chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clots in his lungs (After second dose); A spontaneous report was received from consumer, concerning himself, a 71-year -old elderly, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clots in lungs (Pulmonary embolism).  The patient's medical history was reported as unknown. Concomitants reported included Metoprolol, Tamsulosin, Gabapentin, Metformin, Fenofibrate and Losartan for unknown indication.  On 8 Mar 2021 patient received second of two planned doses of mRNA-1273 (Lot number: 040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 18 Mar 2021 patient went to doctor and after some studies that included a CT scan they discovered he had blood clots in his lungs. The event blood clots in lungs (Pulmonary embolism) was medically significant. It was reported that, he was prescribed with a blood thinner for treatment purpose.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, blood clots in lungs was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain in opposite arm, in right arm, from the top of shoulder to fingers that began later that evening after taking COVID booster Pain has continued until now.  Throbs, aches, and keeps me awake a night. Feels like it's in the muscle and sometimes joints. Sore when poked.  Pain goes and comes, but has been persistent, daily, since 9/24/21.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Information has been received from a health professional concerning a 12 month old pt who in June 2005, was vaccinated with a dose of varicella virus vaccine live. It was reported that the baby returned the week of 12Sep05 with zoster on the forehead. It was noted that it was a very mild case with no fever. The physician started acyclovir and the zoster went away. Additional information has been requested.
Exactly 7 days after my first vaccine shot, my injection site arm started itching quite badly. It continued to itch and felt hot to the touch, along with raised/inflamed. By 6 pm on 4/27/21 my arm was incredibly itchy, I had a huge oval shape of redness, itchiness, and it was raised to the touch. This lasted 7 full days. 4/27-4/29/21 were the worse days and it slowly got less red and itchy each day after.
Headache; Arm is sore; Arm pain; Body temperature is low; Took my temperature, my body temperature is 73.8; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore; Arm pain"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "Body temperature is low; Took my temperature, my body temperature is 73.8". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient had the second shot (Pfizer COVID 19 Vaccine) and is looking at the side effects. Patient have headache and the arm is sore. Feel like patient want to 'run it' but and have a arm pain. One of the concern was that when patient took temperature, patient's body temperature is 73.8. Patient wants to know if that is a reason for concern. Patient just took it the previous day and do not have the card. Patient wants to know why body temperature is low.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Phone call from mother stating child's Left upper arm is swollen and feverish.  States lookes inflamed with yellowish skin on top, area 4 1/2 inches long and 4 1/2 inches wide. States has used ice packs and ibuprofen. Mother told to take to MD if continues.
Numbness, Tingling arm, hand, post Hepatitis a vaccine (#1) Medrol dose pack, Naprelan (left arm hand) improving
Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient's original BP was 91/57 and second reading was 92/72. She fainted for less than a minute and regained consciousness. She suffered from severe nausea/abdominal pain and vomited. Patient was given water and felt much better after throwing up. She also complained of feeling tired.
For six days, from my jaw down to my elbow the surrounding muscles were so sore and hard to where I could barely turn my head. The muscle in my neck become to stiff to move. The doctor told me to put heat on it, take Tylenol, and move around. It eventually went away.  The other lingering effect is that random patches of my skin will burn like they are on fire for a few hours. No discoloration or rash. Just hurts to touch.
10-21-13 3 pm HA's, dizziness, weakness, not feeling well. Symptoms lasted -> 10/25/13. 10/25/13 8:30 pm -> developed fast heart rate, increase B.P. and palpitations. Treated at E.R. (hosp) for malaise, weakness.
Patient came to ED with worsening symptoms of Covid including shortness of breath, generalized weakness, cough, and congestion.  She was admitted to the hosptial with Covid pneumonia.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.     No treatment medications were reported.
Patient with positive COVID 19 test after vaccination series complete (breakthrough). ASYMPTOMATIC, prescreening test prior to medical appointments
It was like the first 5 mins my temperature went up by four degrees, my blood pressure go really high, I felt dizziness, lightheaded like I was going to pass out. I had to go to the ER, said my body reacting so quickly because I had COVID a month prior.
Received two shots in R deltoid, believe this is a reaction to flu, not pneumonia based on swelling sites (could be wrong). Day 1: pain increased from dull ache of average shots (two given in same arm) to persistent pain in R upper arm around shot site. Day 2-3: extreme pain in upper arm, thought it was an abnormal sensation with the fibromyalgia, reacting to nerve being hit, bad enough I required narcotics to move my arm at all (Percocet prescribed at 36 hrs after trying previously-prescribed Vicodin), not majorly swollen, did radiate some heat. Day 4: progressed to swollen and red, radiating heat, entire upper arm, not just deltoid muscle, even drew lines around it like cellulitis, no noticeable fever, very painful. Day 5-7: swelling lasted at least two full days before fading very slowly, shrinking in size and color before pain. Day 8: upper arm still tender to the touch but returned to normal, 3 cm lump under flu shot site, minor <1 cm bump at pneumonia shot site, some pain when using the arm, not sure if that's the reaction or just lack of proper use for a week.
Arm was sore as expected.  Woke up the next morning with mild headache at base of skull and muscle ache tightness in upper shoulder.  First dismissed this as "sleeping in the wrong position" or tension from work.  Headache/muscle ache tightness really has not gone away since receiving the vaccine.  Have been to chiropractor 3 times for adjustment with no improvement.
Case previously recorded as MA2009-4544. Case report received from a nurse, on 18 NOV 2009. 16-month-old female patient was vaccinated accidentally with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 102126P1A) on 17 NOV 2009. It was an out of label use because the patient was younger 4 years. No adverse event was reported. Reference no.: NA09-008426.
Hives - 3 or 4 on face; Face was red; Face was hot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives - 3 or 4 on face), ERYTHEMA (Face was red) and FEELING HOT (Face was hot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy, Food allergy, Fish allergy and Latex allergy. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced URTICARIA (Hives - 3 or 4 on face), ERYTHEMA (Face was red) and FEELING HOT (Face was hot). On 09-Feb-2021, URTICARIA (Hives - 3 or 4 on face), ERYTHEMA (Face was red) and FEELING HOT (Face was hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sore Throat; Arm Pain - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) and INJECTION SITE PAIN (Arm Pain - Near Injection Site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and INJECTION SITE PAIN (Arm Pain - Near Injection Site). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and INJECTION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medication were reported.  No treatment information was provided.
Severe Dizziness with injection site pain. No other symptoms. Resolved in 2 days. As reported by patient.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 30th of 104 patients described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area; This spontaneous case was reported by an other health care professional and describes the occurrence of CONTUSION (linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CONTUSION (linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area). At the time of the report, CONTUSION (linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of CONTUSION (linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CONTUSION (linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area). At the time of the report, CONTUSION (linear bruising in groups of four that appeared on her left upper thigh and on the right side around the wrist/ palm area) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Ataxia and dysarthria with brain stem and cerebellar inflammation. No other etiology found with exam. Annual follow up on 02/09/04: "Pt did not recover from adverse events.  Improved, remains ataxic with dysarthria.
Fever developed on 12/19/18 and 12/20/18 on and off, fever reached its highest temperature at 101.4F. On 12/21/18 in the evening around 5:30pm it was noticed that the face had  irritation around the nose and cheeks area. Around 7:30pm the irritation on the face looked more like hives and hives started forming on chest and upper back. On 12/22/18 around 8:00am the hives had continued to spread down her chest, onto her belly and lower back. I called the doctor, scheduled an emergency appointment for 11:30am that day. Around 11:45am I noticed the hives were spreading onto her legs, feet, arms and hands. Around 12:05pm she was seen by Dr. whom said something along the lines that this reaction was extremely rare but typical with the vaccine. She would get worse before she got better; expect it to last 7-10 days; give Benadryl every 6 hours.
23JAN95 coughing,diarrhea,fever (low grade) started APAP was given-coughing & diarrhea got worse-breathing diff,wheezing;29JAN95 hospitalized & was dx w/bronchiolitis
One dose of Pfizer vaccine administered as booster 12/14/21. Menstrual cycle delayed over one month and cycle length 39 days vs normal 28-30. Ectopic pregnancy with possible heterotopic pregnancy diagnosed 2/6/22. First cycle to try for pregnancy immediately after booster.
Pt started complaining of being dizzy and dry mouth about 10 minutes after vaccination. Denies SOB/ difficulty breathing, increased HR, chest pain. No rash or  hives. Patient vitals: HR 84, Resp 18, B/P 160/70, O2 94%, BG 191. Patient specified dizzy when her legs are crossed. Expressed she has not eaten since 6 AM and was sitting in the sun for 1 hour prior to arriving for vaccine. After drinking 2 bottles of water , and resting, patient denied EMS services. PT released.
pt recv vax & grandma noted leg to be blotchy bluish color;4-5 hr later mom was changing diaper & noted diaper area font & back to be bluish tinted like not getting circulation to area;taken to ER;t100, fussy;
Itching tongue and palms, red ears, upset stomach, grandmother stated occurred within a "short" time, pt arrived about 40 mins to clinic with s/s was immediately instructed to go to ER. BENADRYL and steroid packs.
She reports about 5 minutes after receiving the vaccine she went to stand up, felt lightheaded, next thing she knew she was on the ground with staff around her. Of note patient was called as a rapid response initially to the vaccination area.  Few compressions had been done as the nurse who initially noted her to be down had difficulty filling a pulse.  However patient had not lost the pulse. Patient does however report that she did lose some control of a small amount of urine which is never happened her before.  No seizure activity was noted by staff and patient reports no prior history of seizure activity. States that she did used to faint frequently when she was a child in the setting of shot/pain.  But reports she has not had to have vaccinations in many years. Rapid response team came to vaccine observation area and pt went to emergency department.
I've had flu vaccines in the past with NO adverse reactions. The day after this vaccine I started having fever, diarrhea, aches all over, this lasted for 12 days. Since then I have tingling in feet, hands, arms. throat tightening, pain in neck and throat, arms. numb feet.
Patient awakened about midnight with nausea. She took a tums and went to bed. This morning when she woke up she had diarrhea, abdominal cramps, nausea but no vomiting. Muffled hearing. Her whole body went numb and she felt like she had heart burn. They symptoms lasted about 5 minutes. The symptoms have resolved except for the heartburn and chills with waves of mild nausea.
Pulse rate usually 55-57, after vaccination increased to 97. Headaches, Oxygen levels low (90), blood pressure increased to 170/110.
Patient received Pfizer COVID primary dose instead of bivalent booster. Patient to return in 2 months for correct vaccine.