a left deltoid intramuscular injection of H1N1 (lot number Up 063AA) on 28 January 2010. She experienced a "tick" shortly after receiving the vaccination (date not reported), which went away after 4 weeks. She was seen by a neurologist for the "tick". No further details were available from the reporter. Documents held by sender: None.
A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 29-Nov-2012. The patient experienced INADVERTENTLY GAVE FLUMIST TO A 16M ONTH OLD which started on 29-Nov-2012. The outcome of the event of INADVERTENTLY GAVE FLUMIST TO A 16 MONTH OLD is unknown. The report was considered to be non-serious.
Moderate to severe allergic-local reaction, 20cm x 19cm erythema with 5x5cm induration.
Soreness in arm where PNEUMOVAX administered. Several red, patchy, painful spots on arm and axillary region.
waited the required 15 minutes at the vaccination site.  As I was driving home, my throat swelled up, breathing was labored, and I became dizzy.  I quickly pulled over to a gas station and called 911.  EMT's arrived and transported me via ambulance to the hospital.  En route, I was administered 50 mg of Benadryl.  Diagnosis was anaphylactic reaction to vaccine.
Confirmed Breakthrough Case 1st Dose 1/28/2021 Pfizer EL9261 2nd Dose 2/18/2021 Pfizer El9267 3rd Dose 10/7/021 Pfizer EW0164
RECEIVED VACCINE IN THE AM.  IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS.  AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN.  I FINALLY WAS ABLE  TO SLEEP AGAIN AROUND 7AM.  I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY.  I SLEPT MOST OF THE DAY.  AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
LOCALIZED REDNESS AND SWELLING AT INJECTION SITE 48 HOURS LATER
pt felt had a temp on 9JAN-on 10JAN noticed spots on back & neck that looked like blisters saw MD 11JAN dx w/chickenpox;has lesions in throat, mouth & nose 12JAN98;
as soon as patient began to walk to the observation area immediately after vaccine administration, she says she felt a heat rush to her head (especially the back of her head)and felt dizzy as if the room were spinning and had blurry vision. she stated that her father had recently passed away and she was anxious, depressed and very nervous and trembled a lot when she cried. she said her left arm had been trembling so we decided to inject on the right arm. we did place a cool pack in the back of her neck and we monitored her for an hour. when she felt better, i walked a distance with her to see if she was alright and she said she felt better. her daughters were with her and left with her. i told her to go to ER if she got worse during the night (she does not have a primary care dr).
some possible increase in heat exhaustion; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 06Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, patient experienced some possible increase in heat exhaustion. Patient experienced some difficulty in carrying out usual exercises as compared to before. Physician mentioned some possible increase in heat exhaustion, but he was not positive that it was caused by the vaccine. Physician would like to have some information in regards to precaution that may be aware of regarding an increase in heat exhaustion after "x" amount of days after getting the vaccine. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021757388 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757389 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757390 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021755866 Same reporter/ drug/ AE, different patient
Joint pain, muscle pain, nausea, abdominal pain, headache, fatigue, chills, swelling, pain and redness at injection site
several doses of FLUZONE QIV PFS and FLUZONE HD QIV were activated on 20Nov2021 and then administered on 22Nov2021, 23Nov2021, and 24Nov2021; Initial information received on 24-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional via Agency (under the reference 00872588).  This case involves 22 patients who received a dose each of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Wrong technique in product usage process) on 22-Nov-2021, 23-Nov-2021 or 24-Nov-2021 after the vaccine was activated on 20-Nov-2021.  The patients' medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 22-Nov-2021, 23-Nov-2021 or on 24-Nov-2021 each of the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325KA, UT7384NA and expiry date: 30-JUN-2022) which was activated on 20-Nov-2021 via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong technique in product usage process (latency : same day).  It was reported "Caller states several doses of FLUZONE QIV PFS and FLUZONE HD QIV were activated on 20Nov2021 and then administered on 22Nov2021, 23Nov2021, and 24Nov2021. Caller is looking for information on if they need to revaccinate and if there are any other issues that may arise from administering on a later date after activation."   Reporter stated that the syringe cap was removed from the Fluzone Quadrivalent syringes and the needles were attached on 20 Nov 2021, and then the activated syringes were not administered to the patients by the end of the business day.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
was admitted to hospital with symptoms of pericarditis, chest pain,  on 3/25/21; chest CT and echo showed moderate pericardial effusion; no tamponade;  improved with ibuprofen and discharge on 2nd day 3/26/21; DDimer was positive and sed rate and CRP were elevated;  chest sxs all resolved by 2nd day of hospital and felt well; repeat cardiac echo 4/26/21 normal, no effusion;  no recurrence of sxs after 3/26/21 and doing well as of 7/18/21
The following day most of patient's left leg puffed up noticeably and much of the left thigh was red, the area of the injection was also very warm.  No treatment was given as he didn?t seem to be in any discomfort.  The issues resolved themselves in approximately one week.
Stiffness left side of body from the tip of head to feet, also stiffness in  neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness left side of body from the tip of head to feet, also stiffness in  neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness left side of body from the tip of head to feet, also stiffness in  neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness left side of body from the tip of head to feet, also stiffness in  neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Almost immediate after vaccine, pt became very pale with perioral cyanosis, and fainted, with associated brief tonic clinic seizure-stiffening of legs, jerking of arms. She was non responsive for 1-2  minutes, then tired and dizzy for approximately 1 hr, then fully recovered. BP and O2 Sat, HR all normal.
Covid Arm. Red, swollen and itchy. Lethargic. Started approximately 7 days after Moderna vaccine injection.
Pts mom states that injection was given too high and as a result pt is experiencing pain.  Pain was immediate after injection and has been persistent.
Tinnitus, ringing in both ears.  Started within a week of the first shot, has not gone away so far to date.  Loud enough to keep me from going to sleep.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reaction were reported. Additional information has been requested.
little tired; influenza like symptoms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult 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 tiredness and influenza-like symptoms. On an unknown date, the outcome of the tiredness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the tiredness and influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient: US2022AMR081863   Additional Information: GSK Receipt Date:19-MAY-2022 Reporter's Comment: The case was reported by the patient.  The patient was 58 years old at the time of reporting. The patient had good health. The patient didn't recall too much other than feeling a little tired and flu like symptoms after the Shingrix 1st shot. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR081863; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081863:Same reporter
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; went for another kind of test and had antibodies; This is a spontaneous report from a contactable consumer, the parent. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Jan2021 (almost a month ago) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021 (10 days ago), the patient was not feeling well and had a positive COVID-19 rapid test. The patient was feeling better currently and went for "another kind of test", on an unspecified date in 2021, and had antibodies. The reporter queried when the patient should go for the second shot. The clinical outcome of "positive COVID-19 test with symptoms" and "went for another kind of test and had antibodies" was unknown.  Information on batch/lot number was requested.
9 days after getting the vaccine to left arm developed redness, swelling, warmth, and itchy to left arm
I had a lot of pain in my stomach specifically my right side and I was nausea all the time. I also had headaches. It wouldn't go away. I was given a CAT scan, blood work, and x-ray in and they couldn't find anything. It went away on 5/3/2021 on its own.
The same day I received my first dose of the Pfizer covid 19 vaccine, I began menstrual spotting and it continued for 8 days. My period is very regular and I do not spot at any point other than during my menstrual phase which only lasts for four days.
trouble breathing like there are something in her chest; trouble breathing like there are something in her chest; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. This consumer reported for a patient (Grandparent). This case is for grandparent 1. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that grand daughter's grandparents had got the same vaccine and didn't experience reaction immediately. After sometime, they had trouble breathing like there are something in her chest on an unspecified date. And did not report the reactions. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021298909 similar report from same reporter
Fussy after vaccines. Fever x 3 days. No redness or tenderness of site. Dx with viral illness 8-19-16.
2 days after vaccine had been given woke up with left sided face twitching , Headache, nausea.  took motrin for Headache.  Facial twitching lasted 2 days. and then went away on own.  He did not go to dr. or hospital for treatment.
Rash with pustules all down the opposite arm that the vaccine was given. Patient reports it started getting better after a few days.