chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lightheadedness, tongue felt funny, neck  was sore, very thirsty, flush  pt was given 5 ml of benadryl (12.5mg/5ml) as a one time dose. Emergency responders  was called to tend to the pt pt 's husband was called and she went home with him I spoke to the pt at 6:45 pm today and she was much better, just drowsy from the benadryl
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On 08-NOV-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T017179 was confirmed to be valid, expiration date 26-OCT-2021 for prophylaxis (exact dose, dose #, route and anatomical location were not provided).
About 30 minutes after the administration of the vaccine, his case manager came to ask for assistance because the client was feeling unsteady and his speech seemed slower than it normally is.  She was worried about an allergic reaction.  He did seem a little shaky.  They had him sit on a bench outside for fresh air.  He said this was helping.  I took his radial HR.  It was regular, 70 bpm.  I was unable to get his blood pressure due to a broken cuff.  He was feeling much better at that point.  He did eat breakfast.  He said his arm felt fine.  No rash or hives observed and no shortness of breath.   His case worker brought him some water.  We sat there for about 15 minutes.  He felt much better and the case worker said he seemed back to 'normal'.
pt recv vax & devel a rash w/severe generalized redness, swelling, & fever; MD felt that there was a problem w/the particular lot;
Achy arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Achy arm) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced PAIN IN EXTREMITY (Achy arm). At the time of the report, PAIN IN EXTREMITY (Achy arm) outcome was unknown.            No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658776, US-MODERNATX, INC.-MOD-2022-658814; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658776:wife (second booster dose) US-MODERNATX, INC.-MOD-2022-658814:Wife (1,2. 1st booster)
Patient received flu shot at pharmacy. Came in 3 days later w/redness, swelling, pain around injection site.
After second dose developed hives over head which lasted 4 days; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (After second dose developed hives over head which lasted 4 days) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN (AVAPRO), APIXABAN (ELIQUIS), METOPROLOL, SPIRONOLACTONE and DILTIAZEM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (After second dose developed hives over head which lasted 4 days). In March 2021, URTICARIA (After second dose developed hives over head which lasted 4 days) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-416128 (Patient Link).
LEFT ARM FELT HEAVY AND HARD TO LIFT ARM WITHOUT FELLING PAIN; NAUSEOUS; SORE ARM ON THE SITE OF INJECTION/PAIN IN ARM WHEN LIFTING; LOW FEVER; WEIRD TASTE IN MOUTH; CHILLS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On 09-SEP-2021, the patient experienced weird taste in mouth. On 09-SEP-2021, the patient experienced chills. On 09-SEP-2021, the patient experienced sore arm on the site of injection/pain in arm when lifting. On 09-SEP-2021, the patient experienced low fever. On 10-SEP-2021, the patient experienced nauseous. On 10-OCT-2021, the patient experienced left arm felt heavy and hard to lift arm without felling pain. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth on 12-SEP-2021, chills, low fever, and nauseous on 10-SEP-2021, and sore arm on the site of injection/pain in arm when lifting on SEP-2021, and was recovering from left arm felt heavy and hard to lift arm without felling pain. This report was non-serious.
Information has been received from a physician concerning a 14 year old male who on 16-JUL-1997 was vaccinated with a first dose of MMR II.  On 05-OCT-2000, the patient was vaccinated with a second dose of MMR II (route, site and lots number were not reported).  On 17-NOV-2009 the patient experienced right parotitis.  The patient was afebrile.  On 27-NOV-2009, lab tests revealed: IgM less than 1:10, IgG 7.3, and serum amylase 137.  On 14-JAN-2010 the patient was diagnosed with mumps.  Follow up information was received from the physician reporting that the patient was 13 years old.  On 14-JAN-2010, the patient experienced right parotitis.  On 14-JAN-2010, lab tests revealed: IgM 0.26, IgG 2.8, and serum amylase 68.  On 12-JAN-2010 the patient was diagnosed with mumps.  The outcome for mumps was not reported.  This is one of several reports from the same source.  No further information is available.
i started with a rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 1st dose of Shingrix. On 9th January 2020, 30 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash. The reporter trying to determine what the rash may be coming from. The reporter wanted to know how long after the first shingles shot would side effects show up.
Myalgia; Fever (Highest: 100F); Chills; Injection site pain; Headache; This is a spontaneous report from a contactable pharmacist, the patient. A 34-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and Concomitant medications included Cetirizine (MANUFACTURER UNKNOWN) 10 mg once daily for an unspecified indication on an unknown date. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on 04Mar2021, as single dose for COVID-19 immunisation. On 23Mar2021 at 15:00, the patient experienced fever (highest: 100F), chills, myalgia, injection site pain, headache. The patient received acetaminophen as treatment for the reported events. The patient events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever (highest: 100F), chills, myalgia, injection site pain, headache was recovered on an unknown date at the time of this report.   No follow-up attempts are needed. No further information is expected.
About thirty minutes after receiving my first dose, the left side of my face started to feel numb. I received my dose on a Friday and by Tuesday, it was still numb. At the doctors office, he referred me for an MRI. I was also referred to a neurologist at the local pain clinic on 04/28. They went over my results with me and told me that if anything else happens or becomes worse to come back. The numbness in my face lasted mostly over the weekend after receiving my vaccine, but it took a few months to where it started to finally fell "normal." I still have moments where my face feels funny, but it doesn't last long.
Chills, Headache, Dizziness, Nausea, Body aches, Fever.
Received vaccine 8/22/02. On 8/23, 102 axillary. Couldn't get down post meds given. To ER. Treated with Tylenol-decrease 102.4 sent home 8/24/02-decrease urination, lifeless-"wouldn't respond", received IV therapy, test. had seizure in care before getting to hospital. Released with diagnosis. To see MD advised. 8/26/02-mom noticed top of scalp retraction. Went to children's outpatient-told "didn't know what was wrong," "wasn't dehydrated." Again advised to watch and f/u with private MD. 2 days later retraction appeared worsening-talked with MD's staff and advised to go to ER. MD at ER acknowledge retraction, CXR only told didn't know-see MD within 2 wks. 4 days later saw MD problem resolved. MD not concerned. NO further f/u advised. Per mm everything same as before. No effects noticed.
I have chronic afib but have not had an episode in several years.  My pulse is usually around 100.  Within hours of receiving the vaccine, my fingertips went cold and the pulse/ox gave me a pulse of 122.  This continued for several hours and restarted again the next day.  As of this writing,1600 MT 2/1/21, the effect is not noticeable.  Injection site pain is still noticeable 2 days post-injection.
Patient accidentally received PENTACEL instead of their TDap vaccine in the office with no adverse event; 43 year old patient accidentally received PENTACEL instead of their TDap vaccine, with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a physician and consumer/ non-healthcare professional via Media Information (under reference 00796958).  This case involves a 43 years old female patient who accidentally received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] instead of their DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE in the office (wrong product administered and product administered to patient of inappropriate age).  Patient did not receive other concomitant vaccines.  The patient's medical history, past medical treatment(s), past vaccination (s) and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 mL dose of suspect PENTACEL (VERO) (Total, lot UJ440AA and expiration date: 29-May-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration (same day latency).  It was reported "Doctor states that a 43 year old patient accidentally received PENTACEL instead of their TDap vaccine in the office on 04OCT2021 and asked for recommendations on how to proceed. Doctor states that she could not find any information online other than for children that inadvertently received the vaccine. Doctor states that no Adverse Events have occurred and that they will continue to monitor the patient."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pt has a red discoloration over her right bicep.  Area was swollen, warm to the touch, and the skin felt slightly tighter than non-affected areas, which pt said developed around 10pm on 9/15/10.  Recommended taking Ibuprofen on a regular basis (pt had an Rx for 800mg, recommended using this), and to seek medical help if unresolved after 3-5 days or if area or symptoms worsen.
vaccine administered at 1040. 30 minutes of observation occurred. At 1126, patient returned to clinic reporting dizziness, and generalized redness on her body. Vital signs taken- temp 99.2, HR 108, O2 96%, BP 192/96, RR 18. First Responder called. Pt offered water and reported her throat was closing. Epipen was administered. VS after Epi 96% on 2L O2, HR 117, BP 192/101. Pt reported lips starting swell (not observed by RN). First Responder team arrived. Report given. First Response team transported patient to the ED for further evaluation.
This spontaneous report as received from a pediatrician, participating in market research, refers to a male pre-adolescent patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. Pediatrician reported that the patient suffered "dizziness" and "faintness" immediately after receiving first in a series of three injections of GARDASIL vaccine. Patient recovered quickly and suffered no reactions to the subsequent injections in the GARDASIL series. Therapy with GARDASIL was continued. The relationship between "dizziness" and "faintness" and GARDASIL was not reported. No diagnostic tests were performed. Additional information is not expected.
Pt started feeling sick 48 hrs after injection. She spent 2 days in bed with achy body and general malaise. She continues to have profound fatigue, body aches, weakness. But is improving, slowly, leg muscles are weak. She has difficulty getting up from chair. No respiratory issues.
I had a fever for about 12 hours that was staying around 102-103. I was extremely achy and had a migraine. Then I contracted Covid. I had lots of lower back achiness that as persistent for about 24 hours. I started developing a sore throat and runny nose. No more fevers. I did an at home Covid test and it came out positive.
Patient experienced shivering, fever,upset stomach, nausea and diarrhea which resolve after resting. No medication used.
Throat started to tighten about 10 minutes after shot. 50mg of Benadryl helped stop it. About 20 hours later, throat tightened again. Benadryl did not help and tongue started to swell. Called doctor and he prescribed Pepcid and Medtral dose pack. Throat still not 100 percent at time of report filing, but it is better than it is much better than before.  Vaccine also caused severe nausea and upset stomach.
Sore arm/arm feels like its broken; Numb spots; Radiating pain all the way down to my fingers; I can't lift, I can't let my arm hang like normal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/arm feels like its broken), HYPOAESTHESIA (Numb spots), PAIN (Radiating pain all the way down to my fingers) and INJECTED LIMB MOBILITY DECREASED (I can't lift, I can't let my arm hang like normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm/arm feels like its broken), HYPOAESTHESIA (Numb spots), PAIN (Radiating pain all the way down to my fingers) and INJECTED LIMB MOBILITY DECREASED (I can't lift, I can't let my arm hang like normal). At the time of the report, PAIN IN EXTREMITY (Sore arm/arm feels like its broken), HYPOAESTHESIA (Numb spots), PAIN (Radiating pain all the way down to my fingers) and INJECTED LIMB MOBILITY DECREASED (I can't lift, I can't let my arm hang like normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.  Patient's second dose of the vaccine was scheduled on 21-Apr-2021.
his arm also hurt/pain in my arm; couldn't sleep enough/could not sleep well; felt more and more ill; whole body hurts/body hurts; chills; very tired; his head hurts too; This is a spontaneous report from a non-contactable consumer reported for the patient (brother) via medical information team. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that yesterday the patient got the vaccine around 10:00, was fine, but moved his arm and it hurt a lot, couldn't sleep enough because of the pain in arm, today went out for a walk but felt more and more ill, came back and whole-body hurts, have chills, very tired and head hurts a little on 10Mar2021. Experienced pain before, but it accentuated. The patient inquired what can he taken as a treatment and what should he do. His body temperature is 97.7 ° F. His brother considers taking Ibuprofen to relieve symptoms. The reporter inquires if the patient can take Ibuprofen to relieve the symptoms experienced. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
I received the Guardasil shot series over the course of 6 months. After the first shot given in  May, I was nauseous and vomited. I also developed severe facial acne that I'm still experiencing, two weeks after the first shot.  I don't remember any problems after the second shot in August. Severe symptoms started on the evening the third shot was administered December 14, 2009. I had constant tingling in my right limbs (arm, all the way down to the tips of my fingers, and leg, from the knee down to the foot): the shot was given in my right arm. I was still able to walk and use my arm. It was not a sharp pain, just constant. By Thursday, Dec. 17 at 4 A.M., the tingling was prevalent in all my limbs and my feet felt numb. I went to the emergency room on Thursday, Dec. 17, 3 days after the shot as the tingling was worse and not subsiding. They ran a CT scan to rule out shunt problems since I have a VP shunt.  All was fine with the shunt. On Friday Dec. 18, I went to another emergency room so I could be evaluated by a neurologist. He ran reflex tests and everything was working well.  He diagnosed neuropathy and said he thought it would eventually subside.  That night I experienced swimming vision for a few minutes and a headache. I had trouble sleeping each night, unable to get comfortable in bed; the tingling seemed to be worse when lying down. The next day I felt dizzy, had an intermittent headache, and experienced vision problems if there were bright lights.  By Sunday, the symptoms became less severe and over the course of the next week, diminished completely.
INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients.  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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced inappropriate dose of vaccine administered. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Not received his second dose; Rash/Rash on his arm, leg, and back; bad reaction on arm/rash; Itchy; Blisters/"big bubbles with fluid in them"; Bad reaction on the arm where he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), INTENTIONAL DOSE OMISSION (Not received his second dose), VACCINATION SITE PRURITUS (Itchy) and RASH (Rash/Rash on his arm, leg, and back) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (bad reaction on arm/rash). On 12-May-2021, the patient experienced RASH (Rash/Rash on his arm, leg, and back). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not received his second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), VACCINATION SITE PRURITUS (Itchy), RASH (Rash/Rash on his arm, leg, and back) and VACCINATION SITE RASH (bad reaction on arm/rash) outcome was unknown and INTENTIONAL DOSE OMISSION (Not received his second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment for the event included antibiotic cream.
FLARE OF POISON IVY RASH, ABOUT 2 WEEKS AFTER VACCINATION; This spontaneous report received from a health care professional concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's past medical history included: pituitary tumor, and concurrent conditions included: poison ivy rash. The patient was previously treated with methylprednisolone for poison ivy rash.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-AUG-2021, the patient experienced flare of poison ivy rash, about 2 weeks after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare of poison ivy rash, about 2 weeks after vaccination. This report was non-serious.