chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was mistakenly administered a Fluad vaccine which is only indicated for patients 65+ and he is 56. It was intended to administer a standard quadrivalent flu vaccine. Patient was informed of the error and potential side effects to be aware of. No immediate adverse reactions occurred.
Initial report received from a consumer ion 02 OCTOBER 2013.  A 74-year-old male patient has received first dose of FLUZONE HD (batch number, route, and site of administration was not as "NA") on 25 SEPTEMBER 2013. The patient had received flu injections in the past. The patient had hypertension at time of vaccination. The patient had history of allergy of sulfa, NSAIDS and some beta blockers. The patient had egg allergy 40 years ago but he could eat egg. Six month prior, the patient had history of TIA (Transient Ischemic attack). The patient's concomitant medications included Lipitor, ASA and Alonopine and had received AZOR until one week.  On 25 September 2013, one day after vaccination the patient had oral surgery and developed dizziness and vertigo, on 27 September 2013, the patient was sent to Emergency room for dizziness and MIR of head was normal and on 30 September 2013, the patient developed sleeplessness.  Laboratory tests and corrective treatment were not reported. At the time of this report, the patient was not recovered. List of documents held by sender: None.  Follow-up information received from  non-healthcare professional on 28 February 2014. The patient received intramuscular dose of FLUZONE HD (batch number: U4717AA).
pt recv vax & w/in 45mins became nauseated & SOB-  today w/marked nasal hyperemia & SOB & swollen rt arm & armpit; no fever; exam reddened inj site w/swollen upper arm area &  quite tender ax adenopathy
Patient received vaccine through pharmacy at employer vaccination event. Presented to clinic on 04/13/2021 and noted to have imaging confirmed "There is occlusive superficial clot starting the upper lateral right thigh and extending distally through the mid to distal lateral calf. This appears to be within a superficial varicosity. Findings are consistent with extensive superficial thrombophlebitis of a varicose vein of the right lower extremity."
Hives and allergic reaction, rash on arms, chest, other places  Went to urgent care facility on 1/1/2022 and was treated with steroids (methylprednisone and others), antihistamines (loratadine, Benadryl)  Rash fading as of 1/6/2022
Vasovagal syncope (4 times) between 4:00 and 4:30 a.m.
Vomiting, sweats, chills and fever to 101.  Resolved by next day
Localized swelling and erythema approx. 3x5cm left upper arm. Arm was red and warm to touch 48 hrs post injection.
I have noticed that my menstrual cycle went from 28 days to 24 days. And period last about 10 days when it use to be 6 days. My cramps are more severe as well.
Vertigo; Face swollen; Temperature of 99.4F; Arm is very sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Balance disorder since an unknown date. Concurrent medical conditions included Allergy NOS (Allergic to benzodiazepam).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.4 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Benadryl.
15 minutes after receiving vaccine, throat closing, itchiness, chest tightness. EPI injected and given Benadryl. 911 called Transferred to  ED via EMS. In ED given Solumedrol and an additional EPI SQ. Observed in ED for several hours. Advised not to get 2nd vaccine. Discharged home in stable condition
About 3 hours after injection,  Very significant pain and stiffness along cervical spine. Tight feeling  up cerivial spine and swelling along sides of neck. Still had quite a bit of pain and stiffness after 2 months. PCM referred me to physical therapy.  Feb. 13, 2020 was first appt. of 4.  Stopped after 4 as  PT treatments made it worse. Pain in neck continues still today in muscles along neck and cervical spine (4/9/2020) with crackling and stiffness, tight feeling .  Some relief with muscles in sides of neck (not spine), with Airrosti treatments to release knots in sides of my neck.  Pain and stiffness never completely goes away, an is much worse at night, affecting sleep.  HOPING THIS IS NOT PERMANENT.
PM Tingling and numbness to both legs. She said this is the type of reaction she gets when she has an allergic reaction to a decongestant. 50mg of PO Benadryl. Vitals where unremarkable throughout. Dismissed her by wheel chair directly to her husband at 9PM on 1/4/2021 due to legs still being a little shaky.
Fever; She is pregnant; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Primary immunization completed, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "She is pregnant". Additional information: MD self reported had a fever after receiving omicron booster. She is pregnant. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a 16 week patient who on 09-JAN-2008 was vaccinated with the first dose of Rotateq.  The patient is not experiencing any known symptoms.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Early kidney disease" (unspecified if ongoing); "sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid as COVID 19 treatment.
About 2 months after the shot, I started to encounter issues with cystic acne. These became so troublesome I needed to go to the doctor because they started to become infected. We have tried several aggressive treatments, but so far nothing is working. My skin went from being clear to COVERED in large cystic nodules that become infected. While we have no proof these are linked, this is the only thing that changed.
Pt had mild arm pain at site of injection for 2-3 days which eventually resolved. But 10 days after injection pt developed 8 cm x 5 cm erythematous hot to touch area circumferentially and pain at site of injection.  Pt has been treated with an antibiotic for probable cellulitis.
Fever, cough, congestion, nausea, fatigue, headache, MS flare, hospitalized for MS flare, received high dose steroids for MS flare (4 days)
2NOV95 pt rt arm showeing redness around rt deltoid area; evidence of some swelling hence no complaints of SOB; pt was referred to clinic to be evaluated for poss rxn to Td vax; warm to touch
Pt developed a severe migraine after vaccination lasting > 1 week. She gets migraines frequently normally but describes this as clearly the "worst headache of her life." It was bad enough to the point that she could barely walk around or leave her house. She normally takes Topamax 75 mg BID for migraine prophylaxis and Triptans PRN but as these did not work, she called her neurologist who put her on Nabumetone and then eventually a Methylprednisone taper.
Chest pain.  "Brick on my chest". Couldn't breathe. Kidneys had shut down.  Pt with MI, kidney failure and now needs cardiac cath.  Was fine on Monday.
Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ...  Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66.   Also , has had intermittent dizzy, foggy head or wobbly legs.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 17-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache intermittent recurring right sided headache associated with pressure sensation right eye Narrative:  post first dose of vaccine: intermittent right sided headache x 4 days then resolved post second dose of vaccine: intermittent right sided headache, more intense and now lasting for 2.5 weeks but still evident. also associated with pressure sensation behind right eye (no visual changes) but also loss of some pigment of both eyes
Skin eruption in neck (left side) - (10/20/2014). Day after immunization presented arthralgia local reaction in injection site. (10/04/2014).
2-3 weeks, post vax, pt got a fever that lasted 2 days; maximum <103F and left cheek was swollen for 3 days.
Case number PHEH2015US025196, is an initial spontaneous report received from a pharmacist on 01 Dec 2015. This report refers to a 53-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) on 12 Oct 2015. She experienced arm hurting on an unknown date. The outcome, seriousness and causality of the event was not reported.
arm swollen, itching to wrist; no rash; given in deltoid; no resp sx p/2nd dose;
big bump similar to that when you get a bite and the area gets hard; area gets hard; feels irritated; the injection site started to itch; feels extremely tired; injection site swelled up; arm soreness the day of which went away the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness the day of which went away the next day), MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated) and VACCINATION SITE PRURITUS (the injection site started to itch) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leg pain. Concomitant products included IBUPROFEN from 16-Mar-2021 to an unknown date for Leg pain, HYDROCHLOROTHIAZIDE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness the day of which went away the next day). On 16-Mar-2021, the patient experienced MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated), VACCINATION SITE PRURITUS (the injection site started to itch), FATIGUE (feels extremely tired) and VACCINATION SITE SWELLING (injection site swelled up). On 09-Mar-2021, PAIN IN EXTREMITY (arm soreness the day of which went away the next day) had resolved. At the time of the report, MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated), VACCINATION SITE PRURITUS (the injection site started to itch), FATIGUE (feels extremely tired) and VACCINATION SITE SWELLING (injection site swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient tried putting something cold against injection site area for a few minutes but trying not to touch the area.
First shot / It was extremely painful; Received the first shot / about two years ago / didn't get part two; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but was selected adult as per vaccine indication. The patient received 1st dose of shingrix two years ago, and it was very painful. The patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. Patient questioned that need to get one and part two again considering the time span between doses.
Arthralgia, UrticariaPruritus, injection site pain Employee reports injection site pain/discomfort/redness/swelling/itching and joint pain which began 6 days after receiving vaccine. Patient is still experiencing some mild itching as of date of this report (01/14/2021). Reports took Benadryl (diphenhydramine) 50mg by mouth once, then Benadryl (diphenhydramine) 25mg PO at bedtime.
Case number PHEH2012US003914 is an initial spontaneous report received from a medical assistant on 15 Feb 2012 with a follow up received on 24 Feb 2012. This case refers to a 13-year-old male patient. He was vaccinated with MENVEO (batch number: A11033 and expiration date: Jan 2014) at a dose of 0.5ml intramuscularly on 03 Feb 2012. It was reported that the administered MENVEO vaccine before reconstitution was stored in temperature of 32.7F on 01 Feb 2012 and was then at 35.6F at 4:30 pm on the same day. The reporter stated that the vaccine was not frozen. No adverse event was reported. Follow up information received from the medical assistant on 24 Feb 2012: Updated patient's age.
Immunizations received 3/29/23; both Tdap and MCV give in left deltoid.  Next day 3/30/23 at school developed raised red patch with some tenderness to left arm.  No fever or other systemic symptoms.
Patients received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) 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 UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received, narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Same reporter
Person states:   Localized rash to Rt. Deltoid,   Fever greater than 102 F,   Muscle aches,   General Malaise.
3 x 3 cm painful hard nodule in thigh at injection site. Initially red -> now redness gone. Nodule still present 10 days after vaccination & s/p warm compresses & massage. Fever x 2 days after vaccination as well.
Got my second vaccine yesterday and i have a pounding migraine; feel like I'm bruised all over; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Got my second vaccine yesterday and i have a pounding migraine) and CONTUSION (feel like I'm bruised all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Got my second vaccine yesterday and i have a pounding migraine) and CONTUSION (feel like I'm bruised all over). At the time of the report, MIGRAINE (Got my second vaccine yesterday and i have a pounding migraine) and CONTUSION (feel like I'm bruised all over) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Patient developed chest pain the next day after receiving the covid vaccine.  He had no shortness of breath, palpitations, orthopnea, or edema.  He also had an elevated heart rate of 120 with just walking.
Patient was pregnant - which she did not inform and then had fetal demise - the cord was wrapped around fetus arm and shoulder 4 times.
MY HAIR IS FALLING OUT, I AM LITERALLY ALMOST BALD. STILL GOING ON,
On Jan 5, 2021 patient received the vaccine at k8k30, around 1700 she got joint pain at 1900 she got a headache and at 1000pm she got sinus congestion. These symptoms lasted 26 hours then on 1-12-2021 she developed pain in the right axilla and breast area that last 24 hours. Joint pain and severe edema to the BLE, she was tired and fatigue, with redness at the injection site.
Father returned to office with infant, shortly after they had left. Described 3-4 short episodes of whole body jerking and frothing at the mouth.
Wed morning 10/21/09 patients upper lip was very swollen and had a red rash on his cheeks. No rash anywhere else.
Patient was given a flu shot on 9/18/17. She developed redness at injection site. She went to a clinic who then sent her to emergency department. She was treated for cellulitis and was given an antibiotic for the infection.
HPV series completed on 8/20/07. Had dizziness same day 1st dose on 2/19/2007. Has progressed with body rashes and continues to have petechiae on her face, swelling of her eyes, cheeks, and lips and rashes, has been treated with Benadryl, ZYRTEC and has an epi pen at school and at home. She ended in the ER on 1/22/2008 and was give prednisone. All this has been going on since she first started with the HPV vaccine.
self resolved episodes x 4 of upper body & w/extremity shaking & w/extremity stiffening for few min;first episode on day 3-4 p/vax;
difficulty swallowing  Narrative:  He reports PMH significant for "throat cancer" s/p radiation. At baseline, he reports occasional difficulty swallowing large pills and consumes food with liquid to a/w swallowing. About a day after the initial vaccination, Patient reported difficulty swallowing large pills. This concern lasted less than another day before spontaneous resolving (which is typical for him). He did not think to report it to his healthcare team previously b/c this has occurred in the past. He denied pruritus (except minimally over injection site), urticaria/hives, flushing, swelling/angioedema, difficulty swallowing, confusion/disorientation, lightheadedness/dizziness, weakness, LOC/syncope, SOB, stridor/wheezing, tachycardia/palpitations, nausea/vomiting/diarrhea or abdominal cramping. He was able to complete his normal actitivies of daily living w/o any issues and able to additionally eat/drink w/o any disruption.
SITE SWOLLEN, RED HARD PER MOTHER. TEMP 101.5.  SHE STATES SHE TOOK HIM TO ER ON SATURDAY AND NOTHING WAS DONE FOR CHILD. SHE BROUGHT HIM IN HERE 06/13/2016 FOR EVAL.  SITE OF BOTH KINRIX AND MMRV WERE RED.  KINRIX SITE HOT, SWOLLEN AND HARD, ALSO. REFERRED TO ANOTHER FACILITY.
fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved.            No concomitant medications reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was  not applicable.   This case was linked to MOD-2021-018435 (Patient Link).   Reporter did not allow further contact
Shingles eruptions, intense itching, skin senstivity on arms and upper chest.   Received the first shot of the new shingles vaccine in December,2020.  Also had the original shot several years ago.  The symptoms were readily identified by my husband who has had recurring bouts of shingles.
Site pain, fever ro 102°F for 2 days, body aches, headache, fatigue, and weakness