chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient says she developed a small hole at the site that was itchy- she says she scratched it and then it started to become red.  She says a small bump appeared and she tried not to scratch it anymore but she did in her sleep scratching the bump off and making a scab, she saw NP about it and she said it was not a vaccine reaction but rather from the scratching.   However, patient believes it is possibly caused by the vaccine.   She was advised to use Neosporin on it which she is doing and she said it is healing up but is worried because it is taking so long.  We talked about the signs and symptoms of infection- to watch for worsening or spreading redness, any puss or discharge, any swelling, any fever, any warmth at site.  She said she is not having any of those.  Advised her to see a doctor/ NP again if if she has any of those symptoms or remains concerned.
Progress Notes PA-C (Physician Assistant) ? ? PA Medical ? ? 6/12/2020  9:42 AM ? ? Signed   I stepped in to see left upper arm.  Had PPSV23 a week ago in left arm.  She has no allergy to anything.  Never had any issues with vaccinations in past.    Moderate edema in lower upper left arm, more medial, noticeable from walking into the room. Mild redness and does feel warmer than other skin on left and right arm.  Had 2+ Bicep reflex in both arms on exam  Grip strength is 4/5 B.  Can flex and extend left elbow joint as well as pronation and supination.  Unable to reach away from her body.  She reports her left upper arm and even posterior shoulder last week after injection was swollen, which is not now.    Recommend starting keflex 500mg QID x 7 days.  Can use warm compresses to arm.  Will see her back in a week or sooner if sx's worsen.  If her ROM is still decreased at that time, ortho consult recommended, or trail of prednisone? Will consult with PharmD, CDE, BC-ADM      I spoke with PharmD, CDE, BC-ADM about the above.  Agrees with plan, certainly atypical.  Lets see how she does with this plan and if not better in a week, can do prednisone with close eye on INR.  May also need to report this vaccination adverse reaction.
Pain and stiffness in left shoulder, initially severe and some radiating down arm, which has lessened over time but is still somewhat present 4 days later. Headache, body aches, lethargy, and sleepiness that evening and for two days following, which also improved with time.
Left leg red, swollen at site of injection. Hot to touch, itching. No fever. Antibiotic Keflex 250 mg/per 5 ml, 8 ml BID. Ice and elevate.
Information has been received from a registered nurse concerning a male patient over age 65 on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot#'s 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain), generalized malaise and low-grade fever. The nurse reported that two patients (not specified which patients) received either dexamethasone (MSD) or dexamethasone as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
cardiac arrhythmia; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, 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: ARRHYTHMIA (medically significant), outcome "unknown", described as "cardiac arrhythmia". Additional information: The reporter stated "Web site to report adverse reactions for covid vaccine was very difficult to use for myself related to cardiac arrhythmia and I am a physician. A non-medical person would give up. Poor information regarding Covid-19 vaccine. ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event cardiac arrhythmia with BNT162b2 OMI XBB 1.5 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient came in and received 1st dose on May 18 2021, 2nd dose on June 16/2021, and a 3rd dose on Nov 8, 2021 by LPN  even though the patient is not immunocompromised. No adverse reactions happened to patient while at the clinic.
Rotarix was ordered. It was most likely improperly reconstituted as 4 vials of vaccine remained in an open box with- out any syringes of liquid. Therefore the infant did not receive the vaccine component  The parent was contacted and is bringing the infant back in for readministration of the vaccine
Pt. is a 3 y.o. male who comes into the clinic today with his mother with complaints of a possible reaction to his influenza vaccine which he received yesterday (10/3/2022) when he was there for an ENT visit. He got this about 12 PM yesterday and was limping most of the afternoon complain does some discomfort in this left leg but parents thought it was just because of the pain after administration.  He is receive this vaccine 3 times in the past without issues. After his bath at around 6 PM they noticed his left leg was double the size of his right. They called and they advised to apply warm compresses and continue to monitor.  He went to bed fine but then when he woke up his swelling in his leg was down a little bit but they noticed that he had swelling around both of his eyes.  He did not really have any rash at that point but by the time he got picked up from school at around 11:30 a.m. mother gave him a dose of Benadryl for the 1st time in noticed some red blotches kind of all over.  She does not feel like those have gotten worse but they have not gotten better since the Benadryl was given.  He has been eating and drinking okay.  No troubles breathing.  He has never had an allergic reaction to anything in the past.  He does not have a history of skin sensitivity.  No allergy issues.  Mother just wants to be sure that they are doing everything they need to be doing to help improve his symptoms.  Mother denies any new lotions, detergents, medications or anything else new in his life that could of causes the symptoms to start.  All other ROS is negative.
I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; This is a spontaneous report from a contactable consumer (patient herself). This 52-year-old female consumer (patient) reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation was Solution for injection, Lot Number: EW0196), dose 1 via intramuscular in left Arm on 18-JUN-2021 14:30, as single dose for COVID-19 immunization (age at time of vaccination 542 years). The patient was not pregnant. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. The patient medical history included Allergies, Asthma. The patient concomitant medications included DHEA, Pregnenolone, Iron, Calcium, Multi, Calciferol (Vit D). On 19Jun2021 patient experienced a lot of pressure in face, under her eyes (from the left side of her face to right). Also, pressure around her nose, it was very tender on both sides. Her entire face felt tight and has a lot of pressure. The patient had allergies to Sulfa, Ceclor, Amoxicillin, Tetracycline, Wheat, Soy, Yeast, and she was not taking any treatment. The outcome of all events were not recovered.  Follow-up attempts completed. No further information expected.
neck swelling side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (neck swelling side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (neck swelling side effects). At the time of the report, SWELLING (neck swelling side effects) 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.   No concomitant medication were reported. No treatment information was provided by the reporter.
No adverse effect; The patient was vaccinated with improperly stored vaccines.; This spontaneous report was received from a nurse referring to patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 03-MAR-2020 at 09:59, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB)(strength, frequency, and expiration date were unknown) with  lot# S023219, expiration date on 03-MAR-2022 at 09:59 , 0.5 milliliter, intramuscular in the right thigh, and with  pneumococcal 13v conj vaccine (crm197)(manufacturer unknown) (strength, frequency, and expiration date were unknown) 0.5 milliliter, intramuscular in the left thigh with lot # AT8585 and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(manufacturer unknown) (strength, frequency, and expiration date were unknown) 0.5 milliliter, intramuscular in the left thigh with lot # J947T at 10:00 for prophylaxis.  Administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects reported. The temperature excursion was no reported for the other vaccines.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008889: US-009507513-2008USA008877: US-009507513-2008USA008890: US-009507513-2008USA008875: US-009507513-2003USA002275: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932:
I was shivering almost if I had seizures; I was shivering almost if I had seizures; had a cold sensation like If I was cold; it was a little painful but not that bad; at the arm where I got the shot was painful; applying ice pad on my arm to relieve the pain; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Oct2021 14:00 (Lot Number: FF8839) as dose 3 (booster), single (at the age of 69-years-old) for COVID-19 immunization. Medical history included hypertension, diabetes mellitus, visual impairment. The patient's concomitant medications included unspecified medication for blood pressure. The patient experienced, "I was shivering almost if I had seizures", "had a cold sensation like if I was cold", "it was a little painful but not that bad", "at the arm where I got the shot was painful", "applying ice pad on my arm to relieve the pain" on 04Oct2021 2:00. The patient stated, "So the other day it was a little painful but not that bad, but 2 in the morning today I mean, 12 hours later I had a cold sensation like If I was cold and then I was shivering almost if I had seizures. So, yesterday I get the booster shot around 2pm and this morning almost 12 hours later so around 2 in the morning I was, at the arm where I got the shot was painful but not that painful but I was, almost having a seizure. I was shaking a lot in cold and it was not cold so I had to put some covers on top. The anything I can say is that, at the moment I have to apply an ice pad on my arm to see if the pain goes down. I didn't feel the itching only the pain, and then the pain went on little bit to the lower arm and my vein as well. I was shaking a lot, it's almost like I was having seizures I mean I was really really shaking." Therapeutic measures were taken as a result of "it was a little painful but not that bad", "at the arm where i got the shot was painful", "applying ice pad on my arm to relieve the pain". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
pfizer 0.3 ml im given at covid booster clinic, pt also recived hd flu. found out after injection that he had moderna for the first two doses.
Patient presented to ER with weakness and numbness in face, tongue, arms and legs (bilateral). Patient has had these symptoms for over a week and has had 3 falls in the past 2 days. CSF showed elevated protein levels. Symptoms and labs all point to GBS. Neurologist believes it to be AIDP, a variant of GBS.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Sep2022) Negative; (04Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, Lot number: GD8756, from 20Sep2022 to 25Sep2022 as treatment for COVID-19).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He was very nervous to get the immunization and was drenched in sweat.   He lost consciousness right after the vaccine was administered.  He did not  hit the floor.  He quickly regained consciousness and began feeling better.
freezer temperature went from 5 F to 6.4 F for 6 minutes; A spontaneous report was received from a healthcare professional regarding a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273). No adverse event was reported after the administration of the vaccine. It was known that the freezer temperature went above 5 degrees Fahrenheit to 6.4 degrees Fahrenheit for about 6 minutes and went back to 5 degrees Fahrenheit affecting 49 vaccine vials.   The patient's medical history was not provided. No concomitant product use was reported.  On 02 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-Mar-2021, it was known that the freezer temperature went above 5 degrees Fahrenheit to 6.4 degrees Fahrenheit for about 6 minutes and went back to 5 degrees Fahrenheit impacting 49 vials. Of the 49 vials, 35 vials were used and 14 vials were left in the freezer at a temperature of 5 degrees Fahrenheit. No change in physical appearance was reported and all the 14 vials were frozen.  Treatment information was not applicable.  Action taken with mRNA-1273 was unknown.   The outcome of the event, freezer temperature went above 5 degrees Fahrenheit to 6.4 degrees Fahrenheit for about 6 minutes, is not applicable.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 026L20A with no associated AEs.
ONE OF FOUR PATIENTS WHO EXPER.EPISODE CONSISTING OF FAINTING AND/OR SHORTNESS OF BREATH, INCREASE IN PULSE RATE, DIAPHORESIS AND LIGHT-HEADNESS FOLLOWING IMMUNIZATION.
Slight soreness at injection site; fatigue; feeling a little spacey.; This is a spontaneous report from a contactable consumer (patient). The 46-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, lot number: EL8982), via an unspecified route of administration in left arm on 25Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydroxyzine embonate (VISTARIL), sertraline hydrochloride (ZOLOFT), vitamin c [ascorbic acid], fish oil, acetylsalicylic acid ASPIRIN (E.C.). The patient previously took codeine and doxycycline and experienced Allergy. The patient experienced slight soreness at injection site, fatigue, feeling a little spacey on 25Jan2021 11:00. No treatment received. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
3 hours post vaccination the patient began with a rash in both antecubital areas and around his neck in the area his collar.
This case was reported by a physician via sales rep and described the occurrence of injection site blisters in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown. It was unknown if the reporter considered the injection site blisters to be related to BEXSERO. Additional details were provided as follows: The reporting physician had reported this case previously to VAERS. The age at vaccination was not reported. The physician stated that he had the patient, who had blistering at the injection site, after administration of BEXSERO. This case was linked with US2018GSK123548, reported by the same reporter.
Patient is 13 years old, and patient should have received Pfizer vaccine as a booster. 0.25mL of Moderna vaccine was injected to the patient instead. Patient was monitored on site for 30 minutes after the vaccine was given. Patient did not have any signs of adverse reactions up until now (2 hours after the vaccine was given).
081211 phone call from parent - Mom reported patient has a fever 101 degrees, nausea & a headache. She also reported he "passed" out at clinic - this was confirmed with RN. I reviewed s/f from vis with mom and encouraged if she was unsure of his health to call Dr. or go to ER. Support offered. Mom will keep in contact.
Extreme soreness in arm followed by swelling and redness for several days before symptoms subsided.
fever for 48 hrs; arm swelling; This is a spontaneous report from a non-contactable consumer (parent). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date in Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.. The patient experienced fever for 48 hrs and arm swelling on Mar2021 05:00. Treatment received for the adverse event was unknown. Any other vaccines taken in four weeks was unknown. It was unknown that the patient diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient been tested for COVID-19 was unknown. The outcome of the events was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
mild headache/severe headache; severe tingling and burning on left side of head; severe tingling and burning on left side of head; shingles; nerve reaction; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on 06Mar2021 at single dose for COVID-19 immunisation. The patient recently had the shingles vaccine. Relevant medical history and concomitant medications were not reported. The patient experienced a mild headache, 3 days after second dose the headache became more intense and she experienced severe tingling and burning on left side of head. Caller reports she went to her family doctor on Tuesday, was diagnosed with shingles and later sent to emergency room due to her severe headache and nerve reaction from shingles. Caller had a CT scan (negative). Caller reports that the headache is just now subsiding this week. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
MACULAR PAPULAR RASH B LEGS/GROIN WITH ERYTHEMA + BLANCHES SOLU-MEDROL 0.2ML.