chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; a dose of expired PNEUMOVAX 23 was inadvertently administered to the patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.    On 26-SEP-2020, the patient was inadvertently administered a dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S025133 with expiration date 15-SEP-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Arm developed a heated, red raised bump, very sensitive and painful to the touch, with a hard knot underneath.  It lasted about 4 days. I used benadryl and ibuprofen to manage it.
Client into HD day after shot (24 hrs later) upper right arm swollen and warm to the touch. Its also has erythema halfway around arm but on underneath side. No c/o itching or pain just soreness. Client took Tylenol and relates that swelling going down. Temp at HD 99.7.
Twenty days after my second shot, I developed very painful Shingles across my back and stomach.  I went to my doctor, and I was given an antibiotic and some cream. It lasted about 3 weeks. I received my first booster on 10/09/2021 and I had ruptured appendix on 02/20/22. The surgeon told me that women of my age die with this condition and I was lucky to be alive.
This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the right arm on 09Apr2021 12:45 as 1st dose, single for COVID-19 immunisation. Medical history included GERD and allergy to eggs. Concomitant medication included pantoprazole taken for GERD from 2017 and ongoing. The patient was in the ER (emergency room) after the first dose of Pfizer vaccine and diagnosed with acute pancreatitis on 17Apr2021. Patient was in the ER (emergency room) a week after she had the Covid-19 Vaccine and was diagnosed with acute pancreatitis. She was wondering if others have had this too. She was due to get her second shot on Monday. Her primary physician doesn't know what's going on. She took a nap and woke up in excruciating pain on 17Apr2021. It was on and off but not like it was. She went to urgent care first, and then they sent her to the ER for a CAT (Computerised tomogram) scan. The events required a visit to the emergency room and urgent care. She has a follow up with her GI (Gastrointestinal) doctor. She has an appointment in June, and he wanted her to get an MRI before he sees her. She had bloodwork and a CAT scan on 17Apr2021. Her lipase was 80 something which was double the normal. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
May 8th awoke with sore arm and some nausea and body aches, May 9th body aches began to subside but nausea remained. May 11th nausea intensified to the point of complete loss of appetite or wanting to drink water. Dry heaves but no vomiting. Inability to sleep. May 12th symptoms began to worsen and  with heart palpitations and feelings of anxiety and depletion. May 13th, sought help at the nearest emergency room.
I ONLY got 1st Mederna covid shot. No way I'll get 2nd shot for any local vaccine.  After I got 1st  Mederna covid shot, I got 1 time in urgent care and 2 times in emergency hospital. Those symptoms still with me for 2+ month. Sometimes still feel like they are coming back for 3-6 days.  Symptoms: - disorientation (4+ days) - blond syndrome (extreme uncontrolled silliness, not adequate behavior, unable to quickly make decision,  not sharp thinking, can't concentrate, fall into a stupor, memory loss) - still have it from Mederna covid shot - shortness of breath  - fever - sore throat - runny nose - pain in the upper chest (like bronchitis) - fatigue - enlargement and soreness of the lymph nodes armpits (also itching)  - place of injection is red like red, swollen and itchy (15X15cm) - very sleepy - dyspnea (even when going on 2nd floor in my house - out of breath),  - pallor of skin -  constant fatigue - fast heartbeat  -dizziness and weakness - chest pain VERY abnormal blood test in emergency hospital
This spontaneous report was received from a healthcare worker and refers to unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, drug reactions or allergies was provided. On unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # L004652, expiration date 11-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2014US000898 is an initial spontaneous report received from a health care professional on 08 Jan 2014. This report refers to a female patient of unknown age. She received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), without reconstituted with MenCYW-135 liquid component intramuscularly on an unknown date in Oct 2013. No adverse reaction reported following this administration error.
Headache  and chills    Tylenol  Headache gone after approx 30 hours
I was administered my first dose of the Moderna Covid Vaccine on 1/29/2021 at 12:20 P.M.  I woke up today, 1/30/2021, at 5:30 A.M. and had chills,  significant fatigue, headache, and a fever that was 100.8 degrees when I measured with an oral thermometer.  I believe my fever may have been higher, but I did not measure when I felt worse. I'm reporting this at 3:15 P.M. and believe I may be starting to feel better.  I was surprised to get these side effects after the first dose.
This spontaneous report as received from a registered nurse refers to a 18 months old patient. Patient was vaccinated with VAQTA vial 25/0.5 on 12-MAR-2010 and 07-SEP-2010. The two dates were 25 weeks apart but less than 6 months by calendar days. Inappropriate schedule of vaccine administration was reported. A school board was questioning the timing of the two doses and whether or not the doses were administered too close together. No adverse effect was observed or reported. No product quality complaint was reported. The outcome of events was unknown. Additional information has been requested.
Started as raised urticaria red bumps on day 2 after shot , approximately 1.5i inches in diameter and also swelling of upper arm shot area ; on day 3 additional slight peeling of top layer of skin in this red area,  enlarging red area to 2 inches, upper arm area still swollen; day 4-5-6 progressed to only a reddened area, butterfly wing shaped , of ~ 3 inches , with slight skin peeling resolving but still remained the smaller (1.5) area, within, of raised bumps, some slight itchiness and arm swelling still present ; day7 red area resolving/decreasing, itchiness resolved, raised bumps gone, swelling down; all signs of redness, edema and urticaria resolved by day 10. No doctor office reporting or appoinment made regarding this vaccine issue
This case was reported by a nurse and described the occurrence of erythema in a 5 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The vaccine provider submitted this report directly. On an unspecified date, the pt received the fifth dose of Infanrix (lot DTPA627A2). At an unspecified time following administration of Infanrix on 11Feb04, the pt experienced a severe injection site reaction characterized by redness and swelling. The pt was seen by the physician, who prescribed an unspecified antibiotic. The event resolved after an unspecified period. In the nurse practitioner's opinion, the events were possibly related to the use of Infanrix.
patient being administered IPOL after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; patient received the IPOL after it was not suitable for use with no reported adverse event; Initial information received on 10-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was being administered ipol (IPV (VERO) ) after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and patient received the ipol after it was not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 19-Jul-2022, the patient received a dose of 0.5 ml of  suspect IPV (VERO) (formulation, strength: unknown) lot U1C572M, expiration date:17-Jun-2023, via subcutaneous route in the right deltoid as Immunization   The patient was being administered ipol after it exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  On 19-JUL-2022 the patient received the ipol after it was not suitable for use with no reported adverse event (poor quality product administered) same day following the administration of IPV (VERO).  Action taken was not applicable.  Corrective treatment: None.  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a nurse practitioner refers to a 71 year old female patient. There was no pertinent medical history and no drug reaction/allergies reported. On 03-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # J004747, Expiration Date 20-JUL-2014. 0.5 ml, intramuscularly. No concomitant therapy reported. On 04-SEP-2014 (reported as next day), the patient's arm was a little sore at the injection site. No treatment was given. No lab diagnostic studies were performed. The patient didn't seek medical attention. The outcome of "her arm was a little sore" at the injection site was reported as recovered/resolved on an unspecified date in September 2014. The causality was unknown. Additional information has been requested.
pain around L shoulder joint x 1 week; deferred exercise since the adverse event started; recommended to start ibuprofen PRN per Dr. as of 7/6/20; relief from ibuprofen unknown at this time
Developed large hematoma at injection site.   Normal redness, soreness the first week.
10 minutes following the administration of the Covid-19 vaccine the patient reported symptoms of Vasovagal Syncope, became pale with sweating.  This continued for another 5 minutes at this time 911 was called
Severe fever, chills, arthralgia, diarrhea on-off, severe fatigue, body aches, insomnia, profound exhaustion, severe weakness more so on his left side.
The day after her MMR shot she passed out and did three rhymic movements. Then 10 days later she began to turn blue around her fingers, lips and toes randomly throughout the day. Finally on the day she turned 15 months old she went into seizures. She has been diagnosed with Infantile Spasm Epilepsy. No medical reason for her to have this sickness. The medical record received on 2/18/04 states pt vomited.
Information has been received from the healthcare worker who reported that on 21-APR-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0.5 (units not provided) of M-M-R II (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The case is one of several reports received from the same reporter. Additional information has been requested.
Patient is 15 year old that received Moderna vaccine. No complication following vaccine. Paramedic took vaccine to home so counseled staff about appropriate age for vaccine.
Sore body & bones; Sore body & bones; Headache; Dizziness/Light headed; Nauseous; Vomiting; Fever; Night sweats; Chills; Goosebumps from being so cold; Goosebumps from being so cold; Feeling like I'm in a dream/Foggy; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El1284), via an unspecified route of administration at Left arm on 06Jan2021 08:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included covid-19, Known allergies: Latex.  There were no concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 at time of 03:30 PM, the patient experienced Sore body & bones, headache, dizziness, nauseous, vomiting, fever, night sweats, chills, light headed, goosebumps from being so cold, feeling dizzy, feeling like i'm in a dream, foggy. No treatment received for the events. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Intermittent tingling sensation to left arm for about two weeks.  Sunday Sept.  12th, 2021 at 6am. I woke with indigestion issues. I took some nausea medication that I had and I went to work. Was fine at work. When I came home and was making dinner at about 1830 the indigestion returned with an onset of severe back pain and chest discomfort. I layed down for about 10min. then sat back up  and started to experience severe left sided chest tightness and numbing of my entire left arm. It lasted about 2min. I then took two Asprin. Left side of chest still felt very heavy.  I was scared but decided to wait and call my doctor in the A. M.  My doctor's office suggest that I go to the ER to make sure I was not having a heart attack.  That morning I still had some numbing and tingling down the left arm with left sided chest tightness. I arrived to the ER where they did an EKG that should some abnormality. The ER nurse still made me wait in the waiting room for 2hrs. I finally got back to a room where I was seen by PA .  He ran some labs and came back and told me that my Lipase was at 706. Pa stated that I had acute pancreatitis. I was shocked as I am not a heavy drinker and maintain a pretty healthy lifestyle.  Doctor then recommended a CT scan to make sure nothing else was going on. CT showed normal pancreas. NO INFLAMMATION! Yet lab work stated inflammation of the Pancreas?!  A week later I had more blood work and my Lipase showed normal at 52?!
Hives at 72 hours after administration of Prevnar #3.  Seen in ER, sent home.
A bit pink; Chest tightness; Weird sensation initially on the left arm then it resolved and moved to his right leg; Right leg started twitching; Feels like cramping and constantly present from the knee down to the right calf area.; Itchy (area of the injection); Rash at the area of the injection; Swelling at the area of the injection (left arm); This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.) and VACCINATION SITE ERYTHEMA (A bit pink) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthmatic attack.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). In August 2021, the patient experienced FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A bit pink). At the time of the report, CHEST DISCOMFORT (Chest tightness), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), VACCINATION SITE ERYTHEMA (A bit pink), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)) had not resolved and FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    No treatment information was provided.  Patient reported that symptom started, few hours after the vaccination on the same day (15Aug2021).
Dizziness, hypotension within minutes after injection. Trendelenburg position for 20 minutes. BP stabilized.
When vaccination record card was given to the patient he stated, "Moderna, that's the wrong one."  The patient desired to receive the Janssen COVID vaccine as a primary dose but was given a Moderna booster (0.25mL) instead.  The Moderna help line was called and we were instructed to give another 0.25ml dose and give the second dose of Moderna in 4 weeks to complete his primary series.
Single hive on left hand, itching and redness on back, abdomen, and upper thighs.  Given diphenhydramine 25 mg iv x1 with full resolution of sx.
My upper arm ? below the injection site ? was sore and then got very itchy, red, and slightly swollen.  The rash continued to wrap around most of my upper arm and continues to be very itchy.  I tried ice to no avail.  Have never had a reaction like this to vaccines, including the first two Covid Moderna shots.  May try antihistamine soon.
pt turned grey & pale around 4PM, legs were limp & pt was weak; pt also reported as feeling sleepy; pt felt sick to stomach; lt arm hurts per mom; pt tired & had slurred speech; t99.2 ax;
General cold symptoms: congestion, cough, mild fever. Additionally, mild muscle pain at location of vaccination shot.
mom described spiked temp (did not take it) then had 5 minutes of rhythmic sz;
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant products were not provided. Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up contains no new information.
Patient presented to the ED at Hospital on 5/7/21. Patient presented with signs of a stroke. Patient was transferred to another hospital to receive a higher level of care.