chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had recently spent some time with someone who had tested positive for COVID-19. On 10/20/2022, I woke up with more sinus congestion than normal, a slight headache, and a sore throat. I felt a little suspicious since these symptoms were not normal for me. I tested myself for COVID-19 and it was positive. I took some Alka Seltzer Plus and used some nose spray and then called my physician. He recommended against taking Paxlovid due to some of the medications I am on and the mild nature of my symptoms. He advised that if I get worse, to call him again, but they didn't get much worse. Thursday and Friday, I had the most trouble with my sinuses and I ran a mild fever that reached 100 degrees. I continued to treat congestion with Afrin nose spray and Alka Seltzer Plus, which seemed to control the symptoms. Saturday, I got a little bit better but was still using over the counter medications. On the fourth day, I did not use the nasal spray, but did use the Alka Seltzer Plus and a nasal rinse. Yesterday, I used the nasal spray again and Alka Seltzer Plus. Today, I'm feeling much better but am still congested in my sinuses and using the Afrin nasal spray and I also took Claritin.
16cm x 15cm area of erythema, warmth, swelling distal to injection site on left upper arm.
Information has been received from a pharmacist concerning a pt who in 1995 was vaccinated with one dose of Hep B vaccine. Subsequently this pt developed Jakob-Creutzfelds disease. The pt sought unspecified medical attention. Upon medical review, the pt's experience was considered an "other medical event." Additional information has been requested.  Follow-up information received on 7/31/00 states that the pt was vaccinated in approximately 1992 with hepatitis b vaccine. Soon after the vaccine, the pt developed accelerated dementia and was transferred to a nursing home, the hepatitis b vaccine was the only potential risk factor for this pt. Additionally the physician noted "did not think that a causal association between the pt's dementia and the vaccination was likely." A definitive diagnosis regarding Jakob-Creutzfeldt disease has not been determined. The physician also noted that the pt's neurologist at the nursing home will be doing a lumbar puncture to evaluate for Jakob-Creutzfeldt disease versus Huntington's disease. Additional information has been requested.
rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.
Right after the patient got the shot he told the pharmacist on duty that he was feeling funny and dizzy. The pharmacist told him to put his feet up and gave him some water. He became unconscious and 911 was called. When EMS came they checked his blood pressure and it was very low. He regained consciousness and was back to normal. According to the father his son has had this reaction to the flu shot before because he is terrified of needles.  Patient had the option to go to the hospital with father or EMS and he chose not to go to hospital at all and he left with his father.
Approximately one day after receiving the vaccine, I started to develop small red, itchy bumps, similar to bug bites, on my left forearm. It has now been almost one week since my vaccine and I now have over 20 bumps 2-5cm in diameter from my wrist to my elbow on the arm that got the shot.
Period started a week earlier than normal four days after receiving the vaccine (always on time and track it), lower abdominal cramping, heavy bleeding/spotting very unlike normal light flow experienced.
After administration patient experienced significant back pain, neck pain and throbbing headache.  Patient was given water, offered crackers, ems and offer to contact spouse.  All but water was declined.  After approximately 25 minutes symptoms resolved.  Patient denied any itching, tingling, swelling, puffiness or trouble breathing.
Narrative: arm pain for 1 day  Other Relevant Hx: Symptoms: & injection site pain Treatment:
pt previously received one moderna monovalent vaccine 12/27/22 for first dose in series.  then received moderna bivalent vaccine on 4/18/23 (10mcg, pink cap).  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) instead.  no symptoms reported (mother did call office and report pt was fussy on 4/19/23).  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call the CDC.  CDC recommended pt receive a dose of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received.  no minimum time interval required. family notified on 7/21/23
I got so very very sick from the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness 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 received dose of Shingles vaccine and got so very sick from the 1st shot. The patient stated that when you ask why you got so sick, they tell you it was a coincidence. The follow-up would not possible as no contact details were available. For 2nd dose refer case US2021AMR205295, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205295:same reporter US-GLAXOSMITHKLINE-US2021AMR205296:same reporter
Tested positive for covid approximately 5 weeks after vaccine.  Moderate symptoms for 3 days.  Headache, cough, diarrhea, tired
The booster shot initially caused a severe fever (much more robust than after the second shot which in itself caused a 3-day fever), very strong muscle aches, etc.Following the initial recovery I found that taking a deep satisfying breath is an new and still ongoing experience.  I wake up in the mornings with a sense that someone is sitting on my chest. On bad days I need to take a break in speaking after a few sentences. These side effects peaked in January (about 4-6 weeks after the shot), and are still ongoing to a lesser extent (speaking is easier, but chest pains and difficulty taking a satisfying breath is an issue). The quality of life is objectively impacted. I would like to note that there were no long-term chest pains after the initial 2-shot of Pfizer vaccines.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:45 as dose 5 (booster), single (Lot number: GJ2524) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "Anxiety" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "known allergies: Pseudoephedrine", notes: known allergies: Pseudoephedrine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was Adult (18-64 Years). Patient received Paxlovid treatment for Covid-19. About 6 days after completion of the 5 day Paxlovid course she started to have symptoms. Felt feverish, achy, heady, sticky throat, fatigue, then developed nasal congestion and a cough, swollen glands. Generally feeling fluish.
SORE ARM AFTER RECEIVING THE VACCINE IN INJECTION ARM; FEVER; ACHES; CHILLS; TIRED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm after receiving the vaccine in injection arm. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced aches. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm after receiving the vaccine in injection arm, fever, aches, chills, and tired. This report was non-serious.
Deltoid muscle sore/painful; warm to touch; some swelling 4-5" in length and 2" across.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2012 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a health center. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 30-JUL-2015 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. She was prescribed PERCOCET and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
I had a fever the second day after the shot pain and redness at the injection site. The second morning after the 2nd shot I vomited in the morning, but just once. Then it was fatigue for the rest of the day, drinking fluids and monitoring temperature which the highest was 101. used Tylenol to bring down, it was just fatigue after that, all other sx went away by the 3rd day, but the fatigue stayed.  I went to the doctor about 2-3 weeks later due to the lasting fatigue, shortness of breath and exhaustion after very little exertion.  Blood work was done in May or June showed elevated calcium in the blood and elevated Vitamin D125. She ordered another blood test for inflammation markers and it showed high inflammation.  Blood sugar and AC was high and it was recommended to make dietary changes which I did.  She also did Chest x-rays, chest scan, full body scan At that point I was referred to specialist endocrinology, ENT and cardiologist.  Started feeling better after being prescribed Trulicity. Exercising was very difficult. I am now walking with a cane and I do a few household chores and I can not do them with out being exhausted so quickly.
I had almost every side effect that is mentioned but I also had elevated heartrate between 100-110 for almost 4 to 5 hours. I also had high and fluctuating BP in that same time frame, and I still have sensation in my chest from the event.
pt recv vax 14AUG96 & on 12FEB97 pt devel a rash all over the body;
lungs filled up with blood clots; seizures; strokes; Covid; Covid; This is a spontaneous report received from a contactable reporter (Consumer).  An 83-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (death, medically significant), COVID-19 (death, medically significant) all with onset 03Jan2023, outcome "fatal" and all described as "Covid"; PULMONARY THROMBOSIS (death, hospitalization, medically significant), outcome "fatal", described as "lungs filled up with blood clots"; SEIZURE (death, hospitalization, medically significant), outcome "fatal", described as "seizures"; CEREBROVASCULAR ACCIDENT (death, hospitalization, medically significant), outcome "fatal", described as "strokes". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient date of death was unknown. Reported causes of death: "lungs filled up with blood clots", "seizures", "strokes", "Covid". It was not reported if an autopsy was performed.  Clinical course information: Reporter's mother (patient) who was 83yrs old was vaccinated and her lungs filled up with blood clots and she had multiple seizures/strokes. She was hospitalized for a month. They had to move her to (Place withheld) with him/her which crippled him/her financially and mentally as a full-time caregiver. Reporter's mother continued to have seizures/blood clots/strokes which she has never had before in her life. On 03Jan2023, she contracted Covid and was given Paxlovid started bleeding and died. The reporter took Paxlovid and he/she too was bleeding he/she needs help ASAP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: lungs filled up with blood clots; seizures; strokes; Covid; Covid
pt recv vax 7MAR97 & 5 days later the pt exp convuls, fever & 2 or 3 episodes of vomiting;pt was seen in ER;
Patient is a 9 year old female who should have received the pediatric Pfizer covid vaccine.  The adult Pfizer covid vaccine was incorrectly administered by our immunizing tech in error.  As of writing this, to our knowledge the patient hasn't suffered any type of adverse events.
Bloody nose 24 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).. This consumer reported for an 8-year-old male patient that:  A 8 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 11Nov2021 19:45 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known Allergy: Amoxicillin", notes: Known Allergy: Amoxicillin. The following information was reported: EPISTAXIS (non-serious) with onset 12Nov2021 19:45, outcome "recovered" (Nov2021), described as "Bloody nose 24 hours post vaccination". Therapeutic measures were not taken as a result of epistaxis.  Additional information: If other vaccine in four weeks: No.other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No No follow-up attempts are possible. No further information is expected.
This spontaneous report was received on 20-APR-2017 from a public health official (not further specified if a healthcare professional) concerning an unknown number of patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. The public health official reported that an unknown number of doses of GARDASIL 9 (Lot number L043213, Expiration 28-AUG-2017) may have been administered to an unknown number of patients following temperature excursions (No dates reported) of 1.4 degrees Celsius (1.4C) for 11.5 hours, 1.3 degrees Celsius (1.3C) for 24.5 hours, 10.9 degrees Celsius (10.9C) for 2 hours, and 21.8 degrees Celsius (21.8C) for 6 hours. Previous temperature excursion was reported as yes. The call was because of a data logger. No adverse effects were reported in any patients. No other information is available. Additional information has been requested.
Redness, swelling, and feverish at injection site measured 4 inches x 3 inches  for 3 days. Muscle soreness for 3 days. Very tired and slight fever first two days.
After receiving shot about 3 hours later felt a little dizzy Nauseous  7 pm   Obvious soreness in arm which we expected still currently sore   Wasn?t feeling well nauseous before bed felt   5 woke up same feeling  8 when  he got out  was just sore lagging feeling   8:55 am this morning  9:55 am mark said he had a fever  10:40 he was chills fever is 102 , can?t keep his head up week   I?m home now told him to lay down try to sleep. But fever is still 102 can I give him something for this ? I haven?t yet. Going to fill this out then was hoping to speak to someone about steps
Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
She didn't feel like eating anything; She said she had a bad headache; She said she had a bad headache and nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She didn't feel like eating anything), HEADACHE (She said she had a bad headache) and NAUSEA (She said she had a bad headache and nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (She didn't feel like eating anything), HEADACHE (She said she had a bad headache) and NAUSEA (She said she had a bad headache and nausea). At the time of the report, DECREASED APPETITE (She didn't feel like eating anything), HEADACHE (She said she had a bad headache) and NAUSEA (She said she had a bad headache and nausea) outcome was unknown.            No Concomitant and Treatment medication were reported.    This case was linked to MOD-2021-369303 (Patient Link).
rash; swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) and VACCINATION SITE SWELLING (swelling at injection site) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (rash) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's all previous doses were Moderna vaccines. Patient received previous booster dose, 6 months ago. A week ago, patient developed rash and swelling at injection site. Patient queried if treatment medication can be continued. Patient stated that she will rethink regarding future Covid vaccine injections due to constituent of PEG 2000 in vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-743520 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2023: Live non- Significant follow up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743520:Monovalent case
cough w/thick white mucous 3-6hr p/vax;per mom pt devel thick mucous (white) cough has dec daily since vax;started 3-6hr p/vax;T101 w/APAP q 4-6hr;irritable & had crying spells;devel isolate flu like episode w/T103 20MAY98 in late PM;
left arm ed, hot, swollen from elbow halfway up arm- very fussy, but controllable.
3 vaccines given too early. Var., MMR, Hep A 12 mon. vaccines given to a 6 mon patient.