chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/08/2021 and 01/29/2021. There is no indication of having received any booster doses within the immunization system. The individual presented to a clinic on 09/16/2022 with cough and tested positive for COVID-19 the same day. They were not admitted to hospital at that time but were discharged back to the long term care facility at which they were a resident. They then presented to Emergency Department on 09/21/2022 with primary complaints of low oxygen saturation and recent fall. They were admitted to hospital and diagnosed with COVID-19 pneumonia. A blood culture was positive for MRSA and Klebsiella pneumoniae. They were discharged back to long term care facility on 09/25/2022. They were then seen in hospital (outpatient) for 09/30/2022 for wound care related to a pressure ulcer on the foot.  They died on 10/03/2022. I see no indication they were hospitalized closer to the death date. COVID_19 is listed on the death certificate.
Pt received vaccine and then became anxious, dizzy, and stated she had visual changes. Pt was laid down and then observed. Symptoms resolved 45 minutes after they started.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. Medical history and drug allergy were not reported. On unknown dates the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, route, lot# and expire date were not reported). Concomitant drug was not reported. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 100.7, 7/20/2018 at 3:00 AM. Rash, itching, and swelling at injection site beginning 7/20/2018 which increased in size to two and a half inches on 7/23/2018.
Red spot where shot was administered. Grew  from the size of a dime to a half dollar size and super itchy in a week.  Looks a little like a bullseye. I took pictures as well.
Presented with weakness and rectal pain, fever in ED and hypoxic; Covid + in ED; Admited 9/17 medical  for Covid infection ; tx with 9/17 Vit C, Vit D3, steroids, LMWH,  singulair, zinc; also treated for fecal impaction; Remained on RA for O2 during stay Order to receive monoclonal antibodies after d/c
pt recv vax & devel a rash @ the inj site;No further details were provided;
Localized erythema with induration directly under area of Prevnar/Comvax. Mild warmth.
Injection site reaction/erythema with rash throughout head/face/neck/chest/abdomen/back legs that was itchy without pain. Symptoms over 48 hour time period.
Patient was given PPD Vaccine 0.5ml IM by mistake in the right deltoid. Patient was to receive Tdap 0.5ml IM. Patient was briefed on possible side effects and what to do by Dr.
Hospitalization 6/1/21-6/24-21; repeat hospitalization on 7/2/21. All from prior metastatic lung cancer.
Patient received vaccine 10-4-16, developed warmth and redness on arm of injection site October 9, 2016. Left arm with approximately 4x5cm patch red, raised, warm skin square pattern 2 cm below injection site. Treated for reaction with BENADRYL, prednisone and ZPAK.
Received Hepatitis A, MMR, Pneumovax on 08-01-2006.  08-02-2006 mom called to report left thigh and swollen hip to knee and no weight bearing left leg.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 25-JUL-2016, the patient was vaccinated with improperly stored M-M-R II lot # L029266, therapy type (albumin status) rHA, (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Left deltoid swelling, warm hard 9cm swelling, ice applied, nurse practitioner notified; sent to ER to rule out anaphylaxis at 2:20am on 11/10/06 came back same day with order for Medrol dose pack and Benadryl 25mg po qid x 3 days
On April 12, 2022 I received my fourth Moderna vaccine. Three or four days later I began to notice a slightly irregular pulse once or twice during the day, without symptoms, On Sunday the 17th I felt like I had a flu-like syndrome with weakness, and went to bed. The next day, Monday the 18th, I felt terrific, but I knew that I was in atrial fibrillation (asymptomatic), and this was documented by an EKG by my internist. The following day, I was back in normal sinus rhythm, and my rhythm has remained normal. My electrophysiologist feels that this was related to the COVID vaccine and perhaps with a predilection because of prior atrial fibrillation. As stated before in this form, I developed atrial fibrillation after my valvular surgery the prior December, and this finally required cardioversion, which was performed with a successful outcome on March 3rd, six weeks before the Moderna vaccine.
At area of HPV injection redness, increased warmth, pain developed with fever. Treated with KEFLEX.
Immediate localized swelling around injection site.  Applied pressure X 10 min., then Re pack X 10 minutes.  Swelling mostly resolved, positive hematoma.
Pt has a history of passing out after a vaccine and was very nervous.  After administering vaccine, pt stayed seated in the same chair for observation.  After a few minutes pt wasn't feeling well and vommitted in small amounts about 3 or 4 times.  He then took some small sips of water.  After a few more minutes, he was sweating, and looked like he was passing out.  (Minimal response when talking to him.)  His mom and I lowered him to the floor. He was now flat on his back, knees elevated, his eyes were open and he was moving his head a little, but no responding to direct questions.  His heart rate was at 71.  Within about a minute, he began responding normally and said that he felt fine, just very sweaty.  Over the next several minutes, his heart rate fluctuated between the 70's and 90's.  We kept him in this position for several more minutes. We then had him sit up while on the floor for a few minutes when he was ready.  Then we moved him (by his own power) to the chair.  He remained in the seated position for several minutes. He said that he then felt fine.  He continued to sip water and we continued to monitor his heart rate. After several more minutes when he was ready, he stood, said he still felt fine.  We walked with him to the waiting area, he said that he still felt fine. I recommended that they stay for as long as he needed.   After about another 10 to 15 minutes, he was still feeling fine.  His mom is a nurse and said that she would continue to monitor him. I recommended that they stay a little longer, but they felt that he was fine to go. I asked that they stay in the general area (we are a large store) and that they come back or call me if there are any further concerns.
received the 1 dose / in October 2020 / should have gotten the 2nd dose in April 2021, but she didn't; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not aplicable for this report. The reporter stated that, the patient should have gotten the 2nd dose in April 2021, but she did not, so she was more than 60 days late for it. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details were provided at the time of the call. The reporter consented to follow up.
VARIVAX breakthrough. Had 2 doses of VARIVAX (3-2-04 & 3-4-08). Diagnosed with varicella in our office on 3-28-09. Had 30 vesicles. No fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 22Mar2021 as dose 2, single (Lot number: Er8727), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course included: The patient received Paxlovid (Lot number: Gc0466) from 17May2022 to 19May2022 for the treatment of COVID-19. No known allergies. The patient was not recovered.  No follow-up attempts are possible. No further information is expected.
The next day after vaccine, my arm on the injection site was very sore with limited range of motion. It hurt to lift my arm with extreme pain and does not hurt when rested. These symptoms are still continuing. I have went to two doctors and was referred to PT which is scheduled on 3/15/2022.
I was tired for a couple of days; arm hurt/arm only hurt in certain positions; side effects she experienced were not unreasonably and didn't bother her that much.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was tired for a couple of days), PAIN IN EXTREMITY (arm hurt/arm only hurt in certain positions) and VACCINATION COMPLICATION (side effects she experienced were not unreasonably and didn't bother her that much.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced FATIGUE (I was tired for a couple of days), PAIN IN EXTREMITY (arm hurt/arm only hurt in certain positions) and VACCINATION COMPLICATION (side effects she experienced were not unreasonably and didn't bother her that much.). At the time of the report, FATIGUE (I was tired for a couple of days), PAIN IN EXTREMITY (arm hurt/arm only hurt in certain positions) and VACCINATION COMPLICATION (side effects she experienced were not unreasonably and didn't bother her that much.) outcome was unknown.            No concomitant medication were reported.  She said that the side effects she experienced were not unreasonable and didn't bother her that much.   She asked to not report the side effects as she believes in this vaccine and does not want to complain about it. She wants people to get the vaccine.   She initially stated that her husband had the same side effects but during the call she confirmed with her husband that he did not experience any side effects from his shots.   No treatment drug were reported.
High temperature, redness and swelling at site of injection (behind left arm), followed by 5 more cysts and swelling in thigh, underarm area. Saw the doctor on 5/25/10 was diagnosed as chickenpox and antiviral was prescribed. Symptoms have continued till today 6/2/10 with numerous other lesions/cysts all over body and headaches and temperature.
pt recv vax 9OCT95 & pt was exposed to chicken pox;14FEB96 pt devel a chicken-pox like vesicular rash all over body & itching;no further details were provided;
9/20/02 Left thigh had 1x.5 hourglass shaped, red area with little blisters.
Patient reported feeling itchy all over like she had hives about 30 minutes after receiving the first dose of Moderna. She reported no trouble breathing and no visible rashes/hives present. We discussed reaction with PCP and advised not to receive second dose.
No additional adverse effects reported; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a 3-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 30-JUN-2020, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S012036, expiration date: 17-APR-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number S033779, expiration date: 16-JUN-2022; lot number S030249, expiration date: 02-JUN-2022 or lot number S036204, which has been verified to be valid, expiration date reported and validated as 03-JUL-2022). No additional adverse effects reported.  On an unknown date, the vaccine experienced a temperature excursion between 15 degrees Fahrenheit (F) to 46F (32.9F) for 5 hours, as recorded by a data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA005592: US-009507513-2007USA005952:
Verbalized muscle cramping during injection and post injection. Pain level 8, ice pack applied. Approximately 10 minutes later, voiced tingling in feet & calves. Pain in shoulder radiated up in arm to neck. MPH stayed with applicant x 15 minutes. No shortness of breath, chest or throat tightness or resp. distress. Only s & s - tingling & pain as stated. Participant left after approval from Wellness sponsor HPN with instructions on when to see Dr immediately ie: shortness of breath, tightness chest & throat, wheezing or any other respiratory symptoms. Left with spouse about 8 am.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
HEADACHE; SORENESS AT SITE OF INJECTION; FATIGUE; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced soreness at site of injection. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, soreness at site of injection and fatigue was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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.  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 physician concerning an approximately 4 year old female patient with a history of previous immunization with a dose of PROQUAD (Merck upgrade process) (some time in 2006) at the age of one who in February 2010, was vaccinated with a 0.5 mL dose of VARIVAX (Merck) (lot # not reported). About six months after received VARIVAX (Merck), in approximately August 2010, the patient developed chickenpox. The patient was treated with VALTREX. At the time of the report, the physician reported that the patient still had some visible lesions but she was recovering. The patient sought unspecified medical attention. Additional information has been requested. This is one of two reports received from the same source.
Patient had hx of feeling dizzy/passing out following vaccination as indicated on consent form. Patient began feeling dizzy and sweaty after administration, but during counseling. Patient passed out in chair and urinated. Patient was awoken and given water, then requested to wait while a family member could come to pick him up with a change of clothes. Patient felt well enough to leave with father approximately an hour after fainting.
Large round welt the size of an orange/tennis ball.  Hot to touch.  Red and painful.  Tiredness compared to usual energy but not complete lethargy.  Today, is 10/2/2011 and welt is reduced but not gone.
Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, chest pain, bilat leg numbness, no hives present, denied difficulty swallowing. Pt was brought to a room, placed on 02 10L by face mask. Initial BP 200/105 HR 116. Pt became non-verbal, PA-C dx'd stridor, epi 0.3mg was given deep IM to right thigh. Pt responded positively, within 2 mins, pt became alert and was able to respond to questions. EMS was contacted, arrived and took pt to hospital. She was unable to ambulate c/o of all over body numbness, racing HR. Pt was admitted for observation at Medical Center.
I wasn't feeling great, it started with a tickle in my throat and that was on Sunday. It felt like I had a really bad cold. I woke up on Tuesday and I couldn't walk down the stairs when I took 2 test on Monday they were neg and then Tuesday it came back positive, I slept for 3 days I was really dizzy. I had a low grade fever. I was congested. It felt like the worst flu I ever had. It lasted till Saturday night that it when my fever went away. I lost my taste and smell the following week.
Severe spinal pain 8 hours after shot. Throbbing from neck to coccyx. Then contracted COVID in September, same pain. I have COVID currently (12/20-12/23/21) and spine pain was even worse. Ice/heat help but pain is debilitating.
huge red area around the place the shot was given/She has a red mark around the area she got the shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-year-old female patient received first dose bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8732, Expiration date: Unknown) via an unspecified route of administration, administered in arm left on 29Apr2021 at 08:55 (age at vaccination 23 years) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 was administered was reported as clinic. Vaccination administered at military facility was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. The patient 's medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks was reported as no. Adverse events following prior vaccinations was none. Patient's medical history including any illness at time of vaccination was none. Family medical history relevant to adverse events was none. On 30Apr2021, patient experienced huge red area around the place the shot was given/She has a red mark around the area she got the shot. Caller would like to know whether she should be concerned about her side effect or if she should see a doctor. She was asking the risks of the Pfizer-BioNTech Covid-19 Vaccine and what should she do about side effects. She reported on the Covid 19 vaccine and who explained she just got the 1st dose recently and experienced a huge red area around the place the shot was given. It was given on 29Apr2021 hasn't gotten better and she was calling to see if she should go to urgent care for this. She explained the red area was noticed the next day and it was about the same since it was noticed, not better or worse. Seriousness of the event was non serious. Investigation Assessment was reported as no. Relevant tests was reported as no. Adverse events did not result in Emergency room or physician office visit. The outcome of the event was not recovered.    No follow-up attempts are needed. No further information is expected.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant and treatment medications were reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
This is a 31 y.o. male with abrupt onset urticaria, dermatographism and significant pruritis. Only responding to high dose prednisone and cetirizine.  No significant new exposures other than covid booster. Booster administered 12/1 with urticaria starting on  12/12.  No concern for urticaria after he received Moderna mRNA COVID-19 vaccines in January and February 2021.