chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe body aches; chills; low grade fever; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included hypertension, endometrial cancer and radiation therapy from an unknown date and unknown if ongoing. Concomitant medication included lisinopril. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021 10:00 AM, the patient stated, "the second day I began having severe body aches, chills, low grade fever, diarrhea, and vomiting. I received radiation therapy three days prior to getting Pfizer vaccine". The outcome of the events was recovering. No treatment for the events was given to the patient.  Information on the batch/lot number has been requested.
Death  4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week)  2) COVID Pneumonia (onset interval 1 week)  Other: acute on chronic congestive heart failure
9/15/15-itching. 9/18/15-cold sx (congestion). 9/20/15 Feverish, HA rash spreaad 9/20/15-cold sx improving-rash .
gastric effects; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTRIC DISORDER (gastric effects) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTRIC DISORDER (gastric effects). At the time of the report, GASTRIC DISORDER (gastric effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.    This case was linked to MOD-2021-009966 (Patient Link).
Patient received 12 month vaccines of MMR, Varicella, Hep A, Pneumococcal at well child exam, mom called one week later stating patient started with fever that same evening of vaccines and has had a rash for about 5 days. Patient was brought in that day with fever and scarlatiniform rash. Lab work, RSV and influenza were done and all negative. Antibiotic was given.
fever 1-2 days (highest 103.6 R); tempra every 4 hrs; irritability;
pt. c/o of headache on her back side.   BP 154/73:   P=100;  pt. states feeling better.   Hx- HTN
High fever, rash, weakness, fatigue, stomach ache, sore legs, no appetite, cough, green bugars, swollen throat, threw up.  Now on Day 17 from vaccines & high fever again/sick.
Big red spot on my chest; Headache; my back is itching; I am scratching a lot; This is a spontaneous report from a contactable consumer (patient himself). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161, Expiration date: Unknown), via an unspecified route of administration in right arm on 11Apr2021 as dose 1, single (at the age of 54-years-old) for COVID-19 immunization. The patient's concomitant medications included chlorphenamine maleate (CHLORTAB [CHLORPHENAMINE MALEATE]) taken for allergy, naproxen and hydrocodone taken for knee, start and stop date were not reported. On an unspecified date in Apr2021, the patient experienced big red spot on my chest and his back was itching, he was scratching a lot and headache. It was reported that he noticed mark on chest and he was wondering. He just noticed it today. It was reported that he had the headache might be from his sinus. The patient did not receive any treatment in response to the events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who was vaccinated with ADACEL on 26-Oct-2018 and inadvertently intramuscular dose was vaccinated with the same vaccine in the left arm (lot number: U5980DA, expiry date: 22-Jun-2020) instead of INFLUENZA VACCINE on 16-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered and Extra dose administered. The patient did not experience any side effects from his injection 3 weeks ago. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a consumer concerning her daughter who developed soreness on her arm and neck after receiving a dose of GARDASIL. Lot # is not available. Additional information has been requested.
Fatigue, full body muscle soreness, injection site soreness, injection site swelling, right collarbone lymph node swelling
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient medical history included gastrointestinal (GI) upset with amoxicillin and tetracycline (manufacturer unspecified) and depression with benzodiazepines (manufacturer unknown). Pharmacist reported that these reactions were listed as patient's allergy on patient profile. The patient had allergy to nickel. On 07-JUL-2016, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin (manufacturer unknown) and vitamin D (unspecified). Pharmacist reported that patient received a dose of ZOSTAVAX but dose was inadvertently administered intradermally rather than subcutaneously. Pharmacist also reported that during administration, very small amount of ZOSTAVAX leaked out from needle and patient might not have received full 0.65 ml. On 07-JUL-2016, shortly after vaccination, indurated area (about 9 x 6 centimeters) around injection site and indurated area was tender and warm to touch. Pharmacist recommended for patient to take ibuprofen and use heat and gentle massage to manage adverse effects patient experienced. Patient followed up with her primary care physician, on 11-JUL-2016 and patient was told to continue with ibuprofen, heat and gentle massage. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported. Additional information has been requested.
really itchy; saw a couple of them on my thighs, quads; big welts on the outside of my hands, going up to my elbows on both my arms, and a couple of them on my thighs, quads; Blisters; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (saw a couple of them on my thighs, quads) and PRURITUS (really itchy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced URTICARIA (saw a couple of them on my thighs, quads). On an unknown date, the patient experienced PRURITUS (really itchy). At the time of the report, URTICARIA (saw a couple of them on my thighs, quads) and PRURITUS (really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.   Treatment for the event was not provided.
Red blotches on her face developed and her lips swelled.  She complained of feeling generally tired achy and she developed an eye blinking tick.  Benadryl was administered that evening which had minimal effect on the facial rash and swelling and no effect on the eye twitching.
Started with numbness and tingling from neck down. Started falling and having intermittent confusion and slurred speech. Ended up aspirating d/t dysphagia. Was admitted to hospital with pneumonia, which turned into diffuse alveolar hemorrhage requiring intubation. MD, PT, nursing feel pt has Guillain-Barre Syndrome. At home recovering now.  Continues with numbness and tingling to extremities.
Patients is 17 years old and received Booster dose on 11/05/2021 @ 4:10 PM
*First 48 hrs severe flu like symptoms- achy, stomach ache, fever, chills. *Day 3 - stomach ache *Day 4 - stomach ache, loss of feeling in hands / pins and needles / severe drop in body temperature going as low as 97 degrees / chills / chattering of teeth / freezing hands  *Day 5 - stomach ache, loss of feeling in hands / pins and needles in hands and arms / pins and needles in face / freezing hands  *Day 6 - stomachache, tingly hands and face, freezing / white hands  *Day 7 - very mild symptoms  *Day 8 - severe headache / felt like a migraine  *Day 9 - severe headache / felt like a migraine
booster; I had fever; and I just felt horrible and at last sit a few hours; I was so weak; I couldn''t get up, hardly get stand up; 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) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PYREXIA (non-serious), outcome "unknown", described as "I had fever"; MALAISE (non-serious), outcome "unknown", described as "and I just felt horrible and at last sit a few hours"; ASTHENIA (non-serious), outcome "unknown", described as "I was so weak"; COORDINATION ABNORMAL (non-serious), outcome "unknown", described as "I couldn''t get up, hardly get stand up".  Additional information: Consumer stated, "Yes, I got my third vaccination, let me see, day before yesterday about 3 O'clock in the afternoon and I was fine until about 4 O'clock in the morning. I went to the bathroom, and I was so weak, I couldn't get up, hardly get stand up and I had fever and I just felt horrible and at last sit a few hours. I had, I live alone or maybe 83 years old. So, I had to call my daughter to come and help me and I just felt weak most of the day and but today I feel better. (General statement) I just thought, they want to know about side effects. The follow-up (07Oct2021) is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received expired Moderna booster vaccine. Patient exhibits no adverse signs or symptoms. Patient evaluated and instructed to report any issues. He verbalized his understanding. No treatment given.
Spoke with this patient regarding a full body rash after taking "an antibiotic for 5 days". This happened to follow his 2nd COVID-19 immunization by ~1 week. Patient has seen several different physicians and has had multiple rounds ofs oral steroids. Patient was sent to dermatology for a consult, however was sent to the ED due to an alk phos of 1,000.  Patient denies use of any medications at home other than the prednisone/dexamethasone they received over the past 5 weeks.
About 10 minutes after receiving the shot, patient felt dizzy. He continued walking and fainted. He was caught by his wife and was let down to the floor. After resting, he regained consciousness. After resting longer, he felt better and was able to leave on his own. After about 2 hours, he said he felt fine and had no lingering effects.
pt recv vax & a few days later devel an erythematous rash on the arms & legs;no further details known as of the date of this report
Pt had signed up for a vaccine on 3/22/2021 and scheduled a follow up injection (2 part series) for 4/11/2021.  The pt no-showed the appointment and did not cancel it.   The pt made another 1st dose appointment on 3/31/2021 and did arrive at that appointment to receive her vaccine.  However, she also arrived at her 2nd vaccine dose appointment on 4/11/2021 as she had still not cancelled it.  She checked in and received the vaccine.    IT had been made aware of this glitch only a short time before and had already acted on it, cancelling all no show appointments so that it wouldn't happen again.  However, during a shift change, another IT specialist had just arrived and was not aware of the issue.  The IT specialist overrode the appointment allowing the pt to receive the vaccine.  All employees are aware of the issue and the system is functioning properly which is to cancel the no show 2nd appointments so early doses cannot be given should a pt double book appointments in the future.
Pt states Flu vaccine high in RT Deltoid. Typical initial discomfort in Rt arm when given. Pain has increased since then to include anterior shoulder and persists with any arm movement. No redness or swelling since 1st 2 hrs. Pt perceives weakness but no numbness or tingling - No prior Rt arm probs Rt hand dominant. No improvement
Mother brought child to doctor's office on 7/12/17, reporting child's right upper arm swollen, warm to touch and feels hard. Mother states she used ice to site the previous evening. Patient seen by Dr. on 7/12/17, was prescribed ZITHROMAX 100 mg/5 mL oral suspension 5 cc to start then 2 1/2 cc daily.  Mother called 7/13/17 stating the swelling was going down the patient's arm, advised to go to the ER.
K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type R06.02 - Shortness of breath N18.6 - End stage renal disease E87.5 - Hyperkalemia D50.0 - Blood loss anemia J81.1 - Pulmonary edema I21.4 - NSTEMI (non-ST elevated myocardial infarction)
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
I got COVID on 05/31/2022. So, I was doing some yard work and I thought it was allergies and than the next day I was having hay fever symptoms. I had fever, running nose, cough and my symptoms was mild. I than called my PCP and they called me in the Paxlovid for 5 days. I took the last one today. The last week in May 2022 I took a trip and that's where I believe where I got COVID. I have been quarantine for 7 days today. I took a test and it was negative.
BODY ACHES.  ESTIMATED DELIVERY DATE OF 11/24/21 PRESENTED FOR AN INDUCTION OF LABOR DUE TO IUGR. POSITIVE COVID TEST ON PREADMISSION
About 3 days after vaccination, I began to experience pain in right hand, wrist, elbow, axilla and back. pain was intermittent, sometimes severe, with minimal response to ibuprofen or acetaminophen.  Pain followed path of ulnar and median nerves.  2nd vaccination neither improved nor exacerbated symptoms.  4 weeks later it is much improved, but not gone.  I wouldn't have thought it a side effect of the vaccine, except that my assistant, who received 1st dose same day at same facility, had the same, although more severe symptoms.
Vaccine vial expired on 10/13/21 at approximately 1800. Vial remained out overnight. Patient on 10/14 wanted dose #1 and the vaccine was drawn up from the 10/13 vial at approximately 11:20am. Vaccine was administered in left deltoid at 11:37. Error was discovered at approximately 11:45am. Patient remained in the waiting room for 30 minutes without any reaction. She was informed of error by CNM. Clinical manager, attending physician, pharmacy and manufacturer were all notified.
Fevers; Chills; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; Body aches; Patient suspected that he has gotten infected also from his spouse; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 (Tuesday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported body aches developing the evening of receiving the vaccine, and it has persisted for three days. Patient started to get the chills on Wednesday (06Jan2021). Patient said his wife has been tested positive after he took the 1st dose and he is suspecting that he got infected with the Covid-19 though he already received the 1st dose. Patient thought that he may have been infected by his spouse. He got the vaccine on Tuesday and on Wednesday had fever and chills and still has them. Stated that his spouse lost her sense of smell and taste and tested positive for Covid on Wednesday. Patient stated that this was the day after he received his vaccine. Patient suspected that he has gotten infected also from his spouse and was not aware when he got the vaccine. Stated that now that he is having expected side effects of fever and chills. The outcome events was not recovered. This case was reported as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and suspected got COVID-19 infection via exposure to COVID-19 living with his wife, who lost her sense of smell and taste and tested positive for COVID on 06Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Further information is needed for full medical assessment.
Right arm pain, heaviness, shoulder pain, limited range of motion, numbness and tingling.  Symptoms began two weeks after receiving vaccine.  Patient treated with medication.
After receiving the vaccine, the patient stood up for the next member of his party to get the vaccine. It was about 5 minutes and he fell on the floor because he had fainted.
The following day, about 16 hours later, after waking up she felt very thirsty and when she got out of bed started feeling dizzy, nauseous, with dry heaves and feeling like she was going to pass out, with vision and hearing diminishing.  She sat on the toilet with her head between her knees for a while and it took a few minutes to feel better.  When she went to the kitchen to fill her water bottle her arms got very stiff and painful from the elbows down to her fingers and she could not open her water bottle at the time because her hands were closed in a spasm.  She got back to her bed and sat on her opened hands to stop them from involuntarily closing again.  No color changes were noticed.  The day before she did not have any activity that involved her neck or arms to move differently.     She said she had a mild headache, but no other symptoms.  The spasms resolved a few minutes later and everything was back to normal.  She has been fine since then.
Soreness at injection site - prolonged. Extreme fatigue - chronic and ongoing. Loss of appetite Chills, fever elevated.
5x5 cm area of warm erythmia to lt buttock; t99.9a;
30 minutes after receiving the injection, I started having a dry cough, brought on by bronchial spasms. The cough and spasms are ongoing 24 hours later. I then developed significant pain at the injection site three hours after, which has continued through the 24 hours that has gone by.  At 12 hours post-injection, I began to have myalgia, fatigue, headache and chills.  I used 1000mg of Tylenol at the 16 hour mark, with moderate relief. When the Tylenol wore off, all symptoms returned in full.  I am now 26 hours  post-injection, and still having all symptoms previously mentioned.  At no time, before or after taking Tylenol, did my temperature go above 98.5
Erythematous, hot area 10cm diameter around the area where vaccine was administered. No oozing, no lumping. Treated with BENADRYL. Treated with clindamycin to cover skin pathogens.
diarrhea; dizziness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Information was not reported. Concomitant product information was not reported.   Reporter did not allow further contact
Briefly after taking the first dose, I experienced left arm pain, which traveled to my fingertips, shoulder, and to my chest area. After a few minutes, the pain went away. Two hours later, my head was hurting badly. A week later, I got chills, fatigue, dizziness, throat issues, my ears felt clogged, my nose was stuffy, and felt pulses in my knees and head. My body felt like it was fighting an infection. I felt very cold. Dizziness has not gone away, like when I get up from my seat. I have sinus issues as well. It feels like there is mucus in my throat all the time. My vision has also changed and sometimes things are too bright for my eyes.