chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine received was Tdap. The injection site was becoming increasingly painful, including the muscles of the upper arm and shoulder.  By the late evening, my left arm was paralyzed from the base of the neck down.  I had a hard time gripping anything with my fingertips and could only hold very light objects (paper, pen, etc).  It was difficult to undress and to sleep.  I also felt extremely weak and had intermittent chills and fever.  Last, I had the TB skin test in the same arm on the same day, and had a very big reaction to that as well, except that it took longer to show.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or drug allergies/reactions were reported. On 12-AUG-2013, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number 0660AA is an invalid lot number for ZOSTAVAX; exp. date 04-AUG-2012). No adverse effect reported. Additional information has been requested.
Rash on the palate in the mouth; dry throat; experience rash on cheek; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (Rash on the palate in the mouth), DRY THROAT (dry throat) and RASH (experience rash on cheek) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ORAL MUCOSAL ERUPTION (Rash on the palate in the mouth), DRY THROAT (dry throat) and RASH (experience rash on cheek). At the time of the report, ORAL MUCOSAL ERUPTION (Rash on the palate in the mouth), DRY THROAT (dry throat) and RASH (experience rash on cheek) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: negative (Negative) negative.         No Concomitant medication information provided. No Treatment medication information provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 contains Non-significant information. Patient confirmed further Follow up not required.
Call received 4/20/09 - Pt states itching and feet swelling started next day - took BENADRYL - helped, but is having itching and swelling in feet today - BENADRYL helps itching.
Vaccine was administered 1 day after beyond use date. Pfizer corporation has been contacted for stability study. Patient may be vaccinated again pending Pfizer and clinical pharmacist decision.
Myalgia, chills, malaise Narrative: sore arm at injection site and chills, malaise for 24 hours
patient presented to emergency room with sore right arm and pain radiating up to neck, breathing fast, and color out of face. EKG performed and it came back normal. Patient also had difficulty lifting arm above head. There was no problem at the site of the injection. He was told to ice, use Tylenol. The patient called by the pharmacist after 72 hours and is improving now
Patient started feeling dizzy & lightheaded a few minutes after receiving the vaccine. He decided to lie down on the floor. Several minutes later he started throwing up. I asked the nurse practitioner at the Clinic to help me; she took his vitals about 20 minutes after receiving the vaccine and they were...  HR 70, BP 110/60, RR 18  We gave him some wet paper towels for his head and asked  him to focus on his breathing. We kept him in the observation area for a total of 45 minutes.  He still wasn't feeling great when he left, but he said he wanted to go home and lie down. He only threw up the one time, but he did have some dry heaving once more after his vitals were taken.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:05 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.65.  Concomitant products were not provided. On 20-Mar-2021, Excursion time was 9AM, 10AM temperature was 34, 37 total doses given for the day was 184 for 9AM, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM:34, 10 AM: 30, 11 AM: 41, 12 AM:45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The  explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient presented for 11 year well child visit.  Patient was supposed to get HPV, TDAP and Menveo.  Patient was given a Bexsero instead of Boostrix.  No adverse reactions noted.
This case was reported by a consumer via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, general body pain and fever. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, general body pain and fever were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced large red swollen injection site greater than 100 mm in size, body aches and low grade fever.
After vaccination with Moderna COVID19 009C21A vaccination in LA via IM, the patient is feeling faint, feeling dizzy, hot, sweaty, and decreased hearing in the left ear (has had similar reactions in past).
After 3 days, chest pain that lasted 6 days, noticeable but not worrisome (grade 3-5 out of 10).  More noticeable chest pain after 8 weeks(after 2nd shot)  which last a day or two (grade 7-concernable) and some shortness of breath. #2 restless leg syndrome 3 weeks after first shot (related or not?) #3  oozing raw burn mark which occurred 5 days after SECOND SHOT, quarter-sized, shaped like a horseshoe
Patient begin to feel tired, achey and had a headache, described her left arm as showing angry red band around her arm. Days later the injection site became flaky at the injection site. Arm swelling size of baseball
SHE STATED SHE FELT THROAT TIGHTENING AFTER RECEIVING VACCINE. ON SITE EMS RESPONDED. VITALS ARE BELOW. SHE WAS GIVEN 25MG DIPHENHYDRAMINE CAPSULE. SHE FELT BETTER AND RELEASED TO HOME
Light bruising 8 days after vaccine, red roughly circular rash at vaccine site 9 days after vaccine
Vaccinator reported she injected the pt with 0.5 mL of air instead of the vaccine. reports she had prefilled her syringes with 0.5 mL of vaccine ahead of time and inadvertently drew up air in the syringe  instead of the vaccine. recognized immediately after administration that it did not feel right and the pt confirmed she did not feel the vaccine administered.   further inspected the syringe which visually appeared dry, no left over vaccine, no droplets.  EMS and paramedic called to vaccination station (they were on site), they evaluated pt. VSS, pt felt well other than some bruising and soreness at the injection site. Per paramedic 0.5 mL of air into deltoid will not cause an adverse reaction. But pt may experience bruising. Pt and family verbalized understanding.  (me) called  who recommended calling Moderna and our medical advisor. called Dr.  and also  Moderna. Dr. states the decision to revaccinate the pt is at  (vaccinator) discretion if she feels the syringe truly did not contain vaccine. Dr. confirmed 0.5 mL of air into the deltoid will not hurt the pt.  Called Moderna ? they advised management of invalid doses of the vaccine is at the medical advisor and vaccinators discretion. There is no information available on adverse reactions with double dose. Standard 0.5 mL dose contains 100 mcg.  In a phase 1 study 250 mcg doses were injected into participants, the only information from the trial that is available is related to efficacy and not adverse reactions per Moderna.   vaccinator, pt, and her family consented to receiving re-vaccination as they all strongly felt the original syringe did not contain vaccine. Pt was vaccinated successfully, all questions answered, pt sat in observation and tolerated the vaccination well.   Director of Health was present and spoke with the pt and family about results of Modera information, DPH information, and discussion with Dr.
Infant recvd vax in AM-PM had fever 103 p/APAP; would not eat but would drink; Next 3 days no fever-won't eat was very tired; stare into space; ? stopped breathing;
Started feeling cold like symptoms on 06/23/2022 and tested positive for COVID with a home test. Had telahealth appt was was prescribed  Paxlovid. Had lingering symptoms for 1 month. Have fully recovered now 7/25/2022
contracted Covid-19 almost 3 weeks after his second dose of comirnaty/had mild cold like symptoms; contracted Covid-19 almost 3 weeks after his second dose of comirnaty/had mild cold like symptoms; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "contracted Covid-19 almost 3 weeks after his second dose of comirnaty/had mild cold like symptoms". The event took place after use of the prouduct. The patient contracted Covid-19 almost 3 weeks after his second dose of Comirnaty. The patient had mild cold like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports feeling dizzy, lightheaded, CP, chills, and diaphoretic shortly after vaccine administration. Vitals obtained, BP elevated 156/99, HR 95, oxygen saturation 99% RA. EMS contacted d/t worsening symptoms and c/o feeling faint. Patient transferred to hospital emergency room for further evaluation per EMT. Pt accompanied by Aunt.
The feeling of always having to urinate and soreness and loss of feeling in the gluteus and with erection.  Lasted over a week from that date.
Nausea, extreme shoulder pain, limited arm motion.  Swollen and very tender to the touch.
Patient began to feel dizzy 5 minutes after vaccination. !0 minutes later started coughing related to acid reflux. VSS. Patient improved.
Patient received vaccine on 10/06/202 on his right arm for Pneomonia-23 (pneumovax-23). He came in today 10/09/2020 saying that his arm has been sore ever since he received that vaccine alongside a flu vaccine that he received on the same day on the left arm which was slightly sore for that day. He says the whole right shoulder hurts when he tries to move the arm and the upper arm on the injection site is sore to touch tender around the armpit area. The arm has limited range motion. He can barely lift his arm sideways or forward and according to the patient he cannot use the arm to do anything, He says he had a steroid injection on the same arm about 14 days prior to receiving the vaccine. He wanted to know if that was normal and what he could, The patient says he will contact his primary care physician as soon as he can if there is no improvement.
Broke out in rashes on his neck. He claims it was after he got the vaccine. He came in on 10/15/18  wanted to get the 2nd shot but was refused due to the fact that he still had the rashes on his neck. Was told to see his doctor to make sure he doesn't have the shingles.
approx 1yr p/vax pt exp pock marks, all over torso, began on back
Swelling redness at site of Hep A and fever (100F). On exam she has a 12 x & cm induration on her left arm.
Days after the first shot I began to develop a cold sore on my lower lip.  Two weeks later, days before the second shot on February 25, I developed another herpes patch on my hard palate.  I saw my doctor and he agreed with my diagnosis of a herpes outbreak.   I researched and learned this was not an uncommon side effect of the COVID19 vaccine.
Redness in the left arm; Soreness in the left arm; This is a spontaneous report received from a contactable consumer. A  female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EP7533, Pfizer NTEC), via an unspecified route of administration in Arm Left on 17May2021 at 10:00 (age at vaccination was 54) as 1st dose, single dose for covid-19 immunisation. Medical history included and concomitant medications were not reported. The patient previously took metoprolol 50mg twice a day has been taking this medication for about 5 years for hypertension. After 1st dose of the vaccine she has been experienced redness and soreness in her arm has been persisting since the day she got her first vaccine, on 17May2021. She was not allowed to get the 2nd dose today 07June2021 due to she still have redness and soreness in the left arm and asked to secure medical clearance in order for her to get the 2nd dose she was just waiting for her primary care doctor's response she wants to know what will happen if she was not able to get the 2nd dose on time she will be in Hawaii in 2 weeks time. Caller states that she was calling about the Covid 19 Vaccine. Stated they told her to call and report this. Caller states that she called her primary care provider. Said that she needs to get her vaccines because she was traveling soon and needs them for that. And patient said she tried to fill out the report online but had issues with the website not letting her press the enter button. Caller states she went to the emergency room this past Friday due to the pain in her left arm being worse that day. She was not admitted to the hospital. The outcome of the events was reported as not recovered.
01/11/2021- Found lying on bed in apartment, incontinent, lethargic, unable to respond to questions, unable to do hand grasps. sent to hospital. 01/14/2021- remains in hospital- confusion and disorientation continues, poor verbal skills, limited ability to feed self, out of bed to sit in chair. uncertain of return to facility status.
Fever 102, pain, chest tightness, chest pain, difficulty breathing, unable to move limbs or sit up, general pain in muscles, joints, bones, acute pain in wrist
11/16/22 Rec'd Prevnar 20 vaccine in PCP office, 6 hrs later experience intense muscle/joint/neck pain. The next morning I had wavy lines in my peripheral vision and blurred vision. This lasted about 14 hours and then dissipated. 11/18/22 I have no more issues. 11/17/22 I reported symptoms to PCP
Within 18 hrs I had a mild headache, nausea, fever of 101.8 and chills. Symptoms lasted about 16 hrs and then I improved.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient's concurrent conditions included hypertension, neck issue with bones and joints and hyperlipidaemia. No information regarding the patient's drug reactions or allergies was provided. On 29-NOV-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, injection, lot # L040445, expiration date 15-JAN-2017 (dose was not reported). On the same day, she received steroid shot (not otherwise specified) for neck issue with bones and joints. Concomitant therapies included ibandronate sodium (BONIVA) 150 mg. On an unknown date in 2016, the patient experienced tingling along spine and feet. The had no visible rash. No treatment was given for the adverse event. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided.  Additional information has been requested.
Patient fully vaccinated, admitted to hospital on 05/28/2021 for COVID pneumonia, after being diagnosed per PCR on 05/28/2021.  Patient discharged home on 06/02/2021 and then readmitted 06/08/21 to 06/10/21 for failure to thrive.  Discharge home with homecare on 06/10/21.
Patient appears uncontrolled shaking of both legs and arms 15 minutes after reaction. We had patient sits down and gave her 50 mg of Benadryl, temperature 97.3F. After 15 minutes, the shaking was still occurring and we offered to call 911. The paramedics arrived after 5 minutes, patient's blood pressure is 142/100, pulse is 103, 100% oxygen saturation. Patient appeared to stop shaking. Out of precaution, the paramedics offer to take her to the emergency room, and patient accepted.
Patient reported tenderness and muscle pain to left deltoid after immunization. Two days later the pain worsened radiating to her back and chest. Six days later she developed an area or erythema and induration to her left shoulder.
The patient received the vaccine in his left arm around tow inches below the shoulder on 12/07/09 at 10:00 am. His mother picked him up at 3:30 and his arm was red and itching. The next morning the redness spread and his arm was swelled and hot to the touch. His mother treated him with BENADRYL but no avail. He also reported fever, chills, fatigue, irritability, sore throat, runny nose and headache. His arm stayed red four or five days. He was brought to see the doctor. His mother reported he has had problems with his asthma since vaccination, which his doctor contributed to the damp, cold weather. Yet, his mother reported him having no problems with his asthma to this type of weather before.
WITHIN A FEW MINUTES OF RECEIVING VACCINE, WHILE STANDING IN LINE, PATIENT BECAME DIZZY AND STARTED TO FALL TO FLOOR.  SHE WAS CAUGHT BY OTHERS AND SAT ON FLOOR.  COLOR PALE, ALERT/ORIENTED, BP 100/60, P 88 REG, COMPLAIN OF NAUSEA, MOTHER PRESENT.  MOTHER TOOK CHILD TO MD.  STATED REACTION TO H1N1 VACCINE AND GAVE "MEDS".  MOTHER DID NOT KNOW NAME OF MEDS.  PATIENT RETURNED TO SCHOOL THE NEXT DAY.
Pain; Headache; Chills; Joint pain; Muscle pain; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2022 at 18:15 as dose 4 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; FATIGUE (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; HEADACHE (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering", described as "Joint pain"; MYALGIA (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering", described as "Muscle pain"; PAIN (non-serious) with onset 14Sep2022 at 12:00, outcome "recovering". Therapeutic measures were taken as a result of pain, headache, chills, arthralgia, myalgia, fatigue.  Additional information: Dose received: More than 3. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. Reported Event: Pain, Headache, Chills, Joint pain, Muscle pain, Fatigue. The patient received treatment of Acetaminophen. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a 77 years old female patient with hypothyroidism and allergy to sulfa drugs and cholesterol medications refers to herself. The patient was vaccinated SC with a dose of ZOSTAVAX (lot # not reported) on 14-AUG-2012 to prevent shingles. Concomitant medications included thyroid medication. On 14-AUG-2012 the patient had itching and a red circular rash at the injection. It was oval, and 3 inches long. On 19-AUG-2012 the patient had a breaking out of blistered rash, similar to what she called chickenpox, on her upper right leg. She was not sure if she had chickenpox before. Later she found out the rash on her leg was caused by a bug bit. It was not a reaction from ZOSTAVAX . No treatment information was given. No laboratory test was performed. The outcome of the events is unknown. The patient did not seek medical attention. Additional information is not expected.
Patient got very pale, very week and he was not responsive for few seconds, shaking, his eyes were shut and sweating profusely. He regained conscious quickly after deinking water and soda. He reported that he wasn't able to see for a few minutes and blurred. Patient was able to walk slowly and moved to fresh air area and Pharmacist was attending with him the whole time.
local react started w/in 4 hrs; exam 6 x 8.5 area of erythema w/induration;