chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient only received the DTap-IPV components of the Pentacel and need to re-vaccinated/ No AE; Initial and follow up information was received on 28-Jan-2020 and 29-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional (medical assistant).  This case involves (pediatric) child patient who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was inappropriately reconstituted (Product preparation issue).  This case involves (pediatric) child patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ226AA, Exp. Date 04-APR-2021) via unknown route in unknown administration site, on an unknown date that was reconstituted just with diluent and patient just received the DTap-IPV components (Product preparation issue).  Medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse reactions.   Laboratory details were not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 8 hours after the shot, I began to feel flu-like symptoms beginning with intestinal discomfort and incontinence. Shortly after, fever developed over 100 degrees F.  By +9 hours, fever reached 102, and I became disoriented badly, to include loss of balance and some speech issues.  Went to bed, waking every 1-2 hours to drink 20-30 ounces of water.  Frequent urination throughout the next 48 hours.  Fever peaked at 103.7 at about 36 hours after shot. After 48 hours from shot time, fever was gone with fatigue remaining. Low-grade fever returned at 60 hours, and fluctated continuously ever since between 98.4 and 99.6.  All temps via temporal sensor thermometer.
bleeding of the rectum; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding of the rectum) in a 74-year-old female patient who received mRNA-1273 (batch no. 006M20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No medical history was reported.).  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (bleeding of the rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (bleeding of the rectum) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Intramuscular) was unknown.  Concomitant product use was not provided. Treatment information was not provided.  The caller did not report if she received the IM dose into her left or right arm. She stated that she has called her HCP and is waiting for an appointment. She reported that her second dose in the series is scheduled for 15-Apr-2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.      Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Lack of effect. On Aug. 4, 2021, patent started filling symptoms of COVID-19 infection. She tested positive from a test taken on Aug. 5, 2021. Treatment for ear ache (associated with symptoms)  included Methylprednisolone Dose Pack 4mg Oral Tablet (prescribed Aug. 6, 2021)  and Zithromax 250mg Oral Tablet (prescribed Aug. 7, 2021)
Narrative: 71yo pt with hx of cancer, Mantle cell lymphoma of the colon died on healthcare professional 8/26/2021 during inpatient admission. Per Md's death note, "Death was caused by Acute hypoxic respiratory failure secondary to septic shock and worsening malignancy after palliative extubation (consent from family). "Pt had received covid vaccines on 1/27/21 & 3/3/21 from outside hospital. Death is not related to vaccines.
Swelling associated with area of facial filler (Voluma).  Placed approximately two months prior
Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies who on 08-JAN-2007 was vaccinated with a first dose of Gardasil (lot# unknown). Concomitant therapy included hormonal contraceptives (unspecified). The week of 08-MAR-2007 the second dose of Gardasil was administered. In March 2007, the patient developed a red bump at the injection site. The bump had gotten smaller; however it was not yet resolved. Medical attention was sought. Due to storage at incorrect temperatures, the patient was told that her first and second doses of Gardasil had to be readministered. On 11-MAY-2007, the series for Gardasil was restarted and a first dose was regiven. On 11-SEP-2007, the second dose was readministered. No further information was available. At the time of reporting the patient was recovering. No further information was given. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies who on 08-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 653735/0688Y) IM "RVG" at 4 PM.  Concomitant therapy included hormonal contraceptive (unspecified). The week of 08-MAR-2007 the second dose of GARDASIL vaccine was administered. In March 2007, the patient developed a red bump at the injection site. The bump had gotten smaller; however it has not yet resolved. Medical attention was sought. Due to storage at incorrect temperatures, the patient was told that her forst and second doses of GARDASIL vaccine had to be readministered. On 11-MAY-2007, the series for GARDASIL vaccine was restarted and a first dose was given. On 11-SEPT-2007, the second dose was readminstered. No further information was available. At the time of reporting the patient was recovering. No further information was given. Additional information has been requested. Follow-up information was received from the physician's office. The lot # and route was updated. There were no adverse events reported at the time of the visit on 08-JAN-2007. There were no phone calls from the patient reporting an adverse event. Additional information is not expected.
36 hours after the shot, Patient had two bouts of vomiting. That started early Thursday morning. Friday and Saturday he had diarrhea. Sunday he woke up screaming that he couldn't move his limbs and was in excruciating pain.
Started with Hives on back then bumps and then boils. This has been going on over my entire body but mainly at the injection site for 3 months. I have pictures and hospital/urgent care visitis. I've been to a dermetoglogist. Non stop bumps and boils for 3 months.
about 14 hours after receiving the flu vaccine he woke up with a small amount urticaria at injection site and back.  By hour 16 the hives increased dramatically. His entire thigh was one big angioedema, swollen lips, and scattered hives all over the rest of his body.  Mom gave oral Benadryl and took him to the urgent care.  They observed and gave a steroid in the office and prescribed one for the next day. After a few hours the hives mellowed out and wasn't as swollen, but still red.  Mom treated every 6 hours with Benadryl as the hives kept returning once it would wear off.  On day 3 he didn't need any Benadryl although his cheeks were still flushed and red. No other illness at the time, no new foods or other exposures.  The fact that his injection site was covered in edema is why I believe it was related to his flu vaccine.
PNEUMOVAX Dec 16th, 2011. (Rt) shoulder area painful abduction & local pain developed next day. Now weak (Rt) supraspinatus & sl weak (Rt) infraspinatus. No prior shoulder problems. Also weight lifts.
Patient received 2nd COVID vaccine Moderna 2/3/21 to the left arm and now having redness that is spreading, hot, itchy, and hard lump to injection site that is also very painful. Patient did outline the redness when started to monitor the increase of size that now reporting getting worse. Has pictures of the arm with the progress. Had applied topical benadryl cream to site without improvement. Concerned about cellulitis to the area. Having bad headache, body aches and chills. Reports that she did have the body aches and headache as side effect with the first vaccine but recovered after a day or so. Scheduled appointment in office to further evaluation
Chicken pox 3/18/09 after 2 vaccinations for VARIVAX 9/26/05 12/9/08.
This spontaneous report was received from a patient's mother reporting to her son of unknown age who on 05-SEP-2012, was vaccinated with a dose of MMR II (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother reported that five days later, on approximately 10-SEP-2012, her son began to stutter. No treatment information was reported. At the time of the report, the patient had not recovered. It was unspecified if the patient sought medical attention. The relatedness for stuttering was unknown for MMR II. Additional information is not expected.
1/12/12 12 x 8 cm area of erythema with warmth and tenderness. No mass, no discharge (L) deltoid area.
Pt finished her 20 minute observation time and left. She was sitting in her car watching videos when she noticed her tongue started to swell. We brought her back in via wheelchair to Medical Bay for further assessment. Vitals stable A&Ox4 no rep distress, no difficulty swallowing. 75mins post vaccination pt reported tongue swelling.  Pt reported that she had no previous reaction to 1st or 2nd Dose Moderna Vitals: 127/70, 86, 18, 97% on RA Pt given Benadryl 50mg PO @10:50 and 0.3mg IM Epi @11:20 to Right lateral thigh. Patient observed longer and no change in size of tongue swelling. EMS was called at 12:10 due to persistent symptoms and need for additional observation.  Pt taken to the ER @12:23. NO additional information available to this writer
Temp went up to 102 degrees - 3 days arm hot and red for a week.
Pt recvd DTP/OPV 18JUN later on 18JUN & 19JUN pt had mild erythema @ inject site, & some muscle soreness; t101 orally until 21JUN91; pt taken to MD 21JUN91; c/o ear pain & fever; MD said ears & throat were not infected CBC was drawn;
Anaphylaxis.  Throat closed and I could not breath or swallow. Pharmacist contacted clinic that was on-site.  The nurse and dr/PA (not sure) ran over.  I am not sure of everything they did, as this triggered a seizure.  After several minutes, I was able to whisper and then talk.  911 was called and an ambulance was dispatched.  I heard, at that time when they were relaying vital signs, etc. that an epi pen was used on me.  The EMTs then checked me over (quick physical for any injuries, rashes), took vitals and advised me to go to the ER because I was still having some issue with swallowing and because I had had the seizure.  They wanted to make I was okay because I was still having some symptoms.
Pt received first Pfizer Covid 19 vaccine on 4/12/2021 with report of immediate pain at injection site followed by left arm numbness and tingling radiating to the fingertips.  She states pain and numbness worsened followed by discoloration of entire left arm.  Symptoms resolved after 2 weeks.  Presented to same vaccine clinic for second shot 3 weeks later and reported above symptoms.  Opted to give vaccine in thigh to utilize larger muscle.  Vaccine dose  2 of Pfizer Covid 19 Vaccine given left thigh with no reports of pain or tingling at time of second dose.
Symptoms: extreme nausea, diarrhea, dizziness. Inability to hold down anything,  including  water.. Duration about 6 hours.
Pt given Gardasil immunization in left deltoid area became red and warm to touch within 5 minutes of shot, and spread on pt torso. Benadryl given symptoms relieved
Evening:  around 8:00 p.m.  headache, arm sore, body aches, sleepy.  I slept all night Saturday night, all day Sunday except for a few minutes three or four times, slept all night Sunday night.  Monday I?m still tired and sleepy, now I?m nauseous..
She received the vaccine on 3/11 she was  admitted to hospital  and found to have a relapse of Multiple Sclerosis (her second relapse in 5 years.) She was treated with high-dose steroids and it took her over a month with physical therapy to fully recover.   For the MS, she received Lemtrada infusion in 2017-2018]
3 epi pens day of shot, hospitalized over night, tremors 10/13/2021-present, severe leg pain and weakness,
Lethargic; Severe vomiting; Very severe  diarrhea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included mild heart issue (heart disorder). The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, the patient experienced lethargic, severe vomiting, very severe diarrhea and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargic, severe vomiting, very severe diarrhea and chills were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore arm for 1 day after injection, redness at injection site appeared 6 days after injection. Is not itchy or sore, just red.
Cold sweats, shaking, headache,  congestion., joint soreness, muscle soreness
On the day of January 7, 2022  started having headaches, shaking, abnormal heart beats. I stayed in the bed most of the day for Fri-Sun. I was experiencing abdominal pain, joint pain, nausea. On Monday I contacted my doctor called me in for a physical exam and discussed my symptoms and my blood pressure was high on that visit. I went for blood work on January 13, 2022 waiting on results and have a appt scheduled with the Cardiologist for Tachycardia.
Parents stated patient came out with hives that day, vaccines were the only new thing given that day.
Severe chills , shaking , severe headache nausea , muscle and joint aches started 10 hours after dose
pain with any movements of vaccinated deltoid which causes in arm lift; patient still has pain at the injection site; Initial information regarding this valid unsolicited non-serious case from the via the agency (reference number- 00305801) was received from physician and transmitted to Sanofi on 07-Oct-2020.  This case involved a 61 years old female patient who experienced pain at the injection site (vaccination site pain) and pain with any movements of vaccinated deltoid which causes in arm lift (pain), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 31-August (year unspecified), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection [Lot UJ442AA, expiry date: 30-Jun-2021] via an intramuscular route at the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious pain at the injection site (vaccination site pain) and pain with any movements of vaccinated deltoid which causes in arm lift (pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  At the time of reporting it was reported that, patient still has pain at the injection site. It is not red, swollen or warm.   Details of laboratory data not reported.  It was reported that, anti-inflammatories have been given to patient and they do work temporarily but when they wear off the pain come back.  At the time of reporting, the patient was not recovered from the reported events.  follow-up information was received regarding this valid unsolicited non-serious case from the the agency (reference number- 00305801) was received from physician and transmitted to Sanofi on 09-Oct-2020.  Pain event and formulation of suspect vaccine added and narrative updated accordingly.
Patient received Pfizer Covid 19 vaccine dose #1 on 02/02/2021 Lot # EL9264  in left deltoid IM. Dose #2 as listed above in item 17 administered on 02/23/2021. Patient presented to ER with family on 03/15/2021 with breathing difficulty. COVID PCR Positive. Specimen sent to State Lab for genetic sequencing and reported to VAERS as required.
Fever, body aches, diarrhea, lethargic, cold sweats.
Developed sudden onset anaphylaxis. Taken immediately to ER and intubated. Admitted to hospital.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
12/6 - 3 pm - received vaccines. 5 pm - (1) Burning throat; "itchy esophagus." (2) Felt like throat was "closing up". 7 pm (3) Nausea & vomiting; diarrhea. Nausea & vomiting lasted 4 days. Throat symptoms lasted overnight.
Information has been received from a licensed practical nurse concerning a nine year old male pt with no allergies or pertinent medical history, who on 30Jul98 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot626768/0669H). There was no concomitant medication. On 25Oct05 the pt was diagnosed with chickenpox with 25 lesions. He was afebrile. There were no laboratory studies performed. The pt is recovering. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Shortness of Breath, cough, no taste, symptoms started Sunday afternoon, had send out covid on Monday was neg, (rapid was positive) pt has had both covid shots ? Nausea ? Fever ? Fatigue ? Headache ? Diarrhea Patient is on Rituximab and received doses on 5/12 and 5/29. which was 5 weeks after finishing vaccine.
1. Received shots on 10/18/10. 2. 10/19/10, injection site red & swollen. Feverish, nauseated, & vomiting. Whole body pain. 3. Took TYLENOL. 10/20/10 still feels lousy. 4. 10/21 & 10/22 still with body aches. Site clear.
MILD VARIVAX REACTION- 4CM. X 6CM. RED AREA AROUND VARIVAX INJECTION SITE. A FEW SCATTERED PINK PAPULES ON NECK AND TRUNK WITH LOW GRADE FEVER. STARTED ABOUT 1 WK. AFTER IMMUNIZATION WAS GIVEN.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced flu like symptoms. The reporter did not have any additional information regarding the patient or event. This case was one of the 5 cases, reported by the same reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 56-year-old female patient who received SHINGRIX (batch number 0727D ?, expiry date 24th January 2020) for prophylaxis. The patient had a Family History of shingles (to the patient's husband). On 15th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 17th March 2019, 2 days after receiving SHINGRIX, the patient experienced chickenpox. The patient was treated with VALTREX. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to SHINGRIX. Additional details were provided as follows: The reported batch number 0727D seems to be adjuvant's batch number was not available in sales data base, however it was captured as 0727D ?. After about two days of SHINGRIX shot, the patient developed chickenpox. Therefore, the pharmacist was suspicious that the patient got the chickenpox from her husband. However, the event occurred after getting SHINGRIX. The patient visited her physician and her physician confirmed that she had chickenpox. The physician prescribed VALTREX.
Vaccine given on Monday March 8 2021 second vaccine.  Sunday morning March  14 woke up dizzy & nausea. Passed by 12noon & returned at bed time 10p Monday morning March 15woke up dizzy & nausea & passed about noon did not return. At some point Fri  March  20 slight nausea upon waking from a nap. Sunday  March 21 slight nausea  in morning passed in afternoon.
Loss of taste, muted/loss sense of smell. First noticed mild symptoms 1/9, continuing at time of this report, 1/12. Can smell coffee, candles etc. if nose is held close. Cannot taste coffee, oranges, toothpaste, salt, mustard, etc.  Had no symptoms 1/30, 1/31, or 1/1. Starting 1/2, had a migraine (including nausea) that persisted until 1/8. As patient (me) has cluster migraines, its difficult to say if this was related to vaccine, but feel it should be noted this was an especially intense migraine week (also was with menstruation so likely "normal")  Other than that, feel generally tired.
I felt achy, had chills, and my arm became very red, itchy and swollen. I also had a decreased appetite. I called my doctor and was told to just keep an eye on things to make sure it didn't worsen.
Rash started upper body the evening of 2/11/13 - spread to face, torso, arms & legs including palms by 2/12/13. Fussy and tired.
Passed out (patient has a history of passing out after receiving vaccines). BP 153/81 (pulse 71), followed by 146/75 (pulse 72).
I have been feeling really off; Anxious; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I have been feeling really off) and ANXIETY (Anxious) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced FEELING ABNORMAL (I have been feeling really off) and ANXIETY (Anxious). At the time of the report, FEELING ABNORMAL (I have been feeling really off) and ANXIETY (Anxious) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Patient inadvertently administered dose 1 of Moderna covid 19 vaccine to person under age 18.
pt recv one dose of varivax in 7/97 & in 2/98 pt devel 2-3 skin lesions on his thigh that ``appear to be similar to chickenpox''. f/u from m.d. ofc indicated the ``skin had a discrete maculopapular rash w/approx 60-80 lesions''