chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea and passed out 5 minutes after dosing, dizziness and Nausea 15 hours after dousing
Fever and chills, nausea and vomiting, malaise, mild lethargy, headache. Reported she was possibly exposed to rabies when she removed the head of a dog found to be positive for rabies. Fever reached 104 F. Treatment was APAP and ASA.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received SHINGRIX. On 15th September 2018, 17 days after receiving SHINGRIX, the patient experienced rash, skin peeling and pruritus. SHINGRIX was continued with no change. On 29th September 2018, the outcome of the rash, skin peeling and pruritus were recovered/resolved. It was unknown if the reporter considered the rash, skin peeling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced rash that appeared from neck to feet, the layers of skin peeled and itching after a dose of SHINGRIX. The condition lasted for 2 weeks.
This spontaneous report was received from a registered nurse and refers to unknown number of patients from a group of 5 patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # reporter as M042502, expiration date: 17-APR-2018), reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date unknown) for prophylaxis (dose, frequency and route of administration, were not reported). No adverse effects were reported. The doses of the vaccines were exposed to a temperature of 6 degrees Fahrenheit (°F) to 14°F for a time frame of 21 hours. There were no previous temperature excursions. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1704USA015107:
red, raised rash around injection site. The patient showed me the rash and said it hasn't been bothering her at all, but just wanted to make sure it was ok. I recommended taking Benadryl to help with the rash and to let us know or her doctor's office know if it seems to get larger.
EXPOSED TO TEMPERATURE OUTSIDE RECOMMENDED STORAGE RANGE, UNKNOWN VIABILITY/POTENCY
blurred vision; strong headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision) and HEADACHE (strong headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurred vision) and HEADACHE (strong headache). At the time of the report, VISION BLURRED (blurred vision) and HEADACHE (strong headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-121772, MOD-2021-121772 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event outcome updated.
Fever; Chills; Back aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back aches), PYREXIA (Fever) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (Back aches). On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, BACK PAIN (Back aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter. No treatment medication reported by reporter. Patient states she was "fully vaccinated" 8-May-2021. Consent for follow-up was given.   This case was linked to MOD-2021-058111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received. New event added.
No other AEs or PQC reported; Caller reports GARDASIL 9 was inadvertently administered to a 14 year old who had already completed a 2 dose series.  Caller states the patient was ordered a "Flu Vaccine" but she administered a GARDASIL 9 because that is what she "Usually administer; This spontaneous report was received from a medical assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-SEP-2022, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at dose 0.5 milliliter (lot number U029033 was verified to be a valid number, with an expiration date reported and established as 13-MAR-2024), administered intramuscularly for prophylaxis (strength was not provided), instead of flu vaccine (manufacturer unknown) (wrong product administered). The patient had already completed 2 doses series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse events were reported.  It was reported that the patient ordered a flu vaccine (manufacturer unknown), but received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because that is what the facilitator "usually administered".
Pain in right arm beginning about two hours after receiving the vaccine. The pneumonia vaccine was given in the right arm. Reports limited range of motion. Four fingers of right hand cool to touch.
Informatino has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Peritnent medical history and drug reactions/allergies were not reported. On multiple unspecified dates the patients were administered with doses of improperly stored PEDVAXHIB (lot # was reported as L012837, expiration date was reported as 11-MAR-2018, dose and route were not reported). Concomitant drug was not reported. This is one of several reports from the same reporter. Adidtional information has been requested.
I think it's interfering with my acid reflux sometimes. I have some acid reflux; My voice is sort of hoarse; I threw up; Hand going numb, that affects the tingling but that's better and it was in my elbow; Hand going numb, that affects the tingling but that's better and it was in my elbow; Not feeling good; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration on 12Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I got the shot, the first shot yesterday, the Pfizer vaccine, on Aug2021, I think it was interfering with my acid reflux sometimes. I have some acid reflux and my voice is sort of hoarse and I threw up at 5:30 and I don't feel like I am going to 'throw my gut out' but I am not feeling so 'hot' today and I had a problem with my hand going numb, that affects the tingling but that's better and it was in my elbow but I think that it's nothing with my acid reflux. I am just not feeling good. So, I want to make sure that it was okay to take some acid reflux (Unspecified Medication) and some ibuprofen. Consumer further stated, If I could take acid reflux, My voice is off. I think it is because of the throwing up and acid reflex, I think that shot (COVID-19 Vaccine) is affecting my acid reflux. I think that's my problem. I don't know if you have that issue but I think that's what going on. The outcome of the events was reported as unknown.
Neurology consult note 2/16: The patient is a 72-year-old woman, who states that last Friday she began to notice a strange fullness and numbness and perhaps a mild degree of weakness in her right leg and came to  Emergency Room.  She was seen by ER doctors.  Diagnosis was unclear.  She was offered admission to get physical therapy, but she did not wish to stay for the weekend and returned home on Friday the evening only to come back to the ER on Sunday, 2 days later with progression of further right leg weakness, right leg numbness and a hint of new left-sided symptoms that had not begun before Sunday.  None of her symptoms involve the arms or face and everything was below the waist.  There was no significant pain.  She has not had a bowel movement since Thursday and has lost the ability to void.  Her MRI scan of the lumbosacral spine was reviewed by me on the computer monitor and was unrevealing except for mild DJD.  Thoracic MRI scan shows possible spinal cord infarction versus myelitis occurring within the thoracic spine at the dorsal surface of the cord at the T5 and T6 vertebral body levels to the right of midline.  This was a faint finding and not clearly infarct or myelitis and could be artifact.  It appears that she has hydronephrosis on her scans too and now is using a Foley catheter.  She does have a history of high cholesterol for which she takes a statin at home and was taking a baby aspirin a day when the above symptoms occurred. In summary, the patient has a 72-year-old woman, who presents with progressive right lower extremity weakness and now evolving left lower extremity weakness.  This may be related to an autoimmune process such as myelitis or less commonly cord ischemia.  Normally, I would start her on Plavix, but I think she may need to undergo spinal tap tomorrow if MRI scan of the brain and cervical spine are unrevealing.  Patients with mild hyperglycemia can develop a diabetic amyotrophy or lumbosacral plexopathy simply related to diabetes, which is a diagnosis of exclusion.  Speaking against this would be that her reflexes are intact at both knees at 2+ to 3 and slightly brisk, 1+ at both ankles and 1+ and symmetric in the upper extremities.  We will hold aspirin for today.  Consider LP for tomorrow, but have not ordered as we will try to avoid and hopefully the imaging studies I have ordered will be sufficient.  We will continue to follow.  While admitted to this facility, she was treated with IV dexamethasone 2/14-2/21  She was admitted to an inpatient hospital 2/14-2/23 and discharged to an inpatient rehab unit at a different health system.
This spontaneous report as received from a nurse refers to 7 patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. After 16-JUL-2014, date unspecified, 7 patients were vaccinated with VARIVAX (lot #K002922, expiration date 26-FEB-2016, injection, 0.5ml) subcutaneously. The nurse reported that there were two times temperature affecting VARIVAX. The first excursion was on 16-JUL-2014 and was supported. The second excursion was on 21-JUL-2014 and was also supported. No adverse effects was noted/reported by any patient. Patients did not seek medical attention. No product quality complaint (PQC) involved.  This is one of several reports from the same source. Additional information has been requested.
fluzone high dose quadravalent vaccines were given to a patient twice once on 10OCT2023 and then on 13OCT2023 with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves a 86 years old female patient where influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] were given to a patient twice once on 10oct2023 and then on 13oct2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2023, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot- U8132BA) via intramuscular route in the left deltoid. On 13-Oct-2023 she also received a dose of the same vaccine (lot U8132BA) via intramuscular route in the right deltoid (dose, strength and expiration date: not provided) for Immunisation.  On 13-OCT-2023 the patient developed a non-serious fluzone high dose quadravalent vaccines were given to a patient twice once on 10oct2023 and then on 13oct2023 with no reported adverse event (extra dose administered) (latency- same day) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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 Directive and Regulatory Authority 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.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if patient had acute or chronic long-standing health conditions at the time of vaccination.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No relevant concomitant medications were reported.   The age of the patient was reported as over 65 years.  The vaccine was administered in the deltoid site. On 11-May-2023, 26 patients were contacted, on 12-May-2023, 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone.  No treatment medications reported.   This case contains information for the tenth patient out of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Initial report received from the patients husband who is a pharmacist on 03 March 2011. A 74 year-old female patient with no reported medical history had received an intramuscular injection of ADACEL (lot number not reported) on an unspecified date in 2011. The patient subsequently developed redness and swelling at the injection site. She also complained of drowsiness and a flutter in her stomach. The patient was evaluated by a physician who prescribed antibiotics. Outcome was reported as not recovered. The reporter did not want to report this and would not provide any further information. Documents held by sender: None.
8 days after first vaccine, woke up with extreme vertigo.  Dizziness ,  diarrhea, nausea continues to present.  Went to urgent care and was diagnosed with vestibular problems and referred for vestibular rehabilitation.   Blood pressure is elevated despite medications.
The day after the vaccine, my symptoms began with a very strong heavy metal taste in my mouth. Later that same day I begin to feel very nauseous, and began having body aches. The second day after the vaccine, I was very fatigued and weak. The third day after the vaccine, I was completely debilitated.... I could not move,  I could not stay awake for more than one minute.  I was extremely, extremely fatigued, with pain over my entire body and a constant and painful headache in the front of my head. Day four after the vaccine I started having severe delirium and could no longer feel my legs or my feet.  My primary Doctor, recommended that I was taken to the ER.  I was given an IV with fluids and a subtle pain reliever.  It has now been a week since the vaccine, and I have tingling in my hands and feet, my legs are very heavy, and my entire body is inflamed.
Shot #1 - very painful, sore arm for 48 hours, no other adverse effects. Shot #2 - sore injection location 6 hours after shot. Approximately 10 hours after injection, became very restless, extremely uncomfortable back, restlessness, could not sleep, followed by migraine, severe sweats and chills. Lasted 48 hours from onset.
- Moderate arm soreness at the injection site. Onset within 5 mins of the shot, disappeared 80% within a week, not completely gone 10 days later (present time as of making this report). - Fever started 18 hours after the injection, lasted for 6 hours (peaked at 100.2 F) - Hot/cold chills/shivers during fever - Cough during fever - Skin overly sensitive to the touch the day after injection - Crushing headache the entire day after injection - Overall tiredness the day after injection despite sleeping well for 8 continuous hours - Full recovery and felt great 36 hours after injection
Achy body, typical site reaction, low grade fever, sore hips and back, fatigue X 3 days.
I was out of my home town and was getting ready to travel back home and had to get a Covid test to travel. I had been sneezing and thought maybe it was just allergies. The test came back positive. From there I started feeling worse. I was so fatigued and my sinus' were really dry, like I had been in the dessert all day and it was just so dry and hurt. I was feeling like I was having this popping feeling in my sinus', like when you eat the candy pop rocks and they pop, I had that feeling in my sinus'. I was so fatigued and yet I couldn't sleep. I felt like I had been hit with a 2X4 and was just sore and I had brain fog. I have also had some issues with my heart after my third dose. I get this squeezing that is painful and it feels like my heart is bruised. I even recently had chest pain which was severe enough that I went to the ER thinking I was having a heart attack, we did tests and it was not a heart attack but it felt as thought it could have been.
Development of seizure like symptoms with muscle rigidity & LOC. February 2007 started with abdominal pain & continued with back pain. Oct 2008 started fever & sz symptoms.
Headache and dizziness started that day. Headaches got increasingly worse during the first week along with dizziness and loss of balance. Mid second week, headaches went from moderate to very severe. The nausea and back and forth between diarrhea and constipation began. Horrible headaches. PCP put me on zolfram 1 pill 1x a day. That did not help. I was then put on zolfram 2x a day. I was also put on pepcid AC 2x a day. I also stayed on tramadol for pain. It seemed to help. It delayed my nucala. At the end of week 3, I went in for my Nucala for my asthma. Within hours of receiving that shot, the side effects came back. With the medication, I was beginning to feel better but the Nucala shot brought them all rushing back. Week 4 was even more miserable. I was put on 10mg dextramethazone. My last dose was yesterday morning and today I woke up dizzy again with a massive headache and a sour stomach. I am still taking pepcid AC. My dr. office is working on a plan.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23. On an unknown date the patient experienced sore arm after administration of PNEUMOVAX. Causality was not reported. The outcome of the event is unknown. No further information provided. Additional information has been requested.
My whole right arm from right were the injection site is down to my hand has been sore and cramping.   This is a week later, nothing happened door me during the first week.