chrisvoncsefalvay/vaers-outcomes huggingface dataset:
More muscle pain / aggravated; Hip and joint pain / joint pain described as severe; Muscle skeleton pain; This case was reported by a nurse and described the occurrence of musculoskeletal pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included psoriatic arthritis. Previously administered products included Flu vaccine with an associated reaction of arthralgia (received flu vaccine in 2015, refer case US2020AMR261139 ).   On 26th October 2020, the patient received the 1st dose of Shingrix. On 26th October 2020, less than a day after receiving Shingrix, the patient experienced musculoskeletal pain. On an unknown date, the patient experienced muscle pain and arthralgia. On an unknown date, the outcome of the musculoskeletal pain was recovered/resolved and the outcome of the muscle pain and arthralgia were unknown.   It was unknown if the reporter considered the musculoskeletal pain, muscle pain and arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported the patient administrated Shingrix on 26th October 2020 with the 1st dose of Shingrix and felt a muscle skeleton pain after the injection.  The muscular skeletal pain she experienced after dose of Shingrix began a couple of weeks no exact date provided. The  reporter described the muscular skeletal pain as more muscle pain that also aggravated previous hip and joint pain. The reporter consented to follow up. There is discrepancy in the time to onset of m muscle skeleton pain, the onset date was provided same as vaccination date, however in the narrative it was mentioned couple of weeks and few days after vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261139:Same reporter
Per web report received by Public Health Department and per state Immunization Registry; Presented 11/03/2022 to  Hospital ED for evaluation of sudden onset of slurred speech and confusion that started at 3 PM. Patient was last known to feel well at bedtime yesterday. In the emergency department, symptoms spontaneously improved. Patient was positive for COVID-19 per 4-plex PCR. Patient is vaccinated: Denies having cough, shortness of breath, congestion, or sore throat. Patient has generalized weakness with confusion. Saturating well on room air, no indication for initiating antibiotic management or steroid therapy -Isolation per protocol, plan for 10 days of isolation starting from 11/3/2022. Pfizer 02/02/2021 lot EN5318;  Pfizer 02/23/2021 lot EN6200;  Pfizer 09/22/2021 lot 301308A;  Pfizer BvlntBstr 12+ 11/01/2022 lot GJ6665 Per web report this Patient was recently started on Zanaflex for back pain, 11/03/2022 is day 3 of using Zanaflex. Urinalysis negative for UTI. WBC 8.9, hemoglobin 11.6, random blood sugar 142, creatinine 1.5/consistent with previously, potassium 4.3, anion gap 8, bicarbonate 28, normal liver function test, normal initial troponin, lipase 31, INR 2.2CT. note stated head stroke protocol negative for acute findings. Differential diagnosis of metabolic encephalopathy, infection, TIA/CVA, medication reaction, other. Stroke protocol initiated. CT head negative. The patient was not a tPA candidate because patient is on daily Xarelto. INR 2.2. Symptoms essentially completely resolved. Patient also had a COVI D-19 vaccination 11/1/2022. Patient given 4 baby aspirin. Per web report there was no evidence of UTI or other infections. Patient was admitted to the hospital to continue care. Public Health Department has no further information on this patient?s hospitalization or outcome. Please contact provider for any additional information.
PATIENT WAS GIVEN AN EXPIRED VACCINE.   AT THIS TIME THERE HAS BEEN NO REPORT OF ANY PHYSICAL HARM FROM THE VACCINE.
Patient says that her arm started itching a little the night of 7/15/2015. By morning on 7/16/2015, her injection site had a red, swollen, painful rash that had spread almost to her elbow.  She used Tylenol and Caladryl for relief.  I saw the rash on Sunday (7/19/15) and on Monday (7/20/15) and it had improved. I am unable to determine whether this was a reaction to something in the vaccine or a very mild shingles rash.
Patient present with rash on upper part of left arm. Also reports urticaria that started on 8/28/15. Father advised that he was not aware of anything until 8/30/15. He gave her BENADRYL last night that did help with itching. No signs of redness. No swelling noted.
After 15 minutes of giving KINRIX, VZV and MMR, the child developed coughing, hives and swelling of the lips.
Red spot on left arm where at injection site.  No pain but slight itching and slight pain when laying on arm at night.  Two days after the shot dizziness, light headed, sick at stomach which lasted about 15-20 minutes.  Started to subside about 6 minutes later.
pt. c/o wheezing, coughing, dizziness, symptoms was resolved and pt. went home.
site got itchy; pink; site got kind of hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site got itchy), RASH (pink) and VACCINATION SITE INDURATION (site got kind of hard) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (site got itchy), RASH (pink) and VACCINATION SITE INDURATION (site got kind of hard).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pfizer shot April 16th around 2:00 pm. Ringing in both ears April 16th around 5:45 pm. Ringing continues three weeks after the shot.
This spontaneous report was received from a pharmacist and referred to a 38-year-old female patient. It was reported that the patient had no pertinent medical history, no concomitant medication and no known drug reactions and allergies. On 08-FEB-2019, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (exact dose, lot number and expiration date were not provided) for prophylaxis. On 09-MAR-2019, the patient was vaccinated with the second dose of GARDASIL 9 injection, intramuscularly, lot number R000301, expiration date 29-AUG-2020 (exact dose was not provided) for prophylaxis. On 10-MAR-2019, the patient experienced severe arm pain near the injection site. The patient sought a medical attention by calling the pharmacist. No treatment was given. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and GARDASIL 9 was not provided.
pt was seen in ED a few days prior (to 8/20/22) due to a fall in the home; at that time tested positive for COVID; on 8/20/22, pt back to ED with worsening SOB and hallucinations; requiring more O2 supplementation via NC than usual; Viral pneumonia secondary to COVID 19 infection; positive COVID test on 8/23/22; Remdesivir, Decadron, Vitamins C, D, and Zinc, Combivent, Lovenox; pt's condition declined and he passed away in the hospital
Information has been received from a physician concerning a female patient (age not specified) who on 29-FEB-2008 ("one month ago"), was vaccinated with a first dose of GARDASIL.  The physician reported that the patient fainted post vaccination.  The patient recovered (unspecified date).  Additional information has been requested.
Pt recvd vax & w/in 24 hrs of vax pt devel significant hives that rapidly responded to DPH but persisted off & on for 1 wk following the vax administration; 26JAN93 itchy rash started on wrist & spread to whole body; mom thinks it is hives;
1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE.  SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS.  ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT the CARDIOLOGY department.
Patient developed a severe headache about 30 minutes after vaccination and laid down to rest when she awoke she had leg weakness and went to the hospital for evaluation and was diagnosed with a ischemia cerebral vascular accident.
It was reported in a published article, title as stated above that 11 children developed invasive Hib disease, also referred to as meningitis, after being partially immunized with a median of 1 dose of PedvaxHib (OMPC) (manufacturer unknown) (range 1-2 doses). No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease/meningitis was determined to be an other important medical event. Additional information has been requested.
Pt. had episode of eyes fluttering (15-20s) and fell backwards onto his bottom. Pt. evaluated at hospital and received ATIVAN. Pt. transferred to Hospital and admitted for observation by neurology department. Pt is currently in process of being worked up for seizure disorder.
Redness, swelling, itching, and warm to the touch at injection site on right arm. Also wrist and shoulder pain on left side started 10/28.
Flu-liked body aches 48 hours after administered. Around 5/31, cramp-like, burning pain around left shoulder blade. Intermittent throughout the day. Not relieved by ibuprofen, ice, heat packs.  Not altered by changing position, resting arm, lying down. Feels like a bee is sting me for hours at a time. Have no chest pain, shortness of breath or other symptoms.
Horrible cough where my throat was sore and raw and made it hard to eat for three days.  Along with earaches but I assume it was from all the coughing.   Red, painful rash in left armpit that stated on 7/3 and is still present.   Tiny white sores on gums that are painful from 7/3 and still present.
fever; nausea; get sick after it; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   The patient medical history was not reported.  The patient's concomitant medications were not reported.   The patient experienced fever on an unspecified date with outcome of unknown, nausea  on an unspecified date with outcome of unknown , get sick after it (illness) on an unspecified date with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
After vaccination, pt walked out to car, but came back in complaining of metallic taste and "tongue feels sick." Medical assistance denied by patient, she stated she felt better and willingly went home. Upon follow-up call, pt states she took BENADRYL, 20 mg of prednisone, and an old inhaler. Pt came back through DT and stated she was ok.
43 year old patient received Bexsero.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 43-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th September 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 25th September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 22nd November 2021, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that a 43 year old patient received Bexsero which led to inappropriate age at vaccine administration. The health care professional did not have lot number and expiration date available.  The reporter consented to follow up.
This medically confirmed spontaneous report (initial receipt: 23-Oct-2015) concerns a 45 year-old female patient who had an episode of atrial fibrillation two years ago. On the 21-Oct-2015, the patient received Afluria (influenza virus vaccine polyvalent, batch number U58508) via the intramuscular route for the protection against the influenza virus. On the 21-Oct-2015, 30 minutes after vaccination ('with' two hours of receiving the vaccine) the patient experienced atrial fibrillation. The patient saw her primary care physician on 22-Oct-2015 and may need cardio conversion next week. The outcome was reported as not yet recovered. Reporter's Comments: N/A. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, atrial fibrillation is unlisted. Causality: Possible. Time to onset is within 2 hours of vaccination. It is plausible that systemic reaction resulting from vaccination triggered event especially in individual who was pre-disposed. Past history is considered to be significant risk factor specifically for requiring cardioversion.
Administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, PHENYTOIN, QUETIAPINE and OXCARBAZEPINE for an unknown indication.  On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Presented to ER on 4/8 with slurred speech, left sided weakness, and facial droop. Was diagnosed with right posterior cerebral artery occlusion and started on Alteplase for tPA and transferred to Medical Center on 4/9.
pt started getting weak with a persistent headache.  She states she has brain fog and light headiness.  She says the symptoms come and go but seem worse after she has had something to eat or moves around excessively.  She has been Tylenol and Pepto Bismol.  She says the symptoms are some better but she still has them and cant seem to get rid of them.  Pt is going to call her PCP if she doesnt feel better.
Pfizer COVID Vaccine, was given 4 days past "use by" date. Called manufacturer + was advised "off label" use can be 14 days past recommended 31 days in refrigerator, so do no need to repeat vaccine.
Started with tingling in different places on my arms, legs, abdomen, neck. Started a couple of hours after the vaccine was given and has continued today. This is the first vaccine.
I woke up the night of the vaccination feeling that my airway was constricting.  I did not develop any wheezing or serious difficulty breathing just had the feeling of constriction.  This passed after about an hour and I went back to sleep. The next day, Sunday, I had muscle aches and felt tired all day. No fever or chills. The next day I felt better and went to work. As the day went on, I could feel a cold coming on.  It developed into the worst head cold I have ever had in my life.  Sinus congestion and extreme mucous production. No fever or sore throat.  All in the sinuses.  Worst nighttime nasal congestion ever...very difficult to sleep.  OTC medications did not help.  Did not have to go to the doctor.  Did not miss any work days.  Lasted five days.
I had issues with both shots. First shot, I started with a general headache that eased with time, but it never went away. After the 2nd shot, I had a more localized headache (feeling like pressure) on the back side of my head (left side). In addition, I lost hearing on my right ear suddenly. It started as a feeling of being in a tunnel or underwater. I realized that I could not recognize sound coming from my right ear and I couldn't understand when people talked to me.  I had my 1st Dr's visit on Oct 9th at Health center. I had a follow up appt on Oct 18th and a referral was placed for ENT. I had my appt with on 11/23 with ENT.  In terms of the pressure headache, my Dr said it could be occipital neuralgia, although there has not been trauma to my head or neck. All these events happened after my 2nd shot. I am not sure if they are related to the COVID shots or not, but I would like to report them. I did not feel headaches until the initial headaches with the 1st shot and, after my 2nd one, the headache localized in the back on my head AND the sudden hearing loss. Again, I am not sure if they are related or a coincidence, but I think I should report them.  In terms of 'what's next', ENT suggested transtympanic steroid injections, although he thinks this will not work because it has been over 2 months since I noticed my hearing loss. Also suggested hearing aid.  For the headache, I am now applying heat, although my family doctor suggested gavapentin.  Again, I am not sure if this is due to the COVID shots or not, but I think I should report it since it happened right after my shots.
kid is having a reaction; This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.  On an unknown date (reported as: "recently"), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(strength, dosing schedule, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient was having a reaction, no other specified. The outcome of adverse event was unknown. The causality assessment between the suspect therapy and the event was not reported.
rigors/teeth chattering/chills; body aches for 12 hours; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as age: 50, unit: unknown) received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 18Dec2020 and had no side effects. On 08Jan2021, after receiving the second vaccine, the patient developed rigors, teeth chattering, body aches for 12 hours, took tylenol, well the day after and then the next evening body aches and chills, and then morning after that was fine. The outcome of the events was recovered.   Information on the lot/ batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-JAN-2013 ZOSTAVAX (lot # H0111048/expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot # E010687/expiry date February 2012) (subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003573, 1303USA003574 and 1303USA003576 (same reporter link). Additional information has been requested.
I got Moderna vaccine on 12/24/2020 and had sore arm for 2 days, then 9 days later (1/1-2021) I woke up with a quarter size welt close to the injection site, which increased in size by end of day, associated with redness, heat , itching and tenderness, looks like cellulitis.On 1/2/2021 was bigger in size. It's day #11 (1/3/2021) the area is still inflamed, but it's less acute
p/recv vax pt note purple spots on lower extremities, legs were swollen. next day purpura & petechia noted on both lower extremities. no other lesions. no treatment.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient had no pertinent medical history. The patient had drug reactions/allergies to statins, iodine, penicillin, CECLOR, KEFLEX, erythromycin, tetracycline and azithromycin. On 16-JUN-2014 the patient was vaccinated with ZOSTAVAX (19400 PFU, batch #/lot # K000726, expiration date 09-JAN-2015 (dose, frequency and route unknown). Concomitant therapies included COREG, NEXIUM, SYNTHROID, REQUIP, ZETIA, WELCHOL and CELEBREX. On 17-JUN-2014, the patient developed redness at the injection site after receiving ZOSTAVAX. This report was the second of two adverse events reported by the pharmacist. The pharmacist requested a lot check for the ZOSTAVAX that both of the patients received in both reports since they both had injection site adverse events. Lot check was requested. There was no treatment given for the event. There were not laboratories studies performed. The patient sought medical attention via contacted pharmacist. The outcome of redness at the injection site was reported as recovered/resolved on an unspecified date in June 2014. Lot check has been initiated. This is one of several reports received from the same reporter. Additional information has been requested.
Itchy rash + hives at injection site, started just over a week after injection, no treatment, went away on its own after 4 - 5 days
evening of vax c/o itching of legs, achy joints, weakness, nausea, vomiting, & chills w/inc temp; used OTC DPH day p/vax; seen by MD 2 days p/vax; BC nl feeling better 3rd day;
Episodes of severe vertigo/dizziness beginning 3/25/2021.  Tinnitus started on 3/28/2021.
Redness and indurations 6/4/03 8PM. Redness increased rapidly, spread on 6/5/03 10AM. By 12 noon 5" x 4" erythema with indurations on left thigh.
Date of death  02/18/2022;  hosp notes covid 19; stemi; acute resp failure, intubated in ER , pneumonia; admit 2-4-22