chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme pain on my throat; experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron; experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron; headaches; high fever; cough; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 04Jul2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron"; HEADACHE (non-serious) with onset 26Dec2021, outcome "unknown", described as "headaches"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "high fever"; COUGH (non-serious) with onset 26Dec2021, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 26Dec2021, outcome "unknown", described as "congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "extreme pain on my throat". Addition information: It was reported that: The vax clinician told me to come back in 6 months to get the booster. Fast Forward to 25Dec2021. Right after the holidays I started experiencing a breakthrough infection, likely from the new COVID-19 strain Omicron. Typed on 3rd.  The lot number for bnt162b2 was not provided and will be requested during follow up.
(L) arm swollen and red from elbow to shoulder - No other sign of illness. BENADRYL and Ibuprofen.
6 yr. old child given adult dose of  Pfizer 12+ bivalent 0.3ml injection rather than the 5-11 yr. old dose of Pfizer bivalent 0.2ml injection.
Shortly after patient received vaccine (within 5 minutes) Patient was sitting in area being monitored for reaction.  Patient then fell face forward and hit his face.  Aid came helped immediately and patient was monitored for vitals.  Patient report to feeling dizzy.  He appeared pale and clammy.
It felt more like a normal injection feels with soreness; There seems to have been some fumbling when they were giving it; Case reference number US-BN-2021-001731 is a spontaneous case report initially received from a consumer via regulatory authority (USBAV21-0256) on 03-Jun-2021, and concerns a 51 years-old male patient.  The patient's medical history was not provided.  The patient's concomitant medication details included HRIG (as reported).  On 26-May-2021, the patient received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administered intramuscularly after being bitten by a bat.  On 29-May-2021, the patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administered intramuscularly.  On 02-Jun-2021, the patient received third dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administered intramuscularly. The patient reported that a third shot really felt like a normal injection and he felt soreness.   The reporter assessed the events as non-serious. The reporter did not provide causality and seriousness assessment for the event of soreness.  No further information was provided.; Reporter's Comments: Pain is listed for Rabipur according to the Datasheet. Vaccination error is listed by convention. Reportedly, the patient received RabaVert after a bat bite. Three days later, the patient received a 2nd dose of RabaVert and four days after the 2nd dose, the patient has received a 3rd dose. After the 3th dose, the patient experienced normal injection feels with soreness and reported there seems to have been some fumbling when they were giving it, which is considered vaccination error. Due to suggestive temporal relationship, event of soreness is possibly related to RabaVert. Vaccination error is not  related to RabaVert.; Sender's Comments: Pain is listed for Rabipur according to the Datasheet. Vaccination error is listed by convention. Reportedly, the patient received RabaVert after a bat bite. Three days later, the patient received a 2nd dose of RabaVert and four days after the 2nd dose, the patient has received a 3rd dose. After the 3th dose, the patient experienced normal injection feels with soreness and reported there seems to have been some fumbling when they were giving it, which is considered vaccination error. Due to suggestive temporal relationship, event of soreness is possibly related to RabaVert. Vaccination error is not related to RabaVert.
arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix and had arm pain. The vaccine had not administered Shingrix in office yet but had heard this complaint from patients after she has referred them to a local pharmacy.  Approximately 20 minutes after the Virtual Engagement the reporter called the Office Manager due to audio issues with internet to collect more details and thinks this had happened 10 times in the past 18 months and also volunteered that thinks these patient complaints occurred when the patient was back in their office weeks or months after the patients had received their Shingrix at a local pharmacy, and  could not recollect any patients saying they opted out of a 2nd dose of Shingrix due to the arm pain.  The office did not recollect any individual patients and were speaking in general terms.
Patient became dizzy.  Gave water.  Dizziness continued and increased.  Placed supine with legs elevated.  Tachycardic and tachypneic.  Called emergency response team.  Team came and evaluated patient.  Placed on litter and transferred to emergency room.
1/8/2021 vaccination 1/15 I started to notice a rash on my R arm, 2" below injection site; size of a quarter. Became bigger, red and itchy, warm to the touch. I went to urgent care to have checked to r/o infection.  They ended up giving me a topical steroid. The symptoms lasted for about 5 days after using the steroid cream.
At 3:14a on Friday, 03/26, about fourteen hours after I received my second dose of Moderna, I awoke with terrible chills.  [I felt fine before I went to bed.  Worked until about 8:30p the day before.]  My teeth were chattering so bad I thought they would break.  I ached all over, was shaking from the chills, my head was pounding, and truly felt terrible.  I have tried sleeping if away but that doesn't seem to be doing the trick.  I did take some extra strength Excedrin which helped with the headache.  It is now Sunday and I still ache somewhat and don't feel right.  I have had a "sick stomach" - food just doesn't sit right - and still feel chilled.  I had no problems with the first dose so was totally surprised by this.  NO energy at all.  I work two jobs and had to miss hours at both because of this.  [Have worked, in person, the entire pandemic and have been super careful.]  I feel less terrible now but several friends/family members urged me to report my symptoms since I normally am very healthy - for a 65 year old woman.  I realize the vaccine got emergency usage approval so this information may be useful going forward.  I know I'll be fine but mainly just wanted to report this - since it has lasted more than forty-eight hours.
experienced significant arm pain in the area of injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) 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 PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "experienced significant arm pain in the area of injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional Information: Description of Event: Following administration of the first Pfizer Covid vaccine shot, I experienced significant arm pain in the area of injection site which began about 6 hours after the vaccine shot. Arm pain with lifting of arm. Still present on day 2, about the same intensity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Right arm on 29Jan2021 (at the age of 78-year-old) as single dose for covid-19 immunisation. Medical history were none. There were no concomitant medications. The patient experienced chills on 03Feb2021 slightly loose stools on 03Feb2021, gas on an unspecified date, fatigued on 03Feb2021, slightly right sore arm on 29Jan2021, slight body aches on 03Feb2021. Therapeutic measures were taken with a couple of Tylenol and Pepto Bismol as a result of event chills, loose stools, gas, fatigued, slightly right sore arm, slight body aches. The outcome of event gas was unknown and for event slightly right sore arm was recovered on 30Jan2021 and slight body aches was recovered on 07Feb2021 and for rest all event outcome was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
DAY: 1-2 SORE ARM AT INJECTION SITE.  3-5 : Chills and sweats, flu like symptoms. 6-7 : Swelling of extremities general fatigue. 7: difficulty walking, went to urgent care low fever 100.2 , tested for covid -negative, lungs and heart sound good , prescribed zyrtec, benadryl, pepsin and tylenol if necessary. 8-15 : continued swelling, low appetite, difficulty sleeping ( due to discomfort in entire body) fatigue 15: Increased swelling, neck back and legs very stiff and sore.I continue to follow recommendations on over counter aid.
Pt rec'd flu vaccine 0n 4/11/16 in AM at doctor appt. on 4/12/16 she noticed arm was more painful, swollen around injection site to about 4-5 inches in diameter, and c/o itching and warmth to touch and painful w/ and w/out touch. Given BENADRYL 1st night.
First 5 days I experienced insomnia, anxiety, and vibrations/pulsations on the soles of my feet. I was unable to fall asleep naturally and felt like I had way too much energy (the uncomfortable kind of energy). When trying to sleep, my brain would jolt me awake. I felt two pops on both sides of my forehead the second night after being vaccinated.  After 5 days of only 4 hours sleep per day, I was finally able to sleep more hours. I still have days where I am not sleeping well. My ears also felt full and still do, which I have not experienced in years. After the insomnia subsided, my tinnitus increased to extremities that I have never experienced in my entire life of having mild-tinnitus.  My tinnitus is loud keeping me awake and making it hard to sleep and triggering ongoing anxiety. The enhanced tinnitus began around May 30th and still going.  I have not had anxiety this bad in several years.  The vaccine has triggered this and it is debilitating.   I also feel "cramps" near where my heart is every now and then - which is also concerning.
This spontaneous report as received from a nurse refers to an unknown number patients of unknown age. From 21-JUL-2017 to 07-AUG-2017 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # N002202 for prophylaxis. Sender's Comments: US-009507513-1708USA005022.
Received Covid vaccine. Woke up suddenly with a sharp pain in my right side, which hurt so bad I yelled for my husband who was next to me. The pain suddenly exploded through my right side and hurt so bad I screamed, then the pain immediately subsided. Everything else then seemed normal. No headaches or vision issues and no muscular issues.
Incorrect formulation of influenza was administered, pt is less then 65 years of age and should have received regular dose instead of high dose. Patient was informed of mistake same day by medical assistant who administered , per provider no follow up needed.
not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose on an unknown date).   On 25th May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine and was not feeling well from it. The patient further stated that from everything he or she heard, not feeling well for a couple of days was a small price to pay to hopefully avoid getting shingles. No further information was provided.
Pt called on 9/13 complaining of all his bones in body hurting. Lots of shaking on arms and legs. He also complained of a headache. He was given flu shot on 9/12/14 at 420 pm and by 8 pm was experiencing symptoms.
flushing, near syncopal dizziness, followed by numbness of both feet 2 hrs p/vax;
The morning after the shot, I woke up to the LOUDEST ringing in my ears that I have ever had. Anytime I exercise, it seems to amplify it, but it rings constantly regardless of activity.  It hasn?t even been a week since my Johnson and Johnson shot, and the ringing keeps getting worse and worse. Then today (day 5 post shot), I was exercising and had to stop because the right side of my face and lower right arm became HOT and slightly numb. Again, that has never happened to me before. I am terrified as to what is going to happen next, and wondering how much worse my current adverse effects are going to get.
grandson had first covax couple weeks ago and then went to a concert and now positive with the virus; grandson had first covax couple weeks ago and then went to a concert and now positive with the virus; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A male patient (grandson) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced grandson had first covax couple weeks ago and then went to a concert and now positive with the virus and contracted covid. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Her grandson was received the first Pfizer covid vaccine and then 5 days later went to a concert and contracted covid.  He had recovered from the covid illness, but caller wanted to know what he should do now about scheduling his second vaccine. first time consumer reported about her grandson had first COVAX couple weeks ago and then went to a concert and now positive with the virus and suppose to get the second COVAX. The seriousness reported as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Given HPV 9. Asked to sit for 15 minutes. Sat in exam room for close to 15 minutes. Went to the restroom. Felt very dizzy and weak. Slumped to the floor.  Event was not witnessed by staff. Event was relayed by patient.
5 year old given the Moderna  vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old given the Moderna  vaccine) in a 5-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 08-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old given the Moderna  vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old given the Moderna  vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient has not reported any adverse event at the time of the call.
Swelling; Tenderness; Upset Stomach; Fever; Head ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever) and HEADACHE (Head ache) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever), HEADACHE (Head ache) and NAUSEA (Nausea). At the time of the report, SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever), HEADACHE (Head ache) and NAUSEA (Nausea) 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  No concomitant medications reported. No treatment medications were reported.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 22-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as 016966, expiration date: May 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Pt had a pre-syncopal episode after the vaccinations. Pt was put in a supine position with his legs up. Pt given sips of water. Pt reported a headache. BP at 10:04 was 89/52 HR 65. At 10:15 His BP was 99/63 HR: 65. 10:25 BP 105/63 HR 66. Pt was feeling better and was instructed to sit up. 10:35 BP was 97/69 HR: 70. PT was given more water to drink and pretzels to eat. 10:49 BP was 101/66 HR: 58. By 11:10 PT was feeling much better. His energy picked up and he walked to the bathroom. BP 95/57 HR:67. Pt walked out of the office unassisted and without incident.
Blood in nose for 3 days - not active bleed but when persistent when blowing nose - was blood.  Didn't seem like a big deal - felt fine overall.
Member called unit at 08:16 am with a c/o redness, soreness, and swelling in the back of his Right arm and elbow. Member did not have decending streaks, no was he febrile except for the injection site limb.  Member was assured that this is a normally expected side effect of anthrax injections.  Member was also instructed that if conditions worsen to seek immediate medical treatment and to notify the MDG of this event and to provide supporting documentation related to the treatment for this event.  A follow-up will be conducted prior to deployment.  This was number (7), a booster in the requirements for deployment.
About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Within 2 minutes of shot he felt lightheaded & dizzy, sat down and almost passed out.  Also felt "numbness" all over, sat for 10 minutes, still felt numbness/tingling in face.  Sweaty also.  Sat for 10 min. longer.  Felt better drinking water & glucose tablets.
Severe headache, nausea, dizziness and chills. Rash on chest and neck.
I have had widespread of hives for about 4 weeks ongoing now. Started a day after the vaccine stopped for about a week and now its been 4 weeks. I  had random top and bottom lip swelling last weekend. I have no previous medical conditions or known allergies to anything. I have had to take Benadryl and use topicals for a month. Today I was prescribed a steroid and two allergy medications. I want to know if anyone else has experienced anything similar.
Patient had a 3-4 centimeter welt at the injection site.  Patient was given the CDC phone number and informed that this reaction is normal.  MD requested vaccine before telling family.