chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Illness; subacute thyroiditis; pain in the front of the neck; headaches; fever; general achy-ness; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 10:00 (Lot number: 33B0BA) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 25Mar2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 04Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "Illness"; THYROIDITIS SUBACUTE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "subacute thyroiditis"; NECK PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "pain in the front of the neck"; HEADACHE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "general achy-ness"; FEELING ABNORMAL (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "feeling bad". The events "illness", "subacute thyroiditis", "pain in the front of the neck", "headaches", "fever", "general achy-ness" and "feeling bad" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, thyroiditis subacute, neck pain, headache, pyrexia, pain, feeling abnormal and treated with NSAIDs.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. Moderna vaccine was ordered on 01-Nov-2021 and 15-Nov-2021. The beyond use date of the vaccine was reported as 01-Dec-2021 to 15-Dec-2021. The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. No treatment information was provided.
The booster I had more symptoms than I did for the first two shots. Started with fatigue. Next day head ache, red rash under my arm pits,  nausea, muscle pain . I felt this for 2 more days beside the red rash under arm pit went away.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 09/20/2021. PATIENT WAS FULLY VACCINATED ON 06/08/2021.
Hives all over body starting Sat Oct 29 , blisters left wrist area Sat Oct 29am, Sun night took antihistamine call info MD await return.
died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for twenty patients. This is one of twenty reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
4 1/2cm X 5 1/2cm ERYTHEMA ON LEFT UPPER ARM.  RED AND WARM TO TOUCH
Headache, Arthralgia, PASSED OUT IN BATHROOM/NO INJURY, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:
The next morning after the 3rd dose I woke up with severe pain in the arm and then I noticed later that day I just got really run down, tired, had a headache. Didn't have fever. But then it cleared up by Sunday evening. On the 19th I started feeling sick again. I went to the doctor. I felt fever, body aches, headache. I was worried about so I called the Dr. I started recording my symptoms on 12/19/2021. I thought maybe it was allergies. I didn't lose taste/smell or shortness of breath but my doctor is very particular and then I called back on the 24th and advised I take a Covid test. At home test was Neg. Because I was still feeling sick and symptoms, I called on the 27th I did a visit with the Dr. and then the 28th I went to her practice and did a PCR and Rapid test. My symptoms are coming and going so my doctor is just monitoring my symptoms. No treatment. It feels like a cold or allergies.
From initial information received on 05/29/2003 from a registered nurse, regarding an adverse event occurring in the US, it was reported that a 4 month old male patient received his second dose of DAPTACEL, Lot # C0950AB, IM in the right thigh, IPOL, Lot # W0460, SC in the left thigh, COMVAX, manufacturer Merck, Lot # 1052M, IM in the left thigh and PREVNAR, manufacturer Lederle, Lot # 490907, IM in the right thigh on 03/17/2003.  On 04/02/2003, the patient's mother called to report that the patient had a large, hard knot at the injection site.  On 05/19/2003, the patient was seen a doctor's office and diagnosed with having a soft tissue abscess.  This was lanced off with a scaple, a large amount of yellowish/green fluid was obtained from the site, was not cultured.  The patient is to be seen again in three weeks for a recheck.  The recovery status was not reported.
About 1 week after receiving the vaccine (on 12/31/2020) I developed an itchy, raised, and red hive-like rash at the injection site. It got worse over the next day, and I put some steroid cream on it. It went away gradually and was completely resolved by 1/03/2021
I received the PFIZER Booster Shot on 10/29/21.  I had NO symptoms until 11/03/21. My prior to Pfizer shots were on 03/14/21 and 04/06/21. I had NO symptoms after ANY of those 2 shots. I should also note that I received the 2021 Flu shot in my right shoulder.  My right arm has had no adverser symptoms from the 2021 Flu shot.  On 11/03/21, right after I woke up for the day, I noticed that that my upper left arm/shoulder was causing some pain. I figured that was a normal symptom after receiving a shot. However, since 11/03/21, the level of pain in my upper left arm/shoulder has increased to the point to where it is very painful to raise my left arm up just a few inches. I also can not use my left to  bear any amount of weight (such as if I am trying to use my left arm to push  off the ground to move from sitting position to a standing position.)  It feels like my left arm is just hanging there without much strength within it.
Immediately, during time frame 30-90 mins after inoculation: Shortness of Breath / Labored Breathing, Lighthead-ness, Body felt like it was overheating from the inside out, Narrowed Vision, Tremor/exaggerated twitching.  I went into urgent care at vaccine-administering hospital between 60-90 mins after inoculation, doctor notes were: PR ECG AND INTERPRETATION,   PR IV INFUS HYDRATION INIT 31 MIN TO 1 HR , PR METHYLPRED SOD SUCC (BU PER 125MG) *SOLUMEDROL INJ , PR NORMAL SALINE SOLN 1000ML INF, PR TX/ PROPHY/ DX INJ IV PUSH SNGL/ INIT DRUG , PR ZYRTEC SYRUP 1MG EA .   Continuing Reaction: essential tremors since immediate onset post inoculation.  I'm currently taking Propranolol 60mg, 3 times a day, and Primidone 50mg, 2 twice a day.  The medication is still trial and error to suppress the tremors.  To date, the tremors are not fully suppressed.
Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Woke up morning after vaccine to expected pain at injection site, by early afternoon my upper arm was swollen and 4?x4? area was red, very hard and painful. I took acetaminophen that helped.  At bedtime I took Benadryl to help reduce reaction.  The day the area on arm was very sore, swollen, red and very hard. I continued to take acetaminophen during the day and Benadryl at night. On the 3rd day the area started to be itchy.  Today is March 8, the 4th day after vaccine. The hardness and soreness is gone, only slightly itchy but still red.
Extremely swollen lymph nodes especially in left armpit, swollen the size of a grapefruit.
Started with wheezing in chest-got worse next day then went to hopsital on Sunday and it had traveled to my sinus and worse in chest on antibotics and breathing meds and inhaler
Information has been received from a female registered nurse who as a child, in 1974, at approximately 9 years old was vaccinated with rubella virus vaccine live. The nurse reported that she immediately experienced severe pain in all her joints which lasted for 3 years. At that time, she was taken to an orthopedic doctor who performed blood work and tests and stated that the patient had a reaction to the vaccine (results not provided). The nurse did not remember what, or if, there was intervention to treat the reaction. The nurse also reported that a titer was drawn and she was not immune to rubella. Additional information has been requested.
Patient is a 69 y.o. female with history of multiple medical problems as indicated below including rheumatoid arthritis.  She is a non-smoker.  She tells me she has "a heart condition" and is followed by a cardiologist. She tells me she was in her usual state of health and took her COVID-19 first vaccine today.  Approximately 30 seconds later she noted chest tightness/burning that has been constant.  It is rated 9/10 at maximum and improved to 5/10 after about 10 to 15 minutes.  She also states, "my eyes feel funny.  I feel cold.  I am dizzy." She endorses palpitations and dyspnea. She denies any abdominal pain, nausea, vomiting, fevers, diaphoresis, headache, cough, rash, or syncope. She does have a history of seafood allergies and had similar reactions after eating seafood. She tells me 3 years ago after a flu shot she fainted.  She tells me the past 2 years after her flu shot she had nausea or vomiting. She tells me she fell yesterday and hurt her hip but she did not hit her head.  No LOC. She tells me she takes baby aspirin nightly. Family history: Mom and dad both died at age 82 from lung cancer.  They both had heart disease.   She was sent back from the vaccination area to urgent care to be evaluated after her reaction to the COVID-19 vaccine.
This patient received a flu vaccine 9/16/22.  Since administration, she states she has had decreased range of motion to left arm.  She complains of pain with motion of left arm.  She reports that symptoms are unchanging over the last 10 weeks.  PRN ice has not helped.  Pt was advised to follow up with her PCP asap for further evaluation and treatment.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Dizziness, Myalgia, Fever, Diarrhea,  NauseaVomiting, chills Narrative: Vomiting, diarrhea, myalgia, dizzy,  fever/chills; resolving
Per client, 2 hours after the vaccine she began to feel dizzy, back pain, headache, nausea, and a loss of appetite. Client stated these symptoms lasted for 3 days. She also felt very thirsty. Client stated she spoke to a neurologist who stated that these symptoms were normal and that she needed to rest. I also reassured the client that per the Vaccine Information Sheet, the dizziness, headache, and nausea were all expected side effects.  Per client she understood the neurologist and myself. She has chosen not to get the third rabies vaccination.
Upon arriving in another country in March of 2003, I was very sick. With flu like symptoms that lasted 3 weeks. Doctor at clinic said I may have flu, but was not sure. Severe dehydration followed a few days after. I fainted after eating lunch while walking back to barracks with no ruck sack. In April of 2003 I started having acid reflux, and severe heartburn issues. Neither of which I have ever had. I got sick again with flu like symptoms in April. The official said it looked like the flu but was not sure. Upon returning back to the states in August of 2003 I was severely ill, and had lost so much weight. Before being deployed I was never sick but once or twice a year with hay fever and the flu usually around December. I weighed 235 before deploying and upon my return I weighed 175. Since then I have been maintaining 180 to 190 but have not been able to get over that. I have tried but not able to. I have spoken to my physician Doctor at the hospital and she has only done a few blood test with no negative results. I have asthma now which no one in my family has, and I never had it during my military career. I have been sick probably about 4 or more times a year. Other issues have risen. I only get severe heartburn when I become sick almost like a heart attack. I also have chronic fatigue which is not diagnosed at the facility and I am not understanding that. Restless leg syndrome. Sweats in while sleeping and a skin rash diagnosed as kerotosis. Which I never had.
Fever chills and body aches Narrative:  employee states: after second dose experienced marked body  aches/chills and a temperature up to 101 F in the first 24 hours along with  soreness at injection site. After 24 hours he was fine.
Flu symptoms (achy muscles, fever, lethargy, and chills) began several hours after flu shot and continued off and on for approximately two weeks.
Swollen, hot itchy rash at injection site 9 days after vaccine. Lasted approximately 4 days
Directly after receiving H1N1 inj (shot) developed 4 cm x 4 cm area of swelling at inj site. Cool compress applied to site & 25mg Diphenhydramine po administered. Retained for 20 minutes after vaccination with no further developments. Doctor considered this an allergic reaction.
Initial report was received 25 August and 26 August 2011 via a distributor (Item number 546-7789; Control # 41209), who received the report from a physician. A cluster of two unidentified patients had received an injection of ADACEL, lot number C3935AA (route, site and dates of administration not reported) and on 23 August 2011, both patients developed a 1/2 cm high raised red bump at the injection site. The events required a doctor's visit. Outcome was unknown. No additional information was provided at the time of the report. Follow-up information was received from a healthcare professional on 17 October 2011. The patient had received an injection of ADACEL in left deltoid on 16 August 2011. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: None
dizziness and weakness 10 minutes post vaccination.  observed patient for 20 more minutes while seated. called 911 for patient but patient refused service.  patient was alert the entire time and able to converse coherently.  Patient felt fine afterwards to drive home. Followed up with patient on 4/5/21.  Patient stated that he's perfectly fine after reaching home with just a slight arm soreness which was resolved the next day.
Aches and pains, nausea, temp of 99.8 and chills.
Client was given Hep B as well as a combo vaccine with Hep B. Family was called; unable to contact at this time; will re-attempt to contact. Doctor notified of event
Patient was very anxious about receiving vaccines. Had a near syncopal episode within a couple minutes after vaccines were administered. She became pale and diaphoretic but did not lose consciousness. Patient was allowed to lay down and was given some fluids to drink. Symptoms resolved in about 15 minutes.
pt recv vax 10AUg98 & itching & sore when took bandaid off;It was swallow & very red;still 14AUG989 pt return has a raised area size of 1/2 dollar & red & sl heat;
Severe pain in shoulder for 24 hrs, myalgia, severe fatigue, and headache. All disappeared after 2 days.
For both vaccine doses, does one given 4/12/2021 and does 2 given 5/10/2021 I had a change to my menstrual cycle. Does one on 4/12/2021 caused a period 10 days after administration when the normal cycle should if I stayed on track should have been 20 days later instead.  Dose 2 also caused an abnormal/early period 10 days after administration when the normal cycle track should have been 26 days after administration.  I do not typically have issues with my menstrual cycle, in fact, they are usually on time within 1 day and have been my entire life.  I do not take birth control or have any other issue that I am aware of that would cause this.
Second vaccine 02/19/2021 1150, first vaccine 01/29/2021@1150;  Headache, aching and vomited once
Hands were getting more tingling; This is a spontaneous report from a contactable consumer or other non healthcare professional. This consumer reporting for a patient. This is one of 2 reports: A 7 decades-old (60 s as reported) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 03May2021 as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced hands were getting more tingling as versed to going away on an unspecified date in May2021. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Covid 19 2023-24 age 12 years and old vaccine was ordered. Vaccine given was the Covid 19 2023-24 age 5-11 year dose. Patient currently 14 years old. Patient received smaller dose(10 mcg), should have received larger dose (30 mcg).  Vial for ages 5years to 11 year old was given. Informed MA who administered dose, informed supervisor. MA had recorded the lot number for age 5-11 year old, the vaccine count did not match, mistake was discovered. Contacted Pfizer regarding under dose of vaccine. Informed we can give the full dose of 12 year and older Covid vaccine, no wait time needed. Will contact parent to inform them of under dose and schedule appointment to get the 12 year and older Pfizer covid 19 2023-24 vaccine. Added additional age label to each Conid 19 box. Reviewed location of vaccines in refrigerator with staff. Reviewed need to have another clinical staff check all vaccines before administration to verify vaccines prepared match vaccines provider has ordered.
Sciatica flare up that lead to inability to walk/work. Symptoms began aprox 3 days after the injection and it was at first like the normal signs of a flare, but then it became so severe I was out of work and saw my PCP who ordered an MRI and prescribed medication