chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported in a published article, that a 12 month old patient with severe immunodeficiency was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed disseminated varicella confirmed to be due to vaccine strain VZV. It was also reported that the patient's father developed a rash after exposure to the patient (WAES # 0803USA03578). The article also discussed the experiences of two other patients while on therapy with varicella virus vaccine live (Oka/Merck) (WAES numbers 0803USA04454 and 0803USA04484). Additional information has been requested. This is an amended report. The serious criterion of death was deleted from the report. This is a downgraded report. The serious criterion of death was deleted from the report.
One patient received both VARIVAX and PROQUAD today due to a human error; This spontaneous report was received from a physician concerning a 2 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 03-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (duplicate therapy error) both for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided for the vaccines).
EKG with diffuse ST changes Some PR depression possibly myocarditis Transferred to another hospital
Large red rash on left arm at site of injection appeared 8 days after shot. Arm feels tight and warm, slightly itchy.
I have two noticeable bruises on both my right and left thighs that appeared on 4/25/21 and have experienced painful cramps in my feet and legs periodically since taking the vaccine. Fatigue on a number of days and a headache on the day after vaccination.
I noticed my ears ringing much louder than they usually do.  Asked my general doctor and pharmacist if they had heard of any correlation to which they replied they had not.  Made appointment with my ENT and he also had not heard of any tinnitus related effects.  Had hearing aid evaluation for device with masking  but have not made any purchase as of this time.
Slight swelling, redness, pain to touch (no itching) in the upper arm and around the arm (upper arm).
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient have been reading this every day and putting off getting the shot. The patient got her/his first shot, so happy, sore arm, go back in two months and get the last thanks to all for pushing her/him. The follow-up could not be possible as no contact details were available.
Pt had hive-like bumps that looked like mosquito bites after receiving the Pfizer vaccine.
About 32 hours, post vax, had sudden dizziness followed by hyper-extension of hand, tight jaw, arms flexed, eyes staring straight ahead X 5 minutes. Resolved spontaneously.
Patient called help line and reported that he was having an allergic reaction to the flu vaccination. His symptoms included watery and itchy eyes, sore throat, headache and body aches. He denied a rapid heartbeat, dizziness and shortness of breath. These symptoms occurred about 2 hours after the vaccination.
Pneumovax 23 (pneumococcal polysaccharide vaccine - polyvalent, PPV23) was administered to the patient at 1714 on 5/31. Called at 1855 for Afib with RVR, SBPs in the 80s and HR 150s. Patient reported to have flushed skin on the BLE and maculopapular rash on chest. Metoprolol succinate 50 mg PO, metoprolol 5 mg IV x2, cetirizine 10 mg x 2,  methylprednisolone 125 mg, and famotidine 20 mg IV were administered. Patient's symptoms suspected to be triggered by allergic reaction to pneumococcal vaccine. This morning, 6/1, patient is reported to be stable.
This spontaneous prospective pregnancy report was received from a healthcare worker refers to a female patient of unknown age. The patient was pregnant. There was no information about patient's medical history, concurrent conditions, drug reactions and allergies. On 05-AUG-2015 the patient was vaccinated with a dose of M-M-R II (lot # L003859, expiry date: 05-FEB-2017). Other suspect therapies included VARIVAX (lot # L010148, expiry date: 24-MAR-2017). Reporting healthcare worker stated that the patient was approximately 5-6 weeks pregnant at the time of report on 01-SEP-2015. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. The pregnancy outcome was outcome pending. No adverse effects were reported. Outcome of the event, exposure during pregnancy was unknown. Causality assessment was not provided. Additional information has been requested.
Heavy feeling in head, nose bled, swollen lymph nodes under arm near chest, painful lymph nodes,
2 days after injection Dizzy, heart palpitations, weakness, muscle loss, low Sodium, neck issues, don't recall all of them.  Ongoing
Passed out and had a seizure. Hit head. Orthostatic hypotention, dermatographia.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 23-SEP-2013, the patient was vaccinated with a dose of 0.5ml ZOSTAVAX (lot # J003798, expiry date 28-JUN-2014, subcutaneous). No adverse effect was reported. Additional information has been requested.
Shingles/ Rash. 15 days of acute pain. Chronic sensitivity and pain continues as of this report.
Shoulder and back pain that has persisted. After second vaccination, 02-27-2021, administered at 1:50 pm, nausea and vomiting for two days that started that night. Abdominal pain that has persisted, radiating to back, exacerbated by eating fats and sugars. Pancreatitis diagnosed by labs and imaging. Treatment: Creon and diet.
Vaccine given subcutaneously instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix (subcutaneous) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that an patient received Boostrix vaccine subcutaneously instead of Intramuscularly, which led to intramuscular formulation administered by other route. No patient information was reported. The reporter consented to follow up.
Rash on arms, legs, chest, back. Mildly itchy. No lip swelling, mouth itchiness, tongue swelling or wheezing.
Pt given MENACTRA and Tdap-30 mins after face got very red-next AM c/o back pain. 2 days post (Rt) leg pain with difficulty walking.
Patient developed a large, erythematous, swollen area over injection site on left thigh.
pt recv vax 1MAY97 & 2 days later 3MAY had a redness on face progressing to trunk & extremities;saw a MD on 5MAY & was dx w/a erythema mult type rash w/pruritus over the trunk & extremities;
Pt developed a fever of up to 103 for a duration of 48 hours, accompanied by significant erythema, tenderness and induration of LVL. Seen in office 72 hours post vax and LVL still had residual erythema and induration (greater area than common "knot" after vax).
Soreness, pain and redness of upper lip.  Patient reported very sore and painful for 2 weeks after vaccination and then soreness/pain lessened.  Still has some redness and soreness 70 days later.  Patient applied vaseline to area.
Headaches constantly for weeks, lightheaded off and on, abdominal pain, rib pain, swollen lymph nodes, severe back pain , back swollen
On 04/07/21, 28 yo presented to clinic for immunization. Pt's documented allergies include codeine (rxn: rash; severity: low) since 02/06/2018. Pt had no previously documented encounters. Pt was seen at another institution on 02/06/18 for Generalized Anxiety Disorder and was prescribed sertraline 25 mg PO daily. Unknown if pt continues on this medication. On 04/07/21 at 1141, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #043A21A; Exp: 6/21/2021; NDC #59676-580-15). Immediately after injection, pt became lightheaded, dizzy, diaphoretic and "felt like his vision was closing in". Vitals assessed at 1145 were BP: 94/55, P: 42, O2 sats: 98%. Pt placed in Trendelenburg position with vitals BP: 116/75, HR: 43, O2 sats: 98%.  Pt denied any chest pain, shortness of breath, throat swelling, skin itching or hives. Pt reported no previous reactions to vaccines and no h/o anaphylaxis. Pt did report a similar event during a previous blood draw. Pt remained in Trendelenburg x 10 minutes. At 1159, pt was repositioned to sitting with BP: 120/80, HR: 48. Pt reported a low baseline HR.  After a total observation of ~20 minutes, pt was reassessed by MD and permitted to leave. Event noted as "Symptoms are most consistent with a vasovagal reaction after J&J Covid vaccine."
States that at 1:30 am on 01/22/2021, he woke up with chills and sweating. He states that he was not able to get warm and that he put on more clothes prior to going back to sleep. He states that he then woke up a little while later and was soaking wet with sweat. He states that he had a fever (but did not take his temperature), he was nauseous, and had body aches. He states that he went to work on 01/23/2021 and was "80% recovered" and then on 01/24/2021 he was "100% recovered".
He was hospitalized d/t aspiration, and admitted on the 08/13 to Hospital. His sx. were diarrhea and increased confusion, which began on the 9th.
Initial report was received 26 August 2009 from a health care professional, who is also the patient. A 46-year-old female patient with a history of asthma and allergies to codeine and Tetanus Toxoid, had received a 0.5 ml left deltoid intramuscular injection of FLUZONE SV 2009-2010, lot number U3200AA on 21 August 2009 and eight hours later, she developed a laryngospasm and had a "funny feeling" described as lightheaded. The patient self medicated with an Epipen with clearance of symptoms. The patient had no concurrent illness at the time of vaccination. On 25 August 2009, four days post vaccination, the patient developed a temperature of 101 degrees, muscle aches and congestion. The patient was evaluated by a physician who noted that her lungs were clear and additional testing had not been performed. The patient had a history of 20 prior FLUZONE vaccinations. At the time of the report, the patient's recovery status was reported as unknown. Documents held by sender: None.
Patient developed difficulty breathing with cyanosis and wheezing within 10 minutes of vaccine. Responded to IM Epinephrine. Transported to ER by ambulance.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: PATIENT'S FACE AND EYES WERE SEVERELY SWOLLEN AND ALLERGIC
First day?Sore arm, moderate pain in the arm Second day?Diarrhea in the evening Third day?Nausea, (during the day and overnight), cold sweats, diarrhea, felt faint (late night) Fourth day?Nausea, lots of gas pain throughout chest and back Fifth day?Gas pain throughout chest and back Sixth day to present feel fine
Feels like she is on a boat,like she is rocking; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feels like she is on a boat,like she is rocking) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels like she is on a boat,like she is rocking). At the time of the report, FEELING ABNORMAL (Feels like she is on a boat,like she is rocking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Red spots on chest, trouble breathing, fever , stuttering, stammering, bowel movements once every hour
Refridgeration excursions identified; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a child female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 04-Aug-2022 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medicine were reported. No treatment medicine were reported.
This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies were not reported. On an unknown date, reported as "at least a year ago", the patient was vaccinated with PREVNAR 13. On 24-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N012127, expiration date 20-JAN-2019, 0.5 ml, intramuscularly for prophylaxis. Her concomitant therapies included levothyroxine sodium (manufacturer unknown), losartan potassium (manufacturer unknown), pravastatin and sucralfate. On 24-SEP-2017, reported as "right away after receiving with PNEUMOVAX 23", the patient experienced pain 3 inches below the injection site. On 25-SEP-2017, the patient woke up with swelling and redness 3 inches below the injection site of the PNEUMOVAX 23 that went also down the arm. The patient sought medical attention and contacted the pharmacy. No lab diagnostic studies were performed for the patient and no treatment was given for the events. The outcome of injection site pain, injection site erythema and injection site swelling were reported as not recovered/not resolved. Relatedness between the events and PNEUMOVAX 23 was not provided.
Side effects of / her arm hurting; Side effects of how it didn't feel great; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (also experienced feeling bad after receiving 1st dose on an unknown date, refer case US2021163015).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received the second dose of Shingrix and experienced the side effects of how it did not feel great and her arm was hurting. The patient remembered completing the Shingrix series, but no record was found. The nurse inquired would it be harmful for the patient to redo the Shingrix series. No third dose was administered.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021163015:Same reporter
Cool feeling, dizziness, anxiety, Increased BP. H2O, snack, cool rag, breathing techniques to calm anxiety.  Date: 3/22/2021  Problem: J&J Post-Vac  Notes:   Time: 1114 Pt c/o dizziness, coldness, and anxiety. BP: 207/130, HR 77, SpO2 98%,  temp 97.2F. Offered pt water and crackers. Applied cool raag to pt neck. Coached pt through therapeutic breathing. Pt encouraged to wait 30 minutes. Time: 1147 Pt reports feeling better. Ambulated to restroom independently. Pt has no s/s of distress. BP 152/93, HR 68, SpO2 98%, temp 97.4F. pt teaching on s/s of allergic reactions. Pt ambulated out of building independently.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017; L004014, expiration date 04-MAR-2017; L007560, expiration date 15-JUN-2017; L016428, expiration date 30-JUL-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported rash, itching, headache, and dizziness.  Patient given IM Diphenhydramine 25 mg twice and IM injection of Triamcinolone 40 mg once and monitored closely over 2 hours due to her multiple allergies to inactive ingredients in oral medications.
tested positive on 21 Feb 2021; tested positive on 21 Feb 2021; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 01Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive on 21Feb2021 on 21Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive: negative on 19Feb2021, sars-cov-2 test positive: positive on 21Feb2021. The event was assessed as medically significant. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Recv'd TD vax on 12/11/99. Pt states that on 12/13 she noticed redness & hard bump at injection site. Also noted a rash spreading from injection site down to elbow. Pt complains of itching but denies pain.
This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Unknown),via an unspecified route of administration on 2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced just received vaccine and was kind of worried,the arm was sore a little bit on an unspecified date.When asked about the vaccine lot number,patient stated that they don't have vaccine card right now.The outcome of the events was unknown.
Encephalitus inflammation of the brain causing myclonic jerks; confusion hallucinations and falls
Developed loose stool x 7. Rash on face, arms, back, chest, arthralgia, crying, won't eat. Coughing congestion. Unsteady gait.
Rash & Urticaria Pruritus PREDNISONE 30 MG EVERY DAY for 4 days, HYDROXYZINE 25 MG HS PRN, TRIAMCINOLONE UNITS BID PRN
This spontaneous report was received from a nurse via company representative refers to a 13 year old male patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unknown. Approximately in 2008 (reported as about 8 years ago), the patient was vaccinated with the second dose of GARDASIL via intramuscular route. Nurse reported that following the second dose and before the third dose of vaccine, the patient developed planter warts around every finger and on his right elbow. The patient required medical attention. Nurse stated that they burned off the warts and the patient did not received third vaccine dose. Outcome of the event was unknown. Reporting nurse had not assessed the causality of the event with respect to therapy with GARDASIL. Additional information has been requested.
Had swelling, redness and itching/pain at injection site. She showed me the arm and it was still red and slightly warm to the touch.
Patient.  COVID-19 Vaccination  1st Dose: Pfizer on 06-04-2021 2nd Dose: Pfizer on 08-03-2021  Patient made an appointment for the booster on www.healthmartcovidvaccine.com. Patient was administered Moderna booster (on 12/23/2021) before the recommended interval of 6 months. Error was found when updating in system after vaccine administration. Patient was contacted on 12/27/21, she said she didn't experience any adverse event or side effects from the Moderna booster vaccine.
fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.2 F) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A and 013M208) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PYREXIA (fever of 99.2 F). At the time of the report, PYREXIA (fever of 99.2 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 99.2 (High) fever of 99.2 F.         No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Received Moderna vaccines on 1/15/21, 2/12/21 Tested positive for COVID by PCR on 8/2/21 Admitted to Hospital on 8/2 and transferred to another Hospital on 8/3/21. Patient is asymptomatic for COVID and was hospitalized for acute pancreatitis.