chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site soreness; hematoma; muscle in my arm bothers me a little bit when I move my arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jan2021 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site soreness, hematoma, muscle in my arm bothers me a little bit when i move my arm on an unspecified date on 2021. Reported as, "experienced a sore arm after the dose and the sore arm has continued for weeks/still present. muscle in my arm bothers me a little bit when I move my arm. asking if this was normal for the injection site soreness to last weeks. patient also asked if this pain could be related to taking a blood thinner. continues to ask questions about hematoma. she was having, the injection site was sore and she was calling because it was still sore and it has been quite a few weeks. She also mentioned that she is on a blood thinner (unspecified medication) and she asked if that was anything of concern". No treatment was given for the events. Outcome of the event injection site soreness was not recovered and unknown for rest of the events.  Follow-up attempts completed. No further information expected.
Shortly after receiving the vaccine, patient began feeling numbness and tingling down right arm to finger tips and stated that her right arm felt cold.  She also reported a hot flash after receiving the vaccine.  She waited for 1 hour after receiving the vaccine with no reports of improvement but denied any worsening of symptoms.   The RN assessed the temperature and grip of each arm, reporting equal in both sides.
pt recv vax 29JUL96 & 14AUG96 pt exp varicella-like lesions;
Redness local irritation soreness at site. Onset at 3:05 PM. Gave pt cold pack to applyat site for local soreness. Informed pt to notify physician.
Soreness in arm for first 2-3 days Fatigue for 1 week so far, still ongoing
Abdominal pain, vomiting, diarrhea, 12 hrs approx after taking vaccine, went to ER. Then admitted 1 day at a cost of $16,000 for none related (abdominal pain) symptoms. I have no insurance coverage and cannot pay it. The following evening I passed out causing bruises just above my eyes and returned to ER.   11/23 and 11/24/2009 MR and DC summary for 11/1-11/5/2009.
My arm where they gave me the shot ached severely for 48 hours.  Tender from 48-72 hour time period.   I had a slight fever and chills the first night after the shot and had difficulty sleeping.  The next day I was lethargic with slight fever and slept for 13 hours starting at 7PM in the evening.  Two round red dots about 3 inches in diameter, sore and hot to the touch showed up below the injection site after 24 hours and lasted for 72 hours plus.
She received Pfizer COVID-19 vaccine on 12/31/2021. On 1/3/22 she noted a metal taste in her mouth which was followed by severe pain in her mouth. This has slowly started improving, but is still quite painful.
Fluzone administered on 18 February child stated it hurt right after it was given.  Came into clinic on 20 February.  Arm was markedly edematous and swollen from shoulder to elbow.  Free range of motion of shoulder, elbow, and wrist.  The area was NOT WARM.
13MAR2023 COVID-19 Test-Positive. I had the worst muscle and joint pain I have severe felt in my life including the bottom of my feet. No loss of smell or taste. 23MAR2023 rebound included a loss of taste and smell COVID-19 Test-Positive.
vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The BUD date was reported as 08-Sep-2021. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  Date Stored in Standard Freezer for the lot 007B21A was 2 degrees F high, -1 degrees F low on 16-Mar-2020.   Treatment information was not provided.  This case contains information for the 37th of 45 adults described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
1.   Moderate headache starting an hour after receiving first dose; resolved after 24 hours 2.   Mild nausea starting an hour after receiving first dose; resolved after 4 hours 3.   Moderate fatigue starting an hour after receiving first dose and became mild after 24 hours. Mild fatigue still unresolved as of 11Mar2021. 4.   Mild brain fog that started on 10 March 2021 after receiving first dose on 07 March 2021. Still unresolved as of 11Mar2021.
Swollen lymph nodes under both arms, urgent care, referred to ultrasound tech, mammogram, referred to general surgeon (awaiting appointment). Lymph nodes stayed swollen after first dose, got worse after second dose, and have been swollen since.   Swollen lymph nodes in neck, hard to breathe, went to hospital, told it was just the vaccine and to wait it out. Lymph nodes in neck went down in swelling after 2-3 days.  Irregular menstrual cycle, started approximately 2 weeks after first dose. Have had a menstrual cycle for 5 days every 9-12 days since first dose.  Hospitalized for stroke-like symptoms (lost vision, couldn't form sentences) on 5 Feb 21. Discharged after CT scan and MRI came back fine.
Information has been received from a nurse practitioner concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # N022703 and expiration date of 27-FEB-2019, intramuscularly (anatomical location was not reported) for prophylaxis, which was stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 3 hours and 15 minutes. No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.
A couple hours after the shot I became very tired and then began to get a headache. I also became nauseated and had chills. I took Aleve and this helped with the headache. In turn it made me less nauseated as well. I kept hydrating with electrolytes and water.  The next day I woke up in a pool of sweat. I woke up fine but then within a couple of hours became tired and needed to sleep. I started getting a headache once again. I took Tylenol this time and it took longer to feel relief from the headache. I would wake up a couple hours later and feel fine but then get tired once again. I kept hydrating with electrolytes and water.  Sunday morning I woke up feeling fine and a couple hours later became tired. I napped and kept hydrating with electrolytes and water.  I am currently reporting all of this at 10pm Sunday evening.
On Jan 5 had a terrible headache, lasting 2 days.  Cough, chills, general body aches. Next day had terrible bouts of tachicardia (up to 110) with hypotension 90/50, saturation O2 100 percent.  Nausea. Chest tightness, difficulty breathing. By Saturday almost all the symptoms went away. Occasional episodes of tachycardia were still present on Saturday. By today everything is gone, and energy level is back to normal.
Influenza injection administered, within 5 minutes itching at site, at 10 minutes redness and heat noted, ice applied. At 15 minutes 6cm hive at site with nausea and dizziness, 20 minutes felt "woozy". 30 minutes looking pale and having difficulty breathing.  Taken to Emergency Room for treatment.
On 1/16/21 at approximately 8PM  started to experience left axilla discomfort. Initially she thought she may have a muscle strain. On 1/17/21 reports she continued to have left axilla pain and the pain was worse. On 1/18 & 1/19 she continued to experience pain in the left axilla and now in the left arm. The injection site was normal. On 1/20 the pain continued (able to work) and now she had redness and swelling at the injection site. The perimeter of the injection site had plum size redness with some mild to moderate swelling and warm to touch. I instructed to call her PCP that she may be experiencing a localized rxn., to the COVID vaccine. has no other sx.  notified her PCP and has a 3pm, scheduled ZOOM call today.
Headaches   Dizzy  spells/lightheaded Fatigue  Swollen eyelid
Two days after receiving the 2nd Pfizer shot, my daughter said her genital area was sore all day at school. When she got home she looked and saw that both sides of her labia were covered in aphthous ulcers. I took her to her pediatrician who tested her for Herpes even though she is not sexually active. She also referred her to a gynecologist for a second opinion. The gynecologist said they had a case a few months earlier with another 14 year old girl with the exact symptoms, also right after the 2nd Pfizer covid vaccine. My daughter was negative for any STDs and the doctor just recommended baths and topical analgesic to help with the pain. She couldn't urinate without getting in a warm bath due to the excruciating pain. This continued for a solid two weeks before she was able to resume a normal life.
Moderna COVID?19 Vaccine EUA Red, warm, and swollen at the injection site as of 1/21. I suffer from chronic migraine that was in a dormant state for a few months. The Friday after the vaccine my chronic migraine has returned.
Pt called to clinic and states, I was wondering how long the Pneumonia vaccine is suppose to hurt? Pt states, I got the injection yesterday, my right arm hurts, the skin feels hot to touch and it does seem swollen. Pt denies any drainage or known temp. Pt called and report same symptoms on 8/25/10.
This patient was given a Pfizer Booster (0.3ml) and she was 17 years old. The booster is only approved for 18 years and older. It should be noted,  the patient received doses 1&2 on March 31, 2021 and April 25, 2021 at a different facility. She was 16 years old at the time. May 10, 2021 was the date Pfizer was approved for 12-17 years old.  I called  the mother on 11/19/2021, at approximately 7pm, and the mother did not report any reactions from the vaccine.
My arm is swollen at the injection site. This is the second day. The swollen area is approximately 2-3 inches wide and it is warm to touch at times.
No bowel movement or signs I need to go to the bathroom. Feels like concrete there. Which is not usual in my case. Started the morning after vaccination.  Will go to the Urgent care today.
I had chills, severe body aches, head ache, weakness, fever of 100.5. Symptoms lasted around 36 hours.
Per recovery RN notes:  05/10/2021 at 1052AM Patients  female Vaccine time: 1022AM  Symptoms: Patient stated, " I feel like a little lightheaded" Intervention: RN had patient wait an additional 15 minutes and gave her some water. After another 15 minutes patient reported she was "okay" and left the clinic at 1107.
1hr and 5min after receiving Td, c/o L arm itching and rash itching.  Small red raised bumps present (rash).  Benadryl 50 mg prescription given.
Information has been received from a licensed practical nurse concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA000471: US-009507513-1707USA004998: US-009507513-1708USA000472: US-009507513-1708USA000474: US-009507513-1708USA000475:
This spontaneous report was received from a physician regarding a 13 year old male patient. Patient's pertinent medical history, allergic reactions and concomitant medications were unknown by the reporter. On 25-AUG-2016, the patient was vaccinated second dose in a series and the physician was unsure if GARDASIL or GARDASIL 9 was administered intramuscularly (dose, strength, vaccination location, expiry date and lot# were unknown). On 26-AUG-2016, the patient played basketball and experienced muscle pain, weakness and he could not walk. On the same day the patient was moved to emergency room by his family where his laboratory values of electrolytes were normal but his creatinine kinase (CK) was very high. The patient was admitted to the Hospital. The physician felt that the patient had rhabdomyolysis. The patient required intravenous (IV) fluids and his electrolytes remained normal throughout his hospital stay. On 29-AUG-2016, his creatinine kinase (CK) values were normalized and he was discharged from the hospital. The patient recovered from rhabdomyolysis on 29-AUG-2016. Causality was not reported. Upon internal review the event rhabdomyolysis was considered to be medically significant. Additional information has been requested.
Pt recvd 1st dose of Hep B vax w/no noted problem; Pt recvd 2nd dose of Hep B vax 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
tip of their fingers presented concentric ring-shaped marking; Very tender to the touch; This spontaneous case was reported by a patient and describes the occurrence of SKIN REACTION (tip of their fingers presented concentric ring-shaped marking) and PAIN OF SKIN (Very tender to the touch) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SKIN REACTION (tip of their fingers presented concentric ring-shaped marking) and PAIN OF SKIN (Very tender to the touch). At the time of the report, SKIN REACTION (tip of their fingers presented concentric ring-shaped marking) and PAIN OF SKIN (Very tender to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.  The patient had to be treated in the hospital. After 11 months of first vaccination, the patient was interested for second dose.
After second dose I had menstrual bleeding for 3 months. Big clots. I told my regular doctor. He wanted me to go to my gynecologist. I saw a medical perfessional she said it was a side effect of the covid vaccine, and said many women have had this happen, and I was given a pelivc ultrasound and transvaginal scan. I had a 16 mm thickened endometrium. Multiple cycts in my cervix. I have a fibroid. I now need a biopsy of my uterus. I never had any of these problems before being vaccinated. I also have muscle tremors on my right side rib cage. It has effected my daily life due to fatigue and bleeding I have to be in bed alot. I do work part time and it is getting difficult to do my job.
the upper right arm was red and itching , he also received the shingrix  lot # z34g7 first dose on the right arm but no side effect on that arm. was advised to use diphenhydramine 25 mg and if got worse then see medical help by the dr
pt recvd vax & began fussing & crying for 1/2 hrs periods & then would stop for 10-15 mins & start crying again & this lasted from about 3PM until 12MN;
Pt was given two doses of Hib vax (Comvax and Act-Hib) at the same clinic visit. Mother reported fussiness and temperature of 99 that evening. She stated that there was no redness or swelling on legs 04/10 or 04/11. No fussiness on 04/11.
After the vaccine, patient said that his arm was hurting. The morning after, patient started feeling sick, chills, weak. He texted his mom from school. He reported nausea, severe headache, eye pain such that he didn't want to open his eyes, dizziness severe enough for him to need support to walk, weakness, and fatigue. A little after 2 pm on June 30th, he was evaluated in the ER. The abdominal pain he described as centering around his belly button, and feeling worse when he moved or took a deep breath. They noted there was no rash. They diagnosed ?vaccine reaction?. The ER noted  "Nonspecific central and right lower quadrant mesenteric subcentimeter lymph nodes-presumably reactive and potentially reflecting mesenteric adenitis. Otherwise no acute abnormalities". He was in ER for 4.5 hours and was treated with morphine, ZOFRAN, and TORADOL which gave him enough relief for him to be released. He was released with a Naproxen prescription for pain. His symptoms as of 7/19/17 are eyes have been hurting and burning, plus he has been extremely fatigued. He has an appointment with an ophthalmologist to evaluate in a week.
Arms and Legs Started twitching.  Nothing rhythmic, not constant, not seizure like activity, no pattern.  Just occasional twitches that lasted on and off from about 7:30 pm until around noon on 10/30/2009.  Symptoms went away as of now.
The pt experienced hives from the upper arm to wrist of the left arm. He made the statement "I need to get air". The pt was less alert and experienced a low grade fever.
Pt complained of extremely sore arm after the shot. She believed the RPh had administered the shot too high. She was sore that day and the following day. Made appt w/her doctor to see if anything was wrong.
This case was reported by a consumer via call center representative and described the occurrence of confusion in a adult female patient who received Influenza vaccine (batch number unknown, expiry date unknown). Concomitant products included ACTOS, lisinopril and NORVASC. In October 2014, the patient received Influenza vaccine. On an unknown date, the dose was an unknown dose. In October 2014, less than a month after receiving influenza vaccine, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown. The reporter considered the contusion to be almost certainly related to influenza vaccine. Additional details provided as follows: The reporter was the patient's son. The patient's contusion was described as bruising on arms and hands.
Severe headaches that have come and gone over 2 months - pain relievers, headaches are continuing Joint pain in ankles and wrists that continued for 2 months - no treatment, joint pain dissipated after 2 months
Shingles blisters on right leg near the knee.  Sought medical help on 9/2/2013. Taking acyclovir.
I felt fine until 6 the following morning, 2/24. I woke up with a sore arm and arm pit. At 9:30 2/24, I started experiencing severe back pain. I talked to a physician at a clinic my mother works at and they told me to take 800mg ibuprofen and apply heat. By the evening, my back pain subsided. My arm pit however, was still having a lot of pain. I continued taking the ibuprofen to help pain management. I noticed some soreness in my throat as well. I now know that my lymph nodes were swelling a lot and causing the pain. The right arm pit was so swollen I had a lump in it. Today 2/28, the swelling has gone down but I am still experiencing a little pain. Nothing compared to where it was.
Information has been received from a registered nurse (RN) concerning a 25 year old female who on 15-FEB-2007 was vaccinated iM in the left deltoid with a first dose of Gardasil lot # 653938/0954F and on 05-APR-2007 was vaccinated with a second dose of Gardasil lot # 653736/0014U. Concomitant therapy included Nexium. On 05-APR-2007 the patient developed loose green stool, injection site redness and injection site swelling. The loose green stools lasted for 24 hours and then resolved. On 27-APR-2007 patient had an office visit and it was noted that the injection site redness and swelling resolved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 25 year old female patient who on 15-FEB-2007 was vaccinated IM in left deltoid with a first dose of GARDASIL lot # 653938/0954F and on 05-APR-2007, at 1:30 PM was vaccinated with a second dose of GARDASIL lot #653736/0014U. Concomitant therapy included NEXIUM. On 05-APR-2007 the patient developed loose green stool, injection site redness and injection site swelling. The loose green stools lasted for 24 hours and then resolved. On 27-APR-2007 patient had an office visit and it was noted that the injection site redness and swelling resolved. In follow up it was indicated that on 06-APR-2007 patient recovered. Additional information is not expected.
Patient called me on Wednesday 10/26/22 to report they ended up in hospital on Sunday 10/23/22 after recieving vaccine on Saturday( 10/22/22)  . No doctor attributed the vaccine to patients increased heart rate but it was erratic . Patient is now taking  it easy at home and using a walker to steady themselves .
Patient received immunizations on 9/2 and became back to our clinic for an acute visit. Patient had a hard lump and red patch approx 3-4" wide on left leg where shots were given. Area warm to touch.