chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tenderness at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness at the injection site.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Tenderness at the injection site.). At the time of the report, INJECTION SITE PAIN (Tenderness at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
tongue felt really weird and started tingling; A spontaneous report was received from a Consumer concerning an unknown Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event: Paraesthesia Oral.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, Caller received the moderna covid 19 vaccine which has been recalled with some issues. He had read about a situation where an individual could not feel their tongue after receiving the vaccine. 20-15 minutes after he received his vaccine, he had some water then his tongue felt really weird and started tingling which dissipated after a couple of minutes.  Laboratory details were not provided.  No treatment information was provided as the event dissipated after a couple of minutes.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event: tingling on tongue was resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), utcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
lymph node swelling/pain beginning in my neck with neck pain.  Progressively spreading until 2/14, large lump in breast, red streaks.  Pain in groin and shoulder, all on left side.
Pt received blister like rash around injection site. Diarrhea, and flu-like symptoms.
haven't even ate some nights; haven't eat last night and went to sleep at 7.00 pm extremely tired; felt like someone hit her over the head with a sledgehammer.; felt really tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (haven't even ate some nights), FATIGUE (felt really tired and fatigued), FATIGUE (haven't eat last night and went to sleep at 7.00 pm extremely tired) and HEADACHE (felt like someone hit her over the head with a sledgehammer.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     no medical history was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 20-Apr-2021, the patient experienced FATIGUE (felt really tired and fatigued) and HEADACHE (felt like someone hit her over the head with a sledgehammer.). On 23-Apr-2021, the patient experienced FATIGUE (haven't eat last night and went to sleep at 7.00 pm extremely tired). On an unknown date, the patient experienced DECREASED APPETITE (haven't even ate some nights). At the time of the report, DECREASED APPETITE (haven't even ate some nights), FATIGUE (felt really tired and fatigued), FATIGUE (haven't eat last night and went to sleep at 7.00 pm extremely tired) and HEADACHE (felt like someone hit her over the head with a sledgehammer.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR form appended on 26-MAY-2021:Patient stated AE from the firstvaccine resolved . Second dose information given and denied further follow-up
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: TENDERNESS AT SITE REACTION TO COVID-19 VACCINE ALSO
Got the vaccine and she got shingles twice/Suspected vaccination failure; Got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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: 27-Apr-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient got the vaccine and then she got shingles twice. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR071761, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071761:Same reporter.
Pt recvd 2nd dose of vax FEB91 & 3 to 4 days following vax exp inc in sx described as a persistent exertional myalgias/arthralgias, & easy fatigability; seen by MD muscle biopsy of OCT91 revealed mild non-specific changes;
Myalgia, NauseaVomiting, heartburn, bloating Narrative: Per nursing report: "2nd dose of COVID 10 vaccine on 2/3/21 and called this morning [2/4] at 8am with complaints of heartburn, nausea, body aches, chills, bloating, indigestion. Employee state that she did not report her symptoms following her first dose but wanted to share them today. She report that she experienced vertigo and dizziness the following day after receiving her 1st vaccine."
Narrative: Patient reported Pruritis at injection site lasting up to 6 days post injections, but resolved without treatment.
Body aches, and fatigue started 6 hours after vaccine administered. The next day I had a moderate headache that I took ibuprofen, and Tylenol for. Body aches, and fatigue continued the next day. It was difficult for me to participate in ADL's. Headache, nausea, and fatigue continued to two days post vaccine.
Systemic: Confusion-Mild, Additional Details: pt did not go with the paramedics, but 911 was called. held pt from 12:45pm (injection time) to 1:36pm (after additional monitoring)
sore arm; This is a spontaneous report from a Pfizer Sponsored program. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a bit of sore arm in Jan2021. The outcome was unknown  Information on the lot/batch number has been requested.
Large 2" hard knot at injections site, slight itch started Jan 21, 2021 No treatment
High Fevers 105 degrees, shaking, Weak, Loss of appetite. On day 4 of fevers, broke out in rash. Tiny red dots on trunk of body treated around the clock with fever reducing medications in order to keep fever less than 104-105 degrees.
11 days after receiving anthrax vaccine patient presented with a rash. Developed low-grade fever, chills and red rash on leg and feet. Rash became more erythematous and edema developed. Entire lower extremities had 3 + edema. There were numerous petechiae that became confluent as purpura. Condition resolved over the next few months. 4 mm punch biopsy showed leukocytic vasculitis. Follow up information received 2/3/04 Patient had scattered red macules.
Received 6 mo DTaP, Polio, Hep B, PCV-13 and Rotavirus -> had seizure within 12 hours of vaccines. Few hours later -> had 2nd seizure. 1st documented fever was after 2nd seizure.
Myalgia, CoughWheeze, Syncope, Chills Narrative:  covid tested positive 1/1/21. symptoms resolved 1/2/21.
Severe vertigo for over 24 hours.  Patient is fine as long as prone. As soon as upright, vertigo results in vomiting.
1-2 days after receiving vaccine patient states localized muscle pain, tiredness and difficulty lifting his right arm. Went to MD 11/13/15 prescribed BACTRIM DS #20 now reported to pharmacy 11/15/15 states he still has no relief, has also tried oral OTC pain meds and topical OTC SALON PAS.
Hip and knee pain, both legs, 2 days Chills and fever, 1 day, same day as shot Constipation, 3 days Loss of appetite,  2 days
No adverse effects; Received one dose of improperly stored RECOMBIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 19-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot # R021372 (expiry date: 25-MAY-2021) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009509: US-009507513-1906USA009510: US-009507513-1906USA009514: US-009507513-1906USA009522:
Janssen COVID -19 Vaccine EUA Headache, extremely tired,  burning up & chills off and on all night, muscle aches.  Lasted about 24 hours.
This is a spontaneous report from a physician referring to a male who received his 1st Lymerix on 5/22/99 and subsequently, he experienced a "tetanus -type reaction" of injection site pain. The pt received the 2nd dose of Lymerix on 6/22/99 and subsequently, he experienced joint pain, body aches and a worsening of the "tetanus-type" arm reaction. Symptoms resolved after 2 days. The most recent information, received on 7/22/99, reports the condition of the pt is resolved.
Per patient- When I got my second shot in my right arm I had excruciating pain from my shoulder through my hands the next 2 days to the point that I couldn't really use my arm.   I just got my booster last week but decided to do my left arm because I was in so much pain in the right one.  Well it was very similar to the right.  My elbow and wrist hurt so bad that I couldn't move or get comfortable to make the pain stop. My hand almost felt like our was asleep but without the tingling that happens if your leg goes to sleep.   I took Tylenol and even the pain meds left over from my surgery throughout the 2 days after to try to get some comfort.
No adverse event. But pt did develop breakthrough infection. Seen at ED on 7/21/21 for nausea and right-sided abdominal pain, diagnosed with cholecystitis. Transferred to Hospital for laparoscopic cholecystectomy (done on 7/22/21). Incidentally found to be covid+ on routine admission screen on 7/21/21. No covid symptoms noted.  Patient previously received covid (Moderna) vaccine on 4/15/21 and 5/13/21 (lot numbers and facility that gave injection is unknown to reporting facility).
Consistent migraines since vaccination, two years later and I still get them once every two months. I never had migraines before. I use Advil to treat them and cannot work or function when they occur.
A report was received from a health care professional on 11/10/03 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
The patient felt like he was going to pass out and requested to lay down.  He was sweating.  We placed him in a recumbent position on our immunization mat until he felt better which was about 10 minutes.
Pt seen in primary care clinic, was given Pneumovax vaccine (lot #0256W Exp 1/8/05) on 6/19/03. Next day pt called clinic and complained of swelling, redness and area hot to touch. Was informed to come to ER for evaluation. Pt arrived at ER at 16:37. Pt left ER at 18:45 stating that he could not wait any longer to be seen.
DIFFICULTY WALKING; TINGLING SENSATION STARTED AT THE TOES AND CONTINUES TO SPREAD UP LEGS TOWARDS HIPS AND BUTTOCKS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. Patient had no known previous medical conditions. Patient had no known medication usage history. The patient was an athlete. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced difficulty walking, and tingling sensation started at the toes and continues to spread up legs towards hips and buttocks. Laboratory data included: Magnetic resonance imaging (not provided) Ruled out spinal conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling sensation started at the toes and continues to spread up legs towards hips and buttocks and difficulty walking was not reported. This report was non-serious. This case, from the same reporter is linked to 20220109867.
Vaccine was placed in refrigerator on 18-Oct-2021 and was administered on 20-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 18-Oct-2021 and was administered on 20-Oct-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 18-Oct-2021 and was administered on 20-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 18-Oct-2021 and was administered on 20-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The vial was placed in refrigerator on 18-Oct-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event. No Treatment medication reported.
Patient reports having major insomnia lasting one week, and a restless leg -type syndrome (involuntary movement/spasms) affecting the left calf and toes lasting all day for approximately a week and a half. The patient reports the symptoms appeared around a week to 10 days after after receiving the first dose of the Pfizer vaccine.
2 hours after injection: lightheaded, nausea, dizzy, difficult breathing. Anthrax #2. No signs and symptoms after Anthrax #2.
This case was reported by a physician and described the occurrence of injection site pain in a 58-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to ceclor, allergy to cipro and bactrim allergy. Concurrent medications included Calcium with vitamin D, Benefiber, Aspirin, Metronidazole, Fish oil, Pravastatin, Stool softener and CLARITIN. On 17 August 2012 at about 17:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm). On 17 August 2012, within hours of vaccination with BOOSTRIX, the subject experienced injection site pain and painful to move arm. The physician reported the subject had continuing pain at the injection site from her BOOSTRIX vaccine. The site is not tender to the touch, but whenever she moves her arm it pulls at the site. This has been continuing since the date of injection. The pain has improved slightly since the injection. At the time of reporting the injection site pain and painful to move arm were improved. The physician considered the events were probably related to vaccination with BOOSTRIX.
This spontaneous report was received from a physician concerning an unspecified number of patients (demographics unknown). On an unspecified date, the patients were vaccinated with doses of improperly stored GARDASIL (Lot # K011562; expiration date: 08-APR-2017) (route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
got COVID after the booster / tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID after the booster / tested positive) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced COVID-19 (got COVID after the booster / tested positive). At the time of the report, COVID-19 (got COVID after the booster / tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.         Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter. Patient got COVID after the booster on an unknown date, may be few months ago and had minimal symptoms. Patient tested on 30 Dec 2021 and the positive result came on 31 Dec 2021.  Company Comment: This is a spontaneous case concerning a 63-year-old, male patient with no relevant history, who experienced the unexpected, non-serious, AESI event of COVID-19 on 31-Dec-21. SARS-CoV-2 antibody test was positive. The event occurred unknown duration after the third/booster dose of mRNA-1273 vaccine given for COVID-19 immunisation on an unknown date. At the time of report outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case is assessed as non-serious as per report.; Sender's Comments: This is a spontaneous case concerning a 63-year-old, male patient with no relevant history, who experienced the unexpected, non-serious, AESI event of COVID-19 on 31-Dec-21. SARS-CoV-2 antibody test was positive. The event occurred unknown duration after the third/booster dose of mRNA-1273 vaccine given for COVID-19 immunisation on an unknown date. At the time of report outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case is assessed as non-serious as per report.
Headache, Arthralgia, NauseaVomiting, Chills, fatigue Narrative:  Other Relevant History:
Developed seizure disorder within 24-48 hrs of receiving 12 month vaccines. Seizures have been very difficult to control with medication. Per discharge summary, pt experienced emesis and fussiness. Follow up information received 06/09/2004: Continues to have retractory seizures.
Redness on both injection sites, on thighs - 1 day after vacc.
heart rate quickening; skin tingling; facial numbness; This is a spontaneous report from contactable consumer. This 44-year-old male consumer (patient) reported that: A 44-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is a 44-year-old male who received his first dose of the Pfizer BioNtech covid 19 vaccine and 17 minutes later experienced side effects of heart rate quickening, skin tingling, facial numbness. He stated this went on and off for about 15 minutes. Patient reported he has had side effects since. The patient underwent lab tests and procedures which included heart rate: quickening on an unspecified date heart rate quickening. The outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Rash on cheeks, about 45 minutes, later, entire body was in a rash. MD suggested Benadryl or Claritan and to watch for breathing problems.