chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after receiving my 1st COVID vaccine, I had a CBC draw.  My platelet count went from < 400 to > 450.  I also experienced heaviness in both my arms and tingling/numbness in my fingers.  Platelet count resolution is TBD (will get retested 6 weeks post 2nd shot).  Heaviness in arms/tingling in fingers resolved after one week.
Rapid heart beat, heart palpitations admitted to ER 12 lead EKG Tropin analysis CBC Chest X-ray
Low grade fever, chills, body aches, headache. Symptoms began 12 after injection and lasted for 36 hours as strong symptoms quite bothersome than slowly began to ease
Patient stated that from injection site to just above elbow, she was experiencing itching and swelling around the entire upper arm.
woke up at 2 AM WITH RIGHT HAND TOTALLY CRAMPED UP AND PAINFUL; NOW RIGHT HAND IS TINGLY AND PAINFUL AT TIMES; SPEAKING TO MD today
Left arm (upper) became erythematous and swollen at site of DTAP #5 vaccine administration IM in left deltoid the previous dose.
Initial misuse report received from a healthcare professional on 11 NOVEMBER 2013. The case is invalid as the individual patient identifiers were not reported. It was reported that FLUZONE was administered to several of the patient who are under 65 years of age. No adverse event was reported. List of documents held by sender: none.
staff gave Fluzone Quad .25 to a female patient age 5 months with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 months old female patient who received a 0.25 mL first dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot no: UJ256AB, Expiry date: 30-Jun-2020) via intramuscular route in left Vastus Lateralis on 11-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate age at vaccine administration.   It was reported that the staff gave Fluzone Quad .25 to a female patient age 5 months. Fluzone Quadrivalent 0.25ml was administered to a baby before her 6 month birthday.  At the time of reporting, the patient had no 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.
Pt complained of SOB/tightness of chest and eye issues roughly 2 hours after vaccine. Took BENADRYL as advised from MD and woke up in AM w/eyes swollen, pus/mucus and redness MD advised patient may have had RXN to the vaccine/previous lots could have had actual live vaccine in it, I informed MD that was not the case w/ the vaccine. Pt was given steroid shot and MD prescribed TAMIFLU BID for 5 days as she was running a fever as well, she could have been reacting/fighting infection. Pt was given BENADRYL, EMERGEN C, and TAMIFLU at pharmacy per MD orders and she was feeling better following shot.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates the patients were administered improperly stored VAQTA (lot # L002717, expiration date 02-JUN-2017) (dosage, strength and route unknown) following a temperature excursion on 23-NOV-2015 and 07-JAN-2016 (32.2 degree F for 1 hour and 10 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt tested positive for COVID on 11/2/21, and was hospitalized with acute onset of SOB on 11/3/21. In the ER he was found to be hypoxic with chest x-ray indicating atypical or viral pneumonia. I did extend his remdesivir to a 10 day regimen. Started on dexamethasone.  Started on ceftriaxone and azithromycin for a total 5 day course of antibiotics for secondary bacterial pneumonia. Found to have leukocytosis and elevated procalcitonin
patient called reporting testicular pain the evening of the vaccine. It resolved, but is now back again today. I advised him to call PCP.
Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 40th of 40 adult patients.  Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 18:00 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 at 10:45 as dose 2, single (Lot number: EN6202), in left arm and on 13Dec2021 at 18:30 as dose 3 (booster), single (Lot number: 33030BD) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LEXAPRO, start date: 14Jun2010, stop date: 03Jun2022; IBUPROFEN, start date: 21May2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive, notes: Recent COVID test @ (institute name-withheld) on Sat 21May was Positive; (28May2022) Negative, notes: On 28May I tested and was Negative for COVID; (02Jun2022) Positive, notes: On Thursday, 02Jun while at work I felt the COVID symptoms again. Went home and tested positive for COVID; (03Jun2022) Positive, notes: Also had a test at booth Ive gone to many times today 03Jun and tested positive for COVID. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient received treatment for COVID-19 included Paxlovid.
Pt reported previous adverse reactions to previous moderna vaccines. Stated he was approved by his doctor to receive vaccine. Vaccine Given at 1235. Pt stated at 1245 he was feeling itchy - no visible rashes at redness noted. Given 2 x 25mg PO of Benedryl. Vitals taken vs 97% RA, HR 70, BP 124/80, Pt AxO x 4, communicting w/o difficulty 1310 pt repeated dizziness and mild chest pain, Provider was notified -> patient transported via wheelchair to clinic for further evaluation. vs remain stable, pt remains orientated throughout exam 1320->EMS called & pt transported.
Swollen lips Nerve pain  -sciatic  Body ache Fever Headache Chest tightness Back pain  Rib pain Cold then hot in waves Burning eyes Swollen lymph nodes in throat Joint pain Kidney pain Short of breath Fatigue Trouble sleeping Mental focus off
Constant chills and shivering for 1 1/2 hours -- used several blankets and they stopped. Headache that started strong and lessened over 24 hours. Fatigue that lasted a couple of days.
Dizziness, Headache, Myalgia, Fever, Rash, Diarrhea, HYPERglycemia, CHEST PIAN RASH ON ARM WENT TO ed ELEVATED BS. Narrative:  Other Relevant History:
Injection site pain developed the evening of the vaccine administration and continued for several days. Two days later she developed redness around the injection that over several days appeared to spread. Today the redness is subsiding as well as the pain.
patient received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 28th June 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 28th June 2022, the patient received the 3rd dose of Shingrix. On 28th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 1st July 2022 Reporter's Comments: Consent to follow up was granted via postal. Additional supportive information: As patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with US2022101097 reported by same reporter for patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022101097:same reporter, other patient
She started having "seizures" or "staring episodes" and her eyes started getting blurry or double vision at times in June 2008. She was so sick she was admitted to the hospital that month. The only thing they found was SVT.  Feb 2009 they found she has hypoglycemia.  May 2009 She started having slow speech and started dragging her left leg.  June 2009 Both legs started feeling "tingly" and heavy- she couldn't support herself all the time.  She is in a wheelchair more that not, or uses a walker the rest of the time.  She can't speak at all at times- it comes out like baby jibberish or child like speach. July 2009 she started retaining water?? We noticed she had cushy bags on her back that come and go. Also that month she started "gagging" like she was going to throw up, but nothing comes out- except maybe a burp.  Everyday she feels sick.  Her life has completely been ruined becuase she is too sick to do anything.  We have taken her to several types of doctors, but they said they think it is a "conversion disorder" because they haven't found what is causing it all.  I know better than that.  It is a cop-out to label it as that just because they don't know what is wrong.  All these symptoms started after she had the Gardasil Vaccinations.  I know this has caused the problems!  9/17/09 ER / hospital records received 4/5/08 to 5/27/09. Many visits and complaints, extensive diagnostic testing. Assessment: Left side weakness, aphasia. Conversion disorder. Originally presents with pelvic pain and a history of cysts. Epigastric pain. Right ovarian cysts. Sinus tachycardia, syncopal episode. Thyroid nodule. Patient later presents with difficulty standing, imparied speech, stuttering, difficulty walking, dragging (L) foot, weak grip. Subsequent visits: tachycardia, abdominal pain, elevated lactate. Presented to emergency room with many episodes of shaking, blurred vision, and could not talk. Begin as a "lightness" or "tightening sensation" all over body. Fever. Panic attacks. Fatigued and tired.
About 3 am woke up very hot but no fever.   Felt like I was burning up.  Ended up standing outside in 3 degree weather in shorts trying to cool down.   Had to do that several times.   Again no fever.    Took several hours to go away.   Occasionally still get for lack of better term hot flashes
Tingling, numbness, Left rib pain, nausea, muscle tightness Vital Signs: Blood pressure: 160/94, Pulse 78,
Child has had two VARIVAX vaccines on 9/30/10 and 9/27/12. Child presented in the office today with varicella.
Her symptoms consist of pain, redness, swelling, blistering and maybe peeling skin on the foot. Advised pt to contact her physician as soon as see can.
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided. Concomitant therapy included sterile diluent (manufacturer unknown).  On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot # T002848, expiration date 23-JAN-2022) for prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000749: US-009507513-2009USA000762: US-009507513-2009USA000777: US-009507513-2009USA000894: US-009507513-2005USA009352: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000747: US-009507513-2009USA000757: US-009507513-2009USA000931: US-009507513-2009USA000958: US-009507513-2009USA000971: US-009507513-2009USA000976: US-009507513-2009USA000991: US-009507513-2009USA001003: US-009507513-2009USA001006: US-009507513-2009USA001097: US-009507513-2009USA001099: US-009507513-2009USA001111: US-009507513-2009USA001114: US-009507513-2009USA001123: US-009507513-2009USA001129: US-009507513-2009USA001135: US-009507513-2009USA001194:
Itching; My Chest hurt and I had hard time breathing; My Chest hurt and I had hard time breathing; I was sweating very very bad; The muscles and the upper part of my legs hurts and still hurt; The muscles and the upper part of my legs hurts and still hurt; Very tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6199and expiry date 30-Jun-2021) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12 Mar2021 around 8:00 in night, the site where she had the needle it started itching. The patient's chest hurted and patient had hard time breathing. Patient was sweating very very bad and the muscles and the upper part of my legs hurted and still hurt and just very tired. Patient was a cardiac patient so, do not know. The patient did not wanted to go through this again on the second shot. Consumer was informed about Pfizer Medical information department and was provided with the number. Further probing was not done, hence limited information was available over the call. The outcome of itching, breathing difficult, chest pain, sweating, very tired was unknown and muscle ache and leg pain was not recovered.  No follow-up attempts were possible. No further information was expected.
Fever & chills; enlarged lymph node under right arm; Fever & chills; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 12:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL). Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jan2021 13:45 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. Since 18Feb2021 01:45, the patient experienced Fever & chills, enlarged lymph node under right arm. No treatment received for AE. Outcome of the events was recovering.
Nausea, chills, fever, body aches, headache, swollen right armpit (all day the following day from shot).
The patient was brought to the mass vaccination clinic by their father for their initial dose of Pfizer vaccine on 5/12/21. Father went to the website and rescheduled the boys' second dose appointment due to location convenience. The patient presented on 5/27/21 for a second Pfizer vaccination, dose spacing was only 15 days apart instead of the minimum recommended of 18 days separation between doses. The registered nurse called and spoke with the patient's father, discussed the concern. The patient's father reports child has not experienced any adverse reaction and is aware that VAERS is being completed.
This spontaneous, non-valid report was received from a registered nurse and refers to seven unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. From 03-NOV-2017 to 20-NOV-2017, the patients were vaccinated with improperly stored ROTATEQ, orally, lot# reported as "N000592" , expiration date: 12-OCT-2018 (dose and frequency not reported). The vaccine underwent a temperature excursion between 9 to 25 Celsius degrees for 1 hours and 50 minutes. No previous excursions were reported. Digital data logger was involved in recording the excursion. No adverse effects were reported. The lot # M064719 has been verified to be not valid for ROTATEQ. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received for patients vaccinated with ROTATEQ vaccine that was involved in a data logger excursion. Follow up information has been received from registered nurse on 01-JUN-2018: This spontaneous report was received from a registered nurse and refers to 15 months old patient unknown gender. On 03-NOV-2017, the patient was vaccinated with improperly stored ROTATEQ, orally, lot# reported as "N000592" , expiration date: 12-OCT-2018 (dose and frequency not reported). This is one of several reports received from the same reporter (1806USA004013, 1806USA004061, 1806USA004062, 1806USA004063, 806USA004064 and 1806USA004065).
administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-339498 (Patient Link).
After 5 minutes getting the first dose of Pfizer COVID-19 vaccines I fainted at the pharmacy. The ambulance was called and I was checked in place. ever since I got the vaccine I started feeling my heart rhythm changed, either my heart is slowing down or it beats really fast or get a discomfort  feeling in heart and get the feeling  of passing out again. This made me loose my appetite to eat for several days. On two instances, i went to the emergency room. I've been following up with my doctor about this issue.  The discomfort will happen every several days. Before getting the vaccine I had none of the symptoms.
This spontaneous report as received from a female patient (also healthcare professional) of unknown age regarding herself. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with HEPTAVAX-B VIAL 10/0.5 for an unknown indication (dose, route were not reported). Concomitant medications were not reported. On an unknown date, the patient reported that she received a booster dose of HEPTAVAX-B VIAL 10/0.5 and mentioned she had high titers approximately 30 days after vaccination. The outcome of high titers was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.