chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 69-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date: 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
< 24 hours Lt arm redness with swelling & heat 11 x 13 cm. Cold compress, BENADRYL, TYLENOL.
Asthma attack. Treated with albuterol inhaler, BENADRYL.
This is an administration error not an adverse reaction.  I miscalculated the date for the second dose of the Moderna vaccine. The patient received the first dose on 5/24/21 and was told to return on 6/14/21 instead of the correct date of 6/21/21.  The patient received the second vaccine one week early.  When the pharmacy discovered our error, we contacted the patient and called the Moderna clinical line.  Moderna told us to check to make sure the patient was not experiencing any symptoms and they advised us to not administer another dose for this patient. The patient reported feeling fine even a week later.
Parasthesis in head, arms, legs, spine, face Headache, facial pain around trigeminal nerve, pain at base of neck Fatigue Feeling out of body Balance issues
Burning sensation in my left hand moments after the shot. 10minutes after, burning sensation in my left foot, 3 minutes after foot burning (13 minutes after shot) left breast burning sensation. By 25 minutes after shot, burning sensation dissipated to a tingle (like when your limbs fall asleep) and was normal about 35 minutes after shot.
weakness; dizziness; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.
Large, golf ball sized swelling in my left arm pit.; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of COVID-19 prior vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no any known allergies. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cefadroxil (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN); all started on unknown date for unknown indication. On 22Mar2021 at 01:00, the patient experienced large, golf ball sized swelling in his left arm pit (swelling armpit). The patient did not receive any treatment for the adverse event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event swelling armpit was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a certified Medical Assistant and from a certified medical assistant staff refers to a patient of unknown age and gender who on 16-APR-2015 was vaccinated with an improperly stored dose of PEDVAXHIB from the lot K015462, expiration date not reported (dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccinated with ZOSTAVAX in 2013. Diagnosed with shingles last week.
Rash occurred at injection site after one week. Rash was round, about the size of a dime. Redness  (erythema) with itchy, mildly painful bumps. Bruising appeared at the same site approximately 2 days prior.
Initial solicited report received from a consumer in study on 05 October 2015. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject was well after taking a dose of vaccination and did not get sick. However the subject had mild side effects on an unspecified date. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
The evening after his appointment, he developed swelling of face and hands.   The next day, he presented to ER with complaints of  fever, chills, malaise With further evaluation including peak troponin of 8, an NSTEMI was ruled in. Patient states he has been experiencing shortness of breath after walking 3-4 mins for the past month, and had abnormal stress test done February 2020.    He was stabilized and brought to OR for coronary bypass surgery.    The vaccine reaction  exacerbated  pre existing coronary artery disease
I received the Shingrix vaccine on 1/24/20 in the am at my primary care physicians. It was properly administered to the upper left arm in the muscle. I had significant soreness at the injection site (sore to the touch) persisting through 1/26/20 in the evening. On 1/25/20, I developed chills, fever of 101.2, headache, muscle aches, and fatigue. These persisted through the night but was resolved by the morning of 1/26/20 with the exception of the muscle soreness.
Frozen vaccines from excursion were administered to the patients, no AE; Initial information received on 22-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves approximately 26 patients of an unknown demographics who were received frozen vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot: UT6657MA Expiry date: 30-Jun-2020), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Lot: U6522AA, U6560BA, expiry date not reported) and IPV (VERO) [IPOL] (Lot: P1F491M,  Expiry date not reported) via unknown route in an unknown administration site on an unknown date for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Product storage error temperature too low.   It was reported that nurse from clinic reported that temperature excursions for Menactra, Fluzone Quadrivalent 0.5 ml single dose and IPOL. Two of the IPOL were opened. Temperature excisions occurred on 29-Jan-2020 when refrigerator reached a temperature of 46.2 F for one hour because of malfunction . Due to an emergency in the clinic the vaccines had to be transported to another facility. Temp reached 24.9 F for a total of 35 minutes during transport to the other facility. Reason for excursion was due to temperature instability with transport cooler. Nurse stated that she was told the vaccines were okay to use but they are not. They have administered these vaccines that were frozen.  It was also reported that vaccines that have reached a temperature< 32F not suitable for use.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
8-12 lesions erupted on patients face Watery, large volume stool  7/20/2011: no concerning rashes or lesions except for one erythematous papule with halo just beside lateral epicantheal fold of right eye.
Headache, nausea, clammy sweats, blurred vision, high fever within 12 hours of immunization. Redness & swelling at site (L) arm.
Rash on chest developed @ 1 week after administration of vaccine.  On 11/21/2009 sudden onset of severe arthalgia and myalgia in knees, shoulders and arms progressing to hips, wrist, chest and neck, accompanied by stiff joints.  Worse at night. Pain relieved somewhat with ibuprofen. Patient is active runner and can not participate in physical activity since onset of symptoms on 11/21/09.
loss of taste started around 10am 1-5-2021 and has continued. major headache aprox 2 hours after injection received on 1-4-2021.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5ml (unspecified dose) with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Incorrect immunization was given. Patient was given Tdap and was given KINRIX (DTaP and Polio combo).
Initially reported discomfort at injection site. But had same symptoms overnight. Vaccine (Menomune) administered ~ 2:40PM Tues 9/11. After 4am 9/12, pt reported nausea and lightheadedness. Pt was awakened around 7am, experienced dizziness, nausea and watery diarrhea. Post showering, felt increased lightheadedness, needed to sit with head b/t legs. exp. increase weakness. SXS B/T 7:30-9am. Pt taken to ER with severe low BP-orthostatic. IV hydration x 5L with continued orthostatic BP. Pt hospitalized 9/12, kept overnight.
Fell sick w/fever for 2 days post vaccination arm is red & inflamed & hot to touch.
Terrible stomach pains really sharp pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's daughter). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on Jan2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Jan2021, the patient experienced terrible stomach pains really sharp pains. The reporter states ever since her mom has been experiencing terrible stomach pains really sharp pains. The reporter would like to know if this could be related to the vaccine.The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe nausea May 8 @ 10 PM - May 10 @ 1 PM severe chills/insomnia May 8 @ 10 PM - May 9 @ 6 AM 103.6 fever May 9 @ 6 AM- May 11 @ 10 PM body pain, sweating, shaking, dizziness for the duration dizziness, confusion, shortness of breath on and off to present
one of two patients vax from the same vial who exp a local reaction (9x10cm) consisting of erythema, inc warmth & sl raised skin; seen by MD;
Severe fatigue the next day. Rapid sounding heart beat the night after her injection was given lasting into her next day. Large local reaction on arm 3 x 4". Hot and warm to touch, pt stated her tongue was on fire after the injection.
Lengthy and heavy menstrual period. Heavy days were generally 3, but I had about 10 days. I also experienced strong rectal pressure, while having such a strong menstrual period, which I had not experience before.
it itch like crazy but the itch only lasted 5 minutes then it goes away; Hives; This is a spontaneous report from a contactable consumer (patient).  A 88-years-old male patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9807), via an unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical was not reported. patient was Allergic to Penicillin. The concomitant medication was not reported. the patient received first dose of vaccine (historic vaccine), BNT162B2 (Lot EL1283) at Left Shoulder on 25Jan2021. He experienced hives on the next day and that lasted for 3 days. The patient got Second Dose on 15Feb2021 and experienced hives the next morning, which lasted for 11 days, it is still there but going. He did not do anything to treat them, he just left them alone, it itches like crazy but the itch only lasted 5 minutes then it goes away and then different one comes up. There is no cure for Hives, that's what the doctor said. The outcome of event urticaria was resolving, whereas the outcome of event itch was unknown.  No follow-up attempts are possible. No further information is expected.
Cellulitis - Area became red and hot.  Affected area expanded over the course of 2 days.
Information has been received from a registered pharmacist concerning her 17 year old daughter with depression and anxiety who 07-NOV-2006, 28-FEB-2007 and 19-JUN-2007 was vaccinate with first, second and third dose of GARDASIL (lot # not reported respectively). The patient experienced four syncopal episodes with clonic movements on 25-JUN-2007 while she was playing soccer (only time the patient was hospitalized, in October 2008, on 31-DEC-2009 while playing hockey and in February 2011 in another country when she was studying, each episode lasted "a few minutes" according to the registered pharmacist. Patient fell and injured during the 31-DEC-2009 episode. Cardiac tests and EEG were performed, however nothing had revealed a possible cause. At the time of reporting the patient had not recovered from fell and injury, the patient was recently referred to an epilepsy specialist. Also the patient just recently told not to drive. The events not life threatening according to the registered of pharmacist. The health care professional contacted during the telephone follow-up could not supply the following information: lot numbers. Follow information has been received from a registered of pharmacist who reported that her daughter had no previous syncopal/ tonic events (prior to June 2007). She had approximately 1 event per year. Symptoms included fainting and tonic clonic events. After first and second dose of GARDASIL the patient did not experience syncopal or tonic clonic events. This is an amended report. The year for the second dose in therapy screen was changed to 28-FEB-2007. Additional information has been requested.
Left arm warm to touch, swollen, and itchy. It feels like a lump. Symptoms  started 2/15/21.
First headache, increasingly worse throughout the day, Pain at injection site waking out of sleep, chills throughout the night, lowergrade fever, headache did not leave throughout symptoms, body aches throughout the night into the morning, lessening by 11am. Headache still present.
shaking; myalgia; joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of tremor in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number N4C23, expiry date 15th November 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th June 2019, with no issues arising).   On 13th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2019, less than a day after receiving Shingrix, the patient experienced tremor, myalgia and joint pain. On 14th August 2019, the outcome of the tremor, myalgia and joint pain were recovered/resolved.   The reporter considered the tremor, myalgia and joint pain to be related to Shingrix.  Additional details were provided as follows: Emergency room visit required.
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. The reporter states that the  patient received a dose of the Moderna COVID-19 Vaccine that expired on 25 July 2021.
Swelling in underarm; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05 Nov 2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient reported experiencing swelling in underarm.
Nausea that is not going away; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea that is not going away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced NAUSEA (Nausea that is not going away). At the time of the report, NAUSEA (Nausea that is not going away) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.
Reported to ED with rash on 5/16/2010 to right side of neck and head that was there for about 1 week. Treated in ED with acyclovir.
got the vaccine /, shingles, / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got the vaccine and four years later, shingles, however case was lessened. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Was fine until I stood up at approximately 9:30pm. Immediately got very fatigued, head started hurting. Bent over to pick something up and my back hurt around where my lungs are; it hurt to breathe. Within 15 minutes I could barely stand up. After about an hour of the symptoms intensifying, I started to get a low grade fever. I took something for the symptoms (alka seltzer daytime pill), but went to bed shortly. I started waking up off and on around 6 (I normally sleep in until noon). At 7am, I woke up feeling like I was on fire. I grabbed my thermometer from my nightstand- it read 104 degrees Fahrenheit. I tried to open my medicine but I was so weak I couldn?t do it myself. I walked downstairs and woke my mom up. She took my temperature and it read 103 since I was no longer in my bed warmed by my body heat. She opened my nighttime alka seltzer and gave it to me along with 800 mg ibuprofen. I went to bed with nothing but a sheet and a cooling pillow. At some point my mom came in and handed me my water but I don?t remember it, however it helped cool me down when I fell asleep with it in my bed. When I woke up at 11, my fever was only 100 and it was the only symptom I had. When I got out of bed at 1, I was fever free. I?ve been fatigued the rest of the day but the fever hasn?t returned and I?ve been taking 325 acetaminophen every 4 hrs.
On 09/24/2021 I began showing signs of facial paralysis. I went to the ER the next day 09/25/2021 where they diagnosed me with Bell's Palsy after some basic motor function tests. They prescribed me with Prednisone  and sent me home. As of 09/28/2021 I am still experiencing full facial paralysis on the left side.
PATIENT CHOSE TO BE REVACCINATED WITH PFIZER AFER RECEIVING 1 DOSE OF MODERNA.  PATIENT DID NOT DISCLOSE THIS INFORMATION TO THE PROVIDER WHICH WOULD HAVE PROMPTED EDUCATION ON RECEIVING 1 DOSE OF PFIZER.
Headache, Myalgia, Fever, CHILLS Narrative: Pt reported fever, myalgia, chills & headache on same day after received 2nd dose of covid vaccine. Pt took ibuprofen for treatment.
Extreme pain in left arm.  Could not lift arm at all and it had throbbing pain.  Almost 3 weeks later still can?t lift my arm up without pain.