chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Slight stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Slight stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Slight stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: Very limited information regarding this event/s has been provided at this time.  No further information is to be expected.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  No further information is to be expected.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication and medical history was not provided. On 11-AUG-2017, the patient was inadvertently received an expired dose (unspecified in series) of M-M-R II (expiration date 16-JUL-2017; dose, route and lot # were not reported) for prophylaxis. No adverse events were reported.
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions and concomitant medications. On an unknown day in 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On unspecified dates, the pt experienced shingles and was admitted to the hospital. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) inoculation, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Beginning at 3 AM: Chills, 101.7 fever, headache, total body ache, feeling disoriented, elevated heart rate (108),loss of appetite.  No treatment.  I feel worse than when I had Covid!  Considering not doing second dose.
Extreme itchiness, especially around face and arms. Slight redness. Very itchy.
2/19/07 fever of 104 degree after 2 hours of vaccine administration. Pt won't walk due to pain in thighs.  2/20/07 doctor prescribed Tylenol with Codeine, Motrin and Benadryl
Parent brought patient to clinic on 3/10/22 to show redness and swelling on patient's right arm from deltoid to elbow.  Parent denied that patient was experiencing fever or pain.   Parent was advised to apply cool packs to affected area and see healthcare provider or Emergency Room if symptoms worsened or did not improve in a day or two.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe
9 days p/vax pt t101R temp & had a prolonged sz >1hr;adm to ICU;
The site of the injection became red and slightly swollen within the first 5 minutes. Later that day at around 3pm, the site became itchy. Patient was running a slight fever. He woke up from sleep at 4:00 AM sleep walking and talking. Something that he has never done before and didn't remember doing when he woke up. The site of the vaccine was still itchy on day two and still slightly red and swollen--but itchy was mainly what he experienced.
Positive rapid test on 23May2022; Positive rapid test on 23May2022; slight nasal drip; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022 at 14:00, outcome "recovering" and all described as "Positive rapid test on 23May2022"; NASAL DISORDER (non-serious) with onset 23May2022 at 14:00, outcome "recovering", described as "slight nasal drip". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Posative, notes: Positive rapid test on 23May22. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of nasal disorder. clinical course: Positive rapid test on 23May22, 5 days after finishing Paxlovid. At that time, similar mild symptoms returned, specifically slight nasal drip. Other medication in 2weeks: No Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer biontech covid-19 vaccine lot EN6205, ER8727, FF2590  was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326.The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. The final scope was determined to be the reported finished goods lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   No follow-up attempts are possible. No further information is expected.
Approximately 20 minutes after vaccine administration patient noted that she had some lightheadedness and chest pain after the vaccine, but that it had already completely resolved. She stated that she got lightheaded shortly after administration, and noted that it lasted approximately 10 minutes before resolving. She stated that she had an episode of mild chest pain that lasted approximately 2 minutes before completely resolving. She expressed anxiety related to vaccine administration noting history of anaphylaxis after influenza vaccine and PPD testing. Patient monitored for another 15-20 minutes without incident. Patient noted that she was feeling well and had no concerns upon leaving. She verbalized understanding to call EMS or go to ER if symptoms change or worsen.   Follow up call placed to patient 12/31 @ 1720. She states that she is feeling fine and had no other symptoms after leaving. She denies any concerns at this time.
Fever up 102.9 Ax and 103.6, Rectally. Mom describe a shaking episode of all extremities and up rolling of the eyes for 20 minutes according to mom. Called 911
Administered vaccine at 0920. Patient got up, went to the bathroom then returned to seat. Around 0935 started feeling hot. Water bottle given to patient and cool cloth applied to neck. Patient began to feel dizzy. Encouraged patient to lean forward, resting head on arms and taking slow deep breaths. Patient states that leaning forward was not helping. Encouraged patient to lean forward further or gave option to lay down on ground. RN assisted patient to ground when patient stated that she was starting to feel tingling in her throat. Denies SOB. Called urgent care provider, in at 0936 to assess patient. Provider arrived to vaccination conference room at 0938 and assessed patient. Patient states she is having tingling in throat, denied having trouble breathing but then started to cough. Provider directed RN to give epipen injection of 0.3mg to patient. RN administered 0.3mg EpiPen to patient in her left lateral thigh at 0941. Provider informed patient that we would call EMS to bring her to the hospital. Vitals: O2 100%, pulse 79, BP 138/91. Provider stepped out of room to get additional supplies, RN remained with patient. Patient and husband agreed with plan. Patient then started to feel SOB, gasping for air and face became red.  RN alerted provider and had MA in room call EMS called @ 0943.  Provider back in room at 0944. At 0944, BP 148/99, pulse 116, O2 100%. 2L of oxygen applied via face mask per provider. At 0946, BP 142/92, pulse 112. Patient's face no longer bright red, breathing slowed at regular rate and patient closed her eyes. Patient less alert and denied trouble breathing states her throat still tingles, answers to commands with stimulation to rouse patient. At 0950 BP 129/80, pulse 90, O2 100%, patient is oriented x4, is following verbal commands states she is "just tired". At 0951, EMS arrived and assessed patient. Report given to medics and patient was transported to nearby hospital. Patient left via EMS at 1002.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
EARACHE; SINUS BLOCKAGE; FACIAL PUFFINESS; ITCHY; RASH ON FACE; RED SPOTS ON FACE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included rosacea, and concurrent conditions included osteoporosis, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received COVID-19 VACCINE ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at 10:40 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced earache. On 19-MAR-2021, the subject experienced sinus blockage. On 19-MAR-2021, the subject experienced facial puffiness. On 19-MAR-2021, the subject experienced itchy. On 19-MAR-2021, the subject experienced rash on face. On 19-MAR-2021, the subject experienced red spots on face. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from earache, sinus blockage, and nausea on 20-MAR-2021, had not recovered from rash on face, facial puffiness, and red spots on face, and the outcome of itchy was not reported. This report was non-serious.
Pt recv vax on 10/23/98; on same day pt exp local rx of red, tender, swelling, sore; trouble sleeping; tx=ice, moist heat, Darvocet
FELT SORE IN THE SHOT LOCATION; NAUSEA; DIZZINESS; COULD NOT SLEEP BECAUSE OF NAUSEA; This spontaneous report received from a patient concerned a 45 year old male. 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 07-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced could not sleep because of nausea. On 07-APR-2021 14:00, the subject experienced dizziness. On 07-APR-2021 14:00, the subject experienced nausea. On 08-APR-2021, the subject experienced felt sore in the shot location. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, had not recovered from nausea, and felt sore in the shot location, and the outcome of could not sleep because of nausea was not reported. This report was non-serious.
slight headache; sore arm; This is a spontaneous report received from a contactable reporter (Nurse).  A 89 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 89 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "slight headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Additional Information: Nurse stated that the patient is in a long term care facility and was checked and there were no other indications. Nurse stated that events will resolved in 2-3 days, no fever or no other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx 20 mins p/inject pt eyes swelled closed & nasal passages occluded; given DPH & Decadron; MD ordered Medrol; ice applied to face; VS remained nl throughout;
pt recvd vax 7SEP95; 12SEP95 pt had a t103.4 fever for 1 day w/no other signs x/dry cough; 13SEP a few small bumps broke out on face & legs; By 15SEP had them all over body-small pink rash like prickly heat but worse & everywhere;
CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included she's a dialysis patient. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and low grade fever. This report was non-serious.
Very hard, swollen arm at injection site around 1 week after injection.; Moderate pain in arm pit, by lymph node; Very hard, swollen arm at injection site around 1 week after injection.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included "simultaneously experiencing bad poison oak rash" and the patient had sensitivity to bananas. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and unspecified collagen supplement; both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021, the patient experienced very hard, swollen arm at injection site and moderate pain in arm pit, by lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very hard, swollen arm at injection site and moderate pain in arm pit, by lymph node was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse event noted. Administered expired vaccine. Vaccine expired on 4/1/2022. Administered on 04/19/2022.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of GARDASIL on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Sinus infection that lasted 3 weeks; extreme fatigue, heavy yellow mucous discharge.
In November 2022, my wife and I were monitoring our blood pressure on our automatic blood pressure machine. It indicated that I had an irregular heartbeat. I scheduled an appointment with my doctor to discuss what he thought about it. He had me wear a Holter heart monitor for two weeks. The results did show I have an irregular heartbeat, but I am not in Afib. I was given a small dose of Metoprolol to take daily to help with the irregular heartbeat.
Received DTaP in left thigh and area reddened warm to tough, swollen at site and tender to touch. 10.5cm x 9.5cm redness and swelling top left thigh.
11 month old patient received a dose of Kinrix instead of the Pediarix; 11 month old patient received a dose of Kinrix instead of the Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made  without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 11 month old patient received dose of Kinrix instead of Pediarix in the left leg, which led to wrong vaccine administered and inappropriate age at vaccine administration. No other reactions reported. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patient was vaccinated with doses of MMR II Subcutaneous Injection, (lot # L009213, expiration date 17-MAR-2017 and lot # J013431, expiration date 24-OCT-2015 (strength, dose series and route not reported), that were inappropriately stored. No specific dates of vaccination for each lot # were provided and no adverse effects were reported. This patient was also vaccinated on 25-AUG-2015 with a dose of VAQTA that was inappropriately stored (captured in MARRS # 1509USA000495). This is one of several cases from the same source. Additional information has been requested.
Parent called stating that her daughter developed a body wide bumps/rash 2 days after receiving vaccine.  Parent denies any breathing issues.   Recommended diphenhydramine and monitoring for worsening symptoms.  Parent has not followed up with any updates on daughter's condition.
Patient in for a flu vaccination, Bivalent Booster given by mistake. Last Covid vaccine was 05/18/2022 - for a total of 5 doses.
Pt had injection site reaction. Injection site was inflamed and a rash that continued to grow out. Pt was experiencing pain and discomfort. Pt notified pharmacy of condition on 7/17/14 at 0800.
She presented with right sided weakness, altered gait, slurred speech, facial droop on March 28, 2021 in the afternoon. She contacted her PCP on March 30,2021 who advised her to go to the ER. Her symptoms were improving when she arrived at the ER. CT brain showed a left basal ganglia lacunar infarct
Severe vomiting, irritabile. Woke up the following morning with hives on his face and legs. Doctor advised 3/4 tablespoon of Benadryl and to come into the office if symptoms persist.
Received DTaP immun in (R) thigh on 1/14/14. Mom noticed erythema and swelling in PM on 1/15/14, increasing size, (+) warm to touch. No fever.
About 18 hours After receiving  the 1st dose of Moderna  a fever spiked and had extreme muscle aches. This lasted for 4-6 hours.
after being well hydrated and adequate food intake, i awoke to go to bathroom at 3:30am and felt fine, after voiding began to feel nauseated and felt as if i would pass out.  called for help-when my spouse came in i was on my hands and knees-when he tried to lean be back against the tub, he tells me my head went back and i was ''gone''    i do not recall anything after feeling i would pass out.     i awoke flat on my stomach gurgling fluid and my husband was had phone calling 911     was able to let him know i was waking up    did not call 911, but i was not able to get up and slept on bathroom floor for 3 hrs-awoke feeling sore and mild weakness    resting the day-felt better
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: patient was having given epipen then felt better but called 911 then they took her since epipen was administered but while leaving the pharmacy she was in good condition feeling better no need to administer 2nd dose of epipen
She woke up this morning with a bright red diaper rash in her genitals. She also has a small red circle around one of her shot injection sites.
Following the first shot I have developed what appears to be tennis elbow in my left arm.  Not sure if it is related or not.  Symptoms did not begin until after I received the shot.  Also, I have not been sleeping as well.  I have never had a sleeping issue but now find myself waking up around 4-5AM whereas this never occurred before.  These are not terrible side effects but just wanted to report them to see if anyone else is experiencing anything similar.
NURSE MISCALCULATED THE DOSAGE AND GAVE .6CC INSTEAD OF .3CC
My adverse event started on 12/2022 I probably think in the morning but not sure about the time exactly. I noticed Psoriasis on fingers and now it's on my upper lip. I went to a Dermatologist last week on 01/11/2023. They are trying to see if my insurance covers the medication. They haven't prescribed me any medications yet. I have three insurances they are trying to figure out who can cover the medications. As of now I am just using over the counter medications which is not helping. I have a follow up coming on 04/11/2023 to discuss about the medications options from my insurances.