chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 events :  1st-4/15- Hives on both arms.  Just watched them and kept an eye on them and used  Benadryl and anti-itch cream, postponed allergy shots from Friday 4-16 until Monday 4/19.  Hives went away in the next day or two.  2nd event-Lower right back pain achy off and on and eventually wrapping around to the right side.  Went to urgent care on 4/29.  They did a CT with contrast and found a large kidney stone that I would not be able to pass without surgery, referred to neurologist. Saw neurologist on 5/3,  kidney X-ray confirmed an 18 mm kidney stone in my right renal  pelvis. Scheduled lithotripsy with stent placement on 5/10. Had  that done on 5/10. Had follow up kidney X-ray and stent removed on 5/17.  Then on 5/24 another follow up kidney X-ray. Results weren?t easy to see due to gaseous distention but he thought I had passed most of the larger particles. Will see him in 6 months. May see him sooner because I?m still experiencing achy  pain in the same areas off and  on  that same side.
pt recvd vax;exp ringing in ears & edema & pain at inject site;
headache; nausea; fever; arm hurts a lot; feel very bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced headache, nausea, fever, arm hurts a lot, feel very bad. Patient received yesterday the COVID-19 vaccine (Pfizer-BioNTech). Today patient woke up with a headache, nausea, fever, and patient arm hurts a lot. Patient couldn't go to work, patient feel very bad. What medicine can patient take. Patient is 65-years old, recently received her first dose. Agreed to be contacted by the Safety Department, declined to file a report on www.pfizersafetyreporting.com. Consumer already contacted her Doctor and is waiting for a response. She is welcomed to call for future medical questions related to the COVID-19 vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (03Apr2021): Follow-up attempts are completed. No further information is expected.
dark urine; liver pain; light colored stools; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose 1, single), for Covid-19 immunisation; Moderna vaccine (Dose 2, single), for Covid-19 immunisation; Moderna vaccine (Dose 3, single), for Covid-19 immunisation. The following information was reported: FAECES PALE (non-serious) with onset 2023, outcome "unknown", described as "light colored stools"; CHROMATURIA (non-serious), outcome "unknown", described as "dark urine"; HEPATIC PAIN (non-serious), outcome "unknown", described as "liver pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that "I have had 3 previous Moderna vaccines. I received a Pfizer vaccine ( I thought it was going to be Moderna) in Oct2023. I have never had any ill side effects until the Pfizer shot. I have a fatty liver. I am tested for liver enzymes every 6 months. My enzymes are always low, 20 and around 17-19. After the Pfizer shot I had light colored stools and dark urine for 10 days. I had AND HAVE liver pain.".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
When patient came in for his second dose, a vial was pulled from the fridge and administered that had been out of the freezer for more than 30 days (30 day expiration was 10/9/2021 and administered on 10/13/2021). We notified the patient immediately upon discovery and reported this event to Moderna. Moderna responded stating the second dose given past 30 days out of the freezer was not studied. They also stated the dose should be repeated immediately (no minimum interval), but to be given in the opposite arm. Patient states roughly 24 hours from the additional vaccine dose he experienced difficulty breathing, swelling of lymph nodes and swelling of tongue/throat. He went to the local ER where he was treated.
Pt reported burning after injection. Waited and left store ok. Called back reporting swelling and tingling at L arm. Recommended she go to ED.
This spontaneous pregnancy report as received from a consumer who called to report her daughter, a 15 years old female patient. The patient's history of previous pregnancies and live births is not known. Patient had no pertinent medical history and no drug reactions/allergies. On an unknown date within 6 months (estimated as June 2012), the patient was vaccinated with GARDASIL (lot#, dose and route unspecified), and patient got her last injection on 04-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-DEC-2012 the patient got pregnant during her GARDASIL regime. The LMP and EDD is not known. Initial exposure to GARDASIL was at 0 week(s) (reported as Pregnant Gestation: 1 Trimester). No treatment information was reported and no lab diagnostics studies performed. The outcome of the event was unknown. Patient sought medical attention: called physician. No further information is available. Follow up information as received from the physician who reported that the baby was born full term and was normal and healthy with no anomalies. Additional information is not expected.
feeling achy all over; This is a spontaneous report from a Pfizer sponsored program COVAX US Support reported via non-contactable consumer or other non hcp(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling achy all over (pain). The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Father reported to school nurse on Mon 5/24/04 that son's left arm swelled and was itching and reddened at deltoid injection site on Saturday 5/22 AM. Father said when he questioned son, child said the swelling and itching began on Friday 5/21/04 PM. Father also said he believed him to have a slight fever and administered Tylenol. Father also said he noticed scratch at sons left wrist and slight swelling at arm began at wrist. School nurse notes swelling at bicep on Monday 5/24/04. Per father, child not seen by physician over the weekend.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm. This case is link with case US2020028073, reported by same reporter. Reporter consented to follow up.
Developed nausea approx 7 hours after vaccine given.  Started vomiting approx 9 hours after vaccine given.  Continued vomiting for the next 6 hours.  Felt better the following morning of 11/12/21.  No treatment was given.
patient was accidentally given the liquid portion of Menveo; patient was accidentally given the liquid portion of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 30-NOV-2023) for prophylaxis.   On 07-JUN-2023, the patient received the 2nd dose of Menveo. On 07-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was accidentally given the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient was accidentally given the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 The reporter was a. medical assistant. The reporter called to report that a patient was accidentally given the liquid portion of Menveo and wished to know how to proceed.  The partial information about event, vaccine and patient was collected.  The reporter gave only partial information and ended call on own accord. The Vaccine Administration Facility was the same as Primary Reporter. The reporter called to report that a patient was accidentally given the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a non-contactable consumer. This (age: 56, unit: unknown) female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 30Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Patient was tested positive for Covid today, 14Jan2021. She was scheduled to get her next dose 20Jan2021. She had no symptoms. She received a negative Covid test result yesterday (16Jan2021). She would be quarantining for 2 weeks. Outcome of events was unknown.  No follow-up attempts are possible; Information about Lot/batch number cannot be obtained.
2SEP97 pt recv vax & 4SEP97 rash-zoster in T4 dermatome resolved w/o tx;
HYPOXIA 11/24/2022 &  3/5/2023  --
Patient experience syncope approx 10 minutes following  vaccine. Episode was lasted less than five seconds and patient was coherent nearly immediately after losing consciousness.
This spontaneous report as received from a pharmacist refers to a 16 year old female patient. On 23-OCT-2013 the patient was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscular in the left arm, lot number not reported). On 23-OCT-2013 after receiving GARDASIL, in the medical office, the patient became unresponsive while still in the office. The patient's eyes were open and she exhibited tonic clonic movements. She did not lose function of her bowels or bladder. This occurred over a 1 minute period and then the patient became alert. No lab test performed. The patient was observed for 20 minutes and then left the office. The outcome for both events was reported as recovered on 23-OCT-2013. The relatedness between GARDASIL and events was not reported. Additional information has been requested.
Redness, swelling, tenderness on 09/27/04. No generalized reaction.
51 yo with h/o depression, PTSD, and poorly-controlled DM presents to the ER with SOB and rash. He relates that he received the flu vaccine yesterday and shortly thereafter began to feel tightness in his throat and SOB. Today, he also noticed diffuse maculo-papular, mildly pruritic rash on his back, chest, abdomen, face, and upper legs. He denies new exposures. Apart from getting flu shot there was no other new medications. The patient has been getting flu shot every year without any reactions in the past. Symptoms: Erythema Multiforme & dyspnea. Treatment: Methylprednisolone, diphenhydramine, ranitidine.
while in school noted by teacher pt stiffened w/clonic tonic movement of extremities for few seconds; pt was afebrile @ time, lethargic for aobut 2 wks;
Fever, rash at injection site, seizure, high pitched screaming for 24 hours. Did not want to be held, screamed whenever touched.
Patient received a different dose; Syringe issue; Underdose; A spontaneous report was received from a pharmacist concerning a unspecified age of male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patient received a different dose, syringe was disconnected from the needle/ syringe Issue and lost half a dose approx/ Under dose.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number:032M20A) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection.   On the same day, prior to receiving mRNA-1273, the syringe was disconnected from the needle and lost half a dose approx. Therefore patient received a different dose. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, syringe was disconnected from the needle and the patient received half a dose approx. were considered resolved on 11 Mar 2021.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Not sure if the site of injection being my left upper arm may have been impacted because it is the mastectomy side from a lobular stage 1 breast cancer diagnosis with no lymph  node involvement is a factor but about two hours after the injection I started feeling pain at the injection site that worsened  at about 5 hours post injection such that there was some swelling at the site and sustained pain that traveled further down my arm and it was difficult to lift my arm at all.  The next day the pain had not subsided at all and I finally took two Exceddrin extra strength tablets which helped but I realized I was feeling sore under my armpit and determined I likely was experiencing a sore lymph node.  It took about 5 days before the stiffness and soreness at the inj. site become almost  unnoticeable.  I had a headache for about three days, felt fatigued more than usual and refrained from doing anything requiring much exertion and even a week later felt sluggish with a bit of either sinus allergy from all the pollen or possible something going on as I had greenish mucous when blowing my nose.  Mostlly I was surprised that under my arm I was sore even as the injection site had become tolerably sore.
Breakthrough case admission after 4 vaccines  Moderna 1/4/21 Lot# 025J20A;  Moderna 2/1/21 Lot# 012L20A;  Moderna 11/17/21 Lot# 067F21A;  Moderna 6/10/22 Lot# 014B22A
At the beginning first 2 weeks I exp. pain in my muscles, fever, headaches, vomiting, fatigue and nausea. At the injection site of my right arm was red and pain. After a week the nausea disappeared I started to exp difficulty breathing. I felt as if when I'm breathing it wasn't going inside of my body still having breathing issues to this today.
I went to the doctor in February 2023 for a routine appointment.  I had my usual lab work done.  The doctor found Anti-Phospholipid Antibody Disorder.  I was seen by an anticoagulation clinic and began taking Warfarin.  Subsequently after being on Warfarin for 3 weeks, the doctor decided I could try taking a coated aspirin until further blood tests were taken in the future.
Numbness in left arm. Improving. Acetaminophen 650 mg given.
I did have Covid in between vaccine 1 and vaccine 2; I did have Covid in between vaccine 1 and vaccine 2.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 11:00 (Batch/Lot number was not reported) as single, dose 2 via an unspecified route of administration, administered in right arm on 06Apr2021 11:00 (Batch/Lot number was not reported) as single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did have COVID in between vaccine 1 and vaccine 2 on an unspecified date with outcome of unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client into clinic with c/o pain and swelling of left upper arm after receiving TD on 04/30/2001. RN unable to verify induration or erythema. client also with complaint of left cervical lymphadentopathy. Client stated she is concerned about the possibility of serum sickness. Convinced client to see PP on 05/17/2001  stated improved but soreness moved up to right . Has appt today with PP.
from my shoulder to me elbow was swollen, warm , red, and painful, fever, fatigue, hives, confusion. was told not to have further vaccines due to risk of a more severe reaction.
Began with what felt like menstrual cramps in lower abdomen between 2-4pm, became worse and felt like painful gas in mid abodmen. Intense pain continued non-stop for 24 hours not allowing sleep. Never felt such intense pain for so prolonged a period. Was the worst experience. At 5:30 am on 5/28/21 began vomiting and could not hold down liquids or food for 7 hours after. Took Ibuprofen at 8am and was able to sleep for a small time. Continued to use as directed in order to rest until around 5pm that evening. At this time was finally able to eat and drink. Pain subsided after 24 hours of initial cramping. Constipation for the next 24 hours until 5/29/21. Stomach was still a bit upset days later. After a few days energy was back up, rest, food and water was as normal.
vesicular lesions legs, arms, face, chest, back, ears;tx atarax syrup;
fever; she is not able to hold herself up to walk; ringing in her ears/buzzing in her ears; pain in her lower back has become stronger/pain in the lower back worsened; severe headache; she can't even stand; she can't walk; little bit of pain in her lower back; very tired; really thirsty; my lips felt like I had become dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: EW0191) via an unspecified route of administration in arm right on 27May2021 15:00 (at the age of 46-year-old), as a single dose for COVID-19 immunization. Patient medical history included fever. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 06May2021 (at the age of 46-year-old) as a single dose for COVID-19 immunization. It was reported as patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 27May2021 at 15:00. The next day she went to work but two hours later she had a severe headache, fever and some pain in her lower back. The next day she was fine but since yesterday the pain in the lower back worsened. Today she woke up with such pain that she can't walk, she can't even stand, she feel like she have a fever and a ringing in my ears. The day after the vaccine, she felt very thirsty, her lips felt like she had become dehydrated. She is also very tired. On 01Jun2021 it was reported as the pain in her lower back has become stronger, on 02Jun2021 it was reported as she is not able to hold herself up to walk today. She is feeling feverish and has ringing in her ears and buzzing in her ears. She also stated that the next day after receiving the vaccine she was really thirsty and feels like she's dehydrated. She took Ibuprofen. Her right arm didn't ache but she had the other symptoms. She had to get the COVID 19 vaccine because she works with a lot of people. She had to get the vaccine for work. She reports she has no other medical conditions and she only takes Ibuprofen if she has discomfort. She works as she normally does. These symptoms she had with the second dose are normal symptoms. She was told to treat her symptoms in her house. She has the symptoms listed above and pain in her lower back on the left side but now she can't support herself to walk. On the day after she received the COVID 19 vaccine she was thirsty and she felt tired and she feels buzzing in her ears. Outcome of events headache, Fever, really thirsty, Dehydration, Difficulty in standing, Unable to walk was unknown and not recovered for other events.  Follow-up attempts are possible; Additional information is been requested.
Temperature of 101°F; Sore arm; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Not feeling well) and PYREXIA (Temperature of 101°F) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MALAISE (Not feeling well). On an unknown date, the patient experienced PYREXIA (Temperature of 101°F). At the time of the report, PAIN IN EXTREMITY (Sore arm), MALAISE (Not feeling well) and PYREXIA (Temperature of 101°F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 101°f (High) 101°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include migraine medication, No treatment information was provided.
Contracted COVID-19 in less than a week from the first vaccination, and developed pneumonia.  My symptoms and signs were cough, loss of appetite and  fatigue.