chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediarix - Administration after expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 10-APR-2023, the patient received Pediarix. On 10-APR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix - Administration after expiration 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 Information: GSK Receipt Date: 12-APR-2023 The nurse reported the administration of an expired Pediarix vaccine dose to a 3.5 years old patient. The reporter asked if the patient had to be re-vaccinated. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. The patient received a Pediarix vaccine which was already expired, which led to expired vaccine used.
The following progressed 2 hours after injection and continued for 5 days.:  Injection site stiffness  Tingling in shoulder joint down arm thru fingers  Nausea (still continues) Diarrhea (still continues) Extremely tired  Whole body aches Headache  Fever & chills
At 8:30 PM noticed a sudden rise in temperature (normal temp is 97.0 went up to 98.6), my son was irrtable and tired so I let him drift off to sleep. By 11PM he became even more uncomfortable and as I changed his diaper I notice some dark patches on his back, so I took his temperature which was 100.8 so I took him to the emergency room.
Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via unknown route, on 22Mar2021 (last Monday) as a single dose for COVID-19 immunisation. Patient's medical history included Bell's palsy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number and expiry dates were not reported) for COVID-19 immunisation. Patient stated that patient received COVID-19 Vaccine second dose last Monday, (22Mar2021). He had started with annoying headaches for 3-4 days. On Friday (26Mar2021), had lost control with talking, eyes were droopy etc. Patient mentioned that he had Bells palsy once before, and that now got it again. Patient asked if it would be possible that the vaccine caused the disease?. He mentioned that the hospital gave him Prednisone and Valtrex. Seriousness of the events was considered as hospitalization. Outcome of the events was unknown.  Information on about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
the day after the vaccine around midday I started feeling aches tired chills, persisted through that Saturday, all symptoms resolved the 16th. That weekend I had heart palpitations, the Monday after my standing heart rate chest xray, ddimer - possible lung collapse, any exertion my heart rate would elevate, they performed an MRI with contrast, there could be a blood clot in the lung so I went to see a cardiologist, They put me on epinolol and did an echocardiogram, everything else checked out in my tests. I have not recovered my breathing still bothers me and my heart rate still elevates with exertion.
4 days after receiving vaccination, patient reported, "I have been sick since I was in the office last Thursday.  When I woke Friday I had fever which could have been vaccine response but I am exhausted and coughing and have no stamina.  I also have chills."  Patient declined to be seen for further evaluation, stating he had "turned the corner".
Patient reports pounding headaches every day since vaccination ("like someone is hitting her with a hammer"), a large, itchy red bump at the site of vaccination that has not improved, and a very sore arm.
1st time arm swelling  2nd time on 4/22 L arm swelling, tender, redness, fatigue, headaches, generalized pruritis, cold sore to L upper lip, and vermillon border of lip swelling
On Sunday, Jan 17 noticed enlarged  Left supraclavicular lymph node.  On Monday/Tuesday noticed rash, redness, swelling on Left arm below the injection site. Also noticed bruise at injection site.  (Note: arm did bleed more than normal at time of the injection).  By Wed 1/20, rash had gotten larger, itched some and was warm to the touch.  Applied Hydrocortisone cream to site a couple times that day.  Lymph node still enlarged (maybe larger?) Wed 1/20 at bedtime took Benadryl 25mg.  Thurs 1/21 swelling less on L arm, less itching, still red with some rash.  Lymph node smaller.
A Hive like rash appeared on my left arm approximately 2 weeks after my 2nd shot, and now appears over various parts of my body such as, both arms, my torso, my legs, and my back, however, it comes and goes throughout the course of the day with minimal itching.
New onset re-occurring urticarial rash over entire body, including face few times a week, lasts for less than 12 hours, mild pruritis, resolves on own.
Patient was given pediatric dose(5-11 year old) 0.2ml, but should have been given Pfizer 12 and up vaccine 0.3ml. no adverse effect noted from vaccine. Mom was notified immediately and child had no issues from being under dosed. mom was educated that when child came back for  2nd dose, child would receive proper dose of 0.3 with the 12 and up pfizer vaccine.
Fever of up to 102.5 F, convulsions (with absolutely no control over my muscles), migraine, chills, extreme fatigue, stomach cramps and nausea.
One week after shot, had "Covid Arm",  red, itchy, and pain to touch around injection site. Approximately 2" in diameter.
Pt was given ZOSTAVAX instead of Varicella for his 4 year imms., no adverse reaction at this time.
Patient presents to ER with a complaint of facial swelling, tightness in throat and chest, and shortness of breath.  Patient states that his symptoms first began yesterday (4/27) at approximately 1400 shortly after receiving his first dose of the Pfizer Covid vaccine.  Patient was seen in the ER for this yesterday, was treated and released.  Patient was given prescription for prednisone to take at home, however states that he has not filled or started this prescription yet today.  He states this morning he started to have some returning chest and throat tightness, redness around his chest and face, and shortness of breath.  He states symptoms of been constant since onset.  He states he took a single p.o. Benadryl and used his albuterol inhaler at home, with minimal relief.  At this time patient is reporting some mild dyspnea with intermittent nonproductive cough, mild throat tightness, and redness to the skin.   IV Solu-Medrol, Pepcid, Benadryl, IV fluids, nebulized breathing treatment.  Symptoms improved in the ER, no longer shortness of breath. Pt to continue PO steroid
Pt received the flu shot in the Left arm and pt states that she got lightheaded and she fell from a standing position forward and then fell to the floor.  EMS was called, but she refused and she asked for the EMS to be cancelled.  Pt stated that she feels fine now and really has no complaints.  Pt got up to a sitting position and then moved to a chair with no complaints or issues.  Pt stayed sitting in a chair for approximately 30 minutes with a cold compress to her head.  Patient had no injury.   RPh called the patient at 4:20 pm to check on her and she states that she is feeling fine and has no issues.  RPh encouraged her to drink plenty of fluids over the next few hours.
Day 2: Arm pain, skin sensitive around injection site, swelling, redness. Day 3: more swelling at injection site, hard lump formed, redness spread, tiredness. Day 4: swelling decreased but lump stayed, headache with no relief after taking Tylenol, itchy at injection, run down feeling, tired. Day 5:  itchy at injection and lump still there.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided. Reporter wife was fine. No major issues even after getting the second shot.
Patient received her second dose of varicella vaccine on 04/28/04 at a school immunization clinic without any reaction at that time.  I was called to her school to evaluate her left upper arm.  There is a round, raised area of redness measuring 5 cms x 6 cms.  The area is a bit 'itchy' and is around the injection site.
Lt upper arm--upper arm lateral side, 3 inch x 2 inch erythematous arm more intense redness in the center, a little warm to touch , not indurated, not very tender.
both legs and feet numb; both legs and feet with pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both legs and feet numb) and PARAESTHESIA (both legs and feet with pins and needles) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, PREDNISOLONE, ESTRADIOL (ESTROGEN), PROGESTERONE and THYROID (ARMOUR THYROID) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, 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 experienced HYPOAESTHESIA (both legs and feet numb) and PARAESTHESIA (both legs and feet with pins and needles). At the time of the report, HYPOAESTHESIA (both legs and feet numb) and PARAESTHESIA (both legs and feet with pins and needles) was resolving. Not Provided          Treatment details are not provided   Reporter did not allow further contact
Fever (99.9); fatigue; headache; muscle and joint aches; muscle and joint aches; chills; This is a spontaneous report from a contactable consumer (Patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL 3247) via an unspecified route of administration in arm right on 12Feb2021 10:30 (age at vaccination 26-year-old, Patient non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. No other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration in arm right on 22Jan2021 10:45 AM (age at vaccination 26-year-old) on as DOSE 1, SINGLE for COVID-19 Immunization. The patient experienced Fever (99.9), fatigue, headache, muscle and joint aches and chills on 12Feb2021 22:30. The patient underwent lab tests and procedures which included body temperature (99.9) on 12Feb2021. The outcome of events were recovered on 13Feb2021.  No follow-up attempts are needed. No further information was expected.
This spontaneous report as received from a county health nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients may had been vaccinated with improperly stored PEDVAX HIB (dose, route, lot numbers and expiration dates were not provided), Excursions began on 08-JAN-2014. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
throat hurts glands are swollen; strange, odd feeling; crawling sensation in her left arm,upper body part,chest; heart was pounding fast; sweating; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (crawling sensation in her left arm,upper body part,chest), PALPITATIONS (heart was pounding fast), HYPERHIDROSIS (sweating), NAUSEA (nauseated) and LYMPHADENOPATHY (throat hurts glands are swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Otitis externa and Drug allergy. Concomitant products included ERYTHROMYCIN for Sore throat and Glands swollen.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FORMICATION (crawling sensation in her left arm,upper body part,chest), PALPITATIONS (heart was pounding fast), HYPERHIDROSIS (sweating), NAUSEA (nauseated) and FEELING ABNORMAL (strange, odd feeling). On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (throat hurts glands are swollen). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FORMICATION (crawling sensation in her left arm,upper body part,chest), PALPITATIONS (heart was pounding fast), HYPERHIDROSIS (sweating), NAUSEA (nauseated), LYMPHADENOPATHY (throat hurts glands are swollen) and FEELING ABNORMAL (strange, odd feeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Redness approximately 2.5 inches below injection site, warm to touch, sore arm
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Recent gout diagnosis." (unspecified if ongoing). Concomitant medication(s) included: NASACORT, start date: 01Mar2022; MOTRIN [NAPROXEN], start date: 15May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022 at 20:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID on day 10. Therapeutic measures were taken as a result of Covid-19. Clinical course: Patient received antiviral treatment for COVID-19 from 18May2022 to 23May2022. Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PT is 8 years of age and was given a Dtap instead of a Tdap
Three hours after injection, severe pain at injection site (arm muscle). Grew worse through the evening. Unable to sleep that night due to muscle pain, flu-like symptoms, general weakness. Early morning temp 103 degrees. Temp fell to 100 by late morning, then to normal by afternoon. Next four days, strong cold- or flu-like symptoms (weakness, mild nausea, little appetite, muscle pain, periodic coughing from deep in lungs; but no more fever), As of today (five days after vaccination), soreness at injection site finally gone, but cold- or flu-like symptoms continue.
Injection site soreness immediately Nausea a few hours later Fever that night - up to 102.8 Headache Chest pain Fatigue
States had itchy, raised rash starting on right shoulder, then progressed to upper back, back of neck, then other shoulder. States used hydrocortisone cream.
After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10.   First response called and patient taken to ER for further monitoring.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, 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 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
terrible pain / never was OK; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's neighbor. The age at vaccination was not reported. The reporter stated that the patient's doctor talked her into the shot quite few years later, and for a couple years she was in terrible pain. No further information was provided. This case has been linked to US2021AMR138446 and US2021AMR092424, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138446:same reporter US-GLAXOSMITHKLINE-US2021AMR092424:same reporter
This case was reported by a physician and described the occurrence of guttate psoriasis in a currently 34-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included psoriasis. On an unspecified date the subject received a dose of FLUARIX (details unknown). Less than a month after vaccination with FLUARIX, the subject experienced urticaria and 4 weeks after vaccination with FLUARIX, the subject experienced guttate psoriasis. The subject's guttate psoriasis may have been triggered by urticaria according to the physician. The physician reported the suspect product as FLULAVAL, but provided a lot number for FLUARIX. No further details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Patient received vaccine after beyond use date of  07/29/2022 (30 day freezer to fridge dating).
Ache; Armpit swelling; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), SWELLING (Armpit swelling) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PAIN (Ache), SWELLING (Armpit swelling) and CHILLS (Chills). At the time of the report, PAIN (Ache), SWELLING (Armpit swelling) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Since the evening of the 2nd shot I had a softball sized swollen area on my left arm.  It was heated, itchy and last about a week.  I had a small similar area with the 1st shot however it only lasted a few days and was the size of 50 cent piece.  I have tests showing the spike protein was still present in my body 603 days after the 2nd Moderna vaccine.  My symptoms have been consistent even though they vary daily:  Feel like I'm wearing a lead suit all the time.  Worse on rainy days.  Balance/coordination is off, takes more effort to climb stairs,  etc.  Migraines, 90% of the time within 1-2 hours of waking. Severe 2-3 days a week forcing me to do nothing (reduction in headaches after diet changes), starting get worse Feel like I can't get a full breath/ baby elephant on my chest.  Get winded when talking for a while or walking for extended period.  Dizzy spells when changing positions, a few when standing still. Worse in extreme heat/ cold At times can't regulate my body temperature, no fever when occurring.  Feels like my entire body caught fire inside, not like a hot flash. Other times I'm under blankets.  CAN'T tolerate hot temperatures. In the Summer I would want to drop down to my knees the moment I walked into the heat. Everything would start to go white and I would get dizzy.   Hard to get warm when temps are cold, even with layers,  blankets,  etc. Heart randomly racing with no/ little activity.  Washing dishes is taxing.  Brain fog, can't remember simple words/ tasks Loss of strength in hands. No real appetite for food like I use to, force myself to eat at times.  No real interest in meat.  Depression is worse Anxiety high No focus at all. I feel like a ping pong ball is in my head most of the day. Can't read books right now due to focus issue.  Random vibration in left foot Blurry vision off and on. Clear floaters. Mostly in right eye Achy joints, especially right wrist/ pointer finger   Certain materials annoy me Randomly feels like I'm being poked with a hot poker Tremors in hands Eyes seem to constantly realign Muscle jumps left arm Shooting pains in eyeballs Bones hurt, ear canals, face, legs Shooting pains in hips Losing coordination/leg function back of knees week.  Twitches in neck Feel I've been beat across my ribs. Sometimes kicked in left side
Patient developed a Cellulitis type reaction that her doctor diagnosed as cellulitis. He prescribed Keflex, but I do not have the details of the prescription. Purportedly, the patient improved within 2 days of starting it. She is out of the country as of this time so it's difficult to reach her to get more details. Of note: the patient also received FLUZONE HD at the same time as the Pneumovax, but it was given in the opposite arm, and had no adverse event.