chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955) at the age of 57 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ORAL HERPES (non-serious) with onset 17Mar2021, outcome "recovered" (19Mar2021), described as "Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: Facility type vaccine. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. Known allergies was reported as No.
No additional AE; patient was administered VAXNEUVANCE and ROTATEQ after they experienced a supported temperature excursion; This spontaneous report was received from a medical assistant and refers to a 7-month-old male patient  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with improperly stored doses (Product storage error) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, pre-filled syringe, 0.5 ml, lot # reported and confirmed as: X004289, expiration date reported and confirmed as: 10-DEC-2024 (site and route of administration were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot # reported and confirmed as: W036404, expiration date reported and confirmed as: 24-APR-2024, administered orally. Both vaccines were administered for prophylaxis. Temperature excursion information: 11.2 degree Celsius for 2 hours 36 minutes; no previous temperature excursion. There were no side effects reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA003962:02447222 US-009507513-2308USA004183:02447220 US-009507513-2308USA004087:02447221
Patient was accidently given 0.2 mL of adult Prizer 30 MCG/0.3 mL instead of Pfizer 10 MCG/0.2 mL. There have been no known adverse events reported, or treatments needed that facility is aware of.
Report received from a clinic nurse regarding a 41 year old male who experienced injection site induration with pain, swelling and warmth. On 28JUN2013, the male received his fifth dose of BioThrax intramuscularly. On 27July2013 (greater than 24 hours after injection), he called the clinic to report a finger width size bump around the area of the shot accompanied by pain, warmth and swelling. He denied the symptoms with previous injections. At the time of report, the outcome was unknown. Further information was requested but not received.
Patient had syncope (BP 100/59 -- > 97/63), flushing/sweating, dizziness, nausea. Stable -- released from vaccination site.
Dose given at 1:43pm. Symptoms started around 1:50pm. Symptoms include arm numbness and chest pressure. Pulse ox: 98 Bp: 168/95  Heart rate: 89 Pain: 8 of 10 chest pain moving to left Arm  Pt reports numbness in the left arm all the way to shoulder & in the right arm numb to elbow. Pt states having breathing problems. Gave pt oxygen. Pt reports pain with inhalation and exhalation. Pmh: diabetes, no cardiac hx, thyroid problem  Per pt, took medications today, ate quesadilla for breakfast, & was feeling good before vaccine administration. Pt has never felt these type of symptoms. No fever, no cough Medications per pt: glipizide, synthroid Recommended to go to the hospital; sounds like anxiety but pt wants to go to the hospital.  Pt feels tightness of throat, but o2 is sat is 99@2:02 Pt was very nervous and didn't want to get the vaccine. Her legs are numb/falling asleep 2:05pm Nauseous at 2:08pm but dry heaving, no actual vomit   911 called at 2:10pm. Chest pain @ 2:11pm is 8 out of 10 and numbness is still present in hands and feet, per pt. o2: 99 and pulse: 87 at 2:13pm Temp: 36.0 BG 8am  before breakfast: 118 Ambulance arrived @ 2:19pm and transported pt to hospital
Severe pain of upper arm that over a period of 24 hours had move to the shoulder and elbow area.  Unable to move arm.  Vomiting, diarrhea.  Used Hydrocodone for pain.  Aleve and Tylenol didn't help a bit.  Using Hydrocodone only helped slightly with the pain.  I was in absolute agony.
Scheduled a Patient appointment for unilateral tinnitus (several month tinnitus). He seemed to know what was happening and I mentioned to him that a week prior a food item sensitized my mouth and slackened my neck muscles. When mentioning a soar throat, he prescribed Cephlaxin. An early dose (several doses) of Cephlaxin Immediately numbed my mouth and a unilateral facial palsy the next morning occurred, requiring and EM visit([s] - several during subsequent months) (prescribed prednisone when dissolved in water became a fabricy diaper-material-like substance that darks within several days). PT, and other associated issues. During a subsequent appointment within several days a staff and a nurse of that same group administered a dTd vaccine. Since, that arm has felt cold and that sensation of coldness feels as if it has traveled to other parts of the same side of body (leg, chest, neck) and eventually other side. Since, shoulder has become crackly, trap muscles friable, and mucous membranes feel like they're dry (this sensation was limited to mouth are after food ingestion). Currently, there's a feeling that whatever residue that was within mouth traveled down sternum.
Vomiting at 11:00PM then again after taking a sip of water at 1:00AM on 10/30/2013. Complained her "tummy hurt." Also complaining of leg pain where injection was given and refused to move her leg.
pt recvd vax 230PM; 6PM devel red, sl raised rash on head, neck & face which lasted 1 1/2 hrs; also @ same time noticed burning rt arm; inject site of vax;
pt noticed a large wheal on rt deltoid so came into the office to have it checked out;
Onset of fatigue and muscle pain within 12 hours of injection. Elevated temp to 100.0 degrees within 30 hours, lasting a total of 6 hrs. Increased fatigue overall after 12 hours. Required a day off work due to extent of symptoms.
Pressure from neck to hip area; Vertigo; Body pain (stomach, chest, back) for 48 hours; Body pain (stomach, chest, back) for 48 hours; Body pain (stomach, chest, back) for 48 hours; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours) and BACK PAIN (Body pain (stomach, chest, back) for 48 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours), BACK PAIN (Body pain (stomach, chest, back) for 48 hours), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours), BACK PAIN (Body pain (stomach, chest, back) for 48 hours), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Fever to 101, large erythema at vaccine site with single vesicle and pain to touch. Erythema measuring 10x8 inches.
Pt vaccinated with MMR c/o pain in the joints of his lt hand & wrist & pain at the site of injection. c/o occipital headache, pain in his lt knee (transient), paresthesias of the skin of his lt forearm. Physical exam-normal.
Was given Pfizer Bivalent Vaccine and should have been given #2 Pfizer Monovalent vaccine
Pt recv vax on 9/7/95; on 4/3/99 pt exp 40 lesions on trunk, scalp, face, groin, palms of hands, buttocks
unresponsiveness, irritability w/fever 3 episodes 4 days post vax; EEG nl;
(Hep A and MENACTRA) Tdap 8/407. Head ache /st over time developed fatigue (sleep up to whole day) and headache (1st concerning Reaction). (2nd reaction) After Hep A on 10/29/08 HA started that he did not have at time of apt and vaccine for pain and HA. Seen 10/31/08.
Patient received Td vaccine appoximately 3:30 - 3:45pm 09-23-03 @ health department site without incident. Mother described event as follows: Patient took (1) Ibuprofen at work apporximately 4pm (09-23-03)to help decrease possibility of fever and/or pain.  Repeated dose at 8pm.  Arrived home from work approximately 10:30pm with compaints of neck & back hurting and tempature of 103 F.  Took (2)Ibuprofen apprpoximately midnight.  Did not sleep that night.  Approximately 7:30am Wednesday (09-24-03) "could barely lift head from pillow" and was "having difficulty breathing" and took 2 more Ibuprofen.   Family physician,  was contacted.  He instructed mother to alternate Tyleno & Ibuprofen every 3 hours and to start Claritin and to contact him at 4pm if she was not improved. Dr.  told mother he felt the difficulty breathing was "due to anxiety."   09-25-03 mother reported to health department that pt was not improved that evening and they had taken her to Emergency Room at a local hospital where "blood & urine tests and spinal tap" were done.  Family was told by doctor that she was "allergic to tetanus and her days of having tentanus shots were over."  Prednisone dose pack was prescribed. 09-026-03  I spoke with father today by telephone and he stated pt was much improved and they were getting ready to "go out of town for the week-end" Father did not know if she had taken the prednisone dose pak.  Will attempt to contact mother again on 09-29-03.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves an unknown age patient who received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2018, the patient received a 0.5 ml dose of suspect PENTACEL VACCINE lot number not reported via intramuscular route in the left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. PENTACEL was reconstituted with QUADRICEL instead of PENTACEL and then injected. No adverse event occurred. 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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
tingling in the center right above her upper lip; swollen with some redness in the same area; swollen with some redness in the same area; This is the spontaneous report from a contactable consumer.   A 72-year-old female consumer reported that: This patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:20 (Batch/Lot Number: EN6205) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Contrast media allergy, urticaria and Dyspnoea from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Tingling in the centre right above her upper lip on 03Mar2021, swollen with some redness in the same area on 03Mar2021, swollen with some redness in the same area on 03Mar2021. The Outcome of event was unknown for event Tingling in the centre right above her upper lip, the outcome of event for swollen with some redness in the same area was recovering and the outcome of swollen with some redness in the same area (Redness) was recovered on 04Mar2021. Upon follow up received on 05Mar2021 Investigation Assessment was not provided. Vaccine was not Administered at  and there was no history of all previous immunization with the Pfizer vaccine considered as suspect, there was no Additional Administered Vaccines. AE(s) did not require a visit to Emergency Room or Physician Office.   Follow up (05Mar2021): This is the spontaneous report from a contactable consumer. This report included: Height and weight, Outcome of events, Dosage details and clinical information.   No follow-up attempts are possible. No further information is expected.
On Tuesday, XXXXX, my wife and I stopped by the XXXX Pharmacy, XXXXXX to get two vaccinations: a tetanus shot for myself and a shingles shot for my wife. At the counter, a young woman asked if she could help and I told her that I needed a tetanus shot and my wife a shingles shot. During our conversation, the woman twice verified that I needed a tetanus and my wife a shingles. After filling out some forms we were told it would be 20 minutes before someone would be available to give us the vaccinations. Returning after 20 minutes, we had to wait another 20 minutes before being escorted into a consultation room where everything was all laid out. The woman giving us the shots (not the same as the first woman) asked our birthdates, but cut both of us off after the day/month. My wife went first. As I was sitting down to receive my shot, I commented about why I needed a tetanus shot and asked why my doctor would recommend me to get one? She was concentrating on giving me the shot and mumbled something about every 10 years and something about measles shots. My wife asked if my shot had the measles vaccination as well. "No" was her response. She never gave us any information about the procedure or the medicine. After she gave us both our shots, she suggested we hang around for a few minutes to see if we had any after effects. Neither of us had any, so we completed our other errands and went home. When we got home, I examined the paperwork given us at the pharmacy and I noticed that the injection given me was "SHINGRIX VIAL KIT", not a tetanus shot. My first reaction was: "They could have killed me!" They injected me with a drug that I have no desire to take, never taken, and have no idea how I would react to the drug! I was/am outraged over this. I called back to complain and, I believe I spoke to the woman who gave us the shots. When I stated our grievances, she responded with a flat, emotionless, "Ok". Unwilling to admit there error, I called the store manager and because he "was in a meeting", had to deal with the store assistant manager who agreed that this was a "big deal" and that she would investigate and get back to me. She ended our conversation with "Have a nice day!" which only aggravated me even further. How could I have a good day when someone just gave me an injection of something I did not authorize? To make matters worse, my wife examined the additional "XXXXX Alert Immunization Information" sheets accompanying our paperwork and the one attached to my vaccination was from some other patient! So, now they give me the wrong drug and revealed another patients private information!
Received Rubella 10-12 days after receiving vaccine; left hand and left leg stiff. Then went to both hands and legs next day. Feeling better today.
I am experiencing menopause and am taking HRT. After the Moderna shot I bled heavy for 3 weeks in April following the shot. Since then I have been experiencing headaches,  tinnitus, dizziness and vertigo. The vertigo is the most concerning because I do not want to fall while riding my bike. Need help for the vertigo and would pay to  go to the doctor for help if they could do anything for the symptoms.
Pt took a Tuberculin PPD test on the Monday after the Covid Shot (taken the Thursday prior) and that evening broke out in a "Moderna" rash with heat at the site of the injection.  The rash 6 days later was 3X3 inches and pink in color with heat still at the actual stick site.  Patient was advised to continue with ice and take Benadryl (50mg for night time dosing).
Shaking chills, high fever, severe body aches, nausea, diarrhea, vomiting, massive headache
Dizziness, Myalgia, Fever, fatigue, chills, decreased appetite Narrative:
I had heart problems first when I was given an EKG , And chest pains followed, as well as sickness for three days, then on May 27 at 3:00 am my eye whole socket , mainly behind my right eye started hurting tremendously and would not stop at all so I went to clinic and after testing they sent me to hospital where I was diagnosed as having a stroke. which affected my left side with weakness. And I have had a headache ever since May 27 that doesn't want to go away , Now I'm on a heart monitor until June 22 the day that it comes off. Im still having pain till today and weakness, I have been to two Hospital which kept me in the hospital From June 27 to June 29. I was given Morphine, Fiorcet,Tylenol, and they sent me home I have still been having pain and weakness so I went To a different Hospital they gave me Reglan, and Tylenol.
L tricep-localized indurated reaction, mild pain-no 2/L, sl. TFP, OTC Tyl/ice.
This is a spontaneous report from a contactable consumer (parent of the patient) for a patient enrolled in a Pfizer-sponsored program; this report regards events related to a product that is not involved in the program. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness afterward on an unspecified date with outcome of unknown. The next day she developed rash on her arm and on her face specifically the chin area where there was redness with outcome of unknown.  The reporter did not see this as being a side effect. Was it and if so would an OTC product be useful. Information on lot number has been requested.
I am on antiviral suppression medication for herpes simplex and herpes zoster. Have not had any outbreak for years on this medication. Hours after the shot, I felt the beginning of a cold sore. My usual nerve pain from my shingles also began. I have had pain and a bad cold sore since the vaccine 6 days ago.
Pt felt dizzy after receiving Pfizer vaccine. She was placed on floor, continued to be responsive, denied headache, chest pain, SOB. VS stable. Denied nausea, took sips water, tolerated well. Monitored for 30 min, no further symptoms. Sibling who received Janssen that day had vasovagal event, as did another sibling who was present but not vaccinated that day.
I went to give Hep A vaccine on patient's right anterior thigh. When needle was placed I went to inject the vaccine and all the fluid from the syringe came out where the needle and syringe are connected. I took out the needle and examined it and made sure the needle was secured tightly and it was. I did not see any other visible damage as to why the fluid would have came out instead of injecting into the patient's thigh. I discarded the needle and syringe in proper container. I informed mom that we may have to do the Hep A vaccine again after proper steps were taken in regards to the incident. She understood and was okay with re-administering if we needed. This entire process happened in a matter of a minute or two. Patient was crying due to me already giving one other vaccine prior to the Hep A injection. After all other vaccines were given, mom picked up patient and was soothing him and that helped him calm down. I signed that I administered vaccines and told mom we would be in contact in regards to the incident and up date her when we have more information and left the room.
vaccine recieved 3/29/21, on 3/30/21 patient expired in his home.  cause of death assumed to be cardiac related.  Pt. was not feeling well after covid vaccination, therefore refused to go to dialysis (3/30/21).  Collapsed in basement and was found by spouse 30 minutes later.  Patient was DNR.  spouse stated she feels death was not directly related to vaccine because he had several health conditions in which he has been noncompliant with and has not been following his medical providers treatment plans.
Patient had immediate facial flushing/redness Does have a history of anxiety and is not sure if he started to get anxious Seen in emergency department and was given IV Benadryl, steroids and was given an Epi pen Rx
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Cholesterol.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure and cholesterol medications. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No new information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PAPULAR RASH BOTH THIGH AT INJECTION SITE WITH NO LOCALISED REDDNESS OR TENDERNESS
urticaria chest/arm//legs 3hr p/vax;no angioedema, no wheezing;nl vital signs;
Rash at injection site, fever/chills, severe nausea;  rash started next day as did fever/chills.  Severe nausea started 2 days post vaccine
Drainage from (R) arm, body aches, H/A, fever. To ER on 7/29/12 tx BACTRIM.
Pt vaccinated /w DTP immediately /p given noted paleness & circumoral cyanosis lasted about 5 second & recovers by himself. These witnessed by Dr. & mother in Dr office.
Pt was given TD at school on 3/27/00. On 3/28/00 pt developed a local papule and walnut sized adenopathy (axillary). Pt was seen by MD on 3/29/00, node still large but resolving. No treatment was given.
Pt was found on floor about 3:00 A.Mm this morning. At 8:00 A.M. nursing home reports left upper and left lower extremity weakness. Complained of chills. Was taken to hospital and remained there from Saturday A.M. to Wednesday P.M.  records received 11/14/08 for DOS 10/11-10/15/08-DC DX: right occipitoparietal CVA. Noted to have left side weakness, left homonymous hemianopsia, left hemineglect. Developed hematuria while on Coumadin. Follow-up Information 09-DEC-2008: Therapy given for weakness and to restore vision in left eye.
Saturday @ 5PM fever was 102;APAP didn't work;took to ER @ 7:00; devel ear infect by 23JUL97;
Developed DVT (2 new blood clots) within 24 hours, went to ER on 10/23/23, now on Eliquis to eliminate blood clots and prevent future blood clots from happening,  No prior history of ever having a blood clot, first time ever of having Covid-19 vaccine,.