chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 3 month old patient of an unknown gender. On 05-FEB-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
sudden severe h/a w/dizziness @ 7PM;vomited 7:05;fell into deep sleep 7:15;vomited when sat up to awaken @ 7:30;vomited 5 times from 7-8PM each time was moved;deep sleep between vomit;h/a & dizziness cont
ADMITTED TO HOSPITAL ON 8/21/21 FOR CENTRALIZED ABDOMINAL PAIN TIMES 4 DAYS.  LAPAROSCOPIC EXPLORATION SURGERY WAS PLANNED.  NO OTHER SYMPTOMS ARE NOTED.
Pt rcv'd vax 1/21/2000. Devel classic herpes zoster rash on L hip and thigh.
pt recvd vax; 30 mins later devel fever 105.8; shivering w/ convuls lasting 3 mins;evaluated by paramedics;
6 to 8 weeks pregnant, suffered miscarriage, due date October 2022, Symptoms included severe abdominal pain, respiratory distress, fluid on lungs, severe menstrual cramps and bleeding.
Sore injection site beginning last night. This morning, woke up with chills, began feeling "feverish" throughout the day. Pt took Excedrin prior to calling.  Vaccine Administration dates: 1/06/2021, 02/02/2021
Large swollen area, approximately  2 inches below injection site, hot, hard and red, and very itchy.   Began regimen of Ibuprofen, antihistamine tablets, betamethasone cream.  The  affected area is resolving, slowly.
burning; she had an allergic reaction to Imovax; It started under my armpits and moved to my heart. I had a rash under my armpits; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old patient who received a unknown dose of vaccine RABIES VACCINE [IMOVAX VACCINE], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that having like burning inside. It started under my armpits and moved to my heart, had a rash under armpits. Doctor did not think that it was related to the vaccine. Had a fever of 99.2 which was a fever for me. My heart was palpitating and I went to the ER and they put me on a heart monitor for 2 weeks. Going to have an echocardiogram to see if the heart was damaged. Still had heat in heart and armpits that was not to the same degree as it was 3 months ago, but it was still there. Three months in after getting my last shot at while at a physical (on 25-Sep-2019) temperature was 99.2 and then it would go down to 98.6 or 98 point something and began breaking a little. Normal body temperature was in the 97 degree range. Under arm pits and between the arm pits and back was really hot and that was where my heart was. This area was still really. Have to wear hair in a bun and off neck because it would start sweating there if hair touched it. Had no treatment for this. Have not had Tylenol or Ibuprofen.  At the time of reporting, the patient had adverse event.  The batch number information was requested.
Patient sustained febrile seizure one day after receiving vaccines as listed above. Patient did not have any other illnesses present at this time.
Passed Out; Possible Seizure; Swollen Tongue; itchines; Headache; shivering; shaking really bad; A spontaneous report  was received from a nurse who was a 42- year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness.  The patient's medical history was not reported by the reporter. Concomitant medications were not provided.  On 19-Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-Jan-2021, 24 hours after vaccine administration, the patient reported that she was shivering and shaking really bad and had a headache day afterwards.  On an unknown date, she reported that her tongue was swollen. She also reported that the she passed out and doesn't know if she had a seizure (date unknown). The patient reported that she took ibroprophen for her headache and diphenhydramine for itchiness.  On 28-Jan-2021, she reported that she felt fine.   Treatment for events included ibroprophen and diphenhydramine.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of events, experienced some side effects was unknown, shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness, were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the information provided and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Headache and chills are consistent with the known safety profile of the vaccine
This spontaneous report was received from a 25 year old female patient via Company Representative. On 05-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date not reported). Other suspect therapies included a dose of GARDASIL (dose, route, lot # and expiration date not reported). It was reported that the patient felt sick after receiving 4 vaccines including GARDASIL and PNEUMOVAX 23. The patient felt sick on the night of the vaccination but recovered later. Additional information is not expected.
At approximately 3:45pm on Tuesday, January 5, I developed a sore throat, chills, sore neck, and headache. These symptoms resolved by the following morning. Again on Wednesday, January 6, at approximately 3:30pm I developed the same symptoms. Again they resolved by the morning. Today, January 7, at approximately 4:15pm I developed the same symptoms. Each time my temperature has been no higher than 98.8. I went for a rapid and PCR COVID test on the evening of Tuesday, January 5. Both tests came back negative.
8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registering in ER tachycardia. Throat mouth dry and tight change to hoarse voice lightheaded. EpiPen administered. Ekg done.   Other meds provided: 500 ml saline bolus. Famotidine, prednisone, benadryl    Angioedemia and readmittance to ER approximately 18hrs later: prednisone,epipen, benadryl iv and po, famotidine, saline bolus
redness, swelling, painful to move;fever, chills, nausea, gen body aches x 24hrs to 72hrs in length
The patient experienced severe shoulder pain the morning after getting both immunizations. He could not lift his arms, therefore he decided to visit the doctor who prescribed MEDROL DOSE PAK. Patient states that the steroids made him feel better.
Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (pulse 72). O2 sats 93% and 95%.
Difficulty swallowing within minutes of vaccination.  no progression of this symptom and also developed a mild headache to base of skull.  chest feels a little tight.  12.5 mg of Benadryl given about 30 minutes in to observation.  After another 50 minutes, headache gone, chest pressure less, and swallowing improved.  patient advised to return to ED if symptoms returned or worsened.
Patient called two days after receiving her second covid vaccine and said her arm at the injection site was warm, swollen, and red. I recommended that she take ibuprofen and benadryl to see if that helps but to also follow up with her doctor. Her doctor called back and said they were closing for the day but want her to follow up with urgent care.
Information has been received from a health professional concerning a 81 year female pt with unspecified allergies who in November 2003, was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reaction which included injected site swelling, soreness and erythema. She was treated with Benadryl and cold compresses. As of 03DEC2003, the pt's adverse events abated. There was no product quality complaint involved. The reporter indicated that three other patients and had similar experiences following exposure to dose of pneumococcal 23v polysaccharide vaccine. Additional information has been been requested.
COVID Bivalent given as a first dose in vaccine series.  No adverse reactions to report.
Patient developed a cellulits from the injections. Her arm was red and swollen, tender to touch 20cmx9cm area.
PT CAME IN 2 DAYS LATER AND SHOWED ME HER ARM. IT WAS SWOLLEN AND RED AND HOT TO THE TOUCH. SHE SAID IT STARTED THAT NIGHT. I WOULD OF SENT HER TO THE DR. BUT SHE SAID IT WAS LOOKING BETTER AND NOT AS SWOLLEN. I TOLD HER TO TAKE BENADRYL 50 MG EVERY 6 HOURS, AND TO ICE BACK EVERY 2 HOURS.
Tongue felt numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tongue felt numb) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Tongue felt numb). At the time of the report, HYPOAESTHESIA ORAL (Tongue felt numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
pt recvd vax 8AUG94 & had sx of achiness, swollen glands, fever, dizziness; 2nd day post vax felt better for awhile; 3rd day cheeks flushed-vomited, rash on cheeks, nose & chest; dx poss scarlet fever; hands & feet cracked & bleeding;
Patient had a syncopal episode while driving, colliding with a telephone pole, flipping the vehicle on it's side.  He was transported to local ER for evaluation, blood work, radiographs, EKG, EEG, CT scan, ultrasound.  He was hospitalized for 24 hours and no other cause for the event was found.  Stress test and cardiac monitoring have also not revealed any other cause.  He continues to be evaluated.
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, (Lot # L006181, expiration date 13-DEC-2016), doses were not specified. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Pt. received vaccines on 1/7/10 and was found unresponsive in crib on 1/28/10. Autopsy showed pt. died from Fibroelastosis of the heart.
This spontaneous report was received from an unknown healthcare provider via a physician and a company representative, who referred to an unspecified group of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. On unknown dates, the patients experienced a slight headache, were disoriented, very tired, their arms swelled up from the injection site down to the elbow and were red and very painful after receiving ZOSTAVAX. The unknown healthcare provider reported that this happened all the time to patients at their clinic after getting the vaccine. The outcome of the reported events was unknown. No product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA009805:
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
3/5/2021 APPROX 3:30 PM, ITCHING RASH STARTED ON RT. ARM, TO NECK, CHEST, SHOULDERS, STOMACH, HIPS, LEGS; DIZZYNESS, BACK PAIN,  HEADACHE THEN ESCALATED TO POUNDING SEVERE HEADACHES, PRESSURE ON LEFT EYE, AND BEHIND RIGHT EAR. DURATION FROM 3/5/3/7/2021, ITCHING STILL CONTINUES MOSTLY AT NIGHT
Experiencing COVID ARM (rash/redness / itchiness on my left arm) Also, full body skill feels itchy
I went to my regular doctor visit for my cholesterol, and I did a calcium scoring test. They found neuroendocrine tumor in my left lung. I also had all my COVID-19 vaccines in my left arm. On the 24th I had CT scan on the chest, and they saw the same neuroendocrine tumor. I was schedule for a lung biopsy, and it was determined that I had a rare tumor. I referred to a cardiothoracic surgeon 09/20/2022 and she did a breathing test. Then the surgery was scheduled on the 09/29/2022 and they removed all the tumors.
Heart racing; Stomach ache; Weakness; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness) and CONFUSIONAL STATE (Confusion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness) and CONFUSIONAL STATE (Confusion). At the time of the report, PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Stomach ache) and CONFUSIONAL STATE (Confusion) outcome was unknown and ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not used. Treatment medication was not used. The patient did not remember all the symptoms.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Moderna COVID-19 Vaccine EUA   I experienced body aches, headache, nausea/diarrhea (both came on 48 hours after the vaccination), on and off low grade fever, chills, tenderness to injection area, tiredness.  Taking OTC tylenol and rest has been helping
Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of Gardasil (Lot # 0530U).  There was no concomitant medication.  On 21-SEP-2007 the patient developed a rash and had itchiness over her body.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.  Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of GARDASIL (Lot # 0530U) intramuscularly in the right arm.  There was no concomitant medication.  On 20-SEP-2007 the patient developed raised colorless macules over her arms and chest for three days.  The patient recovered from this adverse event.  On 21-SEP-2007 the patient developed a rash and had itchiness over her body. Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested.
Patient did not recognize her own dog, then didn't know who she was.  Taken by husband to ER and was admitted for transient global amnesia.  Symptoms resolved by the next day and she was discharged.  All testing reported negative by patient, but I do not have any hospital records at this time. Of note, patient did have her initial dose of Augmentin 875 mg and Sudafed 30 mg at 3:00 PM that day, 1 hour prior to onset of symptoms.
dose 4 (booster); dose 4 (booster); COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FR4856) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Apr2022, outcome "unknown" and all described as "dose 4 (booster)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, the events Drug ineffective and Covid-19 is assessed as related to the suspect drug Comirnaty.
headaches, mild but moved around mostly on right side; moderate to at times severe joint pain in hips, knees and hands. Headaches started 12/25/20 and continue today 12/28/2020. Joint pain started afternoon of 12/24/2020- was worst 12/26/2020 but some relieve with high dose ibuprofen.  Still joint pain and stiffness, mostly in hips, knees, lower back and hands.
Mother noticed the patient's injection site becoming red, swollen, and warm. Area of redness and swelling measures approximately 7 cm and is round.
I developed a rash on my hip. It was about 2 inches in diameter with approximately 10 puss-filled bumps. They eventually popped or subsided and I was left with what looks like blood blisters. The area was itchy with a bruise-like or prickly pain in and around the area.
Developed RLE pain and swelling on Friday. Progressed over the weekend. Evaluated on Tuesday. Found to have distal DVT. Started on anticoagulation.
No adverse effects. Patient was given wrong vaccine (varivax). Provider, patient and mother was notified of the error. Correct vaccine (MMR) was then given.
Really severe joint& muscle pain in shoulders, hips, knees.  Similar to  arthritic pain
Fatigue, Headache, Muscle pain, Joint pain, Chills/sweats, Nausea/vomiting, hard time sleeping, very sever migraine ( rescue medication didnt help)
Hospitalization: 2/21/2023 - 2/23/2023 (2 days) Presentation to the ED: multiple syncopal episodes  COVID + date: 2/21/2023 Treatment: none. Discharge to: home.  002A21A 2/24/2021 017B21A 3/29/2021
After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced shortness of breath like I'd run a mile. Breathing so heavily, when I got to car, had to wait 5 mins before I caught my breath.  Stopped for errand & had same experience.  No other symptoms until next night at 012:15 on 01/24/21 when i woke with shortness of breath, clammy, nausea, heart skipping beats, BP 178/106.  Went to ER.  Had EKG, check xray,troponin levels checked 6 hrs apart.  All were negative.  Released.  Since that time, I continue to have:  chills, no temp, shortness of breath, fatigue, mild headache, sore throat, runny nose, occasional nausea.  Went for Covid test 02/04/21  Results were negative.  Just began feeling more normal today--2 weeks after innoculation.
Pt's left arm instantly had sharp shooting pain. Red and swollen 1 day after vaccine was given. Pain, redness and swollen continue for 2 weeks. A bruised developed at the injection site 2 weeks after vaccine and is still present today 10/03/2023 (the  bruise is around 1.5x0.5 inches).  Pt received a steroid pack on 09/25/2023 and the shooting pain went away. However the bruise is still present and the injection site is still bruised and tender to the touch.
pt recv vax & 4hr later became pale & lost consciousness, & became apneic;pt was adm to hosp;MD believed had aspirated something;workup was non-diagnostic;pt was d/c w/an apnea monitor
This spontaneous report as received from a pharmacy technician regarding of unknown demographics. There was no information about concurrent condition and historical medication. On 22-SEP-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # L007720/ expiration date- 08-JUL-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information is not expected as reporter does not wants to get contacted.
Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pain in left side; Dizziness/lightheaded; Left side of face swelling; Lips and tip of tongue numb; Itchy around injection site; Swollen throat; Left eye discomfort/swelling; Tension pain in left side of neck; This is a spontaneous report from a contactable Consumer, a patient. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EL9266), via an unspecified route of administration in the Left arm on 20Feb2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID 19 immunisation. The patient's medical history included Asthma. The patients' concomitant medications were not reported. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck. The patient did not receive any treatment for the events. The clinical outcome for the events arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck was recovered. No follow-up attempts are needed. No further information is expected.
May 20. Diarrhea headache fever chills Since last shot mild dizziness slight nausea almost every day.
pt recv vax & exp pain & soreness radiating down arm, on the same side as inj; pt also exp redness & edema down arm & felt hot;