chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 07 October 2013. A female patient of unspecified age, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID, (batch number-UT4721BA, route and site of administration not reported) on an unspecified date. On 07 October 2013, same day after vaccination, the patient experienced pain from the injection site down to fingers. The patient stated that she had to sleep with a hot compress to make it feel better. Laboratory details were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information from a health care professional on 31 January 2014. The patient recovered on an unspecified date.
joint pain, left-sided shoulder, arm, back and head pain, fever, stomach pain beginning at 11PM and continuing through present time 8:15 am the next morning
my booster; bad outbreak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: I also had shingles 32 years ago; "HSV2" (ongoing), notes: I have had HSV2 for about 25 years, mainly suppressed. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:1, I did not have any outbreak after the first vaccine. I felt Pfizer should have this info.), for COVID-19 immunization; Bnt162b2 (Dose number:2, When I got my 2nd vaccine and my booster, each caused a pretty bad outbreak.), for COVID-19 immunization, reaction(s): "bad outbreak".  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "my booster"; HERPES SIMPLEX (non-serious), outcome "unknown", described as "bad outbreak".  No follow-up attempts are possible, information about batch number cannot be obtained.
Per, patient received Janssen COVID vaccine on 5/12/2021.  Patient admitted to the hospital for COVID symptoms on 12/20/21, and remains admitted today, 12/21/21
Initial unsolicited report received from a consumer on 31 October 2015. This case involves a (66-year-old) female patient who was vaccinated with a [route and dose series not reported] dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) on 27 October 2015. It was reported that, patient had FLUZONE HD last season and also had same reaction but by day 5 she was better. Concomitant medications were not reported. On 27 October 2015, same day "later that day" following the vaccination patient feeling weak and very tired and arm was "inflammed" and swollen. It was reported that, five days post vaccination, patient still feels very weak, not able to get up off couch but may be three times in a day, feeling extremely tired. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none. Follow up information received from a consumer on 07 December 2015. It was reported that, the patient was vaccinated with 0.5ml dose of FLUZONE HD (batch number-U1452AA, expiry date-25 April 2016) intramuscularly on left deltoid. It was reported that the patient was allergic to vaccine component thimerisol and had recieved pneumonia vaccine in the past.
Headache, hoarseness, rash 24 hours also had tightness in chest, (thought was heartburn Tums and otc antacids would not cure).
I have been presenting a lot of pain in my legs, swelling in my feet and in my right hand, I also see that the veins in my legs are showing
Red splotchy rash on left and right upper flank areas; itching and burning associated with rash; itching and burning associated with rash; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient).  A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm, at the age of 28-years, on 21Jan2021 15:30 (03:30 PM) at a single dose as Covid vaccine. Medical history included cyclic vomiting syndrome.  There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had known medication allergies including diphenhydramine hydrochloride (BENADRYL), propranolol hydrochloride (INDERAL), sumatriptan succinate (IMITREX), metoclopramide (REGLAN), and benzatropine mesilate (COGENTIN). The patient experienced red splotchy rash on left and right upper flank areas, itching and burning associated with rash on 23Jan2021. Treatment was not received for the events. She had no Covid prior to vaccination. She has not had Covid tested post vaccination. The outcome of the events was not recovered.
had tingling arm in the arm he had the shot in; tingling in his fingers that felt like pin and needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PARAESTHESIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "had tingling arm in the arm he had the shot in"; PARAESTHESIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "tingling in his fingers that felt like pin and needles".  Additional information: It was reported that right after when he received the shot he stayed a little longer and experienced the events. The pharmacist said to hangout a little longer so he stayed a half an hour and was now (day of report) driving home but was still experiencing the pin and needles.  No follow-up attempts are possible. No further information is expected.
R29.90 - Stroke-like symptom I63.9 - Cerebrovascular accident aborted by administration of thrombolytic agent (CMS/HCC) R29.810 - Facial weakness
Severe local reaction in left arm with pain, redness, swelling, and warm to the touch from elbow to shoulder. Swelling and redness resolved 5-6 days, pain after 10 days. Firm knot at injection site for 10 days.
Patient showed me her arm at 8:00 on 5/18. It was red, warm to the touch, and looked bruised around the injection site. She said she was dizzy, had nausea/vomiting(?), fever. I told her those are common injection site reactions, but if she would feel better, to call the doctor. She did and they told her to come in. She went in; the doctor said it was an injection site reaction, measuring 4x8 cm, and had developed into cellulitis. She gave her an rx for Bactrim DS and told her to come back on 5/22.
pt recvd vax & that evening awoke shaking which neurologist considered sz x 45 mins;sz stopped x 1 hr while in abm pt had another sz x 10 to 15 mins;also had 3 to 10 spots which MD felt might be chicken pox;pt hospitalized dx w/febrile stat
Tight chest, followed by painful chest pains lasting 1-2 seconds. Happening every 2-3 minutes.
cellulitis; having a skin reaction the size of a tangerine; Her skin is hot to the touch and red; Her skin is hot to the touch and red; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2) Solution for injection, dose 2 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as Single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On unknown date, Apr2021, the patient experienced cellulitis, having a skin reaction the size of a tangerine, her skin is hot to the touch and red. The outcome of the events was unknown.  Information about the lot/batch number has been requested
Fever, nausea, diarrhea, stomach pain, fatigue, vomit.
Pain and swelling of shoulder; could not lift arm. Chills then high temperature; fast heart beat. Joint pain, muscle pain, and headache.
Developed nodule under skin, very painful 7 in total, located on back and stomach.  Long standing pain in left arm.
PATIENT REPORTED THAT VACCINE MAY HAVE BEEN GIVEN TOO HIGH IN ARM. VACCINATION CAUSED IMMEDIATE ARM PAIN AND HAS SINCE PROGRESSED INTO ARM SORENESS AND LOSS OF MOTION (PATIENT CANNOT LIFT ARM UP, CANNOT DRIVE). PATIENT WAS ADVISED OF OTC REMEDIES TO USE, BUT PATIENT ENDORSED 1ST TRIMESTER PREGNANCY. PATIENT WAS ADVISED TO CHECK WITH OB ABOUT SPECIFIC RECOMMENDATIONS MADE BY PHARMACIST. PATIENT WAS ALSO INSTRUCTED TO MONITOR CONDITION AND REPORT ANY WORSENING/PROGRESSION OF SYMPTOMS.
SE started 2 weeks after the vaccine: radiating pain throughout the body with muscle and joint pain
I was 7 months pregnant for the first dose, and about 8 months pregnant for the second dose.  I gave birth on April 15, 2021.  Since then, I've had one period, beginning July 24, 2021.  I am not currently pregnant, and my period is over 4 weeks late (as of today).  I am not sure if the irregular periods are due to my age and being postpartum, or if there is any relation to the vaccine.
Two days after vaccine was administered, pt. began with a burning sensation near elbow on left arm. By the next morning symptoms had progressed to whole left arm and both legs, progressing to paresthesia. Pt. has been diagnosed with Guillain-Barre.
03/26/21 11:30am patient reported dizziness. patient was brought back to exam room. Vital signs  were obtained and patient was seen by our PA. 11:40 patient c/o of throat feeling tight.  over the course of 15min patient was given benadryl, epi, decadron then epi again. Ambulance was called and patient transported to hospital. patient left our office at 12:05pm
Midsternal chest pain, described as sharp and 5 out 10 in severity; a rash on her right thigh going down her leg/ petechia; hematocrit was low; large welt on her arm at the injection site; fever; body aches; headache; no energy; throbbing arm pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity) in a 31-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.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ASTHENIA (no energy), PAIN IN EXTREMITY (throbbing arm pain), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). On 23-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (large welt on her arm at the injection site). On 29-Apr-2021, the patient experienced PETECHIAE (a rash on her right thigh going down her leg/ petechia) and HAEMATOCRIT DECREASED (hematocrit was low). On 03-May-2021 at 2:00 AM, the patient experienced CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity), PETECHIAE (a rash on her right thigh going down her leg/ petechia) and HAEMATOCRIT DECREASED (hematocrit was low) outcome was unknown and ASTHENIA (no energy), PAIN IN EXTREMITY (throbbing arm pain), VACCINATION SITE URTICARIA (large welt on her arm at the injection site), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to ER for treatment of chest pain on 03-May-2021 and was discharged same day.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-099479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received on 03-May-2021: AE of Chest pain added; 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.
Fainted 11 minutes after shot administered. Fell to floor and was alert again within a couple seconds. Pediatric staff provided ice for bumped head and sips of water, checked vital signs, and extended observation period. Released to go home approx. 20-30 minutes after incident.
Aches; Pain in her arm/arm felt very sore; Fever of 100F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches), VACCINATION SITE PAIN (Pain in her arm/arm felt very sore), PYREXIA (Fever of 100F) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCODONE for Pain.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Aches), VACCINATION SITE PAIN (Pain in her arm/arm felt very sore), PYREXIA (Fever of 100F) and CHILLS (Chills). At the time of the report, MYALGIA (Aches), VACCINATION SITE PAIN (Pain in her arm/arm felt very sore), PYREXIA (Fever of 100F) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves four months old female patient who was vaccinated with 0.25ml dose of FLUZONE QUADRIVALENT (Batch number: UT6259NA, expiration date: 30 Jun 2019, dose, route was not reported) in right thigh on 10-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. The baby was kept for 1 hour for monitoring. It was reported that, 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. List of documents held by sender: none.
pt recv vax & w/in 24hr had a h/a which persisted 3 days;pt then had a grand mal sz & was hosp;LP & analysis of the cerebrospinal fluid led to the dx of mild encephalitis;pt disch from hosp 12FEB98 & recovering slowly;
I received my second Moderna booster for COVID-19 on 5/26/2022. On the evening of 10/16/2022, I had a bit of a sore throat, a very runny nose, and sinus congestion. When I woke up on 10/17/2022, I still had a very runny nose, some phlegm, a headache, and lethargy. I took a daytime cold medicine to treat my symptoms, and it did not help. I took a home test for COVID-19 and got a positive result. On 10/18/2022, I called my doctor, who prescribed me PAXLOVID, which I began taking that night. On 10/19/2022, I was really sick and stayed in bed all day. I had extreme fatigue, a headache, and a very runny nose. This situation continued on 10/19/2022 and 10/20/2022, with the same symptoms. I also had body aches. On 10/21/2022, my symptoms improved. My nose was less runny, my throat hurt less, and I had more energy. I work from home, and I was able to do some work tasks for the first time since the onset of illness on that day. On 10/22/2022, I felt like I was on the mend. I took another home test on 10/23/2022 and got a negative result. I was fully recovered by the following week. At the time of this writing, I still feel that I made a full recovery, though I do have a bit more phlegm now than I did prior to having COVID-19.
Abdominal Pain; This spontaneous case was reported by a health care professional and describes the occurrence of APPENDICITIS (Abdominal Pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was reported.     On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced APPENDICITIS (Abdominal Pain) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 24-Apr-2021 due to APPENDICITIS. The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Abdominal Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Computerised tomogram: abnormal (abnormal) Acute Appendicitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Acute bacterial bronchitis, acute urinary infection, bladder infection, dehydration, fever, headache, migraine, Viral syndrome
fever 100 ax;red rash on lt arm radiating to back-rash all over back;also hot to touch;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took 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: Negative, notes: Testing positive after testing negative; Positive, notes: Testing positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: COVID 19 Treatment was given as Paxlovid from 01Aug2022 to 06Aug2022. Other medications in 2weeks included Cold Medicine, and Alko-Seltzer from 01Aug2021 to 07Aug2021. The patient was Tested positive after tested negative, post-nasal drop, congestion, cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd MMR vax 20JAN92 & on 27JAN92 devel a fever of 104 & was found stiff in bed which MD felt was probably due to a febrile sz; On 29JAN92 devel a red macular rash; 31JAN92 seen by MD;
redness/swelling of lt arm-cellulitis;tx w/Keflex, Motrin,Vicodin 6JUN97;9JUN97 inc sx, given Rocephin 11JUN97 improved;
Information has been received from a physician concerning a boy who on an unspecified date was vaccinated with VARIVAX (Merck) (lot # not reported). After several year of vaccination, the patient got a case of chickenpox. The patient received unspecified medical attention. At the time of the reporting, the patient's outcome was unknown. Follow up information received from a physician indicating that the information leading to us sending the letter resulted from our representative's misunderstanding. This is one of several reports received from the same source. Additional information is not expected.
Myalgia, Arthralgia, Fever, Fatigue, arm soreness, chills. Narrative:  Myalgia, arthralgia, fever, fatigue, arm soreness, chills.
Child vomited once during the evening of 5/16, then awakened on 5/17 with "Little red bumps everywhere" according to Mother.  Upon questioning, Mom states that rash was on stomach, neck and back.  Rash was bright red upon awakening, but after child had played awhile with just diaper on, it became much fainter.  Child has also been fussy, but Mom says this could be attributed to teething. Mom denies fever.  On 5/18, child still had rash so Mom took her to Dr's office.  He told her rash was from MMR vaccine, and for her to use ibuprofen.  At this time, child still has rash.
Site: Pain at Injection Site-Mild, Systemic: Fatining/loss of conciousness - otherwise no sysmptoms of anaphylactic reaction - however pt said that he doesn't respond with that severity to the flu vaccine and was concerned about his reaction to this vaccine which usually only happens with blood-draw-Mild, Systemic: Flushed / Sweating-Mild
Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, swelling of tongue
Since taking the vaccine, after a few days, I continue to have nightmares, heart palpatations, severe headaches, constant diarreah, lump feeling in upper chest and throat.
This spontaneous report was received from a pharmacist via a company representative and refers to an 81 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-NOV-2017, the patient was co-administrated a dose (reported as "one shot") of PNEUMOVAX 23 (strength, route of administration, lot number and expiration date were not reported) for prevention of pneumonia and an unspecified "high dose flu vaccine" (manufacturer unknown).The reporter also stated that both vaccines were administered in the same arm, but it was unknown whether were administered in the left arm or the right arm. On an unknown date in 2017, the patient developed feelings of weakness and achiness as well as red, painful swelling at the injection site. The patient sought medical attention by seeing the physician and was given an unspecified treatment for the events. The outcome of the events was unknown. The reporter's causality assessment between the events and the PNEUMOVAX and unspecified flu vaccine was not reported. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA003096:
A customer came in Thursday who received pneumo & flu shot Tuesday and she had a red patch on her arm. It was lower than the injection site and not connected. She didn't complain of any other issues. She said she was going to contact her doctor but came in to see if we could tell her which shot caused it. She got both in the same arm so I couldn't say.
Started feeling ill soon after taking the vaccine.  Temperature rose to 101.8 by next morning, remaining over 101 all day, decreasing to over 100 next day.  Felt like I had the flu the entire next day, joint pain, head ache, weakness and muscle pain.  Welt about 1.5 inches in diameter and .5 inches high.  Extreme soreness at injection site.
Miscarriage Pt was not aware she was pregnant at time of vaccine Pt was 5-6 wks pregnant at time of vaccine. H/o prior miscarriage about 1 yr ago.
consistent joint pain in all of my extremities this has never resolved and it has been almost 1 month after 2nd dose