chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 1hr p/vax the inj site became reddened, swelled (from the inj site to the elbow) & a small amount of ecchymosis was noted at the elbow;the arm is painful;
This spontaneous report was received from a 65 year old retired registered female nurse, who refers to herself. The patient's pertinent medical history included seasonal allergies and chronic sinusitis, she was also allergic to penicillin, tetanus and unspecified sulfa drugs. In approximately 1980 (reported as 36 years ago), she received a tetanus shot. A few hours after administration (approximately in 1980), she experienced an itchy rash all over the body similar to poison ivy. The nurse took oral diphenhydramine (BENADRYL reported as BENEDRYL) but the symptoms did not recover. She went to the doctor's office and received a cortisone shot and oral cortisone (manufacturer unknown) to treat the reaction. The nurse reported that the reaction took several days to clear up. On an unknown date in approximately 2013 (reported as 2 to 3 years ago), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) injection, in arm (dose, route of administration, lot# and expiration date were not reported), for shingles prevention. Concomitant therapies included fluticasone propionate (FLONASE), azelastine hydrochloride (ASTELIN), ezetimibe (ZETIA), lisinopril (+) hydrochlorothiazide (manufacturer unknown), fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), alprazolam (XANAX), aspirin (manufacturer unknown) and ascorbic acid (VITAMIN C). On an unknown date after the vaccination, the patient experienced cellulitis in the arm where the vaccine was administrated. The nurse went to the doctor and was given an azithromycin (ZITHROMAX Z-PAK) to treat the infection. Lab diagnostic studies were not performed. Product quality complaint (PQC) was not involved. The outcome of the event was reported as recovered on an unspecified date, about a week later. The relatedness between the event of cellulitis and suspect vaccine was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.  Additional information has been requested.
Headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with ADALIMUMAB (HUMIRA) (subcutaneous) on 01-Apr-2021 at a dose of 40 mg once a day. At the time of the report, HEADACHE (Headache) was resolving.        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 product information was not provided.  Treatment information was not provided.
doctor told her it was her body's reaction to the vaccine; still warm; injection site looked swollen; felt uncomfortable; discomfort in arm; itchy; hot to the touch; Pain; soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy) and INJECTION SITE WARMTH (hot to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes and Cholesterol. Concurrent medical conditions included Seasonal allergy, Allergy to chemicals, Allergy to chemicals, Drug allergy, Drug allergy and Drug allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Pain) and PAIN IN EXTREMITY (soreness on arm). On 08-Feb-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch) and FEELING ABNORMAL (felt uncomfortable). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection site looked swollen) and INJECTION SITE WARMTH (still warm). On an unknown date, the patient experienced ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch), INJECTION SITE SWELLING (injection site looked swollen), INJECTION SITE WARMTH (still warm), ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine) and FEELING ABNORMAL (felt uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "migraine" (unspecified if ongoing), notes: Other medical history: migraine; "EDS" (unspecified if ongoing), notes: Other medical history: EDS. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication=Treatment of COVID-19; (07Sep2022) Positive, notes: Return of symptoms on eve of 07Sep2022, positive home covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was unknown if other medication received in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Local inflammation tenderness with decreased mobility of arm (50% ROM) worsening over 24 to 48 hours.
30 cm band of erythema and swelling extending and enveloping all but 3 cm of the upper arm.  Within 12 hours, also fever of 100.7, muscle aches and joint pain, now largely resolved except persistent near circumferential upper arm erythema. While I anticipate resolution with time, returning to primary care physician today to ensure nothing further needs to be done.
Started spotting day after first injection, my period ended three days before? Spotted for 2 weeks, then had a ONE DAY period. Looked it up I am not the only one who had menstrual changes after the first dose! Hundreds of thousands of women from all over the world did! My period is still irregular my one day period ended and a day later I felt as though I was about to start again and I woke up to my period all over only this lasted half a day, it is still not normal, my second dose was 3 months ago.
COVID-19; illness; *very* mild-low grade fever; headach; Slight congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ILLNESS (illness), PYREXIA (*very* mild-low grade fever), HEADACHE (headach) and NASAL CONGESTION (Slight congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), ILLNESS (illness), PYREXIA (*very* mild-low grade fever), HEADACHE (headach) and NASAL CONGESTION (Slight congestion). At the time of the report, COVID-19 (COVID-19), ILLNESS (illness), PYREXIA (*very* mild-low grade fever), HEADACHE (headach) and NASAL CONGESTION (Slight congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicines were reported.   Reporter did not allow further contact
The dat after the second dose just before noon I suddenly had eye floaties in my right eye. Unlike a usual floatie that might come and go these have a shape that changes as I move my eye. There is no pain, they are a sudden annoyance that i hope will go away but I wanted to make sure I reported it.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was dizzy with elevated HR and elevated BP.  Pt was dizzy around 1203 pm.  Vitals @ 1206 were 137/85, HR 104, OSat 99%.  Vitals @ 1209 BP 108/76, HR 83, OSat 99%.  Symptoms resolved after 30 of monitoring
had water blisters on my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 49 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: BLISTER (non-serious) with onset 31Mar2021, outcome "not recovered", described as "had water blisters on my face". Therapeutic measures were not taken as a result of blister.  No follow-up attempts are possible. No further information is expected.
Received the vaccine by attending the clinic and altering DOB to make it appear she was 18 y/o, when entering into the state immunization reporting system discovered she was not 18, patient called and she insisted DOB was correct, asked for photo ID to confirm DOB, none was provided, called number in the state system and spoke with patients mother that verifies she is only 17, she says she was aware she getting a vaccine she thought she had found Pfizer.  Spoke with mother about options for booster and we will wait until patient is 18 y/o to administer the booster.
SIRVA; injection site pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021. The most recent information was received on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (injection site pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Ehlers Danlos Syndrome, Arthritis medly.  The patient's past medical history included Ehlers-Danlos syndrome and Arthritis.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter once. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (injection site pain). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) outcome was unknown and INJECTION SITE PAIN (injection site pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported No treatment medication were reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: No specific follow-up information recorded.
sore shoulder; This is a spontaneous report from a contactable other-HCP. This 74-year-old male other HCP (patient) reported for himself.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Feb2021 (Lot number: EL9262) at the age of 74 years as dose 2, single and administered in arm, administration date 27Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (Flu shot), administration date: 15Dec2020, when the patient was 74 years old. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore shoulder".  Additional information: Patient had no problem with the first two doses and all. But had sore shoulder and did see all kind a little bit (Not clarified) for the 4,5,6 hours but the another day It was fine.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
about an hour after the injection, the allergy symptoms and cough completely disappeared completely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cough variant allergic asthma" (unspecified if ongoing), notes: I have cough variant allergic asthma, take inhalers for it, but cough incessantly. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "about an hour after the injection, the allergy symptoms and cough completely disappeared completely". Additional information: It was reported that even with the patient's allergy injection where cough was always there disappeared completely. The patient stated that it was a happy side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, myalgias, slight cough. Tamiflu 75 BID x 5d; Tylenol pm) assuming intercurrent flu injection with H1N1.
3/17/21-patient started to have SOA, fatigue and cough-CT scan done showed infiltrate RUL-TX'd with antibiotic with resolution of infiltrate on repeat CT scan of chest 5/2021-patient noted to have bradycardia (asymptomatic) on Fit bit 4/1/21- EKG done showed 2nd degree block mobitz type 1-patient scheduled to have pace maker placed in one week
This spontaneous report was received from a physician via representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, LOT # unknown). Physician had cell phone photo of patient's injections site reaction post dose two of GARDASIL. Patient developed a quarter inch diameter hypopigmentation at the injections site, unspecified which arm. Patient received no other vaccines on that day. This occurred over the summer of 2013. On an unspecified date, the patient came into office to seek medical attention. Patient had recovered. Since then patient received a third dose of GARDASIL, with no adverse effects reported. Additional information has been requested.
Phone call from patient on morning of 05/01/2013. She had received several travelers vaccinations on 04/30/2013 including oral typhoid which she took her first dose of that date about 10:20 PM. Pt says she slept fine, but after breakfast had onset of illness. Pt reports 8-9 episodes of watery diarrhea over 3-5 hours with waves of abdominal pain reaching intensity of 8/10 on 0-10 pain scale. By 12:00 noon diarrhea had resolved and waves of abd pain were much less frequent and less intense, about 4-6/10 on 0-10 pain scale. Pt denied any fever, chills, rash, itching, breathing changes, nausea or vomiting. She did feel a little weak and fatigued. She was recommended to contact PMD, rest, fluids (clear liquids). If any diarrhea continued next day, she was told not to continue second dose, or if PMD recommended to stop. I followed up with patient on 05/06/2013 and she states all symptoms had resolved and she was feeling "normal" so she took second dose as scheduled, had two loose stools and some mild cramping, resolved quickly. She took third dose as scheduled and had one mild loose stool with mild cramping, resolved quickly. She plans to take final dose as scheduled on evening of 05/06/2013.
c/o stomach ache. Temp 100. Lungs clear, no cough. Student active and alert. Tylenol 160mg po. Guardian called and dismissed from school. Report given and instructed to call ped if symptoms worsen.
My arm was sore at the injection site the next day, as expected.  The soreness has not gone away, and now there is a painful-to-touch raised bump there.
Severe headache lasting months/year. Checkup at Doctor and brain scan with negative results. Headaches continue to this day but are not as severe.
Subsequent to receiving vax the pt developed lymphadenopathy. She sought unspecified medical attention. No further information is available.
About 3 weeks after receiving the second dose of Janssen Covid vaccine, I woke up and my right arm was completely numb. I didn't pay much attention to the numbness, but within 1 week of this happening, I contacted my doctor. I thought that I just slept wrong and pinched a nerve in my neck. I was referred to a thoracic doctor and he performed a MRI. I went back to my original doctor and at about two months later, I received an epidural in my neck which helped. I tried physical therapy, but that didn't really help. I had surgery on my hand where they had to pull a tendon from the front of my hand to the back. I wear a brace on my hand all the time now. I can almost fully open my hand. I also tested positive for COVID-19 about 6 weeks after the vaccine and I tested positive again 11/16/2022.
Patient received an un-diluted dose of the covid-19 vaccine. MA accidentally drew vaccine out of vial without reconstituting with the required sodium chloride. No side effects or adverse symptoms were observed by guardian.
Atrial Fibrillation/she has this prior to getting the first dose of the vaccine; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age (unknown if pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation. Concomitant medications were not reported. Pharmacist stated that his patient had Atrial Fibrillation 10 mins after getting the first dose of the vaccine. Asking if this would be a counter indication for her second dose. Also added that she has this prior to getting the first dose of the vaccine. The outcome of the event atrial fibrillation was unknown. The event is considered as serious (medically significant).  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug profile and available information the reported  atrial fibrillation is unrelated to bnt162b2.  This is an intercurrent  medical  history in a patient with a history of  atrial fibrillation.  Case will be reassessed if additional information is received.
headache, chills, bodyache   persisted from approximately 7am-6pm the day following vaccination (05/01/2021)
Palpitations, nausea around 0745, chills and headache around 1330, fever of 101, extreme fatigue, flushing, and nausea 1930 and on
Pt. started to vomit persistently.  Also developed diarrhea.  Symptoms persisted despite switching to Pedialyte.  Taken to ER at on 2/18/11 and given IV fluids for 24 hours in short stay suite.
Inability to swallow, numb lips, slurred speech, double vision possible stroke or Myasthenia Gravas
suspected vaccination failure; nowhave shingles; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had the shingles shot and now had shingles, very painful. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Severe Headache, hives on upper legs,and stomach,  rash on upper legs, eyelids, neck and behind ears.  Memory loss, severe depression, exhaustion in the last 3 months after the shot. Headaches have continued but gotten better. I break out in the rash on eyelids, neck and upper legs every couple weeks.
pt recv vax 30APR97 & ran a fever that noc-area around inj site became hard w/sl redness on medial side & a few small blisters-fever cont to 2MAY more blisters noted on Friday;came back to clinic on Friday;seen by MD;infect;
This was my first booster.  My original vaccine was administered 3/10/21 and was a Jannsen vaccine. My side effect from the booster was a fully cycle of my period after just finishing a complete cycle 15 days before this.  I started to spot on 4/9 and on 4/10 I had a full period 13 days early,
Pts mom called PCHD on 5/30/2000 stated that pt still had a knot at site where immunizations were given. On 6/2/2000 there was still a pea-sized knot under the skin without redness or warmth.