chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm at the injection site; very vague / mild headache; This is a spontaneous report from a contactable other hcp (patient). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 31Jan2021 10:15 (at the age of 75-year-old) as dose 1, single for covid-19 immunisation.  Medical history included arteriosclerosis from an unknown date and unknown if ongoing. Patient was allergic to penicillin, cephalosporin. Concomitant medications included atorvastatin calcium taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date 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. On an unspecified date in 2021, the patient experienced sore arm at the injection site, very vague / mild headache. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Initial and follow up information has been received from consumer, a 19 year old pregnant female, and her aunt, for the Pregnancy Registry for GARDASIL vaccine (yeast), who on 12-JUN-2008 was vaccinated (route unknown) "by accident" with the first 0.5 mL dose of GARDASIL vaccine (yeast) (Lot # unknown). No medical history and or drug reaction/allergies were reported. It was reported that the patient was supposed to receive an unknown vaccine for "negative blood". The patients LMP was reported as "18-MAR-2008". The aunt reported that the patient has lost ten pounds since the vaccination, probably due to stress. The aunt also reported that the patient is taking prenatal vitamins (unspecified). This is a consolidation of two reports concerning the same patient. No further information is available.
Within  20 minutes after I had the vaccine I developed a sudden feeling of warmth in my upper body,  most intense over my face and especially my neck and back.  I was sweating  too and I also developed palpitations and chest pressure.
Had fever, chills, body aches. I didn't take any medicine. I sweat out my fever that night (1/28/2021) and i felt better the next morning.
Moderna EUA - Patient who is nonverbal and  received his second COVID vaccine today reportedly developed evidence of discomfort by closing his eyes, gritting his teeth and trying to lay down within 15 minutes of his injection.  This had not occurred w/ his first injection on 4/19/2021.   A medical assistant reported seeing distended right neck and right arm veins, and his family member reported seeing urticaria.  Vitals per MA were bp 97/59, pulse 102, pulse ox 96% on room air.  Upon my arrival, there were no visible distended neck or arm veins, and patient was seated comfortably, upright in the backseat of his family member's vehicle.  There were horizontal linear indentations across his right neck, as though he had been resting his head against the back of his seat, or a seat belt may have been rubbing on it (but seat belt would have been on wrong side).  He was in no respiratory distress.  There were no visible urticaria.  BP was 115/69, pulse 92.  Lungs were clear to auscultation and cardiovascular exam revealed mild tachycardia, regular rhythm, no murmurs, rubs or gallops.  He had received 10 mg of Benadryl through his G tube just as I arrived.    I recommended that patient be observed for 15 more minutes and patient went home without further incident, to go to ER if developed respiratory distress.
Extreme weakness, chills,  mild fever,  body & joint aches,  headache,  coughing,  one episode of chest pain!  Trying to recover by resting and staying in.   I will be contacting the my doctor, just as soon as I finish this inquiry!
Patient c/o neck pain and weakness of arms and legs to the degree that she had difficulty even walking up a curb.
Hospitalization for abdominal pain and diarrhea due to COVID-19 on dates 8/2/2022  8/13/2022. Treated with prednisone.
This spontaneous prospective pregnancy report as received from a registered nurse, concerning her daughter (age not provided) was currently pregnant and has a history of mild case of chickenpox as child. Approximately five years ago, in 2009, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # and expiration date not provided). Co-suspect therapy and concomitant medications were not provided. The reporter stated that her daughter was currently pregnant, received a dose of (Oka/Merck) VARIVAX prior to nursing school acceptance approximately five years ago (in 2009). Varicella titers were taken and her daughter did not seroconvert after receiving the (Oka/Merck) VARIVAX. At the time of the report, the patients outcome and the relatedness between the event and suspect therapy were unknown. Additional information has been requested.
pt recv vax & became very ill & had a grand mal sz;MD then said could no longer recv pertussis;
swelling of lymph nodes and underarm day after booster, progressively got worse over the course of 5 days. currently it is swollen, painful both dull and sharp, entire left arm is weak, but it?s a normal skin tone. lump looks to be around 3in diameter.
I took the vaccine at about 11:00 AM on 2/12/21. On 2/13/21 at about 10:00 PM, I suddenly got major swelling in both sides of my lower jaw and lower cheeks. Both my hands have become itchy. Earlier in the evening on 2/13/21 I had a feeling of air stuck in my upper chest, so I took an Alka-Seltzer, then later an Allertec allergy pill.  All of the above is currently happening. I have not yet talked to any medical people, just writing this down as it occurred. It is now 2:00 AM on 2/14/21.
experiencing dreaming; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV Virus", start date: 1997 (ongoing), notes: Verbatim: HIV Virus; "Seizure" (ongoing), notes: Verbatim: Seizures; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: LAMIVUDINE taken for hiv infection (ongoing); PREZISTA taken for immunodeficiency (ongoing); LEVETIRACETAM taken for seizure; LAMOTRIGINE. Vaccination history included: Bnt162b2 (Batch/lot number: ER8729 , Dose 1, single, anatomical site: left arm), administration date: 19Apr2021, when the patient was 54 years old, for COVID-19 Immunisation; Pneumonia vaccine (Verbatim: a month prior in March he got the pneumonia vaccine.). The following information was reported: ABNORMAL DREAMS (non-serious) with onset May2021, outcome "not recovered", described as "experiencing dreaming". Therapeutic measures were not taken as a result of abnormal dreams.  Additional information: Patient concomitant medication included avacruir tablet 600 mg, daily for HIV virus from 10 years, ongoing. It was reported that a couple of weeks after first injection.  Caller stated there is a summer camp of 128 kids that got sick. His first vaccine was on 19Apr2021 and his second second shot was in May2021. After the second shot within a week later he has been experiencing dreaming good, bad, and weird dreaming, start around 15May2021-20May2021, treatment - none. He was negative for the vaccine he clarified he had no antibodies and because he is immunocompromised. He clarified that he had no antibodies prior to vaccination. He has been on medication for the HIV virus for 15 years. Patient did not visit emergency room and physician office. did not have prior vaccinations.  No follow up attempts are possible. No further information is excepected
Given Ciprofloxacin 500mg orally after Meningitis exposure- Pt took Cipro 500mg @ 10:00. At 10:45 he states, he started hving watery eyes and nasal draingage/running/
74yr old male admitted on 11/3/2021 from Medical Center. The patient had a past medical history of COPD, PE, Hyperlipidemia, Gastroesophageal reflux disease, Hypothyroidism, Cholecystectomy, R knee replacement, PEG on 10/29/2021 and a Percutaneous tracheostomy on 10/27/2021. Pt was vaccinated with Johnson and Johnson vaccine in May 2021.  Pt's son passed away from COVID-19 infection. The patient tested positive on 10/5/2021.  The patient was transferred to bigger hospital from smaller Hospital with COVID-19 pneumonia and sepsis. When the patient arrived to bigger hospital the patient had a pulseless electrical activity cardiac arrest requiring chest compressions and 1 dose of epinephrine prior to returning to spontaneous circulation. The patients post cardiac echocardiogram showed an ejection fraction decreased to 23%, the pt. also developed acute kidney injury related to acute tubular necrosis.  The patient was given tocilizumab, remdesivir and steroids.  The patient's hospital course was further complicated by DVT and pulmonary embolism.  Pt was noted to also have right upper lobe necrotizing pneumonia due to Pseudomonas.  Pt was seen and was on Meropenem.  Pt was unable to be weaned off of the ventilator and underwent a tracheostomy on 10/27/2021 and a PEG placement on 10/29/2021.  The patient's family met with palliative care and they wanted to continue current care.  On admission to Select the patient was on assit-control mode of ventilation with a tidal volume of 380, PEEP of 5, respiratory rate of 14 and FiO2 of 40%.  The pt. had also had pneumothoraxes and on admission to Select the pt. had 2 right sided chest tubes and a chest tube on the left.  Pt's condition worsened and on 11/12/2021 Pulmonary noted that he had a long discussion with the family, discussed with them the surgical additional chest tube placement needed, but family decided on comfort cares at  that time.  Pt was placed on comfort cares and expired on 11/12/2021 at 1500.
Patient had cardiac bypass surgery in Nov 1997.On 08-25-15 he had his aortic valve replaced. He was recovering well (09-28-15 seen by heart surgeon, 10-05-15 seen by cardiologist). He was seen by his PCP on 10-08-15 and was given a PREVNAR injection. A few hours later he developed neurological symptoms of mental confusion, tremors, issues with coordination, vision and hearing problems.
Mother called. Immunizations given on 3/20/01. The next day, left leg reddened approx. the size of a baseball and was warm to touch. The following day it had less redness but area was 2 times larger in size. Today, center is slightly red, white area around and outer area slightly red. Will see MD today, (Endocrinologist) and will let us know MD visit outcome.
dry mouth; Diarrhea; felt sleepy/tiredness; joint aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), DIARRHOEA (Diarrhea), SOMNOLENCE (felt sleepy/tiredness) and ARTHRALGIA (joint aches and pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DRY MOUTH (dry mouth), DIARRHOEA (Diarrhea), SOMNOLENCE (felt sleepy/tiredness) and ARTHRALGIA (joint aches and pain). On 16-Feb-2021, ARTHRALGIA (joint aches and pain) had resolved. On 18-Feb-2021, DRY MOUTH (dry mouth) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, SOMNOLENCE (felt sleepy/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD21-034189 (E2B Linked Report).; Sender's Comments:  MOD21-034189:same reporter, husband case
This case was reported by a pharmacist via call center representative and described the occurrence of eyelid boil in a female patient who received Shingrix for prophylaxis. In February 2019, the patient received Shingrix. In February 2019, less than a month after receiving Shingrix, the patient experienced eyelid boil, periocular swelling and stye. On an unknown date, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the eyelid boil, periocular swelling and stye were not reported and the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. It was unknown if the reporter considered the eyelid boil, periocular swelling and stye to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that about one month ago, the patient was preparing a Shingrix dose and as she was removing air from the syringe some Shingrix squirted out  into her eye which led to inadvertent exposure to vaccine and exposure via eye contact. The patient had a bump on the eyelid and swelling around the eye. The patient consulted physician and ophthalmologist who thought it might be a stye. The reporter declined to provide address or date of birth and does not want follow up with her physician and did not consent to follow-up.
Red, itchy, swelling, hot to touch left thigh 8x10cm induration. R thigh nickel size induration.
Small, hard mass started 2 days after the 2nd vaccine shot in left breast and turned into a mass the size of a golf ball after 3-4 weeks, that is painful and has not gone down in size.
I typically get allergy shots, I waited about a half an hour to an hour after my first vaccine and was given Benadryl by one of the nurses at the hospital for symptoms and went to bed. I then had hallucinations in the middle of the night, and had to go to the bathroom. I suddenly felt like I was having a low blood sugar attack, and wanted to lie down on the cool floor. The next morning I woke up and went to the bathroom, I was totally unaware that I passed out and there was a hole in the wall. I went to the allergist and then went to my internist. Internist stated that this may have been caused by Benadryl. I did not have any other problems that I can recall after the vaccines.
screaming x 2 hrs & off & on 8-10 hrs; vomited x 2;
PT BECAME SYMPTOMATIC 2 HRS POST VACCINE: DIZZY, UNSTEAD GAIT, BILAT ATAXIA, VOMITING. NEUROLOGY RECOMMENDED TPA FOR ACUTE CVA, ADMINISTERED ALTEPLASE WITH SYMTOM RESOLUTION.
tingling in face and fingertips; heightened neuropathy in feet; Headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6703) via an unspecified route of administration, administered into the left arm on 09Mar2021 17:00 as a single dose for COVID-19 immunisation. Medical history included guillain-barre syndrome survivor and breast cancer survivor. Patient was not pregnant. Concomitant medications included levothyroxine sodium (LEVOXYL),  hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN+HCTZ/MYLAN) and letrozole (LETROZOLE). On 09Mar2021, patient experienced headache and fatigue. On 10Mar2021, she had heightened neuropathy in feet. On 12Mar2021, she experienced tingling in face and fingertips. The patient did not receive treatment for the events reported. Outcome of events was not recovered.
pt c/o h/a, mild fever, spots on back (13-14) 27MAY98;28MAY98 spots have spread (16) back, (2) underarm, (4-5) groin & 2 on bottom of feet;
Severe dizziness and severe ringing in ears.  Unable to walking without holding on to something.  Still ongoing after 15 hours.  Taking meclizine for dizziness.
Child received varicella on 10/23 and returned to North clinic on 10/25 C/O redness and swelling at L arm site.  Normal temp recorded.  Pt was given rocephin im for cellulitis.  Patient returned next day to PCP, had temp of 99 oral, 90% difference in redness, started on keflex oral antibiotic for 10 days.
The pt developed fever of 104 deg. F., fussiness, swelling (right leg) with red lump for 3-4 days. Fever was down at 101 deg. F. for two days. Fussiness and decreased appetite lasted for 2 weeks.
Tdap and MenQuadfi given in R arm IM. HPV9 given IM in L arm. Patient sitting on table then moved to chair to sit but sister. Patient then stated within 2 minutes of last vaccine (HPV9) that she felt like she would pass out. Patient passed out on her sisters shoulder mom then picked her head up and childs eyes tolled back. The Dr. came in and laid child down on seat and monitored her for at least the next hour. Once patient felt ok, water given and family helped child to restroom and then left office. Nurse from our office called mom next day was doing better.
Within 15-20" minutes of vaccines my throat was scratchy. This progressed to swelling & severe tenderness of lower, external neck X 1wk. Hard to swallow.
Leg ulcer; Rheumatoid arthritis flare up on shoulders/arm/legs; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ULCER (Leg ulcer) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up on shoulders/arm/legs) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   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 SKIN ULCER (Leg ulcer) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up on shoulders/arm/legs). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, SKIN ULCER (Leg ulcer) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up on shoulders/arm/legs) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  Company Comment: This spontaneous case concerns an elderly (in the 6th decade of life) male patient with pre-existing rheumatoid arthritis being treated with Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis, described as flare episode of the pre-existing condition, affecting the shoulders and extremities. The non-serious event of Skin ulcer, reported as appearance of sores on the legs, was also reported. The events occurred on an unknown date after receiving a dose of mRNA-1273, reported as booster dose. Description of the symptoms and clinical course were not provided in the case. The patient was prescribed with hydrocortisone and the reported outcome is resolving. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Adalimumab (Humira) was cited as co-suspect in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly (in the 6th decade of life) male patient with pre-existing rheumatoid arthritis being treated with Adalimumab (Humira), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis, described as flare episode of the pre-existing condition, affecting the shoulders and extremities. The non-serious event of Skin ulcer, reported as appearance of sores on the legs, was also reported. The events occurred on an unknown date after receiving a dose of mRNA-1273, reported as booster dose. Description of the symptoms and clinical course were not provided in the case. The patient was prescribed with hydrocortisone and the reported outcome is resolving. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Adalimumab (Humira) was cited as co-suspect in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Injection site tenderness, pain and slight swelling, generalized body aches, migraine, back ache, generalized fatigue, weakness, dizziness
Immediately after administration I felt pain at right upper deltoid with progressive right shoulder sharp joint pain and restriction of movement. I reported this to my primary Rheumatologist on 1/28/2022 and he ordered Right should PT which began 2/14/2022 and is ongoing to increase range of motion.
within 1-2 days of administration, pt describes erythema, pain, allodynia, and a blister
Sore, painful arm, c/o burning, pins and needles sensation to bilateral face, almost like a sensation of a rug burn. Client observed pores on face enlarge, which after this subsided she c/o her cheek muscles being very sore.  This episode lasted approximately 30-45 minutes.  Client took Tylenol mid way through this episode. Nest day, no residual side effects noted to face, still has extremely sore arm. Only received the Adult Hep. A vaccine.
Diarrhea, headache, nausea, weakness, light headedness, chills
I track my blood sugar 3x per day (morning, an hour after lunch, an hour after dinner).  Blood sugar is very well controlled using insulin - fasting blood sugar is consistently 115-125, sometimes varying to 110-130.  When I got the second Covid shot, my fasting blood sugar the next two days were 147 and 143 - the highest values I have EVER recorded since I started taking insulin (earlier this year).  Correspondingly, the values after lunch and dinner yesterday were very elevated.  This afternoon and evening, the numbers have returned to normal, and I expect tomorrow morning's fasting value to be back around 120 again.  This was not dangerous, but as an engineer, I found it to be a fascinating and statistically significant  outlier.  The other symptoms I had from the second shot was a fever (over 100 degrees from 11/28 5:30pm through 11/30 8am, and over 102 from 11/28 10pm through 11/29 9am), some general aches and fatigue, and injection site soreness.  I had no adverse reaction to the first shot (a month earlier) except for injection site soreness.
Influenza virus vaccine (FLUVIRIN) 2008 - 2009 formula expiration date 6/30/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus (FLUZONE) 2009-2010 formula after error discovered.
Vaccination area was red; Sore left arm; Vaccination area was burning; Vaccination area looks like rash; Vaccination area was Itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Vaccination area was red), INJECTION SITE PAIN (Sore left arm), INJECTION SITE PAIN (Vaccination area was burning), INJECTION SITE RASH (Vaccination area looks like rash) and INJECTION SITE PRURITUS (Vaccination area was Itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Vaccination area was red), INJECTION SITE PAIN (Sore left arm), INJECTION SITE PAIN (Vaccination area was burning), INJECTION SITE RASH (Vaccination area looks like rash) and INJECTION SITE PRURITUS (Vaccination area was Itchy). At the time of the report, INJECTION SITE ERYTHEMA (Vaccination area was red), INJECTION SITE PAIN (Sore left arm), INJECTION SITE PAIN (Vaccination area was burning), INJECTION SITE RASH (Vaccination area looks like rash) and INJECTION SITE PRURITUS (Vaccination area was Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.