chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blind in one eye; This case was reported by a consumer via interactive digital media and described the occurrence of blind in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced blind (serious criteria GSK medically significant). On an unknown date, the outcome of the blind was recovered/resolved.   It was unknown if the reporter considered the blind to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient became blind in one eye.
Nausea; dizziness; fainting; vomiting. 1:20 am I blacked-out and hit my head on floor.
Janssen COVID-19 Vaccine EUA:  experiencing headache, fatigue, muscle aches, fever.  Took 1000mg Tylenol and all symptoms except headache are relieved within 1 hr of medication ingestion.
Patient complaint rash, pain and swelling to left upper out arm. Localized redness and swelling observed.
9/19/22 I woke up and all my joints from my neck to my toes ached. It was a strong ache. It lasted about a week or week and a half. It subsided except for my hands which got worse. It has never gone away. I now have arthritis in my thumb and take turmeric, ginger and ADVIL for the pain. I developed a rash on the bottom part of my shin that has never gone away. I have been tested and sent to a Rheumatologist and was tested for auto immune diseases and all came back negative except the ANA test which showed inflammation in my body.
pt was admitted for poss laryngospasm; r/o sz vs apnea; not certain of this was a sz vs laryngospasm was fed shortly a/episode; also stiffened;
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 71 years old female patient who experienced developed a huge brown, purple rash or cellulitis and received FLUZONE HD given in middle of arm. Nurse reported it was not given in the deltoid and was about 3-4 inches below the deltoid, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. It was also a case of an actual medication error due to vaccine administered at inappropriate site as patient received FLUZONE HD given in middle of arm. Nurse reported it was not given in the deltoid and was about 3-4 inches below the deltoid. On 10-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U19778C, expiry date not provided via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious developed a huge brown, purple rash or cellulitis (vaccination site rash & vaccination site cellulitis) with Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was developed a huge brown, purple rash or cellulitis. No corrective treatment was received. The patient outcome is reported as Recovering / Resolving for developed a huge brown, purple rash or cellulitis. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
Initial report received from a healthcare professional on 04 October 2013. A 43-year-old female patient had received an intramuscular dose of FLUZINE ID (Lot number UT4725AA, anatomical site of vaccination was not reported) on 04 October 2013. The patient was pregnant. The last menstrual period date and the expected date of delivery was not reported. The patient was healthy during pregnancy. At the time of this report, the patient did not experience any adverse event. List of documents held by sender: none.
Pt provided self attestation of 2 prior pfizer vaccines >4 months since 2nd shot. However, after receiving booster dose on 4/1/22, it came to my knowledge on the database, that pt had received his 2nd pfizer dose on 2/02/2022. No adverse event noted in clinic. Pt notified that the dose today was too soon and that he would qualify for additional booster dose after waiting at least 4 months.
Mom noted increased redness, swelling and warmth at the injection site on her left thigh on 3/12/02. On 3/13/02, pt was seen in office with swelling, redness and warmth. She was started on Duricef.
- Swelling and redness to patient left arm.  - DX. Cellulitis arm. - TX. KEFLEX 250/5.
After the second Moderna vaccine shot, a red rash began enveloping right arm beginning  near the injection point and then gradually spreading just below my elbow.  Today, I began seeing noticeable swelling  in right arm, especially around elbow. Severe itching of rash. Treated using Diphenhydramine 25 mg, ice bag, hydrocortisone, and metholatum rub.
venous thrombosis Narrative:  one day after vaccine developed calf swelling. swelling persisted. Ultrasound 10 days after vaccine showed popliteal and post tib vein clot
I had arm pain at the injection site. I was also fatigue.  My head felt stuffy.  These symptoms lasted for about 2 days.  On Jan 17th, I tested positive for Covid-19.  I has lot of sinus pressure, headache, chest pressure, coughing, and running nose.  I feel weak.  These are still ongoing symptoms.
immunization given 25OCT95, approx 5hrs later febrile sz w/hypotonic, hyporesponsive episode seen in hosp ER
62 year old female took her first capsule of Vivotif on 12/06/2004.  One day later, on 12/07/2004 she developed abdominal pain, headache and generalized weakness.  On 12/08/2004 she took the second capsule.  The symptoms continued in same intensity, they did not increase nor decrease.  5 years ago the patient was vaccinated with Vivotif without any problems.  At the time of reporting outcome was unknown.
Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low grade temp, fatigue, hair and scalp hurt. Symptoms lasted about 36 to 48 hours.
On 7-14-2004,(2 days after Td administered) returned to clinic for ppd reading.  Client showed her left deltoid to clinic nurse.  Soreness, large erythematous and edematous patch below and around Td injection site.  Warm to touch.  Client stated that shoulder and arm very stiff and sore.  Client stated she had MD appt. for the afternoon of 7/14/04.  Highly recommended to have site assessed by MD.
Information has been received from a physician concerning a 6 year old male patient who on 29-JUL-2004 was vaccinated with the first dose of MMR II. On 27-JUL-2007 the patient was vaccinated with the second dose of MMR II. On 15-JAN-2010 the patient experienced both side of the parotitis and had a fever of 103 degree F. It was unknown if the patient experienced orchitis. There was no other symptom. It was unknown if the patient had exposure to others with mumps. The patient had blood work performed on 18-JAN-2010. The serum immunoglobulin M test result was <1:10. The serum immunoglobulin G was 7.42 and the serum amylase was 440. On 18-JAN-2010, the patient was diagnosed with mumps. At the time of the report, the patient's outcome was unknown. No further information is available.
patient received Menactra twice within a week apart/ NO AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old female patient who received 0.5 mL dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] twice within a week apart lot U6365AA, expiry date: 23-FEB-2021 via intramuscular route in the left deltoid on 20-Aug-2019 and 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines received.   It was a case of actual medication error due to extra dose administered.  It was unknown whether the patient had any adverse event.  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 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.  Documents held by sender: none.
Chills/Rigors for ~2+ hours starting before bed.  ~1:30 am had high fever (102.2) and lack of mental clarity.  Took 1g tylenol for fever which broke  in the early morning.  Also had severe headache during this time.  Day 2 after the vaccine, lack of mental clarity and mental "fog" all day.
DEVELOP MUSCLE PAIN (NOT NERVE PAIN) ON ARM FROM 2ND DAY MORNING OF VACCINATION. PAIN DIDN'T GET LESS. TYLENOL AND IBUPROFEN DIDN'T HELP. SAW MD ON 10/20/2010 AND GOT VICODIN AND SOMA FOR MUSCLE PAIN. MD ADVISED PT FOR MORE MASSAGE. NOW PAIN ON ELBOW AND WAIST. PAIN WHEN USE FINGER AND LIFT HEAVY ITEM. PT WILL SEE MD AGAIN.
Patient had just finished with her plasma donation, to RN for tetanus vaccine, after 15 minute mandatory wait time donor was feeling fine and cleared to go.  She remained in center and approx 35 mins after her shot she started experiencing dizziness and pallor and came to see RN, she admitted to not having eaten in the past 4 hours prior to donating and had just smoked a cigarette.  Stayed with RN for approx 25 mins, rested, gave 12 oz water and crackers, BP and pulse WNL at this time, recovered fully in approx 25 mins and was cleared to leave center with friend.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. In 2009 the patient was vaccinated with the first dose of GARDASIL (route of administration and anatomical location were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that today (date of report 05-DEC-2012) the patient will receive her 2nd dose (inappropriate schedule of vaccine administration). No treatment information was reported. The outcome of received her first dose of GARDASIL in 2009 and will receive her 2nd dose today is unknown. No other information provided. No adverse effect reported. Additional information has been requested.
Pain and soreness in left ear.  Pain when opening an closing jaw around left ear.  Ear ache in left ear, and some reddening in right ear.    Dr prescribed amoxicillin for the left ear and neomycin-polymyxin-hydrocortisone for the left ear.  RESULTS:  all seemed OK after 1 week.  Left ear discomfort returned by  Oct. 19th
Pt received FLUZONE on 9-3-10 at approx 11 AM. By 6 pm same day pt suffered from severe nausea, shaking, chills, body aches, weakness. Sx subsided in overnight hours.
Case PHEH2016US028832 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to adult female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in right deltoid on 12 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been notified will revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
I began to feel very tired and cold and dizzy about 4pm Sept 28, 2021.  I then b egan to get itchy and sleepy.  My left side began to itch and be sore to touch.  I broke out in a bright red rash on my left arm to my elbow, chest, neck.  It itched horriblly.   I took Tylenol.  It did not hellp. I put Benedryl cream on it.  It continued itching and spreading .  I used Benedryl over the counter pills.  It still itches.
NauseaVomiting Below inj site red hard welt, tingling in arm and arm pit and breast right side. R foot tingling Narrative:
chills; super cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NASOPHARYNGITIS (super cold) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concomitant products included CABERGOLINE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced CHILLS (chills) and NASOPHARYNGITIS (super cold). At the time of the report, CHILLS (chills) and NASOPHARYNGITIS (super cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Unknown concomitant medication for taken for blood pressure.  No treatment medications were reported.
Blisters on arm, hand, big toe; Rash; Bumps on hand; Arm below injection site is itchy; Bump in palm of hand/looked like a hive; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Bump in palm of hand/looked like a hive), BLISTER (Blisters on arm, hand, big toe), URTICARIA (Bumps on hand), VACCINATION SITE PRURITUS (Arm below injection site is itchy) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Bump in palm of hand/looked like a hive). On 10-Mar-2021, the patient experienced URTICARIA (Bumps on hand) and VACCINATION SITE PRURITUS (Arm below injection site is itchy). On an unknown date, the patient experienced BLISTER (Blisters on arm, hand, big toe) and RASH (Rash). At the time of the report, URTICARIA (Bump in palm of hand/looked like a hive) had resolved, BLISTER (Blisters on arm, hand, big toe), URTICARIA (Bumps on hand) and RASH (Rash) outcome was unknown and VACCINATION SITE PRURITUS (Arm below injection site is itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was reported.  Patient's treatment information include diphenhydramine (Benadryl) lotion on rash. The patient reported that the bump looked like a hive and then it flattened out. On 10-Mar-2021, everything broke out.
Patient showed me a red welt on her left arm that was about 3-4 inches in diameter. She stated the redness and itching started a day or 2 after receiving the vaccine on 10/28/17. She tried applying triamcinolone 1% cream that she had on hand and used ice to help with the inflammation and itching. She is going to report to her doctor this afternoon after counseling with me (pharmacist).
Dizziness  Weakness Chills Body aches  High heart rate Body shaking Migraine  Arm swelling Hot at ejection site Nausea
PLAN: Very pleasant 72-year-old female presents for 4 to 6 weeks of general fatigue.  States that she gets very tired after prolonged standing and just does not have her usual energy.  Additionally notes generalized joint pain for the same amount of time.  She contacted the Covid nurse this morning who advised she come in for repeat Covid testing.  She states she did receive both Covid vaccines, the second vaccine was last February.  She has not had any fever chills cough wheezing, loss of taste or smell.  No travel to the East Coast and no tick bites.  No near syncope or syncope.  No dizziness or headache.  No vision changes. CBC, CMP, thyroid panel and urinalysis.
joint pain; This is a spontaneous report from a contactable consumer (wife). This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021251024 Same reporter and product, similar event; different patient.
The day of vaccine I felt tired, achy, and feverish, but after 24 hours I felt fine and didn't have any lasting side effects except soreness to my arm but nothing remarkable or out of the ordinary. Starting in February, on both of my elbows it started to get red, hot, swollen, and extremely painful. I contacted dermatology and tried every antihistamine and topical steroid but the rash spread all over my body- on both legs, both arms, and face, and the only place I didn't have it was abdomen and my back. It spread quickly to the point where nothing was helping and it was extremely painful. I went into dermatology appointment and got it biopsied and ended up having to take steroids. It was indeterminate and wasn't autoimmune and they weren't sure what spurred it. I had to take two steroids for almost 2 months for it to subside and it still pops up here and there and I'm using topical steroids. They can't identify what caused it and I've had no new medications or changes. It's still on elbows and flares up on my face and spots on my body if I'm not using steroids.
Hx of presyncope with needles who had recurrence of presyncope. Also had nausea and one episode of emesis.
Altered mental state; Itchiness of injection site; Muscle pain; Redness of the injection site; A spontaneous report was received from reporter concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain/ Myalgia, itchiness, redness of the injection site/ Vaccination site erythema and altered mental state/ Mental disorder.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) via unknown route in left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the day after administration, the patient experienced muscle pain, itchiness, redness of the injection site and an altered mental state. The patient was getting better now, after taking metoprolol and azithromycin.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events were resolving.
had the vaccine and just diagnosed with them/Suspected vaccination failure; diagnosed with them; This 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.   On an unknown date, the patient received Shingles vaccine. On 16th August 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and just diagnosed with them one day before the reporting date. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Lethargic, arm sore Narrative:  Pt reports ADR to Moderna vaccine dose 2: arm soreness and "lethargic". Denies HA or fever.
the day following the injection. I was standing at the counter and suddenly felt very heavy.  I began to drop to the floor and couldnt move my arms to catch myself.  My torso landed on the counter in front of me and I began to loose black out.  I began sliding to the floor when I suddenly had control again.  The total time I'm guessing was 10 seconds.  I was tired, disoriented for a short time.
Moderna Booster Patient reporting that she lost control of legs and arms, hours after getting vaccine. Body aches all day, chills.
sore arm; down arm and backside; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (down arm and backside) and INSOMNIA (can't sleep) in a male 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.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (down arm and backside) and INSOMNIA (can't sleep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (down arm and backside) and INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
This is a 87y.o. male with past medical history of peptic ulcer disease, GERD, cardiac cath placement, hypertension, but hyperlipidemia, CKD, type 2 diabetes who presents to the ED on 10/5/2022 due to an unwitnessed fall.  Patient history limited secondary to dementia.  Per chart review patient had rhabdomyolysis on presentation, as well as elevated troponins and COVID infection.  Patient's admission has been complicated by bleeding duodenal ulcers causing altered mental status and agitation.
I have a slight ringing in my ears. - Tinnitus. I noticed it the week after my first shot. I have not gone to the doctor yet, but will be calling today. I have tried ear drop removal and it didn't help at all. It started around April 7 and is still here today.
on March 31st I was diagnosed with Shingles. Pain, blisters ongoing.  Prescribed anti viral drug.