chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It hurt like hell; was sick for 12 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and sickness. On an unknown date, the outcome of the pain was unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the pain and sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a Shingles shot and was hurt like hell was sick for 12 hours, but nothing like what would happen if he/she were to get Shingles. The follow-up could not be possible as no contact details were available.
Flu shot given about 2 pm-by 4-4:30 pm throat lips swollen, inside lips very red-Patient went to clinic-practitioner called medical director and prednisone for 3 days and ZYRTEC for 10 days was prescribed. Lips better but still a little swollen today.
experienced a sore arm; Hypertriglyceridaemia Diagnosed about 2 years ago; This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and hypertriglyceridemia. The patient was treated with fenofibrate. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the hypertriglyceridemia was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and hypertriglyceridemia to be related to Shingrix.  Additional details were provided as follows: Two years before the reporting date, the patient was vaccinated with Shingrix at 50.2 years of age. The patient had sore arm. The patient was diagnosed with Hypertriglyceridemia about 2 years ago. The patient was receiving Fenofibrate to treat hypertriglyceridemia. On 26th February 2021, the patient was vaccinated with Pfizer BioNTech Covid vaccine and experienced pain or tenderness. The reporter consented to follow up.  Note- Hypertriglyceridemia was reported as current condition and Fenofibrate as concomitant but since the patient also received Shingrix vaccine around the same time, Hypertriglyceridemia considered as adverse event and Fenofibrate as treatment.
she said I don't need my walker so she was walking without her walker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing), notes: my roommate has A Fib; "Diabetic" (unspecified if ongoing), notes: she is diabetic; "lung cancer surgery" (unspecified if ongoing), notes: she had three lung cancer surgery; "requires a walker to walk" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she said I don't need my walker so she was walking without her walker".  Additional information: Reporter noted that patient had issues walking with her knees, hips and whatever and requires a walker to walk. Patient had been able to walk without her walker without any pain after 6-7 hours of receiving the second dose. Reporter confirmed that patient had no adverse effect with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381311 Same reporter, drug, and event; different patient
Vaccine administered after use by date. Efficacy study done by Moderna and vaccine deemed effective and no re-vaccination needed Moderna Case ID
The patient mentioned she had gotten dizzy with the previous vaccine.  She walked over to the bench and sat on the bench.  The mom asked if we had any bottles of water we could give her but we did not.  I sent my technician to get some water while I observed the patient. She turned very white and made abnormal faces.  She got up to leave with her step dad and then started to kneel on the floor due to dizziness.  I told her  and her step dad that the 15 minutes were not up and I observed her a few more minutes until she felt better and let with her guardians.
During monitoring period, client started coughing and having to clear throat, then possible itching in throat, PO benadryl given
Arm Pain: started at 8:15pm on 21 Jan 2021, injection site started to hurt and intensity of pain increased over the next few hours and continued throughout the next few days.  Ibuprofen helped to decrease pain slightly.   Pain was so severe that sleep was impacted the night of 21 Jan 2021, could not move arm on its own, had to use right hand/arm to move the left.  Arm pain decreased in intensity on 23 Jan 2021.  Slight soreness 24 Jan 2021 through 27 Jan 2021. Fatigue: started on 21 Jan 2021 and was worse 22 Jan 2021 through 23 Jan 2021. Alternating sweating and chills: throughout 22 Jan 2021. Headache: started evening of 21 Jan 2021 and lasted until 23 Jan 2021.
11/2/10 1225p c/o (L) face cheek and left side of tongue tingling B/P 124/84 P 70 denies itching, lightheadedness, SOB, handgrip =, smile = active ROM both arms no edema or redness at injection site. 1235p B/P 120/90, P 70 acyanotic 1245p 140/90 P66 R18 1250p c/o shortness of breath and trouble thinking, appears tired. Denies panic feeling called 911 c/o shortness of breath and c/o numbness both sides of face.
I woke up with cold symptoms, a cough, fever & some congestion. I thought maybe I had COVID or the flu, so I took some over the counter medication. I also did a home test which came back negative. I also went to the clinic to have a more accurate test done which came back Positive for Influenza and negative COVID.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy. Concurrent medical conditions included mast cell activation syndrome. On 21st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced diarrhea, pain in arm, tremor, muscle pain, fever, shivering and movement disorder. On an unknown date, the outcome of the diarrhea, tremor, muscle pain, fever and shivering were recovered/resolved and the outcome of the pain in arm and movement disorder were unknown. It was unknown if the reporter considered the diarrhea, pain in arm, tremor, muscle pain, fever, shivering and movement disorder to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The age at vaccination was not reported. But, it could be 61 or 62 years old. The patient experienced bad diarrhea, fever (body temperature: 100 degree F), shivering, shaking and muscle aches which lasted between 2 and 3 days. The patient also experienced arm soreness such that, she could not use her arm for days. Lab Comments: Lab test was performed on an unknown date.
First night after second dose of vaccine significant chills and cold sweat lasting all night. Began to get better by morning. Early morning muscle and joint paint (1/10)gradual began and increased to a significantly uncomfortable level throughout the day (6/10) along with general malaise.  Treated with 600mg ibuprofen at 1500 and 2300. Woke with same type of pain on 1/27/21 (3/10).
Patient received first dose of vaccine at another facility. Patient had received Moderna vaccine as first one and given Pfizer for second dose.
Throat started to feel as if I needed to clear it.  Soon felt as if I had swallowed a walnut.  Eyes began to swell shut.  Immediately took two Benadryl capsules by mouth and followed up with two more 2 hours later.
Patient is continuing to have muscle soreness at the injection site after more than 3 months after the vaccine.
Received 1st Moderna covid vaccine on 11/17/21.  Woke up the next morning with swelling and pain in arm, and swollen lymph node.  The next day, bruising was noted extending to the end of the right breast nipple, color was a dark purple.  When reported today, the bruising is becoming lighter in color, with a yellowish tent.   Is concerned regarding getting a second vaccine.  Instructed to see PCP.
7 month old who received two doses of Fluzone Quadrivalent that were less than 4 weeks apart, no AE; Upon second medical examination of the case during internal review, a significant correction was performed on 01-Nov-2019 to update/ correct valid case from non-case.  Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old patient who received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], first dose on 22-Sep-2019 and second dose was less than 4 weeks later.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error case due to Inappropriate schedule of vaccine administered.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on batch number is requested.  Addendum: 01-Nov-2019:  significant correction was performed on 01-Nov-2019 to update/ correct valid case from non-case.
Patient received a bivalent dose twice, inadvertently. He received a bivalent booster on 10/1/2022 and then came to this facility and received another bivalent dose on 1/7/2023, as he and the staff were unaware that his last booster was in fact a bivalent booster until after he had been vaccinated.
patient called 10/12/21 around 7:20pm to tell the pharmacist that gave the shot that she has hives now after receiving the second shot
This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patients were vaccinated with ROTATEQ (lot #, expiration date and dose unspecified), oral for prophylaxis that had been improperly stored. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Stomach discomfort; Anxiety; Shortness of breath; This is a spontaneous report from a contactable consumer (patient) via medical information team. An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number and Expiration date: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. No investigation Assessment was provided. Patient was called about the Pfizer covid vaccine. It was a personal question, asking if everything that was happening to her was normal or not. If the things that she was experiencing, or feeling was normal. This was her first dose. She got the vaccine on Tuesday and by Thursday she started to have some stomach discomfort, it was not like diarrhea, it was just the feeling like she needed to go to bathroom. Friday, she started having anxiety. At times it was a thing that comes from time to time where she feels anxiety, shortness of breath and the need to deep breathe or take deep breaths and then it goes away and it comes back again. Reporter did not specify any seriousness. The outcome of shortness of breath, anxiety was reported as not resolved and stomach discomfort was unknown.  Information about lot/batch number has been requested.
COVID-19 infection Omicron variant; COVID-19 infection Omicron variant; This is a spontaneous report received from non-contactable consumer.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years, all intramuscular for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovered" and all described as "COVID-19 infection Omicron variant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2021) Positive, notes: Omicron variant. Therapeutic measures were not 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.
Injection site reaction, blisters-vesicles. Skin reaction of papules and vesicles. Mild varicella form eruption. 1 week duration.
Redness, edema at injection site. Redness extended down arm where injection was given. Also had headache and nausea.
I spiked a fever and became symptomatic and then tested positive via a rapid viral test.
Experiencing right arm pain, swelling and discomfort to the right arm. She reported there is some warmth to the skin tissue surrounding the injection site, some redness that is radiating from the injection site, approximately five inches, and a lump around the injection site. Patient reported she presented to the local urgent care the next day since symptoms didn't resolve and self medicating with ibuprofen didn't resolve the pain or discomfort. She reported she was prescribed antibiotic, Benadryl, and an epinephrine pen. Caller is trying to determine if what she is experiencing is normal since she hasn't ever had these symptoms after receiving any vaccines in the past.
patient was seated in chair in waiting area about 2-3 minutes after vaccine. he started seizing and straightening up his body and began falling out of chair. i ran over and caught him before he fell all the way out. i supported him in the chair for about 10 seconds and he came to. the whole ordeal only lasted about 15 seconds. he said he felt weird and remembered dropping his phone. he stated he did not eat that morning. i gave him water and a snack and we watched him while EMS was called. they showed up in about 5 minutes. took vitals, everything came back normal. pt did not have hx of any disease states. parent picked him up from pharmacy.
11.09.07 12:30pm soreness, redness, swelling, hot where the shot was given, headaches;       11.10.07 am where the shot was given Skin irritation growth up to 3 x 3 cm and very hard, headaches, hot feeling, redness on skin of head and dekolte, light flu like symptoms - 4:00 pm weakness;                                   11.11.07 same symptoms as day before,where the shot was given Skin irritation growth up to 5 x 5 cm and very hot and hard, pm hives, strong flu like symptoms, 8:30 pm dizziness for about 5 minutes, nearly felt down;                 11.12.07 same symptoms but less then the day before, no dizziness, pm - skin irritation shrinks and is less red and hot;                       11.13.07 skin irritation nearly gone , not red and not hot, not hard anymore, hives, light flu like symptoms - feel much better.                   From 11.09.07 until 11.12.07 4 times a day 400mg Paracetamol, 300mg Ascorbinsäure, 50mg Coffein, 5mg Chlorphenaminhydrogenmaleat, 1 once a day, 1000mg Vitamin C, 35 drops of Umckaloabo = Perlargonium reniforme/sidoides 80,0g;     11.13.07   2 times a day 400mg Paracetamol, 300mg Ascorbinsäure, 50mg Coffein, 5mg Chlorphenaminhydrogenmaleat,                      1 once a day, 1000mg Vitamin C, 35 drops of Umckaloabo = Perlargonium reniforme/sidoides 80,0g.
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN SYSTEM (#151931417) WITH DIFFERENT DATE OF BIRTH. CHILD TOO YOUNG FOR VACCINE ON 09/02/2021.  SEE VAERS #685372 REPORTED FOR FIRST DOSE ON 8/12/21.
At the beginning of the year, I had a positive COVID-19 test: headache, congestion and major fatigue.
Began with chest tightening at 3PM and progressively worsened through the evening. By 6PM it was difficult to breathe. Administered 2 puffs albuterol at 6PM, 8PM and 11PM. Administered Advair at 8PM and again in the AM on 11/14/10. Around 9PM, both eyes began burning & watering, and turned red. I do not have asthma, and am not allergic to eggs. By Sunday evening, symptoms had almost completely disappeared. Administered albuterol several more times on 11/14/10.
Patient presented due to leg swelling on 11/28/2022 that started on 11/24/2022.  An ultrasound was found to have a venous thrombosis in the greater saphenous vein of the left leg, extending into the thigh.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 12 months old female patient who was vaccinated with a 0.5 ml dose of ADACEL (lot U5829BA and Exp. Date 24-NOV-2019) via unknown route in the left deltoid on 02-OCT-2018 instead of DAPTACEL. Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197); MMR and Influenza Vaccine for Immunisation. The patient's medical history not reported. It was an actual medication error due to wrong vaccine was administered and inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Information has been received from a physician concerning a female child who was vaccinated with a dose of varicella virus vaccine live. Approximately 3-4 weeks post vaccination, the patient developed a generalized rash all over her body. It was also reported that the patient was in close proximity to her 4-5 year old cousin a few days later who developed a rash on her chest. The patient was coming into the physician's office to be seen so she hadn't yet seen the rash. Additional info has been requested.
occurrence of chest pain following the second Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "occurrence of chest pain following the second Covid vaccine". Additional information: Patient would like to know the occurrence of chest pain following the second Covid vaccine as he/she have has recurring chest pain ever since his/her second vaccination 2 years ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 11NOV97 & pt fainted approx 5min later in waiting room;fainted again taken to exam room w/twitching of extremity;epi given;pt c/o sore throat w/swallowing & stomach;transferred to hosp ER by amb;
Developed arm soreness x48 hours after vaccine.  However, the adverse event is now a rash over my left shoulder.  It is tender to touch and blanching.  I'm not having fevers or chills.  The rash actually itches.
The vaccine was beyond use per the Pfizer Inquiry website as of 8/31/22. The vaccine was marked on the box with a 10 week use by date (10 weeks post receiving the vaccine from dry ice). As such, patient was administered a vaccine that was expired 2 days prior.
This retrospective pregnancy case was reported by a physician and described the occurrence of stillbirth in a female patient who received BOOSTRIX. On 20th May 2016, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On 24th May 2016, 4 days after receiving BOOSTRIX, the patient experienced stillbirth (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the stillbirth and vaccine exposure during pregnancy were unknown. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fetal demise. The physician requested a call back.
07/04/2021 F.D.A. Representative; I am writing for two reasons; 1). On April 27, 2021, I recieved a Phizer Vaccination #ER8731 On July 02, 2021 I recieved my second vaccination however it is Moderna Vaccine #026C21A. I am experiencing a Front & Back headache/slight and the snifles so far 4 hours after the Moderna shot. The lady assured me that it was safe due to the lapse of time between the two. (This came to her through higher channels).  What does F.D.A. say? 2). I need the History of the down fall of Darvon, between 2002 - Now "Thank you". PS.---(8:30)pm small fever, achey/Neck/Back/Joints/Feel bad/Headache. 11.30 Body Aches/Headache Bad Fever/Chills 2:01 am 07/03/21 lungs congested, BodyAches Headaches/Still neck; Chills. Fever feel Bad. 800 am Flat on my back 12.00 Flat on my back sick 3:00 Feel a little better eat 1 soup. 07/04/21 Feeling Better still a little Feverish - Diarea a little