chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 48 hours after injection, patient developed redness at the injections site spanning 2 inches in diameter. She also developed aching in several joints and what she described as "flu like" symptoms.
2/14/2005 came in with lesions inside mouth and vesicles all over body.
Pt vaccinated with HIB. 3 days later, developed rash everywhere - red, puffy, patchy.
On day 8 (March 23rd) my left upper arm area/shoulder started to ache, swell and turn red.  It was hot to the touch and visibly swollen compared to right arm.  By Day 11 (Mar 26) my shoulder was essentially back to normal.  On Day 13 (Mar 28) , my arm started to itch and red patchy spots appeared in early morning.  By evening half of my upper left arm was covered with raised, red splotches.  In the morning on Day 14, my whole upper left arm was covered by the red raised splotches and aching.  Took Benadryl on day 13 before bed, but it didn't help.  I took Benadryl on day 14 at 2pm and waiting to see if it will help.   Waiting for call from the Doctor.
joint swelling; pain radiated to his shoulders; whole body pain; arm pain radiated to his shoulders, down the opposite arm/opposite arm pain; pain in the arm of the vaccination site; bedridden; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19. Concomitant products included prednisone.   On 14th April 2022, the patient received the 2nd dose of Shingrix. On 14th April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization). On 15th April 2022, the patient experienced shoulder pain (serious criteria hospitalization), general body pain (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the patient experienced swollen joints (serious criteria hospitalization) and bedridden (serious criteria hospitalization). On an unknown date, the outcome of the injection site pain, shoulder pain, general body pain and pain in arm were unknown and the outcome of the swollen joints was not recovered/not resolved and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, general body pain, pain in arm, swollen joints and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date:23-JUN-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix and on the day of the vaccination he had pain in the arm of the vaccination site.  The reporter stated that, the next day the arm pain radiated to his shoulders, down the opposite arm, then whole body pain. The patient stated that, later he developed joint swelling which made him bedridden for two weeks. The patient stated that, the pain and swelling progressed until he was required to be hospitalized for five days.  The patient stated that, his knee required joint aspiration five times. One day after receiving Shingrix, the patient experienced shoulder pain, general body pain and pain in arm. Less than 2 months after receiving Shingrix, the patient experienced swollen joints and bedridden.  ER (emergency room) visit required.  The reporter consented to follow up.
Red mark around Injection site; hand pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE ERYTHEMA (Red mark around Injection site) and PAIN IN EXTREMITY (hand pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red mark around Injection site) and PAIN IN EXTREMITY (hand pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE ERYTHEMA (Red mark around Injection site) and PAIN IN EXTREMITY (hand pain) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-036745, MOD-2021-036745 (Patient Link).
Swollen red patch over injection site, appeared a week after injection. Itchy and sore to the touch. Initially ~3in in diameter; spread to ~6in in diameter of the last several days. Appears to be clearing up, but still visible at the time this form is submitted.
any:  Narrative: Received his both Moderna Covid vaccines. First dose on 2/5/21 he had no reaction. Second dose was on 3/5/21/ On 3/6 he developed a nose bleed that lasted approx. 40 minutes. He did not require any kind of medical intervention nor was he evaluated at the ER. He reports having one more episode of bleeding since then, again minor requiring no medical attention, No other side affects reported. .
"Moderna COVID-19 Vaccine  Left arm began getting sore the morning after the vaccine, 5/22/2021.  Also started having chills, tiredness and fever, itching to front of both thighs and red blotch's.  Still ran a fever of 102.3 through the night.  Took 2 Tylenol and this helped.  Was feeling better by Sunday afternoon, 5/23/2021.  Still have soreness in left arm Sunday evening, 5/23/2021.
Received ADACEL on 4/16/09 and by 4/18/09 the right arm became entirely swollen and the injection site became indurated, reddened, painful and swollen. Additionally, both hands became red, itchy, and swollen. She experienced fever to 101 F and had systemic itching. Took TYLENOL and BENADRYL.
Patient with single J+J vaccine on 03/30/21 who admitted to hospital with complications from COVID.  Provider note below:  "Brief Summary of Hospital Stay: Patient is a 71 year old male who presented to the ED on 1/2/2022 due to shortness of breath and cough. The patient was diagnosed with COVID on arrival and was started on COVID directed therapies as well as supplemental oxygen. He was also noted to be in hypertensive emergency on arrival with flash pulmonary edema. The patient stated he had missed several doses of his blood pressure medications due to not feeling well. He was originally admitted to the ICU due to elevated blood pressure. His blood pressure came down appropriately and the patient was placed back on his oral medications with moderate control of his blood pressure. His hypoxia continued to improve over the course of his stay and the patient was only requiring 1-2 L of oxygen at time of discharge. He will be discharged with home care and home oxygen. Patient has 24 hour assist at home and was adamant on going back home. He needs to continue to follow up with his primary physician and nephrologist regarding his blood pressure. "
Dose administered from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) had 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 were reported. No treatment information was provided. On 03-Aug-2021, the vaccine vial was opened to be administered to the patient but the vaccine was provided on 04-Aug-2021, the next day. The reporter kept the opened vial on the refrigerator at a temperature of 32 to 36 hours until the administration was done.
COMPLAINT OF FEELING DIZZY, STOMACH UPSET ON 1/16/2021 SAW FAMILY DOCTOR ON 1/20/2021 HAD
2/21/22 was taken to the Medical Center in cardiac arrest, CPR, intubated; found to be positive for COVID; 2/22/22 pt was transferred to a different Medical Center for higher level of care; hypotensive, vasopressors and chest tube placed; concern about anoxic brain injury; dexamethasone, ABX, vitamins C & D, zinc, thiamine; DNR; pt expired in the hospital
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 09-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were reported. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
SHE PRESENTED TO THE PHARMACY TODAY WITH A RASH ON THE ARM WHERE THE VACCINE WAS GIVEN.  SHE STATED IT WAS FEVERISH.  IT DID NOT HAPPEN RIGHT AWAY.  I TOLD HER TO TAKE BENADRYL AND IBUPROFEN AND COLD COMPRESS.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 07Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 02May2022 as dose 4 (booster) , single (Lot number: FM0698) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (24Jul2022) positive, notes: positive covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that on 24Jul, 5 days after patient took the last dose of Paxlovid, patient  experienced what her doctor said was "Covid Rebound." Scratchy throat, stuffy nose, fever and positive covid test.
In 45 minutes I had a rash on my chest, back, and neck.  Chest tightness, some shortness of breath.  First O2 reading was 94%.  They gave me Benadryl, 50 mg prednisone, and a breathing treatment.  This got it under control.  They also drew blood to check levels of histamine.  (No results yet).  A few hours later I had some more breathing difficulties.  6 hrs after the shot I had hives.  Benadryl helped with all of that.
This is a spontaneous report from Pfizer Medical information department for a contactable nurse. This nurse reported for a 9 year old male consumer who received PREVNAR 13 on 11Jun2012 at an unknown dose and frequency for immunization. The relevant medical history included asthma and autoimmune deficiency since an unknown date. The relevant concomitant medications included QVAR, both since an unknown date at an unknown dose two puffs two times a day for asthma and multivitamins daily (duration, dose and indication unknown). On 11Jun2012 after two hours of receiving PREVNAR 13 vaccine he experienced hives. The laboratory data included unspecified test on an unknown date in 2012 done after thirty days of receiving PREVNAR 13 vaccine to check how the consumer responded to the medication and the result was good. Therapeutic measures taken in response to the event included BENADRYL (duration, dose and frequency unknown). At the time of the report he was recovering from the reported event. Follow-up (05SEP2012): Follow-up attempts completed. No further information expected.
Narrative: Patient developed pain at the injection site with gradual improvement following administration of Pfizer covid vaccine.
Received flu vaccine in left arm and TDAP in right arm. Developed increasing Rt upper arm, Rt upper back and neck pain over subsequent couple days. Developed fever to 102 degrees F, diarrhea and nausea, dizziness. Eventually had trouble abducting rt arm and moving neck. Fever, diarrhea, nausea, and dizziness resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8732), on 16Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 07Feb2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jan2019, stop date: 12May2022; CARVEDILOL, start date: 01Feb2021, stop date: 12May2022; AMLODIPINE, start date: 01Oct2021, stop date: 12May2022; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: 01Jan2019, stop date: 12May2022; ACYCLOVIR [ACICLOVIR], start date: 01Jan2019, stop date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10May2022) Positive, notes: Rebound of covid symptoms 5 days after last treatment of plaxovid. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient did previously receive a COVID-19 Vaccine. No treatment ae reported. No known allergies.  Follow-Up (18May2022): Follow-up attempts are completed. No further information is expected.
given expired dose; called pharmacy and they state no clinical data available; up to the physician; physician decides not to repeat dose as it is a live virus
No adverse effects; the patient was inadvertently administered one dose of expired M-M-R II; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history and drug reactions/allergies was not provided. Concomitant therapy included sterile diluent.  On 26-APR-2019, the patient was inadvertently administered one dose of expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number N009799, expiration date 24-MAR-2019; strength and rote were not reported) for prophylaxis (Expired product administered). The nurse confirmed that the sterile diluent was not expired, although she did not have lot and expiration available. No adverse effects were reported.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated that doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017) (dose and route of administration were not reported), which had been exposed to a temperature outside of the recommended storage temperature, had been administered to the patients on unspecified dates since the temperature excursion (incorrect product storage). Concomitant therapies were not reported. No adverse experiences had been reported. At the time of the report, no additional information was provided. This is one of two reports from the same source. Additional information has been requested.
Patient fainted a few minutes after receiving the vaccination.  He woke on his own less than a minute after loss of consciousness. Patient was provided a small fan, cold pack, water and orange juice upon request.
Terrible arm pain for a week. Horrible headache for 3 days. Intense itching for a week but no rash. Had my flu shot at the same appointment in right arm.
This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Half dose as first dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.  No Medical History information was reported. On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Half dose as first dose). On 08-Nov-2021, ACCIDENTAL UNDERDOSE (Half dose as first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient had not received any previous COVID vaccines.
hit with ton of brick; body ache; Fever; Disoriented; pain at injection left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hit with ton of brick), DISORIENTATION (Disoriented), VACCINATION SITE PAIN (pain at injection left arm), MYALGIA (body ache) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) 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 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DISORIENTATION (Disoriented) and VACCINATION SITE PAIN (pain at injection left arm). On 24-Mar-2021, the patient experienced PAIN (hit with ton of brick), MYALGIA (body ache) and PYREXIA (Fever). On 25-Feb-2021, DISORIENTATION (Disoriented) and VACCINATION SITE PAIN (pain at injection left arm) had resolved. At the time of the report, PAIN (hit with ton of brick), MYALGIA (body ache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
Case number PHEH2014US003788 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 70-year-old male patient who was accidentally vaccinated with MENVEO (batch number: A11077, expiry date: Apr 2014) at a dose of 0.5 ml intramuscularly on 11 Jan 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).
Red utchy bumps started appeaing on various extremes of my body within a day of innoculation. Bumps continued to erupt for 8-10 days on arms, legs, back, stomach and buttocks .  I had NO previous  similar reactuon to Pfizer 3 Booster Shot.
pevlic pain started a couple of weeks after the 2nd dose of Moderna, so she wonders if this was related. Pt went to ER on 8/8/21 for chest pain; CTA chest negative; ws dx with a viral infection        -States she was "feeling drained" from the right pelvic pain- had f/u u/s with Dr.  and the previously noted thrombosis had resolved; was tx with flagyl and doxycycline as well due to concern for possible infection (endometritis0
no adverse effects; dose of PEDV AXHIB tbat was inadvertently administered past its expiration.; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 15-JUL-2019, the patient was inadvertently administered a dose of expired haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection (lot # M045207 has been verified to be a valid lot number, expiration date 30-JUN-2019) (exact dose and route of administration were not provided) for prophylaxis. The reporter informed that the clinic did not share information regarding any adverse event and had no VAERS reference.
Received Pfizer-BIONet COVID-19 vaccine on 1/14/21 and 12/21/20.   On 4/8/21 the patient developed rhinorrhea, cough, and headache.  Tested positive for COVID-19. Treated with monoclonal antibodies.
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 13-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PROQUAD (lot # K007801, expiration date 29-NOV-2015, route and dosage not specified). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Patient arm was painful, hot, swolen. Bruising started the next day and has continued until today, 5 days after vaccination and covers approximately 5 inch area. The bruise is purple/black and unusual shape. The patient reports being on blood thinners but never had a reaction to vaccine in past
Maculopapular rash started on LUE (wrist and forearm). Rash spread to other arm and both lower extremities. Rash associated with intense itching which was relieved when she took Benadryl. No other body part affected except sparingly on hands and feet. No other symptoms. Rash seems to be resolving. Rash started on 6-9-04 at 1300.
sore, red arm, fever, chills, headache, muscle aches started within hours after receiving shot - fever blisters on lip appeared the next day, started feeling better within a few days