chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note - I worked in the medical field for 16 years, and did not take submitting this form lightly or without careful consideration. This began with a 2-3 cm area on the upper right buttock of raised itchy bumps within 24-48 hours of the 3rd booster shot. This was NOT the area of the injection site. Within 2 days the area on my buttock became abnormally bruised. Over the next two weeks, the itchiness spread across from right to left in the same area. Topical prescription creams had no effect. Additionally, I would feel a strange sensation in my lower extremities when relaxing in bed that I did not have prior. After 1 month went to a Dermatologist and she couldn't determine the nature of origin and said to continue cream - she didn't think it was anything I ingested or a normal allergic reaction. However, over the past two days, the itchiness became even more extreme (along the rash was not even evident other than one or two small spots on the left side) and spread to my lower legs. I have NEVER had anything like this in my life, and the ONLY change in my lifestyle is the administration of the third booster shot.  I am waiting now for a new prescription for the cream.  I have no idea whether this is related to the booster, but I had no other side effects from the first two other than arm soreness and minor fatigue for 12 hours. It is odd that this strange situation with the extreme itchiness (and only minor ever-changing rash/bumps) appeared within a day or two of this booster shot, and has continued for a month. I feel that I am having some type of immune response.
Patient was administered Pfizer monovalent 5-11 years old orange cap covid vaccine during appointment on 02/06/2023. However, patient should have received Pfizer Bivalent 5-11 years old orange cap covid vaccine. Patient had already been vaccinated with two doses of Moderna  6 month - 5years covid vaccine on 06/27/2022 and 07/27/2022. Patient should not have received another monovalent covid vaccine.
Patient said his arm was sore for approx. 1 week following vaccine and he felt flu like symptoms including tiredness and weakness.
PATIENT EXPERIENCED A INJECTION SITE REACTION.  HAD REDNESS THAT EXTENDED FROM INJECTION SITE.
Patient was vaccinated - 1st dose with Moderna at approximately 1330 on APR. At 1337 pt noted to be fanning herself during her 15 observation period. Nurse approached the pt and noted she was diaphoretic and was losing consciousness. Pt became unresponsive to voice or stimulation for approx. 30 seconds. Code Blue was called.  Vitals at 1341: BP 122/76, HR 82, SpO2 90%, increased to 98% without supplemental O2 RR 14.
Approximately 5-6 hrs after receiving flu vaccine,  consumer reports that she was very diaphoric general weakness and strained breathing.  Individual states self-improsed bedrest for two hours.  symptoms relieved after 2 hours.
got an outbreak of herpes; she got COVID; she developed a fever for about 2 days after getting both vaccines; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection. Previously administered products included valacyclovir.   In AUG-2022, the patient received the 1st dose of Shingrix (left arm). In SEP-2022, less than 2 months after receiving Shingrix, the patient experienced covid-19 (Verbatim: she got COVID). On an unknown date, the patient experienced fever (Verbatim: she developed a fever for about 2 days after getting both vaccines) and herpes virus infection (Verbatim: got an outbreak of herpes). The outcome of the fever was resolved (duration 2 days) and the outcome of the covid-19 and herpes virus infection were resolved.   It was unknown if the reporter considered the fever, covid-19 and herpes virus infection to be related to Shingrix.     It was unknown if the company considered the fever, covid-19 and herpes virus infection to be related to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2023 The patient stated that she got her first Shingrix vaccine and she developed a fever for about 2 days. She also stated that she got COVID after she had gotten the first vaccine but prior to having the second vaccine. In addition, she had a history of herpes that she took valacyclovir (confirmed generic) for continuously.  She stated that she also got an outbreak of herpes between the first and second shingrix vaccine, but she believed that she had stopped taking her valacyclovir. The reporter did not consent to follow-up. For tolerance to 2nd dose, refer case US2023AMR073462; Sender's Comments:  US-GSK-US2023AMR073462:1st dose
Right facial weakness;  Treatment: prednisone 60mgx1week;valacylovir 1 week; physical therapy; acupuncture; Outcome: recovered;
felt weird for 2 days; bright; Vision and audio was not normal; never felt like this before in her life; felt like some one drugged me LSD; nausea,; throwing up; fatigue; very scary; could not read her vision was not clear; very strange; fussy feel; very odd; ringing in her ear; so sick,; sweating; very hot; shaking; dripping sweat; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel) and FEELING ABNORMAL (very odd) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue). On an unknown date, the patient experienced FEELING ABNORMAL (felt weird for 2 days). At the time of the report, FEAR (very scary), VISION BLURRED (could not read her vision was not clear), FEELING ABNORMAL (very strange), FEELING ABNORMAL (fussy feel), FEELING ABNORMAL (very odd), TINNITUS (ringing in her ear), MALAISE (so sick,), HYPERHIDROSIS (sweating), FEELING HOT (very hot), TREMOR (shaking), HYPERHIDROSIS (dripping sweat), FEELING ABNORMAL (felt weird for 2 days), VISUAL BRIGHTNESS (bright), SENSORY DISTURBANCE (Vision and audio was not normal), FEELING ABNORMAL (never felt like this before in her life), DIZZINESS (felt like some one drugged me LSD), NAUSEA (nausea,), VOMITING (throwing up) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The pharmacist gave her a pill for her adverse events but she doesn't know the name.
Patients mother said he had a red bump to right upper leg where shots were given. She said leg felt hot. He had no fever, no SOB, no hives, no rash. Mother said she doesn't know if it was a reaction because he was kicking, made legs hard and moved a lot. Mother said she did not see bump until 2 days later on Monday.
The patient suffered a fever higher than 104 degrees and was extremely lethargic. This high fever lasted for a total of 5 days.
approximately 3 or 4 days later developed fluid on the lungs. Had an angiogram and had 2 stents put in..
loss of fine motor skills in left hand; severe muscle pain below left elbow radiating down into left hand; loss of strength/hard to grip things safely; severe muscle pain below left elbow radiating down into left hand; This is a spontaneous report from a contactable consumer (patient).   A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 20Feb2021 (at the age of 57 years) as dose 2, single for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had not experienced covid prior vaccination and the patient had not covid tested post vaccination. No other vaccine was administered in four weeks. The patient received other medications (unspecified) in two weeks. Specific concomitant medication was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 30Jan2021 (at the age of 57 years) as dose 1, single for COVID-19 immunization and the patient experienced severe pain. On 23Feb2021 at 12:00 the patient experienced loss of fine motor skills in left hand, loss of strength/hard to grip things safely, severe muscle pain below left elbow radiating down into left hand. The patient reported that now after dose number two he was experiencing severe muscle pain below left elbow radiating down into left hand. The patient also had a loss of strength and a loss of fine motor skills in her left hand. He found it hard to grip things safely. The patient did not receive treatment for adverse event. The outcome of the events was not recovered.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained. Information on the lot/batch number has been requested.
No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was reported that Hcp did not report any medical History or condition for the patient. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose) on 18-Aug-2021; for COVID-19 vaccination: COVID-19 VACCINE (2nd dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and Moderna COVID-19 Vaccine.    On 21-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    No concomitant information was reported. It was reported that the vaccine been expired about 8 or more days. Patient was not aware that he received an expired dose. No treatment information was provided.   Reporter did not allow further contact
Caller reported PROQUAD administered to a 19 year old patient; Caller also reported patient had titers drawn that showed she was non immune to Varicella and Mumps; Caller also reported patient had titers drawn that showed she was non immune to Varicella and Mumps; This spontaneous report was received from registered nurse, referring to a 19-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rHA) 0.5 milliliter, lot #W004026, expiration date: 02-AUG-2023, administered intramuscularly, for prophylaxis (product administered to patient of inappropriate age).  On an unknown date in 2022, the patient had blood titers drawn that showed she was non immune to varicella and mumps (mumps antibody test negative and varicella virus test negative). No other information was provided.  At the time of reporting, the outcome of mumps antibody test negative and varicella virus test negative was unknown.   The reporter's causality assessment between mumps antibody test negative and varicella virus test negative with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
chills, fever, bone pain,  joint pain, headache, fatigue, delirium all for approx 8-10 hours.
pt. recvd. booster vax & developed ringing & burning sensation in ears,dizziness,hot flashes,& pallor.
Went to emergency room 4/12/2022. Facial droop, headache, left eye closing, mouth uneven. Diagnosed with Bel Palsy Given steroids to take for about a month.
The nurse reports that an unknown number of adult patients, names and other demographics not provided, received doses of PEDVAX HIB on unknown dates.; No adverse effects were reported in any patients.; This spontaneous report was received from a nurse referring to an unknown number of adult patients of unknown ages and unknown genders. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On unknown dates, the adult patients was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis(wrong patient received product). No adverse effects were reported in any patients. The causality of the event was not provided.
Sharply demarcated 10 x 20 cm ovoid area of erythema, warmth and sl. induration with tenderness anterior (L) bicipital aspect. Tenderness (L) axilla without discrete nodes. No pustules or inject site infect. Treat with local heat, observation. Notify if fever, malaise.
Note: Resumption of interrupted anthrax reactions seem to be occurring more frequently. Edema, erythema, mild pain.
Post vax, the pt's right upper arm became red, hot, and swollen. Treated with Bactrim, Zyrtec, and ibuprofen.
Tdap was given to the patient instead of DTap on 6-22-2011. This adverse event was reported to the State health department and to the doctor.
A large wheal developed on each arm. Also c/o nausea as well as pain at injection sites.
This case was reported by a healthcare professional, via Merck, and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of ENGERIX B (unknown). On an unspecified date, on an unspecified time after vaccination with ENGERIX B, the subjects experienced not responding to therapy. After the next vaccination with ENGERIX B the event did not recur. On 17 November 2009, it was reported that a nurse mentioned an unknown number of subjects who received TWINRIX or ENGERIX-B had negative titers. These subjects repeated the series and responded. No further information was available at the time of reporting. (Please see case ID A0817629A for details on the unknown number of subjects who received TWINRIX).
very bad rash develop a week or so after my 2nd dose of the vaccine in mid February; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (very bad rash develop a week or so after my 2nd dose of the vaccine in mid February) 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. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH (very bad rash develop a week or so after my 2nd dose of the vaccine in mid February). At the time of the report, RASH (very bad rash develop a week or so after my 2nd dose of the vaccine in mid February) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Treatment medication was not provided. Concomitant medication was not provided.
p/vax pt exp redness, swelling, vomiting & nausea; addl information requested
Night of immunization arm pain, next day achy, slight temp then increased pain, warmth around site and extending down arm, no itch.
I received two doses of Pfizer in April 2021 without issue.  This is the Pfizer Booster given by Pharmacy FH8030 is what the card says.  I received the vaccine on 11/27/2021 and today is  11/29/2021.  My arm has swollen to the size of a small baseball at the injection site.  I have taken ibuprofen and zyrtec to try and manage the swelling and may have to go to an urgent care center if the swelling does not subside by this weekend
Body aches; This is a spontaneous report from a non-contactable consumer. A 37-year-old non-pregnant female patient received booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Sep2021, the patient experienced body aches. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperarance. States she is on beta blockers and gets light headed often. no medications given. Client recovered quickly. This information was obtained by her daughter. She denies any problems with her first dose, and only thing now is some soreness in her shoulder.
Patient has syncope/nausea after vaccination and was transported to ED for further eval. Patient states that she typically faints/has syncope when giving blood. Patient received one dose of Zofran PO in ER and was discharged.
Numbness and tingling in Rt arm. Tightness in chest. Inj given in Lt arm.
Patient got a chicken pox type rash, on left side and middle of back, now starting on neck and head.
9/27/13 patient stated day after vaccination developed rash over back which itched and had sore achy shoulder patient applied BENADRYL and rash resolved on 9/27.
Swollen lymph nodes on collarbone and armpit on the same side as injection. Still present 3 weeks later.
PATIENT REPORTS WAKING UP SUNDAY 5:30 AM 5/16/2021 (15H POST VACCINATION) FEELING "HOT, SWEATY, DIZZY, SHORT OF BREATH, BODY ACHES, AND A FAST HEARTBEAT".  NAUSEA STARTED ABOUT 10:00AM AND CONTINUED ON AND OFF  ALL DAY.   PATIENT REPORTS HE WAS UNABLE TO EAT OR DRINK MUCH AT ALL.  PATIENT STATES THAT HE ASSUMED THIS WAS A NORMAL REACTION TO THE VACCINE.   THE EVENT CONTINUED WITHOUT IMPROVEMENT AND PATIENT FELT HE WAS WORSENING AND IT WAS CARDIAC RELATED.  HE CALLED FOR 911 ABOUT 1:00AM MONDAY AND WAS TAKEN TO THE ER.    ER DISCOVERED THAT HIS VENTRICULAR TACHYCARDIA HAD BEEN TRIGGERED @ 2:30 AM ON SUNDAY.  ER CONFIRMED THAT PATIENT SUSTAINED AN ELEVATED VT ARRYTHMIA FOR MANY HOURS.
Pt exp blindness p/receiving an influenza vax; This case is in litigation; No other info is now available; Add'l info will be requested from the MD;
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 08-JAN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
That night I didn't feel well, I went to bed early. Chills in mddle of night. I didn't go to work (wasn't planning on it) and I didn't get up and I realized I couldn't get out of bed. I somehow got up and put leggings on and I couldn't stand up and I unlocked the door because a repair man was going to be coming to fix the dishwasher. I fell asleep after he left - he had to bring me my checkbook - never took my prednisone for the day - I had chills and fever all day. I had fever - 104. I had nausea, body aches, vomiting, diarrhea and my husband gave me 20 mg of steroids when he got home and two of my Florinef and two ice chips to swallow. He carried me upstairs - I was not cognizant of what was going on. I wasn't cognizant the whole day of Wednesday. He gave me soup later and more doses of steroids. I didn't have a fever - or else it was down to 100. I still had diarrhea, nausea, headaches, body aches and I only ate the BRAT diet. I couldn't go to the office Thursday or Friday. On Friday, I still had a horrible headache. I was still doubling up on my steroids that day as I still felt so horrible. That Friday night, I finally felt wonderful. But I had taken a lot steroid after all that.
Client reported some feeling in the center of her chest said it was not pain, she just felt something and she was dizzy.  10:34 b/p110/62  Pso2   99%   pulse 76  Respirations even and unlabored.  Skin pink warm and dry.     Re check feeling better not dizzy Pso2  98% pulse 65 10:39 symptoms gone Pso2 99% pulse 66 b/p 106/64 Patient monitored a little further then released.