chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness; injection site is itchy, red, and hot; injection site is itchy, red, and hot; injection site is itchy, red, and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is itchy, red, and hot), VACCINATION SITE PRURITUS (injection site is itchy, red, and hot), VACCINATION SITE ERYTHEMA (injection site is itchy, red, and hot) and VACCINATION SITE PAIN (soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site is itchy, red, and hot), VACCINATION SITE PRURITUS (injection site is itchy, red, and hot) and VACCINATION SITE ERYTHEMA (injection site is itchy, red, and hot). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness). At the time of the report, VACCINATION SITE WARMTH (injection site is itchy, red, and hot), VACCINATION SITE PRURITUS (injection site is itchy, red, and hot), VACCINATION SITE ERYTHEMA (injection site is itchy, red, and hot) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.   This case was linked to US-MODERNATX, INC.-MOD-2021-071274 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071274:crosslinked
pt recv vax & devel a fever & a varicella type rash, greater than 100 lesions w/pruritus;
Pt developed a fever 2 hours after vaccination. Fever of 100-101. Vomited 3 times total. Once at night of 10/26/10 & 2 times morning of 10/27/10.
Patient received monovalent instead of the intended Bivalent (pt has already received 3 injections of the primary - monovalent)  no adverse side effects known
Moderna COVID-19 Vaccine EUA. Approx 10 hrs post-vacc, sore arm & feeling that my body was "fighting something" (much as after other vaccs/inf post-BMT (shingrix, reclast). At 12 hrs post-vacc, feeling feverish, chills, body aches, trouble sleeping, temp=98.6, pulse=72 (unusual for me. Normal vitals: temp=97.2 to 97.5, pulse=55-62). Trouble sleeping throughout the first night, only 5 hrs sleep maximum. Next morning, at 23 hrs post-vacc, continued trouble sleeping, body aches, chills, sore arm, temp=99.7, pulse=90 (at complete rest, very unusual for me). FYI, i was well hydrated. At 27 hrs post-vacc all same symptoms plus headache, significant malaise, brain fog, remained in bed all day, temp=99.5, pulse=75. Fever.....Fever broke at aprox 35 hrs post-vacc, began to feel a bit better, temp=98.7, pulse=78.  At 38 hrs post-vacc (4/10 at 2:00am), i got up from bed to pee, feeling alot better & vitals approaching normal, temp=97.8, pulse=58.  At 43 hrs post-vacc (4/10 @ 9am), feeling tired but otherwise recovered, vitals back to my normal ranges: temp=97.2, pulse=56.  FYI, after dose #1 of Moderna covid-19 vacc, i had sore arm, mild feeling that my body was "fighting something," and trouble sleeping the first night, but NO fever and no other adverse symptoms.
A mother reported that her daughter, now 14 years old, received TD vaccine in 1998 and subsequently, developed an upper respiratory tract infection. She recently developed cold symptoms that the reporter believes are related to previous vaccine administration. The adolescent was seen by a physician and received testing for allergies and blood work. MCV and MCR were reported to be elevated and allergy testing results were unknown.
Flu shot administered R shoulder deltoid IM. Soreness in R deltoid and trapezius muscle began that day. Progressed and continued to shoulder pain and numbness/tingling R shoulder area and upper arm muscle spasms along with R bicep area. This is day 14 and symptoms not letting up. Infection Preventionist notified.
Initial information has been received from a female whose husband on 12-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 16-NOV-2007 the wife developed shingles.  It was reported that the shingles were initially located around her right torso, nerves 8 to 2.  The patient had symptoms of tingling, numbness and burning, and was hospitalized.  The patient had no lesions.  The symptoms had spread down her leg to her foot.  The patient had no history of shingles.  The patient was treated with VALTREX.  At the time of the report, the patient had not recovered.  Additional information received from the patient indicated the physician's assessment determined that she did not have shingles.  Follow up information from the patient's physician indicated that the patient's neurological symptoms had been diagnosed as probable multiple sclerosis.  Current patient status was not reported.  No further information is available.
Reports tongue started feeling thick, throat felt slightly tight, numbness in lips. Benadryl 50 mg given orally. Symptoms improved and then resolved before leaving the site. VS remained stable.
Patient came in for 4 month f/u appt. Pt given flu vaccine at 09:30am during this appt. Pt kept in exam room for 15 min following vaccination to monitor for possible reaction. Pt went back to lab for bloodwork and started c/o red bumps on both lower forearms. Dr. observed and prescribed 125mg SOLU-MEDROL and 25mg BENADRYL. Immediately given in left deltoid. Pt became pale and diaphoretic. Blood sugar taken, was normal. Pt taken to exam room. Vitals and EKG obtained. 2L O2 administered via nasal cannula. BP and pulse low. 1mg epinephrine given. IV started with normal saline. EMS called. Pt's BP and pulse still no improvement. Another 1mg of epinephrine given. EMS arrived and patient transported to hospital.
Administered adult dose of Hepatitis A (Havrix) instead of pediatric dose to pediatric patient. This was realized 5 minutes after patient had left while charting. Notified Public Health RN who advised that patient should only experience increased tenderness and swelling at injection site and possible fever consistent with routine side effects of immunizations. Notified patient's mother and discussed possible increased tenderness, swelling, and fever, and advised home care. Incident report filed, nursing supervisor and patient's PCP notified.
Pain & bruising at injection site. Pain in both shoulders, neck, hips & low back. Still painful as of 07/02/2016.
pt recv vax & devel blanching, erythema, tenderness @ deltoid inj site;no fever, no induration;otherwise well;onset w/in 24hrs of inj;
Stress; Rapid heart beat; Cold; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (Cold), STRESS (Stress) and HEART RATE INCREASED (Rapid heart beat) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold) and HEART RATE INCREASED (Rapid heart beat). On an unknown date, the patient experienced STRESS (Stress). At the time of the report, NASOPHARYNGITIS (Cold), STRESS (Stress) and HEART RATE INCREASED (Rapid heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Heart rate: 105-107 (abnormal) 105-107 BPM (beats per minute).     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.   The patient's medical history was not provided. No concomitant medications were provided.  The patient was lying in dark calm environment to reduce stress. Treatment for the cold included cough medicine and steroid.   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.; Reporter'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.
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  The Chief, Medical Staff and the Commander were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
After I got my second dose, I experienced light headaches. As time went on, I developed a lump on my right breast in the area of my lymph nodes, also. When I took my third dose of Pfizer in 12/2021, the light headaches became severe. I was given prescription ibuprofen to take as needed, and it helps. The frequency of the headaches varies. Sometimes I might get one during a week and then two during another. They just come on. I'm having the lump in my breast monitored. I undergo mammograms every six months. It hasn't grown. The doctor says that it's not cancerous, but they are keeping an eye on it. The doctor says that she has seen other women come in with similar lumps, and she thinks it could be linked to the COVID-19 vaccine. The lump is tender to the touch, and the doctor thinks it could be a fatty lump.
Marked viral cellulitis at primary vaccination site on left deltoid with autoinnoculations to left chest and left wrist.  Fevers and adenopathy also present
Same day arm hurt really bad, started getting the chills, felt run down, mild fever. My arm hurt for about 3 or 4 days. The flu symptoms were mostly gone in 2 days. Then 2 weeks later, I wake up dizzy and having balance issues. Gets better the longer I sit up. Continues for 4 days. Then the next day after the dizziness I start having nausea and trouble eating. Couldn't really drink diet pop any more. Only really water. Couldn't eat much without feeling sick until dinner time I could eat a slightly bigger portion. Water gave me heart burn. Some things I use to like to eat now sound reclusive. Another episode of dizziness about a week and a half after the nausea started. That was a bit more mild and lasted 3 days. Nausea and trouble eating has gotten better but still is an issues to this day. Started having episodes that felt like low blood sugar but took my blood sugar and it was fine. Had random episodes of light-headedness. When the nausea first started I didn't feel dizzy but foggy or off in my head. Sometimes trouble tracking a conversation. Now dizziness is back and happening throughout the day and getting headaches
A couple hours after the vaccine I developed a high fever about 101.7 fever and shakes and was extremely cold which went on about a week.  After that week my body seemed very weak causing me to see my Cardiologist and my TSH level was extremely high.  I was referred to my Thyroid Dr who did another test and see the TSH level was still extremely high.  I was then referred to a Rheumatologist and who advised I have Sjogren's Syndrome and prescribed me Hydroxychloroquine 200mg to help with the pain.  5/12 about 1:30am the joint pain and fever begin coming back again and took 2 Tylenol to help with the pain.  The pain is has now gotten a little better and is now about a 7 but the pain keeps coming back, the fever keeps coming back and I continue to feel down each day and I have to take Tylenols daily to help with the pain, but after 1hr after I take the Tylenol I go into a massive sweat and my body gets soaking wet.  An X-Ray of my the right side of my lung  was done and noticed the right side lung is now almost about 30cm smaller than my left lung and a CT Scan has been ordered 11/7 to check that further.
administered / liquid component /without the Lyophilized component; administered / liquid component only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA519A, expiry date 30th April 2022) for prophylaxis.   On 12th August 2021, the patient received Menveo. On 12th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that, they inadvertently administered the menveo, liquid component only to a patient without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
he is got like a crawling feeling on his face and his head; He started having pins and needles in both his hands and feet; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 18Apr2021, outcome "unknown", described as "He started having pins and needles in both his hands and feet"; FORMICATION (non-serious) with onset 19Apr2021, outcome "unknown", described as "he is got like a crawling feeling on his face and his head".  Additional Information: The patient got the Pfizer shot on Friday (16Apr2021). Yesterday (18Apr2021), he started having pins and needles in both his hands and feet and today (19Apr2021), he got like a crawling feeling on his face and his head. The patient asked if he should even get the second one though he was having this reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Localized swelling, redness, soreness in arm with each Anthrax injection, worsening headaches, chronic fatigue, myalgias, arthralgias and night sweats since 4/98. Had (+) PPD 9/97 with 6 month course of immunizations. Initially, thought symptoms were due to INH; now thinks are due to Anthrax.
Pt was sent home from school on 02/15/2001 with suspicious bumps on her torso. The next day she broke out with the chickenpox. Her siblings have not as yet shown any symptoms of the chickenpox.
ANAPHYLAXIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry date: UNKNOWN) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had anaphylaxis post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210335633-Covid-19 vaccine ad26.cov2.s-Anaphylaxis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
It started out as a rash and then it turned into hives and then water blisters and now I'm stuck with an autoimmune disease called bullous pemphigoid which is common for people in their 60 and above and I'm only 36 years old I have been to 6 different hospitals since I got the COVID vaccine and they have me on steroids antibiotics and pain pills and it's not getting better and now I can't work in the public because I'm supposed to be in a sterile inviroment at all times and I'm in pain all the time.
Infant received MMR and Varicella vaccines on 08/20/01. On 08/27/01, she developed a rash spreading over her body. On 08/29/01, developed fever of 102.2; by 08/31/01, rash and fever resolving, but vomiting from 08/30/01 - 08/31/01.
Pt devel flu sx 3 days p/immun; t100 (R), runny nose, bad cough, poor appetite, erythema @ site, tender to touch;
Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions; We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H11A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions).    No relevant concomitant medications were reported.   We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions. Data shows the vaccine was below 36F for a total of 166 hours. The minimum temperature reached was 31.658 F. The vaccine was above 46F for a total of 67 hours. The maximum temperature reached was 50.234 F. Lot 023H22A was delivered on 11/10/22, 11/14/22, and 11/15/22. Lot 041h11a was delivered on 11/22/22. Product was not used after 12/6/22. This is for a fridge excursion only.  No treatment information was provided.
started with a knot and pain in her injection site and redness. Fever appeared 12 hours after injection, never higher than 100.1 F. The redness has continued since, but the fever has subsided. She has taken tylenol, benadryl and applied hydrocortisone cream to the area.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II(albumin status:rHA) lot # M000768, expiration date 05-JAN-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine had been stored under the lowest temperature 49.3 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Follow-up information received on 05-DEC-2016. On 05-DEC-2016, a call was placed to the Medical assistant who stated that she would research and send in the patient identifiers and dates of vaccination. No additional information is available.; Sender's Comments: US-009507513-1610USA004834:, MERCK 1609USA013240:Mfr number.
pt recv vax; six days later, pt exp breaking out in 10 varicella like lesions;
moderate swelling and redness of left upper arm where vaccine was administered, no other symptoms, improved and much better after 3  days
Patient had severe weakness, legs felt numb and paralyzed. This lasted for 3 weeks. Patient says her Dr told her it was rhabdomyolysis.