chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Apparent perm swelling at injection site. Swelling still visible today 9 months later.  Just had booster shot in right arm and same swelling occurred.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter
This spontaneous report as received from a medical assistant reports that some unspecified patients on an unspecified date may have received a dose of GARDASIL (lot number H016238, expiration date not reported; H016238, 11-APR-2015, H020002, 08-AUG-2015) (dose, frequency and route not reported) that from 22-MAR_2013 to 26-MAR-2013 some vials of GARDASIL had been exposed to 0 degrees Celsius for 96 hours and had developed a filmlike coating inside the vial. The medical assistant reported that some vials were clear, with cloudy sediment that resuspends, and that others were essentially clear, with the same resuspending sediment, but also appeared to be coated with a film-like substance. The solution was reported to be clear, and maybe thinner than expected. No adverse effects reported. A product quality complaint has been filed for appearance change of vaccine. This case is linked to MARRS #1304USA000421, 1304USA000422, 1304USA001054. Additional information has been requested.
Had inject 27NOV90 2 days later developed "thrash - tongue, back of throat rx mycostatin.
Diffuse rash all around area of vaccination site. Not resolving but not getting worse. Does not itch or cause pain.
Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patient was vaccinated with one improperly stored dose of RECOMBIVAX HB (lot # M010671, expiration date 02-JUN-2018, dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information is not expected as there is no contact consent to follow up.
Dr ordered varicella & pt was given ZOSTAVAX in error. Pt experienced swelling & redness at injection site per mother on 2/1/12. Pt's reaction is resolved and he will follow up as needed. Employee was let go. Pt's sx have resolved.
(Since the participant is unsure what date or time her symptoms began, the date of 5/25/2021 is being used, as it is the date she saw her doctor.) Around late April, I began having sleep problems. Whenever I wake up, I'm as tired as I was when I went to bed. As a result, I'm always tired. I dealt with the worst of this for about a month before I finally saw my doctor. I went to my PCP on 5/25/2021, and she suspected I had sleep apnea, so I was referred to a sleep specialist. I went to the sleep specialist on 6/16/2021 for a consult. He referred me to a sleep study, which was performed 7/2/2021. On 7/14/2021, I got the results that I had severe sleep apnea. The overall respiratory disturbance index was 57.2 events per hour. The lowest oxygen level noted was 79%. I was referred for a second sleep study to try a CPAP. The second study was on 7/20/2021. A CPAP has been ordered, and I hope to receive it 7/29/2021.
Patient was administered vaccine. Afterwards approximately 2 minutes she was in line to check out and felt light headed and proceeded to faint. A staff member caught her and she woke right up. EMT was called and went to ER.
This was the 2nd shot of the new shingles vaccine. After the first shot 4 months ago I had some modest fever, chills, achiness that evening, but it was gone the next day. After this 2nd shot, I got the same symptoms that evening but they continued all through today (the 2nd day)--they are still with me although beginning to diminish. I kind of expected these symptoms although not of this intensity. But the strange thing is last night I could not sleep at all night. I laid in bed trying to sleep but my mind kept racing at 100 mph all night, almost like I was drugged up on something; I could not stop it and could not sleep at all (as in 0 sleep). I certainly hope I can sleep tonight.
Area of erythema 8.5cm x 5cm and area of pustules 8cm x 1.5cm at injection site.
Patient received Covid vaccine (Jansen) in early March. Patient was diagnosed 7 to 10 days later with Covid. Patient self quarantined for 14 days. One week prior to ED visit patient had exertional dyspnea and SOB. Came to hospital ED and admitted to floor. Twelve hours later patient coded and expired of PE
Patient reported 'no problem with the first dose' administered on 4/09/2021. Approximately 3 minutes after  administration of the second dose patient reported a sharp pain in the middle of her back that radiated down her spine to her 'tail bone'. Staff phoned 911 which arrived within about 5  minutes. Patient reported no other symptoms other than the excruciating pain in her back.  Pain was subsiding somewhat by the time EMS arrived. Patient began  feeling weak in a couple of minutes and was transported by EMS to local hospital for further evaluation.
Mother reports that she noticed infants right thigh was reddened around Immunization site.  The follow day around 3pm and later that night she noticed swelling in that area.  Mom said that infant has been very fussy but has continued to walk and play.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. The vial did not undergo any temperature excursions. Date vial was initially stored in the refrigerator was unknown. Total of 173 doses were given from LOT 070H21A with expiration date 07 APR 2022 Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
While laying in bed to sleep, my heart rate was 90 BPM when my normal resting heart rate is in the high 50s. While waiting to see if it would slow down, my heart rate went up up 120 BPM and remained elevated for approximately a half an hour. I went to urgent care and arrived after my heartbeat was normal. An EKG showed a premature heartbeat but they detected no other issues and sent me home. I was later given a Holter monitor for 24 hours which did not detect a premature heartbeat or any issues. On 06/08, while resting, my heart rate slowly climbed to 120 BPM for no apparent reason, then slowed down again after an hour.
2nd dose: fever (100101°F) for 1836 hrs after receiving vaccine; very sore arm at injection site; Mild headache; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267) via an unspecified route of administration in Arm Left on 22Feb2021 12:45 (at the age of 24 years old) as dose 2, single for COVID-19 immunisation at vaccine school or student health clinic. The patient medical history was not reported. There were no concomitant medications. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982) via an unspecified route of administration in Arm Left on 30Jan2021 13:45 (at the age of 24 years old) as single for COVID-19 immunisation and experienced sore arm. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced 2nd dose: fever (100-101 f) for 18-36 hrs after receiving vaccine, very sore arm at injection site, mild headache on 23Feb2021 09:00. No treatment were given for the adverse events. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 100-101 fahrenheit on 23Feb2021. Outcome of all the events were recovered on Feb2021.  No follow up attempts are possible. No further information is expected.
Noticeable but not extreme redness about 2 inches wide, 4 inches long around (mostly below) the location of the shot on the upper right shoulder/arm. This was the first of the two SHINGRIX shots. Other side effect was the predictable muscle pain from the shot for the two day since vaccination.  I had the old Shingles vaccine four years ago, and a moderate case of Shingles (diagnosed by dermatologist) a year ago.
Breakthrough varicella infection with numerous pox lesions. Followed clinically. No hospitalization or treatment.
Rash on injection arm. Red, itchy and tender to the touch. Itchy and tender subsided 5 days later. Slight redness persists 2 weeks later
Leg weakness, unsteady gait. Ascending paralysis with difficulty breathing and holding up head. Given IVIG with some clinical improvement most notably with improved respiratory effort.
Fever 101.6, tachycardic 120's, flushed, SOB. Had some mild SOB after vaccine, fever and vital changes started late morning on 1/13
A 69 year old female patient with a history of " a reaction to butyl alcohol contained in a epidural injection which resulted in hospitalization" received a left deltoid intramuscular injection of FLUZONE on on 15 October 2008. Thirty minutes post vaccination the patient developed nausea, a metallic taste in her mouth, and diaphoresis. The patient was advised to see her family physician. No further information was provided. Follow-up information received on 23 February 2009 from the health care professional. Per the reporter, it is unknown what the recovery status of the patient is. No further information is expected. List of Documents held by Sender: None.
Pt was vaccinated on 9/7/22 and noticed redness and swelling to injection site on 9/8/22.   Pt seen on 9/9/22 and in no acute distress. Reaction is localized and improving per pt. Mild, localized erythema, edema and tenderness to injection site on right posterior arm.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after it had been punctured for greater than 12 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 029H21B) for COVID-19 vaccination. No Medical History information was reported. On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2022 at 11:05 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2022 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after it had been punctured for greater than 12 hours.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Feb-2022 at 11:05 AM, EXPIRED PRODUCT ADMINISTERED (Dose administered after it had been punctured for greater than 12 hours.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had not reported any symptoms and not received any additional doses, medications or treatments at that time. No concomitant medications were reported. Treatment information was not provided.
Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.
Extremely large, hot, hard red welts at both injection sites developed by 16hr, unresolved. Excessive vomiting 10hrs post-vacc to 36hr post-vacc. Rectal temperature exceeding 103.2F by 9:30PM, administered 3.75ml of 160mg/ml Infant TYLENOL. Fever persisted to 46hr, ranging from 100.8 to 102. Inappetance entire day following vaccines. Upset when having head/fontanelle touched.
could not get warm; hard time breathing; severe body chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (could not get warm), DYSPNOEA (hard time breathing) and CHILLS (severe body chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING COLD (could not get warm), DYSPNOEA (hard time breathing) and CHILLS (severe body chills). On 06-Mar-2021, FEELING COLD (could not get warm), DYSPNOEA (hard time breathing) and CHILLS (severe body chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Pyrexia: 102.2 (High) 102.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was having hard time breathing so he hooked up to his cpap machine & it helped him.  Patient is having heart issues& spoke with his cardiologist.  No concomitant medication information provided.  No treatment medication information given.
caller's daughter received the 1st dose and forgot to schedule the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (caller's daughter received the 1st dose and forgot to schedule the 2nd dose) 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 ADHD since an unknown date.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller's daughter received the 1st dose and forgot to schedule the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (caller's daughter received the 1st dose and forgot to schedule the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, Myalgia, sore throat, injection site pain, fatigue, chills Narrative:
(R) arm injection site swelling, redness, warm to touch, feverish. Continued sx prompted office appt. & antibiotic tx on 2/14/11. Area still draining w/low grade temp. therefore appt on 3/1/11. Area on (R) arm draining. C & S obtained. Culture negative.
Cough; want to take a nap; runny nose; headache; COVID-19; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (Cough), SOMNOLENCE (want to take a nap), RHINORRHOEA (runny nose) and HEADACHE (headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cough (Had cough for year and half and didn't think much of it.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ROSUVASTATIN for an unknown indication.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced FATIGUE (Fatigue). On 15-Aug-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (Cough), SOMNOLENCE (want to take a nap), RHINORRHOEA (runny nose) and HEADACHE (headache). At the time of the report, COVID-19 (COVID-19), COUGH (Cough), SOMNOLENCE (want to take a nap), RHINORRHOEA (runny nose), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-1 test: negative (Negative) Negative. On 15-Aug-2021, SARS-CoV-1 test: positive (Positive) Positive. On an unknown date, Body temperature: normal (normal) 99.6 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that her pulse ox was 97 at the lowest and also states that her symptoms are mild. No treatment medications were provided.   This case was linked to MOD-2021-132775 (Patient Link).
Case number PHEH2016US030839, is a spontaneous report initially received from a pharmacist on 20 Nov 2016. This report refers to a 77 years old female patient. Historical condition was not reported. Current condition included chronic lymphoma leukemia. Concomitant medication was not reported. The patient was vaccinated with FLUAD (batch number: 166103, expiry date: Apr 2017) intramuscularly at a dose of 0.5 ml on 10 Nov 2016 at 18:00. On a same day after vaccination, the patient experienced pain at the vaccination site. On an unknown date, the patient lost range of motion, had a pain around the rotator cuff area, the patient reported that it was 30-40% better but the pain keeps her awake at night, it was reported as pain began a couple of days after injection. On an unknown date, the patient had swelling of lymph nodes in her neck. It was reported that, the patient's husband was a physician. The patient took ibuprofen for the symptoms reported. Upon follow up it was reported that, the patient said, was in a pain. The outcome of the events vaccination site pain and pain around the rotator cuff area was reported as condition unchanged (pain was still lingering/ was in a pain), and for other events it was reported as complete recovery. The seriousness of the events was reported as non serious. The causality of the event swelling of lymph nodes in her neck was reported as suspected (related to the FLUAD) and for other events it was not reported. Follow up report received from a pharmacist on 04 Jan 2017: Updated vaccination time, outcome of the events, seriousness as non serious and narrative.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 25-FEB-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34 degrees C and 168 hours with 33 degrees C as the highest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Bitter taste in mouth with or without food/drinks; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in the left arm on 03Apr2021 at 11:45(at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had a history of allergies to penicillin and IV dye and Percocet. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), vitamin d nos (VITAMIN D), vitamin b12 nos (VITAMIN B12) and chondroitin sulfate, glucosamine (MOVE FREE) all taken for unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 13:00, the patient had bitter taste in mouth with or without food or drinks. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event bitter taste in mouth with or without food or drinks was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
sore throat; Earache; This is a spontaneous report received from a non-contactable consumer (patient). A 32 years old female patient (no pregnant) received BNT162B2 on an unspecific date at single dose for COVID-19 immunization. Medical history was covid prior vaccination. Concomitant drug was not reported. Adverse event reported as Earache and sore throat. No treatment. Outcome of the event was Recovered. Covid test post vaccination: covid test type post vaccination Nasal Swab with unknown result.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
I am having  torticollis-like spasms in the right side of my neck in the C2-C4 areas. It wakes me up. It comes and goes. It has a sharp deep pain that hits for a second and comes and goes in 10-12 second increments or 10-12 minute increments.
had nausea 24 hrs p/vax, lasting 12 hrs; no ther sx, no one in family w/similar sx;
Initial misuse report received from a healthcare professional on 23 January 2014. A '67-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL on an unspecified date, and no adverse event was reported i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 29-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster.   On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Pepsid 40mg, 2 times per day Azelastine HCl nasal spray - .1% 2 times per day 2 puffs each nostril Aspirin 81mg every other day Lovastatin - 40mg tab 1 time per day Singulair - 10mgs per day Aller-fex - 180mgs per day Mixed Vespids Event lasted about 1 day. Did not go to ER/Dr's office. Aches, headache, extremely cold, wore gloves in the house and winter hat. No fever 96.4.