chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash around vaccine area on arm started the next afternoon after vaccine. (Also had upset stomach and low grade fever). The 2nd day after vaccine (2/20) rash/splotchiness started from arm to upper torso, stomach, groin, arms and neck. By end of day, rash area was red (like a sunburn) and swollen, covering same areas as mentioned. Went to Urgent Care that night, they prescribed Prednisone, which I didn't take. They said since I wasn't having difficulty breathing or having other severe effects, I could continue with BENADRYL and Loratadine, over the counter. On 2/21 the rash had decreased by about 30%, on 2/22 rash had decreased by 80%, continuing BENADRYL and Loratadine.
Pt reports receiving shot in her LD around noon on 01/09/2019, and pretty much on the dot at 3 PM 01/09/2019 she started getting an intense, "excruciating pain" building in her left arm. Within seconds, her pain level had reached a 9/10 on 0-10 pain scale and she felt weak, shaky and that she was going to pass out. She was at a local business, but had to lay on the floor and request help. They brought her water (she drank about 90 oz within a few minutes), gave her some ibuprofen and sat with her until a relative came. She thought about going to ER but says that after about one hour laying down there she felt okay to go to home. That evening, she developed some mild fever and chills. She reported minimal swelling at injection site and minimal redness but states she has very limited movement and strength in her arm. She describes it pretty much as an "arm paralysis". She denies any airway involvement nor rash. But even after two days (she reported to me on 01/11/2019) she still doesn't feel very good, still has little movement in her arm and almost no strength. She is taking ibuprofen 800 mg every six hours and Benadryl about the same schedule. She reports with medications, her pain is tolerable at a 2-3 pain level, but without medication and resting it is around a 4-5. If she tries to lift or move her arm, the pain quickly becomes 8-9 on 0-10 pain scale. I spoke with pt again on 01/14/19 and she feels she is on the mend but still only has about 80% normal range of motion and 60% strength in her arm. If she tries to lift her arm, it quickly becomes a 7-8 on pain scale. She spoke with a Dr. over the weekend who told her she likely had an anaphylactic reaction and should not receive any future doses. She spoke with an NP today and was Rx'd prednisone x 5 days to see if there was any benefit. Both providers agreed that she has nerve involvement from the inflammation process in her arm. She doesn't feel shaky, chilled or any other symptoms at this time besides her arm pain and limited movement. She does plan to potentially follow up with her PMD, Dr especially if no further improvement from the prednisone. Again, she denies any respiratory involvement, no rash, no major swelling or redness. Her arm is very tender to the touch at the injection site. Pt is a long practice RN who is a professor with local university nursing program, so does feel she has pretty good medical background. She reports she anticipated some pain and potential reaction, but nothing to this severity, length and involvement.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches. On 27th July 2018, the patient experienced injection site rash, injection site pain, injection site erythema, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder. On an unknown date, the outcome of the injection site rash, injection site pain and injection site erythema were recovering/resolving and the outcome of the red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder were unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder to be related to SHINGRIX. Additional details were provided as follows: At 12:30, the patient received SHINGRIX vaccine in the right arm. The next day after receiving the SHINGRIX vaccine, the patient developed three or four red bumps that looked like mosquito bites at the injection site. When the patient put her finger on them they were sore. They were resolving and had faded into a red blotch. One or two areas in the red blotch were redder than the rest, but there were no longer raised areas. It was still tender if she pressed on the area. Also, the next day after receiving the vaccination, the patient developed a headache at her forehead, the back of her head, and the back of her neck. The pain from her forehead runs up to the crown of her head with the top of her head feeling tight. The patient said the headache had occurred every day since the vaccination but varies in severity. The patient reported that she had issues with temperature control since the next day after receiving the vaccine. The patient got hot and then gets cold. The patient had two occasions where she had experienced bad shivering. One of these shivering episodes was at night and she did not sleep well. The patient said that around the third day after receiving the vaccination she was feeling better, the next day was bad again. Reporter gave permission for her physician to be contacted.
evening of vax mom noticed a few bumps around inj site;gave APAP & cold compresses;pt has been very irritable since then;3JUL96 has many more bumps there & non anywhere else;5JUL seen by MD says viral infect;
This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKilne). On 7 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 7 October 2008, and into the next day, the subject developed a generalized itchy rash. On 11 October 2008, four days after vaccination with FLUARIX, the subject developed hives and was seen in the emergency room. He was hospitalized overnight and diagnosed with shingles. On 21 October 2008, the events of rash, hives and itching were resolved. The healthcare professional considered these events and shingles unrelated to vaccination with FLUARIX. Similar events occurred in three additional subjects. Linked case include: A0753769A, A0753770A and A0753771A.
On the 15th in the evening I started having very bad body aches, fever chills, headache.  My fever got as high as 101.8 friday night, and on Saturday the symptoms started easing off but my temperature kept rising throughout the day.  By Sunday I felt mostly better.
Pt reporting chills; 0.3 mg EPIPEN given. Decreased chills. BP prior 118/78, 18, 60, 97.9, 120 apical. VS after 100 apical.
This spontaneous report was received from a medical assistant who reported that M-M-R II, HSA, reached temperatures that were outside the prescribing information. No adverse effects reported. This is one several reports received from the same reporter. Additional information has been requested.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient 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 (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Chest Pain (08/02/16); hives (08/03/16) ongoing; hoarseness (on 08/04/2016)-ongoing.
On the day after immunizations, 7/20/01, the child was acting normal until early afternoon, when he developed nosebleed and then difficulty breathing which he then progressed to respiratory failure requiring intubation and mechanical ventilation X 2 days. Seizure was suspected by some MD's but not confirmed. Had a similar previous episode on 4/23/01 not associated with vaccine. The full extent of developmental recovery is unknown.
Patient received flu vaccine on 8/18/21 at around 10 AM. Patient did not contact the pharmacy or pharmacist until 8/30. Patient states that she had tremendous pain after receiving the vaccine and was concerned about the shot being too high on the arm causing this pain. Patient was counseled to perform light stretching on the arm by circular rotations to help the pain subside. Patient states that for greater than 1 week, she has been experiencing pain and not being able to move her arm fully. She states that she has tried hot/cold cream, ice on her arm, and taking ibuprofen to manage the throbbing pain at night. Patient states she would go see her PCP because she feels as if the pain will not go away.
Pt who resides in an assisted living facility w/multi comorbidities p/w SOB w/exertion, coughs and bodyaches. Was found to be COVID positive and O2 sats in the 80s. Was admitted for medical management of acute hypoxic respiratory failure 2ndary to COVID-19 viral PNA despite having received Moderna vaccines (1/26 & 2/23). She was initiated on dexamethasone and O2. Showed rapid improvements and was ultimately discharged 2 days later back to her assisted living facility w/follow-up.
Left arm pain 2 months later. In all left arm major muscles and joints. Arm is functional sometimes. Other times it doesn't do what I tell it. Gives out and drops things.
Employee notified Emp Health on 3/12 that she was seen in UVA ED for redness soreness and significant swelling of left arm @ injection site for Tdap on 3/6-2 days after given injection-no probs with site until then-Also dev URI sx. Was given Vicodin, ibuprofen and released. Still with palpable one inch diam nodule @ (L) inj site with 6cm area mild swelling.
Patient received Moderna COVID Vaccine on 1/11/2021. Patient started to noticed redness and soreness on and around the injection site on 1/19/2021. The area is warm to touch, redness was measured at 3inches x 2 inches. Patient also felt itchy on the area.
On 6-13-11 Tdap administered (L) thigh, Hep A #2 in upper portion (R) thigh and MCV-4 lower (R) thigh. On 6-14 developed redness. On 6-15 complained of pain & itching in both legs (L) thigh had 7cm x 6cm area of red induration. (R) thigh had 8cm x 7cm of erythema & induration.
Seen 8/12/04 in our office by Dr with scattered lesions vesicular, on head, in mouth, on back, legs, and genitals. Diagnosed with modified varicella. Afebrile. Rash developed 8/11/04 in evening and lasted till 8/16. Had varicella vaccine on 02/12/97.
Pt called center medical staff 3 days after injection to report severe swelling, pain, redness, limited movement of arm, hot feeling to arm, fever and diarrhea for the last 48 hrs.
Patient came into the pharmacy a few days after injection showing an area of cellulitis-like skin below but not near the injection site (but on the same arm). He said a few hours after the injection he noticed it starting to appear, with redness and heat from the area and the area also being sensitive to the touch. His wife is a nurse and she said that she thought it looked like cellulitis. He came into the pharmacy a few days later and showed us the site and we agreed that it looked like cellulitis. It has since gone down in redness and heat but is still tender to the touch.
Client received Pediarix, Hib, and Prevnar on 11/06/07 at approx. 4:00 p.m.  At approx.  5:00a.m. 11/07/07, client was transported to Medical Center for uncontrolable seizure activity and then sent via life flight to  Hospital.  Client was hospitalized for 3 days and has been hospitalized four times since. Child is currenty under care by the Neurology Department. 3/24/08-records received for 2/26/08-admitted for frequent seizures and EEG. Developed fevers after four month vaccines, had a grand mal and developed jerking movements. Currently on Keppra with no improvement per parent. Now has runny nose and cough for a few days. Right ear red and bulging tympanic membrane. DX: Seizure disorder and otitis media. 1/20/2010 According to the mother of patient, " he has developed Epilepsy since he had his shots". He is under care of a neurologist and is currently being treated with Klonopin, Lamectol, and Topomax.
I am experiencing continued pain in upper arm and shoulder.  I can't lift my arm above my head without searing pain.
Hospitalization for acute respiratory failure due to COVID-19 on dates 8/24/22-8/30/22.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
On 4/31/21, sore are around 5 p.m. On the night of 4/31/21, developed slight fever, then thoughout the night body aches got worse and couldn't sleep well. On 5/1 /21, developed extrem fatigue, some nausia, continued body ache, slight fever, and chills. After taking an Aleve, the aches fever subsided, but still had extreme fatigue and  cold sweat.  On 5/2/21,  no more fatizue and cold sweat, but has a large rash, 12x4 around the injection site. On 5/3/21,  the rash is getting itch, so I took a Benadryl at 10:30. By 12:00, the rash looks about the same but not as itch.
Blood clot blocking blood flow to brain -  1st episode: ( 3/12/21) stabilized, minor limited movement left side -  2nd episode: (3/24/21) no blood flow to brain, death (maintained on life support for organ donation)
Booster vaccine was given 10 days after the beyond use date of 11/20/2021 patient notified, no adverse reactions and patient has chosen not to revaccinate
Medical Information Potential AE; The problem is her memory; she doesn't speak very well; This is a spontaneous report from a contactable consumer reported for female patient (reporter's mother). A 69-year-old elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot Number: ER8734) via an unspecified route of administration in deltoid Left on 29Mar2021(at the age of 69-years-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient told him she received the second dose of the vaccine at a different hospital in a different county than the first dose, however she had no record of receiving the dose, was not given a vaccination card for either dose, which had been an issue in their area. Patients are being told to get the information from their patient portal. Reporter had contacted both hospitals, local and state health departments, as well as the CDC and no one had record of her receiving the second dose. She is going to be moving into an assisted living facility and needs proof of receiving both doses and asked would it be safe for her to get a third dose in case she actually had received a second dose for which documentation may not have been entered. We have no safety or efficacy data outside of the dosing schedule followed in the clinical trial, no data is available at this time from the Booster dose study, and Pfizer cannot recommend the use of the vaccine outside of the recommendations in the PI. Reporter stated, height may be 5 feet he guesses. She got the first shot; we do not know if she got the second shot. She may very well have received the second shot, but we just do not know. The problem is her memory (incomplete sentence) she doesn't speak very well (Further clarification was unknown if patient experienced this problem after getting the first dose or not, hence captured as event), so we don't know. Nobody else thinks she got. Reporter stated, she did not have any problem (voice not clear). The clinical outcome of the events was unknown.
Dyspnea;  Full evaluation with EKG (normal); treated with albuterol inhaler and OTC therapies with close monitoring and education for rapid follow up with ER if changes in chest symptoms or worsening.
Suspected vaccination failure; Came down with it,; Nerve pain was excruciating; luckily mild rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-Mar-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shots and still came down with shingles, luckily mild rash but the nerve pain was excruciating. Four months later still having nerve pain. The patient thought to be smart out there and get the shots. The patient hate to think what it would had been like if she/he had not had them. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
difficulty breathing; chills; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), CHILLS (chills), PYREXIA (Fever) and FATIGUE (fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032P21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT), ALBUTEROL [SALBUTAMOL], FUROSEMIDE, PAROXETINE, THEOPHYLLINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), NIFEDIPINE, PANTOPRAZOLE, DOXAZOSIN, B COMPLEX [BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE], APIXABAN and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced DYSPNOEA (difficulty breathing), CHILLS (chills), PYREXIA (Fever) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), CHILLS (chills), PYREXIA (Fever) and FATIGUE (fatigue) was resolving.            This case was linked to MOD-2021-375448.
Nausea, pain that continues in UE and unusual joint instability at shlds and hips. Paraesthesias that begin distal and move proximal in UE and LE, randomly. Recent adversions to sensory inputs to exteme of immobilization to smells. Continued since date of injection. Stomach pain.
Changes in his thinking process/Cloudiness; jerking in sleep; Severely depressed; sick/hurting; Feeling Cloudiness; Chills; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting) and FEELING ABNORMAL (Feeling Cloudiness) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.    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 THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting), FEELING ABNORMAL (Feeling Cloudiness), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting), FEELING ABNORMAL (Feeling Cloudiness), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose of concomitant medication was increased during the vaccination time.   This case was linked to MOD-2021-235712 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Non-significant follow up appended. Follow-up information received on 25 Jun 2021 and does not contain any new information.
A report was received from a health care professional on 11/19/03 concerning an approximately 50 year old male vaccinee who inadvertently received two doses of Fluvirin on 11/19/03. On 11/19/03 a vaccinee inadvertently received two doses of Fluvirin. The vaccinee he had not experienced any adverse events related to this incident at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Extreme chills constantly, mild chest pains, headaches, cough, upset stomach, soreness at injection site.
Ran high fever, then became increasingly fussy and hard to console. Within a week, began screaming inconsolably and wouldn't stop. Took him to the emergency room where they administered Tylenol with codeine. Was diagnosed with encephalopathy and autism.
3cm  pink , slightly  swollen  areas around injection  sites.   Hydroxyzine  oral . Triamcinolone 0/1% cream