chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body ache; started to feel real fatigued; muscle aches; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concomitant products included VITAMINS NOS and KRILL OIL for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache). On 17-Aug-2021, PAIN (body ache), FATIGUE (started to feel real fatigued), MYALGIA (muscle aches) and HEADACHE (had a headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-30.
Breakthrough case admission after three vaccines Pfizer 3/8/21 Lot# EN6206;  Pfizer 3/29/21 Lot# ER8732;  Pfizer 12/9/21 Lot# FH8027
At first, no problem.  Just minor soreness at injection site.  Around 8:00 PM that night (Monday), I started to get a slight pain in my side if I took a deep breath, like I bruised a rib, but I hadn't.  For the next two days, the pain started to increase in my side, and the pain started also moving up to my right shoulder.   Like an idiot, I just kept hoping I'd ignore it and it would go away.  After a sleepless night Wednesday, Thursday morning I went to my primary care Clinic and saw PA.  She had Doctor look at me and they immediately agreed I should go to the ER; the symptoms were those of a possible blood clot in my right lung.  At the hospital I was admitted and put on heparin and steroids.  I was given all kinds of tests and Friday morning, the pain had drastically decreased.  The VQ scan I had Friday morning showed no sign of blood clot and Doctor said it was an inflammation of the lining of my lung, most likely caused by a side effect of the Pfizer vaccine I had on Monday.  I was released and have been taking Prednizone tablets for a few days (5 day prescription). Today is Monday August 30th and I feel great!  Absolutely no pain.
Had vaccine on 1/18.  No reported fevers or change in functional status/fatigue.  Patient appeared in usual state of health.  Is ambulatory with rollator.  No prior h/o DVT.  Was found in bathroom after presumed fall on 1/27.   When attempted to lift patient become hypotensive (40-60 systolic). hypoxic (PO would not read).  Was placed on 10 L oxygen without PO reading.  Sent to ED-required 15 L nonrebreather to get PO into 90s.  Was diagnosed with large bilateral PEs.  Found to have dvt RLE.  Patient was hospitalized  4 days.  His covid test was negative.  He returned to facility without oxygen, on Eliquis.
On 03JUN2021 she came down with what seemed to be covid; Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiration date was unknown), via an unspecified route of administration on 24Apr2021 as 2ND DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient also received the first dose of bnt162b2 (Solution for injection, Lot number and Expiration date: Unknown), via an unspecified route of admiration on an unspecified date as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. It was reported that around 03Jun2021, she developed COVID-19 symptoms, which are now fading away. She explained she had a PCR (Polymerase Chain Reaction) COVID-19 test which came back negative. She said she really does not believe this result. She explained the false negative rate was not low with PCR (Polymerase Chain Reaction) tests and they are thus not reliable. She listed the following symptoms: fever, chills, diarrhea, and breathing difficulty. She specified she does not usually get fevers and never experienced chest and lung problems. She referred to her difficulty breathing as the chest and lung problems and repeated she never had such issues. She said she never even had a chest cold. She also explained that the HCPs, where she was located, are overwhelmed; and they do not assist further when you get a negative COVID-19 test. She added they refer you to the state department of health website if you have questions. She asked if an antibody test could be used to detect COVID-19. She also asked if Pfizer would not recommend her to pursue such test. The patient underwent lab tests and procedures which included Polymerase Chain Reaction test: negative on unspecified date in Jun2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
low grade fever; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional event: After receiving 3rd/booster dose patient experienced low grade fever, headache, and fatigue.Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from an office manager (also reported as healthcare worker) via a company representative refers to unknown number of patients of unknown age and gender without past vaccination records. On an unknown dates, the patients were vaccinated with more than three doses of GARDASIL (dose, lot #, expiration date were not reported). No adverse effects was reported. Additional information has been requested.
Patient went to bed not feeling well. He woke up at midnight with chills, sore throat, headache along with facial swelling.. He also says he was short of breath. Took 2 tablets BENADRYL and fell back to sleep. Woke up at 5 am with facial swelling that has decreased through the morning.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 24th of 24 patients described by the reporter.  Concomitant Medication use information was not provided.  Patient age was between 6 months to 5-years.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake  They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.  Treatment Medication use information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
This is a spontaneous report from a contactable health care professional via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced redness and swelling of the arm in which she received the vaccination on an unspecified date with outcome of unknown.
Information has been received from a physician who in December 2007 was vaccinated with a dose of PedvaxHIB. Subsequently the patient had fallen ill, had a pretty high fever, achy, couldn't get out of bed, and also had laryngitis. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Patient had long term discomfort and weakness in left arm which led to tingling in her fingers.  Continued about 6 weeks.  5 other patients had similar side effects from a small vaccine clinic with the same lot number.
A 78 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/12/02 and experienced congestive heart failure and was admitted to the hospital (unknown date). Patient was discharged on 3/7/03. Patient has a history of Chronic Ischemic Heart Disease and COPD. The Investigator assessed the event as unrelated to the study product. Follow up information received on 6/13/03: A request for patient's records has been requested from hospital. Other records requested from the primary physician. The information received from the patient's primary doctor did not include any information regarding his hospitalization. An attempt will be made to contact the patient for information. The investigator assessed the event as a possible relationship to the study product.  Follow up on 06/27/2003: "Progress notes: 03/06/2003.  2nd Echo with Doppler 1) Technically difficult study. 2) NL LV site with mild conc. LVA, with NL overall LV function, est EF is 55%. 3) LA and RA enlargment 4) Dilated RV 5) Echo dense ascending aorta may reflux atherosclerotic plaque or calcium deposits. 6) Thickened aorta leafuts with mild AI, no AS by Doppler.  NP B Cardiology: 77 year old male with PMB of HTN, CAD - S/P CABG -99, A.Fib, NHL -'91, asthma type 2 DM.  Admitted 03/05/2003 with several day history of SOB and LE edema, + ocassional wheeze.  Pulmonary consult per doctor in ER.  Patient admitted for further evaluation.  S: "I'm feeling better"; O: 97.2 - 73-20  780/75 Tele. A. Fib; W: S1, S2 irregular/irregular;Weight 232.3lbs; Resp. -bilateral crackles; Abdomen: soft/nontender; Ext: 4 edema + distal pulses; Neurological: alert and oriented x 3.  A: #1 CHF - diuresing start Diovan - on Lasix. #2 Asthma - as per pulm. #3 NL LV function with EF = 55% per Echo 03/06/2003. #4 HTN - BP stable. #5 CAD - s/p CABG '99. #6 NHL - '91. #7 Lumbar pain - as per ortho.  2nd MLI of lumbar spin to lg. spinal stenosis.  Type 2 DM - on Prandin,  Diovan 80mg po qd; Decrease Norvasc to 5 mg po qh; K-Dur 40mg po x 1 for K + 3.6; MRI of lumbar spine; Continue med. prescription.  03/07/2003: Paitent discharged to home via wheelchair with all belongings.
Fever/chills/body aches for 48 hours. Ibuprofen 600 mg twice a day. Slept alot.
Large (3-4 inch) red area around injection site.  Area is tender and warm to the touch.  Dr has prescribed an antibiotic.
First day after, 23rd, arm was pretty sore. 24th it was fine. Going in to the 25th - getting difficult to walk; joints were very rigid. Both hips and both knees and ankles -whole lower body very rigid. Muscles were really tight and tense. It felt like all muscles were engaged stiff and wouldn't relax. Joints wouldn't bend (butt on down). I couldn't walk. During the day on 25th those symptoms still persisted but could walk a little - very challenging - couldn't ambulate well and it was painful to walk. Day of 26th and symptoms could still persisted and seemed like the morning wasn't as bad but by evening it was really bad again. I didn't equate it to the vaccine because on the 24th I felt fine. 28th I tried to work but left early to go to Dr because I had trouble walking that entire shift.  Dr ran tests - Lyme Disease and CBC and SED rate and Rapid Strep test and Antistreptolycin - if any antibody in body for strep; rheutomoid factor ; TSH; C reactive protein; Uric Acid; pathology for Lyme Serology  IG/IGG; ANA with Pathology - all was C reactive proteins was elevated - Put on Prednisone Pack and that made it better until most symptoms resolved and I felt like I could move again. I ran out on a Sunday and by Monday I back to not being able to move again. Got blood drawn Wednesday (Jan 6, 2021). And they rechecked CBC, SED rate; C reactive proteins and rheumotoid factor; CCP antibodies; and they did a comprehensive metabolic panel. And those were all normal except C reactive proteins was elevated but not as much as initial test. A week later added CK test - tested for muscle breakdown and that was normal  Jan 6, 2021 - meloxicam was prescribed and that managed most of my symptoms but I can only use Tylenol with and not Ibuprofen (which doesn't work as well).    Urgent care initially went to.
polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8737/Batch was not reported), dose 1 via an unspecified route of administration, administered in arm left 03Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation and experienced muscle pain in upper right arm on 05Apr2021. The reporter stated that patient received the vaccine in left arm on 03apr2021. On 05apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse and contacted her physician. Physician ran multiple blood work, ruled out possibilities and gave me a diagnosis of PMR (polymyalgia rheumatica). Started prednisone 30 msg on 24May21 in decreasing doses. Pain was relieved and she still on the medication. The reporter stated that patient have never experienced such intense pain in her life. Physician attributed her pain to the vaccine. The event polymyalgia rheumatica assessed as serious. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. The reporter stated the events result Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of patient for the events with prednisone 30 msg started on 24May2021. The outcome of the events pain in extremity, condition aggravated was resolving and polymyalgia rheumatica was unknown.  Information about lot/batch number has been requested.
died approximately one week after receiving the Pfizer vaccine; This is a spontaneous report from a non-contactable consumer. A 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included cardiovascular disease and other conditions (could not name). The patient's concomitant medications were not reported. The patient was ill but was able to walk around on own and found pretty weak for age. It was reported that the patient died approximately one week after receiving the vaccine on an unspecified date. It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died approximately one week after receiving the Pfizer vaccine
Sore arm; Swollen Glands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 12:30 (Lot number: EL3249) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 01Jan2000 (ongoing), notes: Verbatim: Hypertension; "COPD", start date: 01Jan2000 (ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Jan2021 16:00, outcome "recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 21Jan2021 16:00, outcome "recovered", described as "Swollen Glands". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Vaccination facility information was reported. Seriousness criteria reported as not serious. The patient received second dose on 11feb2021 at 12:30 via intramuscularly in left arm with lot number EL9265 and experienced events sore arm, chills, fever, rash on trunk   No follow-up attempts are possible. No further information is expected.
Swelling to hand and cheeks. Rash to cheeks. Rash to neck.
pt recv vax 11DEC96 & 13DEC96 pt exp croup;reporter felt that the croup was not r/t varicella vax;
Soreness, "pinched nerve-like conditions", etc. Symptoms are in the shoulder and neck regions and have lasted > 1 week.
first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on Moderna COVID19 Vaccine on 02Mar2021 and  second dose on 09Apr2021) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Patient initially coughed twice after the vaccine. We had a 3 minute conversation about over the counter items and then went into her car. After a few minutes returned and said  that she was having difficulty breathing. Could not stop coughing and stated she had chest tightness. Physically the patient looked like she was in distress in the throat and chest area as well as almost wheezing. I administered an adult 0.3mg EpiPen, which the patient's throat and chest looked to relax and she looked alleviated. Stated she felt better and could breath a little bit better. Was shaking a few minutes after administrating the EpiPen and an ambulance was called to assess her.
SeveRe debilitating head pain continually (went to ER due to pain) for 3+ weeks, Discomfort on day of shot and (100/10) pain) for 1-4 hours or more a day. Peak pain at day 6 and day 20.  Pain gone now. Brain Scan / CT done Negative
Since getting the vaccine I have had 3 bouts of painful cold sores. I used to get cold sores as a child and young adult, but had not had any for many, many years.
Vaginal spotting began 2 days after vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: Rr8729) via an unspecified route of administration, administered in arm left on 13Apr2021 (at the age of 34-year-old) at dose 1, single for covid-19 immunisation. Medical history included Known allergies: Onions. Concomitant medication included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient did not have other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient has not tested for covid post vaccination. On 15Apr2021 the patient experienced vaginal spotting began 2 days after vaccination. No other medical reasoning behind the occurrence. Patient did not receive treatment for the adverse event. Outcome of the event was resolved on an unspecified date in Apr2021.  Follow-up (19Jul2021): No follow up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Pt fell face flat on her face within 5 minutes of her injection and scratched her left cheekbone. Look like she was having a seizure but she was already conscious when we flipped her over. She felt fatigue from working a night shift yesterday, and a morning shift today. She ate a couple hours before the appointment.  FS associate, monitored her for an extra 15 minutes before she walked home. I followed up with her at 4:40pm and 7:30pm on 4/22. Recommended that she report this to her PCP.
24OCT93 pt ran t105; 25OCT saw family MD w/t100 & c/o myalgia & bone pain;
From 2:00 PM until 11:30 PM my baby refused to eat. She was screaming crying non stop. No matter what position we tried holding or calming her she cried in pain. This was the first time she recieved vaccines, and the first time she had such behavior.