chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; diarrhea; headache; tiredness; not feeling well; Minor pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 10:30 (Lot number: FE3590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Mitral valve repair" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "cervical Dustin's" (unspecified if ongoing); "high BMI" (unspecified if ongoing); "high blood fats" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tegretol, reaction(s): "Allergies"; Flagyl, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 19Apr2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 25Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "Nausea"; DIARRHOEA (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "diarrhea"; HEADACHE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "not feeling well"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2021 06:00, outcome "recovering", described as "Minor pain at injection site". Therapeutic measures were not taken as a result of nausea, diarrhoea, headache, fatigue, malaise, vaccination site pain.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Lots prescribed, vitamins. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown exact age and gender. There was no information about the patient's concurrent, concomitant therapies or medical history provided. On 02-MAR-2016, the patient was inadvertently vaccinated with RECOMBIVAX HB (lot# L045117, expiration date 06-OCT-2018; dose, anatomical location were not reported) intramuscularly. On 22-MAY-2016, the patient was again inadvertently vaccinated with RECOMBIVAX HB (lot# L045117, expiration date 06-OCT-2018; dose, anatomical location were not reported) intramuscularly. This was outside the labeled recommendations in the prescribing information. No adverse events were reported. Additional information has been requested.
Patient provided incorrect date of birth to pharmacy: 1/14/2003 at time of administration. She received Moderna vaccination, when instead should have gotten Pfizer vaccination. Patient's correct date of birth is 1/14/2004 (17 years old).
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment reported.    This case was linked to MOD-2021-403355, MOD-2021-403376 (Patient Link).
after the first shot, right arm from elbow to shoulder swollen, hard, red and incredibly itchy.
Four days following the vaccine, the left side of my neck hurt, the pain progressed down my shoulder, and left arm, my hand was numb. Out of a scale of 1-10 my pain was a consistent 4-6. My first visit with a physician days after the onset of pain, it was determined to be nerve caused, probably between C5 and C6. Was given pain meds and muscle relaxants that didn't provide much relief. A visit with another doctor resulted in new pain meds and muscle relaxant that also had little effect. I began 6 weeks of PT that offered a little relief. A visit with another physician Clinic resulted in oral steroids, proving some relief, but pain returned just as severely, so he ordered an MRI that I had done at Clinic. A narrowing between C5 and C6 was confirmed. I was referred to Physical Medicine & Rehabilitation and steroid injections have been scheduled for 8/5/2021. Other treatments I have tried during this ordeal have included three sessions of structural massage that offered some relief. Currently, my pain level is about a 4. I am able to bring the pain level down with ice, heat, and Ibuprofin. This affected almost all areas of my life, and most physicians have agreed the vaccine could've contributed.
Localized pink papule left deltoid; Mild tenderness; lump beneath skin approx 2 cms x 2 cms in left deltoid area; This spontaneous report was received from an unspecified health care professional referring to a white male patient of unknown age. The patient did not have medical history or concurrent conditions. The patient did not take concomitant medications.   On an unknown date, the patient was vaccinated in his left arm with a dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R011628, intramuscular (strength, and expiration date were not provided). Other suspect therapies included a dose in his right arm of influenza virus split virion 3v vaccine inactivated(FLUZONE) lot # UJ087A5, intramuscular (strength, and expiration date were not provided). Both therapies for prophylaxis.  On an unknown date, the patient experienced localized pink papule in his left deltoid. Additionally, lump beneath skin approximately 2 cm x 2 cm in his left deltoid area (skin mass) with mild tenderness without redness and warmth.  At the time of the report, the outcome of papule, skin mass and tenderness was reported as not recovered.  The reporter did not assess the relatedness between papule, skin mass and tenderness and suspect therapies.
sweating; achiness; Feeling sick to her stomach/ stomachache; headache; joint pain; tired; Achiness; Chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), PAIN (Achiness), HYPERHIDROSIS (sweating), PAIN (achiness) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (Achiness), CHILLS (Chills) and PYREXIA (low grade fever). On 15-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), HYPERHIDROSIS (sweating), PAIN (achiness), HEADACHE (headache), ARTHRALGIA (joint pain) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 11-Feb-2021, PAIN (Achiness), CHILLS (Chills) and PYREXIA (low grade fever) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Feeling sick to her stomach/ stomachache), HYPERHIDROSIS (sweating), PAIN (achiness), HEADACHE (headache), ARTHRALGIA (joint pain) and FATIGUE (tired) was resolving.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information included Address and email.
Swelling at the injection site; Lethargy; Fatigue; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site swelling, lethargy, fatigue and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, lethargy, fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, lethargy, fatigue and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient did not remember when he had the vaccine, but the symptoms started a few days after the vaccine. The patient experienced swelling at the injection site, lethargy, fatigue, and flu like symptoms for several days. The patient reported that he had a reaction that he hasn't had before with other vaccines. The reporter gave permission to follow up. The outcome reported in the structured field (recovered) and the outcome reported in the source document (Recovered/Resolved with sequelae). So the outcome of events was kept as reported in structured field.
Pt rec'd vaccine Thurs. Rec'd call Fri PM stating lump the size of an egg. It was red and hot in center and raised. Wife applied cool compress and swelling went down somewhat. Follow up 1 week later, pt is fine & symptoms resolved.
At approximately 8PM I began to have significant chills. They lasted most of the night. By morning I knew I wasn't feeling well. I wan not hungry and as a result only had a cup of tomato soup with cracker that day. Later in the evening I had a cup of warm milk. Periodically I would have chills and muscle aches especially in my legs. I went to bed early and am much better today. I am also getting my appetite back.
Patient described 4 inch hard, hot, lump. And symptoms of fever. She was seen by physician who stated that she must have been sensitive to something in vaccine and her arm was infected. She was given antibiotics.
his right arm was hurting so badly; Neck pain; Lose of strength in arm; Collapsing of arm; can sometimes feel a pulse in his neck; very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly; pain from the injection site on the right arm up the shoulder blade and up to his neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm) and PULSE ABNORMAL (can sometimes feel a pulse in his neck) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm), PULSE ABNORMAL (can sometimes feel a pulse in his neck), MYALGIA (very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly) and VACCINATION SITE PAIN (pain from the injection site on the right arm up the shoulder blade and up to his neck). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form once a day and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form once a day. At the time of the report, PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm), MYALGIA (very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly) and VACCINATION SITE PAIN (pain from the injection site on the right arm up the shoulder blade and up to his neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medicines reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: On 21-May-2021, follow up document was received which contains information of both the doses. On 24-May-2021: On 24-may-2021, the reporter's HCP demographics was updated. Reporter demographics was added.
A few hrs after receiving vaccine, pt developed redness, tenderness, inflammation at injection site. Came to clinic the next day. Large red area that wrapped around the right arm 13cm in length. Treatment: BENADRYL, 7 days antibiotics.
Pt developed headache, fatigue and bilateral generalized lymphadenopathy, (cervical, axillary, and inguinal), that continues even 1 week after vaccination.
Heart fluttering; Chest pain when exercising 3 days after shot/ continued sporadic chest pain; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old female patient (pregnant: no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on 20Oct2021 (Batch/Lot Number: FF8841) as dose 1, single for covid-19 immunisation. Medical history included polycystic ovarian syndrome from an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; colecalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took erythromycin and experienced allergy. The patient experienced heart fluttering on 23Oct2021 at 14:00, chest pain when exercising 3 days after shot/ continued sporadic chest pain on 23Oct2021 at 14:00, heart palpitations on 23Oct2021 at 14:00. Reported Event: Sharp chest pain when exercising 3 days after shot, continued sporadic chest pain, heart palpitations and heart fluttering still continuing 10 days after initial AE. The adverse event resulted in emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
An LVN received a bottle of undiluted Pfizer Pedi COVID Vaccination in the morning from the RN.  When there were no more doses left after four doses were given, this was report to the RN.  There were no adverse reactions observed or reported in the patient observation area today.  This medication error was reported to me and immediately escalated to our director at 9:15am.  The nursing director advised us to contact the Infectious Disease Physician for next step.  Dr. advised contacting, Pedicatric Infectious Disease.  Dr. informed that four patients received 0.75mcg instead of 0.3mcg of Pedi Pfizer vaccination this morning.  Dr. kindly consulted:  1. No particular action to be done at this point except to contact the parents and make them aware to monitor for the same potential side effect (fever, headache, etc.).   2. Reassure parent/guardian that their child received a lower dose than a teen or adolescent would have received, even with this extra dose.   3. Patient is at higher risk for these reactions, but he is not particularly concerned from a vaccine standpoint.   4. If patient experiences any significant side effects, have physician evaluate.   5.  Continue with second dose as usual, unless strong reaction from this dose.
Pfizer use for COVID-19 under Emergency Use Authorization (EUA): After receiving her second dose of the vaccine, 40 year old female started experiencing very irregular menses. This patients has a history of regular menses to the exact day. After the vaccine her menses is weeks early or weeks late. No regularity at all.
I experienced immediate pain in the base of my throat when the shot was administered. I carry an epi pen for allergies and told my husband it was in my bag if I started having problem breathing.  I began to feel unwell after we left the pharmacy with a bad headache. The next day I had body aches, headache and sinus congestion.  It worsened over the next day and by Wednesday I had crushing fatigue, severe headache and a fever of 100.7 and body aches so badly I could barely get out of a chair.  I went back to bed at 2:30 pm and slept for hours. Thursday morning I used a home rapid test and it was Positive for Covid.  I had previously taken a home rapid test on Saturday, May 21 that was Negative.  I was not experiencing any symptoms of Covid. I had wanted to make sure I did not have Covid prior to getting the Booster.   When I went to the pharmacy for the Booster I felt perfectly well and had planned to go to dinner.  I felt so unwell after getting the Booster, we did not have dinner that evening.
After shot while driving to work I had tingling in my fingertips.  The next day I had pain at injection sight,  Pain in my elbow.  the following day I had numbness and pain in my inection arm hand and all fingers.  Now I have numbness in every finger but pinky and pain that has been bad enough to cause me to go to emergency room.  Also, I was bone tired for the first 3-weeks after the injection.
Pt presented with body rash and treated with Prednisone, 60mg x 3d, 40mg x 3d, and 20mg x3d.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-SEP-2016, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain herpes zoster. Later in 2016, she was treated at the same medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
PT RECIEVED VARICELLA VACCINTATION IN LLA. UPON RECIEVING INJECTION PT STARTED TO C/O ITCHING AT THE SITE. UPON INSPECTION THE PT APPEARED TO HAVE A SIGNIFICANT OF REDNESS AND SWELLING. PT STATED HE WAS NOT HAVING ANY DIFFICULTIES BREATHING OF AGITATION JUST ITCHING. PT WAS ASKED TO STAY AT CLINIC FOR OBSERVATION. AFTER PERIODIC EVALUATION OF PT REDNESS AND SWELLING WERE SUBSIDING, PT HAD NO C/O OF DIFFICULTY BREATHING. PT FATHER WAS ADVISED TO GIVE THE PT SOME BENADRYL AND WATCH IT CLOSELY, HE WAS ALSO GIVEN A PHONE NUMBER IF HE NEEDED ANYTHING. BEFOR LEAVING THE CLINIC THE PT REDNESS HAD DECREASED TO A QUARTER SIZE SPOT AT THE INJECTION SITE WITH NO FURTHER SWELLING OR C/O ITHCING. PT FATHER WS PHONED AFTER RETURNING TO CLINIC AT 5:30 PM, HE STATED THAT THE PT WAS NO LONGER HAVING ANY PROBLEMS WITH THE SITE OF DIFFICULTY BREATHING.
his rash got worse and spread to other spots/other areas of his body; This case was reported by a consumer and described the occurrence of rash aggravated in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, 1 day after receiving Shingrix, the patient experienced rash aggravated. The patient was treated with prednisone. On an unknown date, the outcome of the rash aggravated was not recovered/not resolved.   It was unknown if the reporter considered the rash aggravated to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient was at his doctor's office that day being seen for a rash on his waist that he thought was poison ivy. The rash was in just one spot. The doctor advised him to use an over-the-counter cream. The patient asked if he could get the Shingrix shot that day The doctor agreed to give him the shot in left deltoid. The next day patients rash was worse and spread to other spots and other area of body after administration of shingrix vaccine. The doctor prescribed him prednisone 5 mg tab. He was instructed to take 40 mg 8 tablets the first day, 30 mg 6 tablets then second day. The patient was on prednisone taper for about 7 to days. The doctor told him he could discontinue the prednisone if his rash resolves. Did not consent to follow-up.
Narrative: Patient is 65 yo m with h/o dm, htn, cad, a fib, adhd, anxiety. Patient had received covid vaccines outside facility on 2/18/21 & 3/18/21. Pt died on 6/14/2021. No facility notes entered since 4/7/21. No information on circumstances of pt's death. Not able to assess if covid vaccines related to pt's death. Likely not related given death was >60 days post last covid vaccine.
patient tested positive for COVID-19 8/8/2021 and was seen in the Emergency Department
pt recv vax 1991 & p/2nd dose of vax in late afternoon, pt exp hives, resp distress, fever & slough over the inj site 5AM;in 1997 la eval indicated titer was non-detectable;on f/u MD unable to confirm second hand info of anaphylactoid rxn;