chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker, and a company representative concerning her 68 year old husband, with no allergies with diabetes, hyperlipidemia, gastroesophageal reflux disease and cardiovascular disorder, who on 12-JAN-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#551330/1048P) (0.5 ml), intramuscularly.  Concomitant therapy included amlodipine besylate (NORVASC), fluvastatin sodium (LESCOL), hydrochlorothiazide (manufacturer unknown), ramipril (ALTACE), aspirin and vitamins.  On 12-JAN-2005 the patient experienced a reaction and the affected area was "twice the size of the other arm".  The patient previously received pneumococcal 23v polysaccharide vaccine on 17-OCT-2000.  The patient had a doctor's appointment on 13-JAN-2006.  The reporter requested a lot check.  The records of testing prior  to release of this lot have been checked by the Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there was no open Quarantines registered against this lot/fill.  No further information is available.
Infant started having new and worsening bradycardic and desaturation events; heart rate dropped to 40's-60's; O2 sats dropped to 60's-70's, some requiring tactile stimulation and increasing FiO2 to recover.  Progressed to apneic events with bradycardia and desaturation about 18 hours post immunizations.
pt recvd vax & exp severe pain lt neck/shoulder/elbow; reporter indicated that pt has not recovered & that pts is currently undergoing eval by MD;
Hepatitis A Peds vaccine given instead of the Hep B pediatric vaccine that was due.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck), (0.5 ml, subcutaneous, lot # reported as H010148, expiration date 17-MAY-2014). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Information has been received from a physician and a nurse practitioner concerning a 60 year old female with a history of childhood chickenpox and hives from DEMEROL who on 06-JUL-2007 was vaccinated SQ in her left arm with Zostavax (Oka/Merck) (lot #657767/0740U). There was no illness at the time of vaccination. Concomitant therapy included FLONASE, ZYRTEC, BENADRYL, vitamins (unspecified) and calcium (unspecified). On 17-JUL-2007 the patient developed a varicella-like rash on both arms and legs, worse at left posterior thigh and ankle. The patient was treated with cortisone cream and a gel for the itching. The patient had not had any recent exposure to chickenpox or shingles. On 24-JUL-2007, a specimen was taken from the lesion which were described as vesicles, papules and scabs (results not provided). At the time of this report, the patient had not recovered. There were no reported adverse events following prior vaccination. The patient was enrolled in the varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck VZV strain. Follow up information was received from a university associate research scientist, who reported the PCR results on the three specimens collected from the patient on 24 JUL 2007. The PCR results, received on 25 JUL 2007 at the lab, included the following: scab-inadequate (not a scab, but a tiny piece of "something"), swab left shin-inadequate, and swab left ankle-negative. VZV DNA was not amplified. B-globulin DNA was amplified, L ankle only. The reporter noted they were still working on CSF. Additional information had been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information was received from a medical assistant who reported on an undisclosed date the patient recovered. No further information is expected.
Patient developed platelet count of 2000 (baseline normal platelet count) on 8/31 when hospitalized.  Patient clinically had petechiae and had tiredness and mild diarrhea.  Workup led to a diagnosis of ITP and patient was treated with dexamethasone 40mg x 4 days as well as IVIG 60mg x 2 days.  Platelet count initially increased to 35, 000 by 9/3 but then decreased back down to 5,000 by 9/6.  Given second course of IVIG x 2 days and started on prednisone 80mg daily.  Currently patient still has single digit platelet counts.
First shot 2/5/21 started to slow down get winded heart would race  second shot was 2/25/21.  After booster two weeks to the day ended in hospital in tachycardia racing 160 beats  in a fib  and they discovered a blood clot in the heart Hospitalized 12/2/21 to 12/8/21
broke out in rash over body  80GM Triamcinolone Acetonide 0.1% C  120ml siladry allergy 12.5/5ml liq
itching on left side of body; rash on top of thigh stomach fingers and back; red circle around the injection site about 2 and a half inches diameter that is warm to the touch; red circle around the injection site about 2 and a half inches diameter that is warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on left side of body), RASH (rash on top of thigh stomach fingers and back), VACCINATION SITE ERYTHEMA (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) and INJECTION SITE WARMTH (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OD9L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (itching on left side of body), RASH (rash on top of thigh stomach fingers and back), VACCINATION SITE ERYTHEMA (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) and INJECTION SITE WARMTH (red circle around the injection site about 2 and a half inches diameter that is warm to the touch). At the time of the report, PRURITUS (itching on left side of body), RASH (rash on top of thigh stomach fingers and back), VACCINATION SITE ERYTHEMA (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) and INJECTION SITE WARMTH (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Maculopapular rash developed w/in 24 hrs of injections. Low grade fever x 12 hrs. Resolved 5 days later.
p/vax lt arm started swelling arm felt hot to touch;lt arm starting itching, reddened & cont to swell;local rxn;
Moderna COVID-19 Vaccine EUA received on Saturday.  Sunday morning in the middle of my sleep, I woke feeling hot and sweaty, slightly nauseated, and like I had to defecate.  I stood up, felt like low blood pressure but wanted to get to the bathroom.  I walked towards the door, opened the door and fainted, falling backwards.  My spouse  states I was pale,staring at the ceiling and kind of stiff in my arms and legs for about 3 minutes.  He spoke to me, checked my pulse, covered me, poked my feet. As I came back to awareness I tried to speak and was unintelligible but then became more conscious.  He tested me with questions to make sure I was ok.  I defecated after that but did not vomit.  I was tired the rest of the day and napped for several hours.  I don't seem to have hurt anything in the fall.  I am instructed to be off work Monday by my supervisor.
got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527957 same drug/AE, different patient
Redness, swelling, heat in left arm above elbow gave 2 Benadryl 25mg on 11-16-13 12:00 PM. When patient came to pharmacy to report reaction. Told her to go to emergency room.
dry skin on his legs /dryness on the legs; cold sore; dry lip; red rash around the hose; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 31st March 2022) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2020, 2 weeks after receiving Shingrix and not applicable after starting acyclovir, the patient experienced cold sores, lip dry and red rash. On 15th February 2020, the patient experienced dry skin. The patient was treated with acyclovir. On an unknown date, the outcome of the cold sores, lip dry, red rash and dry skin were unknown.   It was unknown if the reporter considered the cold sores, lip dry, red rash and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient stated experienced a cold sore.  The patient took acyclovir for 3 days.  The patient experienced dryness on the legs on 15th February 2020 or 16th February 2020. On 17th February patient went to the pharmacy complaining of extreme dry lip, red rash around the nose.  The health care professional (HCP) states that the patient's symptoms were the worst on the 19th and 20th day following administration. The patient was better on 17th February 2020 but was still complaining of symptoms.  The HCP spoke to the patient on Monday night and they were feeling better than they were on Monday morning.
The participant gave consent to his wife to talk to me about his A/E. I notice that he had was tried a lot and he felt drained. He was sleepy a lot. An then we ended up taking him to the doctor because he was having blisters on his arm and stomach. The doctor was treating him for Scabies and his wife said that she didn't have them. So after treating him for that and it didn't work. The blisters start popping up all over his body except his back. The doctor couldn't understand why it was. We had to take him to the ER because his left hand started swelling up and a big blisters on it popped and it was really bad and ugly. Then they put him in the hospital and they through he had gotten into something. He was there for 3 days. An they still couldn't figure out what he had. So they referred him to a wound care doctor and a surgeon. The blister move down into the palm of his hand. They haven't did the surgery yet because they are waiting on test results.
CHILLS; TIRED; INJECTION SITE PAIN; HEADACHE; FEVER; PAIN; FELT MISERABLE; BACK HURTING; LIGHTHEADED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, pollen allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use and was healthy individual at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:00:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced felt miserable. On 08-APR-2021, the subject experienced back hurting. On 08-APR-2021, the subject experienced lightheaded. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 08-APR-2021 18:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, chills, and headache on 08-APR-2021, and fever on 09-APR-2021, was recovering from felt miserable, and back hurting, and had not recovered from pain, tired, and injection site pain. This report was non-serious.
itching and redness immediately after administration; induration developed following day; 40mmx40mm induration remains, itching, redness, warmth also. Provided with cold pack. offered antihistamine.
Patient experienced shortness of breath, dizziness, chest tightness and was light-headed.
WRONG DOSE ADMINISTERED (undiluted) Patient's mother called notifying clinic that there had been a COVID vaccine administration error at an outpatient pharmacy with her son receiving incorrect dose for third COVID-19 vaccine dose (patient is a 21 yo heart transplant recipient).  Transplant pharmacist called patient and his mother to obtain additional information. Vaccine administered at Pharmacy 10am.   Transplant pharmacist called where COVID-19 vaccine (Pfizer) dose was administered at 10am this morning. Per Pharmacist, the COVID-19 vaccine (Pfizer) vial was not diluted as it should have been with 1.8mL 0.9% sodium chloride and patient was administered 0.3mL of undiluted vaccine. There is a total volume of 0.45mL undiluted vaccine which contains six 30 mcg doses in the vial. With patient receiving 0.3mL of undiluted vaccine he actually received 120mcg or equivalent of 4 doses. Per pharmacist vaccine administration error had been submitted to VAERS and ISMP. They stated also calling manufacturer (Pfizer).  Transplant pharmacist called Dr, cardiologist, to discuss monitoring plan. Currently patient  has no symptoms/side effects 6 hours post vaccine administration. Per Dr, plan for patient to call us if he experiences severe flu like symptoms, chest pain, shortness of breath, palpitations. Minor symptoms such as low grade fever, minor chills, or injection site pain are common. This information was relayed to patient and his mother. Transplant pharmacist advised patient and patient's mother to call with any additional concerns.
COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was no, the patient received Paxlovid treatment for COVID 19 treatment from 12Dec2022 to 16Dec2022. There were no known allergies and other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
rt eye puffiness/numbness Narrative:  epi, benadryl, medrol dosepak
Headache & Fever Narrative:  Received 2nd dose 2/17/21 and has been  experiencing tiredness, fevers, headache. All symptoms have subsided at this time.  Other Relevant History:
feeling sick; shortness of breath; headache; shoulder pain; This is a spontaneous report from a contactable consumer (patient) received from a Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, after received the vaccine, at night, patient started feeling sick, had shortness of breath, headache, and some shoulder pain. The second vaccine had been scheduled for 08Apr2021 and she want to know whether the date could be changed by a day to have a few days off, in case she feels sick again. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache for 3 days, cognitive problems that lasted for 2.5 weeks.  I would frequently drop items held in my hands, had difficulty typing on a keyboard, had problems with tasks such as sewing , doing crossword puzzles and remembering things. For example, for many years I would do the  crossword puzzle in ink and be able to complete it.  During this time, I could only finish about 1/3 of the puzzle and then give up in frustration.  Another example: I have been using a Nutribullet to grind coffee beans once a week for years.  I had trouble assembling it for use.  I tried to screw on the top having it face the wrong side.  I could tell this was not correct but it took a minute to figure it out. I did not seek treatment since these things seemed subtle and I did not think clearly enough to think of that option! The symptoms have slowly resolved over a 2.5 week period.  I will not get the 2nd dose because of this reaction.
Patient reported having no reaction the day that the vaccine was administered. However, the morning after administration, she developed a circular red rash around the injection site. The next day (4/29/16) she presented to the pharmacy after going to urgent care because the rash had gotten bigger and was slightly swollen. Patient denied fever, itching, or swelling of any other body parts (symptoms were localized to injection site area). Rash was about 3" in diameter.
APPROX 20 MINS AFTER VACCINATION PT BEGAN  FEELING LIKE HER HEART WAS RACING, FAINT, AND NAUSEATED. NO PRODUCTIVE VOMIT, BUT HAD DRY HEAVES.
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
Fever 102, chills, sweating, dizziness, swelling of hands and face, swelling in throat, headache, body ache. Tylenol and Benadryl given without effect.  Cortisone shot at doctor's office.
Information has been received from a mother of a male child, with no prior medical history, who in approximately 2000, almost 4 years ago as reported on 05/07/03, was vaccinated with a dose of MMRII. There was no concomitant medication. Immediately post vaccination, the pt developed a fever of 103F and was screaming/crying uncontrollably. The pt was taken to the ER and given Demerol to calm him down. It was noted that the pt was never admitted to the hospital. The pt was taken to the MD the following day for follow up. At that time of the report, on 05/07/03, the pt was 4 years old. No outcome was reported. Additional information has been requested.
Patient developed a fever shortly after receiving his immunisations on 8/29. Parents report some swelling of face and testicles, but resolved in a few days. Temp. increased 101deg F. He's had recurrent fevers and developed a red rash all over the body.
Red oval rash at injection site,  about 3 inch diameter now (was penny sized when I noticed it last night)  Itchy and hot, a bit swollen/hard
Patient stated he is still feeling fatigued with flu-like symptoms a week after his second dose.  Specifically, he noted significant body aches.  He is planning on calling his doctor to see if they want to see him to rule out something more serious happening.