chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, muscle aches, stiff neck, chills,swelling and redness at injection site, lost use of arm.
Only to right deltoid (where pneumococcal vaccine as injected). Patient stated that the night of the vaccine his arm hurt badly and could not lay on that arm. The next day the whole upper arm was swollen red and hot to touch
Hip discomfort after receiving Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    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 MUSCULOSKELETAL DISCOMFORT (Hip discomfort after receiving Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MUSCULOSKELETAL DISCOMFORT (Hip discomfort after receiving Moderna vaccine). The patient was treated with DENOSUMAB (PROLIA) for Osteoporosis, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Hip discomfort after receiving Moderna vaccine) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Other treatment given included Steroid pack.   This case was linked to MOD-2021-095168, MOD-2021-095133 (Patient Link).   Reporter did not allow further contact
Patient came in to clinical 1/11/07 for a flu shot and a pneumonia vaccine.  Pneumonia vax given in left deltoid.  4-5 hours after vax given, left arm began to swell and turn red. Arm painful from site to elbow.  Symptoms lasted 4-5 days.
Shivers, nausea, congestion, rash/swelling on right arm below injection site, aches, headache, nervous heart beat.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In March 2018, 30 min after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad. On an unknown date, the patient experienced extensive swelling of vaccinated limb and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb and incomplete course of vaccination were unknown and the outcome of the pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad to be related to SHINGRIX. Additional details were provided as follows: Within 30 minutes after getting the dose of SHINGRIX vaccine, the patient's arm started swelling and turning red and it was very painful. Her arm was eventually swollen from her shoulder to her elbow and hurt so much that she could not use it. That evening the patient also started feeling feverish, weak, and dizzy and had bad joint pains. The patient stayed in bed for 3 to 4 days after getting the dose of SHINGRIX vaccine because she felt so bad. After 4 to 5 days, the patient felt better, except for her arm was still red swollen and painful. It took at least 10 days for the redness and swelling to resolve and the pain lasted for weeks. The patient had not gotten the 2nd dose and was not sure she ever would, which led to incomplete course of vaccination. The patient had denied permission to contact their physician.
Per Mother, about 8 hrs. after injections pt's eyes swelled shut and started to wheeze. Denied difficulty swallowing. Mom called on call. Advised BENADRYL and VENTOLIN inhaler-ER if worsening. Mom continued treatment for 48 hrs and symptoms resolved.
Per pt, he had pain right after injection and next day it became swollen and redness under the skin. The swelling eventually went down and redness faded but he still has pain on the arm. Pt then went to the doctor on Thursday 11/21/19 and MD ordered a MRI for pt.
Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.; No adverse event; Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.), EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.), EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) 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 assessments were provided for PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) and EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.).    No relevant concomitant medications were reported. No treatment medication reported.
received 2 injections in one day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (received 2 injections in one day) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and UNK) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (received 2 injections in one day). On 30-Mar-2021, ACCIDENTAL OVERDOSE (received 2 injections in one day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medication was available.  No Treatment Medication was available.
This is a spontaneous report from a program from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 12:00 (Batch/Lot Number: EW0181) (at the age of 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included complex regional pain syndrome from 1985 to an unknown date (Nerve reflection dystrophy bilateral hands and arms), milk allergy from an unknown date and unknown if ongoing, weight increased from an unknown date and unknown if ongoing, allergy reactions for decades and knows to what to do, mold allergy for decades, urticaria from an unknown date and unknown if ongoing (Initially she had to delay getting the vaccine because she was having hives). There were no concomitant medications. The patient previously took varicella zoster vaccine for immunization on 2021 (Ten weeks prior she had shingles vaccine). Patient stated that she experienced the same allergic reaction within 3 to 4 hours after both doses of the vaccine, initially sinus pressure, head ache that eventually involved entire head, neck, and shoulders, nausea, and congestion that resulted in a really thick heavy mucus when able to clear my sinuses. Within 4 hours of getting the first dose patient had a headache across her sinuses and over her head around the back. This lasted for 2.5 - 3 days. She had neck and shoulder pain and nausea. Described all of this as a heavy ache. Usually all of her reactions are about that long. That tells her there is a lot of mold in the vaccine (as reported). Patient took pain and other medications. Patient added with both doses she had sinus pressure and thick mucus formation. She hasn't had this in a long time. She had an onset of sinus pain. She has had a recurring headache since then. Her neighbor flooded the bathroom floor. Patient feels that there was mold between the flooring. She thinks she was currently being exposed to mold. She developed a bad headache in her forehead that went to the back and sides. This lasted for 2.5 days. She still has a headache but cannot rule out if it is related or not. She also had nausea after the second dose. Patient stated the symptoms took 4 days to resolve after the first dose and 3 to 3.5 days to resolve after the second dose. Patient stated this reaction mimics a classic reaction to mold. Patient stated she has had a mold allergy for decades. Patient stated, It has been years since I have been this sick with an allergic reaction. Patient suspects there may either be a mold component to the vaccine or that the vaccine was stored improperly resulting in microbial growth in the vial. Initially patient had to delay getting the vaccine because she was having hives. She received the second dose on 06Aug2021. It was given in her right arm. Lot: EW0181. The outcome of events was recovered.
Headache, Arthralgia, UrticariaPruritus, Chills, site with erythema at the site. Symptoms persisted for 3 daysf Narrative:
24 hours after receiving the injection the patient complained of numbness in her left arm - the pain radiated to shoulder-the area did ha a local reaction area was red and swollen. She also complained of numbness and tingling in her fingertips.
Swelling of arm, redness of area about 4" x 3", no fever.  Symptoms went away in one week.  Antibiotics for one week.
Few hours post vaccine muscle pain, red splotches under arm, low grade fever.  48 hours post vaccine band of red splotches encircling arm.  Fever spiked 102 degrees 24 hours post vaccine.  Lack of mobility in shoulder for 48 hours.
1-2 hours after receiving flu shot my entire arm became very sore. I didn't know where to put my arm it hurt so bad. Pain subsided later that nite however my upper arm still hurts at times especially when I try to pull on a shirt etc or extend my arm any length.
Both of his hands itched like crazy; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Both of his hands itched like crazy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (Both of his hands itched like crazy). At the time of the report, PRURITUS (Both of his hands itched like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment for the events included a steroid shot, steroid dose pack, steroid cream, and antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received contains non-significant information of updated Email.
admitted to hospital with SOB, N/V; hypoxic; positive for COVID; septic shock, AHRF, AKI, hyperkalemia; given Decadron; intubated with mechanical ventilation; pt's condition worsened; transitioned to comfort care; pt expired in the hospital
Patient reports abnormal chest pain, weird "poking" feeling in heart, and abnormal thigh pain after receiving vaccine. She is still feeling a bit of chest pain but the worst was Monday following the vaccine administration. She has not gone to the ER but was advised to go if she experience any severe pain or difficulty breathing, and was also advised to reach out to her doctor prior to next dose.
FEVER ONSET  9/1 at 9PM,CHILLS, THROAT PAIN, VOMITING TODAY  9/2. General Malaise.
Every afternoon from 2-3pm since administration has experienced dizziness like having gone on a merry-go-round and it just stops after no longer than 30 minutes. Today 4/14/2021 she experienced a fever of 101F and arms and legs began tingling and went away around 3:30pm, still has a fever as of 05:30pm. Took temperature again and has been fluctuating between 98-99.  Arm was sore for 4 days.  Patient has not tried any medications.
Approx 4 hours after injection patient experienced redness and a hard area about the size of a fist. Swelling from injection site to wrist. Warm to the touch and very painful. Took Advil and cold compresses. 5 days later no symptoms.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received FLUARIX QUADRIVALENT. On 20th October 2016, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injected limb mobility decreased, pain in arm, nocturnal awakening and tingling of extremity. On an unknown date, the outcome of the injection site pain, injected limb mobility, pain in arm, nocturnal awakening and tingling of extremity were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, pain in arm, nocturnal awakening, and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not reported previously to anyone. The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT on an arm. The patient experienced pain at the injection site for a couple of days, and for the last couple of weeks from the date of reporting she experienced pain in her arm starting at her shoulder and extending down in to her elbow. Sometimes the pain also tingle down in to her thumb. It was difficult for her to raise her arm. On more than one occasion, the pain had caused her to wake up during the night. Field representative was unable to provide any additional details.
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
Information has been received from a Registered Pharmacist (R.Ph.) concerning a 68 year old male patient with none pertinent medical history and none drug reactions who on 23-DEC-2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30-AUG-2012). There was no concomitant medication. On 05-JAN-2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Additional information has been requested.
VACCINE WAS ADMINSTERED WITHOUT CORRECT VERIFCATION OF PREVIOUS DOSES.  IT WAS DISCOVERED ON 6/26/2023 WHEN PATIENT WAS TO RECIEVE ANOTHER DOSE THAT SHE HAD  RECEIVED 2 DOSES AT PHARMACY ON 07/22/19 AND 09/20/19.  UPON FURTHER REVIEW THERE WERE ALSO 2 OTHER INVALID VACCINES RECIEVED AT A MEDICAL CLINIC ON 8/1/2019 AND 10/1/2019.    PATIENT WAS INFORMED AND NO OTHER DOSES ADMINISTERED.  NO ADVERSE AFFECTS REPORTED.
After thorough investigation found that patient received 0.3cc of air with no vaccine. Patient's mother notified right away. She will be bringing patient back on Tuesday 5/25/2021 for re-vaccination.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 4-year-old male patient who received KINRIX (batch number 4R7NR, expiry date unknown) for prophylaxis. Previously administered products included FLULAVAL (received one year ago and experienced fever, injection site rash (please refer case US2018171870)). On 12th September 2018, the patient received KINRIX. In September 2018, less than 2 weeks after receiving KINRIX, the patient experienced injection site rash, watering eyes, fever and injection site pain. In September 2018, the outcome of the injection site rash, watering eyes, fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site rash, watering eyes, fever and injection site pain to be related to KINRIX. Additional details were reported as follows: This case was reported by the patient's mother. This case was already reported to physician. The patient experienced fever with 102 degree F, watery eyes, and had a reaction on his arm at the injection site. The reporter called it as rash `and said it was all around the injection site which was big and painful and worse and bigger than the last one after flu vaccine.
Patient given Pfizer vaccine for 6 mos to 4 yrs. Should have been given Pfizer Pediatric 5-11 years.
Patient experienced shortness of breath with ineffective breathing.  A blood pressure reading was 220/90, HR 95.  RR over 20.  There was no stridor or wheezing, but short, ineffective breaths.  The patient did NOT lose consciousness.
On July 24, 2022, in the afternoon, he developed fatigue, discomfort, body aches, continued to have pain in his arm, a fever of 102.7 and fell asleep around 6:00 PM, woke up at 10:30 PM, still with fever.  I gave him ibuprofen.  The next morning, he seemed fine so I took him to camp. The camp called me that afternoon and said he wasn't feeling well.  His temp was 101 by the time I picked him up.  COVID-19 test was negative, temperature went up to 103.  He started to become puffy and had discoloration under his eyes, had backache pain and was resistant to fluids.  Continued to administer ibuprofen, temperature would rise again to 103 each time.  His backache pain became more severe. This ibuprofen cycle still is continuing.  This morning 07-27-2022, the fever was as high as 103.5. Yesterday, we went to the doctor. She administered several tests (Flu, COVID-19, RSV- all negative) and said to contact if this continues 7 days. He has never had fevers this high.
Injection site reaction 3 inches -dry skin itch - little prickly rash on face -fever like symptoms.
barely had a sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (The patient was diagnosed with RA 4 years ago). Concomitant products included etanercept (Enbrel) and methotrexate.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JUL-2022 Reporter's Comments: This case was reported by the patient. The patient received first dose of Shingrix in February and barely had a sore arm. The reporter gave consent to follow up. For second dose refer case US2022AMR109364; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR109364:Same reporter US-GLAXOSMITHKLINE-US2022AMR109365:Same reporter US-GLAXOSMITHKLINE-US2022AMR109366:Same reporter
Admitted on 8/4/21 for Bilateral COVID Pnemonia superimposed with aspiration pneumonia
Patient developed shingles after vaccination. 9/7 vaccination around 2pm 9/8 around 5pm patient started to get a tingling feeling. 9/9-9/10 sores started to develop. 9/12 patient say family doctor and was prescribed medication (valacyclovir & prednisone taper). 9/16 sores have crusted over.
Patient reported on 10/3/18 that she had severe swelling and soreness and that as of today (10/3) the swelling has finally resolved but she now has a knot.
This spontaneous report was received from a licensed nurse practitioner and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning a 13 year old male patient who on 14-FEB-2013 was vaccinated with the first dose of GARDASIL lot # H020910 expiration date 18-JUN-2015. No other co-suspect or concomitant medications were reported. The physician reported that on 14-FEB-2013, the patient broke out in hives after receiving his first dose of GARDASIL. The patient was given BENDARYL as treatment for the event. On an unknown date, the patient had recovered from the event and the physician stated that he would not be completing the series of GARDASIL. Additional information is not expected.
pt recvd vax 18MAR94 & pt stated t102; seen by ER c/o malaise 1APR93 called c/o rash white spots in mouth, temp elevated, photophobia;
pt recvd vax & became hyperactive;4hrs p/vax devel a dry, non-productive cough;cough persisted & pt began gagging to the point of vomiting;pt was extremely irritable & was not sleeping at all;pt using a breathing apparatus @ home
Incident occurred about 1130.  Flu shot given in left deltoid. Slight muscle spasm upon needle entry. Jumped and I asked if it hurt or the muscle twitch just made her jump.  She replied the muscle twitch.  About ten seconds later she began to slump over to the side in the chair and appeared to pass out.  Attempted to rouse her and placed ice pack behind her neck.  She came to a bit and opened her eyes then appeared to pass back out again.  This happened several times before ED team arrived.  Eyelids, arms and legs appeared to intermittently twitch.   Only allergies noted are PCN and sulfa.  She has had a flu shot every year (fluarix NOT egg free) since 2017 per our records.  Before being placed on stretcher c/o feeling dizzy.