chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lots# M037248 and M026309 expiration date 21-FEB-2019 and 11-NOV-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
3/23 I felt cold and shivery, had to rest and not do normal activities. 3/24 I felt like I have a fever and was hot and had to stay in bed to rest.
At time of vaccine was approximately 12 weeks and 6 days. Estimated DOD: 11/21/2021. Birth weight unknown.  Symptoms included severe pain in arm that shot was administered over the course of same day of first shot. Extreme fatigue that continued well into four days after shot, even with extended sleep and rest. By Sunday of that weekend, an intense headache developed that did not respond to OTC medications. Mental cloudiness also for duration of five days.
Patient got a localized reaction to shot. There is a aprox.4mm bump on left medial deltoid.  MD notified, gave benadryl at bedside. Transported patient and parent to ER.
Third dose of Hep B vaccine given - Adult dose 1.0cc instead of .5cc.
Cognitive fragmentation (confusion). Flu-like symptoms. Intolerance to cold and heat. Vocalizes tics-verbal and jerking movements, headaches.
Patient called pharmacy a few hours after administration and reported an injection site reaction.  Patient reported swelling, bruising, and a knot around the area of vaccination. Patient had an unusual amount of bleeding at time of vaccination, so there is the possibility that reaction was due to the hitting of a blood vessel, which may resulted in a hematoma. Again this reaction could be related to the bleeding or to a possible allergic reaction. Patient reported 4.
On 3/25/2021, I started having chills; since then I have been running a fever; temperature up to 101.    I predominately have the fever and muscle ache.  No loss of taste or smell.  Some diarrhea (2X).
Erythema and induration at site about 5cmx2cm. Multiple excoriated papules on trunk
Blood clots; internal bleeding; impaired vision; hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 22Jun2022 at 07:18 as dose number unknown (booster), single (Lot number: EW113, Expiration Date: 01Mar2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots"; INTERNAL HAEMORRHAGE (medically significant), outcome "unknown", described as "internal bleeding"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "impaired vision"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional information: Patient was not breastfeeding at the time of administration.  SUSPECT PRODUCT is under agreement with BIONTECH.  No follow-up attempts are possible. No further information is expected.
(R) arm redness, warm, itching. Patient was/received BENADRYL 50mg IM on (L) thigh.
had mentioned that her friend was tested positive even after having the 2 doses of the vaccine.; had mentioned that her friend was tested positive even after having the 2 doses of the vaccine.; This is a spontaneous report from a Program. A non-contactable consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer had mentioned that her friend (patient) was tested positive even after having the 2 doses of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unspecified date. Outcome of events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101300582 same reporter/drug/event, different patient.
Within 60 sec of receiving vaccines, pt held breath and lost consciousness for approximately 30 seconds, after which she vomited, HR was in 40's and returned to baseline of approximately 70 BPM over next 2-3 min. Within 15 min, pt denied any ongoing symptoms.
Severe, uncontrolled shaking from chills, Fever, Angry red blotch (12cm x 13cm) on arm at the point of vaccination.  Vaccination site became hot to touch, EXTREMELY painful and redness continued to increase in size for following 3-4 days.
Information has been received from a registered nurse (R.N.) concerning a female child in elementary school (who is between grades 3-5) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that an outbreak of chickenpox began in an elementary school in November 2005. "Recently", "since November 2005", the female child developed chickenpox and sought unspecified medical attention. No outcome was reported. No product quality complaint was involved.
Initial report received on 11 May 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of DAPTACEL; lot number C2799AA received on 04 March 2008, lot number C2951BA received on 07 May 2008 and lot number C2951BA received on 10 July 2008 and 1 dose of PENTACEL; lot number C3397AB received on 15 July 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 30 March 2012, approximately 2 years and 8 months after the last dose. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 01 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination.  Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not  receive  any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
arm swelling, low grade fever, lymph edema.  painful movement and swelling from arm to trunk area
drooping to one (right)  side of the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of FACIAL PARALYSIS (drooping to one (right)  side of the mouth) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental cleaning in February 2021, Facial swelling (after her first Sculptra injection which lasted 3-4 days before it resolved.) in January 2021, Facial paralysis and Pain. Previously administered products included for Product used for unknown indication: Sculptra Aesthetic in January 2021. Concurrent medical conditions included Seasonal allergy and Osteoporosis. Concomitant products included ALENDRONATE SODIUM (SODIUM ALENDRONATE) for Osteoporosis, VITAMINS NOS for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced FACIAL PARALYSIS (drooping to one (right)  side of the mouth) (seriousness criterion medically significant). On 21-Jun-2021, FACIAL PARALYSIS (drooping to one (right)  side of the mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was injected with Sculptra Aesthetic January 2021 (exact date unknown) to the lines above and below mouth. Patient was injected again with Sculptra Aesthetic on 21-Jun-2021. Patient reported pain during both injections, but she stated it was tolerable pain during the January injection and the injection in June was incredibly painful, lasting several hours. Patient noted lack of effect since her January injection and also after her June injection. Patent had swelling to her entire face in January 2021 after her first injection which lasted three-four days before it resolved. The lack of effect was still there. Patient contacted the HCP and was recommended a second treatment and super photo facial (second treatment and super photo facial done on 21-Jun-2021. HCP stated to patient that it takes eight months to see optimal results.    Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Sculptra aesthetic (drooping to one side of mouth for 2 times) could be a contributory factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Sculptra aesthetic (drooping to one side of mouth for 2 times)could be a contributory factor.
Developed pain, numbness, and paresthesia in right leg; Developed pain, numbness, and paresthesia in right leg; Developed pain, numbness, and paresthesia in right leg; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 26-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), OTC antihistamines and multivitamins all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 27Mar2021, 72 hours after first vaccination, the patient experienced pain, numbness, and paresthesia in right leg. The symptoms improved but did not resolve over time period until next vaccination. Symptoms recurred significantly within 24 hours after second vaccination and had yet to improve or resolve 7 days post second vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with physical therapy and unspecified medications and awaiting neuro appt. The clinical outcomes of the events pain in right leg, numbness in right leg and paresthesia in right leg were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever 99.7 degrees F for 24 hours; hamstrings painful enough I couldn?t sleep for 10 hours; ankles, knees and hips very tight and sore for 24 hours
Fever - evening of vaccine - blisters on hands, face, and in mouth next day.
This spontaneous report was received from the mother of a male patient of unknown age. There were no concurrent conditions, concomitant medications and medical history reported. The patient's mother reported that her son was administered RECOMBIVAX HB outside of the 3 dose schedule for children.  The vaccine was administered on 15-JUN-2012, 09-AUG-2012 and 17-OCT-2012. The last dose was administered at 4 months instead of 6 months. The reporter stated that "the county department of health had informed her that a booster was required, and she needed to reply to the county health department by the beginning of January 2019".
Tested positive for covid with - Headache, low grade fever that lasted less than 48 hours and never got over 101. It was mostly in my nose, head was congested and slight sore throat from post nasal drip. And I had body aches and fatigue. It was mild and the total days of symptoms was 4-5 days from headache to feeling much better. Also 3-4 days after the vaccine, my toes the skin at the base of my toe to the rest of my foot was cracking. And I don't have any problems with my feet. The skin cracked and was bleeding. My toes were red/bluish color and were swollen from the middle of my foot up through the toes-- not my lower leg (heel, ankle).This happened both 1st and 2nd doses about 3-4 days after and lasted each time 3-4 weeks before clearing up.
First, volume of vaccine is 0.7 ml,  VIS version date is 08/15/2019,  exp. date is  06/30/2021.  I started having sciatica pain from left buttocks radiating down the back of my left leg. Still have the pain.
Extreme Arm Pain.  (could barely move my arm) Low-grade fever 99.9,  Instense and persistent headache that lasted 36 hours that would not be relieved with Tylenol.  Aches and Pains, Nausea for 36 hours almost like stomach cramping.  Very lethargic but couldn't sleep
Metallic taste in my mouth within 15 minutes of the shot. Sharp pain on left shoulder blade. Around 7 pm sore throat and I began to lose my voice.  Throat started swelling and my heart was racing.  I alsoI began feeling lightheaded like I was going to faint. My husband rushed me to the ER.
At 11:46 am on September 8, 2022, patient, 29-year-old male with no prior history of syncope, received his second Jynneous Monkey Pox Vaccine dose and went to observation. 11:48 pt sitting in a chair,  began to feel lightheaded, slid down the chair, fainted and fell to the floor, on his left side. His head hit the floor, his glasses fell off, and he sustained left eyelid laceration, approximately ¾ inch, which was actively bleeding.  EMS, MD, Nursing and Safety officer responded to the incident.   Initially, pt. was unresponsive, but within seconds he was responding appropriately to questions. He complained of pain over his L eyelid, feeling lightheaded and weak, without complaints of nausea, vomiting or headache. Prior to vaccination, he had eaten a full breakfast and he drank >32 ounces of water. Medications included Descovy. Patient was further evaluated. Vital signs were taken, and pressure was applied with sterile gauze to laceration, which was cleaned with normal saline. Patient was moved onto his back with legs elevated and initial pulse oximetry was 98% Blood Pressure 100/68 and Pulse was 51. Limited physical exam was unremarkable except for L eyelid laceration.  After initial assessment, 911 was called by MD. Second set of vital signs were taken. Pulse Oximetry was 98%, HR 49, BP 126/80. On arrival,@12:05pm Fire Department evaluated patient, who was alert, oriented, communicative, and answering question. An IV was started with normal saline, glucose reading was 121. @ 12:10 pm. Patient reported symptoms resolving.  Patient sat up for vital signs, but complained of feeling lightheaded again. BP sitting was 105/47, and patient was repositioned on the floor. 12:15 Vital signs were repeated by Fire Depart and reported to be stable. Patient reported feeling better. Active bleeding from laceration had subsided. He was moved to stretcher, and @12:20pm he was taken to Hospital ER at for further evaluation and suture of laceration.  He was accompanied by his brother.
swollen lymph node is axilla and sore arm. First noticed on 1/24. Have taken ibuprofen. Symptoms improving but still present. Will use warm packs and ibuprofen for symptom management.
Starting at 2:00am on 4/9/2021, Patient reports cold sweat and headache. She attempted to go  to work on 4/10/21 but felt weakness when walking so patient went home. She is still experiencing headache, weakness, and some diarrhea.
Extremely dizzy. Room was spinning very fast.  It hit me out of nowhere.  I had driven home from work, took dogs outside, came in and suddenly I was forced to sit down.  I laid down and the spinning subsided. I sat up & was still slightly dizzy, but no room spinning.
Within 6-8 hours of receiving vaccines, patient experienced difficulty breathing and shaking (lasted 10-12 hours after onset); raised, red rash that extended down to elbow from vaccine site (rash gone in 4 days, swelling/raised gone in 5 days from onset); sore joints and extreme stiffness - debilitating, could not get out of bed for a few days (patient is still sore as of 10/13/13 but is mobile). Patient called physician and took NSAIDs to relieve stiffness. Breathing difficulty subsided and physician did not feel therapy was necessary. No antivirals were taken and no hospitalization occurred.
Pt is 20 yo female s/p Pfizer vaccination: dose 1 on 5/26/2021 and dose 2 on 6/16/2021. She has a history of recurrent germ cell tumor currently cycle 1 weekly taxol. Chemotherapy at time of vaccination: Taxol desensitization, Ifosfamide, Mesna and Cisplatin. Admitted with fevers and COVID+ on 8/11. She presented with reports of fevers, chills, productive cough, and SOB at home. Also complaints of nausea/vomiting, with limited ability to take in PO. CXR with evidence of opacity at the left base concerning for pneumonia. COVID swab was positive on admission. She was started on broad spectrum antibiotics with cefepime and vancomycin. Her MRSA swab was positive. For her COVID, she was started on remdesivir and ID was consulted. She received three days of remdesivir with resolution of symptoms. She was discharged with 30 days of prophylactic eliquis. ID recommended discontinued cefepime and vancomycin as symptoms could be explained by COVID. Remained afebrile off antibiotics for 24 hrs prior to discharge. She had hypokalemia and hypomagnesemia during her hospital stay in the setting of poor PO intake. K and Mg were repleted and she was sent home with a seven day supply. She will have labs re-check on 8/17/21. She also had an AKI up to 1.35, she will have labs re-checked on 8/17. Discharged on 8/13.
This spontaneous report has been received from a Registered Nurse and refers to an unspecified amount of unspecified patients of an unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ orally, VAQTA, RECOMBIVAX HB, GARDASIL 9, VARIVAX and M-M-R II  (doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for any vaccine) for prophylaxis. The administered dose of the vaccines experienced an unknown temperature excursion for an unknown period of time, it was called by a data logger. There was a previous temperature excursion; however the details were unknown. The sterile diluent was stored properly. No adverse effects were reported.
Cough began 12/27/20 followed by severe migraine on 12/31/20.
THERE IS A REDISH DISCOLORATION ABOUT 3 INCHES IN DIAMETER NEAR THE SITE OF VACCINATION.  UPON TOUCH, THE SKIN FEELS SLIGHTLY HARDER THAN SURROUNDING SKIN.  PATIENT REPORTS NO PAIN OR IRRITATION AND SHE HAS FULL MOBILITY OF HER ARM.  SHE REMARKS IT ONLY CAUSES PAIN WHEN SHE PUTS PRESSURE ON IT OR SLEEPS ON HER RIGHT SIDE.
Pt had COVID infection with loss of taste and smell 1/2021. Completed last dose of Pfzier COVID vaccine 2/12/21. One month later noted distorted odor with foods, continues to have parosmia now without improvement