chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the booster dose 3 months after receiving the 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the booster dose 3 months after receiving the 2nd dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 005C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the booster dose 3 months after receiving the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the booster dose 3 months after receiving the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-483784.
4-8-07 diarrhea started and had some vomiting and gassy formula changed from Similac advanced to Isomil and giving pedialyte. 4-14-07 Semi-solid stool, 4-24-07 firm stools
0.3mL of undiluted vaccine; 0.3mL of undiluted vaccine; She is currently reporting  warmness in her arm.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Oct2021 (Lot number: FF2589, Expiration Date: Dec2021) at the age of 66 years as dose 3 (booster), 0.3 ml 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 immunisation; Bnt162b2 (Dose 2), for Covid-19 immunisation. The following information was reported: FEELING HOT (non-serious) with onset Oct2021, outcome "unknown", described as "She is currently reporting  warmness in her arm."; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 28Oct2021, outcome "unknown" and all described as "0.3mL of undiluted vaccine".  Additional information: Reporter was a contactable Nurse. Patient was administered the booster of the Pfizer covid 19 vaccine 0.3mL of undiluted vaccine today. Reporter was asking there anything they should do or look out for and asked for recommendation where to go from here. She was currently reporting warmness in her arm. In response, provided disclaimer and response from attached SRD - CDC ACIP Appendix A: No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered); and Withheld (PHE) Phase I/II study different strengths. Reporter was given the number of medical information to answer her question and told her to speak drug and safety first and then go from there. Registered Nurse was informed about the role of Pfizer Drug Safety and informed about Pfizer Medical Information department and confirmed the number. Registered Nurse hung up the call abruptly so further probing could not be done. Hence, limited information was available over the call. Full details unable to be obtained as caller disconnected before transfer was complete. No voice contact with caller.  No follow-up attempts are possible. No further information is expected.
Within 5 minutes of vaccine, experienced dizziness, chills, tachycardia/160 beats per minute and fluctuations in blood pressure. Within 6 hours, had elevated heart beat at rest and one other episode - approx. 6 hrs. after receiving vaccine of sinus tachycardia-170 bpm at rest and blood pressure spike-168/90 - normal around 100/60. Treated with BENADRYL, I.V. for hydration and beta-blocker to regulate heart and b.p. Continued heart rate & bp fluctuations 5 days out. Continued beta-blockers.  11/03/2009 Medical records received for DOS 10/22.  Palpitations.  Sinus tachycardia possibly related to anxiety. Atrial flutter not ruled out because of artifact on EEG.  CMP WNL. TPO Ab increased. Cardiac echo WNL.  Improved. D/C to home.  11/30/2009 ED records for 10/22, Dx palpitations, impression: possible adverse drug reaction
Patient woke up on 10/15/12 around 6:30am covered in red, pimply rash from head to toe.  No other symptoms present.  Rash lasted until 10/17/2012 and resolved on own.
Persistant cramping and diarrhea, watery diarrhea. No relief with pepto bismol.
Rash and urticaria pruritus. Diphenhydramine 25 mg PRN, prednisone 5mg.
Patient had complaint of pain and swelling, numbness of entire left arm. Sought medical attention on 11/14/2012.
My patient received her 2-month vaccines on the morning of Thursday 2/11/21. The following morning, on 2/12/21, she had 2 episodes diagnosed as BRUE's within 5 minutes of each other. Per mom, she was being carried in a wearable baby carrier and when mom looked down, she was still and when mom tried to touch her, she got no response. Mom removed her from baby carrier and gave her mouth-to-mouth breaths until she seemed responsive again. Then she seemed fine. It happened again about 5 minutes later. She was taken to hospital.
Left axilla swollen, mild erythema, pruritus-ecchymosis develops 3-4 days after, swelling resolved; area tender.
I felt tremendous body aches all day (the following day), my skin even hurt to touch lightly and a headache.  I took Motrin and even needed Vicodin for the pain.  No fever or nausea.  This is still better than getting COVID and I am just reporting for data purposes.  I was told that this symptom could occur after the second dose.  Some people are talking about blood type being a factor, I am not sure if that is true, but I am A+ if that helps. Vaccine on Friday, Saturday felt horrible and Sunday was back to normal.
I had a small fever; my arm was really sore; I felt really tired and fatigued. I had a small headache. The fever was one day. The arm was sore for two or three days. And my fatigue and headache went away after about two days.
I felt like I was going to die.; Chills; headache; stomach upset; nausea; fever; fatigue; weakness; dizziness; vomiting; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 16:00 (Batch/Lot number was not reported), at age of 38 years old, as single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient previously took dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:00 AM (Batch/Lot Number: 1 as reported) as single dose for covid-19 immunisation.  Medical history was none and no known allergies. Concomitant drugs within 2 weeks of vaccination was not reported. Reported Event as reported: "24 hours after I took my 2nd dose, I felt like I was going to die.  Chills, headache, stomach upset, nausea, vomiting, fever did not go away with Tylenol, fatigue, weakness and I even passed out. I alternated the use of Tylenol and Ibuprofen and it didn't work. Today (03May2021), 10 days after my second dose, i still feel weakness, fatigue, dizziness, stomach upset and nausea and I went to Emergency Room. I did bloodwork today at the and the doctor said that everything is normal in my blood test. They even tested me for the covid, but the test was negative for Covid. I was feeling very well, and healthy before the second dose of the vaccine and now I never felt well again. Terrible and weird side effects." Events onset date reported as 23Apr2021 07:00AM, AEs resulted In: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Zofran used as treatment and still feeling bad Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19 with negative result.  The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax & had pain in lt deltoid & lt wrist; pain in wrist w/swelling & erythema;
It was the next morning I did not have any energy and I had one day I slept all 24 hours, the following day I had nausea from the time I woke up to the time I would go to bed, Then I had fever.
Metallic taste in mouth; Cough; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), COUGH (Cough) and PYREXIA (Low grade fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), COUGH (Cough) and PYREXIA (Low grade fever). At the time of the report, DYSGEUSIA (Metallic taste in mouth), COUGH (Cough) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Next day... pain, red, "swollen to size of a Lemon". Iced and frozen peas/carrots, and oral children's MOTRIN given. Swelling completely gone by morning. Site still slightly red and still slightly tender.
3-4 hours after vaccination, patient developed urticarial pruritic rash on palms of hands and on dorsum of feet and around ankles.
not feeling good at all; redness is running down the arm; redness; highest temperature of 101 degrees F; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), ERYTHEMA (redness is running down the arm), MALAISE (not feeling good at all), PYREXIA (highest temperature of 101 degrees F) and HEADACHE (horrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ERYTHEMA (redness), PYREXIA (highest temperature of 101 degrees F) and HEADACHE (horrible headache). On 25-Mar-2021, the patient experienced ERYTHEMA (redness is running down the arm). On an unknown date, the patient experienced MALAISE (not feeling good at all). On 25-Mar-2021, PYREXIA (highest temperature of 101 degrees F) had resolved. At the time of the report, ERYTHEMA (redness), ERYTHEMA (redness is running down the arm), MALAISE (not feeling good at all) and HEADACHE (horrible headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were not provided No treatment medications were not provided
Fever of 102.1 F, chills, body ache, headache sensitivity to light, onset over night early morning the day following vaccination. Rested and sleep most of the day no medication taken. Symptoms were severe and prevented daily activities.  Day 2 following shot showed same symptoms with decrease in peak temperature. Day 3 decrease in headache and light sensitivity ongoing severe fatigue interfering with daily activities compounded by lightheaded mess, difficulty concentrating and mild intermittent chest pains. Day 4 following vaccination was indistinguishable from Day 3. Day 5 & 6 body aches diminished, headaches stopped. Continued ongoing extreme fatigue interfering with daily activities. Difficulty concentrating and mild intermittent chest pains/tightness. Day 7+ post vaccination, ongoing fatigue and mild intermittent chest pain, difficulty concentrating. Day 10 post vaccination still experiencing fatigue interfering with daily activities, difficulty concentrating and mild intermittent chest pain.
Red inflamed site of injection status post receipt of PREVNAR - 13 vaccine. Recommended hydrocortisone cream twice daily.
Pt. presented to clinic for second MMR on 08-18-2009.  Reported pregnancy with EDC 12-18-2009
Pain in L deltoid muscle daily since injection. Pain with range of motion. I had it checked by my PCP and she thought it was a result of the H1N1. I continue to have pain every day.
This is only a moderate adverse event, but I wanted to add it to the record in case more people have similar experiences. // Day 1 - mild pain at injection site, no other issues. Took Advil. // Day 2 - Flu-like body pains/sensitivity, very uncomfortable, foggy brain, spent most of the day in bed because that made it less uncomfortable. (I understand this is a typical 2nd shot reaction. No problems there.) Took Advil. // Day 3 - Felt fine when I woke, no more full body pains except continuing strong pain at injection site. Pain level totally managable. Continued the Advil. // Evening of Day 3 - Arm hurting a lot now. Migraine started,  back started cramping, neck cramped so badly it became nearly immobile. Pain in arm still pretty strong. Continued the Advil. // Day 4 - Pain continued, very slightly less. Continued the Advil. // Day 5 - Pain considerably less, arm pain very mild, back and neck cramping stopped completely. Residual soreness/stiffness, but that's it. Migraine gone.
Information has been received from a physician concerning a 12 month old male who on 23Sep05 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) In the evening of 23Sep05, the pt presented to an ER with a drug reaction. The reaction was described as a rash all over his body. It was noted that he had no respiratory distress and no fever. The pt was treated with oral diphenhydramine hydrochloride (Benadryl) and was not hospitalized. On an unspecified date the pt recovered. A product quality complaint was not involved. Rash all over his body was considered to be an other important medical event (OMIC) by the physician. Additional information has been requested.
Patient called pharmacy 08/19/19 -  She stated that she recieved the vaccine Friday 08/16/19 around 4pm.   She said the next day her arm was swollen and sore at injection site.  She said she felt tired and achy.   She took ibuprofen.  The next day (sunday) she felt still tired and achy and as a nurse, recognized the first signs of cellulitis.  She went to urgent care to receive steroid and an antibiotic.  Monday morning she started to feel better and arm looked improved.
Her arm has been sore since she received the shot. It hasn't gotten worse, and hasn't gotten better. No swelling or redness at site of injection.
The patient describes nausea starting the morning after the vaccine.  On 4/15/21, the day after vaccination, the patient was at the kitchen sink about to vomit at 11:30am.  She was surprised to wake up on the kitchen floor.  She does not know how long she had been passed out but knows that she went to bed at around noon.  She was sitting on the edge of her bed at around 12 noon.  She then woke up at about 4pm and believes she had passed out again for this period of time.  The patient reports feeling nauseated for a couple of days after vaccination.  The patient contacted her doctor's office to discuss the event but as of 4/23/21 she has not gotten a response from her physician's office.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen test after negative 5 days, after completion of paxlovid; Negative, notes: positive antigen test after negative 5 days, after completion of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & exp fever,body aches,& a rash;events resolved;pt recvd 3rd dose of Engerix-B w/o incident
My left nose is all swelled up; My hand shakes so bad I can't sign a check or write anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Lot number: FC3182) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PHENOBARBITAL. Vaccination history included: Bnt162b2 (Shot date (first shot): 12Aug2021), administration date: 12Aug2021, when the patient was 76 years old, for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "My left nose is all swelled up"; TREMOR (non-serious), outcome "unknown", described as "My hand shakes so bad I can't sign a check or write anything".  Additional information: Consumer stated, I was calling about side effects. My left nose is all swelled up, my hand shakes so bad I can't sign a check or write anything, the second Pfizer shot (Covid-19 Vaccine).  Follow-Up (14Sep2021): Follow-up attempts are completed. No further information is expected.
I had chest pain and I ended up in the ER; swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was; 15 minutes after the shot, shortness of breath, continued until I got treatment at the ER; swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was no longer than 10 minutes and it eased off; he was having a reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (I had chest pain and I ended up in the ER), SWOLLEN TONGUE (swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was), DYSPNOEA (15 minutes after the shot, shortness of breath, continued until I got treatment at the ER), SWELLING (swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was no longer than 10 minutes and it eased off) and VACCINATION COMPLICATION (he was having a reaction to the vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced CHEST PAIN (I had chest pain and I ended up in the ER), SWOLLEN TONGUE (swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was), DYSPNOEA (15 minutes after the shot, shortness of breath, continued until I got treatment at the ER), SWELLING (swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was no longer than 10 minutes and it eased off) and VACCINATION COMPLICATION (he was having a reaction to the vaccine). On 20-Apr-2021, CHEST PAIN (I had chest pain and I ended up in the ER), SWOLLEN TONGUE (swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was), DYSPNOEA (15 minutes after the shot, shortness of breath, continued until I got treatment at the ER), SWELLING (swelling of my tongue and started to swell on the side of my neck but the swelling on the neck was no longer than 10 minutes and it eased off) and VACCINATION COMPLICATION (he was having a reaction to the vaccine) had resolved. Not Provided          Patient was treated with IV Benadryl and IV Steroids for the adverse events and was instructed to take Benadryl as needed. Concomitant medications include 22 different medications daily for unknown indications.   This case was linked to US-MODERNATX, INC.-MOD-2021-089069 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089069:1st Dose case
extreme pain in lower back; minor pain in the arm; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 11Feb2021 13:30 (Batch/Lot Number: EN6201) (at the age of 73-years-old)  as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in a school/student health clinic.  There were no other vaccines received in four weeks. The patient did not have COVID-19 prior to vaccination. Medical history included cancer, heart attack, and allergies to shellfish, tobacco, and penicillin from unknown dates and unknown if ongoing. Concomitant medications included amiodarone; aspirin [acetylsalicylic acid]; carvedilol (CARVEDIL); furosemide (LASIX [FUROSEMIDE]); and lisinopril, taken for unspecified indications, start and stop dates were not reported.  The patient previously took aspirin and acetaminophen and experienced drug allergies.  On 12Feb2021 (reported as 12:00 AM), the patient experienced extreme pain in lower back and minor pain in the arm. The events were considered serious due to disability, and medically significant by reporter. The patient's clinical course was reported as follows: Minor pain in the arm but by midnight extreme pain in lower back. The patient had lower back pain and thought maybe he overdid some of his physical exercise. After 2 weeks of this pain, he stopped his physical exercise to give back a rest. The back pain had completely disappeared. Over the next 9 days, three trips to the ER (once by ambulance) serious pain pills prescribed. Eventually the pain subsided (corresponding to the pain in the lower back returning) 3 months of physical therapy with (facility name) and he continued treatment at home. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and caused disability or permanent damage.  The patient was tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included COVID  test nasal swab: negative on 30Apr2021.   Therapeutic measures were taken as a result of the events. The outcome of the events was recovered with sequelae.
Day 4 became short of breath and continued to increase each day until hospitalized on March 3, 2021.  Wheezing, poor response to home meds. Oxygen sat was lowest 88. Dr thought this reaction was due to prior lung infection 2018 (ARDS - staph pneumonia).