chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've had pain in my right hand finger joints since the next day of booster. Mainly ring finger; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 02Dec2021 at 12:00 (Lot number: FJ8762) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulphas. Concomitant medications included: ATENOLOL, LOSARTAN and unspecified BIRTH CONTROL PILL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP7534, Route of Administration: Unspecified, Anatomical Location: Left arm, Time of Administration: 14:00), administration date: 16Mar2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0150, Route of Administration: Unspecified, Anatomical Location: Left arm, Time of Administration: 14:00), administration date: 06Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; ARTHRALGIA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "I've had pain in my right hand finger joints since the next day of booster. Mainly ring finger". Therapeutic measures were not taken as a result of arthralgia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
After the first dose was administered on 5/20/21, the following day I started my period a week and a half early with severe cramping and bleeding.  After the second dose was administered on 6/10/21, a day later at 2:00 pm I received body aches, chills, fever for 2-3 days until 6/13/21.  Now, I started getting a severe headache on 06/14/21 at 5 pm. The headache is severe, covering the whole region of my head. I suffer from migraines occasionally, but this is different, this feels like a lot of pressure around the whole region of my head. Tylenol and ibuprofen are not working, as well as migraine medication is not working. It has almost been 24 hours since the onset of the headache and it has not gotten better.
Patient presented to pharmacy for 2nd dose of COVID  vaccine. He forgot his vaccination record card and verified with his wife what manufacturer he previously received. When updating his vaccination record card, he realized it said he received Moderna on 04/04/21 at another location. His immunization record also had an incorrect date of birth.  A search on the for his name and both dates of birth didn't retrieve any results. Patient didn't experience any side effects from the error,
Patient was seen by her physician due to developing "redness swollen injection site, and red-circle around the injection site".
It has been 3 weeks since i got my second dose of the Moderma vaccine. I woke up one morning with facial weakness. I called my doctor. I have no taste on my tongue, the right side of my face is weak and had drooped. My doctor diagnosed me with Bells Palsy and put me on Prednizone and Valtrex as my course of treatment.
Nausea once waking up the day following the vaccine. About 30 minutes after getting up and moving around I was dry heaving and later puke a small amount. Started to feel better in the late afternoon.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEELING OF BEING DRUNK; This spontaneous report received from a consumer (husband of patient) concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had some mild symptoms and some strong symptoms but nothing awful as of yet. The patient experienced headaches, fatigue (suspected clinical vaccination failure and suspected covid-19 infection) and almost a feeling of being drunk. The patient was not consulted to any healthcare professional. The action taken with covid-19 vaccine was not applicable. The outcome of the feeling of being drunk, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210913267.; Sender's Comments: V0: 20210913259- covid-19 vaccine -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Vaccine administration errors, not associated with an adverse event.  Manufacture was contacted Moderna is not provide any specific recommendations.
The patient woke up 12 hours after vaccine with severe headache, chills/ rigors (no fevermother took temp) and nausea/ abdominal cramping (no emesis or diarrhea). Symptoms resolved in less than 12 hours with Tylenol. No urgent medical care sought.
Starting in June of 2021 I had developed a tick like rash on my left arm.  It was not a tick.  That summer I had pins and needs in my hands. I received the Moderna booster on December 28, 2021.  The rashes developed into MRSA and HSV1 on my upper lip.  Following that MRSA event, I developed nerve pain in the back of my left thigh which traveled to my bottom buttocks both sides.  I had nerve pain in my face which has continued.  I have seen a neurologist who has done test after test and all have been normal with the exception of the past MRSA infection.  We have no explanation for my nerve damage.
One week after receiving the vaccine my menstrual cycle came back and lasted for a week. I have not had a menstrual cycle in three years. I called my doctor and have an appointment set for October 31, 2022 to have an ultrasound done to rule out the cause of the bleeding.
Two  days after my second shot, I started experiencing really bad joint pain, a headache, a fever and what felt like my veins were on fire. I received the shot on Wednesday and was fine on Thursday and Friday morning, but I had taken Tylenol and Airborne all day Wednesday Thursday and Friday morning in the hopes of reducing symptoms. The headache started on Friday afternoon. The other symptoms on Saturday morning and lasted on and off all weekend. It went a way for a bit, but then came back. The weather was very rainy, so I wrote it off as mild arthritis pain, but it persisted and kept getting worse. But, we had a rainy March and April. It is now May and the pain continues. Sometimes in my joints. Sometimes not. Across the back of my right hand is the worst and almost constant. On and off, I get the headaches, pains in my joints or muscles, or just across my thigh, or my calf. None of this happened before the shot, so I am thinking it may be elated.
45 mins p/immun pt splotchy redness on anterior chest was noted w/semilar red line approx 3 1/2 -4" by 3mm;
I noticed some chest tightness. Nothing bad but noticeable and was there for a few minutes and started to go away. I later have had random chest pains in different areas that would last a few minutes. I also noticed some light headaches
Approximately by 8 PM patient developed high tactile fever and generally not feeling well. He vomited several times and had neck/facial swelling. He also complained of throat tightness. Mom gave BENADRYL due to the swelling and he fell asleep, by the next day his symptoms had resolved.
Pt recv vax on 10/24/98; on same day pt exp hives on face, hand, back & stomach; tx=Benadryl (topical &oral)
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A 74-year-old male patient received PREVNAR 13, via an unspecified route of administration on 04Oct2018 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Oct2018 (reported as a week after administration), the patient went back to the pharmacy complaining of pain and inflammation at the administration site. The pharmacist recommended some pain pills and it was reported that the patient never returned. The outcome of the events was unknown. Information on the batch number has been requested.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: Es5372) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: En9581), in left arm, on 01Mar2021 as dose 2, single (Lot number: En6200), in right arm and on 22Nov2021 as dose 3 (booster), single (Lot number: Fd0809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN; IRBESARTAN. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 28Nov2022 to 02Dec2022 as treatment of COVID-19. The patient had no known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Axillary lymphadenopathy on same side as injection (Left shoulder) beginning day after vaccination; This is a spontaneous report from a contactable healthcare professional, the patient.  A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 03Mar2021 at 18:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 23:00, day after vaccination, the patient experienced axillary lymphadenopathy on same side as injection (left shoulder). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event axillary lymphadenopathy on same side as injection (left shoulder) was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
The arm swelled to twice normal size. Two days later the redness and swelling extended to the elbow.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: none-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extremities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: gave CPR until the ambulance were here.
6/8: Soreness at injection site, nausea, temperature started rising around 6:00 PM; 99.5. 6/9: Body aches, nausea, headache, dizziness, memory lapses, 6:00 PM temperature of 102.4, took prescription hydrocodone that I had left over from a recent oral surgery, temperature decreased and joint pain subsided. 6/10: 9:30 AM temperature of 99.4, soreness at injection site, body aches, 11:45 AM temperature of 98.9, 12:30 PM temperature of 98.5 at Employee Health. 6/11: Soreness at injection site, severe headache and dizziness, 1:00 PM temperature of 98.5, nausea.
This spontaneous report concerning an unspecified number of patients of an unknown gender and age was received from a medical assistant. The patient's concurrent conditions and medical history were not provided. On multiple unspecified dates, an unspecified number of patients were vaccinated with an improperly stored dose of VARIVAX lot # M003441, expiration date 19-JAN-2018. The reporter stated that the vaccine was exposed to a temperature of 10F for 25 minutes and it was detected by a digital data logger. In addition, it was stated that there was no previous temperature exposure. There was no concomitant medications and symptoms reported (no adverse event). No product quality complain was involved. Additional information has been requested.
After lengthy discussion with Dad regarding needed immunizations, permission received for Tdap and MMR. Inadvertently drew up Varicella instead of MMR. Parent notified of error. Returned to clinic. Received MMR. Follow up Appointment made to continue catch-up sched.
9/22 patient woke up with right arm being red, swollen, and slightly warm. Patient called pharmacy and was told to take BENADRYL, use an ice pack, and take TYLENOL for pain. 9/23 patient went to the doctor where he was told the same thing. 9/25 events were resolved.
57 years old given the Fluzone HD in error, no AE; 57 years old given the Fluzone HD in error, no AE; 57 years old given the Fluzone HD in error instead of flu vacccine, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse via office staff.  This case involves a 57 years old male patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA VACCINE (flu vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rash.   On 22 Sep 2019, the patient received a 0.5 ml dose suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AB via intramuscular route in the left deltoid instead of INFLUENZA VACCINE .  It was a case of actual medication error due to Inappropriate age at vaccine administration, overdose and wrong vaccine administered.  At the time of the report, no adverse event was reported. (the patient was doing fine and had no complaints)  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 the sender: none
The patient experienced redness, swelling and tenderness in the area that the vaccine was given. She stated that the arm felt hot to touch and this continued for a few days. She stated that once this resolved the area of the vaccine became itchy and continues to make a scab over where she can see that the needle went into the arm.
Immediate reactions: Respiratory distress with SOB chest pressure, fast heart rhythm, swelling face hands and feet, red itchy skin, nausea, headache, muscle ache, fatigue. The outcome so far: Developed Asthma on inhalers, voice irregularity as in I lose my voice often or speak in a very hoarse whisper, POTS syndrome, pericarditis, multi-layered PVCs, muscle weakness, severe fatigue, constant headaches, elevated D-dimer causing a risk for blood clots, developed elevated IgE causing allergy to milk and constant dermatitis with itching and rashes, brain fog.
About a week later I started to have spotting that I have not had previously before getting the vaccine. From August 6th to about a week ago I was having light spotting and sometimes the spotting would be heavier than others. I have never experienced that before after receiving my depo shot for birth control. When I went to the doctor she said it was a possible side effect from the depo shot. I had some fatigue when I was spotting for almost a month.
blister; chills; headache; Shingles; aches; rash; fever; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533), via an unspecified route of administration, administered in right arm, on 09Apr2021 at 10:00 A.M (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient has no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6207) administered at the right arm, on 12Mar2021 at 10:00 A.M, as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 09Apr2021 (also reported on 03Apr2021), it was reported that within 24 hours, the patient experienced chills and aches, then fever on Saturday night through Monday morning. A rash and headache started on his left but cheek and back it continued to spread and blister. The patient couldn't stand the pain from the rash that he went to a clinic, and urgent care was reported. The patient was diagnosed with the Shingles and the doctor there gave him a medicine and the next day he went to my primary care doctor for follow up treatment. The patient had to see her every week now for check up on the Shingles. The patient received steroid shot, valacyclovir and a pain medicine as the treatment for the events. The events have resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. The events were considered serious (medically significant).
Pt was given VARIVAX with an expiration date of 11/18/2018 (yesterday).
temperature excursion with Moderna Covid-19 vaccine; No adverse event; doses were administered post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with Moderna Covid-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st & 2nd doses administered. 27 total doses were administered post excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
Three weeks after vaccination, patient developed maculopapular rash and thrombocytopenia (PLT 14).
Day 2 2/13,  herpes breakout back of upper rt leg Day 8 red itchy rash at injection sight, some soreness and heat. Enlarged  to slight whelp about 2x4 inches. Reaction almost resolved 2/24. Treated with acetaminophen.