chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a patient who on 26-AUG-1999 was vaccinated with a dose of Varivax. Subsequently, on 28-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Period late, heavier and more painful when started:  I normal have a very regular 26 day cycle. Period should have started 8/25. Period started on 9/7, with significantly more severe cramping and bleeding noted. I was unable to walk due to the cramping for the first 24 hours, despite large doses of anti-inflammatories. I bled through 3 or 4 super absorbency tampons in less than 3 hours for the next 24 hours. I also bled for 7 days, as opposed to the regular 5.
Normal vaccine side effects of fatigue, cold symptoms, and muscle soreness/body aches for the first 36-48 hours post vaccination.  Uncommon side effects that developed after the first 48 hours and continued for the next 6-8 days were vertigo/dizziness/light-headedness similar to feeling mildly to extremely intoxicated and unable to walk steady at times.  Only other common side effects during this time were pronounced fatigue and soreness at the injection site for 5-6 days.  An appointment was made to seek treatment after 5-6 days of these side effects, but side effects cleared up before the date of the appointment (9-10 days post vaccination).  No other side effects appear to be present at this time other than new joint pains that may or may not be related to physical exertion or exercise.
pt recv vax & threw back head & arms eyes rolled & then went limp per mom;c/o dizziness;pt pale;
Not 18 years old and older. They have not experienced any side effects to vaccine at this time.
Lymph nodes painful to the touch; Swollen lymph nodes on the arm where the vaccine was administered; Febrile; Fatigued; Nausea; Vomits; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPH NODE PAIN (Lymph nodes painful to the touch), NAUSEA (Nausea), VOMITING (Vomits), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered) and PYREXIA (Febrile) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LANSOPRAZOLE and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomits). On 26-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes painful to the touch), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered), PYREXIA (Febrile) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 09-Jan-2021, NAUSEA (Nausea) and VOMITING (Vomits) had resolved. On 26-Jan-2021, PYREXIA (Febrile) had resolved. At the time of the report, LYMPH NODE PAIN (Lymph nodes painful to the touch), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes on the arm where the vaccine was administered) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
left lung pneumonia; congestive heart failure; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 15-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in 2016, shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered chest pain, cough and fever. The patient was hospitalized and diagnosed with left lung pneumonia and congestive heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling. Upon internal review, the events of left lung pneumonia and congestive heart failure were considered to be medically significant.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/7/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On Friday, 1/22/2021, I woke up with pain in my left arm.  I thought I maybe had slept wrong until I looked down and saw that my axillary lymph nodes were completely swollen.  I had a lump there the size of an orange/small grapefruit.  It was very painful to the touch and uncomfortable to move my arm.  I contacted medical services (I work at a medical research center) and they asked me to come on-site to be evaluated.  I was seen by Nurse Practitioner sometime in the early afternoon. By the time I got there, the swelling had gone down significantly but the injection site was bright red, extremely itchy, and I was running a slight fever.  The itching at the site of injection lasted for another 24 hours after that and I was very tired and lethargic.  Prior to this, I had only felt what I would best describe as a bee sting at the injection site?. Very localized pain.    NP warned me that since I had reacted to the first dose, that I would probably have a stronger reaction to the second.  I received my second dose on Tuesday, 2/16/2021, at approximately 11:30 AM on my right arm (Moderna Lot#: 004M20A). By 7:30 PM that evening I had the chills and my fever spiked at 102.3 F.  My fever ranged from 101-102 for almost 48 hours along with chills, body aches, and extreme fatigue/lethargy. By Friday, 2/19/2021 I felt back to normal.
administered only the adjuvant portion; administered only the adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: This case was reported by nurse. The nurse stated that the patient was administered only the adjuvant portion of Shingrix. The vaccine administration facility is the same as primary reporter. Additional supportive information: As patient received only the adjuvant portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter consented to follow up.
Information has been received from a physician concerning a pt age and gender not reported, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot 651321/1036P). Subsequently, the day after vaccination, the pt developed severe arm soreness, high fever, nausea, vomiting and weakness. The pt sought unspecified medical attention. Subsequently, the pt recovered. The physician requested a lot check of lot 651321/1036P. The physician felt that the pts severe arm soreness, high fever, nausea, vomiting and weakness were disabling. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 65 years old female patient. The patient was vaccinated with live ZOSTAVAX (lot number not provided) in December 2012. No other co-suspects were reported. No concomitant medications were reported. The patient might have received a partial dose due to leakage from the syringe. In December 2012 the patient experienced a small area of redness at the injection site. No treatment information was reported. The outcome of small area of redness at the injection site was not reported. The relatedness for small area of redness at the injection site was not provided for live ZOSTAVAX. Additional information has been requested.
First sx: hot to the touch started 2 days post Second sx: swelling start 3 days post Third sx: redness and itching 5 days post
Day 8 red, raised, warm to touch rash developed - approximately the size of a golf ball. Woke up in the morning for it. Took OTC antihistamines for it. Still present 24 hrs later.
her eye looks like a bee stung her eyelid, it is swollen; hives on face; rash on her legs and her legs were itching; rash on her legs and her legs were itching; This is a spontaneous report from contactable consumer (patient). A 60-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/lot number: EK9231; Expiration Date 30Apr2021) via unspecified route of administration in right on 11Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history not reported. historical vaccine included BNT162B2 (First dose: 21Dec2021; Lot number: EL0140; Expiration Date: Mar2021) and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient reported hives on face that were red and bumpy. They are not as bumpy but it is still red like her face looks sunburned red and her eye is swollen, rash on her legs and her legs were itching, on 03Feb2021 her eye looks like a bee stung her eyelid it is swollen. Treatment received for the events with Prednisone. The outcome of the events (Urticaria, rash, pruritus) was unknown, her eye looks like a bee stung her eyelid, it is swollen was not recovered.  Description of Product complaint: Caller was calling about the Pfizer COVID vaccine. She says she wanted to report having a reaction. She had  hives, like a rash and her eye looks like a bee stung her eyelid, it was swollen. She had a rash on her face and her legs and her legs were itching, it was like hives on her face that were red and bumpy. They are not as bumpy but it was still red. She has been taking Prednisone and she was not sure if that is why its getting a little bit better but it was still really red and itching and the swollen eye was a new thing. Her Prednisone was in an amber color pharmacy bottle and does not see an NDC lot or expiration on there.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications, reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Anti viral, Batch/Lot number: unknown, Started on 20Jun2022 and stopped on 15Jun2022). Clinical course was reported as, After the 2nd dose of Paxlovid patient started to get hives on forearms started on 21Jun2022. They continued to get worse so she stopped the medication after 6 doses (3 days). Treatment received for symptom Hives included Benadryl. Patient was recovering from symptom.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe local swelling, pain, erythema, induration lasting > 1 wk.
Redness, swelling pain at injection site which extended down to elbow. Seen in ER 5/13 and then admitted 5/15/07 with diagnosis of cellulitis. Discharged 5/10/07 to home.  05/31/2007 MR received for a 1 day admission for cellulitis of the L upper arm at the site of her Pneumovax which was increasing, despite po abx.  Pt/ c/o redness pain, and swellingx 2 days. Placed on po Zithromax, but redness and swelling were increasing.  Txd with IV abx. Discharge DX: Cellulits after recent Pneumovax in the L arm.  Hypertension. Anxiety.  Gastroenteritis-now resolved.  Hx. of Helicobactor pylori (+) antibody.
the doctors thought he had a stroke but it wasn't that, they then tested him for MS on and it came out positive for that.  Testing started on 3/31/2021 and testing is still going on now.
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken.  At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol.  At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest.  2 Tylenol taken.  I was required to check into the ER for Observation.  oxygen saturation checked for 2 hours.  no change in symptoms, no worsening.  I then left work in the ER and went home.  At approx. 1800 ate dinner, no real taste, but needed to eat.  At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol  Through the night I slept very poorly, tossed and turned, woke frequently.  Body and joints with extreme pain everywhere it touched the mattress.  I have a screw in my left foot, it felt like it was on fire at some point during the night.  My left leg ached up into my hip.  On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea.   Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran.   1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe.  1300 - 2 Tylenol  Slept better, just sore January 8 night.    January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea.  2 more tylenol around  1800  January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
Pt recvd rubella vax & devel flu-like sx w/persistent joint pain;
patients got the IPOL dose that was not viable after the temperature excursion with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 years old male patient and reporter reported that 2 patients got the IPV (Vero) [IPOL].dose that was not viable after the temperature excursion 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix); And Meningococcal Vaccine A/C/Y/W Conj (Crm197) (Menveo), NMR, and Varisela .  On 27-Sep-2023, the patient received a 0.5 ml dose of suspect IPV (Vero) Suspension for injection (strength: standard, frequency: once and lot W1A191M) (expiry date: 16-FEB-2025) via intramuscular route in the right deltoid as immunization and patients got the ipol dose that was not viable after the temperature excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Medication error 0.3ml was administered when 0.5ml was the  recommended dose per manufacturer.  Per CDC and the manufacturer no treatment, facility advised to follow up with 2nd dose of 0.5ml of Moderna 28 days post 1st dose administration.
I had a stroke 20 days after my Pfizer shot.; I have damage on the left side of my Brain, but I have damage on the left side of my Brain; I just woke up in the morning and couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old 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 included: "thyroid issues" (unspecified if ongoing), notes: But have thyroid issues and have an autoimmune hasimoto; "autoimmune hasimoto" (unspecified if ongoing), notes: But have thyroid issues and have an autoimmune hasimoto. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I had a stroke 20 days after my Pfizer shot."; BRAIN INJURY (medically significant), outcome "unknown", described as "I have damage on the left side of my Brain, but I have damage on the left side of my Brain"; GAIT INABILITY (non-serious), outcome "unknown", described as "I just woke up in the morning and couldn't walk".  Clinical course: I had a stroke 20 days after my Pfizer shot. I was 53 at the time. I made it in time for major damage to my brain, but I have damage on the left side of my Brain. I want my age added to the stroke victims as I am not 65 or older. But have thyroid issues and have an autoimmune hasimoto. Please respond how I do that be included in that age bracket being lowered. I think autoimmune diseases also have to be considered with the stroke victims because I just woke up in the morning and couldn't walk.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Have Been going through Menopause, had not had a regular Menstrual Cycle over 8 months.  Started Menses day after shot and had extreme bleeding for 3 days. Was very anemic, and wore down.  after the 3 days of extreme bleeding, was a regular menses for 2 weeks.  Have not had any Menstrual Cycle since.
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported.  The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved.  She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered.  Information on the lot/batch number has been requested.
7 days post vax, the pt developed two bumps on his inner left thigh. 5 days later, he developed three small, red and blistery bumps on the injection site with a temperature of 100F.
pt recv vax 26FEB97 1045AM & w/in 2hr pt devel fever that was tx w/APAP;28FEB97 in the AM pt was sleepy w/dec alertness & dec oral intake;2PM pt noted w/inc resp, heavy breathing;t103.2;poss sz;loss of body tone, eyes rolled back;
Ongoing extreme headache for about a week. Rapid heart palpitations currently still on-going.  Tingling down my left arm down to my hand, still on-going.  Heaviness on my chest.
Client received first dose of Moderna Vaccine. Consent signed by the client's father.  Per manufacturer's guidelines, client was not eligible for the  vaccine due to being under the age of 18.  Dr notified Moderna and the Center for Disease Control and Prevention (CDC) of the incident.  Parents were notified that the first dose that was given to the child was not in accordance with the  CDC and manufacturer's guidelines. They were also informed  that the CDC and Moderna were notified of the incident and that the CDC has allowed the second dose series to be administered to children 16 years and older in similar situations.  The parent/guardian was given the option to return  to the clinic at the scheduled interval and for their child to receive the second dose series to provide better protection against the COVID-19 infection.