chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he is shrinking now; He collapse while he was in the shower; weak/been getting weaker and weaker; feeling more unwell every day; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm (also reported as left upper arm) on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included Kidney cancer, bladder cancer, colon cancer, mantle cell lymphoma and was compromised health-wise. Concomitant medications included amlodipine, atorvastatin, losartan, sotalol, terazosin, and warfarin. On 08Mar2021, the patient was weak and feeling more unwell every day. On 09Mar2021, the patient collapse while he was in the shower. The wife of the patient reported regarding some possible side effects for her husband. He had been weak but on 09Mar2021, he collapse while he was in the shower and that was pretty dramatic but he has been getting weaker and weaker and feeling more unwell every day since 08Mar2021; at this point he was literally appointed for the second shot on the 26Mar2021, so wife was asking if it was advisable being he had what maybe side effects between the vaccine and his other health conditions, that he should take his second shot. On an unspecified date, the patient was shrinking now. The patient was due date for second shot on 26Mar2021. The reporter stated that the lot was EN6203, and it could be ENU203, the handwriting was very bad, and she don't know if it was U or 6. Outcome of events was unknown.  Information about Lot/Batch number is requested.
Patient describes waking 15 hours after vaccine with sharp pain right side of chest lasting 1 - 2 minutes;  sharp pain in foot lasting one minute and eye pain lasting one minute. Patient was fine the entire day of vaccine.  Symptoms occurred through the night.
The child was receiving 2 vaccines on same day. She received TDAP first without complaint. She received GARDASIL second and immediately became flushed, developed red rash on neck & shaking. She was alert the entire time.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies were not provided. On 17-JAN-2017,  the patient was vaccinated with an improperly stored ROTATEQ orally, (strength, dose, and frequency were not reported),  lot # M019706, and expiration date 24-OCT-2017, for prophylaxis. The reporter stated that the temperature range of the vaccine was between  >46°F to <77°F, exact range 47F to 50F and the time frame was 73 hours, also she stated that there was not previous temperature excursion, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
pt came reporting that her arm was very red, hot, a little painful and a little itchy, she showed me and her upper deltoid and tricep area was very red and she said hot to touch. she also said a alittle sore to move her arm. she also said she was experiencing sore joints in knees, wrists and both shoulders even though both shots were in 1 arm.
INAPPROPRIATE SCHEDULE OF VACCINE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, and other pre-existing medical conditions included: Patient was a 63 years old male, very good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021, and dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced inappropriate schedule of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000193904.
her period was every four days and she would bleed for two days / bleeding; her period was every four days and she would bleed for two days; spotting; abdominal cramps; cramps; she is been having pain after she has intercourse; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 29-year-old female patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (Dose number unknown - original Pfizer Covid-19 vaccine, ), administration date: Jul2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "after intercourse she hurts in the morning with abdominal cramps and bleeding", "after intercourse she hurts in the morning with abdominal cramps and bleeding", "spotting", "after intercourse she hurts in the morning with abdominal cramps and bleeding". The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "her period was every four days and she would bleed for two days / bleeding"; MENSTRUAL DISORDER (medically significant), outcome "not recovered", described as "her period was every four days and she would bleed for two days"; INTERMENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "spotting"; ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "abdominal cramps "; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "cramps"; PAIN (non-serious), outcome "not recovered", described as "she is been having pain after she has intercourse". Clinical course: reporter stated her 29-year-old daughter in law got the "original Pfizer COVID-19 vaccine" in Jul2021. She was trying to have a child. She was getting her period every 40 days until she got the vaccine. Now, after intercourse she hurts in the morning with abdominal cramps and bleeding. Reporter stated she thinks it was just spotting and stated her daughter in law was healthy. Reporter stated her daughter in law then got a booster in August (as reported). After that her period was every four days and she would bleed for two days. Now she was doing "fertility things every morning peeing on these sticks and stated she can't find out when she was ovulating now. Reporter was  asking if Pfizer has any information on menstrual changes after vaccination with Comirnaty. She has been having pain after she has intercourse and cramps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Patient was administered expired flu vaccine that had been delivered this month with other not expired vaccines. The boxes were visually identical. When RN manually filled in vaccine information in the system after administering realized this vaccine was exp. 6/30/2022. Patient was informaed of mistake by PA. They did not want the correct vaccine at this time.
Large red area on arm of vaccination. This happened after the 2nd dose 2 days after injection, which I expected since this happens with other vaccines.. It went away and then returned again 7 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 at 16:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and seasonal allergy. Concomitant medications taken within two weeks of vaccination included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC) and budesonide (NASOCORT); all for unknown indication, from unknown date and unknown if ongoing. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) and experienced flu shot side effects, delayed immune response, red arm and lymph node areas of her body got red for a few days. 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. On 28Feb2021, the patient experienced large red area on arm of vaccination. This happened after the second dose two days after injection, which she expected since this happened with other vaccines. It went away and then returned again 7 days after injection. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large red area on arm of vaccination; happened after the second dose two days after injection; it went away and then returned again 7 days after injection was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient said she started to feel dizzy then passed out for ~1 minute, patient was hot, sweaty, color drained from face, felt sick, did not throw up. Recovered completely and left store after ~30min. Patient was with her boyfriend.
Lethargic vomited few times 45 ms, after getting shots v pale. 7:35 PM 98.2 160/m 32/m 98% sat. 8:45 PM 158/m 44/m 106/42 100% sat.
Patient was not due for rotavirus vaccine due to age.  Medical assistant gave dose inadvertently.  Patient did not have any adverse events while in the office.
her tongue really hurts; started to experience tongue swelling on Friday/tongue felt swollen/ tongue swelled up big/ tongue swells up big and it's humongous; taste funny; This is a spontaneous report from a contactable consumer, the patient's mother. A 27-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 29Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started to experience tongue swelling on 30Jul2021 (friday) and since she took it every couple days her tongue swelled up big. It was reported that the patient's tongue swells up big and it's humongous, that she woke up and her tongue felt funny, tasted funny on an unknown date in 2021 and tongue felt swollen and that it really hurts on 05Aug2021 and it was so swollen, it kept swelling up with her teeth biting into it. It was reported that the patient went through that all day then it kind of went down. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, chills and fever of 103.5. (This temperature was the highest measured. I did not measure my temperature when I started to get symptoms.)  Fever lasted 18 hours.
Please note that I am not aware if this was Men B BEXSERO OR Men B TRUMENBA; On December 23rd in the evening my son started to feel nauseated with a headache and backache. I gave him 600 mg of Ibuprofen at about 1830. By 1900 his temp was 101.2 F and he was stating he couldn't feel his feet and left arm. This was a Holiday weekend, and I don't have confidence in my designated ER. I read the vaccine info sheet. I hydrated him and administered TYLENOL as I was sponging him with tepid water. His temp continued to climb to 101.8 over the next few hours. My plan was to bring him to the ER if his temp reached 102 despite the cooling measures. By about 2300 his temp began to slowly drop and he was feeling better. Over the next day he was complaining of pain under his armpit. He continued taking Ibuprofen 400 mg every 6 hours for the next several days as he continued with a temperature. The site of the injection remained red and swollen for about 3 days. His temp was normal after 4 days. On the 3rd day we noted that he had a considerable amount of fluid (presumably lymph) under his left arm. It extended from his armpit down his side approx 8 inches, and anterior posterior about 6 inches. This fluid has slowly been presumably reabsorbing, and is now just present in his armpit. This was the most distressing part for him as it was quite uncomfortable. We described it to people as if he had a Jello mold stuck on his side. As you would touch it his whole under arm would jiggle. It was quite obvious on a 6'3" 160 pound swimmer athlete. He finally felt "back to Normal" after approx. 5 days post vaccination. He had no other complaints besides the arm pain, fever, nausea, headache, back pain.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 16-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 27-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) 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 WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    No concomitant medication was reported.  It was reported that patient 3 didn't report any adverse events. No treatment medication was reported. This case is reported for patient 3 out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:master case
itchy scalp rash....hives, both splotchy and linear  scattered over entire body.  Lasted 6 weeks then subsided on it's own.
(R) arm where MENACTRA given swollen, induration, erythema, cellulitis, 2 hours after injection. Placed on AUGMENTIN after IM - ROCEPHIN given with warm compresses.
This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
The Pfizer bivalent vaccine which was given on 3/20/23 had a before use date of 12/22/22. No symptoms were shown.
With two days I developed an itchy rash on my shoulders, which in the last several days has spread to my back, chest, and stomach.  The itching has been serious enough to require benedryl at night.  So far I have been able to avoid the need for any medicine during the day.  The condition seems to be getting worse each day.  My primary care physician was not able to provide any guidance over the phone and suggested if the condition worsens to seek emergency room care.
Patient received Pfizer COVID vaccine on 1/21/21 and 2/8/21. Patient was diagnosed with COVID on 1/5/22 in her nursing home. On 1/9/22, patient admitted to our inpatient facility with acute hypoxic respiratory failure, COVID-19 pneumonia (? bacterial pneumonia), and acute hemorrhagic cystitis. As of today (1/11/22), patient is still admitted in our med/surg unit.
Blurred Vision, double vision, headache, pressure on temple area of head, dizziness, nausea. All symptoms have still been ongoing since the day of Vaccine.
Information has been received from a health professional concerning a 32 month old white male who on 01/17/2003 was vaccinated subcutaneously in the left arm with a 0.5ml dose of varicella virus vaccine live.  Concomitant vaccination included a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live in the right arm.  There was no illness at the time of vaccination.  On approximately 09/27/2004 the patient developed 15 papules on his trunk and arms, and 2 papules on his back.  Unspecified medical attention was sought.  The patient was treated with diphenhydramine hydrochloride and was recovering.  There was no product quality complaint involved.  Follow up information from the health professional indicated that on the 09/23/2004 the patient had a rash of 15 papules that spread to his arms and legs.  The papules on his arms were resolving.  The patient has subsequently recovered.  No further information is expected.
Mild facial swelling maulpapule. No rest. Lasted for about 6-7 days. Remedy Prelone.
Case number PHEH2014US022974 is an initial spontaneous report received from a physician on 14 Nov 2014. This report refers to an 18 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an intramuscular dose of MENVEO (batch number: not reported) on 12 Nov 2014. About 8 hours later on the same date, he experienced fever, rigors, shakiness and chest pain. The events outcome was reported as condition unchanged. The seriousness was not reported, but the event chest pain was upgraded as medically significant based on the information available on the source documents. The causality of the events was not reported.
Pt was fed Enfamil with Iron. At 20:15 the pt was asleep in his crib on his abdomen. He was found unresponsive at about 21:15. DOA at the hospital at about 21:20. Other family members were ill with vomiting for 2-3 days prior to his death. On 12/13/01 at 04:15, a call was received from the child's mother, reporting that her son died last night and wanted to let the health dept know that Family Services will be calling us regarding immunizations given, dates and possible side effects. She expressed concern about Prevnar vaccine and infant's death. She reported that "he just did not act like the same child after he got his shots." I asked her if he ran any fever after he received his shots and she said no. She was giving him Tylenol every 4 hours for 24 hours, post vax. She noticed his "appetite had decreased a little every day since he was immunized and that his muscles seemed tense. He was not really sick and sometimes he would laugh and smile but yesterday, he did not want to eat at all and just wanted to sleep all day." He was seen at ER with a "runny nose" (allergic rhinitis), no medications on 11/1/01. On 12/5/01, his 4 year old sister was vomiting 1/2 hour after eating. Grandmother sick with acute viral gastritis.  Cause of Death as per autospy report - undetermined.
Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, chattering teeth, nausea 4/15/21 1:00 am - loose bowels, minor headache 8:30 am - Vertigo, unable to stand, collapse on floor, major nausea, dizziness - go straight to bed 8:30 am - 8:30 pm - Sleep off/on entire period, arm pain, drink water, take tylenol, chills, nausea, lethargy 8:30 pm - Midnight - profuse sweating soaking clothes, major headaches, nausea - continue to sleep 4/16/21 Midnight - 6:00 am - Restless sleep, loose bowels at times All day - Awake, tired, occasional nausea. limited appetite 4/17/21 Limited appetite - occasional nausea
swollen uvula with a "clear film over it" Occurred am after vaccine administered.  Slight sore throat on morning of vaccination.  No fever at all during that day or the day after.  this has happened before. Pt feeling better 11/20/08 and feels sx not related to flu vaccine.
Since the Covid vaccination, the shoulder frequently "Freezes" and has to be held and supported to "Click" back into place.  The "Cracking" can be heard and felt by anyone when I, the patient", moves the shoulder.   When I went to see my physician, a shoulder series of x-rays were taken and showed no arthritic changes.