chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine; an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician).  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 10 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neurological issue" (unspecified if ongoing), notes: pre-existing neurological issue. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), GAIT INABILITY (non-serious), all with latency 15 min after the suspect product(s) administration, outcome "unknown" and all described as "an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine". The events "an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine" required emergency room visit. Additional information: States the product is the Pfizer BioNTech Covid19 orange cap vaccine 10mcg dose and the reporter had an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine; states the patient was sent to the emergency room immediately and the adverse event occurred immediately within 15 minutes of the patient waiting after the dose of vaccine was administered. States he does not know the route of administration of the vaccine or location of administration but the reporter was stating how she had done the vaccine in the upper arm but he does not want to mistakenly say that and he does not have the date of administration of the vaccine. Caller states the reporter did state that the patient has underlying neurological condition and did not clarify but it was a preexisting neurological condition the patient had before the vaccine was administered but did not clarify further details. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen lips started on 1/16 Redness, rash. on face noticed on 1/17 in am upon waking up.  Swollen lips continues.
Vaccine  temp excursion occurred. Dose administered was affected by improper storage before administration which was caught after the fact.
arm hurt in cold weather; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. In 2019, the patient received Shingrix and had pain arm. The patient took cough medicine later right arm hurt in cold weather.
This patient has back aches, a rash in the groin area, and a rash under the arms.
Two doses administered on same day; This case was reported by a physician via sales rep and described the occurrence of overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received Shingrix and Shingrix. On 7th April 2022, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The doctor reported that two doses of Shingrix was administered to the patient on the same day. Additional Supportive Information: The patient received two doses of Shingrix on the same day, which led to overdose.
50 y/o male PT presented with dizziness and feeling hot after receiving his vaccine. PT was a/o x 4. PT has no allergies, not on any current medications, and has no medical Hx. PT only had coffee while golfing 18 holes prior to receiving vaccine, with no food eaten today. EMT seen patient. PT first set of vitals taken @ 1211 BP 122/85 HR 79 RR 16 spo2 96 on room air pain 0  PT second set @ 1216 standing BP 129/88 HR 90 RR 16 spo2 93 on room air pain 0  PT third set @ 1221 133/91 HR 70 RR 16 spo2 98 on room air pain 0. PT temperature taken @ 1217 = 97.2 PT -EMT Taken into medical area for further evaluation and privacy by EMT. Upon RN arrival patient appeared diaphoretic, sweat on his scalp, no visual signs of distress. Patient speaking clearly. Patient was sitting in chair drinking a bottle of water while EMT took his vital signs. Patient admitted he usually fasts in the mornings and eats ?around this time?12pm, but since he was running late for his vaccine appointment, he decided to skip eating. ?I feel better now that I have had the water?. ? PHN Vital signs looked stable as listed above and patient denied feeling weak, dizzy, or visual changes. Second set of vitals were completed while patient was standing, once again denied feeling dizzy or weak and felt good to walk on his own. Last set of vitals taken while he was sitting and mentioned his son would be driving him home. Patient took a bottle of water to go. EMT verbalized he would escort the patient out of the building. Patient exited building by 12:30pm ? PHN  PT felt much better after drinking a bottle of water and vitals taken. PT was escorted to car where his son picked him up w/o incident.EMT
This spontaneous report was received from a consumer refers to her first brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of M-M-R II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also states that her mother told her the rest of the M-M-R II series was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
I had fever, chills, and extreme fatigue. I had to sleep a lot. I was very tired. I had to take time off work. It was very hard to breathe. It was impacting my chest and lungs. I was absolutely exhausted. I went to the doctor within days of receiving the vaccine. Like the third or fourth day. She said that it was because of the vaccine. She said I should start feeling better in about 7 days. But I was still feeling bad by that time. They did not do any medical tests or prescribe any medications. They just told me to take Tylenol. I had the second dose on 03/09/2021 (lot number 014M20A), and the next day I had the same symptoms but the fatigue was way worse. My lungs felt worse than with the asthma. I had a headache that lasted a long time. It lasted for days. I would get up and try to go to the bathroom and it took all my energy just to go there. I felt like I was totally wiped out. I have been having terrible migraines, which I have not had in years. I cannot get my energy back. My asthma feels worse than it used to.
Hives everywhere, intense itching, asthma symptoms that required a nebulizer treatment every day for 2 weeks
GUILLAIN-BARRE SYNDROME; PAIN; This spontaneous social media report via Johnson and Johnson was received from a consumer via a company representative and concerned a female patient of unspecified age, race and ethnicity. The patient's weight, height and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number unknown), dose and vaccination date not reported, for prophylactic vaccination. The company is unable to perform follow-up to obtain the batch number. No concomitant medications were reported. The consumer reported that, on unspecified dates, that their aunt 'after days of pain and sending her home 3 times' (not reported what type of facility sent the patient home), she was diagnosed with Guillain-Barre syndrome 'as a reaction to the vaccine'.. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the pain and Guillain-Barre syndrome was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from a consumer via social media concerns a female of unknown age, race, and ethnicity who was diagnosed with Guillain-Barre syndrome (GBS) an unspecified period of time after receiving the Janssen Covid-19 vaccine.  Medical history, concomitant medications, clinical symptoms, diagnostic testing, corrective treatment, and outcome were not reported. Information is limited in this case. Therefore, the relationship of GBS to vaccination is considered unclassifiable due to insufficient information. More information will be requested if contact information is available.
Mild rash and itching around injection site; itching around injection site (multiple small red bumps); itching around injection site (multiple small red bumps); This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 14:45 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included celiac disease, Sjogren's syndrome, connective tissue autoimmune disease, allergies to Gluten. Concomitant medication included cetirizine, citalopram, curcuma longa (TURMERIC), ergocalciferol (VIT D), ethinylestradiol, norethisterone acetate (MICROGESTIN), fish oil, hydroxychloroquine, pantoprazole, simethicone, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild rash and itching around injection site (multiple small red bumps) on 31Dec2020, all events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number has been requested.
overheated shaky, sweaty, fatigue decreased appetite, nausea, unable to lift left arm and left arm pain
VACCINE ADMINISTERED AFTER IT EXPIRED; This spontaneous report received from a health care professional concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient had no current medication usage, had no known medical conditions and did not mention any adverse effects. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced vaccine administered after it expired. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine administered after it expired was not reported. This report was non-serious.
Noticed red circle  at injection site in PM on day 12.  Next AM - Day 13- red area had enlarged, was swollen and warm when touched. Continued to enlarge for a couple days then reduced and went away.  No other issues.
Rash on upper arm started 7 days after vaccine at the vaccination site.  some itchy dots underneath  eye. It was hot and itchy. Day 2 it was raised and larger. Day 3 it was at it's worst and I thought I had to go to the ER. The rash on my left arm was very bad and hot and raised. I had taken Benadryl at night and also applied cortisone cream on rash. The rash on my face underneath my eye got worse and it also was now underneath the other eye, My eyes where very red and felt scratchy and got very teary by the end of the day. Also some swelling and itching of upper lip.  Day 4 issues in the face got better, but arm rash spread and even got some on the lower arm. Day 5 no more rash in the face or sensitive yes or lips. It is day 5 now and my upper arm still feels warm and has a rash with red blotches, but it is getting better.
Patient received 3 doses of Pfizer COVID 19 vaccine.  Per patient she had received Pfizer on 1/14/2021 but did not show for her second dose.  She states she was told she needed to start the series over again and called and rebooked a 2 dose series.  It was noted on entry in the Medical Records that the dose given on 3/18/21 was a third dose.
Initial and follow-up information has been received from a pharmacy student and a pharmacist concerning a 72 year old male with hypertension and leukemia and a history of chickenpox who on 10-JUN-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659408/0300X). Concomitant therapy included MAVIK, MSD, omega - marine triglycerides and vitamins (unspecified). Rash did not occur at the site of injection post-vaccination. On 16-JUN-2008 the patient experienced fluid filled nodule, similar to a boil, on his leg after receiving ZOSTAVAX vaccine (Oka/Merck). The nodule was drained by the patient's physician and the patient was placed on antibiotic therapy. The patient experienced two additional nodules in the same area after the initial nodule was drained. At the time of this report, the patient's symptoms persisted. On26-JAN-2008 a specimen on the patient was sent to the laboratory. Final Varicella zoster virus identification polymerase chain reaction test result was negative. Follow-up information from a nurse stating the physician had seen the patient and cultured a blister sent to the laboratory and did not have any additional information to provide. Additional information is not expected.
Pt had some amazing hallucinations and was actively communicating while I believe he was asleep.  He called me on the phone and his voice was slurred and he thought he was being held down by some things that were flying around.  I was able to direct him to sit up after ensuring him that he wasn't being held down and eventually get him to walk to the bathroom, turn on the light and look in the mirror and describe to me what he saw (he lives at a different address than I do).  By this time, he had "woken" up and his voice was no longer slurred and he was "making sense".  My concern was that he had had a stroke or Bell's palsy or something.  He was fine and slept well the rest of the night.  I will bring him to my home after his second shot just in case this happens again.  He hallucinated after his anti-anxiety medications for the first couple of weeks and to a more minor amount with his other medications, again for the first couple of weeks.  I am assuming that his brain reacted to the vaccine with hallucinations but I don't know.   This may be nothing or it may be something that other patients are experiencing, who the heck knows.
he patient presents with PATIENT PRESENTS EMERGENCY DEPARTMENT AFTER HAVING A FALL A COUPLE DAYS AGO WAS EVALUATED IN THE ED WITH NEGATIVE IMAGING.  HAD WENT HOME AND FOLLOWED UP WITH HIS PRIMARY TODAY.  HE WAS HAVING SOME PAIN ON HIS RIGHT POSTERIOR HIP AND BACK STILL AND HAVING DIFFICULTY WITH AMBULATION SO THE PRIMARY USED A WHEELCHAIR AND WHEELED HIM OVER HERE FOR ADDITIONAL IMAGING AND FURTHER EVALUATION.  PATIENT DENIES ANY NAUSEA OR VOMITING.  NO HEMATURIA DYSURIA.  OF NOTE HE IS BEING TREATED WITH DOXYCYCLINE FOR UTI BY HIS UROLOGIST BECAUSE OF FREQUENT KIDNEY STONES.  DENIES ANY CHEST PAIN.  NO DIZZINESS.  WAS MECHANICAL TRIP AND FALL.  HE IS ON XARELTO..  The onset was 2  days ago.  The course/duration of symptoms is fluctuating in intensity.  The degree at present is minimal.  Risk factors consist of age.  Prior episodes: occasional.  Therapy today: doctor's office visit.  Associated symptoms: none.
09:08 PATIENT STATES THINKS SHE MAYBE HAVING A LITTLE HARAD TIME BREATHING. PATIENT HAS NO LIP OR TONGUE SWELLING  AND IN NO APPARENT DESTRESS.  09:20 PATIENT TATES FEELS FINE MOM STATES FEELS OK WITH LEAVING AND FOLLOWING UP WITH URGENT CARE IF SYMPTOMS RETURN FURTHER NEEDS. PATIENT LEFT WITH MOM IN NO APPARENT DISTRESS.
This spontaneous report as received from a physician refers to a 13 year old female patient with non medical history. On an unspecified date in 2014 about 4-6 weeks ago the patient was vaccinated with dose 1 of GARDASIL (lot# was not reported). There was none concomitant medication. The patient became light headed, pale and looked like she was going to faint. The physician instructed the patient to sit down and the patient felt better a few minutes later. No treatment was given for the adverse event. No lab diagnosis study was performed. The patient sought medical attention in the office. The patient recovered the same day that GARDASIL was administered. The physician stated that the patient plans to continue with the GARDASIL series. The physician reported that the patient had not consumed an adequate amount of fluids before receiving GARDASIL vaccination. Additional information has been requested.
Within 24 hours the patients left arm became hot and swollen, Temperature went to 102., her arm was also very painful. Temperature was 100-101 for 48 hours. Redness persisted 4 days, swelling for 7 days. Antibiotics were started on day 3 and continued for 10 days.
Patient was present in the clinic on 7/26/2022 for her 1st dose of Moderna (6 months ? 5yrs formulation, lot number AS1414B). Parent was holding the child. The child had her right vastus lateralis cleaned and exposed for vaccine administration. The RN vaccinator, was close to inserting the needle when the child kicked her leg, and the needle dislodged from the vaccinator?s hand. The needle fell on the floor. The RN was able to confirm that the entire dose remained in the syringe. The RN was able to assess the site in case of any scratching or bruising. The RN discarded the initial syringe, and obtained a new syringe (Moderna, AS1414B, 0.25ml dose).   The RN notified the Charge nurse, (also a registered nurse). Parent received demonstration on how to hold child safely. On the second attempt, the same site was exposed to clean, and the vaccine was administered successfully. The parent was educated on watching the child for any soreness and that the child can be given children?s Tylenol for comfort.
Pre-medicated with Zyrtec per recommendation of immunologist/PCP.  Reported difficulty breathing within 10 minutes, transported where Epi and Benadryl were administered and was then transferred to ER where Solumedrol and Famotidine was given and then patient was kept for observation for 5 hours.  Intermittent shortness of breath continued through day 3.     The vaccine clinic Employee Health Nurse said I should let you know.     Incidentally, when I was walking out of the ED, I was short of breath.  If I sat quietly, I was fine, but I continued to be SOB with walking and talking for 24 hours.   Today I am not short of breath, but I am dizzy.
Right arm where injection was given after 10 hours started to swell and turn red. No fever, chills or sweats. Dr was made aware, ordered Cipro 500mg 1 qd x 1wk. Advised if fever call office or seek medical treatment right away.
Within 5-10 minutes after receiving injectable influenza, became short of breath went for inhaler, & EPIPEN administered by RN, vital signs, recovered without incident.
Went to ER.  Stayed in Cardiac  Ward.  3 days.  Treated  with heparin, nitro drip.  Several test done.
macular erythema on hands (dorsal & palmar) feet (dorsal) w/minimal out break on arms legs; rash is pruritic; also c/o h/a; doubt this is related to vax since no react @ inject site & took codeine day of vax;
Headache, nausea/vomiting, arthralgia, bruising, itching and hives.
biopsy proven acute glomerulonephritis with marked nephrosis (over 10 grams proteinuria) and acute renal failure with Creatinine now at 1.5 mg/dl.  Had rash to shots 1 and 2.  On  third shot had rash and now nephrotic syndrome and renal failure.  Rash was immediate after each shot.  nephrosis was manifested several weeks after third shot
Aching all over the body; chills; headache, no fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aching all over the body), CHILLS (chills) and HEADACHE (headache, no fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Aching all over the body), CHILLS (chills) and HEADACHE (headache, no fever). At the time of the report, MYALGIA (Aching all over the body), CHILLS (chills) and HEADACHE (headache, no fever) had not resolved.            Treatment information was not reported.
Tested positive for Covid on April 14; Tested positive for Covid on April 14; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 13:30 (at the 62-year-old) as single dose for COVID-19 immunization and it was administered in hospital. Medical history was not reported and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Concomitant medication in two weeks included citalopram. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 13:45 as single dose for COVID-19 immunization and had contracted COVID. On 14Apr2021 at 09:00, patient tested positive for COVID. The patient underwent lab tests and procedures which included nasal swab as positive on 14Apr2021 and negative on 12May2021. It was unknown if the patient received any treatment for adverse event. The outcome of event COVID-19 was recovered on unspecified date in 2021.  Information about batch/Lot number has been requested.
This medically confirmed report (initial receipt 28-Mar-2014) concerns an 83-year-old female patient. No medical history was provided. The patient was "otherwise healthy". In Sep-2012, the patient was vaccinated with PNEUMOVAX 23, which may have been a booster dose. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was unable to tolerate the flu vaccine. The patient had been previously hospitalised at an unspecified facility on an unspecified dates. Outcome was reported as recovered. Reporter's comment: The health authority assessed the case as serious. The pharmacist was unsure if the patient received more than one dose of PNEUMOVAX 23 and if the patient was hospitalised after receiving a dose of PNEUMOVAX 23 before Sep-2012. The authority reported preferred term of 'pneumonia'. Case correction (02-May-2014): Ae 1 re-coded. Case correction (10-Jul-2014): AE 1 re-coded. Follow-up (01-Sep-2014)- Case upgraded to serious, patient details, new event, manufacturer information for influenza vaccine, additional suspect vaccine, vaccine administration information and clinical course.