chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2014, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Both vaccines made me start my period early; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced both vaccines made her start her period early. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event both vaccines made her start her period early was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Extreme dizzyness, nauseous, vomiting, diarhea. Went to Hospital to get medication and performed tests
pt found limp p/nursing; attempted resuscitation by EMTs & hosp ER unsuccessful; ME autopsy
Had Moderna COVID 19 Vacc. 10/20/2021, reports since 10/27/2021 had redness, pain and swelling in left arm at injection site and now has swelling and pain and itching below injection site. "...feels like I got stung by a bee then I got burned...'  Reports no improvement with cortisone and aleve.
This spontaneous report was received from a registered nurse refers to a 47 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant medication included STERILE DILUENT (lot# N021895 and expiration date: 29-NOV-2019). On 06-APR-2018 the patient was vaccinated with (Oka-Merck) PROQUAD therapy type rHA (0.5 ml, once) (lot # N019251 and expiration date: 20-DEC-2018) subcutaneously at the age of 47 years (product use issue). No adverse effects were reported. No product quality complaint was involved. "Lot number [N019251] has been verified to be a valid lot number for [measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin]."
Pt c/o swollen lymph node in L armpit, same arm as vaccination. Symptoms started the day after vaccine 9/23/22 and has persisted through the time of reporting on 10/3/22. No treatment reported, pt has contacted her PCP.
swelling and red rash on site of injection; swelling and red rash on site of injection/ red mark on skin is 5 inches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling and red rash on site of injection) and INJECTION SITE RASH (swelling and red rash on site of injection/ red mark on skin is 5 inches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling and red rash on site of injection) and INJECTION SITE RASH (swelling and red rash on site of injection/ red mark on skin is 5 inches). At the time of the report, INJECTION SITE SWELLING (swelling and red rash on site of injection) and INJECTION SITE RASH (swelling and red rash on site of injection/ red mark on skin is 5 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
12 hours after getting 1st dose pt feeling numbness sensation and feels like their is air in forehead, which goes down to cheeks and causes her to lose focus. pt will f/u with md
After receiving PNEUMOVAX injection on 12-24-14 noticed a red rash under arm and spreading up towards arm pit area. As of 12-29-14 problem has resolved.
Menstrual bleeding 10 days prior to period. Got period and then started bleeding again today 11/29. Been bleeding for over 3 weeks.
She got her vaccine, her arm stayed sore for about 4 days and didn't notice it anymore.  She was tired feeling, just yucky feeling, no energy to do anything.  Then after that it was more of not sleeping well, tossing and turning all night.  Then about 2 weeks after that she had noticed that her hair was coming off out of the brush and then her brush was full of hair.  A friend looked at her head and said that she had a bald spot and then realized that there were spots.  The one started at about the size of a half dollar and now are the size of a grapefruit.  The other three are larger than a 50 cent piece.  She has lost about 40% of her hair, and it is very thin especially straight down on the middle, and the others are to the side and one to the corner, which this hair loss has not stopped.   Most of them are in the back of her head but does have one coming in the front as well .   She also has had a headache that she wakes up with every day and takes Ibuprofen and Tylenol alternatively which she did not have before the vaccine.    She went to her doctor when she noticed the hair falling out and has run blood work, urine screening and the only thing came back was that her blood was too thick and she was started on a baby aspirin.   Her doctor wants to do additional testing, CAT scans, and other blood work.
Discharge Provider: DO Primary Care Provider: DO Admission Date: 10/3/2022 Discharge Date: Oct 5, 2022  PRESENTING PROBLEM: AICD lead malfunction  COVID-19    HOSPITAL COURSE: Patient is a 69-year-old female with past medical history of chronic combined systolic and diastolic congestive heart failure with reduced EF of 22%, nonischemic cardiomyopathy, primary prevention single-chamber AICD placement in 2014 presented to the ER with a chief complaint of right hip pain.  Patient has had pain resolved with some IV Tylenol in the ER but was noted to have COVID-19.  No overt hip pathology were noted on workup, x-ray was suggestive of mild degenerative osteoarthritic changes of the right hip.  In the ER she was also found to have RV lead fracture.  EP was consulted for input.  In the ER patient also required 2 L of supplemental oxygen and given impending further medical workup, admission was recommended.  Patient was transferred from ER to hospital for EP evaluation.   On arrival to our facility, patient was treated for acute hypoxic respiratory failure secondary likely COVID-19 and electrophysiology was consulted for RV lead fracture evaluation. In regards to COVID-19, patient received 2 doses of Decadron.  The patient was noted to not require any supplemental oxygen during the morning but does need supplemental oxygen at night which is suggestive of likely underlying obstructive sleep apnea.  Patient was supposed to be using CPAP at night but does not have her device during the hospital stay.  Electrophysiology evaluated the patient and fitted her for a life vest.  Plan is to follow-up with her outpatient to address the limb lead fracture. Given significant underlying heart failure, a structural heart evaluation was recommended and outpatient consult ordered.
Initial and follow-up information has been received from a nurse concerning a 10 year old male with mold allergy and reactive airway disease who on 13-Aug-2008 was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX (Merck) (lot no. 660082/1977U) into the right deltoid. Concomitant therapy included the first dose of HAVRIX (lot no. AHAUB259BA) given intramuscularly and tuberculin purified protein derivative (lot no. 62412) given intradermal. On 15-Aug-2008, "within 48 hours of the vaccination", the patient developed a local reaction after administration of VARIVAX (Merck). He developed a local reaction after administration of VARIVAX (Merck). He developed an approximately 2 inch in diameter, raised red area at the injection site, which was erythema, tenderness, local pruritic and swelling without significant induration. There was no follow specified unless not improved. At the time of this report, the outcome was unknown. The patient sought unspecified medical attention. A standard lot check investigated was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports received from the same source. Additional information is not expected.
Transverse myelitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse myelitis". The lot number for bnt162b2 was not provided and will be requested during follow up.
When giving the Fluzone HD, I stuck the patient and pushed the plunger of the vaccine and the needle was not on correctly & the vaccine came out of the side.
headache after each of the three Moderna Covid-19 vaccines; fever after each of the three Moderna Covid-19 vaccines; chills after each of the three Moderna Covid-19 vaccines; excessive tiredness after each of the three Moderna Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after each of the three Moderna Covid-19 vaccines), PYREXIA (fever after each of the three Moderna Covid-19 vaccines), CHILLS (chills after each of the three Moderna Covid-19 vaccines) and FATIGUE (excessive tiredness after each of the three Moderna Covid-19 vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1C1B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (Severe anemia).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after each of the three Moderna Covid-19 vaccines), PYREXIA (fever after each of the three Moderna Covid-19 vaccines), CHILLS (chills after each of the three Moderna Covid-19 vaccines) and FATIGUE (excessive tiredness after each of the three Moderna Covid-19 vaccines). At the time of the report, HEADACHE (headache after each of the three Moderna Covid-19 vaccines), PYREXIA (fever after each of the three Moderna Covid-19 vaccines), CHILLS (chills after each of the three Moderna Covid-19 vaccines) and FATIGUE (excessive tiredness after each of the three Moderna Covid-19 vaccines) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.  The patient reported that the patient's husband had no immune system and asked whether the patient and the patient's husband should receive another booster shot. The patient was advised to consult with the physician.   This case was linked to MOD-2022-528505, MOD-2022-528526 (Patient Link).   Reporter did not allow further contact
Side effects of the Johnson & Johnson shot I?ve had...weakness , fever,  muscle pain, body aches, headache, cold sweats, dizziness, chills.
Spoke to her daughter, she states, her mother resides at assisted living and her mother has dementia. The staff provide care and supervision for her mother. She has spoken to the staff several times today and staff have denied any further episodes of diarrhea or vomiting. Eating and drinking well. Her mother received the COVID vaccine at the facility on 1-26-2021 at the facility. Vaccine is not documented on the immunization list in her chart. Reporter reports the care facility staff and residents received COVID vaccinations at that time and also there has been gastric "flu bug" going around the facility. She reports her mother had COVID in the fall and was retested but results are pending. Reporter said the ED PCP advised he did not believe it was related to the vaccine.
Area of arm where vaccine was administered is red, painful, swollen and feels hot. Pt is using ice, but refuses ibuprofen. Pt called back on 12-2-05 did take ibuprofen on 12/1/05.
Became extremely tired a few hours after administration of the Jansen. At approximately 12am, 10/1, I was woken up w body aches, headache, stuffy nose, sore left arm & sore shoulder blade, burning eyes,  inability to sleep due to overall discomfort.
Pain in the arm - left arm; Achy feeling and Muscle and joint pain has been worse than before; Muscle pain has been worse than before; Joint pain has been worse than before; Overwhelming fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm - left arm), PAIN (Achy feeling and Muscle and joint pain has been worse than before), MYALGIA (Muscle pain has been worse than before), ARTHRALGIA (Joint pain has been worse than before) and FATIGUE (Overwhelming fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm - left arm), PAIN (Achy feeling and Muscle and joint pain has been worse than before), MYALGIA (Muscle pain has been worse than before), ARTHRALGIA (Joint pain has been worse than before) and FATIGUE (Overwhelming fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in the arm - left arm), PAIN (Achy feeling and Muscle and joint pain has been worse than before), MYALGIA (Muscle pain has been worse than before), ARTHRALGIA (Joint pain has been worse than before) and FATIGUE (Overwhelming fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.  Patient did not took any treatment medication for her symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Contact information updated
Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones).  Patient also reported that patient was having a difficult time breathing.  Treatment for the event included receiving oxygen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Strong side effects, including heart arrhythmia and shortness of breath (possible myocarditis?). Day 0 (Thursday): Received 2nd dose of Pfizer on Thursday evening. Day 1 (Friday): Slept most of the day because of fatigue, alternating chills/fever, aches all over body. Day 2: Still slept most of the day because of same symptoms, though lighter than day 1. Day 3-10: Many times throughout each day I felt my heart skip a beat and felt a sudden, brief shortness of breath. This happened probably 30 times on day 3, then fewer times each day over the next week. After about a week felt back to normal.
This spontaneous report as received from an unknown reported refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H020255, expiry date: 08-NOV-2014) which reported as 08-NOV-2011, therapy type, dose, route were unknown), which was improperly stored vaccine. The outcome of the event was unknown. This is one of several reports that received from the same source. Additional information is not expected.
Red circle around injection site (about 3 inches diameter), pain/tenderness at injection site, nausea
side of injection feels worm to the touch; redness spread to the elbow; site of injection is itching; Redness of injection site; body aches; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (side of injection feels worm to the touch), ERYTHEMA (redness spread to the elbow), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) in a 65-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.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (Redness of injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (side of injection feels worm to the touch) and ERYTHEMA (redness spread to the elbow). On 02-Mar-2021, PAIN (body aches), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE WARMTH (side of injection feels worm to the touch), ERYTHEMA (redness spread to the elbow), VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (Redness of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
lump in arm that was hard; body was shaking, could not sleep; body was shaking, could not sleep; arm really sore; she said she felt pressured to get it.; Shaking like Parkinson's type of shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL9265, Expiration Date: May2021) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TREMOR (non-serious) with onset 12Feb2021 01:00, outcome "unknown", PAIN IN EXTREMITY (non-serious) with onset 11Feb2021, outcome "unknown" and all described as "arm really sore"; MASS (non-serious) with onset 12Feb2021 15:00, outcome "unknown", described as "lump in arm that was hard"; INSOMNIA (non-serious) with onset 12Feb2021, outcome "unknown", described as "body was shaking, could not sleep"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she said she felt pressured to get it."; PARKINSONISM (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shaking like Parkinson's type of shaking".  Additional information: The patient did not receive any additional vaccines on same date. No AE required to visit emergency room or physician office, and patient messaged her doctor but her doctor said it would go away. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Patient has completed the 2 doses of Covid shots, and she is currently pregnant in her 1st trimester, she had Covid in mid-January.  Conclusion: investigation results: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9265 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9265. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
After the second dose of COVID vaccine, the left arm has pain, weakness, numbness which radiate to fingers, hips, and legs.  Unable to grip, walk or stand.  I was unable to work due to weakness in my arm and legs.  The job requires me to do a lot of walking and standing. I am a cook in a restaurant.
Patient called complaining of tenderness, redness, pain, and swelling around the injection site. Stated it hurt to move arm and the pain and swelling had been getting progressively worse as the day went on. I had patient come back in to pharmacy to look at the injection site and determined patient experienced an adverse reaction.
I woke up not feeling well on Monday December 19 2022 I had body aches chills and a slight cough. The next day day still not feeling well I took a home COVID-19 test the result of which was positive. I contacted my physician and received a prescription for PAXLOVID which I began taking on 12/20/2022.