chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point), PRURITUS (Right arm was itchy up to two inches below the injection point), ARTHRALGIA (Joint problems) and FATIGUE (felt tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Lymph node dissection (She had some lymph nodes on her right arm removed about 40 years ago.). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point), PRURITUS (Right arm was itchy up to two inches below the injection point), ARTHRALGIA (Joint problems), FATIGUE (felt tired) and LYMPHADENOPATHY (Lymph nodes in the neck were also swollen). On 25-Jan-2021, PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point) and PRURITUS (Right arm was itchy up to two inches below the injection point) had resolved. At the time of the report, ARTHRALGIA (Joint problems), FATIGUE (felt tired) and LYMPHADENOPATHY (Lymph nodes in the neck were also swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included Voltaren and heat application.
This spontaneous report as received from a Licensed Practical Nurse refers to a 48 year old female patient. On an unknown in January 2013 date the patient was vaccinated with ZOSTAVAX (strength, route, dose and lot # were unknown). No adverse effects reported. Additional information has been requested.
Rash; This case was reported by a physician via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The field representative was notified by a physician that the patient experienced a rash for 2-3 days after receiving Shingrix. The caller was a field representative and did not have additional details.
Swelling within 15 minutes of injection, progressing to dark bruising in distinct rectangular pattern on arm below injection site and above the elbow over next 2 days. Patient did not complain of pain initially.
Eyes dilated, loss consciousness for 20 sec. opened eyes then lost consciousness again for 10 sec, arms drew towards chest as if having seizure and some shaking. Unaware of her location when became conscious again. Diaphoretic and nauseated.
This prospective pregnancy report as received from a physician refers to a 15 year old female patient with no pertinent medical history and drug reactions / allergies. First dose of VARIVAX was administered in 1999. On 19-MAY-2014, the patient was vaccinated with the first dose of GARDASIL lot#H020901, expiration date: 05-JUL-2015, dose 0.5 ml, intramuscular. On the same day (1-MAY-2014) the patient was also vaccinated with second dose of VARIVAX lot#J007019, expiration date: 05-JUL-2015, dose 0.5ml, subcutaneous. There was no concomitant medications. The physician stated that at the time of the patient's office visit, patient was unable to produce a urine sample and was not tested for pregnancy. The physician reported that she has discovered that the patient was approximately 18-20 weeks pregnant at this time, and would have been pregnant at the time of vaccination. The reporter stated that "the patient has been unable to undergo ultrasound as of yet to determine more specific gestation, but stated patient had planned to determine pregnancy but may be too far along with her pregnancy to do so. The patient became pregnant with LMP of approximately January 2014 and EDD of approximately October 2014. On 11-JUN-2014 the patient was seen in Emergency Room (ER) with complained of cramping, no specific treatment provided other than recommendation for follow up appointment at her Obstetrician/Gynecologist OB/GYN. The patient was seen at OB/GYN office on 12-JUN-2014, treatment unspecified. Cramping had ceased as of the 12-JUN-2014 OB/GYN appointment. The relatedness between cramping and vaccination with GARDASIL and VARIVAX was not reported. Additional information has been requested.
"Head rush" sensation followed by visual disturbance/kinda double vision. Visual disturbance lasted a few hours and then went away. Hospital tested for several things and found nothing.
The pt experienced redness 2 1/2 x 2 inches to the left thigh, starting immediately post vax becoming larger during remainder of the day. Mom had problems with immunizations as a child with an allergy to pertussis. Child was given Motrin for 2-3 days. Redness persisted. Seen by MD on 5/4/00.
Dizziness; Redness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), TENDERNESS (Tenderness) and DIZZINESS (Dizziness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Erythromycin), Allergy to antibiotic (Other mycins), Drug allergy (Hydrocodone) and Drug allergy (codeines).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (Redness) and TENDERNESS (Tenderness). On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, ERYTHEMA (Redness), TENDERNESS (Tenderness) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  The patient post receiving their first Moderna vaccine developed redness and tenderness. The patient also experienced dizziness at night.   No Concomitant product use was reported.  No treatment information was provided.
First dosage had fever, arm pain at the injection site, followed by menstrual cycle while on Mirena IUD and had not experienced a period in years. Now I have a period every month since the vaccine.
Restless legs syndrome started as a consistent nightly issue interfering with my sleep on 08/02/2021. Saw primary care physician about this on 08/05/2021, who assessed that it was restless legs syndrome. Shortly thereafter, I reported to the CDC v-safe tool that I had a change in medical condition since getting vaccinated, referring to the onset of RLS.  Primary care physician prescribed over-the-counter 400-500 mg magnesium glycinate as an initial attempt to treat the restless legs syndrome. I was told this can help with sleep and anxiety. Primary care physician also noted that sertraline and other SSRIs can cause RLS as a side effect, and asked me to continue to work with my therapist on my anxiety, and if the RLS symptoms persist, we can consider another medication instead of sertraline or start medication for RLS.  However, I have not started taking magnesium glycinate or looked into alternatives to sertraline or any RLS medications, as the RLS symptoms seem to have since mostly subsided on their own. The symptoms are not gone 100%, but they no longer interfere with my sleep.  Before 08/02/2021, I would occasionally have RLS symptoms sporadically as well, but not in such a way that it interfered with my sleep, so I never reported it to a doctor until it began to interfere with my sleep. The symptoms nowadays seem to have returned to what they were like before 08/02/2021 - sporadic, infrequent, and they don?t interfere with my sleep.
The patient's mother communicates with the pharmacist of the pharmacy at 3:07pm on Monday, December 20, 2021, indicating that the patient presented a rash after administering the vaccine. She sent a photo to the pharmacist on her cell phone, and the rash that the patient presented were plates on both arms. The pharmacist tells him to take the patient immediately to the emergency room to be administered medications by vein, to counteract the effect of the vaccine.
leg tingled; Body ache all over; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (leg tingled), MYALGIA (Body ache all over), CHILLS (chills) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (penicillin-rash). Concomitant products included LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In March 2021, the patient experienced PARAESTHESIA (leg tingled), MYALGIA (Body ache all over), CHILLS (chills) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (leg tingled), MYALGIA (Body ache all over), CHILLS (chills) and FATIGUE (tiredness) had resolved.
Client states R. arm was sore x5 days following injection. States soreness then radiated into back muscles.  States he has seen a M.D. and a homeopathic for this incident and is currently participating in physical therapy for past several weeks.
1 week after shot pt developed a rash on abdomen and back and fever. Mom reports 102 F.
Severe pain in the left hip, groin and leg, lack of mobility and flexibility, stiffness, extreme constipation with  discolored stool and mucus after taking any form of laxative, weight loss, intermittent clamminess and warmth throughout the body
Information has been received from a licensed practical nurse concerning a 68 year old male who on the afternoon of 8/23/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647635/0864N). The LPN reported that on 8/24/04, at 3:30, the patient developed coughing and  two hours later developed a fever of 103F. Unspecified medical attention was sought. The patient was subsequently hospitalized as a diagnosis of pneumonia was made. The patient was treated with IV antibiotics and was discharged from the hospital. After discharge, the patient subsequently recovered from the pneumonia. Additional information has been requested.
Disorientation/ confusion, day of vaccine, no treatment, went away after day 1; Day 3 after vaccine, itchiness on right side of body, neck, mouth, and throat/ throat started to close up/ rapid heart, Benadryl taken once, still itchy around outside of mouth
delayed cutaneous hypersensitivity reaction. hives on stomach and rash on back. Hives sore to the touch. Onset one week after shot Onset 7 days post vaccination. Rash lasted 3 days. the bumps on the skin are still present at time of second dose vaccination but are no longer sore.
Patient is a seventy-nine yr/o female who presents with gross Hematuria. She states last night she noted bright red blood in her urine. Today it has been dark brown intermittently.  She is chronically anticoagulated on warfarin.  Denies any abdominal pain or flank pain.  No fevers or chills.  Reports urinary frequency and urgency but no dysuria.  History of UTI 4 years ago treated with Cipro, but no chronic kidney or bladder problems.
BACK PAIN; FEVER; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and back pain was not reported. This report was non-serious.
after scheduling her second dose appointment patient reported feeling lightheaded, was sitting on the floor. Moved patient to an exam room for privacy and elevated her feet. She asked to lie down because she was getting ready to pass out and then did. Patient was out for approximately 1 minute, was snoring. Applied a sternal rub and eventually patient came to. Patient was very disoriented afterward and discovered patient had urinated. Patients husband was with her, but in the parking lot, brought him in. She reports a history of fainting. BP 134/87, pulse 77. Patient also reported nausea, but states she had not eaten this morning because she doesn't normally eat breakfast. Gave patient a coke to sip on. Patient was recovered when she left.
Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code blue was called, and the patient was taken to the emergency department for further workup. In the ED, the patient was evaluated for hypertension and chest pressure and subsequently discharged after a negative workup (normal EKG, normal troponin). On 1/17, the patient returned to the ED with complaints of numbness in the left arm from fingertips to elbow, with sensation slowly returning over the next 10 minutes.  A head CT scan was performed, showing bilateral acute on chronic subdural hemorrhage (possibly related to fall patient reported having on 12/5/20 down 10 steps of stairs). The patient was eventually discharged on 1/19.
Extreme pain in injection site for a week.  Felt nauseated and had a headache 10 days after shot.
This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 28Mar2017, at single dose, for immunisation. Medical history included blood cholesterol increased. Concomitant medication included NEXIUM, from an unspecified date and ongoing, for acid reflux. The patient previously took Aspirin and experienced drug intolerance. The patient experienced pain in arm like if had just gotten the injection/ woke up with the arm pain on 29Mar2017 with outcome of unknown, flu symptoms on 30Mar2017 with outcome of not recovered, nausea on 30Mar2017 with outcome of not recovered, lost 10 lb on an unspecified date with outcome of not recovered, muscles hurt on 30Mar2017 with outcome of not recovered, no appetite on 30Mar2017 with outcome of not recovered, joint pain on 30Mar2017 with outcome of not recovered, lethargic on 30Mar2017 with outcome of not recovered, arm still aching on 30Mar2017 with outcome of not recovered, hot and cold chills on 30Mar2017 with outcome of not recovered. On an unspecified date the patient underwent lab tests and procedures which included blood test: it came wonderful.
Soreness and swelling at the injection site that lasted 4 days. Muscle and joint pain, headache, shivering, fever, fatigue, dizziness. These symptoms lasted 24 hours.
Incorrect dosage given. Should have received 0.5ml of Moderna blue cap booster dose. Patient received 0.25ml. Patient made aware of error. Not experiencing any adverse effects. Patient is not interested in receiving second half of dose. No other complaints.
Immediately after I had neck pain, aches, and chills. The next day I started itching without hives, mostly on my head and face. November 4th, 2021, I started having chest pains and difficulty breathing, heart palpitations, and random stabbing pains in my stomach and legs.
Vaccine dose leaked out onto patient; Vaccine dose leaked out onto patient; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine dose leaked out onto patient) and DEVICE CONNECTION ISSUE (Vaccine dose leaked out onto patient) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced UNDERDOSE (Vaccine dose leaked out onto patient). 13-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Vaccine dose leaked out onto patient). On 13-May-2021, UNDERDOSE (Vaccine dose leaked out onto patient) and DEVICE CONNECTION ISSUE (Vaccine dose leaked out onto patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Large local reaction, 3x4 cm wheal, developed within 18 hours of vaccine adminsitration.  No systemic or airway symptoms.  Treated with Benadryl and cool compresses
This is an initial report of an AE, received on 18Nov2016, for Protein Sciences Flublok. A 52 year old female received Flublok Intramuscular on 11Nov2016. On 11Nov2016, the same day after receiving Flublok, the subject began experiencing an adverse reaction which included redness and erythema to the arm and face, as well as redness and swelling to the face. The patient reported these symptoms to the reporter on Monday 14Nov2016, by then, the symptoms were subsiding. The reporter would like to be contacted regarding this case so as to further advise the patient on subsequent use of this vaccination and other influenza vaccine. No further details were available. At the time of the report, the events of redness and erythema to the arm and face, as well as redness and swelling to the face were resolving. Medical or surgical history for the subject included an egg allergy. Concomitant medications were not reported. Additional information has been requested.
we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (we had a few patients that were vaccinated with a vaccinethat was 40 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  It was reported that there were no adverse events reported with this event.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up information received contains non significant information.
Received vaccine on Wed 11/6, and on Thur 11/7 experienced body aches, fatigue, vomited once, feeling flushed and warm but didn't have a fever (took temperature it was normal, this lasted till Friday afternoon.
Began having noticeable muscle pain in my chest in the first part of 2/2021. I continued to think it was just muscle pain. Symptoms worsened with severe sharp/stabbing pain with movement and breathing that radiated to my back. Went to the emergency room 3/7/2021. Dx of multiple small pulmonary artery webs that may represent sequela of pulmonary thromboembolism. There is also a 2 mm nodule in lower R lobe of lung.  Eliquis dose increased to 10 mg BID x 7 days then decrease to 5 mg BID.
Bilateral lower extremity weakness with areflexia: Suspected Guillain-Barre Syndrome-presented to ED 10/21/19 Seen in ED 10/10/19 with lower extremity swelling bilaterally When came to ED on 10/21/19 reported progressive weakness on her legs. D/C note states had weakness x5 days when presented Completed 5 days of IVIG on 10/26/19 Hypokalemia 2.9 on date of presentation
The day of the vaccine I was fine but the next day when I woke up I noticed I had a cramp in my arm and it was sore. By Noon I had a a general headache and felt alittle body ache. Next day I woke up and had extreme body aches all over. I started to get very nauseous, began vomitting and had diarrhea. I broke out in a fever running a temp of 100-102. Took Tylenol and Advil every 4 hours. I had brain fog as well. This all lasted about 3 days. It just started to clear up. I still have all over body aches and am still not able to go to work. When I take a deep breath my lungs now hurt and burn. I am calling my doctor to see what I should do.
Moderna vaccine was administered to this patient (under the age of 18) on 04/20/21  in error. Patient denied adverse reaction when error was identified on 5/18/21.
Noticed pin pricking sensation & raised bumps on R buttocks since evening of 7/14/08.  Rash is circular & "tender" - pin-prick sensation continues & is generalized.  Also c/o feeling hot to touch - (patient's complaints).
Approximately 10 minutes after vaccine, patient was feeling "odd" and asked for water. He had sweating and then a chill. Checked his BP and it was low, systolic 99. After about 5 minutes of speaking to patient, re-checked BP and it was 113/89. Patient was feeling much better.
10/19/18 received vaccine "high" left deltoid with sharp immediate pain, but OK. Every day since then worse pain at site, no obvious swelling, bruising, couldn't visualize injection site but tender high deltoid, then self-limiting range of motion related to pain. No fever, no rash. Initial arm pain eval in Employee Health on 11/08/2018, diagnosed with sub-deltoid bursa inflammation and referred to PT for further eval and treatment. 11/27/18 Pain ongoing, PT ongoing.
Mother called 02/06/19 at 8:03AM stating that daughter awoke from a nap on 02/05/19 and refused to stand of walk. Nurse asked if mother had moved daughter's legs, and mother states that she did, and gave her acetaminophen, but no relief noted. Nurse checked with supervisor and called mother back, stating to follow up with pediatrician. Mother called nurse back at 11:05AM and stated that her daughter is now started to stand and walk.
24 hours after vaccine bright red, rash appeared-very hot to touch @ site, itching 19X10cm rt hip.
Heart palpitations starting about 2 hours post-vaccine, lasted about for 5 hours. HR was 120-140 per my Apple Watch. Resting HR is 70, I was laying down, no strenuous exercise. I also felt exhausted.
After second injection, fever, muscle aches, fatigue followed by a large inflamed lymph node under left arm. Enlarged lymph node lasted ~2 weeks.  Otherwise healthy yet had an ischemic stroke on 22Aug2021.
5/13/02-mother noted right face swollen. Taken to ER. diagnosed right parotitis, prescribed Augmentin in 250 mg PO BID X 7d.