chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant drugs not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter did not had the lot number information, because the packaging was discarded for Humira dosing regimen.  Treatment medications were not reported.  The reporter's causality for the event of back pain for Humira (Adalimumab) was not provided.
On 11/5/99, noted swelling by angle of jaw L. Seen 11/6/99, mildly tender L parotid angle of jaw and down, midly large. Stensen's duct, irritated. No fever.
States patient c/o pain and was limping. Area where vaccines were given was swollen, firm and red.
Noticed redness, swelling and itching to injection site at 10:00 pm. Pt symptoms improved after about 4 days. Parent gave pt Ibuprofen 400mg.
Tinnitus - Started slow, got worse. Got second shot, tinitus same, maybe slightly worse
I am not sure if my symptoms are due to the vaccine or just a coincidence, but i received the shot on Feb 3 in the late afternoon and later in the evening the right side of my neck became very stiff w/some shooting pains- could not sleep in bed for next two nights because that caused the pain to increase. By Saturday, Feb 6- my neck was somewhat better- the pain has shifted to lower right side of face by ear & upper neck much less intense now and I do have a swollen lymph node on that side so it may just be a virus. (shot was on right upper arm).
This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (HR higher than normal) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. Concomitant products included Eliquis (apixaban) and carvedilol for an unknown indication. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient experienced increased heart rate (HR higher than normal). At the time of the report, increased heart rate (HR higher than normal) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
Did not sleep well; feeling very tired; headache; soreness at the injectionsite; This is a spontaneous report from a non-contactable consumer. A 64-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot number: unknown), via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 20Mar2021, the patient experienced feeling very tired, significant headache for most of the day and soreness at the injection site. The patient did not sleep well the previous night due to the headache. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of feeling very tired, significant headache, did not sleep well and soreness at the injection site was resolved on an unspecified date in 2021.   Information about lot number cannot be obtained. No further information is expected.
2 hours after booster shot I got disoriented and also chest pressure next day blurred vision lasted 2 days I took low dose aspirin that stopped the chest pressure so I did not get medical attention . I used eye drops  and they may have helped clear the blurred vision. Did get the usual pain in arm but used heat and massage to remedy that
pt recvd vax; approx 2 wks post MMR,pt presented w/ measles exanthema;
Pt developed nausea, lightheadedness, and facial tingling shortly after vaccination. BP 136/72, HR 72, SP02 98%. Pt improved with observation only. EMS services and ER evaluation were offered but pt declined. Her husband drove her home.
Narrative:  Patient developed flushing and headache following administration of second dose of pfizer covid vaccine. Patient required no intervention and was able to be to released after normal monitoring period.
Very swollen lower arm with purple/red discoloration Required antibiotics and Prednisone
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in 2015 (reported as since 29-JUN-2015), the unspecified number of patients were vaccinated with MMR II (route of administration, dose, lot# and expiration date not reported). The MMR II was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
SYMPTOMS: LEFT FACE AND LIP SWELLING, ITCHING IN EARS, HIVES AROUND SITE ON RIGHT ARM AND ABDOMEN. TREATMENT: BENADRYL 25MG IM X1 DOSE OUTCOME: FACIAL SWELLING GONE, HIVES GONE AND ITCHING GONE WITHIN 30 MINUTES OF ADMINISTRATION. NO OTHER COURSE OF TREATMENT NEEDED.
Patient was 33 week pregnant when she got the first Moderna vaccine.  At her initial obstetrical visit 10/2020 she had HIV serology that was negative.  Prior to this pregnancy she had HIV serology checked several times before at routine annual visits which were all negative.  Between her first and second dose of Moderna vaccines she had HIV serology checked on 4/22/2021 as part of routine prenatal care.  Her result came back HIV 1 Ab negative and HIV 2 Ab Indeterminate with reflex HIV 1 Qualitative negative.  Repeat of this lab on 4/29/2021 revealed the exact same result.  On 5/3/2021 she had HIV 2 QPCR drawn at a Lap facility and it ultimately came back negative.  She doesn't have HIV and I do not believe is seroconverting in pregnancy.  Her husband was not tested.  Her infant was a male born via repeat schedule cesarean weighing 8lbs 4oz with no complications.   During the pregnancy the patient had gestational diabetes that was diet controlled but otherwise it was uncomplicated.  The baby was not tested for HIV in the hospital records.
Patient received first dose of COVID vaccination.  Woke up 4 days after with eye redness and swelling.
The patient was prescribed to take 1 dose of PPSV23 a year later, but skipped PPSV23; This spontaneous report was received from a consumer regarding a female patient of unknown age. The patient's concurrent condition and concomitant medications were not reported. The patient's historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). On an unknown date, the patient was prescribed to take 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) a year later (date reported as December 2017) after receiving dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in December 2016, but the patient skipped pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Inappropriate schedule of product administration).
Given injection on 7/5/2013 pt returned home after injection began to feel hives, pt states she felt swelling itching of eyes, swelling of mouth. Pt states she had trouble breathing. Pt also states migraines rash past 3 days. Pt called 7/6/2013 advised to cont BENADRYL. Pt states she went to ER left at time and tried BENADRYL.
Patient told pharmacist she felt dizzy and wanted to faint with past immunizations. Patient given flu and booster for Pfizer. Patient chatted with the pharmacist in the immunization room. Patient told the pharmacist she felt ok. She was told to wait in the post vaccine waiting area.  While waiting in the waiting area patient fainted from the chair and fell to the floor.
A female, now 72 years of age, reported that she received an injection of 1992-93 formula influenza virus vaccine (manufacturer unknown) and subsequently, developed a "bad" generalized rash. The rash was dx'd as an allergic reaction. The pt recovered.
High fever on Sat. Hive for now two days. Treatment Benadryl.
Shortly after receiving MMR, the pt had immediate hives over the area of the injection. These then spread to the opposite area and back. He was given 25mg of Benadryl po. On day 2, he had increasing redness/swelling. Rx'd with Prednisone 20mg BID with good recovery.
MD reports husband was immunized 1FEB95 & w/in 2hrs p/vax pt exp localized myalgia/arthralgia (immunized arm) & gen malaise lasting a few days;myalgia resolved spontaneously arthralgia persists but dec in intensity;no fever or induration
By July I had a major dip in Thyroid levels that had otherwise been steady for years.  I also started getting uncontrollable nerve impulses in my legs that progressed into muscle heaviness and floatiness.  My arms tend to get numb when bent at all which never happened before and I also have to go to the bathroom more at night to urinate (can't make it through the night at all. I have constant muscle aches and extremely low blood pressure (86/60) most recently.
Fever - seizures - 5-20 minutes of seizures - VALIUM 2 milligrams given - tachypneic spell 5-10 seconds recovered without ventilation.  6/12/09 Hospital records and DC summary received DOS 5/19/09 to 5/20/09. FINAL DIAGNOSIS: Febrile seizures, fever. Post vaccination fever and fussiness. Eyes rolled back, contraction of extremities and shaking. Patient was seizing when first seen.  Ativan adminstered which caused respiratory depression, tachypnea. Mechanical ventilation.
Took SHINGRIX #1 Injection on 09/30/2018. Broke out with shingles 10/7/2018 on Left ant neck and face. Also, across ABD bilat.
Peripheral neuropathy; Neuropathic pain; Body ache; Stabbing pain in extremities (arm to fingertip) (knee to toe); Weakness; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Intervertebral disc protrusion. Concomitant products included FENTANYL for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) (seriousness criterion medically significant), NEURALGIA (Neuropathic pain), PAIN (Body ache), PAIN IN EXTREMITY (Stabbing pain in extremities (arm to fingertip) (knee to toe)) and ASTHENIA (Weakness). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy), NEURALGIA (Neuropathic pain), PAIN (Body ache), PAIN IN EXTREMITY (Stabbing pain in extremities (arm to fingertip) (knee to toe)) and ASTHENIA (Weakness) outcome was unknown.            Concomitant product included oxy immediate release (5mg 3 times daily). Treatment medication included Chronic opioid medications.  Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded.  Further information has been requested.  The neuropathic pain, peripheral neuropathy(exacerbation) and pain in extremities are possibly descriptions of the same event.; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded.  Further information has been requested.  The neuropathic pain, peripheral neuropathy(exacerbation) and pain in extremities are possibly descriptions of the same event.
I had my second vaccine today at 1:30PM at Publix store in Windermere FL. I suspect the nurse pharmacist shot the vaccine in the "fat of my arm" rather than the muscle 200% different from first shot. I now have serious nausea, 7 hours and going. I never had nausea for the first shot. Please help should I request another shot? Rose Killy
arm feels worse; Redness/armpit is red; Swelling; arm became red around injection site/upper arm was red; itchy; Settling in armpit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red) and PRURITUS (itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills) outcome was unknown.        No concomitant medications were reported. Ice were reported as treatment medication.
After vaccination, patient's arm had a small knot at injection site. The knot turned into a small, red rash. The red rash is now a pinkish color and is approximately the size of a softball (5.5 inches by 3 inches).
Ongoing fatigue, sore throat, nausea, headache, muscle pain that were triggered by the vaccine and continue to linger 2.5 weeks after vaccine. Muscle pain, headache and nausea have abated on day 18, but fatigue and sore throat persist.  The side effects are not dangerous, but they are lingering much longer than indicated.
Pt developed a marked swelling and wheal (10cm circle), warm to touch and a noticeable limp.
Within minutes of receiving the vaccine, I felt a heavy wave of exhaustion.  I became sweaty and very thirsty.  My brain felt un-focused.  The pharmacist brought me a bottle of water.  I drank it, and left about 15 minutes later with my husband.  When I got home, I developed a headache that began with tight muscles at the top of my neck.  The head-ache got worse and worse.  All my muscles began to feel very tight -- spasm like.  My brain could not focus well.  My heart felt like it was struggling to make the next beat.   I had chills.    I woke up the next morning feeling even worse.  My muscles were so tense.   My heart felt effected, like it could barely make the next beat.  My muscles didn't seem to function well.  Walking took extra effort.  Using my hands and arms took extra effort.    By now the swelling and pain in my arm at the injection site was huge.  This was way worse than anything I experienced with the first two Pfizer shots.    The head-ache and tight muscles lasted 3 days.  By the second day, my arm was so swollen and painful, I couldn't lift it.  The swelling had a diameter of about 7 inches, and it was raised almost an inch at the center where the needle had gone in.    I began to apply cold packs to the sore, swollen arm, and tried to massage it around the edges where it wasn't too painful to touch.  I continued to do cold packs a couple times a day, and to massage.  By day 4 and 5, I could lift the arm, and began to work the muscle a little to see if it would help to reduce the swelling.  It is one week today since the vaccine, and my arm is almost completely back to normal.  There remains just a small amount of swelling, no pain.
Father ran in approximately 10 min. after vaccine administered saying she could not breathe. I found patient to be pale, sweating, and complaining of ear pain also. 911 was called and I administered one EPIPEN.
Have had atopic disease since I was age one. Currently have occasional Eczema outbreaks.  After the second shot, my Eczema turned into a  month outbreak of raw, weeping patches under my breasts, in my groin area and patches on my torso. It was extremely painful. I could not wear underwear or bras for much of that time. It is now healing; It was weeping so badly, all I could do is not irritate it further and try to keep it clean and dry. Cortisone creams were useless and I did not at the time think of seeing a doctor or taking a short dose or oral prednisone. This was the worst outbreak I have ever had.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. It was reported Acute illness at the time of vaccination and up to one month before and Chronic or long-standing health conditions were none. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of adverse event were none. Other vaccine given on the same day as that of Moderna vaccine was unknown. Other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine was unknown. On 19-Mar-2022 at 11:37 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milligram. On 19-Mar-2022 at 11:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. A patient was administered vaccine past its 30 days expiry date vaccine went into 2 to 8 Celsius thaw state on or about to 24-Dec-2021, this vaccine administered was until its manufacturing (Mfg.) expiration date of 04-Apr-2022. No treatment medication information provided. This case was linked to MOD-2022-542869 (Patient Link).
experienced a headache across the forehead that became often/experienced pain from forehead down to her temple; This is a spontaneous report received from a contactable consumer (Patient herself) via Pfizer sponsored program.   A female patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccine patient experienced a headache across the forehead that became often. Afterwards, she had the second dose and experienced the same. She had pain from forehead down to her temple. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
15May90 pt vax; day later exp pain, swelling, & tenderness at inject site.
Site of injection became purple, and very swollen and red..increased as day went on to 4 inches wide to 12 inches long. Very sore and arm fever went in to see doctor.
coughing; diarrhea; headaches; weak/no energy; no taste; chilling; Neither of us felt very well; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 17:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient Medical history included hypertension, inflammation and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included (VERAPAMIL) taken for hypertension, (PROBENECID) taken for an unspecified indication, start and stop date were not reported; (MELOXICAM) taken for inflammation. The patient concomitant medication also included several meds for high BP and medication for cholesterol. On 10Feb2021, the patient did not feel very well on the day he took the shot. On 11Feb2021, the patient had been coughing, was weak, no taste, chilling, diarrhea, no energy and headaches. The patient had no fever. The patient was not hungry but food was tasteless. The patient did not receive any treatment for the adverse events. The clinical outcome of events was not recovered.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171112 Same drug/ reporter, different patient/ AE
Three days after vaccine administered patient states she has hives on some parts of her body. Hypersensitivity reaction, slight itching.
Nausea, vomiting, achiness, dehydration, diarrhea, headache.
Localized reaction in (L) arm - 5 cm erythema with pain - disappeared in 24 hrs. Would not consider this adverse event, pt requested report.
extreme dizziness, nauseous, diarrhea for three days;bedridden for 48hr;uncontrollable diarrhea & stomach cramps, 101 fever;
24 hours post vax, he experienced headache (which lasted 10 days), fever, injection site pain (which lasted 2 days). No treatment was given. These symptoms resolved. On 6/15/99, the pt developed blurry vision. The pt's blurry vision is a bit better but is ongoing. He has been referred to a physician for an eye exam.
Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that she took Motrin for this and is not sure if this is helping.