chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scratching all over; Redness all over; Hotness in the ears; Scratching all over the body with bumps; her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine; A patient developed Sore arm on the day of first dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and MYALGIA (A patient developed Sore arm on the day of first dose of vaccination) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history is provided and concomitant drug are mentioned.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (A patient developed Sore arm on the day of first dose of vaccination). On 07-Apr-2021, the patient experienced SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and PRODUCT DOSE OMISSION ISSUE (her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. On 06-Apr-2021, MYALGIA (A patient developed Sore arm on the day of first dose of vaccination) had resolved. On 08-Apr-2021, SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and PRODUCT DOSE OMISSION ISSUE (her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient took Benadryl(dexamethasone) first dose and her bumps got better and took 2nd dose her redness got better. She consulted her pharmacist with the rash images and her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine. Patient provided consent for safety team to follow up.
Child was given ROTATEQ #1 at age 17 weeks. Had vomiting < 2 x 1 day for 3 days and diarrhea < 4 x / day for 3 days after vaccine given. Also taking propanolol 4 mg TID. No episodes hypoglycemia. No dehydration. No ER visits.
I got my first Moderna shot on May 11th.  I was extremely tired the next day and just napped most of the day.    The second day I was a little better but still felt a little drugged.  This condition has continued to the point that I am ready for bed by four in the afternoon, a sharp difference from my usual 11:00 pm.  Afraid to drive because you might fall asleep at  a red light.  No prior similar symptoms . Also including periodic slight fevers to 99.3, my normal temp is 96.8, headaches and being extremely cold.  Also a lot of muscle aches, everywhere, and dizziness.
The morning after the vaccine was administered, pt woke up at 0600 and noticed red, warm circle around injection site. Pt states the area is tender. Does not impair movement or function of arm. At 1115am I assessed the site and it measured 6cm x 6cm, was reddened and warm to touch. No palpable areas of swelling. Pt states pain is mild. Encouraged cold compresses if needed and to seek further medical care if reaction worsens or does not improve in the next 2-3 days.
6 hours after the vaccine my fever was 101. 4, I had chills, myalgia, arthralgias, dizziness and diarrhea. I was too weak to get out of bed. When the diarrhea got worse  and became constant I had to wear adult diapers - this lasted for 3 weeks. I lost 8 lbs and had no appetite.  The fever and aches subsided after 24 hours post vaccine, but the diarrhea continued and I saw my primary physician on 9/18/2021. I could not get an appointment earlier. By the time I saw her I was feeling better. And my vital signs were back to normal. This was the first time I had experienced a reaction to any vaccine in my life and at age 69 I have received many.
This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004571: US-009507513-1706USA004572: US-009507513-1706USA004573:
Patient has been experiencing a headache since her vaccine. She states the headache comes and goes and is not severe. However, since it has been 8 days, I advised her to contact her doctor to followup.
Breakthrough case admission after 5 vaccines Moderna 1/22/21 Lot# 027L20A;  Moderna 2/19/21 Lot# 038K20A;  Moderna 12/1/21 Lot# 034F21A;  Moderna 6/10/22 Lot# 056M21A;  Moderna 11/18/22 Lot# AS7148B
Gave 3rd shot, patient fainted from sitting position on table. Doctor notified. B/P 110/70. Patient rested on table for 15 min until felt better. Left office without difficulty.
Patient seen in cardiology office one month after J&J shot, referred. Pt noted palpitations several hours after injection and then progressively have more over the next few weeks and then started to subside. Standard lab work completed and was normal. ECG w/o c/o pericarditis or other abnormalities. Echocardiogram was w/o LV dysfunction or any other structural issues. 30 day event monitor did show sinus tachycardia multiple times during its duration and associated with sx (palpitations, chest discomfort, etc). sx improved over two months and patient not requiring medications for tx, but is being observed.
Patient was running a fever of 100.4 about 26 hours after vaccination and both arms (specifically shoulders)were very sore. Patient described pain as being "on fire." Patient was advised to take TYLENOL for pain and she did take a TYLENOL with a prescription pain reliever that she already had at home.
Excruciating pain at injection site about three hours after administration. Unable to sleep for the next two nights. Limited sleep on the third night. Cannot get dressed, use bathroom, apply deodorant or tie back my hair. Pain was relentless for first 24 hours but is getting  more manageable very slowly. Can now rotate my elbow about 6 inches from my body.  Can also dangle my arm. Injection was given high up on my shoulder and pain radiates toward the front of my body.  Fingers are swollen on my left arm.
PT RECEIVED SECOND DOSE ON 8/18/2018 AND DEVELOPED SHINGLE-LIKE RASH ON BACK ON 8/25. SHE WAS SEEN BY DOCTOR ON 8/26--AT THIS TIME IT HAS BEEN CONFIRMED THAT THE PATIENT HAS SHINGLES. SHE WAS PRESCRIBED ACYCLOVIR 800MG AND NORCO (FOR PAIN RELATED TO SHINGLES).
Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches  in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
I am still sick; Fever/my fever was up to 101.7. It is down to 99 now but I still have the fever; Chills; Aches; joints ache; Some muscle pain; Headache; Tiredness; Injection side swelled up; feeling poorly; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: 28Dec2020 (as reported)), via an unspecified route of administration, on 28Dec2020, at single dose, as a preventive measure for Covid. Medical history included blood pressure abnormal (reported as blood pressure). Concomitant medication included amlodipine besilate and amlodipine besilate (NORVASC 5 mg) both for blood pressure. The patient reported, "I received my first dose of Covid19 vaccine on Monday (28Dec2020) and it is now Friday and I am still sick and I am wondering how long these symptoms typically take to get better from because it seems like it is day 5 now so". When probed for events the patient stated, "Everything on the list, fever, chills, aches, my joints ache, some muscle pain, headache, tiredness, injection side swelled up. I was not nauseas or anything like that. I still have fever today. I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever." The patient mentioned, "I kind of like started feeling poorly on the 29th (29Dec2020) late at night but on the 30th (30Dec2020) I had fever and everything." The patient underwent lab tests and procedures which included blood pressure measurement: is always good on an unspecified date, body temperature: 101.7 on 30Dec2020, body temperature: 99 on 01Jan2021 (reported as "I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever"), and laboratory test: unknown results on Dec2020 (reported as "I did go for full series of stuff, checkup but that was more than 2 weeks ago"). The outcome of the events was not recovered.
About 1-1 1/2 hrs p/recvd vax pt began to c/o abd pain, severe headache; had nausea & vomiting; approx 3-3 1/2 hrs p/vax recvd t104.6; seen in ER & tx w/APAP;
Redness, edema, numbness in hand. Follow up information received on 4/11/2003 states: treated arm with circumferential swelling from elbow to shoulder (left arm).
Fever of 102, nausea, flu symptoms i.e. muscle aches, headace.  Lasted about 8 hours, felt normal after symptoms abated
Within 10 minutes of receiving the vaccine I became very dizzy, noticed that I was having difficulty swallowing and my tongue was swelling. My heart felt like it was racing as well. I was treated at the onsite urgency center and given the following via an IV: Type 2 Diabetes, Essential Hypertension, Benign fasciculation cramp syndrome, dyslipidemia, Obesity, Vitamin D Deficiency, Stiff Person Syndrome and sent home with a prescription for a 7 day course of 4mg METHYLPREDNISolone 4 mg dose pk.
expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:15 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. No treatment were reported.
Got it, and now have the flu; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves patient of unknown demographics who got Influenza vaccine, and then had the flu.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for Flu(Influenza). Information regarding batch number details has been requested.  On an unknown date the patient developed a non-serious event got it, and now have the flu (influenza)(unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  Corrective treatment: Not reported.  At time of reporting, the outcome was Unknown for the event got it, and now have the flu.
This spontaneous report was received from two medial assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose, dose number, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; Accidentally administered with 3 different EXPIRED lot numbers; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers).    This case was created for 2nd patient of the 6 patients involved.  Concomitant medication was not provided. It was reported that 6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2023: Follow-up received and added reporter details, patient initials and patients details were added, dosage information added.
Nurse gave vaccines and then left room to get band-aids. Returned to pt's mother holding him up - he was limp, convulsing and eyes rolled back in head. Laid pt on table and took vitals including glucose - finger stick. All WNL.
12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills, body aches, headache. 24 hours after injection, I developed swollen and tender lymph node under my left underarm (the same arm that received the shot). 48 hours after injection, I had horrible night sweats needing to change out of drenched pajamas every 1.5 hours.
needed kidney and/or bladder transplant; within 30 hs after second shot, she died; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (within 30 hs after second shot, she died) and TRANSPLANT (needed kidney and/or bladder transplant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (within 30 hs after second shot, she died) (seriousness criterion death) and TRANSPLANT (needed kidney and/or bladder transplant) (seriousness criteria death, hospitalization and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.            The reporter does not remember if this was from Pfizer or Moderna. Concomitant product us e was not provided. Treatment information was unknown.  This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine.  Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Th; Sender's Comments: This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine.  Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Vaccinated on 12/7/21 in the afternoon. Developed pain in left arm overnight and had trouble sleeping. On 12/8/21  patient states left arm was swollen and hard. Patient is also very tired. Dr, PCP was notified.
Patient tolerated well no adverse reaction, dose was given after moderna bivalent vial was in the fridge after 30 days.
Tdap given between 4 and 5pm -2-18-14. Patient states site sore that evening. The next day site hurt bad then he ran a low fever -just over 100 degrees F for a few days. Fever gone today. Site is a little sore. patient denied noticing any swelling or warmness at the site.
Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis area. General headache.
Beginning the day of the 2nd dose I had elevated BPs (160s/110s) and tachycardia (100s) while at rest, no matter from which arm or position taken).  It has taken approximately 3 weeks for my HR to return close to baseline at rest but my diastolic BPs remain in the 90s (my resting baseline is 120-130/70-80 BP, 60-70 HR).  I am now 4 1/2 weeks post-2nd dose and still 130-140/90s but HR 70s.  Also, I had been diagnosed with CIDP earlier in the year and since the 2nd dose I have been increasingly fatigued and have pronounced hand and foot weakness each passing week--I have walking difficulty at this time and am unable to grasp and lift even 3# weights.
I had the usual symptoms of a vaccine reaction like extreme muscle pain in my upper back/neck, chills, and fatigue.  But then on Monday I noticed a very tender left armpit, and I also have very itchy eyes, something I never have.  I also developed a small purple patch on my leg, and a little skin sore on my left arm.  It looks like more may be developing.
minor sore on the shot area; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "minor sore on the shot area"; HEADACHE (non-serious), outcome "unknown", described as "headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough hives; condition deterioration; This is a spontaneous report from a non-contactable other Healthcare Professional reported for patient. A 35-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was 35 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history included urticaria from an unknown date. The patient's concurrent condition included ongoing chronic idiopathic urticaria. The patient's concomitant medications were not reported. On unknown date, it was reported that patient experienced breakthrough hives. The outcome of the reported event was condition deteriorated (not resolved).  No further information was added.
Patient is a 4 year old male who will turn 5 prior to the scheduled 3rd dose of Pfizer 6 month-4 years formula.  Parents opted to "age up" the child to begin with the higher dose since he is autistic and does not handle injections easily.  Child received the requested first dose of the Pfizer Pediatric 5 - 11 formulation, but upon return 21 days later, vaccinator administered the age appropriate dose of Pfizer 6 month-4 years strength.  Once the error was caught, family was immediately notified and offered the correct dose for the child.  Family waited a week and brought child back to receive the proper 5 - 11 strength.
scattered hives, urticarial rash which appeared about 2 weeks after her first shot
Patient asymptomatic. It was noted afterwards upon chart review patient was given specific meningitis B vaccine instead of more broad meningitis vaccination.
pt recv vax14FEB97 & the following day pt devel pain in lt breast & shoulder;the event resolved on its own on 16FEB97;it is not know whether the pt took any med for the pain;