chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site knot/nodule; Injection site itching; injection site hard; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (injection site knot/nodule), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE INDURATION (injection site hard) and INJECTION SITE ERYTHEMA (injection site red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced INJECTION SITE NODULE (injection site knot/nodule), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE INDURATION (injection site hard) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE NODULE (injection site knot/nodule) and INJECTION SITE PRURITUS (Injection site itching) was resolving and INJECTION SITE INDURATION (injection site hard) and INJECTION SITE ERYTHEMA (injection site red) had not resolved.            Concomitant medication was not reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for Humira: the event(s) of injection site knot/nodule, injection site hard, injection site red and injection site itching was not provided.  Treatment drug was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt reported small outbreak, muscles soreness (that has not resolved), pain in limb and flu like sx.
On 1/28/21 bp skyrocketed so I went to ER.  Did blood work and had low sodium and magnesium and potassium.  Had fog had with bad headaches which lasted for a few months.  Went to kidney dr and had more blood work.  In July 2021.  Went back to ER had another sodium IV.  Felt horrible most of the year.  It was a electrolyte imbalance
Received the Moderna vaccination on 01/08/2021 & received the flu vaccine 18 days after. Suffered 3 seizures the night of receiving the flu vaccination, was hospitalized for 5 days.
Woke up with fever day after receiving second vaccine, Tmax 102.2 with associated headache, fatigue .
Patient presents with Shortness Of Breath,is on home oxygen. Physical examination revealed regularly irregular tachycardic heart rhythm, rales to the bases, mild distress.  Patient positive for COVID-19vitamin C and zinc,IV dexamethasone,IV meropenem.  discharged today to rehab.
Pt was given vaccine on Rt side. Pt has no reaction to vaccine. Pt initially mentioned he needed booster.
6 Sep 11- Nausea, body aches 8 Sep 11- Vomiting 8 Sep 11- Rash 9 Sep 11- Spreading of rash 9 Sep 11- Seen by Dr.; given medications
Eyelids were very swollen; chills; bodyaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Eyelids were very swollen), CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced SWELLING OF EYELID (Eyelids were very swollen), CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (fever). On 20-Apr-2021, CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (fever) had resolved. On 22-Apr-2021, SWELLING OF EYELID (Eyelids were very swollen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Concomitant medication included blood pressure medication.  Treatment medication included Benadryl and Advil for every four hours.
J & J COVID-19 Vaccine: patient received J & J COVID-19 vaccine 09/27/21 and presented to ED (10/18/21) with SOB and Cough. Patient admitted to the hospital for treatment of pulmonary embolism
Headache, Arthralgia, Fever, fatigue and chills Narrative:  Other Relevant History:
Got my vaccine at 5 pm and felt no symptoms. I went to bed that night at 10 pm. Woke up at 11 pm with nausea. I went to the bathroom to throw-up. I fainted on my way there and woke up on the floor. I lifted my head to throw-up again. Once again, I passed-out. This continued, every time I lifted up my head, I would lose my vision, my ears would ring and I would pass-out. I fainted somewhere between 10-15 in between episodes of vomiting. I also had normal side effects (fever 102, shaking chills, nausea, cold sweat), but I also was having extreme brain fog, as well as, repeated episodes of syncope. I was able to get a family member's attention at 1 am. I had to be carried by arms and legs back to my room because of the inability to lift my head without fainting. Once in bed with my head flat, I continued with migraines, fever, chills, but fainting stopped. I fell asleep around 4 am and woke up around 8 pm. The reason I am writing about this experience is because while unconscious, it was completely possible for me to vomit, aspirate and lose my airway. This was a terrifying experience. I was not made aware this event was a possible reaction to the booster.
2nd covid vaxn today @1400. stated she couldn't swallow, turned purple , and trouble with vision. they took her back to pharmacy where vxn was administered.. all symptoms resolved. no SOB, swelling or trouble swallowing.. speaking full sentences  This is a48 Years old Female presenting with 1 minutes of moderate allergic symptoms characterized as inability to swallow and color change of face 2 hours after patient received her second dose of Pfizer COVID vaccine at 1400 today. Patient says all symptoms have now resolved and lasted 1-2 min. After injection the patient was observed for 40 minutes by the pharmacy where she received the vaccine.
Injection site urticaria; Injection site is hot; Injection site is itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (Injection site urticaria), VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE PRURITUS (Injection site is itchy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L30A) for an unknown indication.     No Medical history was provided by reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Injection site urticaria), VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE PRURITUS (Injection site is itchy). At the time of the report, VACCINATION SITE URTICARIA (Injection site urticaria), VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE PRURITUS (Injection site is itchy) 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.   Concomitant medication was not reported  No treatment information was provided.
5 min afer vaccine administered pt c/o dizziness which lasted 40 minutes.
66 year-old was administered Adacel/no AE; Initial information was received on 25-May-2021 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Medical Information (Reference number- 00615161).  This case involves a 66 year-old male patient who was vaccinated with 0.5 mL (once; standard) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: U6900AA and expiry date 18-Nov-2022) via an intramuscular route at left deltoid on 25-May-2021 for prophylactic vaccination (Off label use in unapproved age group).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given.   It was a case of off label use (latency was on same day).  At the time of report, no adverse event 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 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.
On September 24, 2021, patient presented to the pharmacy for her flu shot. She reports with very bad upper left arm pain and states because of the severity of the pain she is unable to move her arm in front of her chest and up and over her forehead and that any side ways movement is extremely painful. She also states picking up lighter items hurt her and that she has been taking extra strength Tylenol.
Information has been received from a medical assistant concerning an 8 weeks old male patient who on 25-JUN-2009 was vaccinated with a first dose of ROTATEQ (2ml, orally and lot number: 663461/085Y). Concomitant therapy included DTaP, ACTHIB, PREVNAR (dates, doses and lot numbers not reported). On 05-AUG-2009 the child was hospitalized with intussusception and surgery performed. The child was released at the hospital at the next day (on 06-AUG-2009). At the time of the report the patient was recovered and an other important medical event. Intussusception was considered to be immediately life-threatening. Additional information has been requested.  9/8/09 Hospital records received DOS 8/3/09 to 8/5/09. Assessment: Intussusception.  Patient presented with a one day history of vomiting and hematochezia. Bloody stool. Decreased activity, poor feeding. Projectile vomiting. Barium Enema - successful reduction.  10/13/09 ICD-9 Code: 560.0 Intussusception.
Two days after receiving my 2nd dose, I began experiencing tinnitus in my right ear. It sounds like a low, rumbling, "whooshing" sound that intensifies when hearing sounds with low/bass frequencies. So far, I've tried treating it by flushing out my ear and applying ear drops, but it has not been effective.
Wrong vaccine given. Patient wanted to receive Shingrix, but was given Moderna. She experienced a fever the next day.
PAIN BEGAN IN RIGHT ARM AND CREPT DOWN RIGHT SIDE INTO HIP. BY AM WHOLE BODY ACHED AND COULD HARDLY GET OUT OF BED. ALL JOINTS WERE PAINFUL.NAUSEA. HEADACHE. FEVER 104. FLUSHING OVER ENTIRE BODY. BARELY STAND
This case was reported by a nurse via call center representative and described the occurrence of needle injury in a 6-year-old male patient who received FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). On an unknown date, the patient received FLURAIX QUADRIVALENT. On an unknown date, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced needle injury and underdose. On an unknown date, the outcome of the needle injury and underdose were unknown. It was unknown if the reporter considered the needle injury to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. Health care professional reports that the needle scratched across the patient's skin. Reporter was unsure if the full dose was administered, which let to underdose.
Fever, and chills for 12 hours. fatigue, brain fog, body aches for three days. Injection site pain for 5 days.
This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 01-SEP-2015, the patient was vaccinated subcutaneously with the improperly stored, second dose of (Merck) VARIVAX (lot number K008823 and expiration date 16-JUN-2016) (dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. The reporter did not know when the patient was administered the first dose of (Merck) VARIVAX. Additional information has been requested.
pt bitten by stray dog 21NOV98 recv vax vax & 6hr post vax T101, pain in both hands, 4th & 5th finger & in, foot complete recovery;
Body aches on 8/15 at bedtime but woke up 8/16 0600 with rash over arms and trunk up to neck and around mouth.
Patient was anxious and reported history of syncope 2 days prior. States he feels dizzy while sitting. His blood pressure was elevated at 179/100 mmHg. Heart rate and oxygen saturation were within normal limits. Retook blood pressure a second time 165/91 mmHg. Third blood pressure 165/87 mmHg. Fourth blood pressure 164/84 mmHg.
Patient passed out or fell asleep.  Once approached he woke up and was shaking for a bit.  He had no issues breathing, no hives, or rash.  Upon awakening he was given some water and quickly recovered.  After a few minutes the patient seemed normal.   We observed him for about another 30 minutes and he continued to be fine.
Severe crying, not sleeping, greenish poop with some mucus, very unhappy baby.
itching at injection site; soreness; sweling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (sweling) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 25-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (sweling).   At the time of the report, INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (sweling) outcome was unknown.      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095685 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095685:Wife's case
Info has been rec'd from Dr's office. It was reported that 4 children who received a dose of Tripedia vaccine (lot # U0583AA) All 4 of the pt's experienced local reactions of redness and swelling. No additional info was provided. A phone call was made to the reporter on 9/12/02, to obtain additional info on pt's. Reporter stated that she does not have any specific information to identify each pt at this time. She agreed to inform the Mfr when the info becomes available. See cases U2002-00697, U2002-00803, and U2002-00805, same reporter.
Around 11:00pm the night of the injection I started to not feel well and so went to bed. That night I was in and out of sleep and was very feverish. Around 3:00 my 12 month old daughter woke up to nurse. I felt so insanely horrible that I opted not to breastfeed, and rather to give her a bottle (which literally quite never happens). Until probably 6:30am, I remained awake, tossing and turning? writhing in pain. My head felt like it was absolutely going to explode and I was having the worst chills. I literally was crying I was in so much pain and was out of my mind with what I was enduring.  I was grasping on to my poor husband for warmth and making meek sounds of utter despair while tossing and turning, feeling as if God?s wrath was striking down on me.    I birthed two babies with no epidural and the pain in my head was comparable, if not more than that.   I got probably an hour and a half of sleep around 0600 and my husband noted that I was ?ablaze? and so put cold washcloths on my forehead and gave me a smoothie, ibuprofen, and water and let me rest . Around the afternoon time I had started to feel a little better, but started to get febrile and not feeling well come ~7:30, and so went to bed early. I felt better on Sunday.
Initial and follow up information has been received from a registered nurse and a 19 year old Hispanic female patient, with no known drug allergies and no past medical history reported, who on Jun 24 2004 at 8:23 pm was vaccinates intramuscularly into the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (lot 645247/1171M). Concomitant therapy included drospirenone (+) ethinyl estradiol (Yasmin). There was no illness at time of vaccination. On Jun 26 2004 at 9:00 am, the patient developed redness, swelling, pain and a low grade temperature. The patient sought unspecified medical attention. At the time of this report, the patient was improving. Upon follow up it was reported that on Jun 26 2004, the patient presented to the emergency room with an abscess of the left upper arm. Subsequently, the patient recovered. No further information is available.
Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine; No adverse event; Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine; This spontaneous case was reported by a physician assistant and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine), PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 19-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine), PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine) 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 assessments were provided for ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine) and PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine).    No concomitant medication was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Live follow up information received: Event (product quality issue) and QE ID no. added.
2 days p/vax pt devel stiff neck,arthralgia "generalized achiness" mid-chest pain & swelling of the gums. No further information was available at the date of this report.
8 Days after my 2nd Moderna Shot, Fatty Blood Clots started pouring out of my mouth(about 50 over a 24 hour period) . There was No cause or affect to it- meaning No cough or Nose Bleeding,etc. I went to emerency room on 03/09/2021 and was admitted for testing. While there they ALSO noticed my heart was Pausing. A 3 day ZIO Test was done. It came back extreme with 39 Pauses and a pulse as low as 35 BPM. A Heart Pace Maker had to be placed in me at Medical CTR on 04/20/2021.
chills, fever, raised, red area at the injection site the size of a baseball one week after the vaccine
Progressive redness, swelling and itching down arm from injection site to elbow. Generalized joint pain by the following day. "Lump" at injection site larger and more painful that usual/expected. She delayed seeking treatment for 1 week. Symptoms slowly resolved. In 1 week she had about 4 cm raised hard tender area at injection site with sl larger area of erythema. Joint pain, rash, and pruritus were resolved.
Headache - felt like a migraine, last 4 days with improvement each day Dizziness / falling / tripping Fever / chills - did not measure Severe swelling at injection site pain in the other arm first 2 days Face / left ear red and burning hot
Petechiae again and was lighter on my abdomen than after the first dose; Petechiae again and was lighter on my abdomen than after the first dose; skin feels a little "hot" in the most intense areas; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date: was not reported), via an unspecified route of administration, in Arm Right on 10Feb2021 at 13:00, (age at vaccination: 73-years-old) as DOSE, 2 SINGLE for covid-19 immunisation. The patient medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included Aspirin (acetylsalicylic acid), cyanocobalamin (VITAMIN B12) and ergocalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to sulfa, relafen, amoxicillin, dodecyl gallate, methyl methacrylate, methylchloroisothiazolinone and methylisothiazolinone. The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date: was not reported), via an unspecified route of administration, in Arm Right on 20Feb2021 at 02:30 as DOSE, 1 SINGLE for covid-19 immunisation. The patient reported that, On the 10th day after the 2nd dose, she developed the petechiae again and this time it was much more and became more intense over 3-4 days and was on her upper thighs in front and inner thighs and to her knees, especially heavy behind her knees and then about halfway down her calf and was lighter on her abdomen than after the first dose. The rash appeared to clear about another 5 days, then began to intensify again, and only began to noticeably clear around day 28. It was now day 30 and was almost clear though the skin feels a little hot in the most intense areas. The patient did not receive any treatment for the adverse events. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Error: Wrong Route (SC, IM, etc.)