chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Intrauterine Fetal Death. On 07-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received FLUARIX. In September 2015, the patient received FLUARIX. On an unknown date, less than a month after receiving FLUARIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX. Additional details were received as follows: This case was not previously reported to anyone. The case was one of the 7 cases reported for adverse events experienced by the 7 patients vaccinated with FLUARIX, at the same facility. This case was regarding the patient who experienced more than usual redness and swelling at injection site. The cases reported for other 6 patients were US2015137455 and US2015137458 (anaphylactic shock), and US2015137461, US2015137463, US2015137464 (redness and swelling at injection site) and US2015137460 (full body rash). There were many employees were vaccinated at the same facility with the FLUARIX, among them 7 patients experienced events.
Sore throat and body aches began the Saturday following immunization and ended within an hour of starting
Patient came back to the pharmacy around five minutes after getting second vaccine (Pneumovax 23 @ 10:02 am) and complained of flushing and dizziness. She couldn't stand up on her own due to the dizziness and had to lean on husband for support. She sat down and reported chest pain and extreme lower back pain. The paramedics were called and once they evaluated her, they took her to the hospital. We spoke to the husband around 2:10pm that same afternoon and he stated patient was feeling better but she needed to stay over night at the hospital to run more tests and be monitored. We spoke to the patient a couple days later and she was fine. She was told by the hospital that they weren't sure why she had that experience and that it was not due to the vaccines.
11 hours after injection redness and swelling to injection site. 24 hours after injection, redness and swelling doubled in size.  Took Motrin, Tylenol and Benadryl 1st day. Day 2 - took the same. Will continue to monitor myself.
This is a non-serious spontaneous case from a consumer or other non-health professional in the USA of BURNING IN JOINTS. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a consumer that refers to a female aged 43 years. The patient's past medical history included auto immune thyroid disease, Grave's disease, and Hashimoto disease. She also had a viral infection several days prior to receiving FluMist. She received FluMist on 12/16/04 at 2 in the afternoon. The patient's concomitant medication included Levothyroxine Sodium. On 12/18/04 at approximately 6 in the evening, the patient's had complaints of intense burning and pain in her joints which caused loss of mobility. The reporter stated the pain at rest was rated a 4 and increased to an 8 with movement. The burning and pain began in the patient's wrist and ankles. Subsequently the burning and pain spread to her hands, arms, and legs. On 12/19/04, the patient was prescribed Naproxen for treatment. The reporter stated the Naproxen alleviated the patient's symptoms enough to rest that evening. On 12/20/04, the patient presented in the physician's office and was diagnosed with a viral infection. The reporter stated the attending physician concluded the events were due to the viral infection and not related to FluMist.
Significant pain in left shoulder (opposite arm of injection site). Pain mainly in upper arm/shoulder, and prevented me from lying comfortably in any position.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/ allergies were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (Lot number, dose and route were not reported) that was stored in an unmonitored freezer and exposed to unknown temperatures for an unknown period of time. Vaccine was unsupported in the absence of temperature excursion details. No adverse symptoms reported. Approximately 9 doses of VARIVAX (Merck) were administered. This is one of several cases from the same reporter. Additional information has been expected.
Patient was administed the Pfizer 5-11 vs the Pfizer 12 +
severe depression x 3 days; pt became irritable & had pain @ inject site starting 12JUN & lasting till 17JUn
Information has been received from a licensed practical nurse concerning a 66 year old female patient with allergy to Morphine and a history of osteopenia and arthritis who on 19-MAY-2008 was vaccinated intramuscularly in her left arm with a first 0.5 mL dose of PNEUMOVAX 23 (Lot number was not provided). Concomitant therapy included alendronate sodium (MSD). On unknown date, the patient had a "local allergic" reaction after vaccination. The patient had redness and swelling on her left arm at the injection site after receiving her first dose of PNEUMOVAX 23. The patient sought medical attention by visiting the physician's office. No laboratory diagnostic studies were performed. At the time of the report, the patient recovered from the events. Additional information has been requested.
Approximately 5 days after receiving her scheduled 6 month vaccinatins including the DTP she had a seizure. After an MRI and two EEG's the docter's never determined the cause. She had a total of 8 seizures during an eight month period of time. She has not had any vaccines since that time and has now been seizure free for a year.
Breakthrough case: My symptoms included a bad head cold, sinuses were packed up, stomach pain, odd bowel movements, and I slept for a couple of days. I felt lousy. A week later, I went to the ER since I couldn't breathe. They called it Covid exasperated COPD. A week after that, I was in the hospital for a mild heart attack.
This case was reported by a consumer via call center representative and described the occurrence of eczema in a male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a day after receiving DTPa vaccine, the patient experienced eczema and pustular rash. On an unknown date, the outcome of the eczema and pustular rash were not recovered/not resolved. It was unknown if the reporter considered the eczema and pustular rash to be related to DTPa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient had his DTap shot and the following day his body broke out head to toe in an oozing rash. Eventually, the physician stated it was just eczema but it was severe eczema and year later had not gone away. The patient had pictures of the rash. It happened less than 24 hours after this shot.
Received Zostavax vaccine 10/29/2007, broke out in vesicular rash right chest/neck next day. Seen by Dr., Treated with Prednisone by mouth and Triamcinolone cream 1% to rash twice a day. Rash "99% better" on 11/7/07.
After receiving dose #2 of Moderna vaccine, patient had proceeded to waiting are for 15 minute observation. After approximately 5 minutes her brother-in-law approached staff asking for a nurse to check on patient. Patient walked on her own to triage area and laid on a cot. She c/o chest pain and heaviness, feeling faint, headache all over her head, shoulder tightness, dry mouth, and was visibly shaking. Vital signs were taken every 5 minutes while awaiting EMS. BP range: systolic 172-190, diastolic 80-94; Pulse 96-100; Respirations 24 per minute. EMS arrive and immediately did an EKG with was within normal limits. Patient was transported to hospital. Upon arrival at hospital patient c/o right sided headache, reported weakness on left side and slurred speech. CT was done and the decision was made to transport her to another healthcare facility. She was give TPA enroute. Patient was admitted. Healthcare facility contacted patient on 4/26/21 and patient reports that she was still in hospital but was expecting to be discharged that day. She stated that she was started on Plavix and aspirin and will be following up with her neurologist as she has had TIAs in the past. Patient reported feeling back to normal.
No adverse event; Improperly stored VARIVAX was administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  Approximately on 01-MAR-2020, reported as "maybe 2 days ago", the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis lot # S020464 , that has been verified to be a valid lot number, expiration date on 02-JUL-2021 (strength, dose number, anatomical location, route of administration were not reported).  The vaccine was administered concomitantly with the sterile diluent (MERCK STERILE DILUENT) lot # S038150 with expiration date on 07-AUG-2022. The temperature of storage was  12 °c for a timeframe of 81 hours without previous temperature excursion and was called because a digital data logger.No adverse effects were reported
This case was reported by a pharmacist via call center representative and described the occurrence of diverticulitis in a 70-year-old female patient who received SHINGRIX. Concurrent medical conditions included diverticulosis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced diverticulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the diverticulitis was unknown. It was unknown if the reporter considered the diverticulitis to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the adverse event via click to chat forum. The pharmacist reported that he had a patient with known diverticulosis who developed diverticulitis within a few weeks of the SHINGRIX vaccine. No further information was available at the time of report.
Patient reported chills, fatigue, dizziness, muscle aches, and headache all of which started around 24 hours after vaccination. She took some ibuprofen which she claimed helped relieve the headache. According to the patient she was not about to get out of bed till 48 hours after the vaccination.
Entire Rt. deltoid swelled within hours, hardened, locally reddened, patches of red around base of deltoid, hot skin, ache so bad the arm could not be raided for 1 day. Hurt to move it for 2 more days until swelling subsided. Apparent allergic reaction. No fever, duration 4 days.
I ultimately only had a little soreness on my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I ultimately only had a little soreness on my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was in refrigerator for 74 days prior to administration making it expired by 4 days.  Patient did test positive for Covid 03/25/23.  Recommended re-vaccination 3 months after recovery from Covid.
It was reported in a published report, title stated above, regarding a case in litigation concerning a female patient who in September 1997, was vaccinated with a second dose of RECOMBIVAX HB (Lot number unspecified) (manufacturer unknown). In September 1997, one hour after receiving the second dose of RECOMBIVAX HB the patient developed "malaise, flu like symptoms, fatigue and joint pain". Ten months later she complained that her symptoms had worsened. From 1998 to 1999 the patient consulted several specialists who provided varying diagnoses including chronic immune fatigue dysfunction syndrome, multiple sclerosis, myelitis and lupus. Upon internal review "multiple sclerosis and lupus" were considered to be other important medical events. No further information is available.
2 days after 2nd dose patient developed a hot rash on arm about 8 inches in size. Starting taking Tylenol and antihistamine. Will observe to see if diminishes.
Patient here for Pfizer Covid-19 vaccine.  Patient was given Moderna Covid-19 by mistake. Patient observed for 45 minutes with adverse reaction. No other treatment given.
My mother and I received the Moderna vaccine on January 20th. About two weeks later on January 31st, she complained about her leg. It was swollen. Later on  that day, she collapsed, was rushed to the hospital. Died on February 4th due to anoxic brain injury due to DVT that caused a massive pulmonary embolism.
Reddened area, left upper arm, measuring 2" x 2 1/2", area swollen and painful to touch. Patient reports temp of 100.2 on 2/27/14. Temp was 98.1 on 2/28/14.
Cerebral aneurysm, nonruptured - Endovascular coil embolization of incidentally found right superior cerebellar artery aneurysm. Hospital recovery. Hospital admission was within 6 weeks of receiving the COVID vaccine.
Fever (onset 24h after injection, resolved)  Sweats (onset24h after injection, resolved) Chills (onset 24h after injection, resolved) 4 inch diameter swollen/hot area below injection site  - immediately and worsened, not resolved after 60 hours
Fever; Flu-like symptoms (including upset stomach,, headache, muscle aches, and sore throat), Pain at injection site that radiated under arm all the way down to hand; bruising from left armpit down left side of left breast; extreme pain in armpit; "fluid pocket" between armpit and left breast; lymph node inflammation under left arm.
Product moved to refrigerator; Receiving expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired dose of the Moderna COVID19 vaccine) and PRODUCT STORAGE ERROR (Product moved to refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product moved to refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired dose of the Moderna COVID19 vaccine) and PRODUCT STORAGE ERROR (Product moved to refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Vial was initially stored in the refrigerator on 18 March 2022.  No treatment information was provided.
I had severe head ache, chills, nausea.  I still have a slight head ache daily since the vaccine
pt became unresponsive/unconscious at home; family called EMS and started CPR; EMS arrived and took over CPR, ACLS protocol, intubated pt; family stated pt had been positive for COVID on 9/14/21 and had become more congested with dyspnea that day; EKG showed PEA then asystole; brought to ED with continued CPR; pt  expired in the ED (Medical Center)
Swelling, pain, fever starting the evening of 11/27/2013 after receiving the flu shot. Pain in left arm radiating down left arm. Swollen left leg and muscle spasms. Patient went to an urgent care center where an antibiotic was prescribed. Employee then saw an orthopedic surgeon who prescribed prednisone, Percocet and physical therapy.
Lightheadedness, digestive upset including nausea and diarhea, extreme fatique.  6 days later, still having same issues
About 24 hours later my entire body was covered in a painful rash/hives that did not go away for a couple weeks. I felt nauseous, fatigued, ran a high fever, and had a bad headache. My entire body/joints/muscles ached.
Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. Took benadryl went away after  10 min
received high dose flu shot 11/23/22 and sick with Flu symptoms since. Lost a week of self-employed work.
Mom stated about 2-3 hours after immunizations administered, child stated he could not breath. Mom took child to ER. Evaluated by MD. Mom stated child received Epinephrine, Prednisone and Benadryl. Child okay now. Mom states MD advised to repeat imm.
Mild case after 1st shingles vaccine; Postherpetic neuralgia impacts my life every day; it impacts my life everyday; This case was reported by a nurse via interactive digital media and described the occurrence of shingles 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, 2 months after receiving Shingles vaccine, the patient experienced shingles, post herpetic neuralgia and activities of daily living impaired. On an unknown date, the outcome of the shingles and post herpetic neuralgia were unknown and the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/ she put off getting vaccinated. The patient finally got the first shingles vaccine and two months later, came down with a mild case of shingles, as what he/she thought. At first, the patient did not even know what it was, it was on the back. By the time the patient figured out he/she had shingles, it was too late for antivirals. The patient stated it had been 15 months of agony. The patient had post herpetic neuralgia. The patient had a nerve block which helped some. The patient stated, it impacts his/her life every day, he/she would never wish this on anyone and urges everyone to go get vaccinated. The follow-up would not be possible as no contact details were available.
Intradermal vaccine injection given to left forearm but did not wheal. Repeat vaccine injection successfully given to left back of the arm subcutaneous.
Started to get a runny nose on 12/30/2009, then on 12/31/2009 woke up with a slight low grade fever, temp not taken. At 12:00 noon child was given tylenol for fever and put down for a nap. He woke up at 3:00 and had a Febrile Seizure his rectal temperature was 103.5. This temp was taken by the ER nurse.
Urticaria everywhere except feet and face; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 08Apr2021 at 13:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and bipolar II disorder. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) at a dose of 20mg once daily (QD) and oxcarbazepine (MANUFACTURER UNKNOWN) 300mg two times in a day (BID) both were taken for unspecified indication since unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 03:00, the patient experienced urticaria everywhere except feet and face lasting 24 hours. On 29Apr2021, the patient underwent a SARS-CoV-2 virus test (nasal swab: colour through work) and the result was unknown (pending at the time of the report). The patient did not receive any treatment for the reported events. The events results in Emergency room/department or urgent care. The clinical outcome of the event urticaria everywhere except feet and face was recovered on 21Apr2021.  No follow-up attempts are needed. No further information is expected.