chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough and heavy periods; longer period length; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 09:00 (Lot number: EP6955) as dose 1, single and administered in arm left, administration date 19Apr2021 10:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE]. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 07Jun2021, outcome "not recovered", described as "Breakthrough and heavy periods"; OLIGOMENORRHOEA (non-serious) with onset 07Jun2021, outcome "unknown", described as "longer period length". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No, prior to vaccination, was the patient diagnosed with COVID-19. Device Date: 27Sep2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 11 years old male patient. Medical history and current conditions were not reported. On 18-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck), lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012. 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Approx one hour after MMR given in Occ Health patient developed itchy face, itchy and irritated eyes and feeling unwell. She went directly to the Emergency Dept here at the Clinic. RN who gave vaccine had patient wait in clinic 10 minutes after giving it.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 14-OCT-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Quick onset of irritability followed by significant depression/despair after 3 hrs of vaccine. Uncontrollable crying and sadness. Symptoms lasted for about 3 hours and have let up significantly by the next day.  I?m not sure what strain flu vaccine other than the regular 2019 flu.
pt recv vax 24JUN96 & 17JUL96 c/o pain in all joints & hands, knees, wrist & ankles;
stomach/cramping/stomach pain; sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th July 2021, the patient experienced stomach cramps. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the stomach cramps was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and stomach cramps to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient reported that, she received Shingrix vaccine yesterday and experienced sore arm and in morning experienced stomach pain and cramping. The pain in arm was resolved and stomach pain and cramping were not resolved till the time of reporting. The patient does not know the lot number or expiration date. The reporter consented to follow up. This case was linked with case US2021148602, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021148602:Same reporter
Pt passed over, hit head on floor.  States was very dizzy all of a sudden.  Pt very pale, vomiting for approximately 1-1/2 hours; approximately 5-10 times.  When standing up pt pale and dizzy.  Observed pt, ok vital signs.  Released pt after no further vomiting and after pt could walk around office without feeling fainter being pale.  Pt to call and report any changes.
Information has been received from a consumer concerning his daughter who on an unspecified date was vaccinated with her first dose of MMR II (Lot # not provided). The consumer stated that his daughter experienced seizures after receiving MMR II. At the time of this report, the patient's outcome was unspecified. It was unknown if the patient sought medical attention. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Approx. 24 hrs at vaccine was administered. Redness tenderness, inflammation to R deltoid area, seen by MD prescribed?
On 3/8/18, 8 days after vaccination, patient had a seizure: while sleeping at 7am, Mother describes clenched fists, whimpering for 2 minutes; post-ictal phase afterwards.
Arm was sore at injection site. Pain became worse with each passing day until excruciating after 3 weeks. Unable to to sleep or lift arm. At 3 weeks, sought Dr.'s care. Was given 6 days of Prednisone. Pain & weakness diminished during Prednisone and returned afterwards.
I had a little soreness at the injection site for about a day. I was exposed to COVID-19 at a festival.  I tested positive for COVID-19 on 05/08/2022. I had difficulty breathing and coughing. All my symptoms were respiratory.  I contacted my doctor and got a prescription for Paxlovid. The taste was awful, but I tolerated it. As of today, I do not have any lingering symptoms.
Fever on 9/28/22 AM, soreness, tender to the touch, quarter sized redness and inflammation starting 9/29/22 am, growing to silver dollar size 9/29 7:50pm.
Bell's Palsy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included high doses of steroids.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Injection site itchy almost immediately followed by redness  swelling, heat and pain at injection site that hasn't subsided. Followed within hours by flu-like symptoms.. nausea, chills, achy, and the worst headache I've ever had which is saying a lot because I suffer from chronic migraine.
COVID symptoms - chills, body aches, fatigue and loss of taste/smell that started on 12/26/2020 (9 days after vaccine). Tested positive for COVID on 12/28. Minor illness, symptoms not severe, recovered quickly, no long lasting effects from COVID that are known at this time
Pt recv vax on 10/20/98; 1st wk of 11/98 pt exp tiredness, malaise & chicken pox
A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on an unknown date. Accidental administration of expired FLUMIST Quadrivalent to a patient which started on 05-DEC-2014 was reported. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a single dose of Zostavax (Merck). Subsequently the patient experienced irritation at the injection site. Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information received indicated that no further information is available.
Ct. reports to clinic approx. 2 hours after receiving MMR vaccine and TB skin test with a macular/papular rash on upper chest and back that began between 12:30-1:00pm while eating lunch in her car.  Vaccines administerd at 11:30am. Ct. denies itching, hives, fever, and difficulty breathing.  No allergies reoprted to food or medicine.  Ct. currently on no medications and has no significant medical hx.  Comfort measures given.  Ct. encouraged to seek medical attention if symptoms worsen and was advised of the importance of immediate medical care if breathing difficulties develop.  Ct. verbalized understanding.
Narrative: He reports having developed a pruritis rash after the first vaccination. The rash started on his right deltoid 4-5 days afterwards. It then also spread to his chest and minimally over his left deltoid. It is unclear how long the physical rash/pruritus lasted for as he scratched until he excoriated the skin. He applied OTC cortizone-10 to the rash, which relieved the puritus. The area was described as mildly erythematous, pinpoint areas of itchiness, not- well circumscribed, w/o pusules/nodules, not warm to touch or indurated. It did not slough afterwards. He denied new medications, detergents, or environmental exposures. On examination - he has scattered areas of excoriation, mostly over his right deltoid. There are some area of past exoriation in various stages of healing of his chest and scanty over his left deltoid. No areas of erythema visualized.
On 05/12/2021 patient was wheeling self down to have dinner when she became diaphoretic and started complaining of not feeling well.  EMS was called and patient was found to be hypotensive and had evidence of inferior wall STEMI initial EKG. She was transferred to a higher level of care. On 05/14/2021 she was admitted to hospice care. Date of death was 05/17/2021.
Patient is not having symptoms at this time.  He was given Moderna Vaccine and he is under the age of 18.
Patient was given the vaccine without the vaccine being put into RECIN first. Writer/administering staff thought that COVID vaccines were not put in RECIN first but instead just given the card with the information. When I attempted to add the vaccine into RECIN the next day when I found out I was suppose to put it in; it would not go in. I contacted my manager immediately.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received MENVEO (batch number 151401, expiry date unknown). On 7th JULY 2016, the patient received MENVEO .5ml. In JULY 2016, less than a week after receiving MENVEO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to MENVEO. Additional details were provided as follows: The healthcare professional reported that a number of patients received the MENVEO vaccine and experienced severe pain at injection site in the arm. The healthcare professional only had information for 3 patients, they all reported to have pain up to a week after administration. No expiration date was provided for the vaccine. This case has been linked with cases US2016099029 and US2016GSK102325, reported by the same reporter.
pt recvd vax & 10 days postvax exp sz was hospitalized for a few days-full workup; details of neurologist work-up were not available @ the time of report;
Got them after taking shot/Suspected vaccination failure; Got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got them after taking shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles even after taking the Shingle vaccine shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This case was reported by a healthcare professional and described the occurrence of leg rash an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757716A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported se was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.
AFTER ADMINISTRATION OF THE FIRST DOSE OF THE PFIZER COVID-19 VACCINE, THE PATIENT RESPONDED THAT THEY FELT FINE BUT THEN STARTED TO SWAY IN THE ADMINISTRATION CHAIR. THE PHARMACIST TAPPED ON THE SHOULDER TO CHECK IF THEY WERE OK, AND THE PATIENT RESPONDED BEFORE TILTING THEIR HEAD BACK AND CLOSING THEIR EYES.  THE PHARMACIST CALLED FOR HELP AND CHECKED IF THE PATIENT WAS RESPONSIVE.  THE PATIENT STARTED TO RESPOND, BUT FELT DIZZY, COLD AND CLAMMY. ANOTHER PHARMACIST ASSISTED IN ADJUSTING THE PATIENT IN THE CHAIR TO ALLOW HER TO PUT HER HEAD BETWEEN HER LEGS.  SHE GRADUALLY STARTED TO BECOME EVEN MORE RESPONSIVE AFTER 2 TO 3  MINUTES BUT CONTINUED TO FEEL COLD AND CLAMMY.  ANOTHER ASSOCIATE BROUGHT IN A BOTTLE OF WATER AND LARGE TOWELS DURING THIS TIME.  WHEN THE PATIENT WAS READY (10-15 MINUTES LATER), SHE WAS MOVED TO THE FLOOR TO LAY DOWN WITH ONE TOWEL COVERING HER AND THE OTHERS UNDER HER.  HER FEET WERE THEN ELEVATED.  A PHARMACIST CHECKED HER BLOOD PRESSURE  AND IT WAS SLIGHTLY ELEVATED 156/84 WITH A HEART RATE OF 73.  SHE STAYED UNDER SUPERVISION WITH AN ASSOCIATE FOR ANOTHER 30 MINUTES, AND WAS ABLE TO SIT UP, STAND, AND DRINK WATER BEFORE BEING ESCORTED TO HER VEHICLE.  A PHARMACIST CALLED HER LATER THAT AFTER NOON AND SHE DID NOT REPORT ANY FURTHER LIGHTHEADEDNESS, BUT SHE DID HAVE SOME ARM SORENESS.
The patient was asking if that would matter because right now she was only feeling the soreness that she originally felt when she first got the Pfizer booster shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The patient was asking if that would matter because right now she was only feeling the soreness that she originally felt when she first got the Pfizer booster shot.".  Additional information: The patient reported she got the Pfizer booster shot, but she realized that she already got the same booster shot a year and a month ago. The patient was asking if that would matter because right now she was only feeling the soreness that she originally felt when she first got the Pfizer booster shot. The patient mentioned that she neglected to let her provider know that she already had the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300138822 Same patient and events, different dose.;
Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
A report has been received from a Health Professional concerning a 10 year old. Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that the physician had accidentally administered expired FLUMIST to two patients which started on 06-Jan-2015. The outcome of the event of accidentally administered expired FLUMIST to two patients was unknown. The report was considered to be non-serious.
Vaccinee is one of five employees who have been identfied as non responders following a series of three Engerix-B inject.
Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side; Tongue was also swollen; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue was also swollen). At the time of the report, DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) and SWOLLEN TONGUE (Tongue was also swollen) outcome was unknown.            Concomitant medications and treatment details were not provided.  The action taken with mRNA-1273 in response to the event was not applicable.  The patient reported that he had gone deaf in his right ear after getting the 2nd dose and could not hear anything on right side. His tongue  was also swollen after getting the 2nd dose.  Company comment:Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pt vaccinated with Meruvax II  on 29JAN90. On 30 APR90 a serum assay revealed a lack of seroconversion.
Swelling in my left cheek with a red area on the surface.; Swelling in my left cheek with a red area on the surface.; "skittle" in the flesh of my cheek; still very sore and swollen; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot_number EN5318) via an unspecified route of administration, in Arm Left on 09Feb2021 10:15 at single dose for covid-19 vaccination. The patient medical history was not reported. Concomitant medication included tizanidine 4 mg ; cannabidiol 10 mg. The patient previously received first single dose of bnt162b2 on 19Jan2021 12:15 PM unknown route left arm single for Covid-19 immunization. Patient previously took Nortriptyline had allergy. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination: Tizanidine 4mg, CANNABIDIOL 10mg, adult mens multi-vitamin. On 09Feb2021 16:00, Patient had swelling in my left cheek with a red area on the surface. The area was first noticed when it felt like there was a "skittle" in the flesh of my cheek. It then grew at a slow rate Tuesday evening. During Wednesday it swelled to the size of a large grape before bed last night. This morning the swelling has gone down slightly, but the area is still very sore and swollen. I have sent a message with photos to my doctor and am waiting to hear back if I should go into the clinic or wait to see if the swelling continues to go down. The reporter considered all events was non-seriousness. The patient received treatment was reported as unknown. The outcome of the events was unknown.   Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19.
LISTLESS, SLIGHT HA; T99.1; CHILLS SORE ARM RESOLVED IN 4 HOURS. Narrative: