chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a lump on her neck; I got super sick; This is a spontaneous report from a contactable consumer (patient herself). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737, Expiration date: Unknown), via an unspecified route of administration on 15Apr2021 as dose 1, single and then received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that she developed a lump on her neck and she got super sick on an unspecified date. It was reported that the patient received both doses of the Pfizer COVID-19 vaccine. She went to the doctor to get a sports physcal on Friday and showed them the bump she got. She told them about that lump on her neck when she got her first dose on 15Apr2021, she thought so and then after she got her first dose, she got super sick and then went to her doctor and told him. The doctor said it would go away after a month, but she got the shot back in April and now its August and she still had it. The doctor said it was normal and it would go away in a couple months. It had been a couple of months but it still had not gone away. It was reported that after the first dose, she experienced the side effects. The adverse events resulted in physician office visit. The outcome of the event lump on her neck was not recovered. The outcome of the event she got super sick was unknown.   Follow-up attempts are completed. No further information is expected.
Case number PHEH2013US012142, is an initial spontaneous report received from a pharmacist on 01 Jun 2013 and a follow up received from the pharmacist on 21 Jun 2013. This report refers to a 12-year-old male patient. He received only Men C, Y, W-135 liquid conjugated component of MENVEO vaccine (batch number: not reported), intramuscularly into his left deltoid, without being reconstituted with Men A component on 01 Jun 2013. No adverse reaction reported following this administration error. Follow up information received from the pharmacist on 21 Jun 2013: Updated site of vaccination and patient's height and weight.
I am having a lot of pain under my armpit and my chest; I am having a lot of pain under my armpit and my chest; pain, not even on my arm, it's just under my armpit and not my whole breast it's just on my breast; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "I am having a lot of pain under my armpit and my chest"; BREAST PAIN (non-serious), outcome "unknown", described as "pain, not even on my arm, it's just under my armpit and not my whole breast it's just on my breast".  Additional information: Patient stated I took Pfizer vaccine (later clarified as Pfizer Covid-19 vaccine) this Wednesday. I was having a lot of pain under my armpit and my chest. Like pain, not even on my arm, it's just under my armpit and not my whole breast it's just on my breast.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt began with macular rash 9/20/04 with low grade fever around 100. Denies pruritis or "bothering" pt or sxs illness. Instructed to take Benadryl prn and tylenol or motrin prn. No meds required.
This vaccine has thrown my cycle off and my hormones off which is effecting my sleep and overall health.
Syncopal episode;  follow up disclosed mitral valve regurgitation which led to open heart surgery to repair mitral valve
The patient presents today with a complaint of a rash that started Wednesday, October 25, 2017 with redness of the face and swollen bumps across the glabella and right eyebrow. The swollen bumps were quite itchy. The facial skin redness had a burning, stinging sensation. The patient woke up this morning October 26, 2017 noting that the red macular rash spread to involve his arms and torso. Tuesday, October 24, 2017 the patient received a flu shot.
Patient became nauseous almost immediately after injection.  He ended up vomiting.  He said he felt hot, warm like a hot flash. He was sent home from work.
stuffy head; nose running; began to sneeze; Arthralgia aggravated; Myalgia aggravated; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy head), RHINORRHOEA (nose running), SNEEZING (began to sneeze), ARTHRALGIA (Arthralgia aggravated) and MYALGIA (Myalgia aggravated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy. Previously administered products included for Joint pain: Meloxicam. Concurrent medical conditions included Secondary pulmonary arterial hypertension, Myalgia, Arthralgia and Rheumatoid arthritis. Concomitant products included TREPROSTINIL SODIUM (TYVASO) for Secondary pulmonary arterial hypertension, SILDENAFIL CITRATE and AMLODIPINE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (stuffy head), RHINORRHOEA (nose running), SNEEZING (began to sneeze), ARTHRALGIA (Arthralgia aggravated) and MYALGIA (Myalgia aggravated). At the time of the report, NASAL CONGESTION (stuffy head), RHINORRHOEA (nose running) and SNEEZING (began to sneeze) outcome was unknown and ARTHRALGIA (Arthralgia aggravated) and MYALGIA (Myalgia aggravated) was resolving.             Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient's father reported that she had not eaten or drank much, if anything, prior to the vaccination appointment in the afternoon. Patient is a premenstrual, young girl, of thin build and small stature, who just turned 12 the prior month. She expressed anxiety about shots and needles. Immunizing technician and father noticed that she slouched dramatically a couple minutes after the shot. But her face became ashen, she slouched more rigidly, and jerked. ~5-10 seconds later she was back to normal
woke up and felt like had been hit by a train. body aces all over., cold shakes, sleeping a lot
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 4 years old male patient who had received vaccines liquid DTAP-IPV portion of PENTACEL instead of QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received a 0.5 ml dose of DTAP-IPV portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Lot C5595AA, exp date: 11/22/2019 unknown route in unknown administration site. It was a case of actual medication error due to inappropriate reconstitution technique and wrong vaccine administered because 0.5 ml DTAP-IPV given from PENTACEL without the ACTHIB portion and liquid portion of PENTACEL instead of QUADRACEL. It was not reported that if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. Documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to a 34 year old female patient. On 19-DEC-2013 the patient was vaccinated with a first dose of GARDASIL, injection (lot #, expiration date and dose was not reported) and on 03-JAN-2014 the patient was vaccinated with a second dose of GARDASIL, injection (lot #, expiration date and dose was not reported). The primary reporter stated that patient was in office (approximately in 2014, date estimated) to receive the third dose of GARDASIL. No adverse event was reported. Additional information has been requested.
Patient received vaccine in left arm (deltoid). Was in post vaccination observation area. About 5 minutes after the injection, while sitting in the observation chairs, the patient fainted and hit his head on the floor. Pharmacist and patient's father got him back up into the chair. Patient quickly regained consciousness, but felt nauseous and warm. Patient was given a little water. But could carry-on a conversation.  Patient vomited a little into a trash can. About 10 additional minutes went by. Patient was able to get up out of the chair and walk out of the facility with the help of his family. Patient had a little bit of bump on head where he had struck the floor, no bleeding occurred. No additional medical assistance was contacted at that time by the facility, family, or the pharmacist. Pharmacist called the patient several hours to after to see how he was doing, but did not get a response. The pharmacist left a voicemail. It is unknown to the pharmacist whether or not the family decided it was necessary to get medical follow-up or not after the incident.
Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EK9231), via an unspecified route of administration in left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse. Patient was allergic to some chilis and animals. There were no concomitant medications. The patient experienced dizzy, flushed after injection on 03Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient been not been tested for COVID-19. Outcome of events was recovered in Jan2021.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 2:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Nov-2021 at 2:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Farenheight  No treatment medications was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Body aches all over; Not able to stand up straight or do anything; Fever of 103 for almost 2 days; Horrible headache that would not go away with anything; Lost 2 days of work.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 11Apr2021 at 09:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the right arm on 21Mar2021 at 09:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 02:00, the patient experienced fever of 103 (units not specified) for almost two days, horrible headache that would not go away with anything, body aches all over and the patient was not able to stand up straight or do anything. The patient lost two days of work. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 103 for almost two days, horrible headache, body aches all over, not able to stand up straight or do anything and lost two days of work was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I was sick for about 4 or 5.  I had flu like symptoms.  I had body ache and chills.  I had back and stomach pain.  Now I am joint pain all over.  I have to take antiinflammation medicine.  I went the doctor about the joint pain and body ache.  She was unsure why I am having joint pain.
I tested positive for COVID on June 20th. On June 22nd, I spoke with my doctor and was given Paxlovid. On June 27th I tested at home for COVID and tested negative. On July 4th I took a test again when I was feeling still sick and it came back positive. I tested again today, July 8th and it still came back positive. I have congestion, nasal drainage, and fatigue.
I received my shot at 10 in the morning on April 8th the I felt pretty good when I got home just a little soreness in my arm but at 3 in the morning I awakened to chills 101.3 fever and feelings of   nauseous in this and very thirsty I laid in bed. I am a dialysis patient I had dialysis schedule for 10 the next morning but I didn't feel well enough to go so they gave me a time later on in the day which by that time I felt good. I was able to drive there and I was good so when I got done with dialysis I could not walk I was too weak to do anyting I had to have my daughter come and get me and drive me home. That had to be a reaction between the injection and the diabetes treatment when does dialysis treatment I'm sorry but yeah then I felt bad the whole rest of the day and I didn't feel good again until the next morning which is now.
DIED; This spontaneous report received from a consumer via social media (J&J corporate) from a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was reported as "Sister in law was told she had 4 months to live, died 3 days later. It accelerates whatever you've got". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220749758.; Sender's Comments: V0: 20220752266 -Covid-19 vaccine ad26.cov2.s -DIED. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Only initial side effect following both injections was moderately sore arm and fatigue.  Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes.  Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital.  Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV.  MD gave me Antivert. Didn't work.  Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.
Hives over body. Controlled with Benadryl 50 mg one time.  Then 2 times Benadryl 50 mg no help. Big welts, itching. Breathing problems and choking on 10/23/2005. To Emergency hospital for injections and RX of antihistamine and prednisone 5 days. Symptoms lasted 8 days. Doctor advised no more flu shots very dangerous.
Associate reported to Employee Health on 01/13/2021 that she experienced a rash on her arms and legs on 01/08/2021.  Patient reported that the rash was present after her first vaccination on 12/18/2020, but she did not report her reaction to Employee Health. After her second dose of COVID19 vaccine the rash re-appeared and spread from her legs to her arms.  Employee Health encouraged her to follow up with her medical provider.  Rash was still present as of 01-13-21.
Right eye lids twitching uncontrollably on and off. It lasts for seconds to minutes then dissipates, then returns minutes to hours later. Also, partial paralysis in blinking with the right eye.    It started with the first dose, but went away after 1 week. It started again with the 2nd dose and has not gone away.
Achy, fatigue, dizziness which subsided.  Rash appeared at injection site 4 days after injection.  Sprayed benadryl.
pt recv vax AUG96 & w/in 5min of vax pt exp tingling over ears toward the back of head, an unusual sensation in tongue, not really a bad taste, sl elevated BP 140/89;
Felt a little sick for a couple of days; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter stated that he/she received vaccine and felt a little sick for a couple of days. No other information was reported.
pt recv vax 5SEP97 & 9SEP97 mom called & stated pt had 101.6 temp 10SEP97;@ clinic 100.9 dx ROM & rx amoxicillin;19SEP97 returned for check up & has a rash over entire body starting feet to face & on palms;
Burning/pain in right arm after shot. Next two weeks-  Persistent pain continued to develop. Inability to sleep on right side loss of movement and constant pain in shoulder, back, tingling down right arm and into pinky. Loss of range of motion, unable to lift arm completely to reach items above my head. Pain is constant and does is not alleviated except with medication. Pain in sides of hips when driving car and getting out that developed about two weeks after shot was given. Pain in hips when sitting for prolonged period then standing.  This pain was not present prior to vaccine.
I am an RN and I received the Covid Vaccine on Friday, felt some expected fatigue and arm soreness on Saturday, but woke up Sunday for my shift with a dry throat and hoarse voice that progressive worsened that day.    I got a Covid PCR swab Monday morning at 0900 and made an appointment to see my doctor that afternoon.  At my appointment I had almost lost my voice, had some nasal drainage, slight sore throat, fatigue, and she felt I had decreased lunch sounds that warranted all abs and a chest X-ray.  I was swabbed for strep, Flu A & B, and Covid antigen testing was done.  All were negative.  The CBC was mostly within normal limits.  The chest X-ray show inflammatory process, a possible beginning pneumonia, and stranding.  She prescribed a ZPak.  I received a negative COVID PCR test result on Wednesday.  I reported to my employee health nurse at my faculties where I work and received the vaccine and she asked me to fill out a VAERS report.  Licensed provider note states   ?December 21, 2020  To whom it may concern,  This is a note to confirm that patient was seen in my office today for a doctors appointment. Patient was seen in office today, x-rays were taken, does as symptoms consistent with bilateral bronchitis, pre pneumonia right side of concern this started with the COVID vaccine. ?
Pt reports that she had heavy vaginal bleeding for 3 days. The bleeding began about 2 hrs after receiving HPV vaccine.