chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am having side effects; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects/adverse reaction.  The patient's medical history was not provided. Concomitant product use was not provided.  On 31 Dec 2020, the patient received their dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient experienced side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, having side effects was considered as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Arm pain, swelling, chills, arm is hot near injection site Started Friday afternoon, worsened Saturday Improved Monday but swelling and pain increased Tuesday
administered dose past the manufacture expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Left-sided face numbness and tingling in tongue approx. 12 hours after receiving the shot Extreme fatigue, back pain/kidney pain, joint pain, extreme pain in both feet, vertigo, ringing in ears, stiff neck, back pain, heaviness in legs, difficulty sleeping,  brain-zaps (forget my thoughts)
Red/Hot to touch 3" in diameter Redness 3 days Motrin given Tylenol, no fever.
Had vaccine and has shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 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 Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporters wife had vaccine 1 year ago and had shingles.  The reporter stated that kind of hard saying it could be worse because that was speculation.  But still advise people to get vaccine but remember vaccine had no guarantee you would not get shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
SOB on evening of vaccine with palpitations. Red/exanthema, raised area at site c/o itching/pain/burning at site of injection.
Noticed numbness in left calf and had spasms during the night. The next day, [12/22/22] went to Dr.  and was sent to hospital [12/22/22] for an ultrasound to r/o thrombosis. Thrombosis was confirmed and followed with further treatment and work-up at ER [12/22/2]. Additional imaging and laboratory tests were completed [12/22/22]. Discharge diagnosis was Acute deep vein thrombosis (DVT) of tibial vein of left lower extremity. Received loading doses of Eliquis and sent home with Rx for Eliquis with instructions to follow-up with Dr. (vascular surgeon) @ Medical Offices for a 6 month Rx of Eliquis (2 week Rx provided by ER). - in the interim on 12/23/22 with Dr. to receive Rx for additional Eliquis. Saw Dr. on 12/28/22 and was advised that the blood clot was in the best location if one was to have a blood clot and that it should resolve with the Eliquis and no follow-up was necessary. No tests were ordered. Returned with questions for Dr. on 01/11/2023 and was advised there was no need for the anxiety about ther blood clot even though I had not had one before. Dr ordered another ultrasound for 04/21/2023 at Imaging. On 04/27/2023 Eliquis was discontinued by Dr. since the ultrasound showed the blood clot had resolved. Aspirin 81gr. once daily was advised to be taken as a prophylactic measure.   On 9/26/23 after filling out the appropriate form for a Shingles Shot @ Drug Store, Pharmacist inquired about the reaction to the flu vaccine in 2021 and then consulted with 2 of his colleagues. They decided a note from physician was needed in order to get the Shingles vaccine. Called clinic the next day and received several from the MA and a nurse who related that Dr. said I could not have Shingles, RSV or the new Covid shot; info had been relayed incorrectly to the doctor so an in-person appt with CRNP on 10/05/2023. Mr., CRNP confirmed "NO COVID shot could be recommended".  Nurse called later in the day to reiterate not to have any of the vaccines mentioned.   Also had follow-up related to other findings reported on imaging studies in ER including CT Scan for enlarged thyroid (Ct scan done on /2023 confirming enlarged thyroid but no prior imaging was available to compare so follow-up scan was suggested for the future), appt with urologist for suspicious area on kidney which was evaluated with CT scan and found to be insignificant. Also followed up with a cardiologist Dr. - 3/1/23 Telephone appointment  who ordered a nuclear stress test  for 3/15/23 which confirmed mild atherosclerosis.
12/3/07 flat red rash, started on abdomen at 0900, spread to "rest of body". Mom reports rash lasted approx. 4 days. Reports "some loss of appetite" and "crabby", no other symptoms. Saw family MD afternoon of 12/3/07. No meds or tests.
Information has been received from a 59 year old nurse via a company representative concerning herself.  The nurse reported that on 14-DEC-2006, she was vaccinated with a dose of Pneumovax 23 (Lot# 651357/0391F) and subsequently had an adverse reaction to the vaccine.  The nurse reported that within 24 hours of getting the vaccine, on 15-DEC-2006, she developed a rash around the injection site and pain that radiated from the injection site to her neck.  She also reported having swollen lymph nodes in her neck.  The nurse felt that her experience was related to therapy with Pneumovax 23.  The nurse sought unspecified medical attention.  On an unknown date, she recovered.  Additional information has been requested. 02/19/2010 The nurse felt that her experience was related to therapy with PNEUMOVAX. 23 The nurse originally indicated she sought medical attention, but on follow up confirmed no treatment or visist was required. On an unknown date, she recovered. No further information is expected.
Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 05-MAY-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with Menveo vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. The reporter did not know which lot number was administered. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Menveo after temperature excursion, which led to incorrect storage of drug.
An hour after shot I heard a very loud ringing in my left ear that lasted a few seconds and now have gone several days with ringing in both ears much louder than I have ever had in past.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 05May2021 at 12:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. The patient received concomitant medication within two weeks of vaccination, but was unspecified. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05May2021 at 13:45, an hour after the vaccination, the patient experienced a very loud ringing in the left ear that lasted a few seconds and than had gone several days with ringing in both ears much louder than ever had in the past. Since the vaccination, the patient had been tested for COVID-19. On 06May2021, the patient underwent test via nasal swab test and the result was negative. The clinical outcome of the event loud ringing in left ear was not recovered at the time of this report   No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19 with Paxlovid from 22Jul2022 to 24Jul2022; Treatment of COVID-19 with Paxlovid from 22Jul2022 to 24Jul2022; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose number unknown, single (Lot number: F#8027) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ADVIL [IBUPROFEN], start date: 22Jul2022, stop date: 23Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19 with Paxlovid from 22Jul2022 to 24Jul2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.
10 hours after vaccine had a 101.4° fever, chills, migraine for about 12 hours. Had a persistent headache and extremely tired 24 hours after the vaccine
I felt completely fine for the first 5 minutes.  I left the store.  After 5 more minutes I started feeling bad (I was seated).  My whole body was sweating and my vision was affected (everything was bright).  I was able to return to the store but was close to passing out.  I sat down for about 10-15 minutes while the symptoms persisted and I was not able to see well.  After that time the sweating stopped and my sight was no longer affected.  This was not anxiety and I have no history of fainting with shots.  This was a reaction to the shot.  After about an hour I felt fine except for muscle soreness at the injection sight.  If the reaction was any worse I would have passed out or asked for help.  I am hesitant to get a second dose out of concern that the reaction could be worse.
This spontaneous report was received from a physician refers to an approximately 22 year old male patient. The patient's medical history included sickle cell disease. On an unknown date the patient was vaccinated with PNEUMOVAX23 vial, lot number, route, strength and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date (also reported as at unspecified time in the past) the patient developed a form of pneumococcal disease (type unspecified) about 7 months after received a dose of PNEUMOVAX23. The outcome of the event was unknown. Additional information has been requested.
Tested PCR positive for COVID 8/12/21 after being fully vaccinated. Asymptomatic.
Sore throat, phlegm, cough, trouble breathing, headache, body ache, fever
pt recv vax 17OCT95 & that evening devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;
Fatigue, joint pain, myalgias x weeks, lot TSH, being evaluated by specialist
Redness swelling and warm to touch at injection site, cold compress to site. 7 previosly reported now 8 out of 28 students had same reaction.
Patient received Covid vaccine dose #2 prior to required 3 week interval between doses. Patient was observed after incident for any effects, none was noted.
Vaccines given to patient and instructed to wait in clinic 15 min prior to leaving, walked outside and came back in door and stated to provider that he was itching, noted swelling to lips, all over body hives, flushed appearance, given tow doses of Benadryl by provider totaling 50mg, given Solu-Medrol 125mg, sat in clinic until symptoms resolved and all hives gone and no itching released at 1425.
Patient developed widespread rash on 4/13/05 which looked target-like. Rash was pruritic and covered entire body to include palms, soles and chin.
received the covid vaccine on 12/29/2020.   On 12/30/2020 has a temperature of 100.2, headache, and bilateral "achy leg". Denies chills, fatigue, cough, or sore throat.  Tested positive for covid PCR on 11/13/2020
headache, cough, fever, chills, body aches, phlegm, itchy throat, diarrhea (mild). starting 12/26/21
Ttongue had felt numb; Metallic taste in her mouth; Blood pressure was high; Headache for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Ttongue had felt numb), DYSGEUSIA (Metallic taste in her mouth), HYPERTENSION (Blood pressure was high) and HEADACHE (Headache for 2 days) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tromethamine).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Ttongue had felt numb), DYSGEUSIA (Metallic taste in her mouth), HYPERTENSION (Blood pressure was high) and HEADACHE (Headache for 2 days). At the time of the report, HYPOAESTHESIA ORAL (Ttongue had felt numb), DYSGEUSIA (Metallic taste in her mouth) and HYPERTENSION (Blood pressure was high) outcome was unknown and HEADACHE (Headache for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided  Patient experienced Fast heartbeat.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021: Contain Non significant information. Address and email were  added
Patient felt like he was going to pass out. He fingers were tingling and he felt like his muscles were spasming. He had a TDaP previously in 2006. The patient expressed that he feels like this every time he gets a shot or gets blood work. He sat and breathed in and out for awhile until he felt better.
By 7:50pm the same night I was chilled with a fever of 101.7 it stayed around that temp until about 1:30am. My entire body ached, my joints felt like they were on fire. It hurt to move. By 3am I woke up sweating with a normal temperature. The next morning I felt weak and tired but no fever. Today I still have a headache abd feel a little tired but almost back to normal.
Received flu shot about 12:30 pm 10/09/2013. Abt 4-5 hrs later, face turned red and hot. Next AM face, neck and throat swollen and nasty taste in mouth lasting for abt 2 weeks. Called office, advised to get BENADRYL. On 10-11 ER gave me oral steroids and prescrip for Prednisone. A few days later noticed BP became irregular, dizzy, weak, out of breath and a few days later had diarrhea for 5 days with some nausea. On 10-18 ER again and admitted, white blood cells elevated, given strong antibiotics intravenously. Started to feel a little better on 10-29-13. 11/03/2013, 11/04 and 11/05 face still swollen for 1-2 hours upon waking up but easing up. Temperatures in the first 2 weeks from 96.6 to 99.6. EKG - normal, BP - abnormal, white blood count high.
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT; This spontaneous report received from a pharmacist concerned a 98 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 21-SEP-2021) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 25-JUN-2021, the patient experienced out of specification product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915748, 20210915852, 20210916455, 20210916520, 20210916228, 20210916401, 20210916553, 20210916312, 20210916658, 20210916697, 20210916959, 20210916907, 20210916849, 20210916910, 20210916808, 20210916768, 20210916715, 20210916584, 20210916415, 20210916129 and 20210916811, 20210916965, 20210917163, 20210917515, 20210917226, 20210913164, 20210916498, 20210917074, 20210917160, 20210916465, 20210917603 and 20210917500.
Patient received vaccine on Friday (5/31/13) and returned on Monday to report that his arm at injection site was swollen and red. Doctor recommended an office visit only if symptoms worsen. Upon follow-up, patient symptoms were resolving (6/4).
nosebleeds; upset stomach; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nosebleeds), ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (nosebleeds), ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (Chills). At the time of the report, EPISTAXIS (nosebleeds), ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (Chills) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.   No treatment information was provided.
pt notes prolonged left arm pain after second covid vaccination. pain is shooting/deep, worse at night, waking him from sleep. starts at injection site, radiates downward. exam = benign, from shoulder, no weakness, no sign for impingement. rounded 2cm soft tissue nodule which is soft, is palpated.  xray neg for bony abn.  very bothersome trialling gabapentin, as tylenol rtc and topical nsaids= ineffective and pain seems to be neuropathic
Patient has persistent left shoulder soreness since day after vaccination. Patient did not report using any over-the-counter therapies. She reports having had a massage between date of vaccination and today. Patient reports using arm to lift weights during exercises on multiple days between date of vaccination and today. Patient reports radiation of pain to neck for last several days. I recommended patient use ice for 30 minutes on, 30 minutes off and Tylenol for pain per OTC directions.
Pediatric Covid-19 Pfizer vaccine was given to 12 years old patient. Error was discovered after shot administered. Father was informed the incorrect Pediatric dosage was given to his 12 years old son.  Consultation was provided. Patient aware that he is going to receive the 2nd dose as for 12 years and older.
DOSE 3 (BOOSTER; Got a huge lump on her arm; It was red and itched; It was red and itched; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION), dose 3 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced got a huge lump on her arm, it was red and itched, it was red and itched on 2021 with outcome of recovered, dose 3 (booster) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of got a huge lump on her arm (limb mass), it was red and itched (erythema), it was red and itched (pruritus).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Itchy rash on left forearm with 10-15 small pink bumps lasting at least 2 days.
2 days p/recv vax pt exp a local react that included soreness, rash, slight swelling, marked tenderness, & warmth to the touch; pt sought unspecified medical attention;
Information has been received from a physician via a company representative referring to a 15 year old female patient. The patient had not had a bad reaction to other vaccines. The patient's concomitant medication and drug reactions were unknown. About 2 months ago (in approximately June 2017) the patient was administered a dose of GARDASIL 9 (dose, route, lot# and expiration date were unknown) for prophylaxis, then immediately developed a subdermal hematoma, on the front side of the left arm, that was changing in color and texture after the immunization. The patient did seek medical attention. Ultrasound was scheduled for 16-AUG-2017. No treatment was given to the patient. At the reporting time, the patient did not recover from the event. The physician did not believe that the hematoma was associate with GARDASIL 9.
fever for about 3 months,  weight loss (30 Lbs), leg muscle pain
On April 11th 2022, I began with a mild sore throat and changes to my sense of taste. The next day, I had body aches and my sore throat was worsening. I then began to have a fever and continued to run a fever for 5 or 6 days. My sore throat developed into a dry cough after a few days. On day 11, I began experiencing back pain and on day 14, I woke up with a sore throat.
Swelling, tenderness and redness to injection site Urgent Care Rx -Bactrim DS -triamcinolone cream -ibuprofen
Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs after first shot.  Headache lasted approx. 3 hours. At time of this report, the stomachache, chest tightness, and shortness of breath are continuing.