chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/20/2021: Patient presents with progressive shortness of breath, associated hypoxemia necessitation oxygen supplements. Patient previously received the Pfizer COVID-19 vaccine on 1/19/2021 and 2/10/2021. Patient tested positive for COVID-19 3 days ago and again on admission.  7/21/21: patient discharged back to assisted living facility. Chest X-ray does not identify any significant infiltrates.
Started on September 6 having severe head pain on the right side, increasing intensity every day, Saturday September 11 I woke up with my face paralyzed on the right side with excruciating pain. I went to the doctor and he prescribed Acyclovir 800mg and Prednisone 40mg. I also had an MRI Brain with and without contrast. 3 weeks have passed and I still have symptoms an deformed face.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On 31st August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. The reporter stated to the representative that she was contacted by a nurse from a nursing home. The only information that was provided was that the patient experienced arm pain. This case has been linked with US2018166437 and US2018166446, reported by same reporter.
Shaking throughout entire body started 20 minutes after injection.   Blood pressure dropped low, weakness and dizziness.   Shaking changed from. Small shakes to larger jerking.  Toes and fingers continued twitching for 2-3 days.
Injection received in wrong location; Pain at injection site; A spontaneous report was received from a consumer concerning 54-years-old, white female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain at injection and injection received in wrong location.  The patient's medical history was not provided. Current conditions included diabetes. The concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 011L20A) intramuscularly and on 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 004M20A) below deltoid for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient received injection at the wrong location (below deltoid) and experienced pain at the injection site  The patient was advised to consult health care professional.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  On 18 Feb 2021, the event of  injection received in wrong location was resolved while on 20 Feb 2021, the event of pain at injection resolved.  The reporter did not provide an assessment for the events pain at injection and injection received in wrong location.; Reporter's Comments: This report refers to a case of product administered at inappropriate site  for mRNA-1273 (lot # 004M20A with second dose) with reported event of vaccination site pain.
This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (sinus infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-076339 (Patient Link).
Nurse administered vaccine even though we requested our baby not receive it. Approximately 2-3 hours later he was excessively sleepy and unable to breast feed properly. (He received the vaccine before his first feeding!) Medical staff repeatedly denied the vaccine caused the sleepiness, although they admitted him to the NICU and started IV fluids for 'dehydration'. This prolonged our hospital stay another 24 hrs!
This spontaneous report as received from a registered nurse who is also the patient refers to herself. Patient medical history and current condition was reported. On an unknown date the patient was vaccinated with ZOSTAVAX via subcutaneous route. Other co-suspects and concomitant medication was not reported. On an unknown date the syringe plunger blew out due to pressure issue after reconstitution, while withdrawing solution to receive ZOSTAVAX, causing her to miss the dose. No adverse effects reported. Product quality complaint has been filed. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 06-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Tdap vaccine administered on 9/6/06 at approximately 4:00 PM.  Mother called the next day (9/7/2006) reporting a fever of 100.9 degrees and c/o stinging in her back and "nerve shocks" down both arms.  No pain, swelling, redness or tenderness at injection site.    9/8/2006 mother contacted their PA and reported above symptoms with pain in knees, back, palms of hands, ankles and legs.  PA phoned Health Department for recommendation.  9/11/06  Mom reports she is back to normal but requests that VAERS report be completed.  Fever broke 9/8/2006 about noon and other symptoms disappeared at that time as well.
Temperature excursion, low temperature 32.82 F for 25 minutes total time with no reported adverse event; IPOL was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and it involved temperature excursion, low temperature 32.82 Fahrenheit (F) for 25 minutes total time with no reported adverse event and ipol was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event , for punctured vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown  dose of suspect IPV (VERO), ( lot:  U1A601M ; expiry date: 2-Feb-2023) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date there was temperature excursion, low temperature 32.82 F for 25 minutes total time with no reported adverse event (product temperature excursion issue) (onset and unknown latency)  On an unknown date , Ipol was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event (poor quality product administered) (onset and unknown latency)    Action taken :  not applicable for both the events.  Outcome: unknown for both the events   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.; Sender's Comments:  01160269: 01160330:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heterozygous Familial Hypercholesterolemia" (unspecified if ongoing). 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient received treatment with Paxlovid on 04Feb2023 and stopped on 09Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received vaccine upon discharge from hospital stay. Within an hour after arriving at home intense pain began at site and spread to whole arm down to hand. Back to ER next morning.
Pain and weakness at site of jab started within hours and persists, almost 3 months later. On a scale of 0 to 10, I?d rate pain at a level 3. Weakness at level 5.
The patient named above was not seen by me when he developed adverse reaction. He was also not followed up by me after developing adverse reaction. Patient was given flu vaccine (lot # U6655AA) in my office on 12/11/2019 @ approx. 330 pm. Parents then took patient to Medical Center E.R. on 12/12/2019 in the evening. Please see copy enclosed with this form from Medical Center E.R. Patient was then taken to different Medical Center on 12/13/2019 where he was then admitted from 12/13/2019 - 12/17/2019. Please see copy enclosed with this form from Medical Center. Thank you.  5Y 3M old male complaining of Reaction to Flu Shot. Patient had a flu shot in the right arm yesterday at his doctor's office. This evening he presents with complaint of pain swelling redness and abrasion to the right shoulder area. He has had flu shots in the past without any reaction. There is no reports of fever. They deny that he has been scratching he area. The patient presents with rash. The onset was 1 days ago. The course/duration of symptoms is worsening. Location: Face trunk back. The character of symptoms is itching and redness. Radiating symptom(s): spreading distally. The degree of symptoms is minimal. Risk factors consist of infectious exposure. Prior episodes: none. Therapy today: none. Associated symptoms: none. Otherwise healthy vaccinated 5-year-old male presents with rash following recent hospital discharge for cellulitis compartment syndrome. Patient was discharged 5 days ago for a cellulitis following a flu shot which led to compartment syndrome requiring surgical intervention. Currently on day 7 of p.o. antibiotics. Yesterday had a popular raised erythematous rash that began on the chest and overnight spread to involve the abdomen, back, and face. Distal extremities are relatively spared. No fevers, difficulty breathing, difficulty swallowing, nausea vomiting diarrhea.
rash over body, (head to toe) everal hrs p/vax; tx DPH elixer;
Injections were given in left arm. Onset of symptoms 11/11/2010. Pt went to walkin clinic. Left arm bright red, swollen from elbow to her shoulder. Walk in provider told her she has infection and thinks it is in her bloodstream. Pt. is shivering unsure of her temp. Pt. pain level 15 out of 10. Pt requests IV antibiotics and become inpatient. Prescribed BACTRIM and Diclofenac 50 mg from the walk in clinic. Dr notified he prescribed VICODIN 5/500 mg and to go to the ER if she had no relief.
AFTER 4-5 HOURS, PATIENT REPORTS FULL BODY HIVES AND WELT AT INJECTION SITE. SHE HAS BEEN TAKING DAILY PREDNISONE 5MG AND BENADRYL PRN TO MANAGE SYMPTOMS. PT REPORTS HAVING HAD THIS REACTION BEFORE DUE TO HER AUTOIMMUNE DISORDER, SROJENS SYNDROME, BUT THIS REACTION HAS BEEN THE MOST SEVERE TO DATE.
local wheal in area of vaccine injection with in minutes after administered-no respiratory sx. (Varivax) Benadryl administered-next day 7/31/07 Sx (rxn resolved)
Developed rash > 50 papules and pustules concentrated on torso, extending onto scalp, face and extremities.
Hypertension; Elevated HR; resting HR is tachy staying over 100 bpm; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), intramuscular in left arm, on 06Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included penicillin allergy. The patient's concomitant medication included lisinopril. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccines were administered in four weeks. On 08Jan2021 at 12 AM, the patient experienced hypertension and elevated heart rate (HR). Resting HR is tachycardic (reported as tachy) staying over 100 bpm. The adverse events resulted in doctor or other healthcare professional office or clinic visit. An additional medication was given as treatment to bring HR down. Post-vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
This gentleman was hospitalized with dyspnea, found to have a leukocytosis and probable right lower lobe pneumonia, hospitalized for IV antibiotic therapy.  He is still hospitalized but improving as of the date of this report. His COVID-19 test was negative on the day of admission. He had no symptoms out of the ordinary on the day of his vaccination. I am reporting this as it occurred in the week after his first dose of vaccine though would suspect the timing is likely coincidental rather than directly related to the vaccine.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date in approximately 2011 (reported as 3-4 years ago), the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not provided). On 19-OCT-2015 (at the time of the report), the patient was in the office to be administered the second dose in the vaccine series. No adverse effect was reported. Additional information has been requested.
Two day after vaccine received I started feeling nauseous at 9:30am slightly, had drank a small coffee and danish, another 90mins later I felt faint and laid down on ground prone vomiting multiple times, also had a diarrhea bout before driving home on Harley motorcycle from desert to home. Next 24-30 hours had another bout of vomiting and diarrhea, finally day three I was better and eating bland foods and chicken soup, now I'm better and feel normal again.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 24-JUL-2015, the patient was vaccinated with ZOSTAVAX 0.4 ml (lot#, expiration date, frequency, site of vaccination were not reported) for prevention of shingles. The ZOSTAVAX unit produced excessive foaming after reconstitution, which caused that only 0.4 ml was withdrawn into the syringe. Even though this amount was less than indicated, the injection was given to the patient. No adverse event was reported. The patient did not seek medical attention. Additional information has been requested.
5 minutes after getting the vaccine it was like a fright train hitting me with everything at once. Tightness in shoulder where vaccine was given through injection site to front of chest.  Severe rapid heart rate like I've never experienced before with my neck artery pulsing out of my neck, dizzy.  I felt the vaccine go through by body from the shoulder down my arms and through my trunk and down my legs that followed with a cold sensation that made my body shiver and stay cold.  This first wave hit hard and lasted about 8 minutes.  Then it dissipated and then hit again with half the strength and lasted another 5 minutes with the same symptoms.   After this I was able to get up and ask for help.  The medical staff was helping another woman about my age so I spoke to the girl at the desk and she just told me to stay a little longer and if it got better I could leave.  I had one mire smaller wave hit and then got really cold and left after sitting 45 min total.  I onkynleft because I knew my husband would be late getting his vaccine and I needed to get back to our kids.  I should have gone to the hospital.  I had typical after shot syptoms that included flush cheeks, brain fog, icky feeling for about 8 hrs then felt fine.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number G44Y2, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th September 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 24th September 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Flulaval Quadrivalent, which was expired on 30th June 2021, which led to expired vaccine used. No further adverse reactions were reported at the time of the call. The reporter consent to follow-up either by email or by phone.
SkinRash, Rash, ErythemaMultiform & UrticariaPruritus Narrative:  Pt. developed symptoms 90 minutes after covid vaccine was given, pt. reported taking po benadryl at home. 24 post vaccine still has rash/itchiness.
Patient reports tingling sensation/numbness in the hands and feet which she states started after receiving the pneumonia vaccine. She also reports Upper Respiratory Illness symptoms after that. Since the onset, the patient has noted increased numbness in the right leg and some tongue numbness. The patient has some left facial droop (more so since her Bell's palsy incident). Complaining of mid back pain.
Pain/soreness immediately. Pain lingered for 3+ months.  Patient sought medical care and MRI.  Per patient, MRI showed the vaccine was administered into the bursa.
Heavy menstrual period after vaccine. Persistent headache, fatigue and lightheadedness.
LA swollen/tender/blister on injection site. Mom states pt given Tylenol/ice pack applied on left arm. Dr is aware.
Menstruation lasted for 3 weeks and stopped for 90 days before it started again. In the 3 weeks it was extremely heavy.
administered FLUZONE QIV NP after the expiration date with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a pediatrician.  This case involves a 15-year-old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] np was administered after the expiration date with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received suspect Fluzone QIV at dose 0.5ml once via intramuscular route in the left deltoid (lot: UT7407MA, expiry date: 30-Jun-2022) for prophylactic vaccination with no reported adverse event (expired product administered) at latency same day.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.  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.
pt called today and said after Arexvy (RSV) vaccines , she got high fever and  her BP went very high after 3 days of vaccines , she went to Er and hospital told her to admit right way , she end up to pace maker , she disgnois with 6 sinus syndrome , she stayed in the hospital for 1 week and now home but taking many Bp medication. pt is ok now but daugher is very upset and asking for lot numer which is 5bn3t and expiation date of vaccines 11/05/24
Flu-like symptoms; Sniffles; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Sniffles) and LETHARGY (Lethargic) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Blood pressure high.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Sniffles) and LETHARGY (Lethargic). On 01-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Sniffles) and LETHARGY (Lethargic) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included (unspecified) medications for for asthma and high blood pressure.  Reportedly, the symptoms were so bad and it took 4-5 days for them to go away.  No treatment information was provided.