chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When she got the shot, it left a big bruise on her arm; It started to swell up; This is a spontaneous report from a contactable consumer (husband) or other non-healthcare professional reporting for female patient (wife). A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) (at the age of 61-years-old)as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced when she got the shot, it left a big bruise on her arm, it started to swell up. The reporter was calling regarding my wife. She just had the Pfizer vaccine eight days ago and originally, first of all, when she got the shot, it left a big bruise on her arm, which the nurse who administered the shot said, that never happened before. Eight days later now, it started to swell up. She is going to call her doctor of course but I thought I should go ahead and give you a call just kind of like to see what this particular number is about, what you guys do. There was no treatment received. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
dizzy; shaky; chills; achy muscles; achy joints; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), NERVOUSNESS (shaky), CHILLS (chills), MYALGIA (achy muscles) and ARTHRALGIA (achy joints) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and birth control for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizzy), NERVOUSNESS (shaky), CHILLS (chills), MYALGIA (achy muscles), ARTHRALGIA (achy joints) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), NERVOUSNESS (shaky), CHILLS (chills), MYALGIA (achy muscles), ARTHRALGIA (achy joints) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
diarrhea; This is a spontaneous report from contactable Other HCP via Pfizer Sales Representative. An infant patient (less than 1 years old, unknown gender) received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced diarrhea after receiving the first dose of Prevnar 13. Outcome of event was unknown.     No follow-up attempts are possible, information about batch number cannot be obtained.
Woke up on the second day after receiving the 2nd dose with a swollen and tender lymph node under my left armpit; It was sensitive to touch (slightly painful) and pressure and took about 48 hours to reduce in size; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 16Apr2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC); taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:00, the patient woke up with a swollen and tender lymph node under his left armpit. It was sensitive to touch (slightly painful) and pressure and took about 48 hours to reduce in size. It was still slightly swollen but no longer sensitive to touch. The events did not result in doctor or other healthcare professional office/clinic visit, 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 woke up on the second day after receiving the second dose with a swollen and tender lymph node under left armpit was resolving at the time of this report. The clinical outcome of the event it was sensitive to touch (slightly painful) and pressure and took about 48 hours to reduce in size was resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Came to me complaining of extreme body pain and discomfort. He laid down on the couch curled up with legs to chest rocking back and forth. His teeth clenched and breathing heavy.  Breathing so heavy that spit was coming out of his teeth as they were clenched. He has a severe headache  and was sweaty.  His pain was so intense he was groaning and yelling out in pain.  We gave him 2 motrin initially with no relief and 45 minutes later gave him another with still no relief.  We wanted to take him to the ER but was in so much pain he could barely walk and just wanted to lay down and rock side to side.  After about 3 hrs his pain came down to about a 5  and  then he began throwing up over and over until all he could do was dry heave.  He also had extreme arm pain in the arm it was administered in so much so he couldn't lift it or move it or even touch it.
For 30 hours after vaccine (Thursday) I experienced headache fever and chills.  At about 34 hours after vaccine (early morning Friday), I awoke feeling sweaty, weak and upon rising felt dizzy so that after ambulating about 15 was forced to lay down on carpet and may have passed out.  I lay there moaning until I was able to get to the toilet where I vomited and then had diarrhea-like stool.  I continued to feel so dizzy that I had to stay perched there until I was able to have strength enough to walk to my chair in the living room.  I reclined there until my husband got up at 6 am to help me get some Tylenol.  Along with this episode, I have had blood in or on my stool for Friday and Saturday which may be unrelated.  I will let my PCP know of this symptom.   I have never had a reaction like this to a vaccine.  I felt much better by Friday afternoon.  No medical treatment or hospitalization needed.  Just wanted to report this incident as it is very out of the ordinary for me.
12/10/21  Two day history of nasal congestion, fever up to 100.6 this morning, body aches, neck pain and stiffness, occasional cough.  States may have had a Covid exposure.  States completed Pfizer covid vaccination and has had booster.  No abdominal pain, nausea, vomiting or diarrhea.  No shortness of air or wheezing.  Sinus pain and drainage.  12/10/21 Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for congestion, postnasal drip, rhinorrhea, sinus pressure, sinus pain and sore throat.   Respiratory: Positive for cough. Negative for chest tightness, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Musculoskeletal: Positive for myalgias and neck pain.  Neurological: Positive for headaches.
I was really weak the day after the vaccine, and I had a hard time carrying some vegetables from the building to the car, which is about 100 meters. I was so weak in between halfway that I had to rest before I made it to the car. I do not remember the next 2 days, they are kind of a blank, then on Sunday the 31st of October I fell and was taken to the hospital. I was trying to move but couldn't. I could not get up and the lower I went the more I could not get up. They drew blood and urine analysis and eventually I got a bed and was held there for 4 days. I was on the fall list so if I got up someone was there. They kept drawing my blood, and they realized that my sodium and my hemoglobin were off, they were both very low and had no energy. They claim that it was a urine infection that went into my blood. And I did not understand why or how it happened. It took me a few weeks to be back to normal. I also had home health to come draw blood for 2 weeks and a physical therapist to help me get strength back. My head was foggy and then it cleared it up as well.
Tingling and numbness from head through tie on the right side within 15 minutes of the injection. Oxygen levels and blood pressure was normal taken by local EMT. Tingling and numbness went away about two hours later. Tingling, pain and numbness on the right side of the face two days later. Theirs symptom lasted several hours and came back later in the day for a few  of hours. No treatment given.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 04-NOV-2015 the patient was vaccinated with MMRII (lot # L012479, expiration date 10-APR-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Presented with SOB x 1, productive cough;  admit with Covid 19 PNA; tx with remdesivir, zithromax, steroids, maxipime, doxycycline, veletri, zyvox, merrem,admitted with COVID 19 pneumonia with respiratory failure. The patient was admitted to ICU and admitted the evening of 8/26. He had showed improvement of ventilator requirements but on 9/5 was noted to have fixed and dilated pupils with loss of gag reflex. A STAT CT showed R cerebellar hemorrhage with signs of increased intracranial pressure. Sedation was held and over the next 24 hours the patient had brain perfusion scan which was abnormal as well as EEG showing no brain activity. Brain death was pronounced on 9/6/21
My throat started getting sore, I had a bad headache like I did the last time I had COVID-19, not a migraine just a weird headache, I felt crummy. I used a home COVID-19 test because my husband and I were supposed to go to a birthday party. I wanted to make sure I was not going to be spreading the virus. I did positive, I called my doctor she was not available, I called and had a telehealth visit with a local Urgent Care. They prescribed the Paxlovid that I started taking immediately. I started feeling better within three days and was testing negative on the February 24th but by February 26th I was testing positive again. It then took another three or four days before I was feeling completely over COVID-19. I feel great now.
Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (quadruple bypass surgery). Concurrent medical conditions included Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include he reported that is scheduled to receive the infusion of drug.  Concomitant product use was not provided.; Sender's Comments: This case concerns a 95-year-old male who experienced nonserious unexpected event of COVID-19 based on SARS-CoV-2 test positive.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Planned treatment with infusion of drug. Event outcomes unknown. Based on 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
Skin disorder; Psoriasis flare-up; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On 21-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2022, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 25-Apr-2022, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced SKIN DISORDER (Skin disorder), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness). At the time of the report, SKIN DISORDER (Skin disorder) and PSORIASIS (Psoriasis flare-up) had not resolved and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  The reporter's causality for the events of dark spots, felt tired and broke out with plaque psoriasis with respect to the Humira was not provided.  The reporter's causality for the events of Dark spots, felt tired and broke out with plaque psoriasis with respect to the Pfizer Biontech was not provided.   Reporter did not allow further contact
Vaccine on April 12, 2021 into left arm.  Cutaneous lesion on dorsal left hand by April 24, 2021. Removed and biopsied July 20, 2021.
Left arm really hurt after shot; Codeine didn't help. Pain goes up into my left shoulder and down my arm. Cannot sleep or lay on that shoulder and arm. Hurts badly to use it. Sat and just cried 2 nights ago.
This spontaneous report as received from a Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored GARDASIL lot numbers K005083 Expiry date 04-NOV-2016, K008931 Expiry date 04-MAR-2017 and K023432 Expiry date 18-JUN-2016 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Woke up day after receiving first dose and was dizzy,  have been dizzy non stop for 6 days.  Went to the Dr today and was put on Meclizine
Information has been received from a physician assistant who is a female pt that was vaccinated with four doses of varicella virus vaccine live and "did not seroconvert", "{per commercially available aviable tests}". It was noted that she was exposed to chickenpox "yesterday" on 29Apr2003 and that she was not pregnant. The pt received Globulin, Immune, VZIG (Human), (VZIG) on 30Apr2003. Unspecified medical attention was sought. Additional information has been requested.
Severe headache; severe neck pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 13Mar2021 at 08:00 AM, as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis, asthma, high blood pressure, heart attack. The patient received other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 00:00 AM, the patient experienced severe headache and severe neck pain. Therapeutic measures were unknown for the reported events severe headache and severe neck pain. The clinical outcome of severe headache and severe neck pain was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
she developed a red; she developed a red, itchy; her right upper arm had an "outbreak of tiny blisters."/outbreak of tiny blisters" on her left abdomen/the same symptoms developed on her left upper thigh; diagnosed with dry skin; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stress.   On 31st May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities, itchy upper limbs, blister and dry skin. On an unknown date, the outcome of the erythema of extremities, itchy upper limbs and blister were recovered/resolved and the outcome of the dry skin was unknown.   The reporter considered the erythema of extremities, itchy upper limbs, blister and dry skin to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 2-3 weeks later she developed a red, itchy right upper arm.  She stated that next her right upper arm had an outbreak of tiny blisters and lasted for one day and resolved.  The patient stated that 1-2 weeks after that she developed another outbreak of tiny blisters on left abdomen resolved after a day then the same symptoms developed on her left upper thigh, lasting one day, and then back to her right upper arm, resolving after one day as well.  The patient stated that sought medical treatment and was diagnosed with dry skin and provided a cream to treat it.  The HCP told her that they felt this was not related to the Shingrix vaccine. The reporter did not consent to follow up. The reporter declined demographics and declined to provide further details for this AE.
At about 8:00 pm I started having chills. I felt cold and it kept getting worse. By about midnight I was shaking uncontrollably. I had heated the room to about 80 degrees and was in bed under several blankets but still felt like I was freezing. This lasted until about 3 am when I finally fell asleep. I had to work noon to 8 pm on the 12th. I was exhausted, tired and cold (even though bundled up with sweater and coat) the entire day. About 10 pm I got the shakes again, but they were very mild. I still felt cold and couldn't sleep well. I felt like I had a hangover the entire day even though I have not had a hangover in 20 years.
Initial report received from a health care professional on Aug 11 2005. A 5 year old, female patient experienced injection site reaction (area red and warm 3 x 4 cm), 24 hours after receiving an intra muscular injection of Tripedia (fourth dose, lot number U1369CB) in the left deltoid on Aug 8 2005. 48 hours after the injection, the area was 10 x 12cm with redness and central induration. The doctor feels it is possible cellulitis. The patient also received the following injections on Aug 8 2005, IPOL lot X10062 in right arm, MMR lot number 0044P sub cutaneously in left arm, and Varicella vaccine lot number 0185P in right arm. At the time of reporting, the patient did nor recover.
Opened at 5:24 PM on 01Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Opened at 5:24 PM on 01Sep2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Opened at 5:24 PM on 01Sep2021). On 02-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Opened at 5:24 PM on 01Sep2021) had resolved.        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 were reported. No treatment medications were reported.   This case was linked to MOD-2021-311328, MOD-2021-311042, MOD-2021-311221, MOD-2021-311042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received contains Added patient details. On 15-Sep-2021: FU Received on 15 Sep 2021,contain Non Significant Info.
mom states pt was dazed x 5 days temp x 3 days 103;