chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When receiving my second COVID vaccination, the nurse giving the injection measured one finger from the top of my shoulder and injected just below, approximately 4cm from the top of my shoulder.  It did not feel like a normal intramuscular injection.  My arm has only been sore in my left shoulder, no where else.  With any previous vaccine, including my 1st COVID injection, I have felt soreness in the muscle.  I am more than sore in this case, I have pain that has woken me up from sleep.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Known allergies: Yes. Penicillin" (unspecified if ongoing), notes: Known allergies: Yes. Penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid from 27Sep2023 for COVID-19.
Pt has had wheezing, nasal congestion, and shortness of breath for 3 days.  Pt admitted with COVID-19 infection with pneumonia.
got the first vaccine 4 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first vaccine 4 months ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first vaccine 4 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first vaccine 4 months ago) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications and treatment medications were provided by the reporter.  The patient got the vaccine 4 months ago did not received the second dose of vaccine at the time of this report.
2/28/2022 changes in motor function and overall behavior, presentation, spouse brought to hospital w/102F fever; no other symptoms reported
Painful and tender arm, unable to lift. Slowly improving today (next day). Nausea during the night of 12th May.  Shivers during night of 12th May. Nausea and shivers lasted about three hours at night, revolved upon waking up in the morning of 13th  Severe headache during the night of 12th May, improving on 13th May
After donation donor was in office and received IMOVAX Rabies vaccine 1ml right deltoid. After injection donor dropped chin down, eyes rolled backwards and made snoring noise. Donor responded to voice in 10 sec. Donor did not fall. Donor moved to bed. Office. Vital signs taken; VAERS and DAE-A filled out. H2O and snack given donor recovered in 17min. Left center.
worsened back pain; chest tightness; shortness of breath; mild diarrhea; This is a spontaneous report from contactable Physician from a Pfizer Sponsored Program. A 82-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 22Jan2021 (at the age of 82 years old) as dose number unknown, single for COVID-19 immunisation; Palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at 75 mg for Metastatic Breast Cancer. Medical history included DM (diabetes mellitus), HTN (hypertension), Crohn's disease, ED (erectile dysfunction), right-sided back pain all from an unknown date and unknown if ongoing. Concomitant medication(s) included letrozole (LETROZOLE) taken for an unspecified indication from an unspecified start date and ongoing. On an unspecified date, the patient experienced worsened back pain, chest tightness, shortness of breath, mild diarrhoea. Initially worsened back pain was attributed to the vaccine, however, symptoms persisted, accompanied by some chest tightness and shortness of breath, therefore, she presented to the ER for further evaluation. The patient was doing pretty well and eating pretty well. The patient underwent lab tests and procedures which included multiple studies completed, including MRI T-/L-spine (magnetic resonance imaging) showing widespread osseous metastatic disease on an unknown date. The action taken in response to the event(s) for Palbociclib was dose not changed. The clinical outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed raised red area around injection site 2 1/2 inches across with itching.  Told patient to use diphenhydramine orally and hydrocortisone topically and contact primary MD.
I received the first dose of the Shingrix vaccine, and for approximately 10 days following my upper arm over the entire deltoid muscle region (the site of the injection) was a pronounced red and  mild to moderately sore. The redness then disappeared, but the soreness not only remained but grew worse, to the point where I discussed it with my doctor at his office on September 9.  He recommended applying heat to the area and an exercise (both of which I did) but by October the soreness continued to increase to the point where  my range of motion in the right arm was significantly impacted.  It is now more 3.5 months since the injection; the soreness seems to have plateaued (not gotten worse or better since October) and the range of motion  is perhaps slightly improved. I have been applying heat and massage to the deltoid muscle area which may be helping.
There is a 3-4cm area of redness on left anterior thigh surrounding the vaccine injection sites from DTAP and Comvax.  Minimal warmth no tenderness.
Pt became fuzzy and febrile approximately 10 hours after receiving vaccinations. T-101 when seen in office next day. Pt cried throughout the night and was inconsolable.
Symptoms of hives (urticaria) onset 11/1/2021 at approximately 2:30pm, nine days from receipt of Moderna COVID-19 booster. Diagnosed as such with angioedema 11/2/2021. Directed OTC antihistamine regiment of two Allegra in the morning and two Zyrtec in the evening for two weeks. Advised to monitor angioedema for possible emergent care (not likely).
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On unknown dates, the unspecified patients were vaccinated with doses of M-M-R II, (strength, dose, frequency, route and anatomical location were not reported), (lot # J016235, expiration date: 19-DEC-2015), which were improperly storage. It was reported that the temperature excursion for M-M-R II was supported with in-house stability data. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Extreme hoarseness, sore throat, headache, fever 102.4, slight cough, congestion. 2 days later fever is 99.8, hoarse, no sore throat, cough and congestion.
heart attack; congestive heart failure; sepsis; pneumonia; edema of the lungs; viral infection; other injuries; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-JAN-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the clinic for routine health maintenance and for the prevention of shingles (herpes zoster). In early May 2018 (also reported as shortly after vaccination), the patient suffered a heart attack, congestive heart failure, sepsis, pneumonia, and other injuries and edema of the lungs as a result of viral infection caused by zoster vaccine live (ZOSTAVAX). These life-threatening conditions resulted in prolonged hospitalization and extensive medical history, excluding but not limited to a heart catheterization and a coronary angiogram. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, she suffered severe injuries and life-long disabilities not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and suffered economic losses due to her inability to work. The patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence, she suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The events of heart attack, congestive heart failure, sepsis, pneumonia, other injuries and edema of the lungs as a result of viral infection were considered to be disabling and life threatening. Upon internal review, the events of heart attack, congestive heart failure, sepsis, pneumonia and edema of the lungs were determined to be medically significant.
On 11/29/2001 experienced nausea. On 11/30/2001 was nausea, headache and slight fever with aches and pains. Also right deltoid swelled with hives 1 inch by 3 inches. On 12/01/2001 hive enlarged to 2 inches by 3 inches. Decreased nausea but had headache with aches and pains in evening only. On 12/02/2001 hives 4 by 6 inches on right deltoid, headache but symptoms improving.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 27-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Feeding problems, gastro-esophageal reflux, Candia of the skin, upper respiratory issues.
had 1/8/21 had Moderna vaccine was fine after the vaccine except arm was a little sore, increased 1/9/21, woke from sleep that night, didn't respond to Ibuprofen, couldn't use L arm-had to use R arm to move L arm, has improved much better on 1/12/21, then did yoga work out  -1/14/21 had inc pain again and wasn't sleeping well,  worsened 1/15/21, using ice and Motrin and now getting better again 1/19/21 no other sx, can't move actively above shoulder without discomfort, is sleeping better; didn't use meds this am has reached out to PCP and waiting for call back
Site: Swelling at Injection Site-Medium, Systemic: Numbness and swelling-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Numbness and swelling
Left arm injection site red rash started on day 8 following vaccination.  Followed by itchy and swelling of site (about 3 inches in diameter).  Currently it is day 11 and swelling, redness and itchiness continue.
The injection site seemed to bleed a lot after I was given the shot. It hurt was in minutes and felt pretty hard and sore shortly after. That evening it got more black and blue  further on the arm it got red. Tuesday the redness seem to increase the soreness the bump under the skin was larger. Today is Thursday the 1st of April of the bruise is turning yellow today and much of the redness has left I'm feeling a little bit better.  Yesterday I was on the couch sleeping all day I've had a lot of cognitive issues which are normal for me however they seem to have increased with a shot. Not sure if the fatigue is doing that or just because I was born with cognitive issues. It's really nothing major or nothing I'm concerned about. Today I can rub my arm against it and still feel the bump around the incision site it is a little tender feels a little itchy I think it's starting to fade and hopefully go away.
Hives, stridor. Patient had started Amoxicillin on 11/25 following an ER visit with diagnosis of otitis media. Was seen in clinic for follow-up after having developed the hives. Parents concerned it was the flu shot that caused this even though most likely a penicillin allergy.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ANXIETY-Medium, Additional Details: WE CALLED 911, paramedics came and her oxygen, heart rate, bpwas fine. pt was given option of going to hospital, but she did not want to go.
Swollen tongue/mouth. Followed by peeling of tongue/mouth. Sore throat accompanied swollen tongue.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 October 2013 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, left arm). The vaccine was administered "using 25 gauge, 1 inch needle." On 24 October 2013, less than one day after vaccination with FLULAVAL, the subject experienced injection site pain. The pharmacist described the local injection site pain as "starting 1 day after injection" but provided an onset date as the same date as the vaccination. The pharmacist also described the pain as "arm soreness", "achy", "annoying," and "dull." Per the pharmacist, the pain did not "improve over time, nor worsened but is low on the pain scale." The pain improves with activity. The pain "has lasted 3 weeks following administration of FLULAVAL." The pharmacist reported the immunization series was not discontinued. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with FLULAVAL. The pharmacist reported another case with FLULAVAL. See A1051253A for details on the other case.
When I caught COVID-19 I had symptoms starting on July 8, 2022 in the evening including a headache, fatigue, a scratchy throat, and congestion. July 9th I went to my doctor. I was prescribed a prescription for  paxlovid. I took it till July 15th. My symptoms stopped on July 12th or 13th. On July 15th the symptoms stopped but I still had fatigue. On July 18th I called my doctor and they said I am having a rebound of COVID-19. They told me to continue isolation. On July 23rd all my symptoms came back. I had a cough, congestion, headache, fatigue, and diarrhea. My symptoms continued yesterday. I feel much better today. I took some ibuprofen and fluticasone propionate.
administered the liquid adjuvant portion of Shingrix without reconstituting it with the antigen component / receiving the shingrix shot that wasn´t mixed; administered the liquid adjuvant portion of Shingrix without reconstituting it with the antigen component; arm was sore; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were received as follows: The age at vaccination was not reported. The reporter reported that patient was administered the liquid adjuvant portion of Shingrix without reconstituting it with the antigen component, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.   Follow up information received from Pharmacist on 27th October 2020: The patient's demographic details were updated. The patient received 50 mcg dose of Shingrix by intramuscular route. The reporter stated that, unknown after vaccination, the patient experienced sore arm for fewdays and was better at the time of reporting. It was unknown if the reporter considered the pain in arm to be related to Shingrix. The reporter stated that, the patient would get shot again in 4 weeks from the incident. The VAERS details were updated.
Information has been received from a physician concerning a 2 month old female who in February 2007, was vaccinated with Rotateq (Lot# 656187/1237F) and received her second vaccination at 4 months of age in April 2007. The mother refused the third dose because after the first two doses of Rotateq, the baby was taken home and put down for a nap. When she woke up about two or three hours after coming home from the doctor, she had a very strange crying behavior, irritability and could not be consoled. She was given MOTRIN and TYLENOL at different times. The physician reported that they were not complete doses of either drug. The irritability and crying was not helped. Additional information has been requested.
Baseball size swollen node under right armpit formed; Baseball size swollen node under right armpit formed very painful; Administration site left leg; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 27Aug2021 at 09:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), sleep apnea and known allergy to penicillin. 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 medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Aug2021 at 16:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 27Aug2021 at 12:00, within 3 hours of vaccination, the patient experienced a baseball size swollen node under right armpit formed which was very painful for 3 days and it had lasted 6 days total. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events baseball size swollen node under right armpit formed very painful was resolved on 02Sep2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 02/01/2001 the patient experienced typical chicken pox rash all over his body. The physician confirmed the rash on 02/03/2001. The rash was well over 100 pox on his trunk, face, scalp, legs and groin area. The patient was given no treatment. Follow up information has been received from a physician who reports the patient had a moderate case of varicella, approximately 100 lesions. No further information was available. Per F/U 6/17/02: Info has been received from the relative of a 6 year old Caucasian male consumer who on 1/20/96 was vaccinated with a 1st dose of varicella (lot 609263/0428B) SC, in the left arm. There was no illness at the time of vaccination. It was reported that on 1/5/96, the pt received the 1st dose of MMRII (lot 616442/1181B) SC, in the right arm and the 4th dose of Hib, IM, in the left arm. Other concomitant therapy included sodium fluoride + vitamins (unspecified) (Poly-vi-flor tablets). On 2/1/01, the pt experienced typical chickenpox rash all over his body. The physician confirmed the rash on 2/1/01. The rash was well over 100 pox on his trunk, face, scalp, legs and groin area. The "varicella resolved without incident. The pt is well." No further info is expected.
Chest pains, rapid breathing, vomiting, neck, arm and shoulder pains. Fever of 104, lethargic, very dry mouth, swollen arm (arm injected), dizziness and more.
Dehydration; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and DEHYDRATION (Dehydration) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness) and DEHYDRATION (Dehydration). At the time of the report, ASTHENIA (Weakness) and DEHYDRATION (Dehydration) outcome was unknown.            No treatment medicines were reported.
Nausea within 5 minutes after injection (1:30 pm).  Then later the same night (around 7:30 pm), headache, chills for 2-3 hours, then nausea, then stomach pain and cramping all night.  The following day, more chills, headache, nausea, and stomach cramping for the entire day.