chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in on 06/28/21 to speak to me (pharmacist), she told me she has been trying to contact someone about reporting her adverse event because she did not know how to do it and she called the place she received her vaccination and they were not helpful at all. Patient received her second dose of Moderna on 06/04, about 6 hrs later she could feel the left side of her face numbing. It looks like she has Bell's Palsy. She can't close her eyes, it feels tight, and visually is droopy. She has to manually close her eyes, she has been using eye drops, she can't blink, and uses an eye mask at night to help prevent dryness. I told her she needs to see her PCP, urgent care, or hospital however she doesn't have insurance so she doesn't want to go.
Chills, fever, headache, muscle ache, tiredness, swollen lymph nodes, sore throat, caugh
Patient reported (via phone) right arm is red, warm and painful. Noticed discomfort/pain the night of the vaccination. Upon inspection of arm in the morning (about 18hr after shot), patient noticed the arm was red and warm to the touch. Indicated pain when touching or moving arm.
This case was reported by a healthcare professional and described a 40-year-old female subject who did not respond to immunization to hepatitis B vaccine (manufacturer unspecified). On an unspecified dates, the subject received " a series" of hepatitis titer was negative. On 05 April 2006 the subject received a dose of Hepatitis B vaccine recombinant (Engerix-B; dose number not reported; lot AHBVBA059AA). The expiration date for this lot of Engerix-B is 09 October 2005.
Around 5 minutes post vaccine, the patient fainted in the observation area. She fell out of her chair face down on the ground. WIthin one minute, she regained conciousness and informed staff that she has passed out at least 3 times prior due to fear of needles. EMS was called to examine the patient due to hitting her head during the fall. Her vitals signs read: 115/74 BP, 99% O2 sat, with HR in the 70's, and RR 14-16. The paramedics cleared her to resume her day without further medical attention.
Deep muscular pain and limited range of motion in various muscles located in the upper right arm, which pain is experienced upon movement of the muscle.  Pain worsens during sleeping;  I try to avoid rolling onto right side as much as possible. Discomfort worsened significantly and became more generalized in upper arm area beginning approx. two days after shot. Pain/weakness is the worst in rotator cuff area at this time. Presently I am under the care of an orthopedic specialist and am in physicial therapy. It is presently unknown how long treatment will be necessary, what future tests/treatment will consist of, or what final outcome will be.
This spontaneous report as received from a health care worker refers to a 54 year old female patient. No medical history was reported. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot # J007301, 0.65 ml, subcutaneous). On 02-DEC-2014, the reporter stated that client was vaccinated with expired ZOSTAVAX. No adverse effects reported. No product quality complaint was involved. Additional information is not expected. Because the reporter refused additional contact.
Pt presented with a large area of discoloration on the forearm of the arm she received her immunization in. It was not red, raised, hot, or itchy. It looked like an old bruise (kind of yellowy/brown). She stated that her father had previously had a similar reaction to an immunization, but did not know what immunization he had received that caused the discoloration. She had not treated it in any way, as it was not causing any discomfort. I recommended diphenhydramine should it start to itch, and to consult her physician if it changed in any way.
Fever 99-100 for 48 hours following vaccine administration, along with shaking chills and fatigue. Tylenol taken Q4H and Naproxin Q12H. Severe muscle soreness at injection site limiting use.  Erythema at site began on 12/13 at 8 cm.  Muscle soreness is less, but reddness contines to date.
My left arm became very sore by the first evening of my shot, and I had difficulty sleeping. It become worse over the next few days, and I experienced a loss of range of motion and pain when using and not using the arm. Understanding that arm soreness is a normal symptom of the COVID-19 Pfizer vaccine, I waited a few days, but the pain did not subside. It has now been over 15 days since my first dose and I am still experiencing significant pain in my left arm. The muscle soreness has lessened, but is still present, however the shoulder joint has been affected significantly. I experience pain when lifting my arm, brushing my hair, getting dressed, etc. For a few days the pain was excruciating and I found it difficult to complete regular tasks.
pt recv vax 21MAR97 & 4APR97 pt exp rash;
Parent called on 01-23-08 at 10:10am.  Area around injection red & painful & warm to touch.  Reaction started off as a size of a quarter and spread further.
Fussy after given vaccine around 9am. High pitched scream at 12:45, trunk movements (pelvic thrust). No eyemovements or of rhythmic movements of limbs. Fell asleep after. No fever.
"This is a 67y.o. male with a past medical history of ESRD on PD, undergoing eval for transplant HTN, Gout who presented to the ED with complaint of diarrhea. Patient states that started to develop mild diffuse abd pain with diarrhea 3 days ago. Has been going up to 20x a day. Denies fever, chills, loss of taste/smell, nausea, vomiting, chest pain, sob, cough. Denies sick contacts."
Redness along the skin of (L) deltoid area from 11/9/2010. Tetanus vaccine. No treatment.
sudden onset of fever up to 102 w/in 24hr;fever persisted w/dec appetite & extreme irritability;prolonged irritability, inconsolable for >2hr;
Headache, pain at injection site radiating down left arm, mild body aches, tiredness. Mild chills. Occasional stomach ache. Loss of appetite.
shortness of breath; wheezing; hot; flushed; cool; clammy; This is a spontaneous report from a contactable nurse received via a sales representative. A 44-years-old female patient received second dose of BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN, formulation: Solution for injection, lot number unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation; infliximab (INFLECTRA, formulation: Powder for injection, lot Number: EJ1527; Expiration Date: Nov2024, after 7th infusion (2nd reload), via an unspecified route of administration from an unspecified date, at an unknown dose for an unspecified indication. Medical history ongoing Ankylosis Spond. Concomitant medication included methotrexate (METHOTREXATE) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), for covid-19 immunisation. It was reported that patient was premedicated with Tylenol and Benadryl, used Humira prior to switching to Inflectra. Patient had received 2nd Covid Vaccination at least two weeks prior. Nurse said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot, event took place after use of product. On an unspecified date, the patient experienced shortness of breath, wheezing, hot, flushed, cool and clammy. The outcome of reported events was unknown.  Information about lot/batch number has been requested.
Pruritus; Diffuse body rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Pruritus) and RASH (Diffuse body rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Pruritus) and RASH (Diffuse body rash). At the time of the report, PRURITUS (Pruritus) and RASH (Diffuse body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
I was coughing, had a sore throat, tired and lethargic. I took an at home COVID test on my own first. I went to see my doctor without an appointment and she kicked me out. I took some Tylenol. I have developed Folliculitis after this and now have trouble sleeping.  All of this has happened since contracting COVID.
No additional AEs; An expired dose of ROTATEQ was administered to a patient.; This spontaneous report has been received from other healthcare professional referring to a healthy 04-months old male patient. No information was provided about the patient's concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 27-DEC-2021, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters(ml), orally (Expired product administered) (lot number # T039454 has been verified to be a valid lot number, expiration date reported and established as 14-DEC-2021; vaccination schemes, frequencies, and anatomical site of vaccination were not reported) for prophylaxis. The nurse reported that the patient's health status was normal. The information regarding redosing guidance after administration of the expired vaccine was requested. It was advised that dose should be repeated and if  the expired dose was a live virus vaccine, should wait at least 4 weeks after the previous (expired) dose was given before repeating it or if the expired dose was not a live vaccine, the dose should be repeated as soon as possible  No additional adverse events reported.
pt recvd vax; scrotum inflammation; swelling & warmth of rt arm; referred to urologist;
Classical shingles rash, unilateral vesicular eruption with blister on the R lateral thorax, following dermatome. Burning and pain.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 22-MAY-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Dizziness; Headaches; Calf weakness; Legs, arms, back tingling; Disequilibrium; Diarrhea; Period cycle change - heavy bleeding; Sinus pressure; Nausea; Skin scab; Vibration in calf; Heart palpitations; Extreme anxiety; Neck muscle tightness / Jaw muscle tightness; Uterine tenderness; Weight loss; Mouth weakness; Clenching; Random sweating; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 09:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included hashimotos. Concomitant medication included levothyroxine, trigonella foenum-graecum seed (FENUGREEK [TRIGONELLA FOENUM-GRAECUM SEED]) both taken for unknown indications from an unknown date. Patient did not receive any other vaccine in four weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 17Mar2021 09:00am the patient experienced dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The patient underwent lab tests and procedures which included weight: loss on 17Mar2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Steroids were received as treatment. Therapeutic measures were taken as a result of dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change - heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness / jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine at 5:15 pm and around 11:00 pm started a rash on legs and arms. Then had chest pain and pain in abdomen. Then started to have numbing on the face and felt like ants were all over her. She felt a strong pulse in her ears and then got up to look in the mirror and her face, lips and cheeks were swollen. She had red eyes.
Within one day post vax, the pts left upper arm was red, swollen and warm to the touch. By that afternoon it had spread to the forearm as well. Pt treated with Riaxin for 10 days.
Reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not reported) unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), reaction, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
10/22/2004: swelling in left arm area 4" diameter. Swelling wasgone by 10/23. ON 10/22 about 11PM also ran fever 103 till 10/25. Saw his cardiologist due to fever on 10/25. MD felt it may not be related to shots.
Positive covid test after getting 1st dose; Arm was so sore couldn't lift; Muscle ache; Low grade fever; Nausea; Chills; Fatigue; Joint pain; Headache; A spontaneous report was received from a consumer concerning a 48 year old, female patient who had positive COVID test after getting 1st dose and experienced muscle ache, low grade fever, nausea, chills, fatigue, joint pain, headache and arm was so sore couldn't lift.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 025J202A in the left arm for prophylaxis of COVID-19 infection.    The patient received her first dose of Moderna vaccine 29-DEC-2020 in the left arm at vaccination center. She confirmed on 30-DEC-2020 that she was exposed to COVID. The patient tested at work on 31-DEC-2020 and results came back positive. Patient stated after receiving the vaccine the following day she experienced arm was so sore couldn't lift, muscle ache, low-grade fever, nausea, chills, fatigue, body aches, joint pain, headache. After that day she felt she was fine, but continues to feel lethargic and nauseous. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events  was/were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of myalgia, arthralgia, pyrexia, chills, nausea, headache, fatigue,pain in extremity,  a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed as unlikely related.
Uremia; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03May2023 as dose number unknown, 0.5ml single (Lot number: GH9842) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AZOTAEMIA (medically significant) with onset May2023, outcome "unknown", described as "Uremia".; Sender's Comments: Uremia is more likely associated with the patient underlying medical condition unlikely to PREVNAR 20 use.  Further information such as complete medical history, concomitant medications, concurrent illness and event term details especially onset data are needed for meaningful evaluation.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
The day following the injection of the vaccine work up with nose running and had a fever up to 102 degrees.
Received flu shot 2-16-09 came to office 2-18-09 left upper arm red & swollen & hard 5 cm no rash
injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Prev dose product=COVID 19,, Prev dose brand=True, Prev dose brand name unknown= COVID19 Vaccine,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose dose number= 2), for COVID-19 Immunization; Covid-19 vaccine (Prev dose product=COVID 19,, Prev dose brand=True, Prev dose brand name unknown= COVID19 Vaccine,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose dose number= 1), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia Started with chills, eye congestion, body aches, fatigue, tireness Narrative:
Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection; Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection/R ankle pain; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 (Lot number: EW0217) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Anatomical site of injection: L shoulder, Route of administration: Intramuscular, Time: 09:00), administration date: 27Jan2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318, Anatomical site of injection: L shoulder, Route of administration: Intramuscular, Time: 09:00), administration date: 16Feb2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 12Nov2021 16:00, outcome "recovered" (2021), described as "Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection/R ankle pain"; JOINT SWELLING (non-serious) with onset 13Nov2021, outcome "recovering", described as "Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection". Therapeutic measures were not taken as a result of arthralgia, joint swelling.  Additional information: known allergies were None. other medical history was None. Patient's medical history was None. Family medical history relevant to AE(s) was None. Facility type vaccine was Workplace clinic. Prior vaccinations were None. Other vaccine in four weeks was None. Other medications in two weeks were None. Concomitant drugs were None. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Relevant tests were None. Specific relevant test for Thromboembolic events with Thrombocytopenia was None. Adverse events resulted in None of the above. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Seriousness criteria for event, R ankle pain was reported as Not serious.  Follow-up attempts are completed. No further information is expected.
patient started to feel nauseous and vomitted 5 minutes out of her 1st dose of pfizer covid vaccince
My arm started feeling sore the evening of the injection day.  I di not sleep well that night as slight chills and general achiness began.  When I got of bed the following morning I felt so weak, woozy and light headed that I was afraid I would fall.  I slept all day but by that evening I began feeling better and by the following day (day 2 after the shot) I felt normal except that my arm was still sore. It is now day 3 and my arm is still slightly sore but not limiting my use and is steadily getting better.
FLUZONE PED QUADRILVALENT syringe injection was administered to three patients all over 36 months_ one 3 1/2 yrs old and her adults parents. The vaccine was incorrectly identified as for older than 36 months. My prefilled syringe is labeled in light punk overlying a lighter pink glass of the syringe; in addition the Lot and Date info is in faded grey on a white back ground; the only easily read black on white info is the bar code and NDC #. Even though the font size is exceedingly small, if it stood out better than pink on pink, perhaps this mistake and error on my part would occur less often. What disturbs me the most is that I looked at the syringe to confirm what I thought was the older >36 month syringe 2 or 3 times. The patients were informed and were very understanding. Thank you.
Painfully swollen axillary lymph nodes on side of injection, painfully swollen cervical lymph nodes bilaterally, nausea, headache. Did not have any other symptoms and did not feel it warranted a dr appointment. Read the covid19 vaccine information sheet and saw all were known side effects. Resolved by 12/21/2020.
Started with chills, but by 8 PM had temp of 102.  Lasted into next AM when it subsided.
Pt presents with shortness of breath. There have been a few cases of COVID at the center. She has a PMH of COPD and CHF. She tested positive for COVID and was admitted for acute hypoxic respiratory failure.