chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician (patient herself). This case is linked with case 2018SA285704, from same reporter. This case involves Adult female patient (age unknown) who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 11-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On unknown date, the patient developed a non-serious swelling at the site about 10-15 cm in size with redness (extensive swelling of vaccinated limb) (erythema) and (vaccination site reaction) with Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was swelling at the site about 10-15 cm in size with redness. As a corrective treatment to apply ice and alcohol compress was adviced. The patient outcome is reported as Unknown for swelling at the site about 10-15 cm in size with redness. List of documents held by sender- none.
Patient came in for covid 19 vaccine. When administering the vaccine the serum leaked out of the syringe at the needle attachment. The patient was given a second dose and held in building for 30 minutes.
Hives; This is a spontaneous report from a contactable consumer (patient reported herself). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her right arm on 15Feb2021 11:30 AM (Lot number: el9267) as single dose for Covid-19 immunization. Facility type vaccine: School or Student Health Clinic. No other vaccine received in four weeks. The patient's medical history included known allergies: sulfa. Vaccine facility, ethnicity and race information were available. Concomitant medication included dimenhydrinate (DRAMAMINE, other medications in two weeks). On 22Feb2021 09:00 PM, the patient experienced hives. AE resulted in Doctor or other healthcare professional office/clinic visit. COVID was not tested prior or post vaccination. The events were assessed as non-serious. The patient received prednisone shot as a treatment for the event. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Cellulitis vs localized vaccine reaction at injection site (5 cm annular, warm, red rash)
heart rate was up to 108; blood pressure dropped to 99/57; oxygen dropped to 95; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate was up to 108), BLOOD PRESSURE DECREASED (blood pressure dropped to 99/57), OXYGEN SATURATION DECREASED (oxygen dropped to 95) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (headache). On 27-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate was up to 108), BLOOD PRESSURE DECREASED (blood pressure dropped to 99/57) and OXYGEN SATURATION DECREASED (oxygen dropped to 95). At the time of the report, HEART RATE INCREASED (heart rate was up to 108), BLOOD PRESSURE DECREASED (blood pressure dropped to 99/57), OXYGEN SATURATION DECREASED (oxygen dropped to 95) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 99/57 (Low) dropped. On 27-Mar-2021, Oxygen saturation: 95 (Inconclusive) dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not provided.  This case refers to a 69-year-old female patient who experienced Heart rate increased, Blood pressure decreased, oxygen saturation decreased and headache following the administration of Covid-19 vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The underlying concomitant medication use of Lisinopril can be a confounding factor.; Sender's Comments: This case refers to a 69-year-old female patient who experienced Heart rate increased, Blood pressure decreased, oxygen saturation decreased and headache following the administration of Covid-19 vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The underlying concomitant medication use of Lisinopril can be a confounding factor.
patient woke up with chills, low grade fever, body aches, injection site aches, headache and nausea. She feels like she has the flu. She is taking gingerale, meclizine, and otc tylenol.
C/o soreness R deltoid area. Full ROM and sensation to arms/fingers. Headaches unrelieved by Tynlenol. Sore throat, no dyspnea, afebrile. Advised Ibuprofin. This relieved sxs.
At 1 1/2 months after receiving the Prevnar immunization, my son was dx'd with Type I Diabetes. He started to show symptoms at 1 month after this shot and was dx'd 1 week after his 1st birthday. Please note this could have been brought on by any one of the vaccinations. I've spoken to a doctor that feels it was the Hep-B vaccine. This is not in our family and he was not sick at all beforehand. The outcome is simple: Type I Diabetes. He was again dosed with Prevnar on 10/12/00 (lot 473043/IM/RL). The annual follow-up states "my son has juvenile diabetes and will for the rest of his life."
Had HPV given on 12/14/15 initial stabbing pain. lasted for 3 days, slept through it, unable to go to school so pain. No swelling noted, ? red/warm, had sharp pain that radiated down the arm lasted 3 days, took ibuprofen without relief. No fever noted.
I am sure you could do but I am just kind of curious why it attacked my right arm that way. It did not do it the first time I got the booster last year which was the regular booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "I am sure you could do but I am just kind of curious why it attacked my right arm that way. It did not do it the first time I got the booster last year which was the regular booster". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Consumer stated, "I was sent an email to Pfizer regarding what happened after I just took the update vaccine booster (Later confirmed as Pfizer COVID-19 vaccine hence, captured as COVID-19 vaccine Booster). I just took it at the beginning of, middle of November and within about an hour after getting the vaccine or the booster, I was getting put in my left arm because I have lot of hardware in my right upper arm on my humerus. There is 2 plates and a bunch of screws (Intent: History). Well everything was fine after about an hour so, my right arm started really hurting, really bad and I thought okay, it will pass but around 5'o clock I got the vaccine around 11'o clock that morning around 5' o clock, I have couldn't take anymore, so I though well, let me take a couple of Advil (Suspect captured Conservatively) whatever see it going to help, which it did temporarily but then it right back, hurting me again and I was about to go to the ER, Are you think that was really was amazing. I am sure you could do but I am just kind of curious why it attacked my right arm that way. It did not do it the first time I got the booster last year which was the regular booster but this time (incomplete sentence)." Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-202201353257 same patient, different vaccine dose/partial same event;
Body aches/quite severe, nausea, chills, headache beginning 4 hours post-injection and lasting 30 hours
Pt noticed a hand sized band of erythema, warmth, and tenderness at injection site two days post vax. Pt advised to take Alleve or Advil as directed, use cool compresses and apply hydrocortisone topically to affected site.
Information has been received from a medical assistant concerning a 2 month old breastfed patient who was vaccinated with a dose of ROTATEQ. Subsequently the patient experienced projectile vomiting. It was unknown whether medical attention was sought. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe; 0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) and DEVICE CONNECTION ISSUE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 24-Mar-2021, the patient experienced UNDERDOSE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) and DEVICE CONNECTION ISSUE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe). On 24-Mar-2021, UNDERDOSE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) and DEVICE CONNECTION ISSUE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) had resolved.        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.   Reporter was not sure how much dose the patient received.  No relevant concomitant medications were reported. No treatment details were reported.
Also being treated for bronchitis; Had 5 Pfizer COVID shots before testing positive for Covid, last shot was Oct2022; Had 5 Pfizer COVID shots before testing positive for Covid, last shot was Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Had 5 Pfizer COVID shots before testing positive for Covid, last shot was Oct2022"; BRONCHITIS (non-serious), outcome "unknown", described as "Also being treated for bronchitis". The events "had 5 pfizer covid shots before testing positive for covid, last shot was oct2022" and "also being treated for bronchitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) unknown result; SARS-CoV-2 test: (unspecified date) negative, notes: after testing negative at home 2 times for Covid; (unspecified date) negative, notes: after testing negative at home 2 times for Covid; (May2023) positive, notes: but the urgent care test came back positive Monday. Therapeutic measures were taken as a result of drug ineffective, covid-19, bronchitis. Clinical course: Paxlovid was prescribed for caller on Monday, after testing negative at home 2 times for Covid, then tested positive last Saturday at urgent care, clarified the test was sent away, not sure if there was a difference in the home tests and the other test, but the urgent care test came back positive Monday. Had drainage that led to coughing, could be part of Covid-19 since patient had never had before. Patient was also being treated for bronchitis and was given a chest x-ray at that time, had horrible cough, bronchitis was no surprise, didn't have pneumonia. Monday night doctor got word and told patient to try Paxlovid. Patient started Paxlovid first dose Monday night.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300203791 same patient, different drug, different event;
1st shot had a thin line of numbness on the tip of my tongue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8733) via an unspecified route of administration in left arm on 16Apr2021 at 04:00 (age at vaccination 65-year-old) as dose 1, single for covid-19 immunization. The patients medical history was none. Patient did not have any known allergies. The patients concomitant medications included calcium, vit d [vitamin d nos] and bupropion hydrochloride (WELLBUTRIN). Patient did not have covid prior to vaccination. Patient did not test post vaccination. On an unspecified date in 2021, after dose 1, patient had a thin line of numbness on the tip of tongue. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
This is an initial spontaneous report from a contactable physician communicated to a Pfizer Sales Representative. A 4-year-old patient (gender unknown) received a dose of PREVENAR on an unknown date for an unknown indication (site and time of administration were also unknown). Relevant medical history, concomitant medications, concomitant vaccines or vaccines given within the last four weeks were unknown. On an unknown date, the patient experienced invasive pneumococcal sepsis which resulted in death. Relevant laboratory data was unknown and it was unknown if an autopsy was performed. The cause of death was reported as invasive pneumococcal sepsis.
Itching for 12 hours Three Hives A deep red line below the skin of the right wrist as if it were following a vein. It reached up to approximately three inches.
15:17 - pt observed in parked car to be slumped over steering wheel, possible syncopal episode, states 'maybe needed more sleep', MD notified for further assessment 15:18 - Fire Chief/lifeguards notified, BP 132/74, pulse 72, RR 17, O2 sat 97% 15:24 - paramedics arrived, pulse 85, O2 sat 96% 15:25 - pt left by their own car after final assessment by paramedics, after signing an AMA
Complains of upper right arm pain since vaccine administered. States is painful to raise arm when dressing. No redness, swelling, or pain with palpation.
Lowered immune system; fatigue; severe flu symptoms; night sweats; pneumonia; valley fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 25Aug2021 at 10:00 as dose 1, single (Lot number: fc3183) at the age of 24 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "Lowered immune system"; FATIGUE (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; NIGHT SWEATS (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; PNEUMONIA (medically significant, life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; INFLUENZA (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "severe flu symptoms"; COCCIDIOIDOMYCOSIS (medically significant, life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "valley fever". The events "lowered immune system", "fatigue", "severe flu symptoms", "night sweats", "pneumonia" and "valley fever" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative. Therapeutic measures were taken as a result of immune system disorder, fatigue, influenza, night sweats, pneumonia, coccidioidomycosis.  Clinical course: Patient took treatment with Fluconazole, doxycycline. No COVID prior vaccination. Patient had COVID tested post vaccination. The patient did not have other medical history and known allergies. Patient was administrated COVID 19, Pfizer fc3183 Dose 2 on 15Sep2021 10.00 to right arm.  No follow-up attempts are possible. No further information is expected.
My daughter stopped breathing in her sleep 4 times the night of the dtap vaccine. She continues to randomly stop breathing in her sleep.  She never had issues with breathing before the dtap vaccine. When she stops breathing we have to pick her up and move her around or startle her to get her back breathing again. We have seen 4 different doctors about this and only 1 is willing to help me investigate this problem. We are now waiting for our appointment with a pediatric pulmonologist. The last doctor we seen referred us to them and said we need to have a sleep study done also so we are waiting for all of that to take place.
Pt developed on lt side of neck, rash that is red about 2 inches, with yellow crust that is still there. Not itchy, not bothering her, not appearing sick. Rt thigh is swollen with redness, about 3 inches in diameter indurated. No treatment is still there, getting a little better.
The patient has had pain redness and swelling at the site of injection for the past week. on Day 5 he developed a diffuse rash throughout his chest abd and back. It is ichy and a bit uncomfortable.
CPT administered Janssen COVID-19 vaccine to the pt 4/5. While sitting in the pharmacy area for his 15 minute observation period, he fainted. He said that he was texting on his phone and the next thing he knew, he was on the ground with people around him asking if he was ok. He stated that he was very sweaty, nauseous, and a little dizzy. We called a code white, provided the pt with a cold compress and elevated his feet. Pt did not want us to call 911. Pt did not have PCP and has not been to a doctor in about 5 years. He said he was very nervous getting the shot and is afraid of needles so that may have contributed. Pt stayed in the pharmacy area for about 45 minutes until he started to feel better and his mom came to get him. I tried calling pt again at 7:10pm to check in, but there was no answer and I could not leave a voicemail due to mailbox being full.
patient said the next day after receiving her first pfizer dose she began to have muscle spasms in the extremities (calves, face, neck muscles, glutes ) she continued to get the second dose 21 days later and she has had the spasms ever since.
Janssen COVID-19 Vaccine EUA. Chills, headache, body aches, mentally fogginess, slight nausea.
Patient was sitting in observation area after vaccination when she began seizing.  Patient was taken to the emergency department.
Pt. states that after receiving the 1st dose of Moderna 07/30/2021, started experiencing symptoms 08/07/2021 of red rash at injection site, fatigued, hot to the touch, itching, and tender to the touch. No Primary visit noted, no other symptoms.
MEMORY ISSUES, SEVERE STOMACH PAIN, HOSPITALIZED.  EVERYTHING CLEAR EXCEPT LOW MAGNESIUM LEVELS.  LATER HAD A STROKE AND IN HOSPITAL.  ALL ISSUES AFTER THE ADMINISTRATION OF SECOND DOSE.
Extremely painful sore arm at injection site , began 8 hours after , Almost fully resolved now  Chills, began 23 hours after Still feeling minor  chills and then 100° temperature , began 24 hr after injection, resolved in about 24 hours  Achy, began 24 hr after injection, resolved about /4 hour later Headache, began 24 he after injection, resolved about 24 hr later Extreme fatigue began 4 hr after injection , , has lessened but  I?m still not functioning at my normal energy levels Severe nausea began mild 24 hr after injection and in another  hours was  severe (couldn?t even  sip water) and was back to  moderate to mild about 48 hours after injection stomach still not completely back to normal Had minor pains I. Stomach several times when nausea was the worst Joint pains in major joints,  Worst in the left elbow below the injection site. Begin 54 hours after injection and resolved 12 hours after that, along with it had some lesser pain in limbs And a little in hands and feet
Patient states she felt tingling on the side of her face 15 minutes after receiving the vaccine.  Right side of face started drooping and right eye does not close and also feels as if there is a difference in the "thickness" between the  sides  of her face. She was diagnosed with  Bells' Palsy 2 months after vaccination.
Rash; Light pain in arm; Headache; light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jun2021 at 10:15 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history included hay fever and allergy to pollen. The patient did not receive any medication within two weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 14Jun2021 at 23:00, the patient experienced light pain in arm, headache and light-headedness. On 15Jun2021 the patient experienced rash about 1 inch in size that appeared about a day after vaccination. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event light pain in arm, headache, light-headedness and rash was recovered on an unknown date in Jun2021.     No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.