chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm became red and it traveled down my arm to my elbow. I went to urgent care on 9/24/2021 and it was diagnosed as Cellulitis. I was given an antibiotic and sent home. My arm is still inflamed on 10/01 and I have finished the meds.
No additional AE reported.; PROQUAD AE: 1 dose administered on 07/27/2022 while the patient was over the age of 12 years; This spontaneous report was received from a medical assistant and refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient started therapy with sterile diluent, solution for injection/infusion (strength, lot #, expiry date, route of administration, and indication were not provided).  On 23-APR-2009, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, first dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided).  On 02-FEB-2010, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, second dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, second dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided).  On 27-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #W007747, expiration date: 04-SEP-2023, for prophylaxis (strength, anatomical location, and route of administration were not provided).The patient was over the age of 12 years, and after patient was already vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) an 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
I am currently experience a severe legs pain, especially on the back of my left leg, and at the bottom of my right foot to the point that I can't walk or sleep at night.  I shared this info with my family doctor, he did not offer any advice.
pt recv vax & was inadvertently stuck w/a needle; w/in 2 days post vax exp chills, fever, & inc white blood cell count;pt will be followed to see if sx subside or it sx are persistent;
Flushed face, urticaria, abdominal pain epitaxis about 10 min after vaccination. Hives and scratch on left arm at sire of MMR. Given BENADRYL in office and observed. Recovered (hives resolved) and sent home with instructions to use CLARITIN.
she got real sick; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got real sick"; PAIN (non-serious), outcome "unknown", described as "body pain".  Additional information: She has not received the second dose and she is already late. She said that she received the first dose last 17Feb. Caller mentioned that she got real sick and she experienced body pain but she said that it is not because of the covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Information has been received from a registered nurse concerning a 12 month old patient. Relevant medical history and drug reactions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number reported as H021709 with expiration date: 07-DEC-2014, dose, route unspecified). No adverse effects had been observed or reported. Additional information has been requested. Lot number H021709 has been verified to be a valid lot number for VARIVAX (Merck).
Soreness at injection site began shortly after injection Fever began at approximately 8:00 pm the day of the injection (2/7/2021)  self treated with Acetaminophen tablets  Headache upon waking up the next morning (2/8/2021) self treated with Acetaminophen tablets
101.3 fever, chills, nausea, severe fatigue next day, moderate to significant fatigue subsequent days, muscle aches, loss of appetite, swollen lymph nodes on right side in neck area and armpit area, congestion, very severe headache particularly day after and 2nd day after.
Patient called stating that starting mid night of the day she received shot she presented with fever of 100.6F lasting about 24 hours, swelling of arm lasting about 24 hours, itchy eyes and swelling of face (no issues breathing or swelling of throat) lasting about 3 days. No medical treatement or appointment with health care professional sought.
First sharp headache after an hour, then metallic taste. 36 hours after muscle aches, chills, flu like symptoms.
This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to DTP vaccine. Additional information received as follows: The age at vaccination was not reported. The patient was allergic to the DPT shot when he/she was little so the patient only had 2 DPT shots.
bad flu like symptoms; we had the first shot in April; nausea; aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type 2 diabetes mellitus.   On 8th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, pain and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and incomplete course of vaccination were unknown and the outcome of the nausea and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix at age of 58 years old and experienced bad flu like symptoms, nausea and pain. Nausea and pain was resolved in 5 days. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient wanted to know whether he can receive 2nd dose of vaccine as soon as possible. The case was considered as medication error with adverse drug reaction. This case has been linked with US2020AMR011890 , reported by same reporter. All the information from case US2020AMR011890 will be merged into case US2020AMR011213 and case US2020AMR011890 will be deleted as it was created in error (created separately for medication error).
Vaccine was given at 21 day interval. Client was informed of vaccine being given too early. No vaccine recommended to be repeated at this time.
Shortness of breath, heart palpitations, cough, exercise intolerance, some nausea/vomiting, pain in left lower leg, fluid retention, swelling in feet.  Symptoms progressed in severity.  Admitted to hospital week of Feb 6 for five days.  Diagnosed with deep vein thrombosis is left leg.  Pulmonary embolisms.  Congestive heart failure.  Tachycardia.  Atrial fibrillation.  Treated with blood thinner, diuretics, beta blockers.  Cardioversion.  Catheter radiofrequency atrial ablation.
MOC states child has been seizure free since 8/08. Has had 10 seizures since start of rabies vaccine series - Has 2 doses left. 1st dose given here others have been given in another state- after parents moved continued seizures
drop foot; spinal stenosis; hands and legs ache; pain at injection left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection left), PAIN IN EXTREMITY (hands and legs ache), PERONEAL NERVE PALSY (drop foot) and SPINAL STENOSIS (spinal stenosis) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and CLOPIDOGREL for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection left), PAIN IN EXTREMITY (hands and legs ache), PERONEAL NERVE PALSY (drop foot) and SPINAL STENOSIS (spinal stenosis). At the time of the report, VACCINATION SITE PAIN (pain at injection left), PAIN IN EXTREMITY (hands and legs ache), PERONEAL NERVE PALSY (drop foot) and SPINAL STENOSIS (spinal stenosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 76-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up information received included reported details added.
Gave patient Moderna 50mcg/0.5ml instead of Moderna BiValent 50mcg/0.5ml. No adverse events reported by patient. Patient without incident.
Tightening pain in right leg, then left leg, then moved to soles of feet, then hand; Itching, tightening, pain in extrenities; This is a spontaneous case initially received from a pharmacist via Agency (reference number: SEQ19-06540) on 12-Nov-2019, concerning a 77-year-old female patient.   The patient's medical history and concomitant medications were not reported.   On 11-Nov-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 262311 and expiration date: 30-Jun-2020] for influenza prophylaxis.  On the same day, after vaccination, the patient experienced tightening pain in right leg, then left leg, which moved to soles of feet and hand. The patient also had itching in extremities.  On an unknown date, the outcome of all events was resolved.  The reporter assessed the case as non-serious and did not provide causality assessment to Fluad (TIV).  Follow up received from pharmacist via Agency (reference number: SEQ19-06982) on 10-Dec-2019: Outcome of all events updated, additional reference number added. The narrative was amended accordingly.  Company comment: The patient developed pain in extremity and pruritus associated with the suspect product, Fluad (TIV). The patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: The patient developed pain in extremity and pruritus associated with the suspect product, Fluad (TIV). The patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related.
altered mental status and vomiting after receiving Pfizer vaccine Narrative:  This is a 70 y/o male with past medical history significant for end stage renal disease on dialysis, diabetes, diabetic foot ulcer, ischemic cardiomyopathy, hypertension, status post left below knee amputation and severe peripheral vascular disease. He received Pfizer covid-19 vaccine on 1/11/21. Patient's sister reported that on 1/12/21 patient complained he "couldn't think straight; his mind was not there" after receiving the vaccine. Sister also noted patient had vomiting and then became progressively weak. On 1/18/21 (1 week later), the patient was brought to the Medical Center emergency room as patient had "fever, diarrhea as well as cough". The patient has h/o covid-19 positive on 7/28/20 but most recent covid-19 test was negative on 1/18/21. On 1/20/21 blood culture showed Staphylococcus aureus (2/2 sets). MRI of the brain on 2/3/21 showed "small focus of acute ischemia in the left occipital lobe".
About 20 minutes after receiving this flu vaccine, patient developed large, red area on upper left arm which was very warm to touch and was very itchy. Large 1 inch area of induration noted. Band-Aid was not used for vaccine administration. No breathing issues or other areas of concern. Within 1 hour, area less red and hot. Patient did take a ZYRTEC 90 minutes after occurrence and 7 hours after injection, patient states area is smaller but warm (not hot) to touch.
Pt received vaccination at 1:30pm, pt ambulated to observation area, began feeling "dizzy and nauseous" while standing in observation area. Pt ambulated to chair, at which time pt lost consciousness and her body became stiff, gagging sounds noted. Removed pt's mask, applied oxygen at 10l/min via face mask. pt regained consciousness within 30 -60 seconds. Vital signs BP 124/82, unable to assess sp02 due to cold fingers and nail polish. HR 102. Pt stated she continued to feel dizzy, and had tingling in her fingers. Vital signs reassessed at 1:43, BP 128/78, HR 80, unable to asses sp02 due to monitor not giving a  reading. Vitals reassessed at 1:46pm, sp02 100%, HR 94. , began titrating  oxygen supply down by 2l/min. Pt seemed to tolerate well for a few minutes,   At 2:00pm, pt complained of tingling returning to her fingers,  pt was receiving o2 4l/min, sp02 noted at 80%, increased 02 to 10l/min, called nursing lead who called 911.   2:10, unable to obtain accurate sp02.   2:17pm pt continues to receive 02 10l/min, stated she "feels okay, just weird and foggy" no tingling in hands.   2:20pm, paramedics arrive, pt states she is "a little bit dizzy"   2:35pm pt taken to hospital via stretcher with paramedics. Pt en route to hospital.  At 2:00pm sp02 80%
10/7/02 Patient received DTaP, IPV, MMR at our office. Called 10/9/02 with report right thigh with red rash at injection site. Patient evaluated 10/13/02 and treated.
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization, reaction(s): "I have permanent hearing loss in my right ear". The following information was reported: TINNITUS (non-serious), outcome "unknown".  Additional information: Consumer stated I have permanent hearing loss in my right ear after pfizer vaccine doses and tinnitus 24/7 since pfizer booster. I think pfizer should pay for my hearing aid. I'm otherwise 41 years old and healthy. Disgusting.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
A territory representative reported that a pt received an injection and subsequently developed flu-like symptoms. The pt was hospitalized. The reporter indicated that 11 pts experienced this event however they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Information has been received from a physician concerning a 16 year old female patient who on 12-JUL-2007 and 16-JUL-2008 was vaccinated with the first and second dose of GARDASIL respectively. On 09-APR-2009 the patient went to see her OBGYN physician and they conducted a Pap smear test and the patient had an abnormal Pap smear and they detected an HPV infection. The physician noted that the patient's mother didn't want her daughter to be vaccinated with the third dose of GARDASIL. There was no lot number available. At the time of report the patient's status was unknown. Additional information has been requested.
Joint pain, lymph node pain in right armpit causing radiating pain down right arm into hand. Cramping in right hand.  Numbness in right arm from swelling of nodes? Headache and neck pain starting at the base of the skull that has lasted a full week with no relief.  Lymph node pain came on at day 2, and lasted 6 days. Muscle pain in neck causing headache in front as well as nerve pain in neck. Have not felt any relief in neck and head.  Have not seen a doctor yet
10 min post vaccine -nausea, diarrhea. 20 minutes post vaccine-lightheadedness lasted a few hours. 30 minutes post vaccine itchiness at back of throat lasted 5 minutes and resolved. Extreme fatigue 30 minutes after vaccine.
I was fine all day and had taken Advil prior to injection. Later in the evening, my arm began to get sore, which was expected.  I woke up that night at about 2:00 am with severe nausea and stomach pains, bloating, a headache that progressed to a migraine, and my arm and entire shoulder joint were VERY painful--much more than I've ever experienced with any other vaccination.  I took Advil, Maxalt, pepto-bismol, Pepcid, and Gas-X and iced my arm. It took several hours to fall back to sleep but I finally slept from about 5:30 am till about 11:00 am.
Information has been received from a registered nurse concerning an 11 year old male child with no known allergies who on approximately 27 JUN 2001 was vaccinated with a first dose of Hepatitis B vaccine recombinant (yeast). On approximately 28 JUN 2001, 24-48 hours post dose, the child broke out in an itchy rash all over the trunk of his body. It was reported that the nurse said "it looks like an allergic reaction, but it is not hives." It was noted that the rash still persists. Unspecified medical attention was sought. Follow up information has been received and indicated that the reporter determined that the rash and the itchy allergic reaction were not related to the therapy with Hepatitis B vaccine recombinant (yeast). Additional information has been requested.
45 minutes after the vaccine, daughter and pt. stopped at a restraint for breakfast.  Pt. stated that he had to go to the bathroom and he felt limp and needed assistance with ambulation to the bathroom.  Went home and sat in the recliner and said he felt like a limp noodle and was incontinent of urine.   Pt. states that he had a fever (did not check it), brain fog and weakness.
Very swollen red itchy arm for four days so far.  Headache and rash on my bottom.  Runny nose and congestion.  Took the free Covid test that I received and it was negative.
diagnosed with a microscopic/colitis/drastic change in bowel habits/ function /always loose and excessive bowel movements 3 to 6 times a day; This is a spontaneous report from a contactable other nurse (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Dec2020 12:00 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunisation at workplace clinic. The patient medical history and concomitant medications were not reported. No structured information. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021 04:00, within 24 hours (as reported), the patient had a drastic change in bowel habits/function even had an accident in his sleep and woke up not knowing what happend. The patient had abnormal and always loose and excessive bowel movements 3 to 6 times a day. Immodium helps on his Drs advice. Patient had had a colonoscopy and was diagnosed with a microscopic/colitis. Patient will soon start a course of entocort (Budesonide). The patient had not taken or was he taking any medications during or prior to vaccination except the immodium when this all began. The patient was certain this was an adverse event from the vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included immodium, stool culture, colonoscopy and entocort. The event did not prolonged hospitalization. Outcome of event at the time of last observation was recovering/resolving.  Information on the lot/batch number has been requested.; Sender's Comments: Based on possible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported event of colitis microscopic. 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
Received Moderna on 4/2/2021.  Received Pfizer on 4/23/2021.