chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 01:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 29Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "T1 Diabetes" (unspecified if ongoing), notes: Other medical history: T1 Diabetes,; "Addison's disease" (unspecified if ongoing), notes: Other medical history: Addison's disease; "hypoglycemia" (unspecified if ongoing), notes: Other medical history: hypoglycemia; "CVD (mild)" (unspecified if ongoing), notes: Other medical history: CVD (mild). There were no concomitant medications. Past drug history included: Avelox, reaction(s): "Known allergies: Avelox", notes: Known allergies: Avelox. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and treated with Paxlovid, treatment start date was 16Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
swollen, red, hot to touch, sore to the bone! Dr. said do not get the second shot but I am still having the same symptoms, almost as bad,  and tomorrow is ONE WEEK. It seemed like it was better on Tuesday but seems to have flared up again????
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022 at 3:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Its 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022  No concomitant medication information provided. No treatment medication information provided.
I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was driving home and did become itchy and developed a couple of small hives that quickly went away.  The main event that I am reporting is a severe outbreak of eczema. I used to get it on my hands as a child and it was caused by citrus. On the morning of 12/24, I noticed itching and a red rash starting on my right wrist and my left hand. I thought perhaps it was from over washing or not rinsing all of the soap off. The rash became worse and I noticed a small area above my lip on the left side, I then developed a large area on the right side of my lower face. There were also a few spots elsewhere but these were the worst.
Administered expired vaccine 6months and up that expired 18-Jun-2023.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in a 7-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) 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 (Administered expired vaccine 6months and up that expired 18-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.).    Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. Expiry date of the vaccine was reported as 18-Jun-2023.  Treatment information was not provided.
2nd dose of Moderna COVID Vaccine received 21 days after 1st dose to prevent wastage of expiring doses. No adverse reaction noted.
pt recv vax & 15-20min later pt devel diffuse urticarial rash all over body responded well to epi & DPH;
After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses. 2nd night- chills, tiredness, sore legs, difficulty walking.  3/7/21- woke up with painful legs, heaviness, unable to walk, continued mild headache.  treatment include: Tylenol, Gabapentin and lidocaine cream, avoiding narcotics rehab therapies
One hour after receiving the Pfizer COVID Vaccine, developed hives on torso and back. They did not resolve for 10 days. Prescribed Prednisone and Azithromycin from PCP. Denies shortness of breath or swelling of lips and tongue, no difficulty swallowing.
Pt experienced fever of 105.2 tympanic rectal equivalent; pink flat rash - trunk.
Hospitalized with Hypoxic Covid pneumonia had monoclonal antibodies on 1/6/2022. IVIG on 1/13.    Sars-COV-2 Moderna vaccine booster given 8/25/2021 NO FURTHER INFORMATION ON VACCINE
removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood; removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood; removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years old female patient who experienced removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood (Vaccination site discharge and Vaccination site haemorrhage), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2019, the patient received a 0.5 ml third dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ247AB (Expiry date 30-Jun-2020) via intramuscular route in the right deltoid.  On 26-Sep-2019, the patient developed a non-serious removed the bandage, she noticed that there was a lot of fluid leakage mixed with blood (Vaccination site discharge and vaccination site haemorrhage) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to vaccine underdose.   (Other relevant tests included no lab data.) Final diagnosis was Vaccination site bleeding and Vaccination site discharge.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for Vaccination site bleeding and Vaccination site discharge.  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 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  List of documents held by sender: none.
Heart palpitations first 24 hours Dizziness last 10 minutes to 3 hours recurrent for 6 weeks Fatigue, recurrent and sudden onset lasting 1-2 days at a time for 6 weeks Cognitive sluggishness for 6 weeks Treatment of all the above has been caution when experiencing symptoms, hydration, good nutrition, rest when needed, limit daily activities. Symptoms resolved without pharmacological treatment.
Left Arm was lumpy and hard to feel approx. 2hours after the shot.  Towards the nighttime also turned warm and red Following morning same symptoms 2 days later hardness decreased but still red and hot
"Patient was hypertensive and tachycardia post COVID vaccine.  Sent to ED. BP 206/108, 183/103, 175/91. P 102, 100, 103. Back to baseline when presenting to ED.
Pain in shoulder, back, and arm despite mult. analgesics and interfering w/ ADL's; >1 mo.
- red, itchy rash at injection site  - red, itchy rash around eyes  - general itchiness entire body  - fatigue, muscle aches, chills   Symptoms began improving approx 24 hours after injection
DTAP & HIB & VARICELLA, right leg: red, hot, swollen 8cm.
Fever for 3 days, peaked at 103.2 on day 2. Rash started on day 3 (8/17/2011). Twitches and despondence started 08/15/2011.
Per mother, within 24 hours of receiving TdaP, had increased redness, swelling, tenderness at site.  Brought child to urgent care about 1 week later while out of town due to swelling and redness.  Urgent care prescribed triple antibiotic cream.  Seen at vaccine providers office on 02/11/08 for follow-up at provider's request.  Very small bruise at site remained, barely palpable induration.
pt had a rash that started on her arm around injection site next day after shot.  The following day it had spread to her abdomen.  It had fever and itching in it.  The following day after a doctors visit and some medicine the rash was almost resolved.
had both vaccine doses back in January and Wednesday 01Jul he drew positive to Covid-19 after a molecular PCR test.; had both vaccine doses back in January and Wednesday 01Jul he drew positive to Covid-19 after a molecular PCR test.; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old male patient received bnt162b2, via an unspecified route of administration, administered in right arm on 07Jan2021 13:00 (Lot Number: EL3246) as dose 1, single, and then via an unspecified route of administration, administered in left arm on 28Jan2021 (Lot Number: EL8982) as dose 2, single, all at the age of 31-year-old for covid-19 immunization. The patient had no known allergies and no other medical history. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had both vaccine doses back in January and Wednesday 01Jul2021 (as reported) he drew positive to covid-19 after a molecular PCR test on 28Jun2021 14:00  (as reported). The patient underwent lab tests and procedures which included PCR (Nasal Swab): positive on 30Jun2021. Therapeutic measures were not taken as a result of event. The outcome of event was recovering.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2to the reported vaccination failure / COVID-19 cannot be ruled out.
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. Patient's medical history was not reported. On 05-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route were not reported). Concomitant medications were not reported. On the same day, after vaccination, the patient experienced tingling down arm. The patient sought medical attention and spoke with the pharmacist. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. This one of two reports received form the same reporter. Additional information has been requested.
I was getting severe pain near my right rib and it moved to my back and chest area. I ended up having to have an emergency gallbladder removal surgery.
Information has been received from a nurse practitioner concerning a 33 year old female who in approximately June 2004, was vaccinated with VARIVAX (Merck). In June 2008, the patient had a negative titer for varicella (less than 0.91). The nurse practitioner was not sure if the dose 4 years ago was the first dose. No problems reported. Additional information has been requested.
swelling of rt thigh, screaming episode > 3hrs; mom ret'd pt to office & was very irritable;
This spontaneous report was received from a healthcare worker referring to a 11 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 30-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a pharmacy technician (also reported as a healthcare worker) referring to an unspecified number of patients of unknown age and gender. There was no information about pertinent medical history and drug reaction/drug allergies. On unknown dates the patients were vaccinated with improperly stored MMR II (lot # K008625, expiration date 16-JUN-2016; another lot# was reported as K010319, expiration date 22-JUL-2016; dose and route were not reported. No concomitant medication was reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
pt received first dose of Pfizer COVID-19 vaccine. hx of vasovagal syncope with blood draws. per medical personnel in monitoring area, noted patient unconscious at 1312 for about 15-20 seconds on the chair. as patient was waking up, she was noted to have "eyes flickering and shaking." pt diaphoretic, pale, and had emesis x1 upon waking up. CODE BLUE team on scene at 1315. BP 138/91, HR 68, RR 16, SPO2: 97. pt transported to ED via wheelchair. pt a&ox3 upon transport.
twitch in muscle on left cheek of face; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 50-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 19Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure (CHF), oxygen saturation low, CPAP (continuous positive airway pressure) and penicillin allergy. The patient took other unspecified medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unknown date in Mar2021, the patient had a twitch in muscle on left cheek of face. It did it for a couple days after first shot then went away. On 19Apr2021, after second shot it seemed to worsen and had not gone away. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event twitch in muscle on left cheek of face (onset date: Mar2021) was resolved on unknown date in 2021 and event twitch in muscle on left cheek of face (onset date: 19Apr2021) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Nurse referring to a 17 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-APR-2016, 12-SEP-2017 and 14-SEP-2018, the patient was vaccinated with first, second and third doses of GARDASIL 9 lot # L040459, expiring on 06-APR-2017, lot # N015087, expiring on 20-OCT-2019 and lot # R008163, expiring on 14-SEP-2018, respectively, for prophylaxis. Lot # L040459 reported for GARDASIL 9 was not valid for GARDASIL 9; However, lot # L040459 was valid for GARDASIL.
Pt reports the day after vaccine feeling chills, slept all day, felt "out of it.".  7/28 she noticed her arm was red and swollen. advised these would all be considered normal side effects.  Need to monitor arm.  If size increasing please notify dr.  If getting smaller should resolve on its own.  All other symptoms other than arm have since resolved.
Trigeminal neuralgia - bouts of shooting jabbing pain on upper part of left cheek lasting about 30 seconds to 1 minute (spontaneous - not from any contact) usually precipitated by burning feeling. Resolved with taking Advil. Still present the next morning (i.e., morning of 4/12) - again responded to Advil. Pain has dissipated but evolved into chronic, dull ache in same area. No visible rash, or sign of any kind of palsy. Only affects left side (nothing on the right).
Case number PHEH2014US019280 is an initial spontaneous report received from a physician on 23 Sep 2014. This report refers to a 5 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. This patient under 18 years of age was inadvertently administered a dose of FLUCELVAX (batch number: not reported) intramuscularly on 22 Sep 2014. It was reported that in the prescription, seasonal influenza vaccine (manufacturer and batch number: not reported) for a child between 3 years and 18 years was mentioned, but FLUCELVAX was given instead. No adverse event was reported following the maladministration. Following an internal review on 26 Oct 2014, a significant correction was done for the information received on 23 Sep 2014: The event inappropriate age at vaccine administration was coded.
Red spots on left side of face, Spots moved to right side of face over time.  Eyes swollen, discharge.  Problem still exists 12/28/09.
Chills, fever to 101F, myalgia, sore arm (no local swelling) for 36 hours post vaccination.
Swelling in the neck, face, lips with bumpy rashes on the face. Two hours later went back to doctor. Told highly likely allergic to the protien in vaccine. Epilepsy seizure and dairy allergy since vaccination.
Patient stated she had redness and swelling at the injection site and very mild itching. She also had headache and just didn't feel very well.
This is one case out of a cumulative total of 240 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 November 2014. These 240 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial solicited report received on 25 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 11 March 2011, 29 April 2011 and 05 July 2011, (routes and lot numbers not reported) and a dose of DAPTACEL on 27 March 2012, lot number C4183AA, (route and site not reported). The subject developed cold-like symptoms on 21 October 2014, approximately 30 months after the last dose. On 21 October 2014, the subject developed a cough and paroxysmal cough without a whoop. The subject experienced posttussive vomiting on an unreported date. The subject experienced sleep disturbance but did not experience apnea. Laboratory testing included negative PCR on 01 November 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 November 2014 for an unknown duration. The subject was not hospitalized. At the time of final contact on 04 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
1 of 2 pts who devel an inj site rxn following vax;pt recvd vax 16FEB94 & devel a knot the size of silver dollar @ inj site; also site became red, tender & itchy;itching persisting @ time of this report 21MAR94;
Patient came to ED with worsening shortness of breath and O2 sat in the 70s.  Patient admitted with Covid pneumonia and treated with remdesivir.
This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient. On 10-JUN-2014 the patient was vaccinated with an expired dose of MMR II (lot # H010135, expiration date 17-MAY-2014, dose and route were unknown), dose 1. No adverse effect reported. No product quality complaint (PQC). Additional information is not expected.
Next morning after flu shot (left arm) 9/27/14 gland in left clavicle area swollen/sore, hands got real red burny/itchy (sunburny) and now peeling (started Oct 7 and current). Lips tingled after shot too. Hands have not stopped peeling/blistering (on triamcinolone ointment).
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The nurse reported that FLUMIST was inadvertently given to a patient with asthma which started on 24-Oct-2013. The outcome of the event of FLUMIST inadvertently given to a patient with asthma is unknown. The report was considered to be non-serious.
High fever, hives, tx with TYLENOL, MOTRIN, ALLEGRA.
Loss of hearing in right ear Extreme Fatigue Dizzy Nausea / Vomiting Headache Muscle Aches Chills Fever