chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VIAL LEFT OUTSIDE OF THE FRIDGE FOR MORE THAN 2 HOURS; ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 37 year old female. 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: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vial left outside of the fridge for more than 2 hours, and administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial left outside of the fridge for more than 2 hours and administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210507453 and 20210507559.
patient felt dizzy and light deaded after 5 minutes from receiving fist first dose of covid 19 moderna vaccine patient was helped to lay down on the floor and his legs were put up . Patient didn't loose consciousness.  pharmacist kept patient for 20 minutes to make sure he is going well.  patient refused 911 call or calling anyone to help pick him up . he was feeling fine when he decided to leave the pharmacy .
Patient fell due to weakness in her legs and unable to stand.  She felt like her legs gave out. Pt then came to the ER and was admitted. Pt was transferred on 4/10/21 to a different Hospital. Pt was discharged on 4/22/2021.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 6th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Status epilepticus-simple partial (motor). Left body started about 48 hours after immunization.
COPIED & PASTED FROM PROVIDER NOTE:  Adverse effect of diphtheria vaccine, initial encounter Comments: local inflammatory response  Reassured Continue symptomatic care prn - reviewed Activity ad lib as tolerated May take several days to resolve No contraindication to future booster Call or RTC if symptoms persist or worsen  HPI: Pt is here today w/ his Mom for a reaction to his immunizations - had shots on 2/9. dtap was in his RQ - just noticed today, gradually getting worse - gave tylenol & claritin at approx 1300 today - no fevers but slept a lot today  PE: Area of mild erythema with underlying mild swelling, mild local warmth, approx 11cmx7cm diam oval shaped area on right upper thigh
Swollen lymph node in neck Pain in ears  Ringing in ears that has not gone away
This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clot was migrating to lungs) and THROMBOSIS (Blood clot in leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high and Gout. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clot was migrating to lungs) (seriousness criterion medically significant), THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg started to hurt/ Very painful) and PERIPHERAL SWELLING (leg started to swelled up). At the time of the report, PULMONARY THROMBOSIS (Blood clot was migrating to lungs), THROMBOSIS (Blood clot in leg), PAIN IN EXTREMITY (leg started to hurt/ Very painful) and PERIPHERAL SWELLING (leg started to swelled up) outcome was unknown. Patient was on concomitant medication for high blood pressure and gout. It was reported as patient had received his booster dose in Mar (unspecified date). After the booster dose his leg started to hurt, swelled up and were very painful. He waited about a week after putting heating packs and wrapping it before ultimately going to the doctor. It was reported as he had a blood clot that was in his leg that was migrating to lungs and at the time of report he was on blood thinners. Company comment: This spontaneous case concerns a 70-year-old male patient with Concurrent medical conditions of Blood pressure high, who experienced the unexpected serious AESI of Pulmonary thrombosis and Thrombosis (seriousness criteria medically significant) which occurred on unspecified day after the third dose of mRNA-1273 Vaccine. Patients with Concurrent medical conditions of Blood pressure high remain a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 70-year-old male patient with Concurrent medical conditions of Blood pressure high, who experienced the unexpected serious AESI of Pulmonary thrombosis and Thrombosis (seriousness criteria medically significant) which occurred on unspecified day after the third dose of mRNA-1273 Vaccine. Patients with Concurrent medical conditions of Blood pressure high remain a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a non-contactable other health care professional (patient). A 25-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: EL1283) dose 2 via an unspecified route of administration on an unspecified date and received BNT162B2 (PFIZER-BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: EL1284) dose 1 via an unspecified route of administration on 20Dec2020 both as single dose (at the age of 25-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. Patient did not diagnose with COVID-19 prior to vaccination. Patient was not tested positive for COVID-19 since vaccination. On 14Jul2021, the patient tested positive for covid and the drug was ineffective. The events were reported as non-serous by the reporter. The patient visited physicians office as a result of adverse events. It was unknown if patient received any treatment as a result of adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 14Jul2021. The outcome of tested positive for covid was not recovered and outcome of drug ineffective was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2.
client stated that she was having a hard time deep breathing that lasted about 3 min, no other symptoms noted. Stated that during her first and second vaccine she also had adverse reaction. Denies symptoms of her throat closing or chest tightness. Client is being observed in post vac for 30 min. She is stable and breathing fine with no distress noted.
A 69 year old female received an intramuscular injection of MassBiologics Td (lot A083A) in the deltoid on April 18, 2016 for wound prophylaxis after injuring her thumb. No other immunizations were reported at that time. The patient has a past medical history of hypothyroidism, anxiety disorder, and acid reflux and reported taking her routine medications SYNTHROID, sertraline, and ranitidine that day. Approximately 3 days post-Td administration (4/21/16), she developed erythema and induration at the injection site. These symptoms subsequently worsened and she additionally developed soreness and swelling around her eyes and forehead, and flu-like symptoms. These symptoms were similar to a previous adverse reaction the patient had experienced following lidocaine administration. The patient contacted the ENT physician who had treated her for the lidocaine adverse reaction and was instructed via phone to restart the same allergy medications she had taken for the lidocaine reaction: fluticasone nasal spray, cetirizine oral tablets, and PROAIR HFA inhaled aerosol. She did not require an office visit. At the time of the report (approximately 3 weeks post-Td administration), the patient had ongoing symptoms of slight erythema around the injection site and swelling around her eyes. Sender's Comments: The adverse events reported by the primary source were assessed as non-serious and contain both labeled reactions and unexpected events. Injection site reactions, such as the local erythema and induration, as well as flu-like symptoms like malaise are listed in the package insert for Td. The soreness and swelling around the eyes and forehead were assessed as unexpected. It is possible that the soreness and swelling of the eyes/forehead were secondary to angioedema, though allergic angioedema typically has an onset over a period of minutes to hours following exposure to the allergen and also resolves over a period of days. At the time of the initial report, the patient had not fully recovered. MassBiologics (Sender) performed a follow up with the patient (primary source reporter) on two occasions as summarized below: Follow up on May 31, 2016: The patient was unavailable to answer the telephone call and a voicemail was left requesting call back. Follow up on June 06, 2016:  The reporter informed MassBiologics over the telephone that she had recovered.
Soreness in all muscle groups, Fatigue, rectal bleeding. (On initial series 6 doses bleeding remained for several months) Concurrent doses 1-2 weeks
WAS GIVEN PNEUMOVAX 23 INJECTION ON LEFT ARM INTRAMUSCULAR, THE NEXT DAY PATIENT'S ARM BECAME INFLAMED, ABOUT AN INCH ABOVE THE ELBOW AND DOWN TO HIS FOREARM, PATIENT SAID HE COULD NOT STRAIGHTEN OUT ARM DUE TO PAIN. INFLAMED, RASH. LASTED OVER TEN DAYS.
Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. The nurse reported that on unspecified dates, multiple unspecified patients received improperly stored doses of the following vaccines: VARIVAX (lot # M006156 and expiration date: 05-FEB-2018, lot # M033213 and expiration date: 13-JUL-2018) (strength, dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature between -15 degrees Celsius and -10 degrees Celsius for 40 minutes, on an unknown date and previous temperature excursion included -15 degrees Celsius and -10 degrees Celsius during a time frame of 4 hours 20 minutes, 1 hour 40minutes and 63 hours and -10 degrees Celsius and 8 degrees Celsius during a time frame of 3 hours 40 minutes and 13 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts on 10-MAR-2017 to obtain follow-up information had been unsuccessful. General, product, events and narrative were updated.; Sender's Comments: US-009507513-1612USA010400:
Received vaccines at 3pm 6/23/03; 6/24 at 4:30am, mother awakened by child crying, trembling all over, very flushed ("red as a beet"), feverish. She called our Dr. who advised her to go to the ER.  A follow up report received 7/10/2003 adds: Pt probably had undiagnosed roseola?
Information has been received from a physician concerning an "about 16 year old" female patient who in approximately 2010, about 2 years ago, was vaccinated with a dose of GARDASIL (dose, route and lot number were not reported). The physician reported that in approximately 2010, about 2 years ago, the patient developed high fever after administration of GARDASIL and then the patient developed encephalitis, seizures and continued mood changes. Patient sought medical attention by visiting physician's office. At the time of the report the patient's outcome was not recovered. Upon internal review, the seizure and encephalitis were determined to be an other important medical event. Additional information is not expected.
Went to ER. Dizzy, fever 104.3 degrees F. Arm swollen to the size of softball.
My left was hurting, I had a physical scheduled, so I had him look at the areas that were hurting me. He determined from what I was telling and his examination that I have plantar fasciitis and Achilles tendonitis. I was advised to take over the counter medication to relieve the pain, a well as given stretches to help alleviate the pain in those areas. I have also purchased orthotics to wear to help.
SICK; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Unknown Manufacturer.), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "SICK".  Additional information: I had been absolutely sick due to round 2 Pfizer but it's worth it in the long run gets vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated that on Saturday she started getting a rash on her arm around the injection site and that it was pretty itchy. Did not have any other symptoms. It started getting better on Sunday and even better on Monday. Did not have this reaction to the first dose.
Rec'd call from pt states pneumonia vaccine administered at our facility and states had "reaction to shot" 5 days later. Facility offered to see pt who opted to follow up with own Dr. Pt sates she was DX with cellulitis, recd ROCEPHIN drip in outpt care and was given an antibiotic. Pt did not f/up at site of administration. It is unknown if physician who followed up with pt completed a VAERS form.
Initial case was received from a non-healthcare professional on 27 May 2014. A female patient of unknown age whose medical history and concomitant medication was not reproted had received FLUZONE High-dose, (batch number N-49281LUV/N-49281Lu4, dose, route and anatomical site of administration not reported) on 21 October 2013. On an unknown date, the patient experienced reaction within two days of vaccination. The patient could not turn her neck and it followed on down to her other extremities. She also developed a rash on both of her lower legs. It was reported that later she was mostly able to function properly except she could not turn her neck all the way. The patient went to hospital and underwent test. The cause was not known and it was recommended not to have FLUZONE HD shot again. No corrective treatment was reported. The outcome of the event was not resolved. The list of documents held by sender: none.
glassy eyes, projectile vomiting, diarrhea, dehydration, flaccid body,  104 fever, unresponsive--within 10 hours of injection. Loss of coordination 5 hours after. Doctor refused to link this to immunization injury. ER thought it might be heavy metal poisoning. Results not released. Refused all further injections to the present.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 6 month old patient, who on 16-AUG-2016 was vaccinated with improperly stored doses of ROTATEQ. Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1608USA012794: US-009507513-1705USA004965: US-009507513-1705USA004961:
Pt recv vax on 4/19/98; on same day pt exp itching of arm & hand, petechia & itchy throat x 48 hr
Headaches have gotten progressively worse since the first vaccine. It has now been 17 days since the first vaccine and the headache never goes away. I tried 4 Advil and 2 Tylenol at maximal doses, simultaneously, for the last 2 days and it has barely helped.  Last night, 4/18/2021, the headache was so severe I got nauseous but never vomited. I was shakey. I took my blood pressure with a wrist monitor and it was 160/105. (My normal BP is about 120/80). I took my BP four times and it was about the same, around 155 or 160 systolic over 110-105 diastolic.  The headache was so severe I nearly went to the ER.   Today (4/19/21) I took 2 Excedrin Migraine tabs at about noon. It might have helped a little. I'm VERY concerned about getting the second vaccine. I have postponed it from the originally-scheduled date of 4/23/21 to 5/8/21 in the hopes that the headaches will ease up. I spoke with my doctor (an MD), a relative who is a DO, and two pharmacists. Everyone agrees that postponing the second vaccine might help. One pharmacist suggested that I might consider not getting the second vaccine; however I want as much protection from Covid as possible. I am very concerned, though, that the headaches and accompanying lightheadedness could last a long time.  A further note: when I started HRT in Sept 2019, I got severe headaches and had to discontinue the meds after just one week. The headaches lasted SIX FULL MONTHS after discontinuing the hormones. That experience leads me to worry that the same thing might happen with the covid vaccine, even though the mechanisms by which hormones work would be completely different than the mRNA vaccine.
Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash.
within one day my lower abdomen swelled up and bloated.  Loss of appetite. Feeling of fullness.  This feeling has continue since October
Patient received dose of Moderna on 11/10/21 at off-site vaccine clinic. Patient received Pfizer vaccine on 11/18/21 at off-site vaccine clinic. Incentives were given at each vaccine clinic.
FEVER DREAMS; LETHARGIC; FEVERISH; This spontaneous report received from a consumer concerned an adult female. 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 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the subject experienced fever dreams. On 28-APR-2021, the subject experienced lethargic. On 28-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever dreams, lethargic, and feverish on 29-APR-2021. This report was non-serious.
reddness, swelling, heat & pain @ rt deltoid site; pt stated had used ice & APAP;
The day after the shot, I had nausea, fatigue and a slight fever. This lasted 24 hours. I fell much better 2 days after the shot but still have slight nausea.
Right deltoid noted to be swollen, red, hot. Full ROM to shoulder & elbow- immunization given 6/7/04 after son played well through 6/8/04. Woke am 6/9 with swelling, redness, heat, afebrile, deltoid to elbow.
Pt developed episodes of cyanosis associated with apnea, low O2 sats and staring, limpness - dx seizures seen in ER on 1/8/00, parents stated some blueness around lips noted 36 hrs before being seen.
Flu shot given 10/31/02. Within 1 hour, experienced wheezing, SOB. Used Albuterol inhaler. Symptoms cleared within 15 minutes. Very large welt on left upper arm where injection given.
Left upper arm noted swollen, red, warm and tender to touch; painful with moving the arm. Treatment:  instructed to apply warm compressor to the left arm. Prescribed antibiotic Keflex for 10 days.
Small pox vaccine administered by 15 punctures to left deltoid region on 11/06/2002. Vaccination complicated by irritation from tape. Vaccinoid response noted and scab fell off in December. In late Jan. 2002, pt noted episodic throbbing pain of inferior left deltoid and stiffness of left shoulder. Warmth and swelling of left deltoid on 03/01/2002 and prescribed Vioxx.