chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Lot number: FW0172), in left arm and on 15Nov2021 as dose 2, single (Lot number: 320308D) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftriaxone, reaction(s): "Known allergies: Ceftriaxone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Pharmacist initially delivered the vaccine Below the deltoid muscle area causing a blood drip that required 2 band aids (first was full of blood ,removed and replaced with another). Within 24 hours round dark bruising about the size of a quarter developed. Bruise was sore and deepened in color over the following 10 days. One week after administration, on 2/5/21, the area under the  point of shot,  began to itch and swelled into a red hard lump.That area spanned  about 2 inches by 1 inch and continued to maintain redness and itching for 1 week, but lump went down in 2 days.
Reports fever, myalgias x 8 hours following covid vaccination on 11/23/20. Within 1 week sinus drainage, wheezing. Seen at EC virtually, neg covid, dx sinusitis, rx'd advair, ceftin. 101-102F x 18 hours, "super sick". That following week experienced cough and sob that progressively worsened. Seen again at urgent care: dx bronchitis, rx zpak, prednisone course. Following week: seen in person, continued steroid course x 5 days and changed advair to Breo. Seen by PCP 2/10: allergy meds were changed to different families to determine if she was pulling a tolerance to her current regimen, Advair changed Brio. CXR, PFT, CBC, CMP, BNP ordered which were all normal. Seen by PA 2/12 - changed to neb meds, given solumedrol IM, started on high dose predniosone. ED visit d/t asthma flare that could not control. Has seen Allergist doctor who ordered a respiratory viral panel, started on 14 day doxy course, bromfed and referred to specialist who manages rare asthma issues. Hx asthma but never hospital, never intubated. States has never had a flare like this ever. Has made reports to vsafe and vaers.        Most recent visit was to ED on 2/17/21 due to increased dyspnea. CTA without abnormal findings. Advised to follow-up with pulmonology as scheduled. Reports continues to have a lot of coughing. DOE even with minimal activity such as when up to get a drink. lightheaded shortly after transition to stand and around coughing episodes; denies syncope or fall. Good days and bad days, overall improving. Has not had a day like last wednesday again. Using 5mg neb Q4 hours. Neb trt 2200. Does wake once around 2-3AM for trt. Previous up to 3/night gasping for air
Pt was injected with updated Pfizer bivalent peds vaccine- undiluted, not adult
Sporadic (both in time and location on my body) hives that started on 4/4 and lasted through 4/16.  Able to reduce with Claritin or Benadryl.
She was sick with flu-like symptoms after her second dose of Covid-19 vaccine; She was sick with flu-like symptoms after her second dose of Covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "She was sick with flu-like symptoms after her second dose of Covid-19 vaccine".  Additional information: Reported that Voicemail left on after-hours MIR 26APR2021 at 23:54 from Merck representative reporting al AE she learned of during a lunch at HCP's office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning one of her baby who on unspecified date was vaccinated with ATTENUVAX. After receiving the ATTENUVAX the patient developed fever. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 3 month old patient of an unknown gender. On 16-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Soreness in arm after first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm after first Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm after first Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Soreness in arm after first Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-026958 (Patient Link).   Reporter did not allow further contact
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
A 2-year-old was inadvertently given the PNUEMOVAX 23 shot; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 23-JUL-2021, the patient was inadvertently given pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) shot for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided) (wrong vaccine administered).
Narrative: COVID infection following COVID vaccine series 07/28 Janssen, dose #1 12/28 COVID swab, result: detected 12/28 pt cc: sore throat x 2 weeks and dry cough. exposure: unknown 12/28 pt admit ED cc: sore throat x 2 weeks and dry cough. dx: COVID-19 LOS: 1 DAY
left axillary and neck lymph node swelling with pain to the area. Still swollen and waiting to see if symptoms clear on their own
Fatigue lasting 1 day, sore at injection site for 2 days, chills lasting 1 day, muscle aches in lower back lasting 1 day.
This spontaneous report as received from a pharmacist via field employee refers to a 52 year old male patient. The patient pertinent medical history and drug allergies were not reported. On 16-MAR-2015 the patient was vaccinated with ZOSTAVAX subcutaneously. On 16-MAR-2015, the patient experienced burning and redness at injection site, approximately the size of a circle (made by connecting his thumb an index finger). The pharmacist reported that the patient on an unspecified date saw an unspecified nurse, at the patient place of occupation and the nurse informed the patient, that the zoster vaccine live injection appeared to be an intramuscular injection. The pharmacist reported that the documentation recorded the patient received zoster vaccine live by subcutaneous route. The pharmacist saw the patient following day and the zoster vaccine live injection site was nothing out of the ordinary. The outcome of the events was unknown. The causality of the events was not reported. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008, the subject received a dose of FLULAVAL at 0.5 ml. At an unknown time after vaccination with FLULAVAL, the subject experienced injection site pruritus. Later, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The outcome of the events was unknown at the time of reporting. Follow-up information received on 19 December 2008 via the initial reporter, indicated that there is no further information to provide concerning the reported events.
Patient experienced tingling in her index, middle, and ring finger of the injected arm. Patient also experienced slight swelling at the injection site as well as some tingling in her bicep area. The shot was administered in her deltoid. Our recommended tx was IBU and cold compresses. Outcome unknown yet, but we've instructed her to follow up with us if the symptoms change and each day.
pt stated felt was going to faint & sat down then eyes rolled back & went limp following vax; pt given ammonia inhaler & assisted to floor; was able talk;  BP 80/50, 76/50; drank cola; said felt faint again; BP 80/56, 76/40, P60 thready;
pt devel on 5/21 soreness @ inject site. 5/16 weak, tired c/o joint pain/fever, lower abd pain & lower back pain. devel hives 5/16. m.d. seen 5/20, no treatment recommended
The fatigue and body aches remained. The fever and headaches were new. The doctor told me to just watch the fever and if they got bad, I should return to the hospital. I also had stomach pains as well. I was hospitalized in May because the fever was constant and the headaches became unbearable. They did 2 MRI's and CT Scans of the head and brain, spinal tap and X-ray. I was given multiple antibiotics and eventually one antibiotic. They could not figure out the reason for the fever. There was no sign of infection. There was no diagnosis for the headaches as well. I still experience headaches. I was given pain medication. I have not experienced fevers since being home from the hospital.
no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse event.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
pt entered drive thru vaccine pod and was triaged for any adverse events during first dose of vaccine, pt stated she had redness and swelling at injection site for two weeks after injection, pt was given second dose of moderna vaccine  at 1:50 pm and advised to wait 30 minutes. pt was routed to waiting area and monitored by Law Enforcement.  At 1:55 pm nurses were notified pt was having a reaction, nursing assessed pt, nursing observed facial and neck redness, pt described symptoms as feeling hot, tingling and scratchy in her throat, pt HR 108.  Nursing administered Benadryl 50 mg 1 mL lot#  as per PHN protocol at 1:57 pm.  Nursing stayed with pt, at 2:10 pm pt symptoms began to subside, neck and facial redness not as noticeable, HR decreased to 85, pt stated her throat was not as scratchy.  Nursing continued to monitor pt and symptoms continued to subside.  At 2:35 pt was allowed to leave after nursing was assured pt would not be alone and was going home to her husband.  Nursing called pt at 3:15 pm pt stated she was feeling better.  Nursing called the following day to check on pt and was told she had a fever of 101.4.  Nursing advised pt to seek medical attention if symptoms persist.
A non-serious spontaneous report of hives in the nostril areas and under both eyes has been received from a health professional concerning a 12-year-old female, subsequent to FLUMIST. The patient's medical history included received injectable flu vaccine in past and patient was healthy at the time of vaccination. The patient received FLUMIST on 16-Aug-2011. Vaccines given on the same day included meningococcal vaccine and DTP. About five to ten minutes after patient got FLUMIST, she got hives in the nostril areas and under both eyes. The patient did not received medical attention. The outcome of the event nostril areas and under both eyes was resolved. Additional information was received on 28-Oct-2011 and incorporated into the narrative: outcome, concomitant medications, medical history and suspect drug information.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 year old  female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was allergic to NSAIDS and had no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient received a negative IgG antibody test and then again on 24-AUG-2021 (confirmed immunological vaccine failure). The patient was calling to inquire if there is any information regarding that situation. She had no other symptoms to report. Patient received vaccination aged 58 years, had birthday week after vaccination and experienced adverse event aged 59 years.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210854725-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine 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
Day following administration of vaccine the patient developed stomache ache, fever, and headache.  Highest fever was 101.
Patient had came in for vaccines, and after receiving the following 2 vaccines became pale. Pt. stated "I feel funny" and his eye rolled back in his head. Pt. was immediately layed down and felt fine within seconds to 1 minute of incident. Pt. was given a cold cloth and water to drink. Blood pressure 96/62.
I had my vaccination on 10/14/2022. In 03/2023 I got a cold. I was COVID-19 negative. The cold got worse and I went to the doctor. I was diagnosed with a sinus infection and prescribed an antibiotic. It took me about 2 weeks to recover.
Patient temperature increased from midnight until this time. 100.8 increased to 102.5. TYLENOL no effective. Pt. reports body aches. ZOFRAN effective for nausea. 01/27/2012 ADDENDUM STATUS: COMPLETED. Received a call at 1.45 am from nursing staff need a TYLENOL order and temp was 102. No focal signs was from vaccination had during day time plan: ordered TYLENOL 650mg now order. Vitals q2 hrs. Symptoms: Myalgia, Fever & Stuffy nose, injection site induration. Treatment: Acetaminophen 650 mg PRN, Ibuprofen 400 mg PRN, Ondansetron 4 mg PRN.
very sick; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) and VOMITING (throwing up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were provided.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ILLNESS (very sick) and VOMITING (throwing up). At the time of the report, ILLNESS (very sick) and VOMITING (throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment drug was provided.
I have been diagnosed COVID Positive as of 29Jan2021; I have been diagnosed COVID Positive as of 29Jan2021; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose and the first dose, via an unspecified route of administration on an unspecified date at single dose for vaccination for COVID-19. The patient medical history and medications were not reported. It was reported that the patient was a Registered Nurse in the state of (state name withheld) and had received both doses of the Pfizer vaccination for COVID-19. The patient received second dose was 3 weeks before 01Feb2021 (in Jan2021) and the patient had been diagnosed COVID Positive as of 29Jan2021. The patient was not sure if we are keeping this type of data or not, but she/he believe it is useful for her/him to reach out and make this known. The patient had no fear that she/he would contract the virus after receiving his/her vaccination but she/he find herself/himself to be a part of the 5%. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Chilling, fever, headache, body aches, tiredness for about 20 hours. Diarrhea for the following 48 hours.  Also some ear aches.
4/6/2021 vaccination Light cramping. I took my son on our daily walk. When going downhill, abd pain more intense pain. When I came home, I was seeing the brown spotting.  Pelvic rest for 1 week per PCM. 4/22/2021I woke up today, bright red spotting.  *Second pregnancy. 1st pregnancy, full term no complications. EDD; 12/16/2021.  **PCM; checking in with clinic in an hour due to the bright red bleeding.
This spontaneous report was received from an unknown reporter via company representative regarding a 53 years old female patient. The patient's pertinent medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with ZOSTAVAX (strength: 19400 PFU) lot # L046893, 19400 PFU, subcutaneously. On an unknown date the patient experienced suspected cellulitis. The patient visited to doctor's office for seeking medical attention and was being treated with steroids and antibiotics (brands and manufacturers unspecified). The outcome of cellulitis was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Pt given Moderna vaccine at 17 years and 10 months when EUA only authorized for patients 18+.  No reported adverse effects related to vaccination.  Pt and mother notified right after error.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Patient noticed rash/redness to the injection site when she took off her band-aide the day after administration. at day 10 she sought medical advice because the area continued to grow, was red, and warm -
Fever of 102.1 Body aches Chills Fatigue Nausea
Fatigue same day and next more pronounced, same day seemed like mild but noticeable-distracting muscle spasms in just unusual places in legs, overnight-lower lung tingling/pins woke me up at 4 pm, also next day more pronounced left and right arm pain nearly constant, and also abdominal pain next day (today). Leg pain noticeable upon resting or sitting or laying. Back pain along spine, mid-and-lower. Lower right stomach pain too. Some sense of tightness breathing. Not enough to go to hospital, but still noticeable in lungs. Throat largely feels fine, but tightness in lower lung it feels like. Again, can breathe fine, but cannot breath as deep without trying to do so, I would say. Right toe tingling. Some finger tingling too, like index fingers (not sure if muscle).  Day after forearm pain, added to shoulder pains. Most obvious forearm pain is in left forearm, but some in right for sure.
Breakthrough case after 2 vaccines Moderna 4/1/21 Lot# 025B21A;  Modena 12/17/21 Lot# 045J21A
Cough; Headache; Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). An 18-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in right arm on 28Feb2021 at 11:30 (at the age of 18-year-old) as a single dose for COVID-19 immunization. The patient's medical history included known allergies: Nuts, shellfish, sesame. Concomitant medication included etonogestrel (NEXPLANON), received within two weeks of vaccination. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has not been tested for COVID post vaccination. On 28Feb2021 at 14:00, the patient experienced headache, fever, chills, fatigue. Cough on day 4 (04Mar2021). No treatment medication was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.