chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed increasing redness around injection site, fever of 100 degrees and blister rash.
This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored VAQTA (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live ( ZOSTAVAX).     Additional information has been requested.
Subsequent to receiving on dose of varicella virus vaccine live, the pt developed a vesicular reaction at the injection site. Additional information has been requested.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Feb-2022 at 1:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Feb 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The ethnicity of patient given. No treatment medication was reported.
Vaccine administered 4/27/16. Parent concerned that later that year (Oct 2016) patient developed signs of polyuria and polydipsia. Diagnosed with IDDM on 10/20/2016. Unclear of correlation.
Received Phizer shot on 12/30/21 from the Clinic and on 01/04/22 I could not breath and went to Emergency room and was admitted with blood clots in lungs.
Redness, sore, painful to lift of left arm. PNEUMOVAX given in left deltoid. Patient given prednisone 20 mg 2 tabs x 4day's 1 tab x 4 days. KEFLEX 500 mg TID x 7 days.
DVT  Narrative:  Patient received 1st shot of Moderna vaccine; two days later (w/n 48 hours) developed left leg swelling with discoloration (purple) from upper leg to ankle. Went to local ER diagnosis: extensive DVT of the left lower extremity with occlusive intraluminal thrombus extending from the common femoral vein with contiguous distal involvement of the entire deep venous system down to the level of the distal popliteal vein. No identifiable provoking factors aside from timing of symptoms post moderna vaccine. Was stated on DOAC apixaban 5mg bid.
swelling all in her face, her cheeks, and as it progressed it included over to her lips; swelling all in her face, her cheeks, and as it progressed it included over to her lips; This is a spontaneous report from a contactable consumer. A 70-year-old female patient (wife) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205, Expiration Date: Unknown), dose 1 via an unspecified route of administration in Arm Right on 25Feb2021 11:05 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Vaccine was not administered at facility. Patient history of all previous immunization with the Pfizer vaccine and any additional vaccines administered on same date of the Pfizer suspect was none reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccinations, patient adverse events were none reported. Patient family medical history relevant to adverse events was none reported. Reporter called about the Pfizer Covid Vaccine. His wife got the vaccine on 25Feb2021. Yesterday afternoon she started getting swelling all in her face, her cheeks, and as it progressed it included over to her lips (10Mar2021 17:00). She looked a pumpkin. Spent all last night in the ER and they gave her some Benadryl, a little shot of steroid and then they gave her an EpiPen. So today they called her primary physician. He said it might be a reaction to the vaccine. This is two weeks later; did that seem possible. In a week from now she was scheduled to get her second shot, and they did not know if she can get it or not. And if she did not get the second shot, what do they need to do. The swelling was still ongoing but drastically gone down and improved. Patient visited emergency room, but she was not admitted. Therapeutic measures were taken as a result of swelling all in her face, her cheeks, and as it progressed it included over to her lips. There was no investigation assessment and relevant tests. The clinical outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt received adult tetanus vaccine as requested on 4/22/03. Called on 4/23/03 with swelling and pain. Evaluated with no sign of infection at IM insertion site but erythema with induration 3.5 cm. Circumoral pattern.
On 5/1/01, noticed fever of 103F (orally). Motrin given. On 5/2/01, AM, mother noticed injection site was red with clear blisters, hard to touch and edematous. Fever of 99.3F in AM. Was sent to school. After school, fever was 101F. Child was irritable, meds given. MD called. On 5/3/01, went to MD or saw CNP. Dx'd as a reaction. Medication for allergic reaction prescribed. Fever in AM was 99.7F. No irritability.
Patient believes that he has Guillain-Barre Syndrome from the Fluzone HD that he received from us.
I noticed my mom was sneezing and having headaches, a few weeks after her first shot.  When I looked at her handkerchief that she blew into it was a dark blood mucus coming from her nose in which I've never seen before. I don't know if it's a blood clot but my mom is on blood thinners because she did have a previous heart attack and a few months back she had covid naturally. She is also a heavy smoker since she was 16.
Severe pain in lower right abdomen, a bursting sensation, and continued pain for about an hour on 4/10/21.  No pain for a week, then moderate pain in same area on 4/17/21 beginning at about 3 pm and continuing at the time of completing this form.  Moderate headache for the entire day on 4/16/20; took 2 Advil at 7 p.m. on 4/16 and it went away and has not returned.
One month after injection the patient woke up with loss of function in her left arm. Went to ER and for therapy. She was told it was nerve damage, undetermined cause. She had a soft cast and was out of work for 2 months.
Mom described that patient rec'd second dose in the PM of 03/30/2021. The next day, he was on virtual classrooms and some classmates pointed out to him that they were having to repeat information they had just gone over. After this happening a few times, he became concerned and discussed with his mom. They then realized he had no memory of getting the second dose, or dinner or any other events from the remainder of 03/30. Mom called MD, who advised they go to ER.
The day after I took the vaccine. I suddenly passed out while driving causing a deadly accident on the highway. I woke up after an hour in the hospital where they told me I had an accident and totaled the car. Thank GOD no one was hurt just me had minor bruises on my arm and redness around both eyes like someone punched me in the face. The urgent care made a CT scan on my head and body and determined that I had a seizure (they wrote on the report Trauma/ Severe Headache). and put me on Keppra. They asked me to follow up with my neurologist . I followed up with my neurologist and now  I am on Keppra medication which that was not the case before the vaccine. I asked my neurologist that I read an article on CNN that vaccines may trigger seizures but she told me vaccine is safe this has nothing to do with it etc. but I am full of doubt and will not take my 2nd dose of Pfizer I cannot risk it. I hope this message makes a difference.
1.5 hrs after vaccination felt like coming down with something. 4.5 hrs later fever 100. Had fever 101-102 until 2 AM 10/19/12 when fever broke. Had fever again 10/19/12 AM until 5 PM (100.6-101.2) also had aches, nausea, headache, malaise. Lasted 28 hrs.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021 at 10:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient had no known drug allergies.  It was reported that patient had experienced no side effects when vaccine was administered and no side effects reported or noticed afterwards.  The vaccine was moved from freezer to refrigerator the day of administration.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2022: Follow up received patient demographic, product information. On 17-Jul-2022: Non-significant follow up received- Narrative updated.
I felt nauseous and had the chills with hot and clods sweats.  Ever since I received the second Pfizer shot on 12/13/2021, I have experienced profuse sweating underneath my arms on a daily basis. The sweating continues to this day.
sometime on 03/20 late to early morning 03/21 patient reports intense pain around left rib cage, back & under left breast, on 03/22 rash develops along the same area. She visited urologist on 03/25 b/c of back pain, thinking it might be a kidney stone. She did internet search of symptoms and thought it was shingles. On 03/29 she saw dr. nunag  and he confirmed the rash was in fact shingles.  On 03/29 she started Famciclovir 500mg 1tid
I had body chills starting within 7 hours of the vaccine.  I developed a headache, nausea, slightly dizziness about 14 hours after the vaccine.  About 15 hours after the vaccine, I still had the headache, nausea,  dizzy,  and additional slight diarrhea, dry heaves, rapid heartbeat, and feeling very tired  and weak but went from chills to hot and sweating.   This lasted for about an hour and then it was back to body chills, headache, nausea, body fatigue for the next 24 hours.   My arm and injection site did not hurt, only if I would rub across that area of my arm.   I have still experienced the fatigue 60 hours after the vaccine.  Nausea has still come on different time during this time too.
After receiving her vaccine client stated that she felt her heart fluttering.  Vital signs obtained by Paramedics.  BP 133/80, HR 64, O2 sat 100%. Client states she feels better.  Discharged home by Paramedics.
On 08/28/2001, 3 hrs after immunizations given, child developed a fever of 103.8 degrees F. and mom said "she could not get it down all the rest of the day with Tylenol and Motrin so she took him to the clinic the next morning on 08/29/2001."
Patients received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) 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 UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received, narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:same reporter
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX about a week ago and still had swelling and a 3 inch red patch around the injection site. The reporter did not wish to provide additional information.
Information has been received from a medical assistant concerning 18 week old patient who in October 2011, was vaccinated with a first dose of ROTATEQ, (dose, route, lot number were not reported). It was reported that the patient was given the second dose of ROTATEQ on 12-DEC-2011. The patient was given the third dose of ROTATEQ early on 28-DEC-2011, (lot number 16592 is an invalid number for ROTATEQ, expiration date 06-DEC-2012). No adverse reactions reported. The patient did not seek medical attention. Additional information has been requested.
Diarrhea fatigue, body aches Narrative: Pt reported on same day of 2nd covid vaccine the following ADRs; diarrhea, fatigue,& body aches. No treatment medications reported
Narrative:  COVID infection following COVID vaccine series 03/05, MODERNA, dose #1 04/30, MODERNA, dose #2 12/20 SARS-COV-2 Variant Sequencing: pending 12/20 COVID swab, result: detected 12/20 pt cc: chills, cough, fatigue, headaches, myalgias, rhinorrhea, exposure: unknown
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) via a company representative concerning a 49 year old patient of unknown gender with negative titers for varicella. On 24-AUG-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) (Lot No. J009165 Expiration date: 24-JUL-2015) subcutaneous  (dose and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
"pt recv vax 4SEP96 & on 5NOV96 pt exp rash (full blown), generalized;"
Bedridden for 36 hours does not remember much from that time period because "was out of it".
Pt said he felt he was losing his hearing in his left ear.   recommended to go see a physician.  Pt goes to urgent department and gets a rx for antibiotic ear drops.  Called back to check on pt, but no answer
On 12-13-2021 at approximately 1010 am, HCP administered a COVID-19 vaccine in the left arm of a female patient.  Within 3 minutes after receiving the vaccine the patient stated she was dizzy.  Pt was seated and the time.  Upon checking her blood pressure, pt asked that I use her right arm as she had had cancer in her left arm. Her blood pressure was elevated.  She had not eaten nor had anything to drink all day and has a history of high blood pressure.  She was given water, food and took her blood pressure meds.  She then stated her left arm was feeling numb and tingling.  Upon inspection of her left arm injection site I noted the band aid to be placed approximately 1 inch below the deltoid muscle.  I removed the band aid and visualized a small red dot injections site.  The site was not swollen nor tender to touch.  I explained that the injection could have irritated some nerves and that I would keep a close eye on her.  Pt was able to move her arm, hand and fingers on the left without limitation or pain.  Within in 20 minutes patient stated she no longer felt the numbness in her left arm.  I re checked her blood pressure and it was with in normal limits.  Pt was released from the clinic by 1100 am.
The area was not initially red on 10/19/20 the area became red, itchy, & PUFFY. No fever. No streaking & no spreading of redness. treatment: oral septra, oral benedryl q 8 hours prn & oral Ibuprofen q 8 hrs prn. F/u if erythema worsening, fever, discharge, or red streaking.
Sore arm, redness around injection site about 4in, headache Have had it it one day now with no change.
I had my vaccination on 10/04/2022. I started to experience sore throat on 02/22/2023. On 02/23/2023 I had fatigue congestion and low-grade fever and developed a cough. I was prescribed Paxlovid in 02/2023. I did rebound 4 days later and the symptoms came back worse. I was prescribed over the counter medication and rest. I presently feel better on 04/06/2023.
Breathing difficulty; Coughing; Runny nose; Fever; Shaking; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jul2021 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 29Jul2021 at 09:00, the patient experienced breathing difficulty, coughing, runny nose, fever and shaking. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events breathing difficulty, coughing, runny nose, fever and shaking were not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patients / received a dose / from the recalled lot / received the recalled lot after the recall date; patients / received a dose / from the recalled lot / received the recalled lot after the recall date; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The medical assistant reported that the patients were administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No symptoms reported. The reporter consented to follow up. The health care professional did not have the list compiled of patients who received the recalled lot after the recall date. The health care professional should be getting the list or details soon. The health care professional agreed to follow-up and noted that follow-up via email would be best.
Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Report a side effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE for Allergy, LEVOTHYROXINE SODIUM for Thyroid disorder NOS, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Report a side effect). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-391837, MOD-2021-391838 (Patient Link).
Child anxious due to ? immunization given injection and within two minutes? light headed and nauseous. Feet ? inhalant administered. Given ? better since no food or drink for 12 hrs. Examined stable throughout.
Headache, fever, severe joint and muscle pain weakness, diarrhea, poor appetite.
PATIENT RECIEVED MODERNA DOSE EVEN THOUGH HE IS UNDER 18.
The pharmacist administering the vaccine, inadvertently administered the COVID-19 vaccine twice to Patient.  She received her second dose and then a short time later, received another dose resulting in a total of three doses.   The patient, her family, and the facility are aware and are observing patient for possible ADRs.  She has currently exhibited no adverse signs/symptoms and is having vitals checked every 2 hours.