chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3cm x 2cm erythromytosis, warm, indurated, no streaks @ site of inj;no temp;cranky;
missing antigen, adjuvant-only used; Administration of adjuvant-only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-DEC-2022 Reporter's comment: The reporter reported that administered adjuvant-only (missing antigen) to 3 patients, for whom she had no identifying information.  The reporter consented to follow up.  Additional Supportive Information: The patient received Shingrix adjuvant-only (missing antigen), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of 9 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022AMR194824:Same reporter US-GSK-US2022AMR194823:same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
Epigastric pain, vomiting for 6 hrs, headache.  Treatment was only to restart liquids and get rest.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy 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 of herpes zoster. In-2014, the patient was treated by a physician assistant for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient received COVID vaccines on 04/08/2021 and 05/03/2021; symptomatic for COVID and tested positive on 05/24/2021. Per chart, COVID symptom onset was 05/20/2021 which was greater than 14 days after 2nd COVID vaccine.
This spontaneous report has been received from a medical assistant, concerning an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose GARDASIL and on 24-AUG-2016, received the second dose. Furthermore, on 14-AUG-2017, the patient received as the third dose GARDASIL 9 lot number N000326 and expiration date 14-OCT-2019 for prophylaxis. No adverse effects reported. There was no product quality complaint involved.
I had one hive that I thought was a bug bite on my face, so I took a Benadryl around 10pm. Around 2:20 am I woke up with very large hives on my arms, though the face hive was gone. At 7am I woke up and all hives were gone.
patient described headache, nasal congestion, and blood in mucus when blowing nose that began after receiving vaccine and has persisted ever since.
reaction for this one was a 12 hour span; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction for this one was a 12 hour span) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (reaction for this one was a 12 hour span). In 2021, VACCINATION COMPLICATION (reaction for this one was a 12 hour span) had resolved.            Patient has concomitant medications but her reporter did not have the list. No treatment reported   This case was linked to MOD-2021-409899, MOD-2021-409908 (Patient Link).
administered after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after excursion). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered after excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medication was reported.  The temperature excursion occurred on 20-OCT-2021.
Arm got swollen; Pain in the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm) and PERIPHERAL SWELLING (Arm got swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm got swollen). At the time of the report, PAIN IN EXTREMITY (Pain in the left arm) outcome was unknown and PERIPHERAL SWELLING (Arm got swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. Treatment provided was muscular relaxants and neuromuscular pain relievers.  Patient reported the pain in the arm got worse after 2 days and the arm got swollen, which is why her physician prescribed muscular relaxants and neuromuscular pain relievers.  The medication helped and now she is feeling well. Her physician explained that it was probably because the needle touched a nerve in the arm, and she did not blame the components of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up included new events and event outcome were updated.
This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (remission after lymphoma treatment which ended 6 months ago). Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The physician had a patient who had reactions after SHINGRIX. The patient developed Herpes Zoster 2 weeks after her 2nd dose of SHINGRIX. This case was linked with US2018GSK113823, reported by the same reporter.
Dtap Infanrix was given at a pt that was 7yrs 9mo old. Needed to recieve the TDap Boostrix.  Per physician pt had no adverse reaction will come in and get the TDap at 11y/o.
Received vaccine 12/31/12 - large softball area of inflammation with inner circle raised & bright red. Cellulitis present very achy & middle area almost blister like appearance.
the patient's Hep B titer came back as "undetectable immunity."; patient that received the Hep B vaccine at the usual scheduled time: 3 1/2 weeks, 8 months and 21 months; patient that received the Hep B vaccine at the usual scheduled time: 3 1/2 weeks, 8 months and 21 months; This spontaneous report was received from a Registered Nurse (RN) and referring to a currently 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  In December 2003, July 2004 and August 2005 (reported as in 3 1/2 weeks, 8 months and 21 months), the patient received Hepatitis B Vaccine (Recombinant) (manufacturer unknown) at the usual scheduled time(all dose, route, lot# and expiration date were not reported; first series) for prophylaxis (inappropriate schedule of product administration). On 23-MAY-2022, physician drew many different titers for unknown reason and the results showed the patient's Hep B titer came back as "undetectable immunity" (Hepatitis B surface antibody negative). As a treatment, the patient had another Hep B series with the 1st dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) on 03-JUN-2022, and the 2nd dose on 06-JUL-2022. (both strength, dose, frequency, lot #, expiry date, and route of administration were not provided) for prophylaxis. And the 3rd dose was scheduled for 5 months and some days. The nurse was asking if the third dose can be given at less than 6 months (5 months +days). It was reported the therapy was continued. The patient had sought medical attention. Outcome of the event Hepatitis B surface antibody negative was not reported.  The causality between the suspect product and the event Hepatitis B surface antibody negative was not reported.
On 9/11/23 The EUA for covid-19 vaccine bivalent, mRNA LNP-S(12 yrs up)(PF) 30 mcg/0.3 mL Suspension [ERX 242317] (NDC 59267-0304-1) expired. An administration for covid-19 vaccine bivalent, mRNA LNP-S(12 yrs up)(PF) (PFIZER-BIONTECH) 30 mcg/0.3 mL injection (EMERGENCY USE AUTHORIZATION) 30 mcg Order ID 1210273174 was found on 9/21/23. This is after the EUA had expired.  No adverse effects of the administration are known at this time.
Information has been received from a nurse concerning a 12 year old  female who was vaccinated with Gardasil, 0.5 mL IM. Subsequently, the patient experienced vomiting and dizziness. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from vomiting and dizziness. Additional information has been requested.
Patient went down in the parking lot while walking back to his vehicle with his wife. Pt was using a walker. When this nurse responded, the patient was on his side and responsive. Pt denied pain or injury. Upon assessment patient was responsive but had a left-sided facial droop, which his wife said was new. Checked grasps and left side was significantly weaker than the right. Unable to check the lower extremities as legs were under a vehicle. Blood sugar checked, which was 168. Pt is diabetic. 911 was called and patient was taken to hospital via ambulance. Pt was markedly improved at the time of transport but was still pale and ashen.
Per mom 6 hours after vaccine had head to toe rash that lasted 2 days.
Intradermal injection of vaccine given in forearm of left arm, but did not wheal. Repeat  subcutaneous injection given to back of left arm successfully.
Information has been received from a physician and an office manager concerning a 12 year old female patient with amoxicillin allergy (AMOXILIN) who on 26-AUG-2009 was vaccinated with the first 0.5 ml of a dose of GARDASIL, concomitantly with a dose of BOOSTRIX (Lot: AC528046AA), a dose of VARIVAX (Lot: 664232/0498Y) and a dose of MENACTRA (Lot: U2815AA). The patient stated that after the vaccinations she felt tired. She went home and had a seizure. The patient went to Emergency room and had computed axial tomography (CAT) done (results not reported). The patient was not hospitalized. The patient's mother called on 27-AUG-2009 at the Physician's office and stated that her daughter was doing better. The physician also stated that he did not consider the events to be Life threatening or to have caused the patient significant Disability or Incapacity. Upon internal review seizure was considered as other important medical event. Additional information has been requested.  9/21/09 ER records received for DOS 8/26/09 with dx:  possible seizure by hx with normal exam in ER. Pt presented after episode of staring, becoming stiff, shaking and jerking, eyes rolling back in head and lack of memory of event.  Confused after.
3/13/21 0500- woke up with 101 fever, severe fatigue, muscle aches, sore arm at injection site. Took Advil 400mg. Around 1pm spiked 103 fever. Took Tylenol 1gram. Still with low grade fever, muscle aches, headache most of the night.  3/14/21- low grade fever of 100 most of the day with muscle aches. Fatigue and sore arm at injection site aren't as severe as previous day. Afebrile by 5pm 3/15/21- swollen supraventricular lymph node on right side. Tender to touch.
pt admitted to hospital with acute stroke and decrease in responsiveness; intubated; positive for COVID; given ABX, dexamethasone and breathing treatments; pt's condition declined and he died in the hospital
Flulike symptoms -- fever, body aches, chills, abdominal pain, fatigue, headache; onset 6 hours after receiving vaccine, resolved 24 hours after receiving vaccine.  HIVES without anaphylaxis -- developed 12 hours after receiving vaccine, still progressing 40 hours after receiving vaccine
FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Right arm red, warm, swollen, painful at the injection site. 7 cm x 6 cm.
pt recv vax 12APR96 & several hr later, pt devel redness & swelling @ inj site;tx w/cool compresses & was recovered as of the date of this report;
Lethargic; Headaches; Feeling tired; Some occasional cough; Pressure on chest; A spontaneous report was received from a 46 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed cough, headache, chest discomfort, fatigue, and lethargy.   The patient's medical history and concomitant medications were not reported.  On 31-DEC-2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 31-DEC-2020, the patient developed headaches, some occasional cough, pressure on the chest, feeling of tiredness, and lethargy. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, cough, headache, chest discomfort, fatigue, and lethargy, were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
lost ability to smell but gaining her sense of smell back; mucus discharge; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost ability to smell but gaining her sense of smell back) and SECRETION DISCHARGE (mucus discharge) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation, Rheumatoid arthritis, Allergy (Patient stated that she has some allergies(unspecified)), Coughing (during the week of her 2 vaccination (before she got the shot) she was experiencing occasional cough and congestion that she thinks were from her sinuses/allergies) since March 2021, Congestion nasal since March 2021 and Fever (When she got the second vaccination she told the nurse that she had a low grade fever.). Concomitant products included PAROXETINE, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SECRETION DISCHARGE (mucus discharge). On an unknown date, the patient experienced ANOSMIA (lost ability to smell but gaining her sense of smell back). At the time of the report, ANOSMIA (lost ability to smell but gaining her sense of smell back) was resolving and SECRETION DISCHARGE (mucus discharge) outcome was unknown.            Patients concomitant medications also include Blood pressure medications and Rheumatoid arthritis medications. No treatment medications were provided.   Reporter did not allow further contact
Vomitting and dry heaves in the afternoon.  Called doctor and advised to take Benadryl.  Gave Benadryl in the early evening.  Baby stopped vomiting.
On 5/7/2021 about fours after receiving the second  shot  I began having extreme abdomen pain followed by violent vomiting,   diarrhea, disorientation for more than 8 hrs, plus  body & muscle pain,  hard to get up without assisatance, needed help,  I am a very active & mobile person.   fatigue, chills, headpain, and more abdomen pain thru the day Sunday May 9th, 2021. On Monday May 10th and Tuesday may 11th stomach is still not  feeling normal, still feeling fatigue.
Numbness in calves, pain in calf muscles, varying from slight to severe;  slight numbness  on occasion in arms and mouth area.  This has not gone away.  It is not debilitating. I had the same reaction to a flu shot several years ago.  This lasted about 1 1/2 years, then slowly went away.
Fever up to 101.9 lasting 12hrs Joint pain: Hands, elbows, shoulders, neck Swollen Lymph nodes under left armpit Injection Site pain Headache
Headache, Myalgia, Arthralgia, chills Narrative:    Other Relevant History:
This case was reported by a nurse described the occurrence of vomiting in an 11 year old female who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 5/19/03, the pt received her second injection of Engerix B. Two days later, on 5/21/03, the pt experienced nausea, vomiting, and diarrhea. The events resolved on 5/22/03. The reporting nurse considered the events were possibly related to vaccination with Engerix B.
a high fever; Persistent dry cough; shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional (nurse). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 61-years) as dose 1, single for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history included asthma since 4yo, under control; high cholesterol. The patient had known allergies to drug Penicillin, Floxin, Singulaire. The patient's concomitant medications included budesonide, formoterol fumarate (SYMBICORT); hctz (HCTZ); simvastatin (SIMVASTATIN) taken for unspecified indication, start/stop date not reported. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks. The patient had been diagnosed with COVID-19 prior to vaccination on an unspecified date in Mar2021. One week following vaccination on 26Mar2021, the patient had persistent dry cough, shortness of breath. On 28Mar2021, the patient had high fever for 24 hours. The patient did not receive any treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event high fever was recovered while the other events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
False Breast cancer symptoms  Lump in R breast , Lactating, stabbing pain in breasts
27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. Vitals in the ER  Revealed tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation
soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: Age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced soreness. This case has been linked with US2019AMR114755, reported by same reporter.
Sudden unilateral hearing loss, rt. ear 4 days post vaccination. Diagnosed and treatment begun. 10/16/23
Information has been received from a physician concerning an approximately 2 month old patient who was vaccinated PO with the first dose of RotaTeq (no lot number was given). Subsequently about 2-3 days post vaccination, the patient experienced "diarrhea that lasted for about a week." Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
DEATH Narrative: 61 y.o. male with pmh afib, substance dependance, renal failure, recent admissions in the community for acute hypotension and acute kidney injury (11/2020 & 2/2021). Was found deceased in his apartment on the afternoon of 03/01/2021. Request sent to ME office for report if one exists. Patient was listed as having no known allergies.
Bells Palsy, started 5/4/21. 1st dose of pfizer vaccine given on 4/14/21. Had been due for second dose on 5/5/21 but will be delayed by a couple of weeks or will switch to J&J.