chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I could not hear anything; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: el8982), via an unspecified route of administration at the left arm on 18Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hearing problem, CAD and glaucoma. The patient has no allergies to medications, food, or other products. Concomitant medication included tamsulosin, levothyroxine sodium (LEVOXYL), omeprazole, acetylsalicylic acid (BABY ASPIRIN) and astorta. On 19Jan2021, 1 day after injection around 5pm the patient reported to have taken a nap, and when he woke up, he could not hear anything.  The patient has a hearing problem only have 10% hearing. He was going to see ENT. The event resulted to doctor or other healthcare professional office/clinic visit. The reporter assessed the event as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered
Patient received a Varivax immunization on 05/26/2023 & then received a MMR II vaccine on 06/09/2023. This was discovered when patient came in to get her second Varivax immunization.  Due to both vaccines being live patient should have received both immunizations on the same day or a minimum of 4 weeks apart.  Patient was notified on 06/16/23 and she reported no symptoms.
This report is for a failed administration of the vaccine.  The person administering had a faulty needle/ syringe and the vaccine ended up all over my arm and the arm rest in the care.  I stated it was spread out all over my arm and car and she said it was a nerve reaction.  It was not.  I know what a nerve reaction is.  I spoke to my doctor and no one knows if I was vaccinated.  This is an issue because I cannot get another vaccine because technically I was vaccinated, even though my car was vaccinated.  I have pictures to show this issue and a witness in the car with me whom had a successful vaccine.  No pharmacy can administer a vaccine to me because the CDC guidelines state if you are vaccinated you cannot get another nor can you switch to Pfizer or Moderna.  I would like to get a Pfizer or Moderna vaccine as I am a woman in the age group with birth control that has high risk.
"Moderna COVID-19 Vaccine EUA"  Approximately 5 hours after receiving injection every joint in my body started hurting as well as my left arm and left side of my left breast.  I also had a migraine start a few hours later.  The next day I took Advil, which helped for a few hours then the pain came back worse. I went to the emergency room at hospital in the middle of the night on Thursday. I was given fluids, medication for nausea and pain. I also had a chest x-ray and CT Scan. I was released on Friday morning. I am still hurting enough to need pain medication.
Hot; Cold sweats/having night sweats, like she was hot and cold; Cold sweats/having night sweats, like she was hot and cold; Chills; Shakes; intense nausea/ nauseous; just feels nauseous and depleted; it feels like she has the flu; she didn't know if maybe her body was low on oxygen, she didn't feel out of breath, but she just didn't feel well overall; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry: Mar2021), via intramuscular route of administration (left deltoid) on 17Dec2020 17:40 at a single dose for COVID-19 immunisation. The patient's medical history included sulfa drug allergies. There were no concomitant medications used. The patient was having some intense nausea, and throughout the night, she had night sweats. It was further stated that she woke up a 12AM, today (18Dec2020), and she just felt like she had the flu. She was nauseous, and she was having night sweats, like she was hot and cold, and she tried to go back to sleep, but then she had an episode of chills and the shakes, and every time she was about to fall asleep, it was like her body would wake her up. Patient stated that in her mind, she didn't know if maybe her body was low on oxygen, she didn't feel out of breath, but she just didn't feel well overall. All these persisted until about 3AM, and then she went back to sleep. She woke up for the day around 530AM, and she feels a little better now, like she doesn't have the hot and cold fever feeling anymore, she just feels nauseous and depleted. She stated that she sees on her information sheet that these are possible side effects to getting the vaccine, but it feels like she has the flu. Outcome of the events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Extreme soreness, pain,  swelling, hot to touch, small red lump in area, difficulty sleeping, feeling weak.
Got shot 3-4-21 then on 4-15-21 arm was still tender and large red rash appeared on arm today 3-18-21 rash about 6" wide x 6" long is still on left upper arm lighter in color but still present does itch on occasion not a lot do have photo of it been putting ice on a couple of times
I received two shots on or about July 6, 2021.  I believe they were Hep C and Shingles.  For some reason the nurse elected to give them both on my right shoulder.  When she gave me the second shot, she said "Boy, your arm really jerked when I gave you that second shot".  It was later found that she falsified the medical record and said that she gave them on my left shoulder.  Trying to cover her tracks, I'm sure.  I have had nothing but severe pains in the last 9 months starting the moment she gave me the second shot.  The pain is excruciating  when I lie down to try to sleep.  Hurts on and off throughout the day.  Hard to drive a car or sit down.  Pain comes and goes throughout the day.  I have extreme loss of range of motion since the shot.  The almost constant pain has also caused depression - hard to be happy when you are in pain.  An MRI revealed a torn rotator cuff (it was not torn before).  Up to that time I personally thought it was that the vaccination needle hit a nerve.  Regardless, I have suffered severe pain since the moment of vaccination.
Dose 2 of primary series was administered on 3/10/2023, the expiration date of the vaccine was 3/8/2023.
I AM EXPERIENCING BLURRED VISION ON THE LEFT EYE CURRENTLY BUT IT DIDN'T START RIGHT AWAY - ALSO EXPERIENCED A THROAT INFECTION 3 WEEKS AFTER VACCINE AND WAS PRESCRIBED ZYTROMAX ANTIBIOTIC
Mom states that child went into shock and fever and had a seizure less than 24 hours, post vax. This was not the 1st seizure the child has had. Called ER and was told they did not feel it was a reaction to the vaccines, that it was probably just another febrile seizure.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and drug reactions/allergies was not provided. On unspecified dates in 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which has a lot # K010216 and expiration date 17-SEP-2016 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The reporter stated that there was no previously temperature excursion. On 25 and 26-FEB-2016, the RECOMBIVAX HB were exposed to 9 Celsius (C) for 10 hours each day and a data logger was used to capture the excursion. No adverse effect was reported. This is one of several cases from the same reporter. Additional information has been requested.
It burns; Rash on their upper back; It itches like crazy; Its red; Rash on the place where they got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (It burns), RASH (Rash on their upper back), PRURITUS (It itches like crazy), ERYTHEMA (Its red) and VACCINATION SITE RASH (Rash on the place where they got the vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0ILM20A) for COVID-19 vaccination.     No medical history reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced BURNING SENSATION (It burns), RASH (Rash on their upper back), PRURITUS (It itches like crazy), ERYTHEMA (Its red) and VACCINATION SITE RASH (Rash on the place where they got the vaccine). At the time of the report, BURNING SENSATION (It burns), RASH (Rash on their upper back), PRURITUS (It itches like crazy), ERYTHEMA (Its red) and VACCINATION SITE RASH (Rash on the place where they got the vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included alcohol topical and some lotion.  No relevant concomitant medications were reported.
PT CAME BACK TO CLINIC 40 MINS AFTER VACCINATION WITH C/O RASHES OF FACE AND CHEST.
We received a call to the call center that the patient Right eye was swelling closed.  Patient did not speak with medical personnel and did not respond to phone call attempt.  Patient was advised to seek assistance at the Emergency Room.
I had herpes in my eye in 2017 after a series of hospitalizations. It was treated and resolved. My retina care physician I found there was herpes in my eye again in May of 2018. This was only two weeks after I had received my first Shingrix injection. I am concerned that it might be triggered as a reaction to the vaccination and am wondering whether or not it is safe to have the second injection.
DAY 1 DIZZINESS FOLLOWING THE VACCINE .  AROUND 5PM ON  THAT SAME DAY CHILLS AND FEVER STARTED AND LASTED UNTIL  UNTIL MID MORNING OF DAY 2.  AROUND MIDDAY OF DAY 2, DIZZINESS IS STILL BOTHERSOME WITH VOMMITING AND DIAHRREAH STARTING.   CAN'T EAT OR DRINK MUCH DAY 3, BODY ACHES AND GENERAL LETHARGARY FOLLOWS.  VOMITING CONTINUES, BUT NOW CONSTIPATION STARTS.   DAY 4 , VISIT MY FAMILY DOCTOR
had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) all with onset Sep2022, outcome "unknown" and all described as "had the Pfizer Covid19 primary series and 1st booster vaccines/ tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: tested positive for Covid last Tuesday and started taking Paxlovid yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Proprietary medicinal product name was Paxlovid. Active drug substance was nirmatrelvir tablets, ritonavir tablets. Reporter stated that her 80-year-old husband tested positive for Covid last Tuesday and started taking Paxlovid yesterday. She stated that she and her husband had the Pfizer Covid19 primary series and 1st booster vaccines and had the flu shot last Wednesday. She and her husband had a terrible metallic taste in their mouth after they stop eating. She asked "was this a normal side effect of Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198146 Same vaccine/event, different patient;
6 hours following vaccination : Rigours, fever of 101-102 F (38.4-39C), severe generalized joint pain, nausea, headache, weakness, unable to eat or drink anything but water for 36 hours. As a normally healthy active 67 yo with a high pain threshold I was bed bound for 36 hours. literally.
patient had possible seizure approx. 24 hrs post vaccine administration. Was evaluated at local ED and  no fever noted.
fatigue, muscle and joint pain, chills, fever of 102, headache initial fatigue set in 5 hours after getting the shot chills lasted a few hours muscle and joint pain lasted 12 hours fever lasted a few hours headache lasted 17 hours did not take any medication to help with symptoms
Acute urticaria (itching, rash, and hives) arose 10 days after receiving the Moderna booster shot. This has persisted for a week now, with no relief other than taking OTC antihistamines (Benadryl 50mg doses in the morning and at night, two 25 mg doses during the day, every dose taken 4-6 hours). I have not sought additional treatment yet, but will be pursuing other options soon.
Is jaundiced eyes a side effect,Is jaundice a side effect; now my eyes are yellow; This spontaneous case was reported by a consumer and describes the occurrence of JAUNDICE (Is jaundiced eyes a side effect,Is jaundice a side effect) and OCULAR ICTERUS (now my eyes are yellow) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JAUNDICE (Is jaundiced eyes a side effect,Is jaundice a side effect) and OCULAR ICTERUS (now my eyes are yellow). At the time of the report, JAUNDICE (Is jaundiced eyes a side effect,Is jaundice a side effect) and OCULAR ICTERUS (now my eyes are yellow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were not provided.
Patient had a heart attack the day after his third dose of the moderna vaccine. Is currently being treated with medications to reduce his chance of having another incident
Maculo-papular rash over abdomen and left side. Was seen in Urgent Care and has been taking anti-histamines for one week with no improvement--2 days ago doubled dose of Zyrtec with no change in rash.
Swelling, warmth, redness; 9 x 6 cm induration in left deltoid.
Patient did have a very bad reaction to flu injection, swelling to double the size, severe pain arm, fever the next day after the vaccine. Patient went to Urgent care where patient was treated with steroids, and antibiotics x 7 days of treatment, Patient has no symptoms now, is back to normal.
A vial that has been opened for 9 days was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medication was given.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  It was reported that the vial was in the refrigerator between 34- and 36-degree Fahrenheit and the  vial was not frozen.
patient was present in the clinic for approx. 30 mins after vaccine was given and was not showing any s/s of adverse reaction. at approx 1:38pm patients mother called into the clinic and spoke with a triage nurse reporting patient was having uncontrollable chills, fever, nausea with vomiting, appeared pale, but denied SOB or chest pain. patient was advised to go to the ER by triage nurse and was evaluated at that time.
Pain; Abdominal pain/pain in her belly button area; Fatigue/Tiredness; Muscle aches; Skin rapidly moves; Twitching in the injection site of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 16Nov2021 15:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Nov2021, outcome "unknown", described as "Twitching in the injection site of my body"; PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Pain"; ABDOMINAL PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Abdominal pain/pain in her belly button area"; DYSKINESIA (non-serious) with onset Nov2021, outcome "unknown", described as "Skin rapidly moves"; FATIGUE (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Fatigue/Tiredness"; MYALGIA (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Muscle aches". Therapeutic measures were taken as a result of pain, abdominal pain, fatigue, myalgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was supposed to have graded challenge with by bivalent COVID vaccine. By mistake she got monovalent COVID 19 vaccine. I wrote the orders but I actually did not check the vial itself.  After administration of the second dose of graded challenge (0.05 cc+0.25 cc) I discovered that the patient got more monovalent Pfizer vaccine (she already had 2 original vaccinations+2 boosters) instead of bivalent COVID vaccine.   Patient was not suppose to receive monovalent COVID 19 vaccine since it is not recommended as a booster anymore.   Patient was observed for 2 hours.  Understandably she was very upset but stable.  I contacted Pfizer safety department and obtained information what to do in case of an error and how to report it. I contacted her on October 1st. She complaints of headache and fatigue, but otherwise stable.
Worsening SOB, fever, sore throat, fatigue started 10/15. Positive home test 10/17/22. Presented to ER on 10/18/22 and admitted.
Feeling tired; Discovered she was Covid 19 positive; Discovered she was Covid 19 positive; This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer reported that a 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation.  Medical history included Allergies from an unknown date and unknown if ongoing, bad back aches from an unknown date and unknown if ongoing.  Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), mometasone furoate (FLONASE [MOMETASONE FUROATE]).  On 16Jan2021, she had her first dose of COVID vaccine, and two hours later she had a positive COVID test done. She is wondering when she can get the second dose, her doctor said she had to wait 3 months for the second, dose, she is questioning that, and wants to know, should she be retested for COVID, since she thinks it may be a false positive, since she has no symptoms of COVID. She states she didn't really have any symptoms other than feeling tired. The outcome of event fatigue was unknown, while the outcome of the other events was not resolved.  Information about lot/batch number has been requested.
h/a, chills, sweats, tired, nauseous, bed ridden 2 1/2 days;
4/30 Felt aches (severe) was bed ridden for 2 days, 5/1 +5/2. Monday, May 3 still sore. Right underarm severe pain and couldn't move legs. It was an inner ache and now an outer ache. Right side more. I can't say fatigue. Just couldn't move.
See attached office and infusion notes - 2 days worth d/t dehydration/vomiting. The patient presents with a chief complaint stated by mother that patient received her 2 mo vaccines yesterday. Last night patient started vomiting at 10 pm. Patient also started running a fever up to 101 early this morning. Also has only had about 3 wet diapers since yesterday evening. Mother states that patient is not keeping anything down. The patient is a 12 week old female who presents with a complaint of vomiting. The patient is here for an initial visit. The onset of the vomiting has been sudden and has been occurring in an intermittent pattern for 12 hours. The course has been constant. The vomiting is characterized as containing undigested food and bilous. The vomiting occurs immediately after meals. The symptoms are aggravated by eating. The symptoms have no relieving factors. The symptoms have been associated with fever, while the symptoms have not been associated with constipation or diarrhea. There has been no previous evaluation.
Left arm pain for 3 days, patient states she can't move (L) arm due to pain.
Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported .
Information has been received from a medical assistant referring to a 4 months old male patient. No relevant medical history or concurrent conditions were reported. On 23-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
02/14/22 presents to ED for "fever, altered mental status". PMHx of "failed renal transplant in 2008, ESRD on MWF HD, type 2 diabetes on insulin, CAD, A fib on eliquis"