chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/3/21, I arrived for my COVID -19 2nd Moderna dose at Hospital. The woman who was administering the dosage asked me to reposition 3 times. She seemed rather flustered and kept saying "she couldn't get the right angle." I had on a polo shirt with the sleeve rolled up above my shoulder to allow for adequate deltoid access. On the 2nd reposition she mentioned that she "may need me to stand up." On the 3rd reposition she had me turn so my back was toward her and she said "ok we got it." She then put the needle in and I immediately knew it was in the wrong spot. It felt extremely high and was the back of my shoulder. As she started injecting it I had a shooting pain go down my arm into my 1st and 2nd fingers. As she was finishing she stated "did that hurt?" "that looked like it hurt." I reported it hurt to her. She stated "She was sorry." My arm was very sore after the first injection so I had hoped that It was just going to be the same and maybe it would be fine despite it being extremely high and in the back of the shoulder. The  pain persisted to the point that I could barely lift my arm by that evening, which continued over the next 5 days. Ibuprofen took the edge off the pain. The pain persisted over the next week in which I contacted my supervisor and reported the incident due to receiving the vaccine at my place of employment. There was pain going into my deltoid, shooting pain in the lateral border of my scapula, throbbing in the shoulder at rest. Due to pain all the muscles tightened up and caused left sided neck pain and headaches. Significant difficulty with dressing, bathing, inability to sleep well, unable to lift arm past 60 degrees of flexion or abduction at shoulder without significant pain. Unable to lift anything in the left arm. Pain slowly improved with PT and use of meloxicam and at current date 5/4/21 still unable to lift items >5lb or bear a lot of weight on the L arm. Continuing to have difficulty at work, unable to do certain mobs/manipulations due to the inability to push/pull.
Mixed series of vaccine; First dose (01-jul-2021) ,Second dose (13-aug-2021); This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed series of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose (01-jul-2021) ,Second dose (13-aug-2021)) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed series of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose (01-jul-2021) ,Second dose (13-aug-2021)). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed series of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose (01-jul-2021) ,Second dose (13-aug-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Patient with single J+J COVID vaccination 06/14/21 who admitted with COVID complications and died.  Provider discharge note below:  "75 YO female with advanced multiple myeloma on chemotherapy admitted with covid pneumonia.  Quickly progressed to needing HFNC despite treatment with steroid.  Due to severe thrombocytopenia, not safe to add anticoagulation (despite platelet transfusion).  Patient died suddenly overnight due to hypoxia."
Patient presented to ED with altered mental status, unable to provide much history beyond feeling unwell for the past few days. She was found to have metabolic anion gap acidosis, with no osmolar gap. Patient was found to have pneumonia and pancolitis. She was treated with vancomycin and meropenem in ED and transitioned to levofloxacin and metronidazole as an inpatient. She was started on norepinephrine due to low blood pressure. She is COVID-19 negative and legionella negative. Blood cultures are pending. Patient currently in ICU.
I did not have an adverse reaction to the vaccine. I have had plantar fasciitis in both feet and has now progressed to tarsal tunnel syndrome. I have had steroid injections in my right foot which helped in little. I have used topical steroid cream which did not help. As of today, it looks like the next step is surgery.
pt recvd vax; later noted that vax was expired;at time of the report, no adverse exps noted;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in right arm and on 03May2021 as dose 2, single (Lot number: EW0170) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Feb2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included PAXLOVID from 24Oct2022.
reported hard lump and itchiness/It is red hard and itchy/3 inch red lump on the location of the injection; reported hard lump and itchiness/3 inch red lump on the location of the injection; reported hard lump and itchiness/It is red hard and itchy/3 inch red lump on the location of the injection; This is a spontaneous report from a contactable other hcp (pharmacy intern calling on behalf the pharmacy). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot/batch number and expiry date unknown) via an unspecified route of administration on 07Oct2020 at 0.5 ml, single dose for immunization. There were no concomitant medications, other conditions and investigation. She said the adverse event was about a 3 inch red lump on the location of the injection from an unspecified date in Oct2020. The injection was administered on Wednesday 07Oct2020 and the lump has persisted until today 13Oct2020, so about a week later. It was red hard and itchy. It has persisted about the same. The reporter asked that how long to wait before seeing a specialist. She did not know the lot expiration at this time. She thought the dose was the 0.5 ml one-time injection. The reporter thought that it was given based on age or guidelines. She believed the patient came in wanting to have their Prevnar 13 completed. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patients received vaccine with silver metal particles; Poor quality vaccine adminstered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine adminstered) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 015M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine adminstered). On 30-Nov-2021, PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine adminstered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No Concomitant medication was reported.  No patient reported having side effects   This case was linked to MOD-2021-403142, MOD-2021-403143, MOD-2021-403144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains patient details, vaccine information updated.
None.  Pt received vaccine that had been stored in conventional freezer since 1/5/22 (expired 1/19/22).  Pt was offered another dose.
tested positive after 5 days of receiving their 1st dose of the vaccine last 07MAR2021; tested positive after 5 days of receiving their 1st dose of the vaccine last 07MAR2021; This is spontaneous report from a contactable consumer (Patient) received from a female patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication were not reported. patient, called and stated that she and her husband, was tested positive after 5 days of receiving their first dose of the vaccine last 07Mar2021. Then they got their monoclonal infusion 3 days after they tested positive, and they are now negative to Covid-19. Patient asked they can proceed with their 2nd dose which will be schedule on 28Mar2021. On 12Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive, on Mar2021again underwent for lab tests and procedures which included sars-cov-2 test: negative.  Follow up information received on(26Mar2021): No new information was added.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
lymphadenopathy, diarrhea, pharyngitis & aches (body)-swollen lt arm;
pt admitted to hosp with c/o SOB, body aches, decreased appetite; states had a positive COVID test on 1/6/22, on 2nd round of ABX; rapid COVID test was negative in ED; PCR test was positive; O2 supplementation; COVID pneumonia, ARF with hypoxia, AKI; steroids, ABX, breathing treatments, zinc, vitamins C and D3; proning; DNR/DNI; became hypotensive; transitioned to comfort care; he passed away in the hosp
Very fatigued, tired, injection site sore, heated, chills, headache,  and body aches.
Presented at her scheduled appointment time to receive his 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported that she experienced throat itchiness and coughing about 5 minutes after administration of first Pfizer COVID vaccine. RN responded. Client reports she was offered 50 mg Benadryl and symptoms began to improve about 5 minutes after intake of benadryl. Client denied any other symptoms at time of event. Client reports she followed with a provider via telephone visit regarding the vaccination.
11/22/21 - had MMR, varicella, and flu vaccine.  Rash started 12/2 - first noticed on her chest and legs, then got some on face which resolved quickly, bumps noticed gone today right before appointment.  No other symptoms - no fever, acting normal, good GI.  No new foods or meds.  Rash was completely flat, no bumps. Face rash is chronic eczema and some on her legs.  Mom did not notice any runny nose; picture shows some dried nasal congestion but did not runny. Rash resolved on day of visit before the visit so Mom says no rash to view on video anyway.  Discussed timing and pictures and verbal description seem a macular rash with timing more likely consistent with another typical viral exanthem than measles-vaccine related, and no features of varicella-vaccine related, but we will report to VAERS as potential adverse event in any case, and this does not impact ability to receive next MMR vaccine in the future.  If rash returns, I recommend in-person evaluation to facilitate better clinical examination and characterization of the rash.
Arm was bruised and tender to the touch approximately 3-4 hours following vaccine. Started feeling dizzy around 8pm on 1/7/21.  Took PM meds and went to bed. Awoke around 3am with a temp of 103, joint aches, muscle aches, chills, congestion, eyes very dry and itchy,  severe headache/migraine with photosensitivity, fatigue on 1/8/21. Left arm was swollen, hot to the touch and very tender to move it. Took Tylenol and Benadryl to help relieve symptoms. Put a heating pad on injection site. Felt about the same all day so I rested. Went to bed around 10pm on 1/8/21. Woke up around 4am on 1/9/21 and my temp was 99.7 prior to taking any meds and after about 20 minutes of being out of bed. On 1/9/21 I still have arm tenderness and bruising, fatigue, headache, left eye redness to upper eyelid with swelling, temp has been running at 99.7 and it?s currently 4pm EST.
1 days p/vax pt devel achy joints & muscle, red macular rash began w/in hr of onset of achiness;seen by MD on day #7 post vax;pt had dime sized red macular rash over trunk & legs w/less involvement of arms;
Had symptoms of COVID/COVID infection; This is a spontaneous report from a contactable pharmacist (patient). A 42-year-old female patient received her first dose of bnt162b2 (BNT162B2) at unknown vaccination age via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient inquired if she can get the second dose if she got COVID19 after first dose. The pharmacist reported that she received the first dose of the Pfizer COVID 19 on 11Jan2021 and had symptoms of COVID on 18Jan2021. It has resolved and she has no symptoms in over a week. Today was day 15 (01Feb2021) since COVID infection so she was out of the isolation period. She added that her second dose is scheduled for tomorrow (02Feb2021). She declined safety report noting she feels the vaccine may have reduced her symptoms. She wanted to speak with a Medical Director for further discussion of clinical trial data. HCP requested information on published data on the phase 3 trial of those 39 patients in the clinical trials that received the first dose of the Pfizer Covid vaccine and were tested positive for covid. She is requesting the safety profile, their antibodies level and how did they tolerated the second dose. The outcome of the event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Dizziness and equilibrium issues upon waking on 01/27/2021. Chills onset between 11 AM and 11:20 AM.
Developed hive-type rash localized to right arm 4cm x 6cm area. Extremely pruritic, approximately 5 days, post vax.
Experienced Nausea, vomiting, dizziness. Dizziness and nausea persisted for about two weeks, along with increased heart rate. Symptoms are still on going. I experience a racing heart and lightheaded on a daily basis. I was not able to stand up and walk without feeling dizzy. The nausea still returns. I am unable to resume my normal daily activities such as running and being active for extended periods of time. I went to see an autonomic neurologist, who suspects that I have POTS. Gardasil is the only vaccine that has induced a dysfunction in autonomic nervous system. Treatment consists of lifestyle changes and is still to be determined.
Pt recvd 2 doses of Engerix-B & 10MAR92 following dose 2 exp pain in the arm from elbow down & tingling in fingers;
Full body rash; full body itchiness; swelling of the skin, toes, fingers and lips.; swelling of the skin; swelling of the skin, toes, fingers and lips.; Joint pain from minimal movement.; swelling of the skin, toes, fingers and lips.; This is a spontaneous report from a contactable consumer (patient). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified) via unspecified route of administration in the left arm, as dose 2, single on 10Jun2021 for COVID-19 immunization (at the age of 15-years-old). The patient medical history was not reported. The patient received birth control medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. There were no known allergies. On 12Jun2021 16:00, the patient experienced Full body rash, full body itchiness, swelling of the skin, toes, fingers, and lips. Swelling goes up at night and down after waking up, Joint pain from minimal movement. The events led to emergency room visit and hospitalization for 2 days. The patient underwent lab tests and procedures which included nasal swab and results were negative on 13Jun2021. Treatment received included benadryl, motrin and atakin, no imaging or steroid medication given. The outcome for the events was not recovered.  Information on Lot/Batch number has been requested.
Numbness in Arm; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Numbness in Arm) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in Arm). At the time of the report, HYPOAESTHESIA (Numbness in Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
t103-105 x 24hr;lethargic;inj site infected;could not walk;poss sz;
Severe joint pain; Fever ranging from 100.2-101.7; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 27Feb2021 08:30 (Batch/Lot Number: EN6205) (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure, asthma, history of breast cancer and allergies from peanuts, corn and tomatoes. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included atenolol; omeprazole; tocopherol (VITAMIN E); and ergocalciferol (VITAMIN D); all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm (Batch/Lot Number: EL9266) (at the age of 49-years-old) on 06Feb2021 at 08:30 for COVID-19 immunisation. The patient experienced severe joint pain (almost unable to sit and stand) and fever ranging from 100.2-101.7 (unit not reported) on 28Feb2021 at 11:00. The patient received no treatment for the events. The adverse events resulted to none. The outcome of event severe joint pain was recovered on 02Mar2021 at 11:00; while outcome of event fever ranging from 100.2-101.7 was recovering.   No follow up attempts are possible. No further information is expected.
Developed "blotches" of red raised whelps around eyes, face, chest with itching after receiving MMRV previous day. Saw pvt MD, given oral steroids and steroid cream. (this was her first mmr but second varicella)
Moderna vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 12/1/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE R57.0 CARDIOGENIC SHOCK 12/1/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE I95.9 HYPOTENSION 12/1/2021 HOSPICE ADMISSION R57.0 CARDIOGENIC SHOCK 12/1/2021 HOSPICE ADMISSION
Patient received COVID19 vaccine (moderna, 1st dose) at 3:20 PM. Approx. 3:28 PM patient reported tingly/numbness in left arm  to clinical nurse at observation station. Nurse assessed patient's strength push and pull and range of motion and deemed good. Patient was advised to call ED if symptoms worsen or for any concerns. Patients left at 4:25 PM, reporting that tingling subsided.
Pt woke up day after vaccine with bell's palsy symptoms, he went to ER where he was diagnosed and treated with steroids and antivirals. Pt states it is "mild case" and he has a follow up scheduled with his doctor.
Patient was inadvertently given BOOSTRIX Tdap, instead of PEDIARIX.
Received a third Heplisav-B Injection; Initial Report Received on 14-Jan-2021  A registered pharmacist reported that a 60 year-old female (race and ethnicity not provided) received a third dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 11-Jul-2020, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  On 13-Aug-2020, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  On 13-Jan-2021, 187 days after having received the first injection and 154 days after having received the second injection, the patient received a third dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and serial number 836086802696 not reported) because she did not know she got it at her doctor's office.  At the time of report, the patient reported no adverse reactions to the injections.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Six hours post vax pt had 3 episodes of vomiting and felt lightheaded.
NO ADVERSE REACTION, THIS IS A REPORT OF AN EARLY BOOSTER DOSE OF PFIZER COVID-19 VACCINE The patient received a booster at 164 days, instead of the suggested 176-180 days.  An appointment had been made in the system, likely due to a misreported 2nd dose date by the patient(our system should not have booked the appointment otherwise.)  This early administration was noticed by the pharmacist after administration.
Pt. developed erythematous & indurated area (at site of injection) painful/measuring 5cm x 3.5cm developed evening of vaccine.