chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 06-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011661:
Immediate LOC, headache, nausea, emesis after injection. Also received Tdap and typhoid on same day. Headache and nausea persisted x 5 days. Did not receive subsequent anthrax vaccination. Had nausea and headache with two previous anthrax vaccines.
24 hours, (L) leg swollen. Thigh to knee. No acute redness. Facial hives, resolving. No fever.
This is a spontaneous report from a contactable Nurse via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme arm pain immediately after dose was given.
Received Pfizer Booster shot on Monday apprx 5:30pm and woke up Wednesday morning at 9am  with an itchy rash on upper chest,  back, shoulder.
site of both inj started to itch;almost immed;by that noc both sites reddened, hot, painful, indurated;both arms more painful & warmer the next day;By Sunday itchy;16OCT flu site remains obviously darkened than surrounding site;
6cm x 6cm raised, red, warm to touch area on right upper thigh.  Started in AM on 03/03/2005, per mother.  Patient afebrile at time of visit on 03/03/2005.
Pt states he was "hurting" became pale, rolles off, random jerking of all extremities lasted < 2min. No fever prior/after. Resolved having normal behavior afternoon.
15-jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273    Laboratory details was not provided.   treatment information was provided Benadryl, Medrol dose park, Zofran.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are unknown  The reporter assessed the event(s), nauseous, throwing up for 48 hours, fever in arm she received the vaccine in, rash going down the arm, hives going across her back , arm on fire, red and fever as  related to study drug.
down to wrist was really hot; swelled, but just a little puffy; administered too high on shoulder; hurting and pain across back; pain on back of shoulder, deep, felt like a toothache; A spontaneous report was received from a consumer concerning a 65 Years-old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced administered too high on shoulder(Product administered at inappropriate site), hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), down to wrist was really hot(Feeling hot), deep pounding sensation in the middle of back(Musculoskeletal discomfort), swelled, but just a little puffy(Injection site swelling), nervous wreck(Nervousness).    The patient's medical history was not provided. concomitant medication includes Advil.    02-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  02-Feb-2021, The patient feels vaccine may have been administered too high on shoulder(Product administered at inappropriate site) and also experienced events of hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), down to wrist was really hot(Feeling hot), deep pounding sensation in the middle of back(Musculoskeletal discomfort), swelled, but just a little puffy(Injection site swelling), nervous wreck(Nervousness). No Laboratory details provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events down to wrist was really hot(Feeling hot), swelled, but just a little puffy(Injection site swelling) is resolved and the outcome for hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), deep pounding sensation in the middle of back(Musculoskeletal discomfort), nervous wreck(Nervousness) is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of back pain, arthralgia, feeling hot and vaccination site swelling, a causal relationship cannot be excluded. The event of product administered at inappropriate site is assessed to be not applicable.
pt recvd vax & w/in 24hrs p/vax exp vomiting, diarrhea w/blood, & fever;seen by MD & placed on Cipro & Lomotil on 26JUL95;vomiting & fever resolved;diarrhea w/blood continues
10/29/2021 1:13 PM: pt called and said her injection site has a hard lump, it's painful and lymph nodes under that arm are inflamed. Same thing happened with first 2 doses.Fever off and on...feels like a "truck" hit her. (Not as high as with first dose it was 102... this time it's been 100)
p/vax pt noticed redness & soreness 10/31/99;pt w/redness & warmth measuring 2 1/2 x 1 1/2;
Fever - 101.2, ached all over, hallucinating, disoriented, even hair hurt. Shot at 11am - dizzy by 5:00pm. Lasted about 24 hours.
Moderna on 4/7 and 5/18. Positive on 8/11 admitted 8/10-current
Pt developed redness and bruising to left bicep muscle and surrounding area around 8:00pm the day after vaccination. Significant swelling noted to the area. Pt also developed a high fever of approximately 102 degrees around 9:00pm. Next day patient was seen in our office, fever resolved. Pt was given a 5 day course of Cephalexin 500mg Cap to take Q12hr for cellulitis.
Information has been received from a registered nurse concerning a 24 year old female student with allergy to penicillin who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # 658222/0927U and expire date not reported), 0.5 ml. intramuscularly in the left deltoid. Registered nurse stated that on 12-AUG-2007, the patient complained of swelling at GARDASIL injection site that was the size of a 50 cent, red and warm area. Registered nurse mentioned that GARDASIL injection appeared to be given in correct site so, they discontinued the GARDASIL series and said that the patient was allergic to GARDASIL, reported as "allergic urticaria". Registered nurse added that patient's had good mobility in her arm and that the injection site was clean. At the time of the report, the patient recovered. It was unknown if the patient sought medical attention. Additional information is not expected.
Registered Nurse  Progress Notes    Signed Encounter Date:  2/17/2021     Signed        Hide copied text  Hover for details Pt reports rash to arms, legs, and back with itching after first Pfizer vaccine, lasting 2 weeks. Pt took Benedryl BID for relief. Pt states, "I have an appointment with my dermatologist tomorrow to get advice on a potential response." Pt refuses a 30 minute wait. He wants to leave after 15 minutes.    Electronically signed by RN at 2/17/2021  3:25 PM
Elbow and wrist hurt; Could not lift anything up with his left arm; Was on light duty at work; Fingertips were burning; Fingertips were numb; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Elbow and wrist hurt), MOBILITY DECREASED (Could not lift anything up with his left arm), IMPAIRED WORK ABILITY (Was on light duty at work), BURNING SENSATION (Fingertips were burning) and HYPOAESTHESIA (Fingertips were numb) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Testicular cancer (Left testes was removed) from 1998 to 1999 and Pneumonectomy (Had a black spot, because of cancer) on 04-May-2020. Concurrent medical conditions included Knee swelling (Got hurt years ago and was still swollen).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Elbow and wrist hurt) and MOBILITY DECREASED (Could not lift anything up with his left arm). In March 2021, the patient experienced IMPAIRED WORK ABILITY (Was on light duty at work), BURNING SENSATION (Fingertips were burning) and HYPOAESTHESIA (Fingertips were numb). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. In March 2021, BURNING SENSATION (Fingertips were burning) and HYPOAESTHESIA (Fingertips were numb) had resolved. At the time of the report, PAIN IN EXTREMITY (Elbow and wrist hurt) had not resolved and MOBILITY DECREASED (Could not lift anything up with his left arm) and IMPAIRED WORK ABILITY (Was on light duty at work) outcome was unknown.            No concomitant medication information was provided.   This case was linked to MOD-2021-288150 (Patient Link).
pt recvd vax;redness,swelling & pain in lt arm;rash like sxs;swelling down to elbow; pain down lt arm to wrist;advil given;
He received his first dose at a different location. He did not speak English. His first dose was Moderna. His second dose was Pfizer.
Eve of injection site red swollen from deltoid down to past elbow - not able to move arm - headache, fatigue. On 12/17 seen in clinic still swelling & redness. Able to move arm - pt afebrile swelling redness receding.
lt arm swelling, redness @ site of inj & entire upper noted on 16OCT98 per pt;fever 102 48hr, weakness, malaise noted on 16OCT98 12noon per pt;advised to take Ibuprofen
After the second shot October 8th, my colon stop functioning for 2 weeks ending up in the hospital ER from severe constipation, pain,  cramping, and blood in stool from straining to have bowel movement for several hours.   I've had to use MiraLax everyday ever since to keep bowel moving along.
Initial report received from a healthcare professional on 08 October 2013. A female patient whose birthdate and age at the time of event, medical history and concomitant medication were not reported, had received a dose of FLUZONE HD vaccine (lot number: U4764AA, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed topical bruising and localized discoloration. Bruise was on the shoulder then traveled to elbow area. At the time of this report, the bruise was only at the elbow. Laboratory investigations and corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None. Follow-up information received on 20 January 2014. The patient received FLUZONE HD vaccine on 13 September 2013. On 08 October 2013, the patient developed topical bruising and localized discoloration.
Patient received second dose of covid vaccine within 5 minutes of injection developed anaphylaxis reaction, 2 doses of epinephrine was administered on site. EMS was called and patient was transported to local emergency department for treatment.
Customer called pharmacy on 2-13-18 reporting muscle pain at injection site that started 1 or 2 days after administration of vaccine.
Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: I am on the lowest dose of an ace inhibitor which has managed my blood pressure for the last 3 years. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional Information: Reporter stated, "I am not comfortable using the form you sent to add personally identifiable information under your stated confidentiality policy. However, I will try to provide information about my situation in an effort to help with reporting possible adverse events. I am a female and have not had COVID. I had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches, tiredness), I had no other symptoms. At the end of Sep, I received the Moderna bivalent booster. Seven days later, my symptoms started. I began having severe visual auras, sight disturbances and dizziness. After consultation with my primary care provider, I had a thorough exam from my ophthalmologist who indicated that there were no changes to my eyes. My doctor then ordered an MRI of my brain. Unfortunately, it was not scheduled until early Dec. I was surprised to learn that I had several subacute ischemic strokes, probably in mid Oct or early Nov. Prior to this, I had no symptoms. I am on the lowest dose of an ace inhibitor which has managed my blood pressure for the last 3 years. My primary care doctor ordered several additional MRI tests, multiple ultrasounds, a heart monitor, EKG, and echocardiogram. All results indicated that I am healthy. At this point, I saw that Pfizer was found to have an increased stroke risk for adults over 65, Since I had kept a diary of my symptoms, I went back and realized that all my symptoms were the most intense in the 3 weeks following my Moderna booster. Since we have ruled out almost everything else, I wanted to report my adverse event in the hope that it will further your research."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-202300067341 same patient/event, different vaccine dose number; PFIZER INC-202300067342 same patient/event, different vaccine dose number; PFIZER INC-202300067343 same patient/event, different vaccine dose number;
At injection site, swollen, red, and feverish. Patient went to the doctor and was diagnosed with cellulitis. Patient received antibiotic treatment and now better.
rush all over their body that has increasingly gotten worse through out the days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rush all over their body that has increasingly gotten worse through out the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Oct-2020. Concurrent medical conditions included Hypertension and Bipolar disorder. Concomitant products included VENLAFAXINE, TRAZODONE and LAMOTRIGINE for an unknown indication.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced RASH (rush all over their body that has increasingly gotten worse through out the days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (rush all over their body that has increasingly gotten worse through out the days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medication include topical creams.
Itchy rash at injection site. Two days after the vaccine. Went away in 8 days.
34 4/7 wks pregnant at time of vaccine on Lovenox.  Delivery exactly 3 weeks post vaccine. Superficial thrombophlebitis starting within 48 hours from vaccine injection and continue multiple times up until and including a few days post delivery in multiple locations.  Rashes starting immediately post delivery in various locations for approximately 3-4 weeks.  Significant back pain starting approximately 1-2 weeks post partum followed by joint pain in almost all joints minus the hips/feet/ankles.  No previous history of arthritis.
Information has been received from a physician concerning a 15 year old female who on 02-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently, the patient fainted after the administration. The patient did not sustain any injuries. The patient sought medical attention in the office. At the time of the report the patient had recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008 Inital and follow up information has been received from a physician and a health professional concerning a 15 year old femaile who on 02-JUN-2008 at 4:50 PM was vaccinated IM with scond dose of GARDASIL (Lot #660553/0070X) in the left deltoid. There was no concomitant medication.After vaccination at 5:10PM, the patient left the office and had a syncopal event at a pharmacy. The patient required medical attention in the office. On 02-JUN-2008, the patient had recovered. Additional information is not expected.
COVID-19 arm, rash, redness, itchiness at injection site. Fever x 3 days.
global headache, myalgia, and fatigue ongoing for weeks following vaccinations.  continuing to experience headaches, which were never an issue before. no tx other than OTC pain management
I woke up thinking I had a bad cramp on left side, above the heart.  Didn't go away!  Called on call Dr,  was told I had costochondritis.   No reason could be found.  Two weeks later, saw my Dr.  Again, no reason found.  Just happens is the basic thought. For me, I would like to add, when I received  the shot, I felt I HAD TO BE IN RAPPORT  with everyone...my husband  made the appointment  for the shot.  I felt "out of choice, no self governance " over my body.  I had wanted to wait, until I  was ready, perhaps  another week or two.  Being in rapport  hurts the connective tissue.   I betrayed  myself.   I cannot blame the vaccine,  only myself  for not listening  and waiting  until I felt 100% capable  of handling  the vaccine  within my body.  13 hours after I had the vaccine,  I became  ill.  My bowels also have been slow to regain  their true rhythm.   Again I blame me for rejecting  the vaccine!!!!  I am only reporting  this, because  I believe  a study about connective tissue and rapport, along with the willingness  of someone to receive  the vaccine  would be interesting  for someone  to study.  I ache, still, from the costochondritis.  I take that ache as a reminder,  and my responsibility  to be more at peace with my choices.   Thank you  for listening,  feels good to express  myself.
Red slightly itchy hives developed  by the next day. Timing not 100% certain but seems to be >4 hours from receiving vaccine. No fever or pain.
Diarrhea, nausea, chills, fever, headache. Began this morning.
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home.  Tuesday and today (Wednesday) I have felt very tired and fatigued.
Developed a fever 6 hours after vaccine administered, had chills, muscle aches, and severe headache, around 10 hours after vaccine, fever peaked at 101.4 then subsided, about 12 hours after shot woke up in night with cramping in my feet, severe headache continued 18 hrs after vaccine and took two Tylenol, headache subsided and went away, fever was reduced to below 99 degrees about 16 hrs after vaccine.  After 24hrs from vaccine all symptoms were gone and has not return to date.
Information has been received from a health professional concerning a 13 month old male who on approximately 27 Mar 2006 was vaccinated with a dose of Varivax (lot#652663/1032R). On 10 Apr 2006, approximately 2 weeks post vaccination, the patient developed chicken pox with a head to toe rash. The rash was described as itchy and uncomfortable. He was not hospitalized but treated with supportive measures by the physician. The patient's current status was unknown. There was no product quality complaint involved. Additional information has been requested.
DIZZINESS, COLOR PALLOR, BRIGHT RED SPLOCTHY SKIN . SATS WERE 97 %, PULSE 112. GAVE ICE PACKS TO BACK OF NECK.AND LOLLIPOP TO EAT. 20 MINUTES AFTER INJECTION PATIENT WAS WALKING ON HIS OWN, COLOR RETURNING TO SKIN AND NOW MORE WHITE AND PINK. MOTHER AND FATHER PRESENT, STATED "HE'S MORE LIKE HIMSELF NOW". PATIENT LEFT 30 MINUTES AFTER INJECTION WITH NO PROBLEMS. ADVISED FOLLOW WITH PEDIATRICIAN REGARDING SECOND DOSE.
He had maybe some slight fatigue, muscle soreness the first few days after both shots; He had maybe some slight fatigue, muscle soreness the first few days after both shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0171) as dose 1, single and administered in arm left, administration date 17May2021 (Lot number: EW0183) as dose 2, single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing). Concomitant medication(s) included: METHOCARBAMOL taken for muscle relaxant therapy; FLU. The following information was reported: FATIGUE (non-serious), MYALGIA (non-serious) all with onset Apr2021, outcome "recovered" (2021) and all described as "He had maybe some slight fatigue, muscle soreness the first few days after both shots".  No follow-up attempts are possible. No further information is expected.  Follow-up (06Jan2022): Follow-up attempts completed. No further information expected.
pt slept about 4hr more than normally does & mom states was acting strange & not responding;when seen in office looked fine was talking, smiling;T98 & dextrostix 110;