chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID arm; Bump on injection site; Painful; TENDER; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (Bump on injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE PAIN (TENDER) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included METFORMIN for Diabetes.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (Bump on injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE PAIN (TENDER). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (Bump on injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE PAIN (TENDER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
2 1/2hr p/vax pt started shivering & shaking all over, turned blue then became very pale, limp & unresponsive except to follow movement w/eyes;episode lasted 5-10min;to ER temp 100 24hr later t101 to 102, lt leg sore, vomiting;
I had trouble breathing then next day it kept feeling worse.  I went to urgent clinic DR put me on  antibiodic for a week told me go to hospital if I was no better. I went to ER   was transferred to different Hospital where I was treated for 4 days and released with meds.  I still am having breathing problems  I have follow up with Dr    on April 7
Within 12 hours of getting the shot, I developed periods of chills and periods of fevers and profuse sweating. 15-16 hours after the shot I had headaches that prevented me from doing any activity. I missed one day of work for the headaches I?m particular. My body was sore but the worst feeling was the intensity of the headache. Two days after the shot, a mild headache remains.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On an unknown date the patient was accidentally vaccinated with VARIVAX (merck) (dose and lot# not reported) instead of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Injection site reaction. A mother reported that her child received 1st dose of Prevnar on 3/28/01. Within 24 hrs the child developed an injection site reaction characterized by swelling and redness of the entire thigh and he experienced difficulty in walking. The child was treated with benadryl and the application of ice packs, he was recovering. Additional information received from the physician on 5/22/01, indicated that the child recovered.
A physician reported that a pt received an injection of Prevnar and subsequently developed a rash. The pt was taking amoxicillin at the time. The reporter noted that this event was a "possible allergic reaction". No further information was available at the date of this report.
Six hours after receiving the Moderna vaccine, the patient experienced palpitations and had a pulse rate between 115 and 130. He was seen in the ER and it was determined that he was in a.fib.
Injection site next day was hot and red, pain radiated to neck and shoulder and had "flu-like symptoms".
I experienced symptoms of pain and difficulty lifting my arm, severe fatigue, headache, myalgia, sweats, felt feverish, very weak, slight cough, and I was not able to do any normal activities or work. The symptoms took over 6 days to resolve.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild
Nausea, tiredness, headache, no appetite. Lasting 36 hours and starting 12 hours after vaccination.
This spontaneous report was received on 10-JUL-2017 from a registered nurse and refers to a 13-months and 17 days old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The registered nurse reported that the patient, on 03-JUL-2017, received PROQUAD (Lot # M034692, expiration date 24-JAN-2018) (Dose, route of administration and site of administration were not reported) and inadvertently received PROQUAD (Lot # M034692, expiration date 24-JAN-2018) on 10-JUL-2017. Both, PROQUAD that were given came from same Lot. Both, PROQUAD were reconstituted with MERCK STERILE DILUENT (Lot number M026303 (as reported) with expiration date of 11-MAR-2017). No adverse effects reported. No further information provided. Additional information has been requested.
Warm feeling throughout body, heart race last 10secs; Warm feeling throughout body, heart race last 10secs; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). This 48-year-old female patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for immunisation. Relevant medical history included allergy to mold and to ragweed. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from 2020 and montelukast sodium (SINGULAIR); these medications were received by the patient within 2 weeks of vaccination. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. The patient was not pregnant at the time of vaccination. The facility where the vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. At the time of the report, the outcome of the events was unknown.
Pt. noted sore throat, scratchy feeling; roof of mouth sore.  Nose stuffy, eyes watery, need to clear throat frequently.
Asthma flare-up three days post vaccination, causing shortness of breath and a persistent cough, required treatment with Medrol dose pack
Very minor pain in right arm near injection site.  Woke up this morning feeling like I had significant indigestion and have been feeling somewhat nauseous since; I also have significant bowel discomfort but no unusual bowel movements so far.  I'm feeling very fatigued and I have a slight headache and very 'foggy' feeling.
Severe aches through whole body started at 3am along with a pain under my left armpit. By 9am there was a golf ball size lump, I'm assuming it's a lymph node. The lump is painful when I move around and makes me unable to sleep. The lump has increased a bit in size and pain has increased to just above my left breast. I have been taking Naproxen and Tylenol for discomfort. I feel flushed but so far no fever has registered.
About 3:30 pm - Began feeling weak, tired, nauseous. Approx one hour later, skin began feeling tingling and itchy. By 7:30 pm temperature was 101 degrees F, skin was red and very itchy/tingling. Skin continued to be bothered beyond 24 hours. Temp at 8:00 am 11/15 was 99 degrees F.
Severe headache  Arm soreness radiating to neck and down back Chills Fatigue
Got hives on legs, hives on arm, shoulders, back of neck, and face. Sore on face, Discoloration on face (skin turning black). Diagnosed with Proregal Nogalaris.
feeling clammy; body ache; Low grade fever 99F with headache; Low grade fever 99F with headache; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (feeling clammy), PAIN (body ache), PYREXIA (Low grade fever 99F with headache), HEADACHE (Low grade fever 99F with headache) and NAUSEA (nauseated) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced COLD SWEAT (feeling clammy), PAIN (body ache), PYREXIA (Low grade fever 99F with headache), HEADACHE (Low grade fever 99F with headache) and NAUSEA (nauseated). At the time of the report, COLD SWEAT (feeling clammy), PAIN (body ache), PYREXIA (Low grade fever 99F with headache), HEADACHE (Low grade fever 99F with headache) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient was vaccinated on 3-28-03 then left for an out of town vacation. While on vacation, she began developing chest pain on 3-31-03. She took tyenol and advil as needed due to the fact she believed she had a pulled muscle. When the intermittent pain continued upon her return, she sought medical attention on 4-03-03. She describes the pain as "tightness, pressure,squeezing". The doctor performed an examination and ekg, reviewed labs drawn on 3-26-03 and ordered an echocardiogram, Holter monitor and antibiotics (Bactrim ds b.i.d x 4d) for the UA done on 3-26.  Please note, patient is a county paramedic and stays on site at the hospital.
Left thigh swollen from knee to hip, leg warm. Treatment for evening Tylenol and Benadryl. Puncture site hard.
Vaccination happened at 0900 on a Thursday.  Felt fine all day until all of a sudden at around 7:00 that evening.  It hit me like a ton of bricks.  Felt bad all over.  Took 600mg Ibuprofen, mainly for unrelated hip pain.   Four hours later I felt very much worse with an axillary temperature of 101.  Fever continued despite further doses of Ibuprofen all day Friday.  Was nauseated.  Threw up once.  Was barely able to  get out of bed except to go to the bathroom.  Dizzy.  Extreme body aches and headache with fever all day Friday.  Still sick Saturday morning, but started feeling better.  By mid afternoon I felt great again.  It left as quickly as it came, but it was as sick as I've ever been.  Thought I had Covid but that test was negative.   Should I get the second dose?  Would it help to take Benadryl before the second dose?
Narrative:  Patient is a 74 yo male with PMH: chronic heart failure, risk of falls, cognitive impairment, thyroid enlargement, HTN, DM2, HLP, CAD, OA, COPD, gout, CKD stage 3b, neuropathy, chronic back pain, depression, paroxysmal atrial fibrillation, hx of alcohol abuse, hx of malignant tumor or urethra. Patient received Moderna vaccine on 12/31/2020 at nursing home. On 1/3/2021, he called out to nursing staff stating that "my throat is closing several times". Nurse assessed that tongue looked swollen, red. No breathing issue noted at that time. Provider ordered prednisone and diphenhydramine, which diphenhydramine was given on 1/3/2021. On 1/4/2021, progress notes showed that patient was better. It was thought that Bactrim possible was one of the contributing factors since Bactrim DS was also started on the same day (MSRA) as when pt received covid19 vaccine (Moderna). Bactrim was held since 1/3/2021 and pt reported symptom improvement. On the same day, 1/4/2021, patient was evaluated the LTC provider and patient reported sore throat, swollen tongue and mucus airway that improved with coughing. Per provider's assessment, it was possible that patient had an allergic reaction with acute oropharyngeal edema possible due to sulfa/trimethoprim or covid19 vaccine. Pt was prescribed prednisone 5 days for COPD exacerbation. On 1/5/2021, lab and CT results showed worsening of pleural effusion, concerning for hemothorax with known traumatic rib fractures several weeks ago with fall occuring at home. Patient was subsequently transferred to a local ER on 1/5/2021 @1332. On 1/8/2021, patient received PEG tube and chest tube at the local hospital. On 1/13/2021, notes stated local hospital discussed the option of hospice. On 1/15/2021, patient passed away.  Symptoms: & swollen tongue Treatment:
Several hours after the injection, I experienced fatigue.  Within a short time after that, I had a fever, chills, and moderate nausea (to the point of not being able to eat).  During the night, I got a bad headache.  The fever, chills, and fatigue continued throughout the night as well and prevented a good night?s sleep.
Pain immediately at time of injection, has continued with decreased range of motion in shoulder, new pain in R hip and R foot that patient relates to the same injection.
pt recvd vax & devel rash lasting 2-3 days on the lt arm from wrist to elbow, back of lt leg; pt also exp localized redness, edema, soreness, fever, achiness, rhinorrhea & cough lasted 1 1/2 wks;
Narrative: COVID infection following COVID vaccines series No prior COVID-19 immunization on record 11/17 COVID swab, result: detected 10/23 pt cc: coughing, wheezing, fever, fatigue exposure: unknown 11/19 clinically resolved
Local heat; Severe itching; Arm is swollen; Arm is red; Arm is tender; Low grade fever; Chills; Myalgia; Fatique; This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, pain in arm, fever, chills, myalgia, fatigue, extremities hot feeling of and pruritus. On an unknown date, the outcome of the swelling arm, erythema of extremities, pain in arm, extremities hot feeling of and pruritus were unknown and the outcome of the fever, chills, myalgia and fatigue were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, pain in arm, fever, chills, myalgia, fatigue, extremities hot feeling of and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and arm was swollen, red, and tender.  The patient had low grade fever, chills, myalgia and fatigue for 3 days.The erythema over my left arm however has increased to about 4 inches at the time of reporting. The patient had local heat with severe itching was very bothersome.
dizziness; hand is getting numb; feeling hot all over; Grabbed at chest "it feels a little tight"; This is a spontaneous report from a contactable pharmacist. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiration date was not reported), dose 2 intramuscular, administered in Arm Left on 14Jan2021 11:30 (age at vaccination 30 years) as dose 2, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1284, Expiration date was not reported), dose 1 intramuscular, administered in Arm Left on 23Dec2020 01:15 as dose 1, single for covid-19 immunisation and experienced 1155 c/o headache. The patient previously took azithromycin, ibuprofen experienced drug hypersensitivity (unknown reaction). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 14Jan2021 11:45 the patient experienced dizziness, hand is getting numb, feeling hot all over, grabbed at chest it feels a little tight. The patient visited emergency room for reported events. The patient experienced Took pt to adult urgent care in wheelchair. Patient was seen in urgent care and referred to ED at 12:50pm. The patient did not receive any treatment for reported for events. On an unspecified date in 2021, the patient had recovered from the events.  No follow up attempts are possible. No further information is expected.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-APR-2010, the patient was inoculated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-MAR-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed gabapentin and VALTREX for management of his painful condition. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
A dose of Pfizer COVID for ages 5-11 years old was given in error.  It should have been a dose for ages 12 and older.
Information has been received from a consumer concerning her 9 year old daughter with no past medical history who on 10/25/96 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 4/2/04, the patient developed a full blown case of chickenpox. The patient had hundreds of lesions. Unspecified medical attention was sought, but treatment was not required and laboratory tests were not performed. The reporter also noted that therapy with varicella virus vaccine live was discontinued. At the time of the report, the patient was much improved. It was also noted that the adverse event abated and the patient is recovering with sequelae. A product quality complaint was not involved. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with hepatitis b vaccine (manufacturer unknown) strength reported as: 2.5 mcg/0.5ml (dose, route and lot # not provided) on 07-JUN-2011, 08-AUG-2011 and on 10-OCT-2011. No adverse effects were reported. This is one of several reports received from the same patient. Additional information has been requested.
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 02-year-old male patient. On 08-MAY-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
Reaction on arm; Itchy; Red; swollen arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to Sulfa, eggs and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included VIIBRYD, quetiapine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 10:00, the patient had reaction on arm on the ninth day following the vaccine. The patient reported that it was itchy, red and swollen. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events reaction on arm, itchy, red and swollen was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.