chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician on 20 Jan 2017. This case involves a 12-year-old male patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, dose in series, and site of administration were not reported) intramuscularly on 20 Jan 2017. Illness at the time of vaccination was reported as reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions Attention deficit hyperactivity disorder (ADHD) and no known drug allergy. Concomitant medications were not reported. On 20 Jan 2017, same day, following the vaccination, the patient had developed a seizure, He fell to the floor and hit his head in the occipital and temporal area, he was brought back into the office and made to lay down and observed, the post ictal period lasted for few minutes, was lying down for 10 minutes after that, he sat up and was feeling dizzy and again he laid down for 10 min, then sat up then seemed more stable. He returned home with his parent and vomited once there. The physician advised that, the patient should be seen in the Emergency room. The physician met the family at the ER. The patient was being evaluated. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: Patient was vaccinated MENACTRA and had seizure which is unlisted, due to which he fell down and hits his head and vomited after some time. Time to onset is compatible, additional information regarding patient medical history, previous similar episode, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
I am very concerned how it is being promoted that everyone should be just line up and get their Covid vaccines and booster. I went March of 2021 and got both my Pfizer vaccines. After the first one I developed a rash on my legs and my voice became very scratchy, my feet also felt a little numb. I went on and got the second shot on March 27th, 2021. No one asked me any health questions except did I have a cold or fever; I didn't. In the middle of the night after received my second vaccine I was violently ill. Vomiting, diarrhea, body aches, and even my skin hurt, I was unable to eat or drink for over two days. Then almost totally lost my voice, had numb feet and ankles, a rash on my legs and swollen lymph nodes. I went to my rheumatoid arthritis doctor who was concerned that I might have Gillame-Barre and recommended that I go to the emergency room. I spent April 2-6, 2021 in the hospital. No one seemed to know what was wrong with me. Doctors and nurses speculated that all my symptoms were caused by the vaccine. They all felt it was too much of a coincidence that everything developed immediately after I got the Pfized vaccine. I was subjected to almost every medical test available. Eventually my rash went away, my voice improved slightly and I was negative for Guillame-Barre. Unfortunately, I still have swollen lymph nodes and my feet are still numb. It is ridiculous that I worked a full time job, on my feet all day long and now I can barely walk around the block. I don't understand how these vaccines can be given with no questions asked. I have Rheumatoid Arthritis. I was on few drugs to treat the arthritis as well as prednisone. No one said there were any red flags. My life and health has been destroyed. I can no longer work. I can no longer walk and I can barely speak above a whisper. How can these vaccines be promoted for everyone? And now boosters are being promoted! How many other people have serious heatlh problems due to the vaccines. There are to be some responsibility from the drug companies. I deserve compensation for my medical bills and my inability to work. I would also, above all else, have my health issues resolved! I cannot begin to list all of the tests performed on from April 2-6 at the hospital. The tests were endless.
Very large bruise on upper arm appeared about a day after injection.   Approx 6 days after injection developed swelling and a hard circular area that itches at injection site.  Painful to touch.
I got my Pfizer vaccinations on 2/12/2021 and 3/12/2021. Both times, I developed an itch and a rash in the evening after receiving the vaccines, but the second time was far worse than the first. After the second vaccination, a rash covered by body from my scalp to my feet. The only part of my body that was left unscathed was my buttocks. I consulted by PCP,  who prescribed me prednisone, because I had already been taking Benadryl, which proved ineffective. The prednisone successfully treated the rash. Right after I finished the prednisone, though, I then began experiencing severe abdominal pain. Dr. ordered blood work, and the results showed high lipase levels, which are a sign of acute pancreatitis. Not long after that, I ended up going to the ER  for severe abdominal pains; I was admitted for a couple of days, and I was treated for pain and the cause of my pain was investigated. Not long afterwards, I was referred to a surgeon, who removed my gall bladder. During the gall bladder removal, it was discovered I had an obstructed common bile duct. I was then referred to hospital where I had a stent placed in the bile duct. The stent eventually passed, and I am  now symptom-free.
Sick after covid booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after covid booster shot) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ILLNESS (Sick after covid booster shot). At the time of the report, ILLNESS (Sick after covid booster shot) was resolving.            It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and treatment information was provided.  The reporter's causality for the event of sick after co id booster shot with Humira (adalimumab) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient received 2 doses of Pfizer COVID vaccine on 2/17/21 and 3/10/21.  Patient hospitalized for COVID on 1/1/22 and remains hospitalized today, 1/3/22
Red itching area on one side of face under eye occurred shortly after administration. BENADRYL given and rash subsided by next morning.
Septic shock syndrome, Acute renal failure, acute tubular necrosis. Non-Q myocardial infarction. Discharge Summary received on 12/07/2004 states hyperglycemia, acidosis, atrial fibrillation, lung dis, atelectasois, and CHF. Medical Records received on 12/07/2004 states rash, fever, SOB, lethargy and itching.
This spontaneous report as received from a healthcare worker who placed the nurse on the phone refers to an unknown number of unspecified gender patients of unknown age. The unknown number of patients might have received a dose of improperly stored GARDASIL, (lot#, dose, route and strength not reported) since 01-OCT-2013 to present (22-OCT-2013). No adverse event reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one several reports received from the same source. Additional information has been requested.
Immediately after vaccine injected pt. bled well. Pressure held to site with cotton ball. Quarter sized raised area developed - looked like was bruising. Pressure applied and swelling resolved a bit. Within 15 min. swelling worsened to slightly larger than quarter size and itching started. Called MD. Called pt. PCP immediately. Advised to continue her ALLEGRA-D and apply ice. See MD if local reaction worsens or if pt. wanted to show it to MD he would see her right away today.
Approx 24 hours after receiving the second dose of the Moderna vaccine, a circular, swollen, red rash developed at the injection site. Since then, the rash has continued to grow and is currently 4" in diameter (36 hours post vaccination).
Fever of 99.8 that rose to 100.6 the next morning at about 5am, headache, drowsiness.
pt recvd vax; had firm lump, 1-2cm dia under skin of the Lt thigh; no redness or erythema noted, but some overlying bruising appears; 30apr93 f/u: lump lasted 1 mo; no tx;
Measles-like rash on back and chest with pruritic qualities, fevers 103*F.
Fever began 8/5/04 up to 103.5 degrees. No other symptoms.
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
This spontaneous case, initial and follow-up (combinedly processed) received from a pharmacist on 15-Oct-2018, concerns a 48-year-old, adult female patient. It was reported that, the vaccine reached the maximum temperature of 56 Fahrenheit and was out of the recommended storage conditions for 8 hours. It was the first excursion. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: not reported) after being subjected to temperatures above 46 Fahrenheit. The reporter assessed this case as non-serious. This case 201804543 was cross-linked with the original case 201804533 due to the same reporter.
swelling, warmth and redness from shoulder to elbow of left arm; swelling, warmth and redness from shoulder to elbow of left arm; swelling, warmth and redness from shoulder to elbow of left arm; This spontaneous report was received from a 66-year-old non-pregnant female patient, who was referring to herself. She has no pertinent medical history and no drug reactions/allergies.  On 18-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter, intramuscularly (strength, lot number and expiry date were not reported) for prophylaxis. Concomitant vaccinations included flu shot given on the same day.   On an unspecified date in November 2020 (approximately 5 hours after receiving the suspect vaccine), the patient experienced swelling, warmth and redness from shoulder to elbow of left arm. The events lasted for several days. No treatment was given to the patient. No lab diagnostics/tests were performed. The patient did not seek medical attention. On an unknown date (reported as couple of days after), the patient recovered from the events.  The relatedness between the events and the suspected vaccine was not reported.
VACCINE WAS ADMINISTERED TO PATIENT THAT IS 11 YEARS 8 MONTHS OLD.
BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced body aches. On 20-MAR-2021, the subject experienced fever. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from fever, and body aches. This report was non-serious.
severe diarrhea; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9269 and Expire Date: unknown) (age at the time of vaccination: 51) via unspecified route of administration, in right arm, on 06Feb2021 09:30 as DOSE 1, 0.3 ML SINGLE for Covid-19 immunisation. Medical history of patient included asthma and diabetes mellitus from an unspecified date and unknown if ongoing. Patient stated she had asthma all her life, and was born with it. Concomitant medications were none. Patient wanted to report a side effect, stated she got the first dose of the Pfizer Covid vaccine on Saturday 06Feb2021, stated one of the side effects is that it gave her severe diarrhea and stated there was no way to hold it. She got the vaccine around 9:30am, and a couple hours after it, started with the headache then the diarrhea. It did not stop with the diarrhea until 3PM the next day, 07Feb2021. She is a caregiver. The outcome of event was recovered on 07Feb2021.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Information has been received from a nurse concerning a 5 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA000697: US-009507513-1711USA010729: US-009507513-1711USA010730:
body aches; sinus pressure; Caller reported he was diagnosed with Covid for a third time on 23Jan2022; Caller reported he was diagnosed with Covid for a third time on 23Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 02095270. (Merck)  A male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Nov2021, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "Caller reported he was diagnosed with Covid for a third time on 23Jan2022"; PAIN (non-serious), outcome "unknown", described as "body aches"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "sinus pressure". Patient reported that he was diagnosed with Covid on 23Jan2022, and the doctor prescribed molnupiravir. Patient confirmed he has not started the molnupiravir yet. Patient stated this is the third time he has been sick with Covid and reported he has been vaccinated with two doses of the Pfizer Covid-19 Vaccine. Patient explained the first time he got Covid was sometime in Jan2020 and this was before he received the Pfizer Covid-19 vaccine. Patient said he received his first dose of the Pfizer Covid-19 Vaccine around Nov2021 and the second dose sometime in Dec2021, but he was unable to provided exact dates and stated he was diagnosed with Covid for the second time in Nov2021; Patient did not know the specific date, but he said it was after he was vaccinated with his first dose of the Pfizer Covid-19 Vaccine. Patient reported he was diagnosed with Covid for a third time on 23Jan2022 and stated again this is after he received 2 doses of the Pfizer Covid-19 Vaccine. Patient stated he has body aches and sinus pressure. Patient did not provide any further details. No additional AE or PQC reported. No additional information provided.    The lot number for bnt162b2 was not provided and will be requested during follow up.
expired Daptacel is administered, with no reported adverse event; Initial information received on 26-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient, reporter reported expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] is administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength: unknown) (expiry date: 21-Jun-2023)  not reported via unknown route in unknown administration site and expired daptacel is administered, with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Shortness of lung capacity; Lungs and chest hurt like patient at high altitude and trying to run a marathon / chest and lungs hurt if patient move to fast; Lungs and chest hurt like patient at high altitude and trying to run a marathon / chest and lungs hurt if patient move to fast; feels like asthma; feels like chemical contamination in my lungs; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 27Aug2021 at 17:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included too many injuries to be listed. The patient was allergic to diesel fuel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 07Aug2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 at 10:00, the patient experienced shortness of lung capacity, the patient could breathe fine but his lungs and chest hurt like he was at high altitude and trying to run a marathon. The chest and lungs hurt if the patient moved too fast. The patient was an athlete and it felt like asthma and chemical contamination in his lungs at the same time. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shortness of lung capacity, chest and lungs hurt and felt like asthma and chemical contamination in lungs were not resolved at the time of this report.
COVID vaccine Breakthrough case.  Received the two dose series along with the booster dose.  Dose 1: Moderna, 030A21A, 03/05/2021.  Dose 2: Moderna, 031B21A, 04-02-2021
Approximately 7 pm I called Mother on phone and she was very incoherent . Nurse checked her vitals and said normal. I was afraid of a stroke so told them to call EMS. They took her to ER. Gave fluids, temp elevated.. kept her overnight as she was still confused.  Sounded normal the next day but  they admitted her for 2 more days as her temp was elevated  and gave antibiotics.   Drs thought reactions were from the Moderna booster shot.
Cellulitis left upper arm secondary to 5th DTaP.  8 cm by 9 cm red, warm, tender with 5 cm by 6 cm induration, vesicles in center.  No systemic effect results in afebrile.  Treated with KEFLEX 250 mg by mouth three times a day for 10 days.  BENADRYL 25mg by mouth three times a day when needed for itching.  Bactroban.
Sore arm, redness, pain, unable to move arm. The redness/pain started by 10/7. Patient presented to the ED by 10/8. She was diagnosed with cellulitis and is being treated with antibiotics.
Localized (mild-moderate) erythema, warmth, swelling at the injection site.
Information has been received from a physician concerning a 24 year old female with no medical history or allergies who in November 2009, was vaccinated IM, 0.5 ml, with her second dose of GARDASIL. The patient received both her first and second dosed of GARDASIL in the same arm. Concomitant therapy included unspecified birth control pills. On 14-JAN-2010 the patient experienced persistent pain at the injection site of the right deltoid muscle since administration of her second dose of GARDASIL. The patient was prescribed non-steroidal anti-inflammatory medication with only slight improvement in symptoms. There were no visible signs of inflammation, including no swelling, redness, warmth, etc. There was no interference with range of motion or strength, and no pain elsewhere in the arm. There were no laboratory studies performed. The patient had an office visit to seek medical attention. Additional information has been requested.
Patient get vaccines on 6/4/13 at clinic. Tdap and MCV 4 at 1. Mother came to the clinic with fever, headache, itching on right deltoid arm and redness; since five days with those inflammation and pain area after get MCV-4 vaccines.
Headache Fever Chills Vomiting  Weakness Moaned for 24 hours! Hard to stand Painful joints Painful skin Painful injection site  Loaned for 2 days
Broken blood vessel in right eye.  Noticed about 20 min after vaxx.  No pain.
A couple of weeks following administration of vaccine patient complained of tinnitus in one ear. Stated had had tinnitus previously but usually doesn't persist for several weeks as was the case currently.