chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT AMBULATED FOR A TDAP VACCINE. HE HAD A HX OF PASSING OUT FROM VACCINES IN THE PAST, SO PHARMACIST SENT HIM OVER. PT SAID THE LAST EPISODE WAS WHEN HE WAS A KID. HIS PEDIATRICIAN HAD HIM LAY DOWN FOR A WHILE AND HE RECOVERED WITHIN A FEW MINUTES. HIS PEDIATRICIAN NEVER TOLD HIM THAT HE WAS ALLERGIC TO ANY VACCINE  AND CONTINUED VACCINATING HIM AS A CHILD. HAD PATIENT LIE DOWN ON THE EXAM TABLE WITH HOE 45 DEGREES. TDAP GIVEN RIGHT DELTOID. PT WAS FINE AND BREATHING NICE AND SLOWLY. 1 MINUTE LATER. HE SAID "OH NO. NOW I SEE STARS." HIS FACE TURNED BEEFY RED, EYE BALLS ROLLED UP BRIEFLY, SPEECH BECAME INCOHERENT FOR 10 SECONDS. AFTER BP WAS TAKEN, HE SLOWLY REGAINED CONSCIOUSNESS. BP 141/62, HR 59. RR 20. HE LAID DOWN FOR 10 MINUTES, SAT UP FOR 10 MINUTES, HAD 2 SMALL CUPS OF WATER, AND LEFT AMBULATORY WITH WIFE HOME. INSTRUCTED PT TO REPORT THE REACTION TO NEW PCP AND NOT TO VACCINATE TDAP AGAIN. IF HE HAS SIMILAR REACTION TO ALL VACCINES, THEN HE SHOULD NOT RECEIVE ANY VACCINE.
Hoarse voice, fever, low blood pressure, cough, aches and pain, hard breathing.
gets the flu every year after flu shot; chills; fever; Initial information received on 20-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who reported gets the flu every year after flu shot, chills and fever while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization. In the context of COVID-19 crisis, the batch no and expiration date were not requested.  On an unknown date the patient developed a non-serious event "gets the flu every year after flu shot" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "chills" (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "fever" (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Caller mentioned a friend's experience with the flu shot".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (gets the flu every year after flu shot, fever, chills).  At time of reporting, the outcome was Unknown for the event gets the flu every year after flu shot, was Unknown for the event fever and was Unknown for the event chills.
Rash to upper and lower abdomen. Took daily allergy meds at home. Patient did not go to hospital or doctors office
She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days; She kept changing her story; scared that she might have uterine cancer; sour taste in her mouth and metallic taste in the mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth), CONFUSIONAL STATE (She kept changing her story), FEAR OF DISEASE (scared that she might have uterine cancer) and VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040021A and 048F21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Patient had the same taste( sour taste and metallic taste) in her mouth during her pregnancy when she had high estrogen and low progesterone) and Dysgeusia (Sour taste/ Metallic taste).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth). On 27-Oct-2021, the patient experienced CONFUSIONAL STATE (She kept changing her story) and FEAR OF DISEASE (scared that she might have uterine cancer). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days). At the time of the report, DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth), CONFUSIONAL STATE (She kept changing her story) and FEAR OF DISEASE (scared that she might have uterine cancer) outcome was unknown and VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Blood oestrogen: 287 (High) she had high estrogen. On 20-Oct-2021, Progesterone: 0.5 (Low) low progesterone. On an unknown date, Blood oestrogen: high (High) During her pregnancy  she had high estrogen. On an unknown date, Progesterone: low (Low) During her pregnancy she had low progesterone.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-365563 (Patient Link).
Hand-sized red rash that tingles a little on left arm around site appeared about 11 days after the injection. I've had it for 3 days now. I noticed it on the first day by seeing it in the mirror. It doesn't itch, but it does feel a little hotter than the rest of my skin.
Initial and follow up information has been received from a registered nurse concerning a 81 year old (also reported as "71" years old) white male retired pharmacist, with an allergy to celecoxib (CELEBREX), who on 26-OCT-2005 (also reported as 26-OCT-2005), was vaccinated intramuscularly at 2:20 pm in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#unknown).  It was reported that the patient was vaccinated in 1999 with a dose of pneumococcal 23v polysaccharide vaccine.  On 26-OCT-2005 (also reported as 26-OCT-2006), the patient developed a severe local cellulitis-like reaction.  Follow up information indicated that on 26-OCT-2005 (also reported as 26-OCT-2006), the patient developed redness of the left acromion with a streak going down axillary nodes.  The patient was treated with amoxicillin 500 mg, three times a day, and a Medrol dose pack.  There was no illness at the time of the vaccination.  Subsequently, on an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
a couple of days after the vaccination I woke up with ringing in my ears that hasn't stopped since
Evening of 11/14/2020 started to experience malaise. Patient 11/15/2020 had extreme fatigue, body chills, loose stools, stomach cramping, tightness during urination. 11/17/2020 body chills, extreme fatigue, loose stools, ongoing cramping, and pain urination. Did have minor pain in arm.  By 11/20/2020 patient went to urgent care  due to ongoing loose stools, cloudy urine. Symptoms persisted till 11/22/2020. Cramping was described as a 'muscle spasm' such as 'labor contractions at the beginning'. Confirmation for UTI and administered antibiotics. Patient describes self as a 'very healthy' individual.   This was the second dose of shingrix.
The costumer received the item on Friday, but it was left out; Case reference number US-BN-2021-000707 is a spontaneous case report initially received on 29-Mar-2021 from other health professional and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On 26-Mar-2021, the patient was vaccinated with RabAvert (rabies virus (Inactivated, Strain Flury LEP) (PCEC)) at unknown dose, route of administration or anatomical location for unknown indication.  On an unspecified date in 2021, medication was left out ('Product storage error') and the reporter wanted to know if the item was still good to use.  At the time of initial reporting, it was unknown whether the patient experienced any adverse events after RabAvert vaccination.  No further information was provided.; Reporter's Comments: Product storage error is listed by convention. Reportedly, RabAvert was left out. Product storage error is not related to the RabAvert but to a human action.; Sender's Comments: Product storage error is listed by convention. Reportedly, RabAvert was left out. Product storage error is not related to the RabAvert but to a human action.
Began having muscle contractions and weakness.  Continues to be ongoing.  Still undergoing workup to determine underlying cause.  So far all test/procedures are normal.  Physician feels it may be MS or ALS - however all tests are negative
PT presents with shortness of breath, cough and fever  Pt is on aspirin; lipitor; lovenox; folic acid;  Inpatient
A few hours after the vaccine, Pt's left shoulder symptoms began: extreme pain in the shoulder joint and immobility. These symptoms continued for several days to the degree that he was not able to use his arm at all, and required help with dressing. It has gradually improved, but he remains with quite limited range range of motion and some pain. I left a few messages on MyChart and the nurse called Pt on August 31. Pt followed up with PA on Sept 1 with an in-person visit. She and Pt discussed that the injection was most likely given too high in the deltoid, and is affecting  the soft tissues around his shoulder joint. We are giving more time for recovery, but at this point he has not regained full function of his left arm, making it difficult to answer the question below about whether permanent damage has occurred.
Information has been received from a nurse concerning a 21 year old female with amoxicillin allergy and allergic reaction to BIAXIN who in August 2007, was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The nurse reported that her daughter had injection site reactions after receiving her second dose of GARDASIL by subcutaneous route on 19-NOV-2007.  The patient experienced localized pain, redness and small lump at the injection site.  The patient had not yet received the third dose.  Three days after the vaccination, the patient recovered from localized pain, redness and small lump at the injection site.  Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Lot number: EW0158), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: 033F), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Reported Event: rash on her legs her hands and her upper arms started 12Jun2022 -seen in emergency room 13Jun2022 urticarial rash on anterior legs dorsal aspect of the hand, upper arms and on the chest. Given prednisone -Seen 14Jun2022 Now some rash on palms and soles, mild oral pruritis. Adverse event start date: 12Jun2022, Adverse event start time: 12:00 PM. Ae resulted in: [None of the above] If patient recovered: Not recovered. If treatment ae: Yes. What treatment received for the adverse event? prednisone, Benadryl, Device Date : 16Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Patient received a 3rd dose of Shingrix 7/18/22. Dose #1 received 12/03/20. Dose #2 received 5/13/21.
This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 49.94 F, time frame: 15 minutes, unspecified dates in October 2015) of M-M-R II with lot/batch # K024035, expiry date 26-NOV-2016 and lot/batch # K024038, expiry date 26-NOV-2016 (dose, dose number, vaccination site and route of administration not provided). There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from same reporter link. Additional information has been requested.
Patient had a vasovagal episode post vaccination. Patient appeared light headed, sweating. Patient was accompanied by his mother, who consented for care. Patient was instructed to lay down and elevate his legs, but refused, instead sat on a chair. Patient was given Water, juice. Outcome: recovered fully, no sweating, no lightheadedness. Patient and his mother educated about ER precaution, to drink fluids lay down and elevate his legs if similar symptoms appeared. Patient and his mother acknowledged understanding. Patient has recovered @ 14:42.  Patient left observation after being watched for another 15 minutes.  Vital Signs: @ 14:20 Blood Pressure: 110/80 97 Pulse: 97 O2: 99% room air.   Vital Signs: @ 14:28 Blood Pressure: 112/80 Pulse: 86 O2: 97   Vital Signs: @ 14:32 Blood Pressure: 112/80 Pulse: 82 O2: 98%
Started 7/26/11 burning & itching & warm to touch using anti-itch spray w/aloe for symptom relief & also reported to primary doctor; took BENADRYL no Rx was given .
high fever for over 48 hours up to 104, bodyaches, severe redness and induration at injection site.
Patient received vaccines and that night mom says she woke up screaming in pain.  Redness, swelling and tactile warmth to left thigh where Quadracel was given.  Mom gave IBU.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 58-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 21-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060527:Original Case : US2023AMR056407 US-GSK-US2023AMR060523:Original Case : US2023AMR056407 US-GSK-US2023AMR060577:Original Case : US2023AMR056407 US-GSK-US2023AMR060588:Original Case : US2023AMR056407 US-GSK-US2023AMR060624:Original Case : US2023AMR056407 US-GSK-US2023AMR060616:Original Case : US2023AMR056407 US-GSK-US2023AMR060629:Original Case : US2023AMR056407 US-GSK-US2023AMR060632:Original Case : US2023AMR056407
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On approximately 22-OCT-2013 (last week) the patient was vaccinated with a dose of ZOSTAVAX (lot # J006829, expiration date 14-SEP-2014, dose and route unspecified) for shingles. In 2013 the patient experienced swelling and soreness at the injection site on the back of the arm. The patient called the pharmacy regarding the reaction. The patient was treatment with ice pack and over the counter pain relievers. The event outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
I received the latest COVID-19 booster shot on Tuesday, October 3, 2023 at 2:00 pm. An hour later I felt very cold. I put on three layers of sweaters, but I was still shivering, and my teeth were chattering. No matter what I did I could not warm up. That lasted for about 8 hours. After that I still felt a little cold, but I could warm up with one sweater. That phase went on for about another 12 hours. During this time my body felt tired, and I was low energy.
pt recv vax then devel herpes outbreak lt buttocks & genital herpes 2-3mon p/vax;pt recv vax @ site of buttock outbreak;
As soon as got the flu vaccine I had pain on the site of the injection. I been in to the Dr. and the stated that I have Nerve damage due to the flu vaccine.  I had an EMG done.
Broke out in hives around chin and neck. About 30 minutes later hives spread to my entire back. The hives remained, subsiding and then getting worse again. I took Benadryl at about 10:00 pm and went to bed. In the morning the hives were gone.  After that I had some of the common and expected symptoms post vaccine (fatigue, body aches and low grade fever).
Information has been received from a registered nurse concerning a 10 year old white female with no known allergies who on 02-OCT-1997 was vaccinated in the right thigh with a first dose of Varivax (lot # 622973/0541E). Concomitant vaccination on the same day included a second dose in the left thigh of MMR (lot # 623503/0741E) and a fourth dose in the left thigh of HIBTITER (lot # M265RF). There was no illness at the time of vaccination. On 12-OCT-2006, at 11:00 a.m., the patient developed two to three red areas with a yellow center. The breast and chest had scattered areas of red spots on the center with fluid. The patient was seen in the physician's office on 13-OCT-2006. At the time of the report, the patient was still recovering. Additional information has been requested.
3 days of pain at injection side, on the left shoulder. It hurts when lifting left arm. I also had left knee pain after 5-7 hours of receiving shot. Luckily, I had no fatigue, no headache or fever.
Patient developed status epilepticus. 6/2/08-records received for DOS 5/14-5/16/08-DC DX: Seizure of unknown origin. Iron deficiency anemia. Presented to ED in status epilepticus times approximately 45-50 minutes. Twitching, eye blinking, frothing at mouth and decreased level of consciousness.
Information has been received from a registered nurse concerning a 38 year old white female with an allergy to cephalexin and no medical history who on 8/10/05, at 9:00 am, was vaccinated SC in the right upper arm with a 0.5ml first dose of varicella virus vaccine live (lot # 648315/0072R). There was no illness at the time of vaccination. Concomitant therapy included topiramate, Sumatriptan succinate, and cyclobenzaprine HCl. On 8/25/05, the patient developed less than 10 skin lesions and vesicles generalized at the site, back, calf, genitalia, and abdomen with a cough. On 8/29/05, the patient was seen at the office with a few more lesions. The patient was treated with calamine lotion and diphenhydramine hydrochloride. It was noted that she also had pain in the arm at the injection site with soreness that felt like it had roots. No redness was noted. The patient was afebrile. No diagnostic laboratory tests were performed. at the time of the report, the patient had not recovered. A product quality complaint was not involved. Follow up information indicated that on 8/25/05, at 12 AM, (10 days after vaccine administration) the patient complained of itching vesicles. There were 3 on the right upper arm, 1 on the abdomen, 1 on the right breast. 14 days after the vaccine, the patient had additional lesions 1 on the left calf, 2 on the right arm, and 1 on the genitalia. There was soreness at the right upper arm injection site, but there was no visible redness. The patient recovered on 9/1/05. Additional information is not expected.
Localized reaction to injection site with swelling, redness, and tightness at site.
Pt. did fine after immunization.  Blood drawn in clinic by MA, approximately 30 minutes after vaccine.  Patient became dizzy and nauseated after blood draw.  Stated room was spinning.  He appeared pale.  He was placed in a supine position lying in the venipuncture chair and monitored.  He continued to feel nauseated on/off for up to 3 hours after the blood draw.  We monitored blood pressure and pulse and offered fluids including grape juice, water, and apple juice.  He had some crackers and grape juice prior to vaccine.  He was awake, alert, and oriented.  After approximately 2 1/2 hours he was offered to go to the ER for IV fluids and nausea medication.  He declined stating he was feeling better but that the nausea kept returning.  While we were speaking he sat forward and vomited approximately 30 cc.  He stated after vomiting he immediately began to feel better.  He was monitored for another 30 minutes, got up to use the restroom without incident, and denied wanting to go to the ER or needing nause medications prescribed from our clinic.  He requested to go home with his daughter, who was able to drive him home with her driver's permit.  He declined needing a wheelchair transport to his car.  He was instructed to call with any worsening of symptoms or should he have any neurologic symptoms such as weakness fatigue or loss of strength in any extremeties, or difficulty breathing or shortness of breath.  He voiced understanding.  Vital signs throughout the day were:  11:59 96/70 pulse 60, 2:35 110/80 pulse 54, 2:45 118/80 pulse 66, 3:04 110/80 pulse 54, 3:27 124/78 pulse 66.  Left at 1600.
Sore arm at injection site.......fever, chills, felt ill....racing pulse as high as 115bpm.  Fever as high as 102.4 which came down with Tylenol.  Felt very tired.. the next day his pulse came down to 100bpm.
Approx 4 hrs after receiving (RABAVERT) inj, day 7, started having a headache, increased heart rate, nausea, dizziness, felt shaky & pain at injection site. Vision became impaired & pt states I felt like a bus ran over me. The symptoms came in waves.
The evening of vaccine, I turned on TV.  I immediately was aware that I was not seeing the full face of the reporter, I could not focus into view the whole picture.  I then began having peripheral flashing lights of all colors going every which way around my vision.  I rested for a few minutes and then checked it by attempting to read but could not keep the letters and words in order,.  This continued for 45 minutes. When I called my dr. They told me to go to the ED and get checked out.  ED Dr. checked for signs of stroke, which there were none. He felt it was related to vaccine.
Low grade fever, followed by severe arm pain and redness at injection site.  Arm pain increased in 72 hrs followed by erythema at site and streaking on arm into axillary surface.
12DEC91 inc temp to 105 15DEC91 no other sx; seen by MD 14DEC91; MD stated reaction to MMR also rash;
pt has been dx w/some expressive receptive language problems-problems w/sensory processing;
As per mother's voicemail that was left on Tuesday afternoon. Patients arm, site of injection, has  gotten red, and some swelling with some pain to site.