chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP reported about temperature excursions with freezer in the facility. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.   The vails were stored in Frozen state.  No treatment information were reported.
Pt recv vax on 11/30/98; on 12/1/98 pt exp coldness, fever; on 12/2/98 pt exp hotness; collapsed; pt died
Vaccination site presented with rash, itching, and warmth 48 hours after injection. Rash size diameter of approx. 4.0 inches; Itching, warmth, and redness is disappearing, beginning February 23, 2021. No other adverse affects noted.  Husband (age 80) received the same dosage at same time with no adverse symptoms to date. Patient (Reporting Party ) is a Licensed Registered Nurse.
Day 0: fatigue, sleepiness, and emesis Day 1: fatigue and baby is moving less than usual  Treatment: Tylenol 250 mg on day 1 Time course: TBD
hematoma at their injection site; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Deltoid Left on 08Jul2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, as single dose for covid-19 immunisation. Pharmacist reported that she has a patient (female, no age provided) who received their second Pfizer Covid vaccine dose on 08Jul2021. The patient has had a hematoma at their injection site (left deltoid) since that date (08Jul2021). The patient feels that since there was a hematoma, that the vaccine went into their blood vessel and not into their muscle tissue. The patient wants to know if they need to be revaccinated since there is a possibility that the vaccine could be less effective if it went into the bloodstream and not the muscle tissue. The outcome of the event was reported as unknown.   Information on Lot/Batch information has been requested.
No additional AE reported; HCP reports patient was accidently administered an expired dose of MMR II on Apr 19, 2022. Product expired on Apr 14, 2022.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On 19-APR-2022, the patient was accidently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) once (lot #T012808, expiration date: 14-APR-2022) (expired product administered) for prophylaxis (formulation, strength, and route of administration were not provided). The product had no known temperature excursions. No additional adverse event (AE) was reported (no adverse event). No product quality compliant (PQC) reported.
Cardiac arrest. Presented via EMS after niece found her unresponsive at home. Per EMS patient was hypotensive with blood glucose of 450 in the field. She was then given 1 L of IV fluids with improvement in her blood pressure. On Arrival to the ED patient was noted to be in a wide complex rhythm with initial blood work showing hyperkalemia. Patient subsequently had a cardiac arrest and was treated with epinephrine, bicarbonate therapy, calcium, insulin with ROSC 6 minutes.
Pain in the underarm area and extending to chest area. Tenderness in underarm. This is after my first shot, which I received in my left arm. The tenderness and pain are on the same side
I was on a mission trip and started having achiness, sore throat, severe headache, fever and cough. On Jan 12 & 13. I took home test and it was positive. On the 15th I got tested and it was positive. On, the 17th I traveled home, with a letter stating I could with an N95 mask. On the 18th when I was back home, I took another in home test and it was positive. On the 19th my symptoms began to get better. However, I still have a cough. Though a lingering cough is not unusual for me. I only took Tylenol.  On Dec 15th I received Hep B and Typhoid  vaccinations so I could go on my mission trip.
Information has been received from a registered nurse concerning a 4  year old patient who on 05/14/98 was vaccinated with a dose of Varivax  (sitte Unknown) Subsequently, the patient developed chicken pox. The reporter indicated that there was  a chicken pox breakout at a day care in her area. It was reported on 01/04/02 that 15 children had developed chicken pox since the end of 12/01. The first onset date was 12/31/01 and the last was 01/03/02. The number of lesions were reported to be unknown. It was also reported that 7 of the children were vaccinated with Varicella virus vaccine live (WAES 0201USA--351, 0201USA999755, 0201USA00757, 0201USA01038, 0201USA01039, 0201USA01041). Additional information has been requested.
Seen on 3/8/07 and rec'd 4 yo boosters Dtap, MMR, IPV. Woke up 3/9 with swollen L arm 3/12 fever 101.5
Interchange of vaccine products; Brain damage; Digestive issues; Brain fog; Anxiety; Depression; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 10Oct2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from a contactable reporter (consumer) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "COVID", start date: Apr2020 (unspecified if ongoing); "Long haul COVID", start date: Apr2020 (unspecified if ongoing); "Type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: MODERNA COVID-19 VACCINE (as dose 1, single), for COVID-19 immunisation; MODERNA COVID-19 VACCINE (as dose 2, single), for COVID-19 immunisation; BNT162B2 (as dose 3 (booster), single), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; BRAIN INJURY (medically significant), outcome "unknown", described as "Brain damage"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Digestive issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog"; ANXIETY (non-serious), outcome "unknown"; DEPRESSION (non-serious), outcome "unknown". Clinical course: The patient had COVID in Apr2020 and since then has had long haul COVID.  After having COVID in Apr2020, she had two primary COVID vaccines of Moderna, two Pfizer COVID booster vaccines, and one Pfizer COVID bivalent booster vaccine. She had some side effects after the second Pfizer COVID booster, but it was very mild. Initially, she had mainly digestive issues. She also experienced brain fog, anxiety, depression, and brain damage (as reported).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201218327 same patient and drug, different dose and event;
Burning rash all over my body appeared next morning after vaccine administered and is continuing to worsen.  Urgent care prescribed an antihistamine and asked that I report it
Heart Burn; Nausea and Vomiting; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heart Burn), NAUSEA (Nausea and Vomiting) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPEPSIA (Heart Burn), NAUSEA (Nausea and Vomiting) and VOMITING (vomiting). At the time of the report, DYSPEPSIA (Heart Burn), NAUSEA (Nausea and Vomiting) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
It started with a sore throat that was raw. I developed a really bad headache and a low-grade fever between 99.9-100.1. I tested positive for COVID-19 on December 06th. I went down to the clinic, but I was not able to be prescribed Paxlovid due to my medication. I was advised to take over the counter medicine like antihistamines and cold medicines. I thought I was over it around December 30, 2022, because I was starting to have real issues breathing which was alarming for a heart patient. The hospital advised me that I did not have COVID-19 at the time of I was hospitalized. I thought I was having a heart attack. My blood pressure was 202/101 when I arrived at the hospital. I was admitted and spent the next 24 hours being medicated to help with my blood pressure. My lungs were severely inflamed from COVID-19, and I was having issues breathing. I stayed another 24 hours and then I was prescribed multiple anti-inflammatory medication and an antibiotic. I'm out and I am walking and back to riding my bicycle. I think I am over the COVID-19, but the lung damage is still there. I am being checked every 3 to 6 months by the cardiologist. I have also spoken with a lung specialist via a video conference. It's unfortunate that some of us who cannot take the Paxlovid due to prescribed medication because the people most vulnerable are unable to use.
Severe swelling in the area of the left clavicle at the supraclavicular lymph nodes. The swelling is severe, painful, and causing pain to shoot down left arm and into finger tips at times. Cannot lay on left side at night when sleeping due to severe pain and pressure that starts in the clavicle area and shoots down arm and into finger tips. On the morning of October 8th woke up with swelling on back side of left arm, in armpit area, and also in the left groin area, but not severe like the clavicle region.  Currently using warm compresses, Motrin ranging from 600mg to 800mg taken twice daily. Also have applied KT tape with the hope that it will help relieve some of the inflammation. Currently waiting to see if swelling will go down and not sure what outcome will be at this time.
weak; sore/Still hurting; triggered her menstrual cycle even though she is postmenopausal; feels awful; nauseas; Injection site is itching; Injection site is red; hurts like she was punched; chills; headache/terrible headache; very tired; swollen like a baseball; bottom of feet hurt; swollen; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (sore arm), PAIN (sore/Still hurting) and PAIN IN EXTREMITY (bottom of feet hurt) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (bottom of feet hurt), SWELLING (swollen like a baseball), FATIGUE (very tired), CHILLS (chills) and HEADACHE (headache/terrible headache). On 15-Apr-2021, the patient experienced ASTHENIA (weak), PAIN (sore/Still hurting), MENSTRUAL DISORDER (triggered her menstrual cycle even though she is postmenopausal), FEELING ABNORMAL (feels awful), NAUSEA (nauseas), VACCINATION SITE PRURITUS (Injection site is itching), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE DISCOMFORT (hurts like she was punched). At the time of the report, ASTHENIA (weak), PERIPHERAL SWELLING (swollen), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (bottom of feet hurt), MENSTRUAL DISORDER (triggered her menstrual cycle even though she is postmenopausal), FEELING ABNORMAL (feels awful), SWELLING (swollen like a baseball), NAUSEA (nauseas), FATIGUE (very tired), VACCINATION SITE PRURITUS (Injection site is itching), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE DISCOMFORT (hurts like she was punched), CHILLS (chills) and HEADACHE (headache/terrible headache) outcome was unknown and PAIN (sore/Still hurting) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-077767 (Patient Link).
Patient called back stating that arm was hurting to move after administration of vaccine. Felt like the shot was administered too high and thinks the arm might be dislocated and out of socket.
patient fainted ( syncope)  after standing up  post vaccination about 7-10 minutes after the vaccine. we then had him lie down  while calling 911. Emt came around 5 minutes later stating he was mostly dehydrated. They gave him an iv of saline and took him to the hospital.
heavy flu-like symptoms; lousy; shaky disoriented; disoriented; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (heavy flu-like symptoms), MOOD ALTERED (lousy), NERVOUSNESS (shaky disoriented) and DISORIENTATION (disoriented) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (heavy flu-like symptoms), MOOD ALTERED (lousy), NERVOUSNESS (shaky disoriented) and DISORIENTATION (disoriented). On 28-Jan-2021, INFLUENZA LIKE ILLNESS (heavy flu-like symptoms), MOOD ALTERED (lousy), NERVOUSNESS (shaky disoriented) and DISORIENTATION (disoriented) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications reported were medication for prostate, medication for helping him urinate, medication for thyroid. No treatment information was provided.
Diaphoretic, weakness. Seen by EMS.  Discharged home at 11:15 A.M. Recorded by RN.
1 of 5 pts w/in a 3 wk period who exp cellulitis following vax devel 5cm x 5cm induration & erythema; no ATB given; react resolved 5 days later;
Local reaction - rash on bilateral thighs - hip to knee pinpoint papule rash - no redness or swelling - similar papules under chin and around neck similar to heat or contact rash.
08/26/22 presents to ED for " increased drainage from her JP drain" "recent LHC with PCI and subsequent R femoral artery injury leading to hemorrhagic shock necessitating operative repair"  PMHx of "hypertension, t2dm, CAD"
About 9 days after my first shot I started feeling cramps and like I had to urinate even after I just had. Then a few hours later I spotted menstrual blood. I thought was probably passing more kidney stones since my period isn't supposed to occur for another 2 weeks. Then the next day I made sure to check where the blood was coming from and discovered it was indeed menstrual blood. The blood only comes when I use the bathroom and isn't a ton but since my usual periods usually flow hard and fast, like 3 days max, this is obviously more than an early period- which I do not have. I am quite predictable.  This is the most significant side effect innmy opinion. I also had an emotional outburst, probably harmonal and definitely not usual for me. I am on day 4 or 5 of spotting. Hopefully it won't last too much longer.
Stomach hurt; covid symptoms; Head hurt; arm is swollen and sore and the size of a golf ball; Severe pain in arm; shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt), PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball), COVID-19 (covid symptoms), PAIN IN EXTREMITY (Severe pain in arm) and CHILLS (shivering) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm) and CHILLS (shivering). On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt), COVID-19 (covid symptoms) and HEADACHE (Head hurt). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt), PERIPHERAL SWELLING (arm is swollen and sore and the size of a golf ball), COVID-19 (covid symptoms), PAIN IN EXTREMITY (Severe pain in arm), CHILLS (shivering) and HEADACHE (Head hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment details were provided.
Mother states that within a week after getting the vaccines, patient started complaining of frequency in urinating. Hence, parents took him to MD; blood drawn an was hospitalized.  07/23/2007 MR received for DOS 7/10-12/2006.  Pt presented with several day hx of polyuria, nocturia, and polydipsia.   Consult with DX of Type I Diabetes, newly diagnosed. Txd with sliding scale insulin with good response. D/C DX: Acute new onset diabetes, currently nonketotic.
Patient was taken to the hospital on 3/15/21 at 8am for Atrial fibrillation.
Right arm redness, rash spreading, arm tender. Warm compresses, ibuprofen as needed area marked with permanent marker. Educated Pt regarding signs/symptoms to report.
Symptoms began about 5 hours after the application of the vaccine and consisted on: fatigue, headaches and  high resting hearth palpitations. During the night and the day after (Friday 04/02) symptoms worsened especially heart palpitations being all day above 120  up to 135 per minute. At moments it was difficult to breath and talk. By the end of the day I also experienced chest pain and signs of low oxygen (blue lips and pale colors) as well as mild fever. After calling paramedics, I was transported to the ER where blood, urine  and Covid test were performed. I was told that some values of the blood test could suggest a blood clot so a CTscan was also performed with negative results. After a few hours in observation with infusion of fluids, potassium and magnesium  I was sent home. Saturday and Sunday (days 3 and 4 after the vaccine) symptoms improved however heart palpitations were higher than normal and I still experience mild fever (98-99F). Insomnia and fatigue persisted for two more nights. Finally today Monday April 5, I could say that I feel back to normal.
Information has been received from a nurse concerning a 56-year-old patient who on 17-NOV-2008 was vaccinated with a dose of 0.5 ml PNEUMOVAX (lot # 658673/0990U, route and injection site unknown).  Concomitant vaccination included a separate injection of influenza virus vaccine (unspecified).  Subsequently the patient experienced an abnormally swollen arm at injection site, described as "worst they have even seen, and over the entire arm".  The patient sought unspecified medical attention.  At the time of reporting, the patient's symptom improved.  Follow-up information has been received from the nurse concerning the patient, who was a 56-year-old female with no known relevant medical history.  On 17-NOV-2008 she was vaccinated with the first fose of PNEUMOVAX (lot # 658673/0990U) via subcutanous route in her right arm.  Concomitantly she also  received a yearly dose of FLUZONE (lot # U2771AA)  IM in her right arm.  On 20-NOV-2008, the patient experienced intense swelling, redness, local pain and itching.  The are affected had a size of a hand.  It had  sharp line of demarcation and was erythematous.  She was treated with  ALLEGRA 180 mg and AUGMENTIN 875 mg.  No laboratory tests were performed. On an unspecified,date, the patient recoreved from the events. This is one of several reports received from the same source.  No further information is available.
Patient notated that they sometimes gets dizzy or faints when getting vaccines. Before giving the vaccine, patient began breathing heavy and felt cold and clammy to the touch. I gave the vaccine and immediately following, patient seemed fine. They stated that they started feeling a little dizzy. I had them sit with me in the immunization room. After about 6 minutes, they began slouching over, eyes wide open. I called them by name, but they did not answer me. After a few seconds they became responsive again and did not remember what happened. I checked their bp at 12:03 it was 88/53. I asked the if them would like me to call an ambulance but them declined. I checked their bp 15 minutes later and it was 125/83. They  stated that they were feeling better. We waited for a few minutes and I asked them to sit out front of the pharmacy for an additional 15 minutes. They stated they were feeling normal, and when I went out to check on them a few minutes later, they had left.