chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date, multiple unspecified patients were administered with improperly stored doses of VARIVAX (Merck) (lot # L017997, expiry date 19-MAY-2017 and lot # L027288, expiry date 12-JUL-2017) dose, route unknown. Concomitant medications were not reported. During the storage the vaccine was exposed to temperature of 70 degrees for a time frame of 60 hours and later the storage temperature was back in range. It was reported there was previous temperature excursion where the same vaccine was exposed to -11.9 degrees C for 44 hours on 14-DEC-2015. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
This patient's parents presented this child to various locations from November 10, 2022 through July 6, 2023 and received 9 COVID vaccines in that time span.  this individual sign up utilizing various addresses, telephone numbers, and emails with same name and DOB.
After the first shot in left arm I felt tingling in my left hand and fingers, the pointer, middle and ring finger felt numb and tingly for two weeks, then my toes my right foot started feeling tingly and numb , my second and third toes are the ones that I keep experiencing the numbness with.
Towards the end of May, my upper arm began to hurt. Over the next week, the pain became intense. Since early June, I've had a stiff shoulder joint and limited mobility of my left arm due to the tension in the muscles.
uncontrollable shivering, rapid pulse followed by high fever, nuasea, dizziness, difficulty breathing and horsenees.
Arm swollen and warm to touch at injection site. Pain in arm; unable to lift arm properly.
rt sided facial weakness (?bell' s palsy): included inability to move forehead, close or blink rt eye, move mouth muscles, skin sagging  @ jaw;sx on rt side of face;
2 days after vaccine given, severe leg pains started. Within 2 days, increased in severity -> admitted - diagnosed with Guillain-Barre Synd (reflexes & weakness ensued). Improved quickly with IVIG.
History of Present Illness:  Patient is a 86 Y male who presents to the Emergency Department after home health nurse became concerned that he cannot take care of himself at home.  Per EMS, patient did not want to be transported, however daughter has power of attorney and wanted him transported.  Of note patient was recently diagnosed with COVID-19, placed on supplemental oxygen at home.  Upon chart review, patient was recently admitted, during admission he was evaluated by physical therapy and SNF placement was recommended.  It seems patient refused SNF placement, and was discharged home with home health.
Nausea, vomiting 16 hours after injection. Mild fatigue, injection site soreness.
Patient was given a third dose of 6-36 month flu vaccine. Patient had already had two doses prior.
Information has been received from a nurse who reported to a representative that the physician's daughter, an 18 year old female was vaccinated with the third dose of GARDASIL vaccine (yeast). On 04-AUG-2008, after receiving the dose of GARDASIL vaccine (yeast) the patient experienced syncope. She also received a TB test during the same visit (results not provided). Subsequently, the patient recovered from syncope minutes later. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/13/21 Lot# 040A21A;  Moderna 4/10/21 Lot# 037A21B;  Moderna 12/12/21 Lot# 039F21A
IMMEDIATELY AFTER VACCINATION, PT SEEMED TO ALMOST LOSE CONSCIOUSNESS OR FAINT.  VASOVAGAL SYNCOPE / DIZZINESS, FLUSHED/PALE, CLAMMY SKIN, NAUSEA, PROFUSE SWEATING, THIRST, NEEDED TO LAY DOWN ON GROUND.  THIS LAST FOR AROUND 15 TO 20 MINUTES, PT THEN LEFT STORE
This spontaneous report as received from the patient's wife refers to an elderly male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The patient's wife stated that her husband received the PNEUMOVAX 23 injection (dosing details, lot#, expiry, strength were not reported) two times on unspecified dates by unspecified physicians (inappropriate schedule of drug administration). One dose was before the age of 65 and another dose was after 65 years of age. The doses were six years apart. On an unknown date, the patient experienced swollen arm and influenza-like illness. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information is not expected as no contact details provided.
Reported Symptoms:  10014222:EDEMA FACE; Narrative:  Other Relevant HX:  Other:
The piece where I have red is hot; Arm is red; Arm swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The piece where I have red is hot), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (Arm swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (The piece where I have red is hot), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (Arm swollen). At the time of the report, VACCINATION SITE WARMTH (The piece where I have red is hot), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The reporter submitted Adverse event via text/text to speak application.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 contains non-significant information.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received FLULAVAL (batch number XZ3SP, expiry date 30th June 2015). Concomitant products included PNEUMOVAX 23. On 30th October 2014, the patient received FLULAVAL (intramuscular) .5 ml. In October 2014, less than a day after receiving FLULAVAL, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL was continued with no change. In 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Turn very red and swollen; Turn very red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Turn very red and swollen) and INJECTION SITE SWELLING (Turn very red and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Turn very red and swollen) and INJECTION SITE SWELLING (Turn very red and swollen). At the time of the report, INJECTION SITE ERYTHEMA (Turn very red and swollen) and INJECTION SITE SWELLING (Turn very red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
< 24 hours after Flu immunization, had complete loss of function of legs, falling, extreme weakness. That slowly resolved over 24 - 36 hours.
(In order of appearance) Headache Muscle aches Chills Extreme thirst Nausea Vomiting Diarrhea
Information has been received from a registered nurse through the Merck pregnancy registry concerning a 22 year old female who during the week of 05-AUG-2002 was vaccinated with a dose of varicella virus vaccine live. On 12-AUG-2002. the patient presented to the physician's office due to vomiting and her urine pregnancy test was positive. Unspecified medical attention was sought.  Follow-up information indicated that the patient "never returned for follow up visits and we were not successful locating her." No further information is expected.
Patient experienced chills/shakes 1 hour post vaccination. Syncope 4 hours later with continued decrease in blood pressure. Patient saw family doctor the following day and blood pressure medication was temporarily discontinued. Blood pressure meds were restarted several days later.  Upon post incident discussion with patient he mention that he had had shakes several hours after vaccination with regular flu shot last year but they only lasted 1/2 hour. This was not disclosed prior to this years vaccination.
This spontaneous report as received from a physician refers to a 2 months old patient. On 29-AUG-2012, the patient was vaccinated with the first dose of 2 ml ROTATEQ oral (lot#unknown) that was expired. No other co-suspects were reported. No concomitant medications were reported. It was unknown that if the patient had sought medical attention. No adverse event had occurred. Additional information has been requested.
Patient reported she experienced pain in the area of the shot in the evening of 10/17/2013. She stated that she still had not removed the band-aid since the shot. Once she removed the band-aid she stated she saw a bump on her arm in the area of the shot. After speaking with the patient, I advised her to have her arm looked at by her primary care physician.
Loss of smell and taste following first dose of the vaccine; Loss of smell and taste following first dose of the vaccine; This is a spontaneous report from a contactable consumer, the parent. An 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 at 14:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications, or other products. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced loss of smell and taste following first dose of the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events loss of smell and loss of taste was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. no information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (PNEUMOVAX23) injection (lot # K019386, expiry date 09-JUN-2016, lot # L001311, expiry date 06-JUN-2016, and lot # L022262, expiry date 05-NOV-2016; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up at 3:30 am due to ringing in my left ear.  Ringing has continued all day.
Vaginal bleeding--got what appears to be my period although I stopped menstruating a year ago.; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 21Mar2021 at 14:00 (Lot Number: ER8732) as single dose for COVID-19 immunisation. Medical history included psoriasis of scalp from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included adalimumab (HUMIRA), loratadine, and omeprazole (OMEPRAZOL); all from unknown dates, for unspecified indications.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 27Feb2021 at 14:00 (Lot Number: EN6198), (at the age of 52 years old), as single dose for COVID-19 immunisation.  On 29Mar2021 at 15:00 the patient experienced vaginal bleeding, the patient got what appears to be her period although she stopped menstruating a year ago.  The patient stated they had both doses and no negative reaction, but the patient inquired if it's just coincidence or if there is a connection with getting your period suddenly start again after its stopped (patient had not had a period in about a year), since the patient did about a week after the second dose. The patient did not receive any treatment for the event. The clinical outcome of the postmenopausal bleeding was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient feels a buzzing or ringing in her ears that intensifies in the morning.  She is planning to schedule a follow with primary care doctor, but as of now no treatment.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 56-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). Concurrent medical conditions included disc herniation and thyroid disorder. On 5 October 2011 the subject received a dose of Flu vaccine (subcutaneous, back of right arm). This was an inappropriate route of vaccination. On 5 October 2011, less than one day after vaccination with Flu vaccine, the subject experienced injection site redness, swelling injection site and injection site pruritus. At the time of reporting the events were unresolved.
a little bit of a sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received second dose of Pfizer-BioNTech COVID-19 Vaccine last Thursday 18Feb2021. The patient reported that first dose was on 29Jan2021, and he had no reactions whatsoever, except for maybe a little bit of a sore arm that lasted for about a day. Patient asked this normal and wanted to know if it is normal or common to not experience side effects after completing the vaccination series. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Despite being very regular, I skipped one cycle.  I started two months late with 5 days of slimy thick blood, Then a very heavy flow that gushed out when I stood.
Fever, myalgias, arthralgias, nausea, vomiting. Pain & swelling at site (R) arm. Cellulitis & abscess at injection site (R) arm.
April 12: Woke up with low grade fever, headache and exhaustion.  April 13: Same symptoms. Rapid test for COVID 19 came out negative.  April 14: vomiting but other symptoms gone.  April 15: injection site red, hot, swollen and itchy. Previously had disappeared.
Information has been received from a 32 year old male who on 05/01/2001 was vaccinated with a third dose of hep b vaccine recombinant. Concomitant therapy included minocycline hcl. On 05/08/2001 the pt experienced swelling under his armpits and in his glands in his neck. He also have hives, swelling of his lips and mouth, redness of ears, chest, face and other parts of his body a warm feeling all over  his body and a slight rash. It was noted that the pt was seen a few times by his physician and on 05/17/2001 was started on prednisone. It was reported that the prednisone helped relieve the symptoms and that as of 05/21/2001 all symptoms were gone.
Having little sore arm for 3 days after booster; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Having little sore arm for 3 days after booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 007M20A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood sugar abnormal (Medication for sugar), Heart disorder (Medication for the heart), Cholesterol (Medication for cholesterol) and Blood pressure high (Medication for High blood pressure).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Having little sore arm for 3 days after booster). At the time of the report, PAIN IN EXTREMITY (Having little sore arm for 3 days after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for sugar, medication for the heart, medication for cholesterol and medication for high blood pressure.  No treatment details were reported.   This case was linked to MOD-2021-405028, MOD-2021-405019, MOD-2021-405059 (Patient Link).
Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day; 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in refrigerator on 04-May-2022. The vial didn't undergone any temperature excursion. No treatment medications were reported.
Swollen arm  Warm to touch Tender to touch All symptoms 7 days later.
Information has been received from a health professional concerning an 18 year old white female student (weight 99#, 61.25") who on 15-OCT-2007 at approximately 11:30 am was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #655849/0263U), IM in the left deltoid. Concomitant medication was not reported. On 15-OCT-2007 at 11:30 am, the patient experienced immediate pain, injection site warm to touch, felt clammy like she was going to "pass out", nausea, dizzy and she was unable to lift her arm. The patient was treated with cold compress to the site and acetaminophen (TYLENOL). The physicians office called the patient on an unspecified date, the patient reported that she felt better but her arm was very tender. Subsequently on 16-OCT-2007, the patient recovered from pain, injection site warm to touch, unable to lift arm, nausea, dizzy and felt clammy like she was going to "pass out". Additional information has been requested.
Pt asked to be observed .  pt's spouse states pt had CoVid in December and was nervous.  Pt stable given water and snacks.
I took the vaccine on Thursday and i slept good, like normal. when I got up Friday morning I had chills all day. I checked my temperature and it was 101 and went up to 104. I took Tylenol every 4 hours but it would not come down, I took cold shower and it didn't come down Friday and Friday night all night. It would get down to 102 or 101 but it would come right back. Saturday all day fever, nausea, and headache.  No matter the medicine I took or when I took a cold shower it would not come down.  Everything continued until Sunday all day until Sunday night, I still took medicine but i couldn't control the fever. I did not want to go to hospital. Early morning hours of Sunday I started to perspire and the fever started to come down to 101 then 99.something.
Immediate malaise.  Later in the day, eye puffiness.  Next day with malaise and blurred and transient loss of vision (2-3 sec).  Sweating and presyncopal without syncope.  Later the second day feeling well, except mild malaise.