chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave Moderna Covid-19 vaccine to a 16 and half years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna Covid-19 vaccine to a 16 and half years old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter. No concomitant medication reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna Covid-19 vaccine to a 16 and half years old). On 17-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna Covid-19 vaccine to a 16 and half years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 1/2 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Experienced tinnitus in left ear roughly 3 days after receiving the 1st dose of the pfizer covid vaccine
hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) had not resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  The event was ongoing since November for 4 months.  No treatment information was provided by the reporter.
Pt recv vax on 12/1/98; on 12/5/98 pt exp fine, red, raised rash all over, cranky, cutting teeth; tx=Ibuprofen
When I got the shot I started getting really fatigued. The following days my muscles, joints hurt, I was in bed for 3 days because it was very difficult to move. I had brain fog and stiff neck. From there I've yet to get back to 100%. It's like my whole body is in pain and I've gotten a lot of dizzy spells. Also weakness and bone pain. It really all started after this booster shot.
Actually getting her depressed.; Feet constantly burning; Feet constantly aching; Can't sleep; Red bump on feet; Red bump on feet; In pain; Can't walk; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Can't walk), DEPRESSION (Actually getting her depressed.), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching) and INSOMNIA (Can't sleep) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced GAIT DISTURBANCE (Can't walk), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching), INSOMNIA (Can't sleep), MASS (Red bump on feet), ERYTHEMA (Red bump on feet) and PAIN (In pain). On 04-Jun-2021, the patient experienced DEPRESSION (Actually getting her depressed.). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and ZOLPIDEM TARTRATE (AMBIEN) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (Can't walk), DEPRESSION (Actually getting her depressed.), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching), INSOMNIA (Can't sleep), MASS (Red bump on feet), ERYTHEMA (Red bump on feet) and PAIN (In pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Two weeks after receiving the 2nd dose on 07-Apr-2021, she developed a red bump on her feet to an extent that she can't walk. She had been referred to 2 different specialists and they said it's from the COVID 19 vaccine. They told her to take Ibuprofen but today they prescribed generic Ambien (zolpidem) because she was unable to sleep due to her feet constantly burning and aching. She has been in pain since 07-Apr-2021 and she was actually getting her depressed.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: report contained no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Within 7-8 hrs of vaccine - child spiked temp of 101-103 et cont. x6 days.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporters (HCP and Consumer). A 21-year-old female patient received BNT162b2 (BNT162B2), on 05Aug2021 at 15:20 as dose 1, single (Lot number: EW0183), in left deltoid and on 26Aug2021 at 09:05 as dose 2, single (Lot number: EW0183) at the age of 20 years, in left deltoid, all intramuscular for covid-19 immunization. Relevant medical history included depression (ongoing); migraine (ongoing); allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) oral taken for depression, start date: 2019 (ongoing); topiramate (TOPAMAX) oral taken for migraine, start date: 2020 (ongoing); buspirone hydrochloride (BUSPAR) oral taken for depression, start date: 2017 (ongoing); montelukast sodium (SINGULAIR) oral taken for allergies, start date: 2016, stop date: 2022. The patient did not receive prior vaccinations (within 4 weeks).  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2021, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2021) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Cellulitis right anterolateral thigh, induration and discolored. Cephalexin 250 mg/5 mL, 6 mL by mouth 2 times daily for 10 days.
pt recvd vax 14JUL92 & lab eval on 1AUG92 showed elevated SGOT levels; repeat test on 11AUG92 was nl;
Received tetanus shot. Within a week was in severe pain and barely able to move. Pain in upper back by neck, shoulder and arm. Severe muscles spasms and loss of sensation in arm and hand followed. Given prednisone and referred to neurologist. Diagnosed with brachial neuritis from shot. Being seen by neurologist and orthopedic surgeion for inflammation that has set into shoulder as result. Physical therapy twice a week. On anti-inflammatories, painkillers, nerve pain medication and muscle relaxers. Unable to work at regular job and do regular recreational activities. Unsure if will be permanent.
chest pain 3 days after receiving 2nd dose of COVID vaccine with no associated symptoms (no shortness of breath, fever, nausea, vomiting), presented to PCP and found to have troponin > 9,000. EKG borderline. Chest pain resolved after ibuprofen same day.
Shaky bones; Low energy; Felt down; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky bones), ASTHENIA (Low energy), DEPRESSED MOOD (Felt down) and VACCINATION SITE PAIN (Injection site pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006321A and 044B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced TREMOR (Shaky bones), ASTHENIA (Low energy), DEPRESSED MOOD (Felt down) and VACCINATION SITE PAIN (Injection site pain). In December 2021, TREMOR (Shaky bones), ASTHENIA (Low energy), DEPRESSED MOOD (Felt down) and VACCINATION SITE PAIN (Injection site pain) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-419281 (Patient Link).
pain on the injection site, joint, knee and ankle; pain on the injection site, joint, knee and ankle; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 06Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After taking the 1st dose in Mar2021, patient experienced pain on the injection site, joint, knee and ankle. Outcome of the events was unknown. Patient was also asking if she can take ibuprofen.  Information on the lot/batch number has been requested.
Redness and bump at injection site 8 days after 1st shot of Moderna. Occassionally itchy at site as well. Possible small rash - not very visible but small bumps to the touch - at injection site as well.
hives appeared on upper body & upper extremities w/in 24hr p/vax;no other sx occurred;mom gave atarax & tavist which got rid of the hives;
Severe stomach pain and cramps, diarrhea, nausea, vomiting, hives. The onset was approximately 4 hours after receiving the vaccine. The peak of pain was approximately 12 hours after injection. Hives remain on abdomen and thighs 48 hours later.
Body aches, particularly in hips and both legs. Sore throat. Sniffling, runny nose. Headache - felt from day after the vaccine was received. Wednesday September 22, 2021. Hair falling out more than usual during washing and combing - started Friday September 24, 2021.
Pt received both FLUZONE HD and PNEUMOVAX 23 intramuscularly in the right arm (at least an inch apart) on the 22nd. She came to the pharmacy today to pick up KEFLEX. Her entire upper arm was red and swollen. She said she was uncomfortable last night (the 23rd). She took her temperature at one point and it was a little over 99. She decided to go into a walk in clinic this morning just to be safe. The doctor prescribed KEFLEX she said for precautionary measures (in case the area had become infected). She seemed to be fine this morning when she came to pick up her medication. Just uncomfortable.
PATIENT EXPRESSED A DESIRE TO RECIEVE A SHINGLES VACCINE.  UPON ADMINISTRATION, PATIENT SAID THAT MAYBE SHE HAS ALREADY RECEIVED ONE DOSE AT A DIFFERENT PHARMACY BUT IT WAS AN OLD VERSION (ZOSTAVAX).  UPON VERIFING INFORMATION USING STATE IMMUNIZATION WEBSITE, IT WAS DISCOVERED THAT PATIENT ALREADY HAD 2 DOSES OF SHINGRIX AT A DIFFERENT PHARMACY AND SHE HAS RECIEVED A 3RD DOSE WITH US.  PATIENT COMPLAINED OF A SWALLEN AND PAINFUL ARM.
Approx 40 post injection, c/o flushing HTN 203/105. Transitioned to ED.
Case number PHEH2015US020627, is an initial spontaneous report from a consumer received on 12 Oct 2015. This report refers to a 19-year-old female patient. Past medical history was not reported. Past medical vaccination included flu vaccine of unknown manufacture on 29 Sep 2015 (10 days prior to BEXSERO). Concomitant medication included loratadine (manufacturer unknown). She was vaccinated with BEXSERO (batch number and expiry date: not reported) at left arm on 09 Oct 2015. On same day, few hours after vaccination she started experiencing a sore arm, and there was a knot at the injection site. She stated that her arm was more sore than she usually experiences with vaccines, and had lasted longer than usual. The symptoms were improving, but not yet resolved. The seriousness and causality of events were not reported.
Information has been received from a registered nurse concerning a 7-year-old female with no pre-existing allergies, birth defects, or medical conditions, who on 27-SEP-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There were no illnesses at the time of vaccination. On 01-JUL-2007, the patient went to the doctor's office with chickenpox lesions all over that were itchy. No laboratory or diagnostic tests were performed. On 09-JUL-2007, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Initial outbreak on scalp that was thought to be seborrheic dermatitis then rash on most body areas arms legs chest abdomen(upper and lower) with intense itching
I received Botox for migraines 3 weeks after the moderna vaccine.  I have been getting Botox for 7 years and never had an issue.  On May 13, 2021 , every single injection site swelled up. I looked like I was attacked by bees!  Thankfully they had went down by next day.  I read that some people had adverse reactions when they had Botox BEFORE the covid 19 vaccine, but none reported after vaccine
The day after receiving the vaccine I was very sick and stayed in bed for the day. On 01/05/2023, I had a dizzy spell and I suddenly fell down beside my bed. I had a blood pressure cuff at my bedside and checked it. I contacted my doctor and left a message. I will be making an appointment for Monday. On off since 01/05/2022, I have dizzy spells and just don't feel good. I tested positive for COVID-19 between dose 1 and dose 2 on 06/30/2022.
Pt states she has numbness in left side of face, 2 fingers on left hand are numb, blurry vision when standing up
Initial solicited report received from a consumer in a study on 05 October 2015. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported, manufacturer unknown). Medical history and concomitant therapies details were not reported. The subject felt sick on an unspecified date, after taking a dose of vaccine previously. The subject was about to take a decision if it was safe to try it again and then would seek that out. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Fever, severe cough, abdominal pain, chest pains, pain in muscles, pain in back, productive cough, nausea, no appetite. Started on Benzonatate 100 mg. three times a day and LEVAQUIN 500 mg once a day for 7 days by Dr. I was in bed and could hardly get up for over a week. Severe chest pains kept me awake. It was hard to breathe, as well.
I am not sure if this was vaccine related but v safe called and asked me to report.  About one month after vaccine I was very sick with shortness of breath, severe cough ( kept me up at night), congestion, hoarse voice lasted about 3 weeks.  Had Covid test which was negative.  Had it been around people except husband.
Heart arrhythmia, shortness of breath during and after exercise, more easily winded, trouble exercising, nearly fainted, heightened sense of anxiety and noticeably increased resting heart rate, issues ongoing.
Moderna COVID-19 Vaccine EUA. About 2 hours after receiving the vaccine, I started to feel severe gastrointestinal and lower back pain. I was bloated, swollen, nauseous. About 4 hours after the vaccine there was some relief, but the pain came back multiple times that night, would subside and was mostly better the next day. I did vomit around 7pm. I took antacids and simethecone with no relief.
Information has been received from a certified medical assistant concerning a 16 year old female patient with no history of seizures or fainting in the past and an allergy to cefixme (SUPRAX) who on 01-MAY-2007, was vaccinated with a first dose of Gardasil (Lot# 658094/0524U). On 11-JUL-2007, the patient was very afraid to receive the second dose. There was no concomitant medication. It was reported that 30 seconds after the vaccine was given the patient fainted. The patient was standing and fell to the floor and did not hit her head. She fell to her knees and her upper body went backwards, head did not hit the floor. The nurse guided the patient to the floor. The patient's entire body shook like she was having a seizure for 5 to 10 seconds. Unspecified medical attention was sought. It was reported that the patient became conscious and rested. On 11-JUL-2007, the patient recovered. No product quality complaint was involved. Upon internal review, entire body shaking  like she was having a seizure was considered to be an other important medical event.  Additional information has been requested.
Muscle and joint pain, excessive sweating, night sweats, trouble sleeping, lymph node swollen, diarrhea, injection site pain.
Malaise & hypersomnolence around 20 hours post-injection.  "COVID arm" around 36 hours post-injection: redness and slightly raised bump all around injection site, ~1" diameter. Sensitive , tender, painful to touch, pain is about 2/10 without movement, 6/10 with palpation.  Feels like a very bad mosquito or bug bite.
Case number PHHY2012US014478 is an initial literature report received on 17 Feb 2012. The intent of the article was to assess the safety and immunogenicity of 4 doses of MENVEO administered concomitantly with routine vaccinations to infants at 2, 4, 6, and 12 months of age. This report refers to 1508 infants, whose age and gender were unspecified. The patient's medical history was not specified and concomitant medications given during this study included PEDIARIX (other manufacturer, batch number: not reported), INFANRIX (other manufacturer, batch number: not reported), ACT-HIB (other manufacturer, batch number: not reported), PREVNAR (other manufacturer, batch number: not reported), ROTATEQ (other manufacturer, batch number: not reported), PROQUAD (other manufacturer, batch number: not reported), MMR II (other manufacturer, batch number: not reported) and VARIVAX (other manufacturer, batch number: not reported); and hepatitis A vaccine (other manufacturer, batch number not reported). These infants were enrolled in a phase III, open-label randomized, parallel-group, multicenter study of healthy infants and were randomized 2:1 to receive MENVEO (MenACWY-CRM, batch number not specified) intramuscularly on to right thigh co administered with routine vaccines or routine vaccines only followed by MENVEO (MenACWY-CRM, batch number: not specified) in the second year of life. The patients were further enrolled into either the immunogenicity cohort or the safety-only cohort. Of the 1508 enrolled patients, 479 were enrolled into the immunogenicity cohort (320 randomized to receive 4 doses of MENVEO with routine vaccines; 159 to receive routine vaccines only followed by MENVEO at 12 and 15 months of age). The remaining 1029 were enrolled into the safety-only cohort (680 to receive 4 doses of MENVEO with routine vaccines; 349 to receive routine vaccines only followed by MENVEO in the second year of life). It was reported that on an unspecified date, 7 days after vaccination, there was 271 incidents of tenderness, 126 incidents of erythema and 89 incidents if induration at local site and incidents of rash, urticarial rash, change in eating habit, sleepiness, persistent crying, irritability, vomiting, diarrhea, and fever were 25, 7, 135, 257, 189, 416, 43, 63 and 46 respectively in MENVEO and routine vaccine, 6 months of age group. In MENVEO and routine vaccine, 12 months of age group; the incidents of local tenderness, local erythema, local induration, rash, urticarial rash, change in eating habit, sleepiness, persistent crying, irritability, vomiting, diarrhea, and fever were 177, 81, 44, 31, 3, 101, 149, 120, 271, 27, 61 and 49 respectively. The outcome of the events was not reported. The author concluded that MENVEO was highly immunogenic in infants and can be used in a 4-dose primary immunization series from 2 months of age to offer protection against these 4 meningococcal serotypes.
watery eyes and are kind of puffy; watery eyes and are kind of puffy; watery eyes and are kind of puffy was reported as worsened; headache; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; expiry date: unknown) via an unspecified route of administration on 23Jul2021 (at the age of 12-years-old) in right arm as a single dose for covid-19 immunization. The patient's medical history, concomitant medications and investigation assessment were not reported. The patient experienced headache 30 minutes after the vaccination and had watery eyes and were kind of puffy on 23Jul2021. The events of watery eyes and were kind of puffy was reported as worsened. She was treated with Zyrtec. Her mother asked if it was okay about the events and should she take the patient to the emergency room. The outcome of all the events was not resolved.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Experienced heavy bleeding of Menstrual and heavy clotting. Also, had a CT Scan done with contrast and had an allergic reaction to the dye, and I am not allergic to anything. I had this CT Scan with dye 5 years ago with no allergic reaction.
Following the first dose of the vaccine, I experienced "tingling" in my hands and feet.  It was mild and dissipated within 24 hours, so I believed this to be anxiety related to the vaccination.  However, after the second vaccine, I was ill for many days and experienced numbness and tingling in my face, arms, hands, legs, and feet.  I sought medical care at Day5-post vaccination, and my PCP ran multiple tests to rule out other causes.  Blood tests yielded nothing remarkable, so I was referred to a Neurologist.  I waited many weeks to see a Neurologist and had persistent symptoms that made it difficult to go about my day-to-day schedule.  At the Neurologist, they ran Sudomotor and ANS tests and determined that I had Peripheral Neuropathy.   I had not experienced this at all prior to vaccination.  Since that date, the condition has improved but is still noticeable on a daily basis.
chills, muscle pain, joint pain, fever, Headaache, GI upset, fatigue-resolved
Pt complained of pain at injection site on the night he received. Next morning leg was red/swollen at inj. site and warm to touch. Redness was 3 1/2 in long and 2 1/2 inch wide. On Day 2 Pt came into office advised to use Motrin and Benadryl
Erythema on right deltoid 4 1/4" wide by 4 1/2" long. Area is warm and firm to touch. Slightly painful. Patient treated with BACTRIM DS 1 tablet twice a day x 7 days. Patient was afebrile when rechecked in clinic.