chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in my face; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced swelling in face. The clinical outcome of the event "swelling in my face" was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
woke up at 1 am and projectile vomitted all over my bed and the floor, thought I was going to faint- did not sleep the rest of the night due to sweats and chills, horrible headache
pt experienced shortness of breath (even after using inhalers) her arm is red and she is in a considerable amount of pain. she went to the ER last night but is back at home.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced confirmed covid-19 infection.  Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection. This report was non-serious. The suspected product quality complaint has been confirmed to be there was insufficient time elapsed for immunity to be developed. product quality complaint was voided. based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case assessed as non serious.
5 cm red, raised, bump at injection sign associated with pain at site starting 9/28/2013.  Symptoms started to subside on 10/01/2013.
DIARRHEA; DOESNOT FEEL RIGHT; ARM WAS SORE AT THE INJECTION SITE; NAUSEA; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced does not feel right. On 02-APR-2021, the subject experienced arm was sore at the injection site. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is sore at the injection site, diarrhea, nausea, does not feel right and tired was not reported. This report was non-serious.
admitted with stroke; He had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2021 (between his 1st & 2nd dose of Pfizer BioNtech).; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number; Unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE, dose 2 via an unspecified route of administration on 21Mar2021 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number; Unknown) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he had symptoms of an illness (perhaps covid like symptoms) starting on 19mar2021 (between his 1st & 2nd dose of pfizer biontech). (illness) on 18Mar2021, admitted with stroke (cerebrovascular accident) (hospitalization) on 08Apr2021. The patient was hospitalized for admitted with stroke (cerebrovascular accident) on 08Apr2021 in ICU currently/still as of 11Apr2021, not yet recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021, sars-cov-2 test: negative on 08Apr2021. Therapeutic measures were taken as a result of admitted with stroke (cerebrovascular accident). A 36 year old brother in law of my friend. He had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2021 (between his 1st & 2nd dose of Pfizer BioNTech). He went ahead and got his 2nd dose on 21March2021. He then went to see his dr in the last week (week of 05Apr2021 I believe) because of not being well. That primary care dr thought the patient had perhaps been exposed to covid between the 1st & 2nd doses (due to symptoms that the dr thought seemed like body's over-reaction to covid) but a covid test was done and it was negative. Then the patient has been admitted to (Hospital name) in (city name) (state name) suffering from a stroke on 08Apr2021. He still has not tested positive for covid (again) but he is in ICU at (Hospital name) with stroke symptoms. This was all related to my by the sister-in-law (my friend (name)). I wanted to report since the 2nd dose Pfizer BioNTech was taken on 21Mar2021 & then in hospital ICU with a stroke (at 36 yrs old) on 08Apr2021. Hospitalized for 4 days in ICU currently/still as of 11Apr2021, not yet recovered, admitted with stroke on 08Apr2021. The outcome of the event for illness was unknown and for stroke was not recovered.  Information about Lot/batch number is requested.
itchy rashes all over her body which started on her left arm; rash; headache; muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy rashes all over her body which started on her left arm), RASH (rash), HEADACHE (headache) and MYALGIA (muscle pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 PRURITUS (itchy rashes all over her body which started on her left arm), RASH (rash), HEADACHE (headache) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency; CALAMINE for Itching, at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and HYDROXYZINE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy rashes all over her body which started on her left arm), RASH (rash), HEADACHE (headache) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
large local rxn characterized by 14 x 8 cm macular erythematous area on deltoid;
Fever, chills (14 hours after vaccination), fatigue (0800 next morning, slept next 25 hours),  mild lingering headache, nausea, loss of appetite  (started 0800 next morning). No treatment, symptoms gradually receding.
Had acute abdominal pain that irradiated to my upper back in the evening. I had experienced a sore stomach earlier in the day, and took Pepto Bismol (assumed it was indigestion).  Acute pain started about 30-45 minutes after eating dinner. Originally thought it was severe indigestion, but pain lasted 3+ hours. Pain alternated between dull and sharp (breathing in and moving my body made the pain worse). I had to be helped off the bathroom floor and into bed because I couldn?t move myself. I got dizzy and had trouble explaining my symptoms. Went away after I laid down in bed, drank water and used a heating blanket. Pulse, BP were normal and I had no fever. Likely unrelated to vaccine since I got my booster shot almost a week before these symptoms, but I wanted to report just in case it is helpful in identifying patterns post-vaccination.
Information has been received from a pharmacist concerning a male physician over 50 years old who was vaccinated with Zostavax (Oka/Merck). The patient received the Zostavax intramuscularly instead of subcutaneously and he got a red arm. Additional information is not expected.
1st dose: Swelling  and redness on injection site (1st day).  Chills, nausea on 2nd day. 2nd dose: Swelling, redness, nausea chills on 1st and 2nd day 10 days after 2nd dose:  nausea, fever, headache, chills that lasted 3 days. Took Tylenol for three days.
Information has been received from a physician concerning a 25 year old female patient, with no allergies who on 05-OCT-2009 was vaccinated a 0.5 mL dose of with GARDASIL, intramuscular route (lot # unknown). Concomitant therapy included ORTHO TRI-CYCLEN. On 05-OCT-2009 the patient noticed tenderness in her shoulder after GARDASIL had been administered in her left deltoid. She experienced severe pain for 2 days, then persistent pain to the present day. The physician reported that there was a tender, hot, swollen area 3 cm at injection site where the pain extended to her shoulder begins. The physician considered it a mild or partial disability because the patient found difficult even to raise arm to put on a T-shirt and she was having problems sleeping. The patient has been treated with an unspecified anti inflammatory with no relief, she was just started on CIPRO and LORTAB and directed to apply heat. The patient sought medical attention at the physician's office. At the time of this report the patient's outcome was unknown. Additional information has been requested.
received a PENTACEL vaccination in the office on 25MAR2022 instead of Boostrix with no reported adverse event; off-label use as per local labelling due to the age of the patient with no reported adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid  non-serious case received from a pharmacist via call center  This case involves a 41 years old and unknown gender patient who had received a pentacel vaccination in the office on 25mar2022 instead of boostrix with no reported adverse event and off-label use as per local labelling due to the age of the patient with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Mar-2022, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection (strength, site, dose, route, lot number, expiry date unknown) for immunisation  On 25-Mar-2022 the patient developed non-serious events received a pentacel vaccination in the office on 25-Mar-2022 instead of boostrix with no reported adverse event (wrong product administered) and off-label use as per local labelling due to the age of the patient with no reported adverse event (off label use) on the same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm start hurting today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm start hurting today) 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.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm start hurting today). At the time of the report, PAIN IN EXTREMITY (Arm start hurting today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was provided by the reporter.   Reporter did not allow further contact
Three days after I got the vaccine I woke up with a bad case of vertigo and still recovering it the next day (today)
It was reported that a 54 year old female pt received a fluzone vaccination administered in October 2001. The pt reports now having pneumonia two times, cracked lips, and a low grade fever since vaccination.
Substantial pain in arm where shot was given.  Onset of shivering at 10:00 PM thus did not sleep well (pain in arm and shivering).  Took ibuprofen to lessen pain.  Pain continues to mid-day following day but effects are lessening.
Patient was at vaccine clinic today for her 2nd dose. She reported to the vaccinator she had a mild reaction with the first dose. Verified with pharmacist we would observe her for an additional 30 minutes as a precaution. She received her vaccination and was sitting in a chair talking with another associate. Associate when she reported she began to feel dizzy, lightheaded, nausea and felt like she might pass out. Patient at this point laid on the floor and put her feet up, a cart was brought to the room and patient was able to get up and climb onto the cart with no difficulty. VSS, respirs easy and non labored. Patient laid on cart supine for approximately 10-15 minutes and then the HOB was elevated aprox 30-40 degrees, she was sitting up on the cart talking with another associate/friend drinking small water bottle provided and eating a bag of chips. She finished the water and stated she felt sick to her stomach, she was offered crackers. She did not appear to be in any respiratory distress at this time. She remained sitting up on the cart resting when she stated she was beginning to feel like she "does when she has a tree nut reaction" she then asked if she could get an "epi shot", we advised she was breathing easy and her oxygen saturation was WNL and did not meet criteria to receive an epi shot. Pt became upset and voiced "this is how I get when I have a reaction and I can breathe fine until I can't". Associate was advised if she felt she might need an epinephrine injection, she should consider being evaluated in the emergency department. She agreed to be transported to the emergency department to be evaluated for a possible reaction to the vaccine. Emergency department was notified of patient, patient was transported by cart to the ED accompanied by RN. report given to ED staff. ED Visit to Hospital Emergency dept: : ED Visit at hospital resulted in patient receiving 2 doses of Epinephrine, solu-medrol and Benadryl.
uneasy stomach; severe diarrhea; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (uneasy stomach), DIARRHOEA (severe diarrhea) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (uneasy stomach), DIARRHOEA (severe diarrhea) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, ABDOMINAL DISCOMFORT (uneasy stomach), DIARRHOEA (severe diarrhea) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
fever, chills, bodyaches, after first day and resolved in 24 hours.  hives started 2 days after vaccine, took 50mg benadryl for this. Prescribed prednisone 40mg daily as well.
Upper abdominal pain, left-sided upper chest pain, and shortness of breath. Patient says her symptoms have been ongoing since her diagnosis of the anastomotic leak in early January but became noticeably worse 2 days ago. She says her stomach pain is a burning sensation that radiates to her left upper chest and left shoulder. She endorses nausea, dizziness, decreased appetite, and retching.
This spontaneous report was received from a 60 years old female patient with high blood pressure, high cholesterol and sulfur hypersensitivity concerning her. The patient was vaccinated with ZOSTAVAX (dose, route, and lot not reported) on 09-JAN-2013. No other co-suspects were reported. Concomitant medications included enalapril maleate (manufacturer unknown), omeprazole, simvastatin (manufacturer unknown) and acyclovir. On 10-JAN-2013, the patient had a red silver dollar sized circle with bumps that hurts. No treatment information was reported. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Patient returned day after immunization showing swelling of upper left arm. Swelling was present from upper deltoid down to elbow (approx 4"-6"). Skin was hot to the touch. Patient made office appt. with PCP for 10-19-12. Taking BENADRYL and Ibuprofen until MD appt (In Left Arm).
This spontaneous report received from a medical assistant referred to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated with GARDASIL 9 on 28-DEC-2015, 01-MAR-2016 and on 22-NOV-2016. Physician stated that the patient developed a knot under her skin at the injection site where {and after) she was vaccinated with the third dose of GARDASIL 9. The knot felt like a large marble that is in the muscle tissue of the patient's arm and the knot has increased in size since the patient received her third dose. Physician stated that the patient mentioned the injection site area is tender to touch. Patient did not receive any treatment for the events and the events had not recovered. Causality was not reported. Additional information has been requested.
Core body chills lasting approximately 12 hrs.  Fatigue lasting 36 hrs.  Strong twitching of extremities & ?jolting? of full body (similar to Restless Leg Syndrome, which I do not have, but at heightened frequency, intensity & duration). Cognizant & lucid during episodes. Lasted approximately 90 minutes until I fell asleep. Upon waking, this symptom was gone.  I have had infrequent, random full body ?jolts? since this time.  I?ve not ever experienced this body twitching in past.
Began experiencing severe right shoulder pain in November 2000. This was followed by severe loss of range of motion and then in January 2001, by severe atrophy of right shoulder as well as numbness. Physical therapy was performed from December 200 to March 2001. This was diagnosed as axillary neuropathy of right shoulder. Pain was so severe that I had to go to a hospital emergency room 12-1-00. Shoulder has gradually regained some range of motion, strength and size, but I have been told by two neurologist that it will probably never regain all of the size, muscle mass and strength it possessed before. This has also lead to pain and stiffness in my right neck, which still persists. I began to experience pain in my right elbow in September 1999. The pain became worse in September 2001 to the point where I had to quit lifting weight for a while. The pain still persists if I lift weight or perform athletic feats such as throwing or shooting a basketball. Also I cannot entirely straighten the elbow. X-rays revealed that there is floating cartlidge and arthritis in the elbow and tendinitis also. Surgery is a possibility, but there is no guarantee it will totally solve the problem. I began to experience dizziness and resulting stomach upset in October 1999. I have since been diagnosed as having Meniere's syndrome. Dizziness became worse around November 2001 and the tinitus has became more noticeable. I see an ear, nose and throat doctor on a regular basis and take prescription medication for the problem, which fluctuates in intensity from day to day and sometimes affects my sleep when it is more intense. My right foot was already giving me discomfort starting in October 1998 due largely to a bone spur on top of the ankle. As the summer of 1999 the pain spread more to the outside of the ankle. Specialist said there is a cyst on the inside of the ankle joint, that is blocking the blood flow to the joint. An operation could be performed to open up the cyst but once again there is no guarantee it would provide noticeable benefits. I began to experience severe fatigue in September 1999. Blood work was done in October 1999 and there were no abnormalities found. Fatigue was so severe at times, I felt I could not keep my eyes open. It persisted on a regular basis until around spring 2001; since that time, it does not seem as severe, or as frequent, but it is still a problem occassionally.
The Order written by the RN was written for DTAP when it should have been written for TDAP. After vaccine was given, TDAP order was written ( but it was after the fact )
Child was given pedi dose of Pfizer vaccine. Wrong dose received was wrong per child's age. Noticed error during documentation. Mother informed of wrong dose given, returned immediately to clinic to receive correct dose.
Became very tired that evening, woke up sore (at injection site and my whole body) and with a headache the following day.
Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration in left arm on 15Jan2021 at 08:30 AM at single dose for COVID-19 immunization. Medical history included CAD (coronary artery disease), mild COPD (chronic obstructive pulmonary disease) and GERD (gastroesophageal reflux disease). Patient had Covid prior vaccination. Patient was not pregnant. Patient has no known allergies. No other vaccines in four weeks. Concomitant medications included rosuvastatin calcium (CRESTOR), carvedilol (COREG) and vitamins (unspecified). On 16Jan2021 at 01:00 PM, the patient experienced fatigue, joint discomfort, mild fever, and mild headache. Patient did not receive treatment for the events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Fever highest so far at 101.6 , heart rate 132 at highest taken.
Screamed from 12N-2300 day of vax; refused most feedings; mild swelling of thighs-dec to nl w/in 24 hrs;