chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack; little red trail in her vision right after she looks outside; were in pain or anxiety; headache is very severe; numbness; tingling around the rightankle", " needles and pins; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00183340 and 058A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), TEMAZEPAM and SUMATRIPTAN for an unknown indication.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) (seriousness criterion hospitalization), ERYTHROPSIA (little red trail in her vision right after she looks outside), ANXIETY (were in pain or anxiety) and HEADACHE (headache is very severe). At the time of the report, CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack), ERYTHROPSIA (little red trail in her vision right after she looks outside) and ANXIETY (were in pain or anxiety) outcome was unknown and HEADACHE (headache is very severe) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Took migraine medicine for headache (medicine name is unknown)   This case was linked to MOD-2021-308647 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received included concomitant medication, second dose details, laboratory data and new events was added and action taken was updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.
Information has been received from a registered nurse concerning a 6 year old female who on 12/03/1997 was vaccinated with a dose of varicella virus vaccine live. On 02/14/2002 it was reported that the pt "now has chicken pox (100-150 lesions). The pt sought unspecified medical attention. Additional info has been requested.
Horrible body aches, fever, arm pain and swelling. Fatigue where I cannot get out of bed. I cannot sleep due to body aches. I have a high pain threshold and this is unbearable. I had Covid back in July 2020 and this is just as bad now as it was then.
2 weeks after the vaccine was administered, the patient reported the injection site to have a red area of approximately 2 inches by 4 inches. The site was also tender, slightly raised and warm to the touch. First thoughts were an infection, but it does not appear to the care giver like an infection. It was decided to monitor the site, and report to primary care provider if site becomes worse or more debilitating.
8 hrs after vaccination - chills, shivering, headache, followed by hot flashes, night sweats, and myalgias
10 cm oval area of warmth, erythema and edema right deltoid and similar 8 centimeter area left deltoid.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:26 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 80.20.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-APR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-AUG-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes shingles. The patient was prescribed acyclovir and prednisone for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Woke with headache. Saw flashes in eyes, then a sizable eye floater in right eye, near the center of my vision. Continue to see flashes randomly. First eye floater ever.
Pt got the shot on 10/1. Sometime afterward about a week he broke out with a case of shingles.  He came to our store to get 2 medications to help shorten the case of the virus. He did not go to the original store that he got the shot. He is not upset and would rather have a minor case of shingles rather than get a full blown case. I am not sure when he showed signs of illness and you would have to contact Dr . to find that out.
The day of the injection and the next I had a little pain, the area around the swollen and itched a little, ihe red are turned into a bump the night after, but then went away. Today, 8 days later the area has swollen again and is red and s little itchy. the arm feels a little weighted too.
Headache and fatigue one hour after the vaccine. Terrible chills where I could not get warm starting two hours after the Vaccine. Also starting three hours after the vaccine I had extremely painful muscle aches and pains. Bruise at injection site and swollen arm. Excruciating pain in both arms and both knees. When the leg pain started, it started behind my knees. I was in tears for about 14 hours in excruciating pain due to the muscle aches and I am still having random hurts of sharp muscle and joint pain.
VACCINE (FLUCELVAX) WAS GIVEN BY MISTAKE TWICE ON THE FOLLOWING DATES: 9/10/2021 AND 10/16/2021. PATIENT WAS CONTACTED BY PHARMACIST. HE REPORTED NOT HAVING ANY SIDE EFFECTS.
loss of appetite; back pain; Felt wobbly; sore arm; body stiffness; body aches; dizziness; headache; Trouble sleeping; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 22nd January 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever and chills. On 23rd January 2020, the patient experienced appetite lost, back pain and unsteadiness. On an unknown date, the outcome of the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness to be related to Shingrix.  Additional details were received as follows: About 4 hours later, the patient experienced a sore arm, body stiffness, body aches, dizziness and headache.  Later in the day, about 8 hours later, the patient had trouble sleeping, had fever and chills.   The next day, 1 day after administration,  the patient had loss of appetite, back pain, and felt wobbly.  At time of report, patient reports symptoms are slightly improving. The reporter did not consented to follow up.  The reporter did not wish to provide demographic information and lot number was not known.
suffered herpes zoster and vision problems.; suffered herpes zoster and vision problems.; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles (herpes zoster).After receiving Defendants' zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered herpes zoster and vision problems. As a result of these symptoms, Plaintiff was seen and treated by medical providers and was still under their care. As a direct and proximate result of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), Plaintiffs sustained severe and permanent personal injuries. Further, as a tragic consequence of  wrongful conduct, Plaintiffs suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiffs have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The lawyer considered herpes zoster and vision problems to be related to zoster vaccine live(ZOSTAVAX).   The lawyer considered the reported events to be disabling.
Vaccine administrator distracted, had husband and wife in room, both getting Corminaty and Fluzone High Dose, gave patient two doses  of Corminaty in both right and left arm, realized error and vaccinated Fluzone High Dose posterior to Corminaty vaccine in right deltoid. Contacted PCP to inform. Will follow-up with patient tomorrow to see how he feels.
Ever since I got the vaccine I have felt like I'm going to jump out of my skin. My anxiety level is very high and at times it is debilitating. I also had a debilitating headache for 3 weeks and the inflammation in my body was astronomical. I'm still suffering from inflammation and quite uncomfortable at times. I had an irregular heartbeat for several weeks. Also the vaccine brought me out of menopause. I had my period every two weeks (3 times). And now my periods are back and longer than they were before. My asthma is at its worst because of the inflammation. I am uncomfortable on a daily basis because of the anxiety that has come with this shot that will not go away. It is a daily occurrence.
Initial information received on 14-Jun-2018 in the United States regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 12-month-old patient (gender was not reported), who was vaccinated with a dose of ACT-HIB (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to expired vaccine used because expired dose given to a 1 year old patient. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown. On 27-Jan-2022 at 11:55 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022 at 11:55 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27-JAN-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient received vaccine past its 30 day. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it's manufacturing expiry date of 04-Apr-2022. This case was linked to MOD-2022-542869 (Patient Link).
Redness and swelling at injection site of VARIVAX also associates with localized itching. Began day after shot was given. Improved with BENADRYL po and cool packs.
Information has been received from a 21 year old female with no medical history or no drug allergies, for the Pregnancy Registry for GARDASIL, who on an unknown date was vaccinated with the first dose of GARDASIL, on 02-JUL-2007 was vaccinated with the second dose of GARDASIL and in October 2007, was vaccinated with the third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified) and progesterone.  In November 2007, the patient found out she was pregnant.  The patient stated that she was given a pregnancy test each time and they came back negative, but it was assumed that the patient became pregnant around July 16, 2007.  The patient reported that she had her baby on 11-APR-2008, and her son was born with heart defects.  The patient stated that her son went to his physician every month too two months and had an electrocardiogram (EKG and ultrasound done), and he would have surgery when his heart gets bigger.  The patient stated that her son's surgery around will be when he is a year old.  No product quality complaint was involved.  Upon internal review, heart defect was considered to be a congenital anomaly.  Additional information has been requested.
Initial report received on 08 December 2009 from a healthcare professional. A 5 year old male patient, with no medical history and no illness at the time of vaccination, received a left deltoid intramuscular injection of H1N1 (lot number UP009AA0 on 04 November 2009 and a right deltoid intramuscular injection of IPOL (lot number not reported) on 02 November 2009. On 18 November 2009, the patient developed hives which were widespread over his body. The patient was taken to the ER. He followed-up with a physician and was seen by an allergist who felt that is was a delayed reaction to vaccination. Reported medications were ZYRTEC, ORAPRED and ALLEGRA; however it was not specified if these were concomitant medications or treatment for the hives. At the time of the report, the patient was improving.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, chills, headache and general body pain. On an unknown date, the outcome of the sickness, fever, chills, headache and general body pain were unknown. It was unknown if the reporter considered the sickness, fever, chills, headache and general body pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was extremely sick with first shot. The patient had a fever, chills, headache and body ache. The patient was very hesitant to get the 2nd shot but received. The patient had luckily no side effects with that one. The patient would definitely recommend the shots over getting shingles.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR254299:same reporter (invalid case).
Activated Shingles neuropathy for 7 weeks, numbness and feet felt like they were on fire, can not tolerate the smell or taste of red meat . Extreme fatigue.
broke out; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (broke out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (broke out). At the time of the report, ADVERSE EVENT (broke out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported treatment medications were reported.
This spontaneous report was received from a register nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on 06-MAR-2015 the patient received the first dose of GARDASIL (strength, dosage, route and lot# were not reported), subsequently on 12-MAY-2015 the patient received the second dose of GARDASIL (strength, dosage, route and lot# were not reported) and finally in order to complete the series received the third dose of GARDASIL 9 (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
20JUN93 temp to 105 x 3 days beginning 4th day p/shots; screaming x 5 hrs; swelling in neck/cheeks/across top of head; seen by MD; 30JUn seen by MD fever due to mumps; rash all over now;
After vaccine administration patient started to feel in her left arm knumbness and tingling, and around her mouth and down her legs, patient was removed from the vaccine cell and taken to the observation area, she was placed on a litter and blood pressure 150/86, HR 73 pulse ox 99 and her left wrist. patient was observed and follow up blood pressure was 143/90 HR 75. patient was observed for 15 more minutes . she was then being escorted out to go to her car and she became lightheaded and dizzy and unsteady she was then placed in a wheelchair and taken back to the observation area, her follow up blood pressure was 1 @ 104/70. Patient was placed on the litter in trendelenberg, Follow up BP @ 1341 was  140/83 HR 75 laying, sitting she was 158/98 HR 75, and then after standing for 1 min she was 172/109 HR 75. Patient reported no feelings of lightheaded or dizzy, she was taken in a wheelchair to her car to meet her spouse.
Pt received Pfizer 0.3ml Bivalent booster in the left arm at 1429 with a flu vaccine in the right arm. While standing up and waiting for her brother to be vaccinated, patient was observed to fall backwards to the ground, hitting the back of her head. Pt had a momentary loss of consciousness and RN observer was at the scene promptly. Team alert was called in and hospital staff arrived on scene. Dr. DO arrived on scene at 1440 with MA and MA. The patient was placed in a wheelchair to the triage tent. Sitting BP was initially taken at 1438 79/39, HR 56. 100% O2 on room air. at 1440, BP was 100/65, HR 69, 99% o2 on room air. while on stretcher at 1447, BP was 114/77, HR 89, 100% O2 on room air. At 1455, patients standing BP was 112/90, HR 81, 100% O2 on room air. During assessment, the pt experienced difficulty answering basic orientation questions. Pt was complained of right side of head Headache (4-5/10 on pain scale) and ringing in her left ear. After examination of the back of pts head, she had a small, bruised area. Pt also complained of feeling nauseous and appeared pale, cold, and dry.  Mother reports pt has no history of syncope. Mother was present at the scene. Pt was examined by DO present at the scene and was cleared to return home at 1456. Pt declined to go to the ER, however, was instructed to call 911 or go to nearest emergency room if symptoms worsen. Pt walked out of vaccine tent with steady gait with mother at her side.