chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, NauseaVomiting, "Lump" at site of injection, night sweats Narrative:
Headache, muscle ache, chills (shivering), extreme soreness at injection site
Initially, I felt fatigued and my left deltoid was sore. On day three after vaccination, I had one episode of hematuria. On day 4, I developed a fever and chills. On day 5, I developed dysuria, urinary frequency, urgency and hesitancy. I have also had some low back pain and purulent urine. I have never had any urinary or prostate issues in the past and have regular annual physical exams. I am an emergency physician and had to work, so I started myself on Bactrim DS (I am avoiding floroquinolones due to numerous black box warnings). I have had several other episodes of hematuria during my treatment. I am on day 13 of Bactrim and my symptoms are improving. I am not sure if this is a coincidence, but I have never had any similar issues and thought this should be reported.
Information has been received from a RN concerning a 20 year old pt who on 11/19/03, "three days ago" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The pt complained of redness, pain and swelling of arm at injection site that was "getting worse". Treatment included application of hydrocortisone cream and antihistamines and there was no change in symptoms. It was noted that reporter placed the call on hold when asked for specific information and then disconnected the call.  No further information is expected.
Fever, Headache, aches, chills, muscle aches, fatigue, sore arm, joint pain.  Lasted 3 days.
Profound numbness of face, tongue, extremities.  Feeling of fullness/swelling in upper chest and throat. Symptoms lasted 12 hours. No rash.  No shortness of breath, nor wheezing.
SORE ARM; CHILLS; FATIGUE; NAUSEA; FEVER; TOTAL BODY MUSCLE ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) UNKNOWN. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced total body muscle aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, fever, and total body muscle aches on 10-APR-2021, and had not recovered from fatigue, and sore arm. This report was non-serious.
Daily headaches began after I got the Booster.  I do get headaches sometimes but these have been different.  I've been extremely sick with my Long Covid (which I forgot to list above) the last several days and am not sure that I've had the headaches the last several days. But I definitely had daily headaches due to the Booster since I got the Booster. Also, it may have been my fault. The questionnaire asked if I'd had any headaches in the last 2 weeks and I answerd "no", but in fact, I did have a very severe headache 1 week prior to the date of the shot. I had forgotten when I answered the questionaire. I"ve had Long Covid for over 2.5 years and it's greatly affected my memory and cognitive processes, along with increasing the pain from my pelvic pain syndrome, and causing such extreme chronic fatigue that I have been essentially bedridden from it, only leaving the house for non-elective medical appts;  so I haven't seen a dentist, etc or had any preventive tests such as mammograms since I got the Long Covid.  Also, the Long Covid caused terrible migraines several days a week until I got the first Moderna vaccine, which unfortunately was not available when I got Covid in May 2020. The vaccine cured the frequent migrainges, thank goodness, but it didn't help the other Long Covid symptoms. I also want to report that when I had Covid, my symptoms were fever and horrid abdomnal pain -- it attacked my pre-existing pelvic pain syndrome which put me on disability 14 years ago as it never responded to any treatments. I didnt' have any respiratory or other more common Covid symptoms. I think this is notable b/c right now a friend of mine has Covid and she's having the same issue I did --- it's attacking the part of her head and eye which have caused her horrific pain for many months, but she also isn't having any respiratory or other more common issues. So, maybe this info is important to help figure out Covid. Also, when I got the Bivalent Booster at Pharmacy last month, I had to acknowledge receiving info pages about the vaccine, but I never received any. I commented to the pharmacist who was giving me the shot about this, but he still put the device in front of me for me to sign that I received the info.
moderate urticaria inboth underarms and crotch area from navel to perineum. Lasted 2 weeks treated with benadryl tabs 300mg per day and eucerin cream to ally serious itching.
shortness of breath, cough, fever, nausea, congestion, soar throat.
At 7am started to get a migraine  felt nausea threw up  took a hot shower drank 7up and eating crackers
Neck sharp, debilitating pain right side Jaw pain right side Shoulder pain right side Memory loss
c/o worseing cough and SOB after a recent diagnosis of Covid 19, already rec'd monoclonal antibody therapy; CT: left greater than right lower lung consolidations which may be atelectasis/pneumonia; Labs: D-dimer 1.31 Tx: Decadron, Vit C, Doxycycline, Lovenox, Levaquin, zinc; O2 @ 3 LPM; discharged with home O2
Within 5 minutes after first dose administration, patient experienced a numb tongue, tingling lips, an increase of mucus/secretions in throat, nose, and ears.
Began with aching muscles/joints on one side of body (opposite side of vaccination site).  Progressed to entire body.  Very painful to move;  intense muscle weakness.  Tingling in fingertips at times.
administered an Expired Engerix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 22nd September 2022, the patient received Engerix B. On 22nd September 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: The registered nurse reported that a dose of Engerix B given today (on the day of reporting) to the patient and it was already expired. The reporter reported that the patient came in for a Engerix booster dose for school due to testing. The reporter inquired how to proceed.  The reporter did not consent to follow up. Additional Supportive Information: The use of Engerix B dose, which was already expired on 21st September 2022, which led to expired vaccine used.
He was diagnosed with multiple blood clots in his lungs/ clots may have appeared in his leg and went to his lung; bed ridden; pain in left side; This is a spontaneous report from a contactable consumer (the patient).  A 70 year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE)), via an unspecified route of administration on 06Feb2021 (Lot number: UNKNOWN) as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Historical vaccination included BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Jan2021 (Lot number: UNKNOWN) as a single dose  for COVID-19 vaccination. The patient reported that he received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 16Jan2021.  On 06Feb2021 he received the second dose of the vaccine. Twelve days later he was diagnosed with multiple blood clots in his lungs, and from "15Feb2021 to 16Feb2021" he was hospitalized. He was prescribed to take Eliquis (Apixaban) a blood thinner, at 5 mg tablets for 6 months.  He also reported that during that period (first part of Jan and part of Feb) he was bedridden because he had a lot of pain in his left side and it would not let him get out of bed, so he was on bed for a while. His primary care doctor told him that the clots may have appeared in his leg and went to his lung. The patient would like to know if any participant developed blood clots during the clinical trials of the vaccine. The clinical outcome of the events was unknown.   Information on the lot number has been requested.
ery sleepy after receiving the vaccine.; redness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness in the injection arm) and SOMNOLENCE (ery sleepy after receiving the vaccine.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness in the injection arm). On an unknown date, the patient experienced SOMNOLENCE (ery sleepy after receiving the vaccine.). At the time of the report, INJECTION SITE ERYTHEMA (redness in the injection arm) and SOMNOLENCE (ery sleepy after receiving the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were taken. No treatment drugs were taken.   Reporter did not allow further contact
pt recv vax @ noon & moments p/vax pt became faint & diaphoretic;pt was helped to floor by RN;pt exp urinary incontinence, loss of consciousness for 15-30sec;cried on regaining consciousness & asked why she was wet;had circumoral cyanosis;
Immediately after vaccine administration patient stated that "Oh that hurt."  Slumped down to the left, I caught him and he flung his trunk back hitting his head on the left side of the exam bed. He was stiff and hands were stiff and jerking. I called for help and RN, came in immediately. She put a wet washcloth on head while I concentrated on keeping his body on the exam bed. The whole event probably lasted 45 seconds. Patient came to and denied feeling bad. Denied nausea, headache, or feeling ill in any way. Reports he did not eat any breakfast prior to coming to the health department, was given a sucker. Noted to be pale. Sat on exam bed for approximately 10 minutes. Reported that he was "feeling fine." Walked to the waiting room with his mother, sat for another 5 minutes. Reported he was still feeling fine prior to leaving. Denies any recollection of event.
I gave the dose of the vaccine and it was not diluted 0.2 mL Pfizer
No additional AE reported; Medical assistant reports patient was accidently administered an expired dose of VAQTA on Jan 19, 2023. Product expired on Jan 14, 2023. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC r; This spontaneous report was received from medical assistant and refers to an unknown age and gender patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions allergies, and concomitant therapies were not reported.  On 19-JAN-2023, the patient was accidently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, lot #U021561, expiration date: 14-JAN-2023, administered intramuscularly (strength, dose and indication were not provided) (expired product administered). It was mentioned that the product had no prior temperature excursions. No additional adverse event was reported.
Nausea, vomiting, dizziness, pale color, low heart rate and blood pressure  Tx: cold packs, laying pt down
Pancreatitis, lipase 9,800 on 6-12-11 abdominal pain, vomiting.
Per ER report: "Parents respond child has been like a "floopy doll" and unable to support her body weight when sitting up. Emesis X2 this afternoon, pupils were noted to be pin point. Has maintained low-grade fever (T 100R).         CT head w/o contrast (negative), basic metabolic panel
Moderna shot 2/10/21.   2/16/21 left arm injection site got large welt, rash left arm and ankle.  OTC benadryl and hydrocortisol 2% cream.  By 2/22/21 rash eventually spread to whole body. Burning and itching.  Bright red skin on forearms.  Attacks of flush face, bright red body, intense burning of skin 2 or 3 time per day for three weeks.  Vertigo. Hard swollen stomache. Sore swollen lymph nodes.  Fatigue, fog. 2/23/21: Treated with Prednisone 60 mg/day for 2 days, 40 mg/day for 3 days. 3/09/21 Hyroxyzine HCL 20 mg 4 x day for 1 weeks plus zyrtec at night, 2xday for 1more wk, currently 1x/day plus zyrtec at night. 3/11/21. Clobetasol Prop 0.05% Oint 60 mg 2 x day to areas for two weeks to date.  Improving to date.
I went out with my son, who just had 1 shot of his vaccine (he didn't say which one he got)...all got covid; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unspecified date, the patient experienced i went out with my son, who just had 1 shot of his vaccine (he didn't say which one he got). all got covid. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Aug2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
General arm soreness within a few hours after vaccine. Progressed to a painful small bump requiring use of acetaminophen for pain relief. By Saturday evening 11/13/21 the injection set was red and swollen about the size of a quarter. By Sunday 11/14/21 if was the size of a half dollar. On Monday site was less painful but still red and became itchy.
I received the vaccine on 1/5 at 10AM and 5PM I developed a few hives in my arms that were itchy. Around 8PM I have a few large welts on my torso. I took 50mg of Benadryl and the rash went away. I didn?t take Benadryl the evening of 1/6 so by 1/7 my entire upper torso and neck had welts. 1/8 I decided not to take Benadryl and through the day I noticed my body becoming or irritated and gradually hives/welt beg sun to appear on my upper torso and upper arms.
Dry nose and throat; Dry nose and throat; Weepy eyes, a lot of tears, water coming from her eyes; Fever; Cough; Cold-like symptoms; Body pain; inflammation under her armpit; Pain under her armpit; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 12May2021 (at the age of 42-years-old ) at 1ST DOSE, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had dry nose and throat; weepy eyes, a lot of tears, water coming from her eyes and had fever; a lot of coughing; cold-like symptoms; body pain; felt inflammation and pain under her armpit in May2021 after the first dose. She mentioned that because of symptoms she could not go to work for 2 days i.e. 13May2021 and 14May2021. The events were reported as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st dose: skin rash and itchiness on arms presenting the day after injection was received. Duration: 3 days. No treatment needed; 2nd dose: skin rash and itchiness across arms, shoulders, face, neck and back presenting morning after injection. Duration: 9 days. Treatment included use of hydrocortisone cream. Steroids were recommended but turned down as patient was breastfeeding.
24 hrs follow administration had sudden onset of vomiting, mental status changes & skin flushing; sx lasted 1 1/2 hrs a/being seen in ER where was treated w/ IV steroids & DPh;
daptacel was incorrectly administered to 3 different patients ages between 11 to 12 yrs old, patients should receive an adacel instead of a daptacel with no reported adverse event; vaccine administered to 12 year old patient with no adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA190320.  This case involves a 12 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was incorrectly administered to 3 different patients ages between 11 to 12 yrs old, patients should receive diphtheria, tetanus and acellular pertussis vaccine [Adacel] instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (Menactra); HPV vaccine (HPV Vaccine); and tozinameran (Pfizer Biontech Covid-19 Vaccine), all for Immunisation.  On 15-Jun-2023, the 12 year old patient incorrectly received 0.5 mL dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: U7549AA; expiry date: 04-Nov-2024) via intramuscular route in the left arm for immunization to 3 different patients ages between 11 to 12 yrs old, patients should receive an diphtheria, tetanus and acellular pertussis vaccine (adacel), (batch number, expiry, route, administration site unknown) instead of a daptacel with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On April 28, 2021 I lost memory for 3 hours. Several test were ran and everything came back negative. The neurologist discovered it was PGA.
Patient previously received a does of Moderna vaccine while under the age of 18, and per current recommendation was given the 2nd dose  while still under 18. no complaints or complications were noted.
8 days after the vaccine I experienced severe itchiness at injection site. The area is extremely red and tender. There is a hard lump there too. Upon researching I learned that it is most likely "Covid arm" and that I should report it.
arm swelling with severe rash, extreme pain in left arm, fever, a little difficulty in breathing and a migraine I took Benadryl and have been using Benadryl cream and I still have a rash and pain in my arm it is still rashed up and I am on day 7 I also have pictures of my arm since day 1 I tested for covid because of the symptoms
Diarrhea nausea w/o emesis and Crampy abdominal pain 30+ episdoes of watery diarrhea no blood in 24 hours. Orthostatic and fatigue.
patient has not had any symptoms. No additional AE; an expired dose of VARIVAX was administered to a patient; This spontaneous report has been received from a medical assistance referring to a patient of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was unknown.   On 22-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (one dosage form, lot # U025205, expiration date: 13-AUG-2023; strength, route and anatomical location were not provided) for prophylaxis (expired product administered). As reported, the vaccine did not have any temperature excursions. The reporter stated that patient did not have any symptoms. No additional adverse event reported.
it was sore for a couple of days; sensitivity to light; headache; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (it was sore for a couple of days), PHOTOPHOBIA (sensitivity to light) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen). On 13-Feb-2021, the patient experienced PHOTOPHOBIA (sensitivity to light) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (it was sore for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 14-Feb-2021, PHOTOPHOBIA (sensitivity to light) and HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (it was sore for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the known safety profile of mRNA-1273.
HEART RATE INCREASED; MILD INJECTION SITE PAIN; INCREASED BODY TEMPERATURE; MUSCLE SORENESS; TIRED; DIZZINESS; FLU; STINGING PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-APR-2021 16:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced flu. On APR-2021, the subject experienced stinging pain in left knee. On APR-2021, the subject experienced mild injection site pain. On APR-2021, the subject experienced increased body temperature. On APR-2021, the subject experienced muscle soreness. On APR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 37.5. On 11-APR-2021, the subject experienced heart rate increased. Laboratory data included: Heart rate (NR: not provided) 90. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu, and the outcome of mild injection site pain, stinging pain in left knee, increased body temperature, muscle soreness, dizziness, tired and heart rate increased was not reported. This report was non-serious.