chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired quadracel on 07/06/2023 was administered to a patient with no reported adverse event; Initial information received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old male patient who was administered expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] on 07/06/2023 was administered to a patient with no reported adverse event.  The patient's past vaccination(s) included Pentacel and Vaxelis. The patient's past medical history, medical treatment(s) and family history were not provided.  On 14-Jul-2023, the patient received 0.5 mL dose 1 of suspect diphtheria-15/ tetanus/ 5 hybrid AC pertussis/ IPV (MRC5) vaccine, Suspension for injection (batch number: C5916AA; Expiry date: 06-Jul-2023) via intramuscular route in unknown administration site no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired quadracel on 07/06/2023 was administered to a patient with no reported adverse event.  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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA220975:01695556
This spontaneous report was received from a consumer refers to an approximately 31 years old female patient. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown. On 26-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. Reporter stated that on an unknown date after vaccination, the patient developed soreness in her arm. She took ADVIL to treat the soreness. Outcome of the event was reported as not recovered. Reporter considered the event to be related to PNEUMOVAX 23.
SNEEZING OCCASIONALLY; This spontaneous report received from a patient concerned a female 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: 1808609 expiry: 04-FEB-2022) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2022, Laboratory data included: COVID-19 rapid POC test Negative. On an unspecified date, the patient experienced sneezing occasionally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sneezing occasionally. This report was non-serious.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient complained of a rash and itchiness on 3/17/21 which has not resolved. I counseled the patient on taking benadryl and applying hydrocortisone and to follow up with his pcp if if doesn't improve.
the next AM p/getting 1st flu shot ever pt's lt arm very sore, red, hot, swollen @ inj site;saw MD 4DEC & was put on Keflex
tested positive with COVID-19 on 04Feb; tested positive with COVID-19 on 04Feb; This is a spontaneous report from a sponsored program. A contactable pharmacist reported for a female patient. A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 04Feb2021 The patient experienced tested positive with covid-19 on 04feb (sars-cov-2 antibody test positive). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Feb2021. the HCP wants to know if she can still give the 2nd dose to the patient. The outcome of the event was unknown  Information about lot/batch number has been requested.
patient received adjuvant component only; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   On 28-JUN-2023, the patient received the 1st dose of Shingrix. On 28-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received adjuvant component only) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JUN-2023 The patient received adjuvant component of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Elevated resting heart rate. Normal resting for me in 70 bpm during the day and 60 bpm when I?m sleeping. I woke up at 6 am and my heart rate had been hovering around 100 bpm since 1 am. (Per Apple Watch). I have buspirone on hand and took that which lowered my heart rate for about 8 hours but once that wore off it went back to around 100. All other vitals are normal. BP 108/75, only a very slight fever.
Presents to the ED complaining of SOB.  Pt states she is vaccinated for COVID, but has not received booster.  Admitted for COVID pneumonia .  Associated symptoms include cough, lower abdominal pain and diarrhea. Encephalopathy due to 2019-nCoV. Aspirating after few days after hospitalization  Tx.  4 L nasal cannula,   intubated ,  Respiratory therapy treatments, Antibiotic therapy with Azithromycin, Continue with Dexamethasone , ZINC, magnesium, Pepcid, LOVENOX.  Patient expired comfort care measures were initiated.
Chest pain, lower left side of chest, feeling of electric shock, numbness in left side of face, left arm, left side of next, nerve twinges in arm, chest, and left leg.
Patient stated nine days after her first dose she experienced tenderness in her left armpit. The next day, the tenderness subsided and a "lifted" rash that was warm to the touch appeared on her left arm. This lasted one day only.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported
None.  (ADACEL given IM to 10 yr old instead of BOOSTRIX).
Parents noted two dime sized firm nodules on right thigh at the sites of vaccine administration approx. 10d previously.  Also there was a quarter sized area of erythema overtop the nodules.  She had Hep A and VZV given in this thigh right thigh.  This was non tender and resolved gradually over about 3-4 days.  She did have fever the two days prior to the 'lumps' being felt but on the day that parents noted the lumps the fever had self resolved.
Patient received a flu and Pfizer bivalent COVID-19 vaccination on 9/23/22. On 11/30/22 another vaccination clinic was held at this facility and this staff member stated she had not yet received her flu or COVID-19 booster. As a result, another dose of the Pfizer bivalent COVID-19 vaccine was given. In addition, an HD vaccine was given in error (patient <65). There were no adverse reactions to receiving both of these vaccinations on 11/30/22
Diagnosed with Bell's Palsy; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th January 2020, 29 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The patient received a dose of Shingrix in right arm. Till the time of reporting, the patient still had the event but it was 80 percent resolved. The reporter consented to follow up.
pt recv Td instead of PPD vax & exp wide spread redness, itching & pain @ test site;disappeared in 48-72 hr p/tx w/cold packs & in some cases topical hydrocortisone cream was applied;
Information has been received from a certified nursing assistant referring to an unspecified number of unspecified patients of unknown age and gender. Since 22-MAR-2016, the patients were vaccinated with doses of incorrectly stored (Merck) VARIVAX (dose and route unknown, temperature excursion on 28.9 F for 2 hours, lot # reported as: L041207, expiry date: 20-OCT-2017). No adverse effects had been reported. Additional information has been requested.
Received second vaccine on Thursday 04/08. Woke up on Saturday 04/10 with a disgusting taste and smell. Had Covid in January. Lost all taste and smell for 10 days.  It has been more than two months since second vaccine and symptoms continue. The taste/smell is of something rotting. I am unable to smell things I normally eat without it being this smell.
Continuous itching at injection site. There has been no treatment.  The itching has continued since injection lasting a week at report time.
Information has been received from a mother concerning her 12 month old son with an unremarkable medical history and no allergies, who was vaccinated with a first and second dose of PEDVAXHIB.  There was no concomitant medication.  On 14-FEB-2008, shortly after receiving the second dose of PEDVAXHIB, the patient developed a rash at the injection site.  Subsequently, the patient also experienced sinusitis, fever, ear infection and loss of appetite.  The patient sought unspecified medical attention.  The reporter states that the rash has improved, but all other events have not been reversed.  No diagnostic studies were performed.  No product quality complaint was involved.  Additional information is not expected.
Rash on left arm, 2" whelp to posterior proximal left arm, no pain, no itching. Cortisone cream as needed for itching. Seen in local Emergency Room on 02/28/2019.
Approximately 3-4 hours after receiving the vaccination the patient developed itching in the "V" are of the neck.  There was no visible discoloration, rash, or hive-like eruption according to the patient or her husband.  No other symptoms. Because of this we were reluctant to give the second dose of the vaccine and she was advised to seek J&J when available.  She is to report this occurrence to her PMD as well.
He started developing right shoulder pain a week after the 2nd dose of the Moderna shot in his right arm. The pain persisted for another month and spread to both shoulders, both hips, and the muscles of his arms and legs. Tylenol and flexeril did not help much. He went to the ER on 3/15/21 where he received an IV fluid bolus and had his levothyroxine dose lowered a little. Since discharge from there, he then followed up in clinic on 3/23/21 where he said his pain and weakness were bad enough that he was having difficulty lifting his arms, grabbing objects especially at/above shoulder level, and holding objects in general to perform his daily activities of living. He was placed on a 2-week tapered course of prednisone on 3/23/21 and again required another 2-week course on 4/8/21 because when the prednisone wore off he was back to having pain and weakness.
Injection site with redness & warmth after injection site remains swollen, red & warm, >72 hours. Area measures 4 3/4 inches wide x 6 1/2 inches long.
Aches, fatigue, hoarseness, congested ears results in treated w/prednisone urgent care. Soreness left arm.
About 2 hours after receiving the vaccine, patient had mild itching on upper chest, scalp, neck and eyes.  Took 25 mg of Benadryl and I hour later, symptoms resolved.  10 hours later, itching returned and patient took another 25 mg of Benadryl.  He noted small blanching palm-sized rash on upper sternum and had mild erythema on his neck.  These symptoms eventually resolved.
pt recv vax; high pitched cry more than 1 hr; question of arm shaking; sx resolved & pt fell asleep on way to er;
He got his vaccine, he was sweaty, his heart was beating real fast to the point that he thought he was going to pass out.  The next week he passed out but could not get up, his wife called her brothers and they took  him to Hospital and they transferred him, did a catheter in his heart and told him that his kidneys failed and that he needed dialysis.  He then started dialysis at Hospital wheeled him to the basement, it took 4 hours to do dialysis.  He was then discharged from the hospital after dialysis.  He has been having dialysis about 7-8 months on M-W-F schedule and he has been going faithfully.  While he was in the ER they ran a lot of tests, did a Hep line and found out that he had blood clots in both his lungs and in his legs.  His pulmonologist said that his lungs are half open and half closed and is now on oxygen and will keep him on that until he is able to breath on his own.  He is also on a nebulizer that he does 3 times a day and is on Symbicort and Albuterol.  He also has an instant chamber in it.  His heart was skipping beats, sees Dr. and was given Amiodarone which fixed that and then his heart was beating too slow,  had a heart monitor on it for 30 days, and he is supposed to see him in November as he wants to do a heart ablation on him.    The hematologist said that the markers and his genes do not match up to having blood clots, and she believes it is due to the vaccines, and going to get more information.   He has to be in a wheelchair when they take out too much water during dialysis, but is able to walk right now.  He goes to Dialysis Unit.    He was perfectly health prior to the vaccine, nothing was wrong with him until he had the vaccine and a week later he has been disabled since then.    He is now sheduled to have a heart ablation, in 2/24 he is supposed to have prostate surgery and to have a biopsy on his kidney as he found cancer in one of his kidneys.  He is now mega sick since the vaccine.
URTICARIAL/EM RASH. ONCE WITH 3RD DOSE IN MAY 2016 AND ONCE WITH 4TH DOSE IN OCT 2016.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 17-JUL-2015, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles. On approximately 20-JUL-2015 (reported as three days after receiving ZOSTAVAX, the patient suffered a rash from his back to his abdomen on his right side. He was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses (considered to mean he received treatment); the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was not recovered/not resolved. Causality assessment was related. The lawyer considered the shingles to be disabling.
Itchiness at the site of the injection; Swelling at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE SWELLING (Swelling at the site of the injection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031ML0A) 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) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE SWELLING (Swelling at the site of the injection). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE SWELLING (Swelling at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a certified medcal assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 06-APR-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA injection, lot # K002831, expiration date 15-JAN-2016 (dose, and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Itching on arm; Redness on arm; Tenderness on arm; Swelling on arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, 4 days after receiving Shingrix, the patient experienced itchy upper limbs. In August 2019, the patient experienced erythema of extremities, pain in arm and swelling arm. On an unknown date, the outcome of the erythema of extremities, pain in arm, swelling arm and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, swelling arm and itchy upper limbs to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced redness, tenderness, swelling, and itching on left arm. The healthcare professional confirmed redness, swelling, tenderness had began to improve. The redness was described as a faint red.  The healthcare professional noted that the itching began on the reporting date The reporter consented to follow up.
very painful rash all over the body; This non-serious case was reported by a physician via sales rep and described the occurrence of painful rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, 2 days after receiving Shingrix, the patient experienced painful rash (Verbatim: very painful rash all over the body).  In JUL-2023, the outcome of the painful rash was resolved (duration 8 weeks).   The reporter considered the painful rash to be related to Shingrix.     The company considered the painful rash to be related to Shingrix.   Additional Information: GSK receipt date: 26-Sep-2023 The patient received Shingrix dose 1 at the pharmacy and got a very painful rash all over the body 2-3 days after the injection.  This lasted for several weeks and probably resolved 8 weeks after dose 1. The physician did believe that the adverse event  was related to the Shingrix vaccine. The reporter consented to follow up.
sore entry point; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore entry point". Additional information included: No reaction but a sore entry point. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Patient presented on 6/30 to the ER after going to PCP for chest pain and neck pain. Had received second dose of Pfizer vaccine on 6/27/21. Was found to have a troponin of 6 and echo with normal cardiac function.
Temperature of 99.5-100 while keeping on pain meds (Motrin and Tylenol alternating), red, itchy eyes starting on the night of the vaccine, 11/13/2021, and continuing through on 11/15/2021.
Redness, Swelling at site, Itching, Fever, Chills.
Felt sick; Chill; Felt tired; Unable to focus; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick), CHILLS (Chill), FATIGUE (Felt tired) and DISTURBANCE IN ATTENTION (Unable to focus) 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 ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, citrate free. On an unknown date, the patient experienced MALAISE (Felt sick), CHILLS (Chill), FATIGUE (Felt tired) and DISTURBANCE IN ATTENTION (Unable to focus). At the time of the report, MALAISE (Felt sick), CHILLS (Chill), FATIGUE (Felt tired) and DISTURBANCE IN ATTENTION (Unable to focus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was 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
Severe frontal headache 1 hour post administration of vaccine. Saw doctor 5-4-04. Toradol 60 mg IM given with total relief in one hour- Had gone to school until 2:00pm 5/4, but stated she had a headache all day.
The pt had a seizure about 10 minutes after the vaccine was given.  She had reported to us ahead of time that she has a seizure disorder.  This was discussed with Dr., and he instructed us to go ahead with vaccination.  We had the patient lie down during and after vaccination, and she was under observation.  Her father was with her in the room.  Her seizure lasted less than 2 minutes, and she was then evaluated by Dr.. She was dismissed in stable condition, with instructions to follow up with her neurologist.