chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A 90 (Age: 90; unit: unknown) male patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 27Jan2021, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.   The reporter stated that the patient received vaccine yesterday and have only developed a sore arm. Reporter asked, if this means the vaccine isn't working? The outcome of event sore arm was not reported.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085223 Same reporter/drug/event, different patient.
Two days after receiving the shot I started a heavy period and have not stopped for 3 months. My drs don?t know why and I have had strong cramping. I have not had a period in over 3 years
Pt reported site was red after immunization when she went home that night on 8/29. Stated next day it was red and larger. 8/31 at around 5 PM she came with husband to the pharmacy. Are at vaccination site was large, red, had two dime size blisters, and many tiny white spots around the area. Told pt if the area continues to get worse or doesn't get better soon to contact her Dr. Told pt to try an astringent on it to pull fluid out(Domeboro). Pt also reported a low grade fever. Told pt to take ibuprofen or Tylenol to keep fever under control.
pt started having elevated temperature about 2 hrs p/DTP; temp went to 105.7 mom reports say gave APAP & sponge bath; had fever x 12 hrs; temp went to 101 p/about 3 hrs; pt was fine p/12 hrs;
First 3 days, I had a headache and trouble sleeping. This turned into flu like symptoms for 4 days. I?m still experiencing flu-like symptoms (congestion, cough, malaise, nausea, headache).
swelling in the throat; difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a 73-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced throat swelling and difficulty breathing. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the throat swelling and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the throat swelling and difficulty breathing to be related to Influenza vaccine.  Additional details were provided as follows: The patient received an unknown flu vaccine 6 years ago and experienced swelling in the throat and difficulty breathing.  The patient was also taking an unspecified antibiotic at the time. The reporter consented to follow up. The pharmacist would be reaching out to the patient's doctor's office to determine which flu vaccine was administered.
jul89 pt vax 2nd hepta B. pt ex paresthesia in extremities and weakness in her gait.  MD made provisional dx of multiple sclerosis.  susequent info indicated pt was dx w/ peripheral neuropathy.  pt recovered.
4 hours after injection, developed pain radiating across shoulders and neck to right arm. Subsequently developed generalized muscle and joint pain, including Achilles tendons, and ear pain.  Developed fever @12 hours after injection, followed by loss of taste and smell.  Fever lasted a few hours; treated with Tylenol.  Loss of taste and smell persists as of this date, with only partial resolution.  Transient vaginal itching/burning at 24 hours after injection; resolved after a few hours. Diarrhea for a few days, starting about 48 hours after injection.  Generalized fatigue for about 2 weeks
Vomiting x 4, fever, chills, body aches, headache, sweating
Tested COVID positive 1/13/2022, sever, went to hospital 1/18/2022 e/t shortness of breath, SPO2 dropped below 92% .  Was admitted for respiratory failure s/t COVID infection 1/18/2022 - 1/21/22, returned to ER with severe asthma attach and discharged home 1/22/22, returned to ER 1/22/22 with ongoing asthma attack, admitted 1/22/22-1/24/2022, discharged home on 2L Oxygen nasal cannula. Continue to experience shortness of breath, especially on exertion, and continue to need oxygen QHS.  Noted cognitive delay
Very tired, fever and chills, cream colored stools X 2 days, post vax. Loss of appetite and headaches everyday since injection. Has private insurance. Referred to PMD. Appt scheduled for 8/2/01 at 09:00.
Hypotonic rxn following DTP; pt returned to office & was observed for 1 hr p/which he appeared to be completely normal
Pt c/o arm being red, itching, sore and swollen.  States "it's warm to touch and Saturday it was the size of a baseball in diameter (resolved).  Pt took Ibuprofen and alternated ice pack and heat to site. States it is better but still itches.
Pupils dilated and he couldn't see.; Pupils dilated and he couldn't see.; shaky; rigid; and was very hot to touch; This is a spontaneous report from a non-contactable consumer (patient). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0202), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. No medical history was reported. Patient had no known allergy. Other medical history was none. No concomitant medication was reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced pupils dilated and could not see, shaky, rigid, and was very hot to touch on 05Jun2021. This was within a few minutes of receiving the vaccine and lasted about 20-30 minutes. Seriousness criteria was reported as no. As AE treatment, Pharmacist used cold compresses and gave him juice. The outcome of the events were recovered on 2021.  No follow-up attempts are possible. No further information is expected.
arm is sore; little muscle soreness; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 05Feb2021, at single dose, for COVID-19 immunization. Medical history included being disabled. The patient's concomitant medications were not reported. The patient reported he had his shot on 05Feb2021. In Feb2020, his arm was sore and had a little muscle soreness. The patient stated that he goes to the gym and has a hard work out and asked if it was okay to take Tylenol or Motrin. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this; Can hardly walk; Going to die; Pale; Sweating; Acid reflux; Cant lay down/couldnt life head; Cough; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Difficulty breathing), INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk) and FEELING ABNORMAL (Going to die) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced COUGH (Cough) and DYSPNOEA (Difficulty breathing). On an unknown date, the patient experienced INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk), FEELING ABNORMAL (Going to die), PALLOR (Pale), HYPERHIDROSIS (Sweating), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and IMPAIRED QUALITY OF LIFE (Cant lay down/couldnt life head). The patient was treated with CODEINE for Cough, at an unspecified dose and frequency. At the time of the report, COUGH (Cough) had not resolved and DYSPNOEA (Difficulty breathing), INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk), FEELING ABNORMAL (Going to die), PALLOR (Pale), HYPERHIDROSIS (Sweating), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and IMPAIRED QUALITY OF LIFE (Cant lay down/couldnt life head) outcome was unknown.            Concomitant product information not provided. Treatment medications also include antibiotics, allergy pills, used inhalers, spray for nose.  Patient stated in June the coughing went down and on July 8th it came back. Now the coughing is ongoing. Patient states she was told to quarantine for 14 days, when she went for her second dose. Consumer states she was not tested for COVID. Consumer also states she had COVID, as far as she known. Patient administered Pfizer booster dose.
Tightness is left deltoid, slight swelling, redness, itching, and warm to touch.
Signs of Bells Palsey on left side of mouth and face.  Numbness started within the first 5 minutes of Covid shot.  Has have numbness every day since in left side of face.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-NOV-2014 the patient was vaccinated with an improperly stored dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Hematoma at injection site accompanied by menagerie of pimples, lasting more than one week. Two weeks later, injection site still produces pimples and remains sore. Headaches and sleepiness the day of.
Short of breath; Pain at injection site; A spontaneous report was received from a 57 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced short of breath/dyspnea and injection site pain.   The patient's medical history was not provided. The concomitant medications on use were also not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their dose of mRNA (Batch/Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On unknown date, patient experienced pain at injection site and short of breath.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events pain at injection site and short of breath were unknown.
Red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE RASH (Red rash at the injection site). At the time of the report, VACCINATION SITE RASH (Red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
got COVID; got COVID; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The reporter's parents got Pfizer as well as her brother (patient) and sister got Pfizer and she doesn't want to get COVID. All 15 got COVID and all but 3 had vaccinations and she couldn't imagine what would be like. She had a couple family members get COVID and one got Pneumonia. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: all got covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt who delivered a baby in 11/1998, was given second dose of varicella virus vaccine live in 03/1999.  The pt has not had a period since the delivery of the baby. She is now pregnant.
04/10/2019: Follow up received from patient: I forgot to include that I felt a very slight nausea when the headache started (evening of 4/3) and had no appetite the following morning.   9:30 PM beginning of a mild dull head ache;  11:00 PM -10-15 minute coughing spell bringing up generous amounts of clear mucus;   1:30 AM awakened with body wracking chills which lasted 3 hours; at 2:30 AM I took 2 Tylenol and added more blankets.  The following morning (4/4) , I was extremely tired and a bit weak but by noon time I felt able to eat and felt better as the day went by.
No adverse reactions per Patient. Patient received adult dose instead of pediatric dose. Patient was receiving a purchased vaccine. Medical assistant asked Provider to verify vaccine.  Patient being 19 years 5 months provider ok'd adult dose of vaccine. Patient was made aware and spoke with patient offering several options that were declined because he stated he was fine and will be checking if he has immunity in a few weeks.
Patient was fevered (up to 101.9), fatigued, sweating profusely, and coughing on both 12/11/2021 and 12/12/2021.  These issues had resolved by Monday, 12/13/2021. At 9:30 AM on 12/13/2021, patient called his wife reporting left leg pain and weakness. She advised him to go to emergency room which he did.  She says that he collapsed in the lobby of the ER department because his leg "wasn't working"  It was discovered that the patient had atrial fibrillation(which had never been diagnosed before) and an arterial blood clot in his left leg. He was transported from there to Hospital and was currently in surgery at the time this information was gathered (4:30 PM 12/13/2021). Patient's expected stay, without complications, is 2 to 3 days
I've had a sudden onset of tachycardia, with dizziness, difficulty breathing, and pain in my chest. So far after going to the doctor, they have not been able to find the cause. It was at one of these appointments that I was talking to a nurse at let me know other women have been through with similar problems and it might be do to the vaccine. In the case that it is caused by the vaccine I wanted to report it in some way. From the experience I've had not be taken seriously about my symptoms, I could understand that it may be something that is under reported in women in particular.
nurse administered expired vaccine to patient with no adverse event; Initial information regarding this unsolicited valid non-serious case from a pharmacist was received on 12-Oct-2020.  This case involved an unknown age patient received a 0.5 ml once dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot number- UJ292AB, Expiration date- 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination on an unknown date. (Expired product administered)   The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications was not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: Same day).  At the time of reporting, patient had no adverse 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 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.
After administering 3 vaccines, patient sat with his mom and started to fall asleep after about 3 minutes saying he felt sleepy when mom asked. Patient face and lips were pale, denies dizziness. Offered him candy and a juice box with color returning to his lips and he stated again he wanted to sleep and fell asleep. Mom reports him wanting to sleep after "ouchies" before but not like this and not after vaccination.   Before vaccination patient was active and was not napping before appointment.   Patients mom continues to wake him up and he plays with phone.   Continued to observe for additional 15 minutes. Patient walked, talked, and played normally. Mom says she will call their pediatrician.
Patient received first dose of influenza and was fine.  I waited a minute and administered boostrix.  Within a minute of receiving the boostrix vaccination, he showed signs of vasovagal syncope.  He was sitting in a chair the whole time so he was safe and there was no injury.  He came to within a minute but was showing signs of sweating.  He was fine within 5 minutes and was under careful watch for the next 15-20 minutes.  During this time he was given a lollipop and water.  After this time he said he was fine.  He stayed at the location for another 15 minutes, walked around,  and then was driven home by his wife.  I followed up with wife an hour later and she reported that he was fine.  Patient reported this had happened previously when he received 2 shots in the same visit over 10 years ago but could not recall which vaccinations were given at that time.
11x13 erythema on left anterior thigh. Warm to touch. Low fever with body aches and general malaise.
surgery for twisted intestine; issue with their throat, was not being able to swallow; A spontaneous report was received from a Consumer concerning an 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Volvulus and Dysphagia.    The patient's medical history was not provided. No relevant concomitant medications were e reported.    On 13-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 27-Feb-2021, the patient experienced the events Volvulus and Swallowing impaired and the patient was hospitalized for 12 days. The patient underwent surgery for twisted intestine. The patient had an issue with their throat that has not been settled and was not being able to swallow. It was not related to the vaccine at all. The patient was discharged on 11-Mar-2021. The second dose was scheduled on 13-Mar-2021. As they could not drive and take their second dose. it will be re-scheduled.   Laboratory details were not provided.  Treatment details were included sodium chloride 1 gm 3 tablets by mouth three times a day with meals and potassium chloride 2 tablets by mouth everyday for 5 doses.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Volvulus  and Swallowing impaired was unknown.  The reporter did not provide the causality between the events Volvulus  and Swallowing impaired and the study drug.; 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.
10-3-13 pt felt achy, 10-4-13 fever 100.4 degrees felt fatigued, took ALEVE, took fluids felt like she had the flu, has improved each day since 10-4-13.
Patient reports receiving Johnson and Johnson COVID vaccine on 3/19/21. He was hospitalized on 4/6/21 for an acute pulmonary embolism.
Onset pain at injection site 24 hours after injection. Continued to increase over next 2 weeks, continues at time of report but improving only slightly. PMD contacted today.
SORENESS, DEEP MUSCLE ACHES LEADING TO IMMEDIATE LACK OF SLEEP, COUGHING, SNEEZING, SWOLLEN EYES AND THROAHT, DIFFICULTY BREATHING. HOSPITILIZATION.
?Describe the adverse events, treatment, and outcomes?: enter: ?Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.?
Information has been received from a physician, via a company representative, concerning a 15 month old male child, who on an unspecified date was vaccinated with a dose of PEDVAXHIB (OMPC) (lot # not reported).  Subsequently the child developed a "very bad localized reaction" (details not provided) at the injection site.  The physician indicated that the child couldn't walk due to the symptoms.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
I first noticed cysts on my lower left legs on my calf. I noticed swelling in my leg, around the calf and ankle. By the following morning, they were even more swollen despite elevation and icing. On 04/02/2022 I went to urgent care where they did X-rays and I also still had a cough. I had been to a clinic on 03/17/2022 I did go to a Clinic for cough and they some testing and all test were negative. They treated me for Bronchitis. Ultrasound ordered but it was a weekend and could not be performed until that Tuesday 04/05/2022. I went I have the Ultrasound 5.5 cm fluid filled cysts interior of the left lower leg only shin bone. The second cyst is behind left knee 3.1cm. They did not refer to it as a bakers cyst.  Two fluid filled cysts were found. No additional orders they referred me to an Orthopedic doctor. I have not yet seen that specialist because I am awaiting to return home for continued care. I was advised to follow up with Orthopedic that the cysts have two alternatives. The first is it would resolve itself and reabsorb and the second choice was if it continued to cause pain to have needle aspiration. It is giving me some pain and can feel it when I walk. I did have a pre-existing condition of blood clotting in the the left leg in September 2020 18 months prior. That was not observed on the recent Ultrasound. They were clear.
Moderna COVID?19 Vaccine EUA.  In the night started with a fever and cold sweats and muscle aches and sleeplessness. The following morning it was nausea and then I felt like I was going to faint, began to black-out. Headache, nausea and fatigue persisted throughout the day.
Pain at injection site, shoulder bones, at left shoulder spreading down to (L) fingers. The pt still complains of pain 2 months later. This was most likely to improper route of administration. Injected at shoulder near bone.
Began about 6 pm, all joints aching & burning, hurt to walk on feet, shoulders, elbows, wrists, all joints in hands, couldn't pick up things. Bad headaches, took Tylenol, no effect. My left knee felt like it was broken for about 9 hours. Feet sore to walk until about 6 pm 02/11/2021.  Felt better when awoke on 02/12/2021, then severe diarrhea started.