chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes are feeling very hot; Palate disorder; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), OCULAR DISCOMFORT (Eyes are feeling very hot), PALATE INJURY (Palate disorder) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (Tired). On 24-Mar-2021, the patient experienced OCULAR DISCOMFORT (Eyes are feeling very hot), PALATE INJURY (Palate disorder) and HEADACHE (Headache). At the time of the report, FATIGUE (Tired), OCULAR DISCOMFORT (Eyes are feeling very hot), PALATE INJURY (Palate disorder) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.   Concomitant product use was not provided by the reporter.   Treatment medication was provided as Paracetamol.   Reporter did not allow further contact
Case previously recorded as MA2009-4341. Initial case report received from a consumer via agency, on 16 NOV 2009. A 2-year-old patient was vaccinated with 0.25 mL i.m. S-OIV FLUVIRIN (batch no. 102124P1) on 12 NOV 2009. It was an off label use because the patient was younger than 4 years. No adverse event was reported. Agency reference no.: NA09-008244.
I have a rash on my face primarily around my eyes and it?s continued since 1/4. I also had a black and blue big right toe and my veins in my lower leg  are dark as well. I did not injure my toe or leg.
I tested positive for COVID-19 on 11/11/22. I had a sore throat, swollen glands, congestion, cough, and runny nose. The cough lingered until sometime in December. I used over-the counter medication, Advil and Chloraseptic. I went to the doctor later because I couldn't stop coughing and was prescribed high dose Naproxen Sodium and Benzonatate. I am feeling much better now.
Swelling, redness & pain of deltoid after IM PNEUMOVAX to (L) arm.
Patient reports SOB and dizziness 15 minutes after vaccine administration. Vitals all wnl. Patient had just seen a different patient taken to ED right before her turn. She took her own albuterol inhaler on symptom onset with some improvement. No other interventions needed.
On February 18, day 13 after vaccine, I woke at 3am with muscle aches in legs and headache and general unwell feeling. Lasted a few hours. On February 19, day 14 after vaccine, woke with mild muscle aches in legs and mild headache. Took shower and noticed my upper arm had big red blotchiness. I had not noticed this before, so I don't know if this has been ongoing or just appeared.
After first shot on Thurs I suffered vomitting and diareahea all day Saturday and Sunday.  After second shot on a Thurs (4/8) I suffered vomitting and Diareahea all day on the following Sat (4/10) and Sunday.(4/11) The very next weekend I continued the vomitting and diareahea all day Fiday,(4/16) Sat,(4/17) and Sunday. Sunday(4/18) at 6:00Pm ,I suffered a seizure and was taken to the hospital. I have no memory of Sunday, Monday Tuesday or Wednesday.  Suffered a second seizure in the ambulance on way to hospital.
Child woke up with red and itchy patches behind knees and arms. Injection site was clear.  By Sat night had hives on arms and legs.  Given Benadryl and symptoms improved.
Never went back to take the second dose of vaccine; Tested positive for Covid-19; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore arm), SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) and PRODUCT DOSE OMISSION ISSUE (Never went back to take the second dose of vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, METOPROLOL and PANTOPRAZOLE for Reflux esophagitis, MONTELUKAST for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 28-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never went back to take the second dose of vaccine). At the time of the report, VACCINATION SITE PAIN (Sore arm) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never went back to take the second dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive Tested Positive For Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant Product includes Allergy Shot.Had question if her mother-in-law can still take the second dose and when can she take the second dose.bTreatment Information was not provided; 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.
Pt presented with a rash with discrete erythematous papules on her back, spread to her arms, legs, face. Some with crusts. Possibly c/w chicken pox.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly stored doses of PNEUMOVAX 23 (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
64-year-old male with a history of hypertension, melanoma, vasovagal events from previous needles presenting to the emergency department today for vasovagal episode.  Patient was across the street receiving his first dose of Covid vaccine.  At that time patient had a syncopal episode.  According to EMS they indicate that nursing there was unable to feel pulse and began CPR.  They did multiple rounds of compressions and patient woke up.  They are bringing patient in today for further evaluation of syncope versus cardiac arrest.  Patient does endorse that he has chest wall pain from where they were doing compressions.
Tinnitus in right ear continuous for 48+ hours since it started.  Fatigue after 2 hours to mid Monday Some nausea and lightheadedness on day 2
Patient and patient's mother came in to store on 06/02/2021 to receive a Moderna vaccine. Patient had previously received a Moderna vaccine at another store on 05/05/2021, but was told that they did not have Moderna in stock for the follow up appointment. Pharmacy employee verified that vaccine history card showed Moderna and that the follow up date was consistent with a Moderna vaccine. Patient's mother was concerned about patient not being fully vaccinated. Pharmacist discussed options and ramifications of the options with the patient's mother. It was decided that the patient would wait in hopes that Moderna would receive approval soon.  Patient and patient's mother came back on 06/15/2021. Patient was going to be going on a trip with a baseball team and wanted to be sure patient was fully vaccinated. Based on company policy, the Moderna vaccine was given with consent of the mother.
very rapid heart beat that lasted about 2 days/increased heart rate; ongoing chronic sweats; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mitro valve prolapse" (unspecified if ongoing); "heart murmer" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; AZELASTINE HCL. Past drug history included: Epinephrine, reaction(s): "allergy", notes: anything with epinephrine or phine ending; Epinephrine, reaction(s): "makes my heart race", notes: anything with epinephrine or phine ending; Neosporin, reaction(s): "allergy"; Metronidazole, reaction(s): "allergy", notes: topical. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP7533, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8735, Vaccine location: Left arm), administration date: 21Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 24Nov2021, outcome "recovered" (Nov2021), described as "muscle aches"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "recovered" (Dec2021), described as "ongoing chronic sweats"; HEART RATE INCREASED (non-serious) with onset 24Nov2021, outcome "recovered" (Nov2021), described as "very rapid heart beat that lasted about 2 days/increased heart rate". The events "very rapid heart beat that lasted about 2 days/increased heart rate", "ongoing chronic sweats" and "muscle aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient experienced very rapid heart beat that lasted about 2 days. She also had ongoing chronic sweats and muscle aches. The increased heart rate and muscle aches subsided in 2-3 days. The ongoing sweats decreased each week until at week 4, she didn't have them anymore. The patient never had sweats before or after the vaccine. The patient did not receive any other vaccines in four weeks. The patient called the cardiologist who asked her to monitor.
On Friday, November 25, 2022, after the holiday after work I had a sore throat.  The next morning, I could barely swallow my throat hurt so bad.  I was coughing and I had body aches.  On Sunday I tested positive for COVID-19 at home.  I called the doctor on Monday and had a video call and was prescribed Paxlovid.  I had the side effect of a metal taste.  I had diarrhea and now I feel like I have a fever and still fatigued.  I don't really feel like eating much because it makes me feel sick.
The evening of the administration hands started to tingle, lasted about half hour.  The next morning felt fine at noon the second day started with violent shaking chills which lasted one hour, at that time it slowly started to stop but felt icy cold with sweating.  Took 2 tablets of advil 200mg at the beginning of shaking.  After shaking slowed down could not talk, stand or hold up hands; she was drooling barely could swallow.  She just wanted to lay down and sleep.  This lasted about 30-45 minutes.  Hands turned BLUE to her wrists lasting 15 minutes.  Resolved without intervention.  Very tired that evening. Slept for 12 hours. Back to normal the next day.
While my general health has been excellent for years, on 5/28/2008, when I had my annual physical exam, my doctor suggested I receive a ZOSTAVAX injection. I had chicken pox as a child but never have had shingles. From early September, 2008 until the present I have had right side abdominal pains and extreme skin sensitivity but no rash. After ultrasound, cholangiogram, chest x-ray and blood tests, my doctor has prescribed VALTREX as he has diagnosed my condition as zoster sine herpete. I feel the vaccine I received in May not only did not prevent shingles but actually caused me to get shingles.  10/7/08 Reviewed PCP medical records of 5/28-10/3/2008. FINAL DX: neuritis pain of ? etiology Records reveal patient experienced achy joints on day of vaccination.  RTC 9/9 w/right sided abdominal pain & back pain x 2 weeks.  Dx w/probable gallbladder disease.  RTC 10/3 w/skin sensitivity right flank.  Dx w/neuritic pain of ? etiology. Tx w/antiviral meds.    Referred for US of gallbladder, CT of thoracic spine/abdomen/pelvis.  No results available.
Severe swelling and pain throughout entire arm after PSV 23 vaccination in clinic, high fever, nausea/vomiting, took several days to improve
pt recv vax 14AUG98 & exp low grade temp;Sunday AM Sunday evening broke out in welt w/pustules forming by Monday afternoon;
mom reports that lump started under the arm 2 days p/vax;5SEP96 the node is about the size of a walnut & maybe inc in size;has been seen by MD;blood work nl, no fever;MD believes d/t vax;pt c/o pain & discomfort;
Rash in inner upper arms and also on top of thighs...occurred over night about 30hrs after initial shot
Information has been received from a physician concerning a 13 month old female with no allergies, medical history, or history of chickenpox or chickenpox/herpes zoster exposure who on 12SEP2003 was vaccinated in the right arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was noted that the patient was vaccinated at 12 months of age and at "15-months" of age the patient developed a case of zoster. The reporter also indicated that a rash did not occur at the site of injection or elsewhere within 42 days of vaccination. Unspecified medical attention was sought and it was unknown if treatment was required. It was noted that the patient had not been back into the office. A product quality complaint was not involved. Follow up information was received from a registered nurse which indicated that on 27OCT2003 the patient was diagnosed with shingles and was started on acyclovir. The patient's maximum temperature was 97.4. On a pain scale of 0 to 10, with 10 being the most, pain was noted to be an 8. No diagnostic laboratory tests, including a direct fluorescent antibody or polymerase chain reaction, were performed. The patient recovered on 25NOV2003. It was also noted that the patient and her siblings had no adverse events following prior vaccination. No further information is expected.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-OCT-2016, the patient was vaccinated with ZOSTAVAX, lot # reported as M035146, expiration date: 26-JUL-2017, intramuscularly rather than subcutaneously (strength, dose number, and anatomical location of administration were unknown). No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Had the shots but still got them/Suspected vaccination failure; Got them; Terrible pain; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots but still got them/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got them) and pain (Verbatim: Terrible pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The case  was received from the patient via interactive digital media. The patient had the Shingles shots but still got them but had a shorter time. The patient was dealing with terrible pain yet. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient developed fever night of vaccination. Next day again and mother noticed a bump in left side of neck. The next day bump kept growing and was painful. Mother took to Emergency Room.
Developed fever, dyspnea, hypoxia shortly after receiving vaccination on 9/27/17.
He was paralyzed, He was put into hospital he came into another hospital, He spend two months in a hospital; her husband got GBS; Pneumonia; Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.; Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknow, single (Lot number: EN6202) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "He was paralyzed, He was put into hospital he came into another hospital, He spend two months in a hospital"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "her husband got GBS"; PNEUMONIA (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.". The patient was hospitalized for paralysis, guillain-barre syndrome (hospitalization duration: 60 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of paralysis, guillain-barre syndrome.  Clinical course: The reporter mentioned that her husband got the Pfizer vaccine and her husband was tested positive for COVID now, she added as well that her husband got pneumonia as well her husband got GBS and she mention that she feels GBS was the symptom of Pfizer vaccine." The reporter mentioned that her husband got pneumonia as well GBS and she wants to clarify if GBS was the symptom of Pfizer Vaccine?". Regarding Lot no, Consumer stated, "Which one do you want? For COVID Pfizer EN6202 (Clarified and captured in tab) and second one it says COVID Pfizer it looks like EDAEP I can't read the second letter and then its 69SS." Expiration date: Reporter stated, "No, there was no expiration date on there." Treatment for the side effect: Reporter stated, "Yes, he was paralyzed from, he ended up with GBS. He was put into hospital he came into another hospital. He spend two months in a hospital in and out and he was in rehab he was, at the towards the end of rehab at that time in his right leg he has 8 muscles out of 10 that are not working so he looked like he was paralyzed from the neck down."
Small slightly raised red bumps appeared on underside of both arms, on torso and buttocks. Didn't itch, nor have fluid in them. Bumps have lessened in redness but not dissipated completely as of 10/26/2011. Bumps appear to increase in redness if patient performs strenuous physical labor which causes him to sweat. No other symptoms. Dermatologist took sample and pathology identified it as lichen planus. On 9/21/2011, Dematologist prescribed one course of Minocycline 100MG 2x daily as a preventative measure while waiting for pathology results. Minocycline seemed to cause rash to lessen but not completely go away. Possible side effect of Minocycline was patient developed prolapsed internal hemorrhoid one week after beginning Minocycline treatment. This was the first time the Patient had a hemorrhoid and didn't strain prior to hemorrhoid appearing. Dermatologist examined hemorrhoid and noted no signs of cancer and advised patient to schedule visit with family doctor if hemorrhoid didn't heal. As of 10/26/2011 hemorrhoid has shrunk considerably.
1 X 1.5 cm firm, palpable mass below skin surface, Rt thigh appears to cause pt no discomfort.  Hot packs to area TID for 30 min follow up /w Dr in 1 wk -sooner if sx increase.
high temperature and body aches  leading to rashes and hives, would go away after 1st week after, high temperature for a about 5 days, eventually slowed down 2nd week after, then bloody nose for 5 days 3rd week, now still intermittent bloody nose, weakness, and fatigue, occasional high temperature-into the 4th week...
Hard Baseball size lump warm to touch, red, itchy. Apply ice QID, Tylenol and Benadryl prn
Unknown at this reporting. Waiting for patient's parents to call back office to notify them of the incident. No report thus far of any adverse effects of the early IPV dose.
14 days p/ vax pt devel a vesicular rash w/3-4 lesions. 30sept pt devel a second rash
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Fatigue,achy,stomach pain,Told to follow up with primary care Narrative:
Moderna COVID-19 Vaccine EUA  that was administered 12/01/2022 at 10:30 a.m. has an expiration date of 11/23/2022 that was realized at the point of charting the vaccine in the patient chart. The patient tolerated the vaccine well and waited in our lobby 15 minutes and left without complaint.  Moderna vaccine line was contacted to report the incident and for further instruction. I was advised that they will conduct an analysis to determine if the vaccine administered past the published expiry provided the necessary protection against a COVID-19 infection. The vial was stored frozen until it was moved to refrigerator on 11/30/2022. Results from the analysis will be ready in 3-5 days for provided by the agent as well as another.
Information has been received from a 23 year old female consumer, who in January 2009, was vaccinated by injection with GARDASIL (dose and frequency was noted as unspecified and third dose). In August 2009, the patient reported she "started getting genital warts" after her third dose of GARDASIL. She also reported suicidal thoughts after these effects. The patient sought medical attention. She was not hospitalized. She reported receiving treatment by having the genital warts frozen off. She also had "blood test" performed (lab studies, dates and results not provided). Therapy with GARDASIL was not reintroduced. At the time of the report, the outcome was not recovered. Upon internal review suicidal thoughts was determined to be an other important medical event. Additional information has been requested.
COPD; Chest problems; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 15Jun2016 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had chronic obstructive pulmonary disease (COPD), and chest problems. Possible adverse event. Her physician was suggesting her to update her vaccine with PSSV 23 but she did not feel she needed it, PSSV 23 was not a Pfizer Product. The outcome of events was unknown.