chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines given at 1140 am. Pt reported feeling fine after shots administered. At approx 1150 am pt reported feeling dizzy, followed by snorting after nauseated, profusely sweating, then blurred vision - paramedics called to ck pt. Pt felt better 15-20 mins later.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient missed a dose of PNEUMOVAX23 lot # not specified, because 5 dose vial was under filled. No adverse effect was reported. The patient's outcome was unknown. Product Quality Complaint (PQC) was filled. Additional information has been requested.
pain/although the worst pain only lasted 2-3 days; got the shots 2 years ago, got Shingles last month/suspected vaccination failure; shingles/Still got shingles last month; 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. In September 2022, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the Shingles shots 2 years ago and still got shingles last month.  The recovery had taken 3 weeks. Less than 2 years after vaccination, the patient had experienced pain. Although the worst pain only lasted 2 to 3 days. The reporter denied to follow-up. 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 suspect was coded as per narrative information.
High fever and body aches 11-12 hours after second dose. Also, my menstrual cycle has been like clockwork for 42 years and an my last cycle started approx May 15. I haven't had a period since I received the shot.
no additional adverse event reported; expired vaccine used; This spontaneous report as received from a other refers to a 62 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 28-JUL-2020 the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S007265 expiration date 07-JUL-2020 (dose and route were not provided) for prophylaxis. No adverse event were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
After the 2nd vaccine, on Apr 3 (Saturday), I started experiencing heart pressure, chest pain, dizziness, tingling on left side, nauseous. I saw Dr  on April 5 (Monday. After she ran a few tests, including Troponin test. The test result from Troponin I was 0.72 ng/mL. Dr  asked me to immediately get admitted. At the hospital, I was diagnosed with MINOCA heart attack (no blood clots were found).   After I was discharged from the hospital on Apr 6, I continued to feel extremely fatigued. out of breath, tingling sensation for several weeks. On May 6, the cardiologist asked me to do MRI test without contrast.  The MRI results identified a small amount of inflammation in the heart.
aneurysm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANEURYSM (aneurysm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANEURYSM (aneurysm). At the time of the report, ANEURYSM (aneurysm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The caller mentioned that her mother developed an Aneurysm, after having the Moderna vaccine.
Severe muscle and joint pain in upper torso. High fever all night long. Headache.
A week after the vaccine, he had no appetite and developed a fever. His cheeks were rosy and upon checking his temperature it was 103.  He ran a temperature for 3 days, ranging from 100-103.4.  He had a reddish/pink rash all over his chest and stomach, moving up to his shoulders, his neck, behind and on his ears.  When I called the Dr's office to advise, they stated it is from the vaccine and is just his body reacting to it and that it was not contagious.    July 31, he had a febrile seizure. The first question we were asked was if he had any vaccines and if he had the MMR vaccine.  I was informed that if he had an adverse reaction to the MMR vaccine, the chances of him having a febrile seizure are highly likely.  There was no history of seizures with him or with our family prior to him receiving this vaccine.
Had Td 5/31/2005. On 6/1/05 injection site began to swell, have warmth redness and pain that worsened  It is swollen from the top of the left shoulder to 4 inches above the elbow. Referred to pmd. Had only had 5 DTPs in the past , first Td.
We received from a patient via the Vaccine Information Service the following information on 02 Oct 2007: An elderly female patient (in late 70s) was vaccinated with a first dose of RabAvert, batch-no. unknown, in 2007 after she was bitten by a feral cat. 2 days after the vaccination the patient's gums started to bleed. INR was checked and it was "sky high". The patient was hospitalised due to right sided chest pain, problems with the right arm and bradycardia. Medical history: fibromuscular dysplasia of carotids. Concomitant medication: Warfarin since more than 20 years; ASA (acetylsalicylic acid) and 5 doses of post exposure HRIG (immunoglobuline human anti-rabies). Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measures necessary.
Swollen Lymph Nodes at the Injection Site; Bad Sore Throat; Chills; Very Bad Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes at the Injection Site), OROPHARYNGEAL PAIN (Bad Sore Throat), CHILLS (Chills) and HEADACHE (Very Bad Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes at the Injection Site), OROPHARYNGEAL PAIN (Bad Sore Throat), CHILLS (Chills) and HEADACHE (Very Bad Headache). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes at the Injection Site), OROPHARYNGEAL PAIN (Bad Sore Throat), CHILLS (Chills) and HEADACHE (Very Bad Headache) outcome was unknown. Not Provided      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.
Prolonged headache (7-10 days), metallic taste in mouth, brain fog, fatigue, light fever (1-2 days after)
Muscle aches on 9/17 and 102.6 fever evening of 9/17.   9/18 - Rash on left arm around site and below, about 4 inches with pain, , itching,   Lasted for 5 days,  Went to Urgent care on 9/20 and they confirmed a reaction to vaccine,  ,On 9/22 went to dermatologist and he prescribed cortisone cream.  The pain in my arm and the heat from the  rash woke me up at night and kept me awake.  I took 500 mg tylenol.   Had no reaction to Moderna dose 1 and 2.  Was surprised at this reaction.
Starting 06/09/2022, I developed mild cold like symptoms. The next day they were worse and I tested myself for COVID-19 which was negative. On 06/11/2022, my symptoms were bad and I tested myself with an at-home test for COVID-19 which was positive. I called my doctor and they ordered a blood test to ensure my liver could handle the antiviral. They prescribed me the PAXLOVID that day and I started it right away on 06/11/2022. The symptoms were like the worst cold or flu I ever had: severe nasal congestion, upper lung congestion, coughing, eye pain and bad malaise. I did not have vomiting which I normally have with the flu. Within 36 hours of taking PAXLOVID, the symptoms were extremely reduced and within the week they were gone.
She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?"; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?") and NO ADVERSE EVENT (No adverse event) in an elderly female patient 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) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?") and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?") 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?").    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  Treatment medications were not provided.   Reporter did not allow further contact
11/30/05 Soreness left shoulder, evening- developed fever 101.5; red area around inj site 12/01/05: Increased soreness left shoulder, fever
Patient's hands felt tingly, was very lightheaded, broke out in cold sweat. After about an hour of lying down, patient felt fine and was able to walk on his own.
Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not provided).  The day after the vaccination, she developed a swollen arm and started to vomit.  At the time of this report, the outcome of the event was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
3-13-07 Mother took child to Hospital with complaints of high fever and swollen left thigh.  Diagnosis: Otitis Media Treatment: Amoxicillin, follow up with doctor for swelling to left thigh.  Sonogram pending.  3-20-07 Mother walked in stating child unable to ambulate since immunizations administered 2-27-07. Non-tender nickel size nodule noted to left mid thigh. Mother was provided with spanish education regarding the potential adverse effects from childhood immunizations, including exaggerated localized reaction, and sterile abcess. Patient demonstrated ambulation without any hesitation, guarding, jor limited mobility.Mother was instructed to follow thru with Hospital referral with doctor to evaluate swelling of left thigh. Child evaluated by PA-C. He identified mass Lt thigh post vaccination most likely represents a sterile abcess or hematoma.  She was referred to doctor as recommended initally by Hospital.  Mom also advised that this could resolve on its own.  R.N.
From initial information received on 07/Mar/2005 from a health care professional regarding an adverse event, it was reported that a forty-five-year-old female patient received a booster dose of DECAVAC vaccine, lot number U1215CA, administered in the deltoid on 03/Mar/2005.  The route of administration was not reported.  An unspecified amount of hours later, on 03/Mar/2005, the patient developed a red raised area 25cm x 10cm at the injection site.  She also complained of pruritis.  The patient was seen by a physician again on unspecified date.  At the time of this report, no other symptoms were reported.  The patient has not recovered from these events.  Follow-up received on 05-Oct-2005.  As per the additional information, the patient presented with complaints of left deltoid pain on 07-Mar-2005.  She had developed injection site erythema, induration tenderness and edema at the injection site.  The area of the erythema and induration was 6 x 6 cms in size.  It was reported that the patient does receive tetanus shots on regular basis and she never had any reaction in the past.  As corrective treatment the patient was placed on MEDROL dose-pack and KEFLEX for an unspecified short period of time.  The patient presented again on 14-Mar-2005 for the re-evaluation, the large erythematous area that was questionably indurated, and erythema was roughly 85% resolved.  There was very small hard mobile nodule under the area of the injection and there was no warmth but there was erythema.  The patient denied any pain but there was intermittent itching.  It was reported that the contact dermatitis to the tetanus vaccine injection nearly resolved.
Got yeast infection on 1/22/21. Took Diflucin on 1/24/21. Now today 1 week after Diflucin yeast is back it has to be the vaccine   because vaccine still in my system
This spontaneous report as received from a nurse refers to a 16 year old female patient with no pertinent medical history or drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with the first dose of VARIVAX (merck) (lot # J003542, Exp date 15-MAR-2015, also reported as 25-MAR-2015) subcutaneously (dose unspecified). There was no concomitant medication. Nurse reported that on 15-OCT-2013, patient complained of a rash and a 20x40mm red injection site reaction. Nurse reported that on 17-OCT-2013, patient had itchy lesions on her chest and back, and the injection site reaction on the right arm was now 40x55 mm. Patient also reported headache. Nurse reported that patient went to an unspecified urgent care facility on 17-OCT-2013 in which she was diagnosed with chicken pox and cellulitis at the injection site. Treatment for the cellulitis was KEFLEX. Nurse reported that on 29-OCT-2013, the patient again visited the urgent care facility in which the injection site was better, and the lesions were "dried and contained". The outcome of chicken pox and cellulitis at injection site was reported as recovered/resolved. Additional information has been requested.
Patient experienced nausea, headache, burning sensation in arm, lightheaded, dizziness
Severe muscle aches as I had when having Mono, sore throat, extreme fatigue and nausea.  Eczema flare up on neck, ears and lower extremities with Prednisone 10mg tabs taken
Gastrointestinal issues Constant pain along with multiple sensations from the soles of my feet to my groin. Numb/dead arm. Vision and peripheral decreased  Loss of appetite   Over the six to seven months these symptoms progressed. I am currently behind on bills due to missing work due to all the specialists I have had to see. Currently waiting for my appointment to meet the neurologist that I will have to see now for the rest of my life. Medications are being altered  to help relieve the pain. This has taken a toll on me. Something I couldn?t afford. I am a single mother of five children who struggled to get herself through school to be a medical assistant after spending 10 plus years being a CNA/Home Health Aid. First it was fighting with my apartment complex to keep hot water on so we can bathe and begging for them to fix the ceiling and water that flooded my kitchen. Now on top of that and million and one things I have to worry about? I also have to worry about fighting to stay alive to see my children grow and marry and have  babies.
several months p/vax pt reported pain in the rt upper quadrant x 2wk, muscle cramps, fatigue, pins & needles sensations in lower extremities, dizziness, visual disturbances, faintness, heaviness & numbness in feet;pain neck;
Aches, head ache, hot/cold chills, mild chest pain, mild pain in joints, fatigue
This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 1-month-old male patient who received ENGERIX B pediatric (batch number GX9X5, expiry date 25th February 2021) for prophylaxis. On 16th December 2018, the patient received the 2nd dose of ENGERIX B pediatric. On 25th December 2018, 9 days after receiving ENGERIX B pediatric, the patient experienced generalized rash. On 27th December 2018, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to ENGERIX B pediatric. Additional details were provided as follows: The healthcare professional reported that the patient was seen in office on 26th December 2018. On 27th December 2018, his parents reported that rash had cleared up. There were no medical interventions/ treatments.
Narrative:  Timing ERROR only, 2nd dose given 47 days after 1st
Systemic: Dizziness / Lightheadness-Medium, Additional Details: about 2 days after vaccination of first dose, pt has noticed prolonged dizziness. comes in waves, especially when pt has been sitting or laying down for prolonged time. will notice dizziness upon standing which lasts about a couple seconds and then goes away. has been occuring regularly starting two days after vaccination and continues to occur now, 3 weeks later.
Information has been received from a physician concerning an approximately 40 year old female physician colleague with psoriasis and no known allergies who on 17-JAN-2007 was vaccinated with Pneumovax 23 in the lateral aspect of the right thigh.  Subsequently the patient experienced feels bad, developed chills, and is swollen and tender at the injection site.  The patient sought unspecified medical attention.  Treatment included comfort measures.  The adverse events persisted.  Additional information has been requested.
3/13/03 PATIENT DEVELOPED NAUSEA, SOB, CP, HA, BP 196/96, PULSE 110.  STATES NO PREVIOUS HX OF CARDIA PROBLEMS.  CONTINUES TO HAVE SOB 4/01/03.
PATIENT HAD ITCHING ON HANDS, THEN FEET, THEN ON ARM WHERE THE SHOT WAS GIVEN.
Same day swelling, pain, redness at injection site, still painful 14 days after receiving BEXSERO injection.
Right shoulder joint pain, especially with flexion/abduction greater than 80 degrees. (+) Acromio clavicular tender to palpation - possible bursitis/impingement syndrome.
Sickness; Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021; Bronchitis; Flu-like illness; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA LIKE ILLNESS (Flu-like illness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021) and ILLNESS (Sickness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In 2022, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 UNK. In 2021, the patient experienced BRONCHITIS (Bronchitis) and INFLUENZA LIKE ILLNESS (Flu-like illness). On 30-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA LIKE ILLNESS (Flu-like illness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021) and ILLNESS (Sickness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Unknown. On an unknown date, Laboratory test: Unknown. On an unknown date, SARS-CoV-2 test: Positive.         No concomitant information provided.  No Treatment information provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Live Significant Follow Up Appended and new event sickness added , lab data added
This spontaneous case reported by a nurse, describes the occurrence of moderate confusion and adverse reaction in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced moderate confusion and adverse reaction. At the time of the report, moderate confusion and adverse reaction outcome: unknown.  The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Pt recvd vax & exp severe h/a & tingling feeling from mouth to top of head;
Patient is 17 years old.  MODERNA is not recommended for those under the age of 18.  Patient attended mass vax event with family.  No adverse events reported at time of vaccination or post-vaccine.
Patient came in for a booster (.25) but received  full dose(.5).  Patient did experience body aches, fever and chills.