chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My sister can't even raise her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My sister can't even raise her arm".  Additional information: NDC number of Covid Vaccine: Unknown, UPC number of Covid Vaccine: Unknown, Reason for no lot number: of Covid Vaccine: Complainant hung up abruptly/transfer incomplete, Expiry Date of Covid Vaccine: Unknown. Consumer stated, "I had first dose Pfizer Covid shot (vaccine) and I had a bad reaction. I have been transfer three times, am I talking to the correct person. " (Further not clarified the previous Department name. Hence, captured as initial report in the tab). When probed for the concern, consumer stated, "I have arthritis and I also have a problem with my heart nothing serious but vaccine did cause in my body to trigger and impact to all my Medical problems. Muscle in my heart was very painful, trouble in breathing like it was that painful my Doctor can't even touch me in that area. He actually sent me to the Emergency Room after the Cardiogram, I never had arthritis attack in my life it looks like I have boxing gloves, my ankle were all swollen in both hands and also my feet, my ankle and my feet. I was unable to lay in bed because my hands were so swelled that I didn't have blood circulation in my hands. I have to get out of my bed and stand up. I did not sleep even 5 minutes, that is how bad, it was. This vaccine caused this problem within days having this vaccine I started feeling pain in my elbow, the pain started in my elbow and went into my arms into my hands and from everything went wrong. How am I supposed to have second vaccine when my body is acting this like they did not tell that the vaccine is safe? It is not safe for everyone, I have someone that use to play guitar and after the vaccine on the left arm he can't even press there cords, the string because he has no strength in his hands to even press to play his guitar. My sister can't even raise her arm. Why do they not tell people that the vaccine is not safe, did not do any research about medical history, some people have "died" (further not clarified) after the vaccine. Vaccine is causing me so much harm and nobody is giving me any answer, it is something like "conspiracy" (further not clarified) because they are not telling that vaccine is not safe, vaccine really very hurts me."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Apr2021 16:30 (at age 62-year-old) (Batch/Lot Number: EP7533) as 1st dose, single dose for covid-19 immunisation. Medical history included neurofibromatosis from an unknown date and unknown if ongoing. There were no concomitant medications and no other vaccines received in four weeks. The patient experienced Bell's palsy on 23May2021 08:00. Prednisone and Valtrex was given was treatment. Outcome of the event was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Size of an orange red, inflamed, hot to the touch area on arm. I, RPh, recommended BENADRYL and ice pack.
My menstrual cycle started 2 and a half weeks early. This never happens to me. I am always very regular.
I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest; I had a slight sore arm; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest), PAIN IN EXTREMITY (I had a slight sore arm), CHILLS (Chills) and FATIGUE (Fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 011L20A and 031620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, VALSARTAN, FOLIC ACID, METOPROLOL SUCCINATE (TOPROL XL), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced HEART RATE INCREASED (I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest), PAIN IN EXTREMITY (I had a slight sore arm), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, HEART RATE INCREASED (I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest), PAIN IN EXTREMITY (I had a slight sore arm), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-368784 (Patient Link).
Swollen, hot to the touch, local hives, sore. Denies any SOB. TYLENOL & BENADRYL.
About 5 minutes after receiving my first Pfizer dose I experiences shortness of breath, lightheadedness, and nearly fainted. Turned completely fail.
No additional adverse event; Administration of RECOMBIVAX HB to a patient on 28-AUG-2023 after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 55-year-old patient. Patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.    On 28-AUG-2023, inadvertently the patient was vaccinated with an improper storage dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # W036194, expiration date 29-SEP-2025 for prophylaxis (dose and route were not reported) (product storage error). The vaccine was exposed to -1.1 Celsius (C) for 5 minutes. There was no previous temperature excursion.  No additional adverse event and nor product quality complain were reported.
Severe right sided thoracic  & chest pain. Onset of blister with redness, continued Rt sided pain 11/10.  In first vacation since Covid and got sick, went to urgent care July 4, 2021, Dx with SHINGLES.   Taking prednisone & valtrex but over next few days, blistering, redness spread between chest/breast to thoracic spine.  Still with symptoms, while out of town on vacation!  I am 55yo, healthy female, no underlying autoimmune disease or anything, no family history of shingles, so how did this happen?  Possibly from Covid vaccine?
pt exp excrutiating pain down lt arm; drove home-self; pt states took APAP; pt states is nauseated from pain; pt has called MD & notified him;
Gave Pfizer Bivalent 12 and older given to pt.  No side effects reported by parents to hospital.
get a dose of PEDVAX HIB as recommended by allergist/immunologist; No additonal adverse event reported; This spontaneous report as received from a physician refers to a 57-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 0 .5 milliliter, intramuscularly for prophylaxis, recommended by her allergist/immunologist (dose number, route of administration, lot number and expiration date were not reported). No additional adverse events reported.
Upper left quadrant abdominal pain several months post 2nd vaccine dose. Underwent many medical procedures including CT scans to find blood clots in spleen and heart. Clot in spleen caused an untreatable splenic infarct. Spent 5 days in the hospital. Unable to find cause of blood clots.
I received the vaccine just after 1700 on 10/26/2021. Due to my flu vaccine allergy I stayed for 30 minutes after to assess for reaction. My skin was crawling on my arm, but this is a normal reaction to vaccines for me since the flu allergy. They thought I looked flushed and I had random itching, but nothing on my face like they were concerned for. That evening my scalp was itchy so I took Benadryl. The following afternoon (10/27/21) when I woke up I felt like a truck had hit me, backed up, and ran me over again. All my joints hurt and my muscles were on fire/pins and needles when I moved. I had a severe headache that was centered between my eyes just above my hairline and at the base of my neck. I also started to develop a fever that did not lower with alternating APAP and Ibuprofen. The morning of the 28th my fever peaked at 102.2 and finally broke. The fire/pins and needles sensation finally began leaving my fingers so I could use my hands without feeling like I was going to drop things from the pain. The injection site was warm and red with blotchy skin surrounding it . The symptoms gradually improved but I had to see a doctor at urgent care on 11/2/21 because I had not been able to work since this had happened. I was still weak and tired easily. I was also having bladder spasms which is not normal for me. On 11/7/21 when I am writing this, I still am still moving much slower than normal and tire easily, but the bladder spasms have gone away.  I am hoping to return to work soon.
Received H1N1 and seasonal Influenza 11/6/09. Presented to clinic on 11/18/09 with swelling and pain right foot. and on 11/20/09 presented with purpuric rash and was sent to the ER.
Next day chills, body aches, headache, diarrhea, fatigue.  These symptoms had resolved by the 2nd day post-injection.
Patient started experiencing the following symptoms in the evening after receiving the vaccination.  His knees, ankles and wrists are all sensitive to the touch.  He has been lethargic since the vaccine and has had to reduce the amount of hours he has been working. He describes that all his muscles are sore and continually ache.
PT received injection, had a syncopal episode and an IV was started at site. PT received Epinephrin IM at site and was transported to local medical facility via ALS.  PT receives IV Benadryl, Zofran, Famotidine. Soulmedrol. PT also received 2L NS IV.
1ST DOSE MODERNA 1/26/2021 LOT# 041L20A; 2ND DOSE PFIZER 2/22/2021 EN6198.
stiffness; little bodyache; joint aches; headaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), MYALGIA (little bodyache), ARTHRALGIA (joint aches), HEADACHE (headaches) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MYALGIA (little bodyache), ARTHRALGIA (joint aches), HEADACHE (headaches) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), MYALGIA (little bodyache), ARTHRALGIA (joint aches), HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medications.
Pt wrote: "My tongue dries out so that my speech is affected. Drinking water helps for a while. It was infrequent at first, now it is almost continuous. My muscles around my mouth feel tired and I was drooling last night. It seems my salivary glands work more at night than in the day. I have to think about keeping my tongue moist to speak correctly. Drinking water helps my symptoms."
About 5 hours after first shot I developed a hive on my face and a red itchy rash on right hand. The hive disappeared quickly but the rash remained for a few days. 6 days after shot I developed  a rash with red blotches on right fore arm that did not itch. It lasted for about 4 days leaving little red marks. A few days after I developed a red rash on upper chest. It did not itch and quickly went away. At this time most symptoms have subsided.
Woke up with flu like symptoms. Patient wanted to have it documented as a result of the injection because he read it on line.
PAINFUL LEFT ARM STARTING ON SHOULDER RADIATING TO THE FINGER; NUMBNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced painful left arm starting on shoulder radiating to the finger, and numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful left arm starting on shoulder radiating to the finger, and numbness. This report was non-serious.
Shortly after the 2nd shot, at the 24hr mark, I felt the normal vaccine symptoms: swelling, joint aches, headache. I got over that in a week. Simultaneously, I had an acute flareup of my gout. I thought it was just joint pain, but when the normal symptoms went away, I realized the joint pain in my legs was still present. I haven't had a gout flare up in 2 years. The pain was the worse I have ever experienced. Within 5 days, I contacted a doctor. I was given a colchicine prescription. A week later, the gout cleared up. The weird thing is I feel like it is coming and going. It is unusual because when I have a gout attack, it is something that comes and leaves for about a year. Now, the gout is coming and going which is concerning to me because I have been taking care of it and it has been under control for some time now.
I started on 05/02/2021 I started having these symptoms where my pulse rate drops down to 46-48 mins per beat and it lasts for a few mins an it last for about 3-4 mins and then it goes back to normal.  An when it happens it feels like a little tightness and heaviness and it mess with my breathing and I have to stop what I am doing to be able to get it back  to normal. Two weeks ago I got Bronchitis and I have never had that before and they tested me for COVID but it came back negative and I was put on Amoxicillin 875mg and put me on a steroid, Prednisone for 10 days and they put me on the Wellbutrin inhaler.  I was weezing, coughing and congested.
Patient started with terrible migraine the day after the vaccination (3/18/21), but 2 days later on 3/19/21 patient developed rash on neck.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 26-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
APPROX 2 HOURS AFTER INJECTION, PT C/O ITCHY EYES, HEADACHE ALL OVER AND EMESIS FOR 2-3 HOURS.  SPOKE WITH THE DOCTOR ON CALL AND SENT TO EMERGENCY ROOM.  PT TREATED WITH ANTI-EMETICS, VITAL SIGNS STABLE AND PATIENT WAS DISCHARGED
Patient came for his 3rd booster Pfizer shot, he filled the covid19-immunization consent form+ the attestation form for additional dose eligibility. He didn't have his Covid card with him, we still gave him the 3rd shot per his form(Pfizer) and he came next day so we can fill the card 3rd dose and that's when we found out that he had Moderna not Pfizer.
Father was to receive the Tdap and daughter was to receive Typhoid.  Daughter has same first name as father's middle name, and both have same last name.  Nurse unfortunately administered Tdap to daughter.
really did not feel good; weakness; nausea; a little bit of vomiting; headache; Her arm felt like a brick had punched her in the arm; chills; fever 100.6-102°F; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (really did not feel good), ASTHENIA (weakness), CHILLS (chills), PYREXIA (fever 100.6-102°F) and NAUSEA (nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 since 17-Nov-2020. Concomitant products included PARACETAMOL (TYLENOL).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever 100.6-102°F). On an unknown date, the patient experienced VACCINATION COMPLICATION (really did not feel good), ASTHENIA (weakness), NAUSEA (nausea), VOMITING (a little bit of vomiting), HEADACHE (headache) and VACCINATION SITE PAIN (Her arm felt like a brick had punched her in the arm). At the time of the report, VACCINATION COMPLICATION (really did not feel good), ASTHENIA (weakness), CHILLS (chills), PYREXIA (fever 100.6-102°F), NAUSEA (nausea), VOMITING (a little bit of vomiting), HEADACHE (headache) and VACCINATION SITE PAIN (Her arm felt like a brick had punched her in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2020, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Tylenol for treatment. She also tried to sleep and drink more fluids. She is currently trying to get more rest.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This is a 75y.o. female with history of PAD with difficulty ambulating who presented on 10/5/2022 for surgery. Findings on imaging consistent with left popliteal artery stenosis. Pt underwent procedure listed above which they tolerated well without complication, see operative report for full details. She went into afib with RVR in the PACU requiring ICU admission. She was started on a cardizem gtt and converted to NSR. She was then started on a heparin gtt and transitioned to Eliquis. Patient recovered well. Hospital course significant for afib with RVR.
gradual onset of swelling/pain in lt hand/esp MCP's/ pip joints) 2-3 days p/vax also in lt shoulder, & rt to lesser degree;
Information has been received from a licensed practical nurse referring to 19 patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the 19 patients were inadvertently vaccinated with PROQUAD (Merck) (dosage, strength, route and lot# were not reported), which had been improperly stored. There was no concomitant medication reported. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not consented to be contacted.
expired dose of TYPHIM VI given with no reported adverse event; Initial information received  on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 39 years old male patient who had expired dose of typhim vi given with no reported adverse event after receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 16-Sep-2022, the patient received 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot T1E371M and 14-Sep-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 16-Sep-2022, (latency: same day) the patient had expired dose of typhim vi given with no reported adverse event (expired product administered) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  It was reported, "expired dose of TYPHIM VI given. This situation is reported as a medication error due to an expired dose of TYPHIM VI being administered to a patient".  Action taken was 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 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.
AT 5:35 PM PT CAME IN FOR HIS 2ND COVID SHOT. PT STATED THAT HE GOT HIS 1ST ONE DONE WITH NO ISSUES. AT 5:45 PM WHILE PT WAS WAITING FOR HIS WAITING PERIOD TO BE OVER, HE BECAME VERY PALE, EYES DILATED, UNRESPONSIVE, AND VERY SWEATY. I ASKED FOR ONE OF MY COWORKERS TO CALL 911, WHILE I GOT THE EMERGENCY KIT OVER TO THE PTS SIDE. AFTER ABOUT 30 SECONDS TO 1 MIN, PT CAME TO, AND WE GAVE HIM WATER AND A COLD CLOTH. WE GOT HIM ON HIS BACK, AND KNEES BENT, WHILE WE WAITED FOR EMS. I TOOK HIS PULSE WHILE WAITING FOR EMS AND DID NOT NOTE ANY BRADYCARDIA OR TACHYCARDIA. EMS TOOK OVER CARE AND FINISHED EXAMINATION IN THE TRUCK. HIS GIRLFRIEND WAS WITH HIM AND SAID SHE WOULD DRIVE HIM HOME.
Immediately after injection of HPV #1, patient states he has severe pain in left arm and neck. Patient stayed for 15 minutes with continued pain and then went home with his parent. Encouraged to take ibuprofen or TYLEONOL and apply ice pack to arm when home.
102.8 fever for 6 hours, body ache chills and for over 36 hrs, a second fever of 101.5 deg 36 hours later.
pt recvd vax 12APR95 between 9 & 10AM @ 5AM on 13APR95 pt woke w/severe itching & hives; site of vax was red & painful; pt was taken to ER & given DPh which relieved itching & hive;