chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the booster at the same time as the DTap; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) from 16-Aug-2021 to an unknown date for Diphtheria immunisation.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap) had resolved.        No Information on concomitant medications were reported.  No treatment details were reported.  Company Comment: This is a case of Extra Dose Administered (lot #052E21A) to an immunocompromised patient with no AEs reported. Further information has been requested.; Sender's Comments: This is a case of Extra Dose Administered (lot #052E21A) to an immunocompromised patient with no AEs reported. Further information has been requested.
Varivax in left thigh with no immediate problems. At 12 hours later, awoke with itching. Mother noticed "itching bumps" on right knee and bilateral ankles with slight "puffiness", but no fever, nausea or vomiting. Benadryl was given and resolved by morning without recurrence. Developed URI, 2 days, post vax.
This spontaneous report as received from a other Healthcare Worker (also reported to be Office Manager) refers to a patient of unknown age or gender. Due to a human error, the patient, who was intended to receive PNEUMOVAX, was inadvertently administered with RECOMBIVAX HB lot # 1106AA (expiry date unknown), 1 ml, intramuscular, Vaccination administered on on 24-SEP-2012. No adverse effects reported. No further information provided. Additional information is not expected.
On day 8 (03/24/2021) after vaccination upper left arm (around area of injection) started itching then developed a large red area that was hard and hot to the touch.  Area was larger and more painful on 03/25/2021.  Saw G.P. on 03/26/21 at 8:00 am to confirm it was reaction to vaccine.   Treated with topical itch cream and took Benadryl at night and Claritin during day for 3 more days until symptoms disappeared.
For two days after receiving the shot I had an extremely bad headache.  It subsided once I took both Acetaminophen and Naproxen.
This spontaneous report was received from a pharmacist and refers to a non dialytic patient of unknown age or gender. The pertinent medical history or drug allergies/drug reactions were not reported. On 23-NOV-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (40 microgram) (Lot number, expiration date and route of administration were not reported) 40 Microgram. On 26-DEC-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (40 microgram) (Lot number, expiration date and route of administration were not reported) 40 Microgram. There was no concomitant medication reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Patient was 17 years old.  Vaccine currently licensed for 18 years of age and older
Tightness in hamstrings; Sorearm; This case was reported by a consumer via call center representative and described the occurrence of tendinous contracture in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung cancer and cataract. Concurrent medical conditions included macular degeneration.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a day after receiving Shingrix, the patient experienced tendinous contracture and pain in arm. On an unknown date, the outcome of the tendinous contracture and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tendinous contracture and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient and calling with her husband on the line.  About 3 weeks ago (of the date of reporting), the patient received dose 1 of Shingrix, in the left arm. 7 days after receiving the Shingrix, the patient experienced sore arm that lasted for 2 weeks. The tightness in his hamstrings lasted for 3 weeks. The patient referred to health care professional.  He consented to follow up.  No further details were provided.  The reporter also reported adverse event for herself, refer case US2019080733.
Menstrual cycle is longer than usual.  My cycle has been clockwork for years and always lasts 3-4 days.  Today is day 8 and I'm still spotting.
Started Sat march 5th @ 9am  high fever (Tylenol, cold compact on forehead, cool shower) ending  Monday 03/07/22 @ 8am  Tuesday 03/08/22 7am broke out in red spots all over body chest, back, thighs, little on face, groin, butt
Left shoulder and left arm in terrible pain. Pain scale 7. Pain has persisted. Left shoulder and arm have limited mobility.
Large bruise on left thigh 1 week after the Janssen Vaccine. Pt did not experience any other symptoms Denies SOB, Headache or ABD pain. No swelling or leg edema noted as well.
35 year old patient received IPOL/no AE; received intradermal, 0.1ml IPOL instead of Tubersol by mistake with no AE; Initial information received on 28-Apr-2021 and additional information was received on 29-Apr-2021, regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2021SA148354 and 2021SA148624 (same reporter).  This case involves a 35-year-old female patient who received intradermal 0.1 ml dose of IPV (VERO) [IPOL] (in the left forearm, lot R1F801M, expiry date-28-Sep-2021) by mistake instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 19-Apr-2021 (product administered to patient of inappropriate age) and (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chief c/o cough and pain in left lower abdomen/groin; admitted for COVID-19 pna; tx w/abx, steroids, zinc; was not hypoxic
A moderna booster dose was given to a patient under age 18.  No known adverse reaction occurred.  The patient had received pfizer for their primary series, but requested moderna for their booster.  The administering pharmacist  did not notice the patient was only 17 until after the vaccine had been administered.
VARIVAX administered after temperature excursion; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 14-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number T002846 has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -10.2 degrees Celsius (C) for 1 hour and 53 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014705: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869: US-009507513-2008USA014951:
PER PATIENT HE HAS BEEN EXPERIENCING FATIGUE, LETHARGY AND BRAIN FOG STARTING 1-2 DAYS AFTER RECEIVING THE VACCINE
Patient presented to emergency room on 8/30/2021 with shortness of breath, cough, and bilateral lower extremity edema. She was admitted for further management and found to be COVID-19 positive. On 9/1/2021, her condition worsened and she was transferred to ICU and was intubated on 9/4/2021. She was extubated on 9/5/2021 and transferred out of the ICU on 9/6/2021. Patient underwent a pulseless respirator arrest on 9/8/2021 and returned to the ICU. Patient was intubated and underwent tracheostomy. Patient was discharged to LTAC facility on 9/27/2021.
Patient is a 33 year old male who received his 4th anthrax (AVA) on 12 Sep 04. Later that pm he stated that he felt a little sore in his back and neck and that the next morning he had increased soreness. He said that he went to work and had to leave at 11 am because he felt so bad. He stated that he had pain in his lower back that would radiate around to his hips and that his neck was also starting to get sore. At 5-6 pm that night, after eating for the first time that day, he became nauseated, had increase back, and neck pain. He also reported a headache in the front part of his head with no reports of altered sensation or visual disturbances. He stated that he felt warm and developed chills. He then went to the emergency room and while waiting in the waiting room he developed knee pain. Once seen he was given an I.V. along with some pain medication and he then developed pain in his fingers. He was released the following morning on 14th with continued but lessened pain and aching all over. He stated he took ibuprofen for that day only and by the 15th he was feeling better.   He currently reports that he is doing well with no further pain. He denies any problems with AVA # 1,2 & 3.09
Received flu vaccine on 9/26/14. Developed hives/rash around the injection site (R thigh) on 9/27/14 and it progressed to cover entire body on 9/28/14.
Increasing headache and nausea through morning  Chills and right shoulder & arm soreness beginning in afternoon  102 F fever in evening Right shoulder pain that night Symptoms subsiding through morning  Still have headache, nausea, and right shoulder soreness
1st shot 3/23/21 I began experiencing what I believed to be heartburn I had never before in my life experienced heartburn and started feeling that within a week 3/26/21 of receiving the shot. I started over-the-counter meds such as Prevacid, Tums, Pepto Bismol and nothing helped. 3 weeks later I went to my primary care doctor for treatment where I was prescribed omeprazole and later on Prilosec first on a dosage of 20mg then a dosage of 40mg. The medication didn't help and only seemed to make it worse.  I was referred to a gastroenterologist in May 2021 and was not able to see my doctor until June 2021. At the time I received the second shot where I began to have ear-burning pain and numbness sensation in my face. I was having numbness around my nostrils, mouth, and cheeks. The ear burning would feel like it's inside my ear canal. My primary care doctor saw no issue in my ears but suggested a gastroenterologist anyway. My gastro suggested I do an endoscopy with bravo and the findings stated I was not having sufficient acid reflux to have the symptoms I was having. Especially the ear burning, he suggested that could be an allergy but did not order an allergy test and I was advised to see an ENT instead. My ENT did an allergy test which came back negative. My ENT also did a barium swallow to confirm no heartburn and everything was negative and I am still having ear-burning pain, minty /hot throat. It is debilitating and painful where it disrupts my way of life constantly.  I currently have no treatment and am dealing with this every day.   My ENT has suggested TMJ as the cause but I had never had any jaw issues in my life up until receiving the vaccine. He is also not 100% sure as some of my symptoms do not line up with the TMJ symptoms. I am still trying to get a diagnosis 6-7 months later. I have also had my upper wisdom teeth removed to see if the pressure of my wisdom teeth was causing this but 2 weeks post wisdom teeth removal I am still facing the same symptoms.
nausea reported around 3am; This is a spontaneous report from a contactable other healthcare professional and contactable consumer.  A 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immuization; tofacitinib citrate (XELJANZ XR, strength: 11mg), oral from Jan2021 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history include ulcerative colitis, heart attack 2018, blood clot. high cholesterol, heart -low ejection fraction. Concomitant medications were not reported. The patient experienced nausea reported around 3am.  Information on the batch/lot number has been requested.
Patient was given to COVID19 Moderna Booster dose of 0.25ml at an age that it is not yet approved for (at age 14). She had previously received Pfizer Peds primary two dose series.
Pt. called complaining of redness, discomfort, swelling and itching at injection site on right arm where Varicella vaccine had been given. Initially treated on 5/23 with Loratadine and ice topically, but then on 5/24 due to increased area of redness and new onset pain and itching, she treated with Cephalexin 500mg BID x7 days with resolution of symptoms.
Patient received COVID vaccine Pfizer first dose in vaccine clinic.  Her symptoms started 5 min after injection, lasted 10-15 min and resolved.  She started feeling tingly in her arms, then noticed a red, raised, blotchy rash on her arms.  She felt hot and a little weak in the legs.  No oral swelling, throat tightening, shortness of breath, nausea, vomiting, diarrhea.  Symptoms onset 5 min after vaccine, symptoms resolved spontaneously within 15 min.  Patient transferred to ED.  No symptoms in ED.  Patient given Benadryl in ED.  Observed, no further symptoms.  Dc home with Epi pen
Fever for 24 hours, vomitting for 9 hours, light headedness still occurring at times, extreme fatigue still occurring, headache 36 hours, hot flashes at times still occurring
Sudden onset of heavy bleeding, including large clots, approximately 2 weeks before usual start of menstruation; continuous bleeding for approximately 4 days; then no menstrual period for the month
Patient she has swelling and redness down the right arm to her elbow. Patient states the arm is warm to the touch and itching. Patient will take benadryl and speak with doctor if symptoms worsen.
Got the vaccine and was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got the vaccine and was pregnant) in a 33-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included HELLP syndrome (Live, full term birth) on 13-Sep-2019 and Pre-eclampsia (Live, full term birth) on 13-Sep-2019. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Shortness of breath, ASA and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 12-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Aug-2020 and the estimated date of delivery was 13-Jun-2021. On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got the vaccine and was pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The cesarean delivery occurred on 02-Jun-2021, which was reported as Premature. For neonate 1, the birth weight was 2700 grams (5lbs 15oz) with an APGAR score of 8 at 1 minute. The outcome was reported as Pre-Term Birth NOS. pregnancy during problem was happen placental abruption, gestational thrombocytopenia, preeclampsia. fetus/infant detail-week gestation was 38 and weight was 2.7kg and length was 48cm and Agar score at 1minutes was8 and Agar score at 5minute was 9. On 12-Jan-2021, EXPOSURE DURING PREGNANCY (Got the vaccine and was pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2020, Pregnancy test: positive positive (Positive) positive.         The patient tested positive for pregnancy on 28-Sep-2020. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Internal review on 21-JUL-2021 resulted in updated of Number of fetus and para gravida. and lab data also updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
After 1st dose there was a metallic taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 12:30 (Lot number: EN6202) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLONASE ALLERGY RELIEF; LIPITOR [ATORVASTATIN]; TYLENOL PM; CBD OIL. The following information was reported: DYSGEUSIA (non-serious), outcome "recovered", described as "After 1st dose there was a metallic taste in my mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: The patient did not suffered from COVID prior to vaccination. The patient did not have COVID post vaccination. The patient also have no known allergies. The patient was also having Claritin as a concomitant drug.  No follow-up attempts are possible. No further information is expected.
Day after shot pain and redness at injection site, tiredness and shivering, head felt funny. It was gone the next day.
About an hour after receiving the shot at a free flu shot clinic at work, I suddenly felt light-headed and passed out. After regaining conciousness, I felt nauseous and got sick twice that night. Since I passed out at work, my coworkers called an ambulance but I didn't feel bad enough to go with them.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
little cataract; blurred vision after receiving the vaccine on 6April2021 and is still suffering from the symptom; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (little cataract) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VISION BLURRED (blurred vision after receiving the vaccine on 6April2021 and is still suffering from the symptom). On an unknown date, the patient experienced CATARACT (little cataract) (seriousness criterion medically significant). The patient was treated with CARMELLOSE SODIUM (REFRESH TEAR) at a dose of 1 dosage form. At the time of the report, CATARACT (little cataract) outcome was unknown and VISION BLURRED (blurred vision after receiving the vaccine on 6April2021 and is still suffering from the symptom) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Reporter states that  blur vision is still there but not like before.  Company Comment  This case concerns a 68-year-old female with a serious unexpected event of cataract, and nonserious vision blurred. Event latency within 24 hours after mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24 Jul 2021 contains significant information: Treatment medication and event added.; Sender's Comments: This case concerns a 68-year-old female with a serious unexpected event of cataract, and nonserious vision blurred. Event latency within 24 hours after mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 08/31/2000 the patient experienced chicken pox with less than 30 lesions and no fever or other symptoms of illness. The mother is unaware if the patient was exposed to wild type virus. Medical attention was sought. The patient recovered. No further information is available.