chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching and rashes on hands and feet; Red spots on feet, ankle and hands; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 at 17:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021 at 17:45, the patient experienced itching and rashes on hands and feet and red spots on feet, ankle, and hands. It had not gone away for 36 hours. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events that included treatment with unspecified antihistamine 10mg. The clinical outcome of the event itching and rashes on hands and feet and red spots on feet, ankle, and hands was not recovered at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
52-year-old previously healthy female who received first dose of Janssen COVID-19 vaccine on 4/7/2021. She started having periorbital right headaches starting on or about 4/14/2021. Headaches were alleviated with OTC Advil. On the morning of 4/18/2021, she awoke with RIGHT arm weakness which, over the course of several hours, progressed to include right-sided leg weakness and aphasia. Initial CT head showing multifocal hemorrhage within the LEFT frontal lobe. Course complicated by epileptic seizure. MRI brain with and without contrast and CT venogram brain notable for superior sagittal sinus thrombosis involving the mid and anterior segments of the superior sagittal sinus.  Patient found to have new thrombocytopenia on admission with platelet level 78k; previously had normal platelets 6/4/2019.  D-dimer elevated > 4.00 mcg/ml  FEU. Started on Argatroban gtt, nicardipine, and IVIG.
The pt was staring, unresponsive and extremely pale X 10 minutes. After 5 hours, seemed to be back to normal.
Received 4 month immunization in AM.  Vomiting blood and blood in stool in afternoon.  Went to hospital ER - transported via ambulance to another hospital.  Diagnosis with interruption.  04/09/2008 MR received for DOS 3/20-22/2008 with DX: Intussusception.  Pt presented to local hospital with bloody stools and vomit and inconsolable crying. Intubated electively and transported to current facility.  Palpable mass noted in LLQ on PE.  Barium enema initially unsuccessful at reduction on first try.  Reduction later sucessful. Pt extubated with mild WOB and decreased BS noted on L with mild stridor.  Resolved with albuterol nebs. Pt to baseline 3/22/08 and D/c.
Information has been received from a literature article. Authors presented a case that highlight the value of viral culture and its appropriate interpretation. An 1 year old girl was evaluated or recurrent fevers with temperatures to 104 degrees F. She had multiple visits to emergency rooms before being admitted for 10 days after becoming symptomatic. Viral culture obtained on the day of admission showed infection with mumps virus genotype A. The child had been immunized with mumps vaccine (manufacturer unknown) 19 days prior. Persistence of the virus suggested immune dysregulation. Other clinical findings and laboratory features to include elevated quantitative HHV-6 by PCR defined a diagnosis of hemophagocytic lymphohistiocytosis. Viral diseases remain the most common infectious diseases. Large numbers of viral pathogens did not have specific therapies. However, specific identification had significant value at the level of the individual patient, the hospital, and community. Viral culture today remains a vital means of diagnosis. It was complementary to current molecular techniques. Additional information has been requested.
66 years old patient was administered Fluzone Quadrivalent instead of Fluzone High-Dose, no AE; Initial information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone.  This case involves a 66 years old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  This was an actual medication error case due to wrong vaccine administered (latency was same day).  The pharmacist wanted to know if they can administer the Fluzone High-Dose as well due to patient.  At the time of reporting, no adverse event reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for this case.
Diagnosed with hypothyroidism, thrombocytopenia, and abnormal liver test (SGOT). Note: This is the second Hepatitis B #3 I received. Last dose was given 15 Sep 2006.
Severe Chest pain; Back pain; I had side effect in stomach; Headache; Nausea; Diarrhea; stomach ache; I am concern and not feeling well/I have been taking Ibuprofen but it's not getting better; This is a spontaneous report received from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW8173), via an unspecified route of administration in right arm on 18May2021 (at the age of 56 years) as 1st single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. On an unspecified date in May2021, patient had side effect. Patient had severe chest and back pain from last 2 days. Patient also had side effect in stomach, headache, nausea, diarrhea and last three days having severe chest and back pain. Patient was not feeling well and had stuff like that stomach ache, headache. It was reported that it's been a week and had "severe" (not clarified) chest pain and back pain. Patient had Ibuprofen 600 mg as treatment which was taken yesterday, took 2 today but events not getting better. Patient was waiting for urgent care because it was not getting better and wanted to know that what needs to be taken to get rid out of the events and just taken Ibuprofen (treatment). The chest pain hasn't been a week. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
No adverse event; 17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility) and NO ADVERSE EVENT (No adverse event) in a 17-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were reported. No treatment details were reported.
Patient is charted as receiving a dose of Pfizer from another company. Patient is confirmed to have received two Moderna doses with the Health Center on 4/12 and 5/10
10/14/21 at 10:30pm: body aches, unable to sleep, by 1am violent body chills and shakes (subjective fever), teeth chattering, feeling anxious and shaky; by 2:30am vomiting, diarrhea, migraine HA (when closed eyes, saw flashing), metal taste when not vomiting, felt very weak. Vomiting resolved by 5-6 am on 10/15/21, but the rest of the symptoms persisted throughout the weekend. As of today, still feels shaky and week, anxious, with periods of body chills/shakes. Patient was breast feeding during the time she received the third dose and with both of the prior Pfizer vaccine doses. The child had no symptoms after the first one, sick (fussy, crying, fever, decreased appetite) after second dose, and no symptoms after third dose.
Covid vaccine x 3. tested positive for Covid on 7/26/2022. Expired on 7/29/2022.
Right deltoid (hep b) 5x3.5cm induration/redness. Left deltoid (DTaP) 8.5x5.5cm induration/red.
Red, swollen patch appeared in the morning by night time patch expanded by next morning patch almost around arm
After receiving vaccination recipient was driving into observation when seizure like activity was observed.  Car was put into park, scene safe. Chief Medical Officer on scene. EMS called to scene.  Recipient c/o nausea and appeared diaphoretic.  Vitals @1009 - BP 122/76 - O2 99% r/a - P48- RR 16.  12 Lead EKG completed by EMS reviewed by Drs.  It was recommended by Dr. that recipient be transported to  Hospital for further evaluation.  Recipient refused transport against medical advice.  Recipient signed refusal of transport with EMS and had a friend pick him up. Vitals @ 1045 - P113/68 - O2 95% r/a - P49 - RR 16 AAOx4 per EMS.
Ongoing Throbbing in my right leg/Feels like a deep pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 16:00 (Lot number: ew0173) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Ongoing Throbbing in my right leg/Feels like a deep pain."  additional information: Patient did not have Covid prior vaccination and Has not been Covid tested post vaccination .Patient did not have other vaccine in four weeks. Patient other medication in two weeks included Vitamins. Patient was Unsure if event was related to the shot, but the pain started about a week after first shot Facility type vaccine: Other.  Follow-up attempts completed. No further information is expected.
Site: Bruising at Injection Site-Mild, Additional Details: Vaccine given in pt left thigh. Patient sitting on moms lab with legs trapped between moms legs and arms held by mom.  Held left leg down while administering vaccine. Able to administer full vaccine but pt moved during process and scratched leg causing about .5in superficial abrasion. Pressure and band aid applied.  (covered wound small circle band aid). Pt fine after vaccine no crying or pain. Checked band aid prior to pt leavingand advised mom to check at home call mc with concerns.
gave a 4th dose; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 10-month-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B  (received 3 doses on an unknown date).   On 29th September 2022, the patient received the 4th dose of Engerix B. On 29th September 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received 4th dose of Engerix-B on the day of reporting, which led to extra dose administered.
3 days post vaccine awoke with severe tinnitus. Tinnitus has persisted ever since.  Sleep now requires interventions  such as melatonin and sound masking  to overcome sounds of tinnitus.
Pt experienced redness, swelling, fatigue, and feeling of heat at site of injection. PNEUMOVAX administered 12-15. Pt is now, on 12-18, starting to feel better. Pt's husband asked that event be reported.
Allergic reaction likely to DtaP, 13 centimeter by 13 centimeter induration surrounding injection site, cellulitis, no fever.  Treated with ANCEF, BENADRYL and MOTRIN.
Around 16:45 patient received the pfizer vaccine in left deltoid. approximately five minutes later 16:50 patient claimed that ear sounds were muffled. patient was taken to cot where vitals were obtained & monitored until EMS arrived.  Patient was signed off by EMS unit, and patient's dad was advised to call EMS if needed.
Started morning after with terrible headache, pain in the eyes, nausea and sore arm. Few days later felt tightness in the chest, shortness of breath and a cough started. Feeling unwell. Continued and went to urgent care. Covid 19 test negative. continued to feel the worse and went back again to urgent care. Same symptoms with nausea and headache on and off. another covid test negative and chest xray. looked ok. Continued with the same symptoms and went to Primary Care Cough worse and pain in chest. Blood work done. Looked ok. Woke up with terrible headache at 3am. Went to the ER. IV ,Blood work ,ct scan, ekg.  No real answersBP elevated. Still struggling but cough improving.
Swelling of entire anterior left thigh muscle.  Able to walk.  No pain.  No fever.
04.24.2021  patient received Moderna first dose and 06.09.2021 - Patient  receive Moderna second dose; 17 years old recieved vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old recieved vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (04.24.2021  patient received Moderna first dose and 06.09.2021 - Patient  receive Moderna second dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old recieved vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (04.24.2021  patient received Moderna first dose and 06.09.2021 - Patient  receive Moderna second dose). On 24-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old recieved vaccine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (04.24.2021  patient received Moderna first dose and 06.09.2021 - Patient  receive Moderna second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received contains significant information. The lab data was added , the event was upgraded unknown to recovered and one event is added (Inappropriate schedule of vaccine administered).
The 2nd day after the vaccine, 05/04/2021- I had all the normal reactions, like chills, body aches, exhaustion. On the 3rd day, 05/05/2021-I was at sitting work and all the morning I just became out of breath, It was an effort to breathe. It just lasted that day and next day I was fine. After both vaccines in May, I had 2 embryo transfers of IVF treatments. 1 transfer on June 8, 2021 and one in July 16, 2021.  A PGT tested normal embryo on each of those 2 dates and both implanted and when they started, they failed to develop, they miscarried. I had a saline sonogram which showed no physical issues with the uterus. A hysteroscopy showed there was no obvious problems with the lining or the uterus. And biopsy taken of the lining that showed no issues of the lining.  Additional blood test that showed no issues for clotting or thyroid problems.  No evidence of clotting disorder or inflammation or no obvious reason to why it had happened. I had no problems that there were any issues. There was a low chance that would have happened. It could be that I am unlucky. But I am not blaming the vaccine.
Started feeling twinges in right shoulder joints. Two months later I started to feel pain in my right shoulder. Went to my doctor the next month and received an X-ray. Afterwards I was referred to a Physical Therapist. Was found that I have a frozen shoulder. Am still going to Physical Therapy and was told that it takes a few months to repair it.
At first my left leg began to drag.  A short period of time went by and I began to have pain on the top of my hip, around to my groin, and in my left abdomen. Pain intensified with shooting pain in left hip.  Later in left knee and continuation of hip, groin and abdomen.  As time went by, I began to need a cane in order to walk.  I began to notice significant muscle weakness in my legs make getting from a sitting position to a standing position very difficult.  Stand to sitting, same pain. No improvement at this date.
About 10 hours after injection began experiencing flu like symptoms: chills, feverish (did not take temp), body aches, in addition to arm pain.  Extreme hot/cold feelings, chills aches and continued overnight. Took ibuprofen for relief. Following day, chills and fever were gone, but had extreme tiredness and aches. 48 hours after injection, felt better over all, but developed pain and swelling in armpit (assuming its lymph nodes) 72 hours post shot, armpit still a bit swollen-- tender and sore and painful when touched. Like a bruise.
Pt recvd DTP/HIB on 14OCT 1030AM, began w/1 1/2 hr high pitched crying-high shrill @ 7PM 14OCT92 extremely irritable, fever 103 AX;
Arm is sore - right arm/ arm is still hurting (right arm); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore - right arm/ arm is still hurting (right arm)) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is sore - right arm/ arm is still hurting (right arm)). At the time of the report, PAIN IN EXTREMITY (Arm is sore - right arm/ arm is still hurting (right arm)) had not resolved.            No Concomitant medications were provided. No Treatment History was provided. The patient reported that his heart rate is usually 42 and has been for the last 27 years. His heart beat lately has been 45, 50, has gone up a couple of points.
Spoke with mom, no reaction as of now. Advised mom to monitor site of injection and behavior of patient and if any abnormalities such as high fevers, difficulty breathing, shortness of breath, ect. to proceed to the ER.
Throwing up 24 hours after shot. Couldn't eat all day. Threw up again after 36 hours and had diarrhea.   The next day everything had resolved itself.
pt got vaccine and was sitting for observation.  Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor.  The patient came to quickly and said he passed out due to stomach cramps .  EMS was on site and did an evaluation. Pt was  given ice for his head and had vitals checked and and EKG done.  EMS recommended hospital transport but patient refused.
Neuropathy (tingling and burning in the feet and legs); A spontaneous report was received from a consumer, regarding herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (tingling and burning in the feet and legs).  The patient's medical history was not provided. Concomitant product use was not provided.  On 13 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection.    On 13 Jan 2021, after the first dose of mRNA-1273 vaccine, the patient noted neuropathy (tingling and burning in the feet and legs). Was inquiring whether this will recur after the second injection. Treatment information was not provided.   Action taken with mRNA-1273 in response to event was not reported.  The outcome of the event, neuropathy (tingling and burning in the feet and legs) was unknown at the time of this report.; 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, a causal relationship cannot be excluded.  Further information has been requested.
Swelling Redness, and tenderness at site. RX; Prelone, Prelactine- started 05/16/05
pt recvd MMR shot & devel severe sore throat, swollen glands, fever for 2 1/2 days, then cough & congestion, very productive cough;
Ringing in ear on day of 2nd vaccine. ~ 10 days later woke with blocked hearing in right ear. Now ringing, negative pressure and nerve damage. Decongestants and then steroids did not clear the pressure. No fluid in ear. Ears appear healthy.
Pt recv vax on 10/14/98; on 11/18/98 pt exp retinal edema, decreased vision, dilated pupils; pt to see ophthalmologist