chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN INJURY (Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced BRAIN INJURY (Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory) (seriousness criterion medically significant). At the time of the report, BRAIN INJURY (Have brain damage shown in several MRI,suffer since mid April of 2021 with my memory) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: have brain damage shown in several mri have brain damage shown in several MRI.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Brain injury (Have brain damage shown in several MRI), that occurred on an unknown date after receiving a dose of mRNA-1273 vaccine (latency between vaccine and event cannot be established).  Patient developed memory impairment for which several magnetic resonance imaging done reportedly showed brain damage with no identifiable cause. The event was resolving at the time of report.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Brain injury (Have brain damage shown in several MRI), that occurred on an unknown date after receiving a dose of mRNA-1273 vaccine (latency between vaccine and event cannot be established).  Patient developed memory impairment for which several magnetic resonance imaging done reportedly showed brain damage with no identifiable cause. The event was resolving at the time of report.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch; It is getting worse and not getting better; It hurts real bad; Pain in arm/but it came right back after a week; After the 2nd dose, after a day or so I noticed pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the 2nd dose, after a day or so I noticed pain in my arm), VACCINATION SITE MASS (After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch), CONDITION AGGRAVATED (It is getting worse and not getting better), PAIN IN EXTREMITY (Pain in arm/but it came right back after a week) and VACCINATION SITE PAIN (It hurts real bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Thyroid disorder and Blood pressure.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (After the 2nd dose, after a day or so I noticed pain in my arm). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/but it came right back after a week). On 27-Mar-2021, the patient experienced VACCINATION SITE MASS (After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch), CONDITION AGGRAVATED (It is getting worse and not getting better) and VACCINATION SITE PAIN (It hurts real bad). On 15-Mar-2021, PAIN IN EXTREMITY (After the 2nd dose, after a day or so I noticed pain in my arm) had resolved. At the time of the report, VACCINATION SITE MASS (After 2-3 weeks from the 2nd dose I noticed a knot in my arm at the injection site/the knot is not hard to touch), CONDITION AGGRAVATED (It is getting worse and not getting better) and VACCINATION SITE PAIN (It hurts real bad) had not resolved and PAIN IN EXTREMITY (Pain in arm/but it came right back after a week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included medications for diabetes, medications for thyroid and medications for high blood pressure.  The pain in arm seemed to go away after the patient rubbed with alcohol.   No treatment information was provided by the reporter.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 16 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Pt was given Fluarix Quadrivalent PFS (36+mos) to left deltoid IM on 09/26/2016. Pt returned with mother on 09/28.  Mother stated pt developed redness/warmth at injection site and surrounding areas starting on 09/26.  Pt then developed itching on 09/28. Pt treated with Keflex 250 mg/5 ml x 10 days.
Anaphylactic reaction. Treated with Epi-pen. EMS transported me to hospital ER, via ambulance. I was monitored there for 6-7 hours, then released.
Pain, redness, and swelling at injection site; overall muscle aches, headache, and fatigue
Bone pain/myalgias, fatigue, ipsilateral axillary & supraclavicular lymphadenopathy
Administered Novartis H1N1 (4 years and older) vaccine 0.25mL IM right deltoid. Should have given Sanofi Pasteur H1N1 (6mo and older) 0.5mL IM. No sign or symptoms distress noted.
This  86  year old  female received the Covid shot on   2/07/21   and went to the ED on  2/12/21     and was admitted  on  2/13/21  with a cerebrovascualar accident, weakness, encephalopathy and UTI and went to the ED a 2nd time on 2/24/21    and admitted on  2/26/21 with  and went to the ED again on  3/22/21     with altered mental status and died in 4/2021.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Had very blurry vision out the side of my right eye; Achy joints; Inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8732, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 28Mar2021 16:30 (at the age of 69 years) as dose 2, single for covid-19 immunization in hospital. Medical history included glaucoma from an unknown date and unknown if ongoing, allergies from bananas and codeine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6205, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 07Mar2021 16:30 as dose 1, single for covid-19 immunization and had achy joints. Patient had no covid prior vaccination. Patient was not tested covid post vaccination. Patient had no other vaccine in four weeks. On 29Mar2021 08:00, the patient experienced had very blurry vision out the side of my right eye and on an unspecified date in Mar2021, patient had achy joints, inflammation. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient had second vaccine at 4:30 pm and the next morning at 8:00 am had very blurry vision out the side of my right eye. Patient went to a retina specialist, because when she called the eye doctor, they thought that it might be a detached retina. After examination it was determined that it wasn't a detached retina. They couldn't explain why it happened. They mentioned that since she also had achy joints, that inflammation may have caused the blurry vision. Also, her eye pressure was 20. Patient had achy joints with both vaccines for several days. Clinical outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
6 days of severe headaches, body aches, cold sweats, swollen lymph nodes; 2 days of on and off fevers (started on 3rd day), over 100 Fahrenheit; 2 days of ears swollen up, red, ringing, and pain.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were unknown, 0.65 ml) subcutaneously. On 10-NOV-2015, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown) at an unspecified clinic. No adverse effects were reported. Additional information has been requested.
Case number PHEH2014US000812 an initial spontaneous report received from a pharmacist on 07 JAN 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 010011A) intramuscularly on 03 JAN 2014. No adverse event was reported following this medication error. No additional information was available.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
No antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (No antibodies) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Granulomatosis with polyangiitis. Concomitant products included RITUXIMAB (RITUXAN) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced ANTIBODY TEST NEGATIVE (No antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (No antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Antibody test: no antibodies (Negative) No antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.  Company Comment : Patient is on concomitant therapy with RITUXIMAB which has been found to reduce the serological response and effectiveness of COVID vaccines as such causal relationship cannot be excluded.; Sender's Comments: Patient is on concomitant therapy with RITUXIMAB which has been found to reduce the serological response and effectiveness of COVID vaccines as such causal relationship cannot be excluded.
Sore right arm with tenderness under the arm and pronounced blood vessels. on 5/1 and 5/2 started to develop swollen lymph nodes. Will monitor and take tylenol/motrin- dual action form Q8H. Will report to the hospital with worsening symptoms such as change in vision, whole arm numbness, and or increasing size of lymp nodes under arm.
Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a minute.   I didn't tell the pharmacist.;/ it went away but my mom.daodni should report it
I was awoken in the middle of the night by significant pain in my upper left arm at the injection site.  I switched sides and was able to go back to sleep, but when I got up in the morning I noticed my arm in that area was swollen and there was enough pain that it made it difficult to use that arm. I had trouble driving.  I called the office and was told to go to the emergency room to rule out infection and cyst.  Nothing was resolved, and I was sent home with instructions to use ice packs, motrin, and rest.  Over the next couple of weeks my arm was strange and painful, with swelling and tingling and numbness of my skin from the top of my shoulder down to the top of my hand.  During this time there was a strange symptom: my arm hairs, on that arm only, all stood straight up.  Eventually/gradually these symptoms have dissipated significantly.  I still have some numbness and tingling here and there, along with some slight tenderness, but the swelling at the injection site seems to be gone.
This spontaneous report was received from a pharmacist refers to a 28-year-old patient of unknown gender. The patient concurrent condition, medical history and concomitant medications were not reported. On 17-JUN-2018, the patient was vaccinated with PROQUAD, subcutaneous for prophylaxis (Drug administered to patient of inappropriate age). No known adverse effects. No PQC (product quality compliant) was reported.
Initial report received from an health care professional on 28 Oct 2010: This patient was vaccinated intramuscularly with only the MenCYW-135 component of MENVEO (batch numbers: (box lot 100022) without the lyophilized Men A conjugate compound. No adverse events reported following this administration.
Did well in week immediately after vaccination. Sunday prior to office visit on 9/27/17 adoptive mom noticed she was not eating as well as usual and felt warm to touch. Did not measure fever. Over next few days slowly developing raised, initially papular lesions with underlying macular erythematous base. They became vesicles. Patient reports both painful and itchy. Lesions are sparsely scattered over right temporal region, torso, back, and upper and lower extremities. Should be noted child was directly exposed to active shingles lesions in the weeks prior to office visit on 9/14/17. Took shower with mom who was developing early shingles and did not know they were shingles.
Fever; chills; headache; injection site pain; This is a spontaneous report from a contactable other health care professional. A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 22Mar2021 at 12:00 (at the age of 39-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single for COVID-19 immunization (at the age of 39-years-old). Patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. On 22Mar2021 at 21:30, the patient experienced fever, chills, headache and injection site pain. No treatment received for the adverse events. No COVID tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large bilateral Pulmonary Emboli, hospitalized and given Lovenox and Eliquis
Exhaustion, low grade fever, chills, extreme headache, body aches, heart palpitations started when I woke up at 6:15 am on 04/23 and subsided when I woke up at 5am on 04/24.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 560 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe anxiety, depression, and sadness lasting for about 14 hours. I am not prone to emotional swings, I'm normally kind of upbeat, maybe a little flat. I've rarely felt this way.
3.0 x 3.5 cm area of erythema very hard and tender to touch.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose and route of administration were not reported, lot # M014929 with expiration date 27-MAY-2017). Concomitant medications were not reported. The patient received the third dose of in the immunization series three months after the first dose. No adverse effects reported. Additional information has been requested.
it wasn't like the first or second vaccine, her arm didn't hurt; it didn't feel like a big bunch like the other 2 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: ER2613) as dose 1, single and administration date 08Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "it wasn't like the first or second vaccine, her arm didn't hurt"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "it didn't feel like a big bunch like the other 2 shots". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101772565 same reporter/patient, different dose/event
They were felling sick; Have a fever of 101°F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (They were felling sick) and PYREXIA (Have a fever of 101°F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00f21a, 0030l20a and 025a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced MALAISE (They were felling sick) and PYREXIA (Have a fever of 101°F). At the time of the report, MALAISE (They were felling sick) and PYREXIA (Have a fever of 101°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 101°f (High) fever of 101°F.         They explain that they are not immunocompromise, but they work with immunocompromise patients, and that way they got their third dose.  No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-331467 (Patient Link).
On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain.  A few days later I noticed I had extreme shortness of breath.  I went to see my PCP on or about 3/31.  He listened to my heart and discovered a rapid heartbeat.  He then took an EKG.  He wanted to put me on lifetime meds immediately.  I was in shock because I truly believe this is a reaction to the COVID vaccine.  I have never had arrhythmia.  In fact, I had a wellness visit with the Dr. about 3 months previously and all was good.  I have been seeing him for four years since I moved.  He does not think my new diagnosis is related to a vaccine reaction, but I find it highly suspect that 4 other women in my large circle of friends also have AFIB after 2nd shot. I spent Easter in the ER and they pumped Metoprolol in my bloodstream.  I did not stay in the hospital that night.  I went to see the Dr. on Monday morning on 4/4.  He prescribed Metroprolol 25 mg and Xarelto 20 mg IMMEDIATELY.  I picked up the meds and started this regimen.  In speaking with other women, I believe this terrible diagnosis is a direct result as a reaction from the vaccine.
I received the vaccine on 01/15/2021 at 8:20am and around 6:00pm that night I started feeling fatigued and weak. I woke up at 1:00am on 01/16/2021 with vomiting, nausea,  fever of 102.3, severe body aches, and chills. I was able to take 400mg ibuprofen and my fever subsided for about 4 hours. Those symptoms continued on for the whole day of 01/16/2021. on 01/17/2021 I was still very weak with body aches which came and went throughout the day. Around 6:00pm on 01/17/2021 i started feeling normal again.
Rash on entire trunk of body for 24 hours followed by a week of skin so itchy I had to take Benedryl daily.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the (Privacy) Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (Privacy). The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Fever, chills, rigors, body aches that began 12 hours after vaccination. Lasted around 36 hours.
Red, hard itchy blisters appeared on hands and feet. Hives on arms, trunk and legs.  Unable to lift arm that received injection above head due to pain; one week later muscle weakness and twitching in left deltoid where injection was received.  Red, hot, round, itchy rash appeared around injection site, approximately 4 inches across.  The area later peeled like a sunburn.
Chills, Body Ache,Shaking Cold, Sweating, Fatigue, Difficulty Breathing . Changing clothes' due to excessive sweating, light headed, shortness of breath.