chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-APR-2009, the patient was inoculated with ZOSTAVAX at a hospital, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 06-JAN-2012, the patient was treated by the same hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
1 of 5 pts who was vaxed from the same vial devel a high fever x 5 days p/vax;
Confirmed no side effects or symptoms reported.; Nurse called to report that a first dose of ROTATEQ was administered to a 7 month old, however calculated age of patient is 5 months old as he was born prematurely at 30 weeks gestation. Nurse reports they do not deliver live viruses in their NICU an; This spontaneous report was received from a registered nurse and refers to a 7-month-old male patient. The patient's medical history included neonatal intensive care unit (NICU) visit. The patient's concurrent conditions included being born prematurely. Concomitant therapies were not reported.  On 07-SEP-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml/one of three doses, lot #1918233, expiration date: 19-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that the patient was 7 month old at the time of vaccination (product administered to patient of inappropriate age), however calculated age of this patient was 5 months old as he was born prematurely at 30 weeks gestation. Also, the nurse reported that they did not deliver live viruses in their NICU and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was a live virus which was why he hasn't received his initial dose while in the NICU. It was confirmed that no side effects or symptoms were reported (no adverse event).
Diagnosis is Dermographic urticaria started approximately 7 to 14 days after booster. Still experiencing this 3 months later. Advised to take cetirizine 10 mg twice daily until next follow up on 6/16/2022.
Local reaction on right arm. Arm began to swell up and was very warm. Pt went to ER for cephalexin 500 and PERCOCET on 11/9/15. She called to follow up on 11/14/15 that she's doing much better. She says it's clearing up good.
PATIENT RECIEVED VARIVAX ON 03-19-99 NOW HE HAS CHICKEN POX.
initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023; product storage error; No adverse event; Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (product storage error), EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered ) 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)) (batch no. 022h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered ). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (product storage error), EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered ) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered ).    No information on concomitant medication were reported. It was reported that the refrigerator was out of range for 13-15 min multiple times Product affected was the bivalent Moderna COVID19 vaccine Date vial was initially thawed 04-Jan-2023 4 adult patients received doses of the vaccines affected by a temperature excursion. No treatment details were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 34 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 14Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 301558A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: OSA with CPAP; "CPAP" (unspecified if ongoing), notes: OSA with CPAP; "GERD" (unspecified if ongoing), notes: Well controlled GERD on medications. Concomitant medication(s) included: CLARITINE, stop date: 12Sep2022; PRILOSEC [OMEPRAZOLE MAGNESIUM], stop date: 12Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Sep2022) Positive, notes: Positive antigen test; (25Sep2022) Positive, notes: Positive antigen test. Continued positive antigen tests now 2 days out from initial rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Sep2022 to 19Sep2022.; Sender's Comments: Based on the information currently available, a lack of efficacy with COVID 19 vacccines in this patient cannot be completely excluded.
shortness of breath; She can't stop crying; fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (shortness of breath), CRYING (She can't stop crying), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced DYSPNEA (shortness of breath), CRYING (She can't stop crying), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). At the time of the report, DYSPNEA (shortness of breath), CRYING (She can't stop crying), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.            No relevant concomitant medications were reported.   Treatment information was not provided.
Headache; sore back; sore legs; joint pain in lower body; some arm; soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8731) via an unspecified route of administration in the right arm on 19Apr2021 at 14:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were included as hormonal IUD (MANUFACTURER UNKNOWN) and ascorbic acid; cyanocobalamin; ergocalciferol; nicotinamide; pyridoxine hydrochloride; retinol; riboflavin; thiamine mononitrate (ONE-A-DAY WOMEN'S VITAMINS) started on an unknown date for unknown indications. 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.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8732) via an unspecified route of administration in the right arm on 29Mar2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced headache, sore back, sore legs, joint pain in lower body, some arm and soreness. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, sore back, sore legs, joint pain in lower body, some arm and soreness were recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Very slight feeling of numbness or pressure in a small area of my face near my mouth; Very slight feeling of numbness or pressure in a small are of my face near my mouth; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 14:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, fibromyalgia, migraine, environmental allergy, anxiety, asthma, hyperlipidemia, blood pressure high, pre-diabetes, neuralgia, neuropathy and anemia. The patient received other medications within two weeks of vaccination, names were unspecified. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 14:15 (at the age of 55-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:00 the patient experienced very slight feeling of numbness or pressure in a small area of face near her mouth. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event very slight feeling of numbness or pressure in a small area of face near her mouth was not recovered.  No follow-up attempts are needed. No further information is expected.
Arm was sore, but not able tonuse for 3 days. There was no strength for any movement.
I went into DKA, my left eye bled, my left arm has a blood clot  I was in hospital 9 days and a rehabilitation place for 11 days.
full body rash; swelling on injection arm; This spontaneous case was reported by a nurse and describes the occurrence of RASH (full body rash) and VACCINATION SITE SWELLING (swelling on injection arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH (full body rash) and VACCINATION SITE SWELLING (swelling on injection arm). At the time of the report, RASH (full body rash) and VACCINATION SITE SWELLING (swelling on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from a registered nurse refers to a now 38 years old female patient without pertinent medical history. The patient received 3 doses of RECOMBIVAX HB (lot number, dose, route and injection site were not reported) on an unspecified date "years ago". No other co-suspects were reported. There was no concomitant medication. The patient was found to have negative hepatitis B antibody titers. There was no treatment given for adverse event. Laboratory diagnostics study hepatitis B antibody titer was performed. The present status of the patient was negative antibody titer at the time of report. The patient had an office visit for medical attention. Additional information is not expected.
right leg/foot developed what appeared to be some sort of foot drop entire leg was "floppy" feeling disconnected making it difficult to walk causing a fall injuring both knees.
Myalgia, shoulder pain with joint use limitation, neuropathic pain to 5th finger Narrative: severe left shoulder pain, inability to move shoulder d/t pain for approximately 1 day beginning less than 24 hours after injection, burning pain/numbness to left 5th finger started 2-3 days after injection and lasted 2 days approximately. Bruising to injection site.
W/in several hrs following vax pt developed urticaria & swelling around her eyes; Tx Terfenadine & the experience remitted in two days;
I  am a post-menopausal woman - 1 1/2 years from my last period. 2 weeks after my second covid vaccine, I began to bleed. The. bleeding continued for 7 days. I contacted my doctor and was seen in the office. She collected a FSH , which was 35.9. She also opted to do a TV U/S. The ultrasound findings were WNL, with the uterus being small and a thin endometrial stripe.  All things looking normal, my physician told me to let her know if the bleeding didn't stop or returned again. I haven't had any bleeding since. I don't know if this unusual bleeding is related in any way to my vaccine.
Hot a fever then full blown covid; Hot a fever then full blown covid; blood clot; organ failure; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer reported that  a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Previously on an unknown date, the patient received the first dose of BNT162B2 vaccine. On an unspecified date, the patient experienced hot a fever then full blown COVID, blood clot  and  organ failure  leading to patient death on an unknown date.   It was not reported if an autopsy was performed.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Drug ineffective; Covid-19; Blood clot; Organ failure
April 10, late evening: fever developed. Most of the night it was 102.2 F. Also, my lying down heart rate was 130, which is 50-60 bpm higher than normal  April 11: A fever between 100 and 101 all day. Took a Tylenol in evening.  April 12: Fever, headache gone. Just a little tired and fatigued. Then I seemed to have been recovered.  April 21-22: Achiness, tingling pain in arms, left back, shoulders.  Then this seemed to have abated.  April 28-29: Tingling pain in arms, hands, sometime back and feet.  I have never experienced these symptoms pre-vaccine so it makes me wonder if it is related to the vaccine
Headache, Myalgia, SEVERE BONE PAIN; FATIGUE Narrative: STATED LASTED 4 DAYS
This spontaneous report was received from a nurse refers to a female patients 2 cousins of unknown age. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient experienced premature ovarian failure. The event of premature ovarian failure was considered as serious due to significant disability or incapacity. It was reported that when the response was requested, the representative stated that premature ovarian failure could present incapacity to become pregnant, at least temporarily for each patient. The outcome of the event premature ovarian failure was unknown. The reporter did not provide the causality between the event and the suspect drug. This is one of the two reports received from the same reporter. Additional information has been requested.
Severe redness, swelling and pain in Left deltoid, 3 days post vaccine. Started on Prednisone and Alavert. Apply ice pack to site PRN
Patient is 2 months old and was given and HPV vaccine instead of the PCV13. Staff noticed error when  putting vaccines in EMR.  Local state agency was made aware of event.
pt recv vax 21OCT97 & 22OCT97 pt devel fever of 101, vomiting & inability to move the rt arm more than a 45 degree angle;
Patient mistakenly received 0.5 ml dose of the Moderna COVID vaccine for their booster dose instead of 0.25 ml. The following day, patient reported fever, chills, and chest pain. They were advised to seek medical attention. When called two days after vaccination, patient reported not seeking medical care but that symptoms had resolved completely. Reported to patient's primary provider.
flu like symptoms with headache 4/8/21. Chest pain, nausea, sweating, lightheadedness  started 4/10/21, was seen in ER and discharged home. White count was noted as 2.8. Chest pain went away after 24 hours and palpitations started 4/11/21, severe at times for several hours at a time. Saw my cardiologist on 4/15/21 for severe palpitations and he ordered a halter monitor to be worn for 2 weeks. I stated  to him that I felt like I was in SVT, or something stronger than just palpitations. This continued for several hours a day from 4/11/21 to 4/24/21, when I was on the telemetry pack at work and went into an arrythmia that was later evaluated by my cardiologist as SVT and A FIB. On 4/25/21, I had mild "palpitations" but have not had any incidences since. I am now on metoprolol to control it and did not have a cardiac issue prior to receiving the vaccine.
Hives on neck, back, and back of neck, around the mouth, Chest, Abdomen, Burning sensation in back, chest, abdomen, neck and face.
Information has been received from a healthcare worker concerning a 22 year old female with a penicillin allergy and Benadryl allergy and no pertinent medical history who on 21-MAR-2007 was vaccinated IM with 0.5 mL Gardasil (lot # 656372/0243U). There was no concomitant medication. On 25-MAR-2007 the patient developed a rash on her torso. No lab diagnostic studies were performed. The rash was treated with an injection of prednisone, and as of 29-MAR-2007 the patient was fully recovered. Additional information is not expected.
pt recv vax 21OCT96 & 3FEB97 pt exp a temp of 100, loose cough & nasal congestion;4FEB97 pt had resp virus cult positive for influenza A;tx included flumadine on 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases;
pruritic papules around site of DTP, MMR & PPD >5 cm diameter well circumscribed areas w/ a far lesser # @ PPD site;
Suspected vaccination failure/Had the vaccine but still got shingles in my 6th week; Got shingles; Pain is horrendous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine but still got shingles, in his/her 6th week. The patient stated that pain was horrendous. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported narrative it was not clear whether patient was stated after vaccination in 6th week got shingles or shingles occurred and was in 6th week, therefore in worst approach time to onset was captured as unknown.
A report has been received from a physician concerning a 4 year old female patient. Concomitant medications and concomitant diseases were not reported. During 2011 the patient started receiving FLUMIST (intranasal). The patient experienced hives which started on 11-Nov-2011. The action taken with FLUMIST was unknown. The outcome of the event of hives was unknown. The report was considered to be non-serious by the reporter.
A year after the event the patient described raised red rash with hives and the length of her arm up to the injection site that lasted for over a week.
Pt reported constant diarrhea, stomach upset for 3 weeks after vaccination. Pt reports recurrent episodes of diarrhea about every three weeks and increased intolerance of fermented foods, dairy even with use of Lactaid, fatty foods. Possibly related to the second dose of vaccination. (Will submit another adverse event for the second dose.)
After receiving vaccines, patient reported developing a high fever for several days and large part of arm became red and swollen.