chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/17/22 presents to ED for "rapid heart rate". PMHx of "NIDDM, SVT on cardizem, hypothyroidism, prostate cancer on chemo"
Liquen plano-  a chronic inflammatory skin ,form lacy white patches that later turn into purplish in feet, legs, back, stomach, arms, wrist, vagina, buttocks, scalp in the hair. Cause significant itching, swelling and irritation
pt recvd vax 19MAY95 & 27MAY95 pt devel gen severe varicella eruption accompanied by prolonged, very high fever;maximum recorded temp was 106 R:
Covid-19 vaccine EUA; 7 days after injection left sided axillary and sub clavicular lymph nodes became swollen and painful; 9 days after injection the site of the injection became red, warm, rigid, painful.
Right upper arm reddened, swollen, warm to touch, itching, about the size of a golf ball.
Fever Muscles Ached Rash on Deltoid at injection site measuring 5x8 cm Aleve prior to vaccine, again at bedtime  Wed. Thursday Aleve in the morning and at bedtime.
Well I had a runny nose with mild headache and a little sore throat off and on with fatigue it was mild. I didn't have much cough I thought it was contributed to the runny nose. I started the PAXLOVID and that caused a horrible taste in my mouth and was bitter when I was eating and I didn't get rid of those symptoms till 2 days after I stopped taking the PAXLOVID. I didn't go out or do anything.
Patient stated today that 1 hour after receiving vaccination immediately left upper arm and below left deltoid to right above left elbow is swollen; became hot to touch; painful like itch (no aching).  Felt nauseated 45 minutes after vaccination.  Subsided now, but swelling and warmth left upper arm still present.
Pt presented with oval shaped red whelp about 2 -2.5 inches across. Pt stated was warm to touch and itching slightly. I suggested a cold compress and oral BENADRYL, according to protocol. Pt was NOT WORRIED about reaction.
Patient was a 79 yo F who presented to hospital on 1/29/2021. On admission patient was severely hypoxic with symptoms of SOB, cough, and severe dyspnea . The patient was COVID-19 positive on admission with symptoms starting 4 days prior to admission. Patient's labs on admission showed elevated ferritin, CRP, and d-dimer. Patient was diagnosed with COVID-19 infection with sepsis and respiratory failure with hypoxia. On arrival to hospital patient's O2 sats were in 60's and improved to upper 80s after nebulizer treatment. Patient was started on azithromycin 500mg once daily for 3 days, ceftriaxone 2g once daily for 2 days, dexamethasone 6mg once daily for 3 days, zinc 220 mg once daily for one dose, and duo-neb 3ml q4h for 3 days. Patient's respiratory status declined and was placed on BiPAP and comfort measures. The patient continued to decline until her passing on 2/3/2021.
24 weeks pregnant at the time of first vaccine EDD 10/5/2021, baby born 10/15/2021 at 10lbs  Rapid heart rate began sometime after first dose on 6/9/2021 and midwife appointment on 6/14/2021 (pulse was 101 at the time) Diagnosed with tachycardia at 34 week appointment on 8/23/2021, midwife ordered TSH panel to rule out thyroid issue. Thyroid was normal Prior to the first vaccine, heart rate was 88 at 23 week appointment on 6/2/2021. Heart rate remained elevated through the remainder of pregnancy (baby born 10/15/2021) and is now a normal resting heart rate
Slight arm tenderness first 24 hours, then no adverse effects. However, after 9-10 days, I noticed my arm became extremely itchy at the injection site. Itchiness still persists and there is a red rash that did not form until approx. 10 days after injection. Hesitant to get the second shot as this showed up so long after the shot day that I am wary of a second shot and when this reaction will subside.
Patient described throbbing pain from injection site that lasted over 2 months and is spreading to her neck.
Pt. states that after receiving the 2nd dose of Moderna 08/17/2021, started experiencing symptoms 08/19/2021 of lose stool, rash at the injection site, and fatigue. Contact with Pharmacists stating they were putting in a report on Pt.'s behalf.
Redness and swelling less than 50mm persisting for longer than 48 hours.
2 weeks after receiving the 2nd dose,  do you feel loved left neck had an apathy and sore throat, had pharyngitis laryngitis was seen by knee urgent care hand emergency room hand tested negative for Covid and strep. Developed left vocal cord paralysis and constant flu like symptoms that have lasted for six weeks. My vocal cords will mean to me injected need to paralysis
taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-014171), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9) in patient of an unknown age and gender who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route). DEATH occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The doctor died after taking Eliquis with Covid-19 Vaccine. For Eliquis(Unknown), the reporter did not provide any causality assessments. This case was linked to US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-012621 (Linked Report).; Sender's Comments: BMS Medical Evaluation Comment: This patient died after receiving apixaban therapy. Patient also received COVID-19 vaccine.  Based on the limited information available regarding the cause of death and autopsy details, it cannot be ascertained with the reasonable possibility that the apixaban could have caused the event.; Reported Cause(s) of Death: Unknown cause of death
I was extremely tired, incoherently so.  I had to go to bed at 6:30 p.m. (that is extremely unusual).  After sleeping all night with one interruption, I ran errands Saturday morning and by noon had to go back to bed.  I could barely think.  I had to sleep all day.  At some point, I realized the injection site was raised - a walnut in the middle and about 3 inches in diameter.  Ten days later, the injection site is reduced to a marble and finally going down.  It was like I lost 36 hours.
On 1/18/21, received the vaccine at 1007.  At 1035 while working with PT, he became very fatigued and short of breath. Pulse ox was 96%. At 1105, he began shaking uncontrollably and projectile vomiting. BP 100/62, P-100, temp 96.0.  1230: temp 99.0 and still shaking. 1315: temp 100.1, shaking less.  1500:  temp 102.0 no other symptoms.  1600:  Temp 101.3 no other symptoms.  2000:  Temp 99.3 no other symptoms.  Temp continued to normalize through the night. Doing well  and back to baseline on 1/19/21.
Taken to ER for diarrhea dx AOM given Amoxicillin; 22MAR91 seen @ clinic for difficulty breathing dx asthmatic type bronchitis given Albuterol;
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who experienced hives on his body, while he received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Jul-2018, the patient received a dose of suspect MENACTRA lot U5833AA, expiration date: 25-Feb-2019 via unknown route in the left deltoid. On an unknown date, the patient experienced a non-serious hives on his body (urticaria) (Unknown latency) following the administration of MENACTRA. Other relevant tests included no lab data. Final diagnosis was hives on his body. It was not reported if the patient received a corrective treatment. The patient was recovered from the event. List of documents held by sender: none.
Pain, swelling, redness surrounding injection site the morning after receiving FLUZONE HD. On 9/24/14 - Pt visited allergies, is taking BENADRYL. Pt reports symptoms improving but still red.
Patient called office to report that after receiving the Shingrix at pharmacy on 04/30/19 - the next day 05/01/19, she developed fatigue with chills and nausea. Patient states she contacted the pharmacist who informed her that he has had several patients report side effects to him after receiving the second dose of Shingrix and that she should also notify her physicians office of this occurring.
Client reports redness, pain and raised pimples around injection site (Left deltoid) Started within 24 hours of infection and are still occurring on 10/16/07
Streaks/flecks of blood in stool for 3 days after vaccine given, stool were soft, loose, not formed.
FOUR LITTLE RED DOTS ON ABDOMINAL; CHILLS; SEVERE DIARRHOEA; FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to mango, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient has been healthy and vegetarian. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced severe diarrhoea. On APR-2021, the patient experienced four little red dots on abdominal. On APR-2021, the patient experienced chills. On APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhoea on APR-2021, and chills, and fever, and had not recovered from four little red dots on abdominal. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Reddened area was "twice the size" of the first reaction; It was "more itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Reddened area was "twice the size" of the first reaction) and PRURITUS (It was "more itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Reddened area was "twice the size" of the first reaction) and PRURITUS (It was "more itchy). At the time of the report, INJECTION SITE ERYTHEMA (Reddened area was "twice the size" of the first reaction) and PRURITUS (It was "more itchy) had resolved. The concomitant medications were not reported. The treatment information was not provided.
A week after the injection, started having pain in left upper back, shoulder blade area.  The pain increased over the next two days, which were a weekend. Saw Dr. Monday morning and he thought the vaccination had activated the virus in by body.  He prescribed Valacyclovir.  Pain continued moving around upper back for 10 days. I had shingles about 15 years ago, and this was worse pain and lasted longer.
I had sore throat, fatigue, congestion, achiness, and cough. I tested the next day on the 27th with a rapid home test and that came back positive. Those symptoms continued and I called the Dr. and they suggested I come in for a prescription for a antiviral. So the Dr. prescribed the antiviral that day and I would say that by the 30th and 1st all of the symptoms have diminished and that has been for the last couple days.
Inappropriate schedule of vaccine; A little sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose 1 year before the date of reporting and experienced influenza like ilness and felt unwell,refer case US2019AMR192685).   On 23rd October 2019, the patient received the 2nd dose of Shingrix. On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The patient experienced injection site soreness after receiving Shingrix. Because of shortages the patient received his second dose late.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with partial dose of ZOSTAVAX due to syringe or needle leakage. No adverse event was reported. This is 2 of 2 reports from same reporter. Additional information has been requested.
Received shot 2PM Monday, October 11, 2010. Did not feel good, but not bad on Tuesday. Woke up Wednesday, October 13th with sore throat, hives, watery eyes & nose, and a severe headache. Thursday - hives worse, no headache everything else the same. Friday - no headache, sore throat worse, everything else the same. Saturday - hives start to abate, still have sore throat. Sunday less hives. Monday - much better - continued to work.
tingling in hands and tongue. Completely resolved in 20 minutes. Headache after tingling reesloved
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-186802 (Patient Link).
3/6/08 PEDIARIX was inadvertently given in place of DTaP at Kindergarten shot visit.  No symptoms reported.
Fever 102 and large welt on arm at injection site 6 cm diameter. No tx.
Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping
This spontaneous report as received from a medical assistant refers to a patient with no known drug allergies. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient received dose 3 of GARDASIL one year after dose 2. No symptoms reported. Additional information has been requested.
Patient called on 06/14/2018 complaining of arm pain. Counseled patient to take otc pain meds until resolved.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:18 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 26.06 for dose administered on 28-MAR-2021 and 25.98 for dose administered on 28-FEB-2021.   No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion 28-MAR-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-MAR-2021 and beyond use date for the vial was reported as 22-APR-2021. Product moved to clinic on 27-MAR-2021. Batch number 014M20A underwent temperature excursion on 28-FEB-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degrees Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-MAR-2021. Product moved to clinic on 27-FEB-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
The week prior to testing for COVID, I felt exhausted and then I lost my taste and smell and I went and got tested and my COVID-19 test came back positive and I was just exhausted for a week after as well.
1st night after vaccine: chills, fever, extreme weakness in limbs (arms and legs) and could not lift myself out of bed, 2nd day after vaccine: fever, extreme muscle pain and soreness in legs, fatigue, and head fog 3rd-7th day: Difficult time walking and supporting my weight (120 lbs), legs tingle below waist, extreme pain in muscles, knees swollen, right quad had a difficult time "activating"
Area of edema approximately 3 inches in diameter at site of injection. No complaints of pain, redness noted.
Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 82 year old male patient with diabetes and high blood pressure. The patient's relevant past drug history was unknown. The patient was started on PNEUMOVAX 23 0.5 ml every 5 years for prevention of pneumonia 5 years ago. On 17-OCT-2013, the patient was vaccinated subcutaneously with PNEUMOVAX 23 lot # 671401/1158AA expiry date 10-APR-2013, dose 2, .5 ml, subcutaneous. Concomitant therapies included PLAVIX, FUROSEMIDE and METOPROLOL for high blood pressure and GLYBURIDE for diabetes. On 17-OCT-2013, the pharmacist discovered that the PNEUMOVAX 23 the patient received on 17-OCT-2013 had expired on 10-APR-2013. The outcome of the PNEUMOVAX 23 the patient received on 17-oct-2013 had expired on 10-apr-2013 was unknown. There was no relevant lab data. As of 26-OCT-2013, the patient was continuing PNEUMOVAX 23 every 5 years and has not reported any problems after receiving an expired vaccine. Additional information has been requested.
fatigue, joint aches, itching, rash Narrative:   Other Relevant History:
Patient called office to report reaction Flu vaccine. Stated that she received shot and immediately had pain, as time progressed she could not lift arm above head. Has had pain since the flu shot but is better now but has some pain at times. Did not go to doctor.
positive rapid test; positive rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: positive rapid test 5 days after ending paxlovid treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 yo male complained of rash on legs x 2 days.  Received smallpox vaccination 16 days prior.  Skin with erythematous rash vesicles, maculopapular bilateral LE most below kneew, L arm some just below inoculation site, few on abdomen and R arm. Temp 98.6, PE = VSS, Lungs CTAB, Heart RRR, Abd Soft NtND.  Hydroxyzine 25mg, 2PO q 6hrs prn itching, increased to 100mg po q 6hrs.
Pt. complained of dizziness, SOB, heaviness to left chest, palpitations.  Also complained of numbness and tingling in all upper and lower extrimities . Vitals: Bp, 159/85 pulse 118. pt stated " They are higher than normal." Alerted emergency personnel, assessment completed and pt advised to go with them to hospital but pt. refused.  Paramedic recommended for him to not drive and for someone to take him home.  Pt left without notifying us of his transportation.
developed sx including congested cough, nasal drainage, increased fatigue- tested positive for COVID on Abbott ID Now molecular test