chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced series of drastic adverse reactions; Body feeling hot and cold alternatively; Whole bodyaches and pain; Felt like he was going to die; fever (103 degrees); Chills; Headaches all day; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die) and PYREXIA (fever (103 degrees)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.    On 16-Feb-2021 at 6:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die), PYREXIA (fever (103 degrees)), CHILLS (Chills) and HEADACHE (Headaches all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, ADVERSE REACTION (Experienced series of drastic adverse reactions), FEELING OF BODY TEMPERATURE CHANGE (Body feeling hot and cold alternatively), PAIN (Whole bodyaches and pain), FEELING ABNORMAL (Felt like he was going to die), PYREXIA (fever (103 degrees)), CHILLS (Chills) and HEADACHE (Headaches all day) had resolved.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR received
Swollen, redness, hot-3 inches x 2 inch circle. Received vaccine Monday 9/21/ 2100-> 9/22/ 0000-noticed it was red tender, swollen about 2 inch x 2 inch. 9/23 0000 - redness spreading very achey and painful.
PATIENT EXPERIENCED DIZZINESS AFTER THE FLU VACCINE. THIS WAS HER FIRST FLU VACCINE BUT SHE BELIEVES IT MAY HAVE BEEN DUE TO NOT EATING ANYTHING
Almost passed out within 5 minutes of receiving vaccine. Had 2 more waves of significant dizziness within first 30 minutes after receiving vaccine. Vital signs taken with elevated blood pressure initially. No other treatment given except for a drink of water. Sent home. 2 more instances of severe dizziness with almost losing consciousness after leaving the medical office (All within 1 hour after vaccination). Unable to swallow within 15 minutes of leaving the medical office where I received the vaccine. I went to ER and stayed for 1 hour where inability to swallow subsided. Dizziness subsided with oral Benadryl, although I've had a few dizzy spells since then. February 5, I started having severe left arm pain that was not there previously. I went to Urgent Care 2/12/21 when left arm pain radiated into chest, and I started having elevated blood pressure. My blood pressure was previously under control.  My blood pressure was elevated in Urgent Care. I was placed on short-term Isosorbide 10 mg twice daily. My ECG was normal. I was also placed on Flexeril 10 mg 3x daily for severe left arm pain.
Pt states "I received my second covid vaccine at 3:30pm on 02/25/2021 and I started feeling really tired about 20 minutes later at approx. 3:50pm. I started getting really hot and sweaty. I had my temperature taken and it was fine 97.6. My chest turned really red, and I got really sleepy. By the time I got home at 5:00pm my temperature was at 99.0. I had a headache, muscle aches all over, and chills. That evening my temp was 99.6. I took 500mg Tylenol around the clock. It hurt to move and to get up to go to the bathroom. The body aches have went away but I am still feeling really fatigued today 03/02/2021. I don't feel 100%."
On 02/24/2021, developed headache, nausea, muscle aches for about 24 hours.  On 02/25/2021, left arm developed large red rash area.  The area is hot to touch and swollen.  It is painful with stinging and burning sensation along with itch.  Rash area on left are is spreading.  As of today , 02/27/2021 it is about 4.5 inches by 6 inches.    Doctor appointment scheduled for 03/01/2021.
Patient described "paralysis" of left arm. When patient came in on 07/14/16 pt ROM was restored and pt had swelling and pain of left arm treated with exam and pain medication by FNP.
2 HOURS AFTER THE SHOT SHE HAD MUSCLE SORENESS.  LATER IN THE EVENING A RED BLOTCH APPEARED 2 INCHES DOWN FROM THE INJECTION SITE AND IT IS WARM TO THE TOUCH AND TENDER.  2 DAYS LATER, THE SORENESSS HAS SLIGHTLY RELIEVED FROM , BUT THE REDNESS IS STILL AS INTENSE. THERE ARE NO NON-LOCAL SIDE EFFECTS.
Herpes zoster; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 13-MAR-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient experienced herpes zoster.     As a direct and proximate result Plaintiff had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was assessed as not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Flu symptoms, weak,  nerve twitching, swelling, fever, chills, nausea, pain, headache, very weak pulse, heart palpitations, malaise, rigor, a horrible experience lasted 36 hours.
A pharmacist reported that a male patient received an injection of a pneumococcal vaccine (manufacturer unknown) in 09/2002.  The patient has reportedly experienced an inability to achieve an erection since receiving the vaccine.  No further information was available at the date of this report.
Pt recvd vax & tested pos for HBCAG on 28MAR92 & 14NOV92 did not reproduce the pos findings. p/receiving dose 5, pt developed immunity;
Mom states appx 45 mins after receiving 1st dose of GARDASIL pt developed fever of 105.7; chills, body aches, heart rate to 130's and dizzy. No respiratory distress. Temp decreased w/medication. Temp this am was 99.8.
After shot experienced joint pain, left arm and next day work for two hours tired, weak, left early, second day felt sleepy again and chest pain and pounding heart. Third day came to work felt tired went to emergency room EKG. Fourth day sit down felt drowsy heart complications.
Information has been received from a registered nurse concerning a 42 year old female with no medical history or allergies who on the morning of 6/8/06 was vaccinated SC in the left upper arm with a 0.5mL dose of MMR (lot # 650349/0969R). There was no concomitant therapy. The RN reported that on 6/8/06, the patient experienced sluggishness which got worse in the afternoon. The RN also reported that the patient felt weak, dizzy, disoriented, feverish, had chills and body aches. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. On 6/9/06, the patient felt fine as her symptoms resolved. The RN considered sluggishness, weak, dizzy, disoriented, feverish, chills, and body aches to be disabling as the patient was unable to do anything for one evening. Additional information has been requested.
hurt immediately; huge blob of red; itched; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurt immediately /pain, huge blob of red /vaccination site swelling, itched, unsightly /vaccination site pruritus.  The patient's medical history was not provided. Concomitant medications were not reported.  On 17 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) hurt immediately, huge blob of red, itched, unsightly.  Treatment include, diphenhydramine, itch cream, acetaminophen, Antihistamine  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   The outcome of event(s), hurt immediately, huge blob of red, itched, unsightly was unknown.
pt recvd vax & had inc t for several days, tx w/ apap; also v; 12may94, devel jerking mvt; eyes unfocused; shaking; to er via ems confused; cried for next 15-30min; tx w/ motrin;
Mild rash warm erythematous, non-indurated patch upper 11 cm x 6 cm at (L) deltoid upper area. Also c/o nausea, fatigue, malaise. "I feel sick".
tested positive for Covid-19 and was symptomatic; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for Covid-19 and was symptomatic) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Apr-2021, the patient experienced COVID-19 (tested positive for Covid-19 and was symptomatic). On 29-Apr-2021, COVID-19 (tested positive for Covid-19 and was symptomatic) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive (Positive) was symptomatic.. On 29-Apr-2021, SARS-CoV-2 test: negative (Negative) Normal.     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 were reported. No treatment medication were reported.
Patient reacted within 30 seconds of vaccination. Patient experienced vertigo, sweating, pale, and left side chest pain.
Became very dizzy, fainted, vomited, had severe muscle and joint pain and pain at the injection site. Unable to lift arm above head.
Experienced progressive and worsening pain on Left side of my body at base of skull, side of throat. shoulder, arm and back.  Developed lumps under the skin on throat and shoulder.  Developed pain with swallowing at the top of my mouth to esophagus.  This lasted for 3 + weeks.  I saw my PCP who diagnosed Shhingles.   At present I now only have the lumps under my skin down the side of my throat, pain at the base of my skull and throat.  Skin is sensitive to the touch.  I suffered extreme exhaustion for 3 weeks.  Treated with 7 days of acyclovir, lidocaine pain patches and Tramadol.  Neither the Lidocaine or Tramadol helped.
On 8/4/08 child's aunt called to report child had developed red raised rash after immunizations given.  Reports child had fever (up to 101.4) right after immunizations and a very faint rash soon after immunization.  Reports the past few days child developed red raised rash over "back, front, arms and legs".  Reports child has been traveling with father and has not been seen by Dr.  Reports child had slight fever (not taken) on Sat (8/2/08) but is acting more like himself now.
No additional adverse events reported; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report was received from a nurse regarding a patient of unknown gender an age.    There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   Since 15-NOV-2021, a temperature excursion occurred (until reporting time). On 28-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (formulation, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U015678 which had been verified to be valid, expiration date reported and validated as 18-MAY-2023), as prophylaxis (Improper storage of product in use). The vaccine administered was stored at temperature of 51 degrees Fahrenheit (F) for an unknown time frame. There was no previous temperature excursion. No additional AE details were reported. It was unknown if a data logger was used.
Flu-like symptoms; Ball in the mid part of her foot; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), OEDEMA PERIPHERAL (Ball in the mid part of her foot), PYREXIA (Fever) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), OEDEMA PERIPHERAL (Ball in the mid part of her foot), PYREXIA (Fever) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), OEDEMA PERIPHERAL (Ball in the mid part of her foot), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-035546 (Patient Link).
Fever (first 24 hours) fever subsides, gone by 4 PM 10/08 (Day 2) Still fatigued, not as much as yesterday. Muscle pain and weakness Intense fatigue starts to improve. Rash fading Joint pain    Heart rate normal intense fatigue rash trunk area elevated heart rate, skipped heartbeats.
Myalgia, Arthralgia, Fever & Diarrhea  Narrative:  Chills, fever, muscle aches all over, fatigue, abdominal discomfort and diarrhea.
feeling super sick; like couldn't breathe; Arm swelling in shoulder down the back; Did not complete the vaccination series; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling super sick), DYSPNOEA (like couldn't breathe), SWELLING (Arm swelling in shoulder down the back) and PRODUCT ADMINISTRATION INTERRUPTED (Did not complete the vaccination series) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling super sick), DYSPNOEA (like couldn't breathe), SWELLING (Arm swelling in shoulder down the back) and PRODUCT ADMINISTRATION INTERRUPTED (Did not complete the vaccination series). At the time of the report, MALAISE (feeling super sick), DYSPNOEA (like couldn't breathe), SWELLING (Arm swelling in shoulder down the back) and PRODUCT ADMINISTRATION INTERRUPTED (Did not complete the vaccination series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Information has been received from an RN concerning a 15 month old male pt who in July, 1999 was exposed to shingles but did not develop chickenpox. In November, 1999, the pt was vaccinated in his LA with varicella vaccine. On 1/10/00, the pt developed shingles on his right lateral hip. Unspecified medical attention was sought. As of 1/27/00, the pt has recovered and a specimen is not available for PCR analysis. Additional information has been requested. Follow up provided no additional data.
Full body hives. Started in torso and genitals and worked way through whole body. Did a round of steroids for 5 days. Rash is still present. Zyrtec seems to help relieve the hives and itching. Needs to be taken daily. Without it hives start again. Hives are still present as of 12/6/21. Booster Vaccine is the only thing different in all of lifestyle.
Start of December (cannot remember exact date) patient came and reports that he may have some pain in his left shoulder/upper arm  in the same arm as flu shot he received.
This spontaneous report was received from a registered nurse refers to 15 year old patient of unknown gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 28-SEP-2016, the patient was vaccinated with improperly stored doses of GARDASIL from lot# L035105 with expiry date 14-MAY-2017 or lot # L043213 with expiry date date 28-AUG-2017 for prophylaxis (dose, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information is not expected since no further information was available. Sender's Comments: US-009507513-1610USA009528: US-009507513-1610USA005486.
pt recv vax 21AUG96 & 23AUG96 pt awoke w/a local rxn of a band-like area of erythema & mild discomfort;25AUG96 pt exp profound weakness & myalgia of both arms, thighs & lower back;fatigue & fever 104;
ventricular fibrillation; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for himself. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) , intramuscular in right arm on 06Jan2021 at 08:15 (at 39 years) at single dose for COVID-19 immunization. Medical history included mechanical tricuspid valve (as reported) from 2008 and had surgery in 2008 for a tricuspid valve replacement, had a pacemaker, had known allergies to penicillin and contrast dye and unknown blood clotting disorder (as reported, always in therapeutic International normalised ratio (INR) range). Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), lisinopril and warfarin sodium (JANTOVEN).  On 13Jan2021 at 09:45 the patient experienced ventricular fibrillation, serious as life threatening illness (immediate risk of death from the event) and due to hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and  Emergency room/department or urgent care . Nasal Swab on 06Jan2021 was negative. Blood tests done on 21Jan2021 and on 15Feb2021 were both negative. Clinical course was described as follows: Patient had an unknown blood clotting disorder. INR was always in the range of 2.5-3.5 and he took acetylsalicylic acid (BABY ASPIRIN) 3x/week. His heart was 100% paced via a pacemaker. He had surgery in 2008 for a tricuspid valve replacement. A week after he received the first dose of the vaccine, he had ventricular fibrillation that required 25 min of cardiopulmonary resuscitation (CPR) and 6 shocks via defibrillator. He was in the hospital to have a pacemaker replacement and replaced with a new pacemaker/ICD combo. Prolonged time in hospital related to significant trauma to heart, lungs, and liver from prolonged CPR and collapsed lung after initial procedure. Patient was hospitalized for 13 days. Final outcome of the event was not recovering.; Sender's Comments: Event ventricular fibrillation is more likely related to underlying heart disease and unrelated to BNT162B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
15 minutes after the injection I noticed that my heart was  beating fast and I felt anxious.  When I got up an started walking I felt slightly unbalanced.  15minutes later I felt like my lips were swelling and my throat felt tight. On route to the emergency room my lips , tongue and mouth felt numb and tingling. I arrived at  ER at 0930  and was given IV Benadryl and prednisone by mouth by ER Dr.
Fully vaccinated with Covid vaccine x 3 . Tested positive for Covid on 01/21/2022. Admitted to Hospital on 01/04/2022. Expired on 01/27/2022 while still hospitalized.
running fever of 100.4; real achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running fever of 100.4) and MYALGIA (real achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running fever of 100.4) and MYALGIA (real achy). At the time of the report, PYREXIA (running fever of 100.4) and MYALGIA (real achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had first dose of vaccine 4 days ago.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, vomiting, general body pain and fever. On 28th September 2018, the outcome of the nausea, vomiting, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid. The reporter gave consent to follow up. This case has been linked to the case US2019007967, reported by the same reporter.