chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 14-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
pt devel inj site rxn characterized by redness, warmth & swelling from the shoulder to the elbow following vax;
arm pain/ pain and it's spreading down to her fingertips (digits); Shoulder pain up to neck; Pain it's spreading down to distal joints / Wrist pain / Elbow pain; Shoulder pain up to neck/ pain is increasing and the pain is radiating to her neck; bruises at injection site; sleeplessness; Muscle pain; Nerve pain; Noticed changes with her eyes (asked about dry eyes); Tingling in fingertips; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 1st January 2020, 44 days after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the patient experienced pain in arm, shoulder pain, arthralgia, neck pain, injection site bruising, sleeplessness, myalgia, nerve pain and eye disorder. On an unknown date, the outcome of the pain in arm, shoulder pain, arthralgia, neck pain, sleeplessness, myalgia, nerve pain, eye disorder and tingling of extremity were unknown and the outcome of the injection site bruising was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, shoulder pain, arthralgia, neck pain, injection site bruising, sleeplessness, myalgia, nerve pain, eye disorder and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced pain in the right arm. The patient continued having this pain and it spread down to her fingertips (digits) and distal joints. The patient experienced muscle pain, wrist pain, elbow pain, shoulder pain up to her neck, nerve pain (neuralgia) and injection site bruise.  The patient also noticed changes with her eyes (asked about dry eyes but could not confirm that she has dry eyes). S Additionally, the patient had tingling in her fingertips that started about 2 days before the reporting. The patient used medicated eye drops.  The reporter did not consent to follow up.
PATIENT FELT TIRED WITH SWOLLEN, RED ARM THE DAY AFTER VACCINATION. PATIENT TOOK TYLENOL TO RELIEVE PAIN.  4 DAYS AFTER VACCINATION, A SLIGHTLY RAISED, RED, AREA WITH SMALL SCABS OVER (FROM SCRATCHING) WERE VISIBLE ON LEFT ARM. PATIENT WAS ADVISED TO TAKE BENADRYL AND TYLENOL FOR REACTION. OVERALL PATIENT HAS RECOVERED.
Patient, a healthy 15 yr. old HS football player received an intramuscular injection in the left shoulder (2nd dose). One and one-half hours later patient was unable to walk on his own, had severe pain in his chest, back, general thoracic area, and legs, and had to be helped to bed. Mother called the doctor's office, was connected to the Hospital. RN stated to immediately call the rescue squad and have them assess patient. Rescue squad arrived, assessed patient, found the above mentioned medical ailments, plus a problem with patients heart (bundle branch anomaly). Was transported via ambulance to Hospital, then later sent home. Following morning, patient still had pain in all previous mentioned areas, plus some nausea.
Within approx. 18 hours of receiving  immunizations, patient developed generalized urticaria with slight chest tightness.  Patient applied Caladryl and Calamine lotion all over body.  Patient given Prednisone 60-60-40 x 3 and 20 x 3.  To return to clinic if no better and to avoid TDAP in the future.
Patient's husband contracted COVID-19 after initial Comirnaty vaccine series.; Patient's husband contracted COVID-19 after initial Comirnaty vaccine series.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415).  A male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Patient's husband contracted COVID-19 after initial Comirnaty vaccine series.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200106759 same reporter, patient, AE and suspect drug/different dose #;
day p/vax had fever 103-104 ax; c/o stomach hurts, h/a off & on; to MD who stated intestional flu w/flu virus;
Immediate bleeding at time of injection with local swelling.  Approximately 55 hours later I noted extensive bruising, redness extending down the arm nearly to the elbow with slight heat, itch and swelling--hive-like. Bleed and bruising continues one week later--some yellow/green, some blue, purple.  Area of redness is smaller.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06; This spontaneous case was reported by an emergency medical technician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 1:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Feb-2022 at 1:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06). At the time of the report, PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-FEB-2022 13:06) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient received booster dose at 07- FEB-2022 at 13:06:05.  The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. The  vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment information was provided.
Infection in chest; Chest discomfort/tightening of the chest; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Infection in chest), CHEST DISCOMFORT (Chest discomfort/tightening of the chest) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Clot blood (Blood clot in leg but was before vaccination.) and DVT.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Infection in chest), CHEST DISCOMFORT (Chest discomfort/tightening of the chest) and HEADACHE (Headache). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Infection in chest), CHEST DISCOMFORT (Chest discomfort/tightening of the chest) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was not having allergies to medications, food and other products. Patient was not tested positive Covid-19. The patient have not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was taking unspecified medications for blood clots. The adverse events had not cause patient to seek medical care and patient wanted to let a few days pass to see how he was feeling. The patient was taking unspecified medications for his chest infection.
This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L007495, expiry date 04-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 degrees F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
passing blood in his stool; stomach pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATOCHEZIA (passing blood in his stool) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HAEMATOCHEZIA (passing blood in his stool) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach pain). On 07-Apr-2021, HAEMATOCHEZIA (passing blood in his stool) and ABDOMINAL PAIN UPPER (stomach pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinners.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
31.8 degree F excursion and vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a infant female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30-JUN-2023) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: 31.8 degree F excursion and vaccine administered). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 16-MAR-2023 The reporter called to inform that a dose of FluLaval QIV (Quadrivalent) was administered to a patient but such product had been in an excursion where it reached the temperature of 31.8 degree fahrenheit (below freezing).  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The FluLaval QIV (Quadrivalent) was administered to a patient but such product had been in an excursion where it reached the temperature of 31.8 degree fahrenheit (below freezing), which led to incorrect storage of vaccine. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023041460:Same reporter US-GSK-US2023041462:Same reporter
mental capacity is not the same/ brain fogginess; COVID test done and it was confirmed positive / on 02Jan2021; This case was reported by a consumer via other manufacturer and described the occurrence of indecisiveness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2020, the patient received the 1st dose of Shingrix. On 2nd January 2021, 56 days after receiving Shingrix, the patient experienced covid-19 virus test positive. On an unknown date, the patient experienced indecisiveness. On an unknown date, the outcome of the indecisiveness and covid-19 virus test positive were unknown.   It was unknown if the reporter considered the indecisiveness and covid-19 virus test positive to be related to Shingrix.   Additional details were provided as follow: This case was reported by the patient via other manufacturer. Patient received 1st dose of Shingrix on 7th November 2020 and experienced mental deficiency. Patient was tested Covid positive on Jananary 2021. On 19th March 2021 Patient received Covid vaccine in into left arm, batch number (EN6207) Part to the Pfizer COVID Vaccine and the patient mental capacity was not the same and was worse since then. No further information was reported. Consent to contact was given by the reporter. This case has been linked with US2021AMR069448 and US2021AMR069406, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069406:same reporter - girlfriend´s case
Information has been received from a registered nurse (R.N.) concerning a 7-year-old female who on 29-NOV-1999 was vaccinated at another facility with a dose of Varivax. On 01-MAY-2006 the patient developed vesicles on her thigh, right axilla and abdomen. On 03-MAY-2006 the patient was seen in the physician's office. The reported noted that she had a total of 30 vesicles and at the time of the report she had not recovered. No product quality complaint was involved. Additional information was received from a R.N. on 25-AUG-2006 indicating that the patient recovered from the vesicles that were seen on 03-MAY-2006. The R.N. indicated that it was questionable if it was true varicella. It was also reported that on 02-JUN-2006 the child broke out with a similar rash that was diagnosed as folliculitis. The outcome was reported as recovered. Additional information is not expected.
N17.9 - Acute kidney failure, unspecified CHEST PAIN BACK PAIN NAUSEA VOMITING
Fatigue, Temperature 103.1, chills, headache, muscle aches, sore arm.
dizzy, feeling bad, sick, sick to stomach, dry heaves, sweating, chills, intermittently, weakness;dx cleaned ears;
SHIVERS; WORSE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shivers, and worse fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worse fever and shivers was not reported. This report was non-serious.
Narrative:  COVID infection following COVID vaccine series 12/22, Pfizer, dose #1 (non-agency) 01/12, Pfizer, dose #2 (non-agency) 08/06 pt cc: unknown exposure: unknown 08/06 COVID swab, result: detected 08/06 pt admitted to medicine from non-agency Nursing home, pt is confused, combative 08/16 pt deceased
Patient received his 1st Pfizer covid shot on 12/7/21 at 11:40am. Patient was ok until 5 minutes after the shot patient had dizziness and slide off the chair on the floor. Myself and another customer picked him up and put him back in the chair. He felt dizzy and we called 911. Paramedics came to the pharmacy and determined its his BP was normal and was ok to go home. Store management was notified and a incident report was created in the store. Patient said he has a small headache but was not dizzy. Patient wife came to the pharmacy and took the patient home.
Presented 2/17 with ongoing seizures for >60 minutes. Received ativan and midazolam in the ER. Loaded with Keppra. Continued to seize. Intubated. Started on propofol but still having seizures. Loaded with fosphenytoin and started on midazolam infusion. Remains intubated and sedated. Sedation is being weaned and seizures are now controlled on Keppra 1500mg BID, fosphenytoin 100mg TID, and lamotrigine.   Patient had been compliant with lamotrigine and not missed any doses. He had been complaining of severe headache after his COVID booster prior to presentation. His last seizure was 2 years prior to presentation.
SLIGHT SWELLING TO ARM; ARM IS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced slight swelling to arm. On MAR-2021, the subject experienced arm is sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is sore and slight swelling to arm was not reported. This report was non-serious.
No additional AE or PQC reported; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022; This spontaneous report was received from a medical technologist lab manager and refers to a specific patient (age and gender not provided). The pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.  The manager reported that the varicella virus vaccine live (oka/merck) (VARIVAX) was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 (temperature and time frame were unknown). On 15-JUN-2022, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W002599 has been verified to be a valid lot number, expiration date: 24-JAN-2024) for prophylaxis (formulation, strength, dose, and route of administration were not provided) (Product storage error). No additional adverse event (AE) or product quality complaints (PQC) reported (no adverse event). There was no Previous temperature excursion.
Individual received first dose of  COVID19  vaccine on January 8, 2021 and second dose of January 29, 2021 and tested positive for COVID19 on April 16, 2021.
Patient has experiencing pain in left upper arm since getting vaccine on 2/4/21. Currently patient cannot raise are above shoulder height. Advised to see MG if continues.
Information has been received from a health professional concerning an approximately 12 month old male who on 08/28/2001 was vaccinated with one dose of varicella vaccine administered in the leg. Concomitant therapy included one dose of Prevnar, administered in the same leg. On an unspecified date, in approximately August 2001, the pt experienced "itching/scratching" and "scabbing due to abrasion/scatching." It was noted that no prescription drug treatment was required. Subsequently, the pt recovered. Additional info has been requested.
Moderna booster of 0.25ml was administered to pt out of vial that had been opened for > 12 hours. The vial had been opened for approx. 24 hours but remained in the stable temps of 4-5 degrees Celsius. No adverse reaction noted.
Experienced extreme vertigo with nausea & vomitting, brain fog, headaches, sweats, eye twitching, pressure my head, questionable vision changes
02/19/2021 A red rash on left upper arm but not at injection site.  When rash first began, arm was itchy with a burning sensation and swollen that was painful to touch.  Applied Hydrocortisone cream 2.5%.   02/20/2021  Rash still on arm, itchy and burning sensation, applied Hydrocortisone cream.   02/21/2021  Rash still itchy and burning sensation, applied Hydrocortisone cream.
On 03/18 I had a strong paint in my throat, and I went to an urgent care. On 03/21 the paint continues and I had difficulty to swallow, I went to emergency in the hospital they give me steroids and analgesics a send me home. The next day I was worst, I went to emergency, I spend 14 days in the hospital, the first three days in the Intensive Care Unit. The medical reports indicate Ramsay Hunt Syndrome, herpes zoster, shingles.  I was discharge 04/03 to my home under the Hospital control. Today (05/24) my condition is: unable to swallow, feeding by a tube to the stomach, talking with difficulty, have face paralyzed.
Got shot at about 10:53 at about 11:07 I started feeling lightheaded then quickly turned into having sweats and racing heart Then I started shaking uncontrollably and  also feeling like I was either gonna pass out or vomit.  Tried taking slow deep breaths to clam it down but wasn't working. At about 11:20 the pharmacist called an Ambulance. She took my blood pressure and said it was high 185 over something. My pulse was high. I continued with these symptons. Ambulance  got there about 11:35
nauseated; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (friend). A patient of unspecified age and gender received dose number unknown of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not report-ed. On an unspecified date the patient experienced nauseated. Clinical course was reported as her friend received the Pfizer COVID-19 vaccine and became very nauseated afterwards. She would like to know if this is a common side effect. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
After shot my arm was a little sore, but by the following afternoon (Jan 28)it really hurt. When I actually looked at it,the area around the site was very, hot, swollen. That evening I took two Advil and used ice. The next day it was still quite uncomfortable and iced the area and had Advil again.  The 30th was still swollen and red.and itchy/stingy. Used ice and Advil. Today it is not as red but still some swelling and a little itchy and minimal discomfort.
This spontaneous report was received from a registered nurse, referring to unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (which had the lot number L028277, expiration date 28-JUL-2017) (strength, dose and route were not reported). Concomitant medication was not provided. Additionally no adverse effects were reported. It was also reported that the temperature was -8.9 degrees C, in a time frame of 33 hours and 19 minutes, there was not a previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.