chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache, malaise, fever, alternating chills, drenching sweating, exhaustion but unable to sleep due to fever and chills.  Sicker than have ever been in life.   Severe depression during/after.  Continued 4 days/nights, then slowly waned.  Depression, exhaustion another week.
Several hours later at 7pm when felt better temp was taken 99.5 degrees; Subject was irritable in the morning around 10am the next day after 2nd vaccination; Slept fine the night before, that morning was lethargic; Complained of a headache; Tired; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP).  A 7-year-old male patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Lot number: FK5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5127, Administration time: 17:15), administration date: 08Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: IRRITABILITY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Subject was irritable in the morning around 10am the next day after 2nd vaccination"; LETHARGY (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Slept fine the night before, that morning was lethargic"; HEADACHE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Complained of a headache"; FATIGUE (non-serious) with onset 04Dec2021 at 10:00, outcome "recovered" (an unknown date in Dec2021), described as "Tired"; PYREXIA (non-serious) with onset 04Dec2021 at 19:00, outcome "recovered" (an unknown date in Dec2021), described as "Several hours later at 7pm when felt better temp was taken 99.5 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of irritability, lethargy, headache, fatigue and pyrexia.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient wouldn't let take temperature in the morning on 04Dec2021. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included sub total thyroidectomy. The subject past medical history included two normal births, one spontaneous abortion and one elective abortion. On an unspecified date the subject received unspecified dose of BOOSTRIX (intramuscular, unknown). Her last menstrual period was on 22 April 2011 and estimated date of delivery was 12 December 2011. The subject was exposed to BOOSTRIX during unknown trimester. On an unspecified date, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy. The pregnancy was by normal conception. At the time of the report, there was no evidence of a defect from prenatal testing. The outcome of the pregnancy was unknown. Follow-up information was received on 03 April 2012. It was reported that the subject was 28 years old. Conception was reported to be normal. BOOSTRIX was administered to the subject intramuscularly, at 0.5 ml on 29 September 2011 (29 weeks, plus 3 days gestation). The mother prematurely delivered a live neonate of unspecified gender in October 2011. No defects were noted at birth. No further details were provided.
Anaphylaxis, RespDepression, UrticariaPruritus, tongue swelling, throat closing, itching all over Narrative:  states shortly after receiving her injection she begin itching and  her throat begin closing as her tongue swelled; states she was given dose of epi and Benadryl and instantly begin to recover;
Shortness of breath, burning in chest, not feeling well since second vaccine dose.  Now admitted with acute hypoxemic respiratory failure with PULMONARY EMBOLI and pulmonary infiltrates that are suspicious for COVID 19 with + Ab testing but many negative PCRs.
2 days after getting vaccine patient developed covid-like illness that has persisted for 10 days, including runny nose, congestion, cough, wheezing, shortness of breath, body aches, fatigue, malaise, headache, nausea, vomiting, diarrhea.
COVID SYMPTOMS; tested positive for covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid19) and SUSPECTED COVID-19 (COVID SYMPTOMS) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced COVID-19 (tested positive for covid19). On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID SYMPTOMS). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for COVID-19, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid19) and SUSPECTED COVID-19 (COVID SYMPTOMS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Guillain Barre Syndrome (AIDP).  Previously healthy and active 75yo pt developed progressive bilateral leg weakness accompanied by sensory changes over the course of 36hrs beginning 7/25-26.  Hospitalized 7/27 with progressive bilateral leg and arm weakness, absent reflexes, eventually unable to stand.  LP showed increased protein, normal cell count.  IVIG x5d started 7/27.  To date no progression to bulbar, facial or respiratory nerves.  Negative workup for other causes including recent viral infections, tickborne illness, diarrheal illness, medication, or other conditions.  Received COVID vaccination (as noted above) approximately 2wks earlier.
Arm turned red not at injection site, but on the back  and under the arm. Looked like it is probably improving now 2 days after the shot was given.
Upon injection, arm was wobbly and felt like fire, and sore. This faded quickly during the 15 minute observation period. No symptoms presented until later in the evening and included a fever of 99-101, chills, body aches, headache, nausea, and vomiting.
BROKE OUR IN HIVES ALL OVER BODY, FACE ,HANDS. VERY ITCHY. LASTED FOR 3 DAYS. TOOK BENADRYL AND STILL DID NOT HELP
Pt reports shakes, chills, sore arm, cant eat due to nausea started night of vaccination 10/11.
p/recv vax pt whole arm all the way to fingers; had tingling sensation & muscles ache;
Tinnitus.  After receiving my first shot on February 19, 2021, I began to experience a faint and intermittent ringing in my right ear and ignored it.  After receiving my second shot on March 12, 2021, the ringing in my right ear became louder and has continued.  Sometimes is it still faint and intermittent, and other times it is more intrusive and distracting.  At this point, I have not sought treatment, but may do so if it continues.
Red, raised, itchy rash anytime I went out into the sun. After a few weeks, I went to dermatologist who drew blood and I was found to have a positive DNA. Dermatologist referred me to rheumatologist, who did other blood work and diagnosed me with subacute cutaneous lupus. I?ve never had an autoimmune disease until this. Not sure if it?s related to the vaccine or not.
I have a 101 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 20th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for this report. The age group was not reported but captured as adult as per vaccine indication. The patient got the 2nd shot last night from the day of reporting.  They taken temperature and it was normal.  The patient got the shot and now the patient had a 101 degree Fahrenheit fever.  The patient did not have this kind of a reaction to the 1st shot.  The patient also asked how long can expect the side effects to last.
This spontaneous reprot as received from a other health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K006960, expiration date 19-FEB-2017 or lot # K011562 expiration date 08-APR-2017. No adverse effect was reported. Additional information has been requested.
That day had severe chills, muscle rigidity/muscle spasms, pain from thoracic area down back. Pt was hospitalized from the above and a severe rise in blood pressure.
Pain at injection site and swelling approx. 1 wk after receiving injection. No evidence of cellulitis.
On April 3rd I had trouble breathing and was out of breath going from the store to the car.  This happened on 2 occasions that day.  I went to my doctor on April 5th, 2021 and the next day they had to put in a pacemaker.  In addition I have numbness in both legs.  None of these symptoms had happened to be prior to the vaccine.
developed chest pain and shortness of breath 12 hours after vaccination and went to ED and hospitalized with PE and DVT and now on xarelto
Approximately 20 minutes after vaccine administered, pt reported feeling flush, heart racing, then dizzy.  Became tachycardic and tachypnic and reported headache.  Rapid Response called and patient transported to Emergency Department (ED).  Cardiac workup, CT of head done.  No acute process found.  Given Ativan, fentanyl without improvement.  Then given droperidol, Beandryl and Toradol and had complete resolution of headache. Other symptoms resolved. Discharged from ED at 2:22pm 2/1/2021.
Pt dx with cellulitis measuring 9cm X 12cm.  Pt tx'd with antibotics (Cephalexin)
Fever, chills, headache, sore and stiff in upper torso and neck and injection arm, sore wrist joints, dehydration, nausea, hives
Patient developed a rash to bilateral legs on 10/13/23. Has been using Cerave lotion which states has helped the redness but still has the bumps. Plans to call her rheumatologist today and then PCP.
Information has been received from a physician concerning a 21 week old white female with no known allergies and no illness at the time of vaccination who on 6/10/02 was vaccinated with a second dose of haemophilus B conjugate vaccine, hep B vaccine reocmbinant IM in the left thigh (lot 642223/0149M). On 6/10/02, the pt was concomitantly vaccinated with a second dose of Infanrix (lot 546192) IM in the left thigh, a second dose of IPOL (lot 60823) SQ in the right thigh, and a second dose of Prevnar (lot 485993) IM in the right thigh. On 7/1/02, the pt presented at the physician's office with severe left thigh swelling. The pt also drainage from a secondary infection. The pt developed an abscess which required surgical drainage. The pt subsequently recovered. It was reported that a little bit of scarring had remained in the area. The reporting physician felt that the pt's experience was an other medical event (OMIC). No additional info is expected.
Stiff Neck , Pain and discomfort , head fullness,pain to right and left side of face /ears
The day after my vaccination, 02/10/2021, extreme swelling on Right arm, fever of 102, fluctuating throughout day, I felt like I got hit by the bus because I had body aches, fever, chills. The next day, 02/11/2021 the swelling increased from the top of my shoulder to about 2 inches to my elbow and it was hot to the touch and red. I talked to a tele-doc on 02/11/2021,  because I was concerned about the swelling on my arm. The tele-doc diagnosed me  with localized swelling, mass on my Right upper limb. The doctor said it should go away on it's own. If it's still the same in 2 or 3 days to call my local provider.
5/5/18 Tinnitus very loud, increased congestion and heavy coughing for 9 weeks. 6/6/18 saw ENT and got Azelastine for tinnitus which I still have. Congestion and coughing necessitated excessive use of meds for 9 weeks.
Information has been received from a registered nurse concerning that a mother reported her 15 year old daughter with acne who on 21-JAN-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 666163/0664Z, expired date 18-SEP-2012) in her right deltoid. On 28-MAR-2011 the patient was vaccinated with the second dose of GARDASIL (therapy route not provided, lot # 667194/1271Z, expired date 11-DEC-2011) in her right deltoid. Concomitant therapy included EPIDUO. 2 days after receiving the second dose of GARDASIL, on 30-MAR-2011, the patient developed an itchy rash with hives "from her head to her toes". There was no reaction reported after the patient received her first dose of GARDASIL. It was reported that the mother did not plan to bring the child into the office for an assessment. No treatment was given for this adverse event. No lab diagnostics studies were performed. Patient sought medical attention via calling to the office. At the time of reporting, the patient had not recovered. Follow-up information was received from the registered nurse who reported that on 28-MAR-2011 at 11:30, the patient was vaccinated IM with the second dose of GARDASIL (lot # 667194/1271Z, expired date 11-DEC-2011) in her right arm. There was no illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. Two days after immunization was given, on 30-MAR-2011 at 16:45, the patient developed generalized hives. She visited a doctor who described the symptoms as urticaria, unspecified. Patient started on ZYRTEC. At time of reporting, patient's status was recovered. Additional information has been requested.
a 14 years old male patient received a 0.5 ml dose of Flublok Quadrivalent/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA291128 and 2019SA291169 (same reporter).  This case involves a 14 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910, expiry date: 26-MAY-2020 via intramuscular route in the left arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient recieved HEPATITIS A VACCINE as concomitant medication.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
06/25/2022 at 03:15 vaccination. Within 20 minutes, became lethargic and vomited at the 25 minute mark. Placed in car, in which he fell asleep which is not normal for pt. in that short distance. Got home and his temp was 100. Called pediatrician office and referred to urgent care. Temp was 101.8 upon arrival. Highest temp was 102 in which pt. threw up 1x more time. Got nausea under control. Fever lasted Saturday into Sunday. 06/26/2022 sniffles started in the morning. Pediatrician stated that it could have been a cold 'brewing' prior to vaccination, lingering cold.
swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: "two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own." The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient had uneasiness and perceived difficulty swallowing. On observation, the patient swallowed her beverage without difficulty and an absence of choking. On inspection of the oral pharynx followed by palpation, there was no edema present and patient's respirations were without stridor.
Chills; Temp up to 101.40 degrees; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in Left Arm on 12Mar2021 (age at the time of vaccination was 72 years) at 08:30 as dose 2, single for covid-19 immunisation. Medical history included liver transplant, immunosuppressed and diabetes type2 all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported and known allergies were reported as no. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809), via an unspecified route of administration, administered in Left Arm on 16Feb2021 (age at the time of vaccination was 72 years) at 09:30 as dose 1, single for covid-19 immunisation. Reportedly the patient did not have covid prior vaccination. On 13Mar2021 at 12:00, the patient experienced chills, temp up to 101.40 degrees and headache. It was reported that, 25 hours, next day after vaccine, Chills, Temp up to 101.40 degrees, headache for 12 hours, and it returned to normal next day, except took two days (48 hours) for headache to subside. On an unspecified date, the patient underwent lab tests and procedures which included body Temp up to: 101.40 fahrenheit (Temp up to 101.40 degrees). Therapeutic measures were taken as a result of chills, temp up to 101.40 degrees and headache which included treatment with Ibuproben, & bed rest until next morning. The patient was not tested for covid post vaccination.  The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Severe hives accompanied by shivering, significant itching,  three fainting  episodes close together about 8 hours after the onset of the hives and very low blood pressure following the fainting episode.  At home treatment taken on phone advise from Doctorr with Benadryl and Fomantadine with no effect.  Prednisone now prescribed.  Doctor had suggested a visit to ER but this was taken as the patient was more stable at this time.  Potential life threatening event due to the fainiting and low blood pressure/heart rate.  These symptoms have occured on previous occassions  as a result of virus and other infections.
red spot on the injection site; cold sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (cold sensation) and RASH MACULAR (red spot on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No medical history reported.).  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE COLDNESS (cold sensation). On 11-Feb-2021, the patient experienced RASH MACULAR (red spot on the injection site). On 11-Feb-2021, VACCINATION SITE COLDNESS (cold sensation) had resolved. At the time of the report, RASH MACULAR (red spot on the injection site) had not resolved.        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 medications reported by investigator  No treatment medications provided by the reporter.
mom states that pt woke up w/fever of 103 R;  pt had flu; pt seen by MD;
Flu like symptoms; Diarrhea; Headaches; Joint pains; Chills; Fever; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Fever, at a dose of 1 dosage form. On 10-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.   This case was linked to MOD-2021-317521 (Patient Link).