chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having COVID/previous administration of Pfizer COVID-19 vaccine; having COVID/previous administration of Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "having COVID/previous administration of Pfizer COVID-19 vaccine". Clinical course: Caller wanted to know if when can she revaccinated after having COVID. There's a previous administration of Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna covid 19 vaccine. 0.5ml given instead of 0.25ml
pt presented w/reactive axillary & cervical lymphadenopathy & day p/vax no tx was necessary;pt was educated & no f/u needed;
Pt c/o flushing/sweating and dizziness.  BP 131/84, HR 71, RR 14.  Pt stable and released from the vaccination site.
I had vaccination 02/02/2022. About 04/2022 I had routine lab work done every 3 months to monitor my liver. My MELD Score kept going up after the vaccination. Since vaccination I have felt muscle weakness, fatigue, I trip and fall, and feel like I always have the flu. I am now on the list for a liver transplant. I was admitted to the hospital in 01/2023 due to syncope. I do have internal bleeding.
Soon after the injections I developed soreness and within a month I hardly could move my should without pain. By late December my should was in pain and had limited ROM. I went to doctor and upon examination after xrays they diagnosed Frozen Should early January 2022.
shot administered on 22SEP81 intermittent fever all that day; 23SEP prolonged sleeping/unresponsive; found dead on morning 24SEP81;
On 3/5/21 at approximately 0200 became congested suddenly.  Doctor was notified with N.O. Torsemide 20 mg tab via PEG-tube NOW, IM Rocephin 1 mg QD x7 days for possible aspiration, Chest X Ray, CBC/BMP in morning, and may suction resident if tolerated PRN. Received both Torsemide and the Rocephin and then deceased at 0350.
pain in arm; new lump under the skin; Upper arm is hot; Upper arm is itchy; entire upper arm is swollen; Upper arm is painful; 2 more red spots; red, raised bump on injection site; A spontaneous report was received from a health care professional concerning herself, a 29-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a red raised bump on the injection site and then 2 more red spots and pain in arm and further experienced secondary reaction as swollen, hot, painful, and itchy upper arm stretching down to elbow.  The patient didn't report any medical history or concomitant product history.   On 06 Jan 2021 at 12:30, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the morning of 07 Jan 2021, she noticed a raised bump on the injection site with 2 more red spot, which went away by 10 Jan 2021. Later on, 13 Jan 2021 again she experienced the secondary reaction as pain in arm and new lump. On 14th Jan which adverse into entire swollen, painful, hot and itchy arm which stretched down to elbow.   A treatment of Keflex was given by ER on 13 Jan 2021 and further she visited an allergist.  Action taken with mRNA-1273 in response to the events was not reported.   The events, red raised bump on the injection site and then 2 more red spots , were considered resolved on 10 Jan 2021. Whereas event, swollen, hot, painful, and itchy upper arm stretching down to elbow was not resolved at the time of report.
This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced "memory issues" and can't remember if she ever had a vaccine card on an unspecified date. Patient stated, she went to get a 2nd dose of Pfizer COVID-19 vaccine and was turned away because she did not have a vaccination card. She wanted to know what can she do about the card. Received the 1st Pfizer COVID-19 vaccine 4 months ago. She went to the hospital shortly after the 1st dose for "side effects from the vaccine." After discharge from the hospital, she never received a 2nd vaccine dose. Has it been too long now to get the second dose? Wanted to know if she needed both doses again. The outcome of event: unknown. The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow-up.
The last dose which was Moderna made me feel not well and I had to miss work; The last dose which was Moderna made me feel not well and I had to miss work; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The last dose which was Moderna made me feel not well and I had to miss work) and IMPAIRED WORK ABILITY (The last dose which was Moderna made me feel not well and I had to miss work) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (The last dose which was Moderna made me feel not well and I had to miss work) and IMPAIRED WORK ABILITY (The last dose which was Moderna made me feel not well and I had to miss work). At the time of the report, MALAISE (The last dose which was Moderna made me feel not well and I had to miss work) and IMPAIRED WORK ABILITY (The last dose which was Moderna made me feel not well and I had to miss work) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient's Year of birth was reported. No concomitant medication were reported. No treatment medication were reported.
Patient received Tdap/Boostrix and MCV4/Menveo at our office on 08-20-2019 in his left deltoid. Presented to office today 08-26-19 with redness and heat to left deltoid. Area is flat, no hardness noted. Will treat with ice pack to area. Started 08-25-19. Per Dad: put ice on it 08-30-19 and it went right away.
Approximately 12 hours after my 2nd injection of the Moderna COVID19 vaccine, I experienced severe nausea and ended up having an episode of syncope  where I passed out on the stairs in my home.
About 24 hours later,around noon on the 19th, I began to feel achy, little upset stomach, took a couple of ES Tylenol which helped. By 5 pm I was feeling worse, and I had a painful tenderness under my left arm (lymph node?) and by 10 pm I was chilling, teeth chattering so I took 2 more ES Tylenol and continued those every 6 hours until 4pm on the 20th when the achiness was gone. Around 7pm, I suddenly got a red, raised rash like hives on my neck, under my arms, on my stomach and back, groin area, itchy mostly on my neck. The rash persisted but had calmed down a bit on the 21st, but still itching especially on my neck so I took 25mg of Benadryl. The rash was improved this morning (22nd) but is still present and somewhat itchy on my neck.  I did have Covid in January and this was my first vaccination which I had read might be worse. I did not feel short of breath or dizzy or anything that made me think I should go to the ER, but I thought I should report the reaction I did have. Thank you.
Patient received incorrect covid vaccine. Patient had already received primary covid vaccine series of Pfizer (late 2021) and Pfizer monovalent booster (august of 2022). Patient should have instead received covid vaccine bivalent booster 12+ dosage.
Complain of itching after YF immunization. After approximately 8 min patient complain of itching, site was red, raised to size of 50 cent piece. Patient refused PO(by mouth) BENADRYL. Ice pack put onto site. After approximately 10 min, redness and swelling down by 3/4. FM call, patient stated that night his face and chest became blotchy; he took BENADRYL. States he is ok now.
On October 28th my husband returned home where my daughters were being cared for by their grandparents.  We noticed small bruises on her legs and swelling in her ankles we took her to the ER where they said it was an injury.  I took her to her pediatrician the following day and found out she had Henoch-Schonlein Purpura (HSP).  This occurred approximately a week after she received her flu mist.  Her flu mist was administered on October 19, 2007.  It is difficult to know if the symptoms occurred earlier because my husband and I were out of town for the weekend and she was in the care of her grandparents.  She has received the flu shot before know as Flu Zone.  She had the flu shot in 2003,2004,2005, and 2006.  This was the first year she received the flu mist. 12/10/07-records received for DOS 10/28/07-DX: ankle contusion. See in ED bruising on ankles. 12/26/07-office note 11/14/07-well visit.
5"X5" area of flat redness, & warmth no induration, around left deltoid muscle.
Site reaction (red/heat), malaise, vomiting, headache, soreness. MD culture confirmed cellulitus and started patient of CEFTIN 250 mg #14- 1 BID x7.
Information has been received from a physician concerning a 15 year old female who on approximately 11-FEB-2008 was vaccinated with her second dose of GARDASIL (lot# not reported) and fainted. The patient had not eaten anything yet. Sometime later at home, patient fainted again and bit her lip. She went to the Emergency Room for stitches. Her outcome was not reported. Additional information has been requested. A coding change request was made - lip injury.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 27 Nov 2021) outcome was unknown. Not Provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Vaccine placed in refrigerator on 27 Nov 2021. Vial did not undergo temperature excursion. No adverse event reported.  Treatment medications were not reported.
Rash B/L thigh the same day as vaccinated. Tx: BENADRYL & given EPI-PEN junior for emergency.
Vaccines administered on 2-19-13 at 1130AM, Pt developed rash on 2-19-13 at 630 pm. Rash started on trunk and groin and began spreading. Saw pt in office 2-20-13 at 8 am. Widespread hives to trunk, inguinal area, scalp line, legs, back Pt was given BENADRYL in office. Pt was Rx BENADRYL, Prednisone, Ranitidine, EPIPEN. No SOB or difficulty breathing. Pt sent home. Called at 3pm to check on pt. mom reports rash has improved, no trouble breathing.
PERICARDIAL EFFUSION/SHORTNESS OF BREATH/CHEST TIGHTNESS; PERICARDIAL/MEDIASTINAL MASS; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. 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, batch number and expiry date were not reported) dose was not reported, 1 total administered on 28-SEP-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, the patient subsequently developed a pericardial effusion, tachycardia along with a pericardial/mediastinal mass that caused heart attack symptoms and was removed on 03-AUG-2022. The patient had also issues with shortness of breath and chest tightness (symptoms subsumed under pericardial effusion), and as of yet patient's cardiologist and pulmonologist had not been able to find the cause of this. The patient still had on going breathing issues at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericardial/mediastinal mass on 03-AUG-2022, and had not recovered from pericardial effusion/shortness of breath/chest tightness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20221038771-covid-19 vaccine ad26.cov2.s - Pericardial effusion/shortness of breath/chest tightness, Pericardial/Mediastinal mass. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
She received vaccine on Friday 9-4-2009. Injection site became swollen and dark, came back to pharmacy to have other family member to get immunization, and show me 2cm size dark bruise (3 days later on 9-7-09). It became better but still sore.
Cheeks and chin because bright red/pink and there was a burning sensation. I called the Dr's office, they said as long as I didn't have trouble breathing to watch it. The redness began to fade after 24 hrs. The burning sensation stayed for another 24 hrs and continues intermittently to this day.
A non-serious spontaneous report of child received two doses of FLUMIST in the same week was received from a health professional concerning a four year old female. On 05 Oct 2009, the patient received single dose FLUMIST at school, on 09 Oct 2009, the patient received a second dose at the pediatrician's office. There is no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
3/02/21 big hard bump at injection site, 3/4/21 bump gone, large red rash almost to my elbow and hot, and 3/8/21 rash fading and not hot not sure if getting 2nd shot because not known why people are getting rash.
Large lump at site of injection, redness that spread, fever up to 102.9, vomiting.
Headache & Myalgia Narrative:  missed one day of work following second dose due to symptoms
Herpes Zoster / Oral Shingles reactivation; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: Er87333) at the age of 32 years as dose 2, single for covid-19 immunisation. No other vaccine in four weeks. Relevant medical history included: "herpes zoster (non-oral)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number: EN6210), administration date: 10Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 07May2021, outcome "recovered with sequelae", described as "Herpes Zoster / Oral Shingles reactivation". The event "herpes zoster / oral shingles reactivation" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Herpes zoster with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Fever, chills, body aches for about 24 hours. Pain at injection site for about 72 hours.
Information has been received from a physician concerning a 12 year old male who on 08-JUL-1998 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported). On 28-JUN-2001, the patient was vaccinated with the second dose of MMR II (route, site, dose and lot number not reported). On 20-JAN-2010 the patient experienced facial pain, parotitis and was diagnosed with Mumps. The outcome for mumps was not reported. On 21-Jan-2010, lab test performed revealed: serum mumps immunoglobulin M antibody test 1:10, serum mumps immunoglublin G antibody test 6.34, and serum amylase test 227. No further information is available.
Diarrhea, body chills, fever, ears ringing, shaking, disoriented,
Shingles rash on upper right torso, consulted physician who prescribed medication. Am awaiting pharmacy to fill the prescription and will begin taking said prescription immediately.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/31/2023 Discharge Date: Feb 1, 2023  PRESENTING PROBLEM: COVID [U07.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 53 y.o. female without significant past medical history. She presented to the emergency department with complaint of shortness of breath.  Recently tested positive for COVID and had worsening dyspnea at home and therefore presented to the ER for further evaluation. She had a CTA which showed no PE, bronchitis, interlobular septal thickening possibly related to pulmonary edema, and splenic artery aneurysm. She was started on steroids for her bronchitis and had great improvement in her symptoms. Also on mucinex and tessalon for cough and congestion. She will need to follow-up with her PCP regarding splenic artery aneurysm. Given marked improvement in her symptoms, she was discharged in stable condition on 2/1/23. She was enrolled in the Transition to Home monitoring program.
Pt presented to clinic with left arm pain, rated a 5/10 at rest and can go up to a 10/10 upon movement. Able to raise arm slowly. Pt able to make left hand into a fist and twist wrist without pain. From pt's left bicep muscle to deltoid muscle was visibly red and warm to touch.  In comparison to right arm, minimal swelling. Had fever previous night, but it went away. Afebrile in office. Pt denied being itchy, SOB/WOB, or the inability to use his left arm. Dx cellulitis following pneumococcal vaccine in L deltoid.
5/21 Around 7:00pm approx. 1 week after receiving 1st dose, site of injection began to turn blotchy red, slight swelling and warm to touch. Redness area about the size of a half dollar.   Following Morning on 5/22  area still red and warm to touch and size of red patch doubed in size. Put icepack on area throughout day-waiting to see if redness or warmth decreases throughout day.
11 y/o female was administered VARIVAX on 5/4/09 at Health Unit .  On 5/6/09 mother presented to health unit with child to report vaccine reaction.  Noted on left arm where VARIVAX was given was tender, reddened warm area approx. 6-7 cm in diameter.  Discussed comfort measures & recommended MD follow up if worsens
severe redness @ the site the size of a grapefruit w/in 24hr of vax;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-031654 (Patient Link).
Mother of pt reports today 31JAN91 that the pt had a high-pitched adnormal cry lasting for 8 hrs after DTP, TOPV given 6NOV90.
Pt explained he had all over body aches and pains Tuesday night following vaccine on Monday. Patient slept and relaxed and woke up Wednesday morning fine.
Several hours after injection of PENTACEL (R) thigh became warm, red & swollen. Mom says patient has also been screaming & very fussy. Mom applied ice pak. Called office. Triage nurse advised to come back in for evaluation of injection sites.
The patient has had substantial anemia, but it's never been bad enough to require a blood transfusion before; This is a spontaneous report from a contactable pharmacist.  An elderly patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  Medical history included anaemia. The patient concomitant medication was not reported. The patient previously took BNT162B2, dose 1 for COVID-19 immunisation.  The patient received a blood transfusion within the past 24 to 48 hours. Patient was scheduled for a booster dose of the Pfizer BioNTech Covid-19 Vaccine on 11Oct2021. The patient has had substantial anemia, but it's never been bad enough to require a blood transfusion before. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event( Anaemia aggravated) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate