chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after child received his varicella vaccine in his R upper thigh, he developed 4-5 raised pink lesions that coalesced into one larger lesion; I was called in to re-examine patient at 11:10 am; child in good spirits and no acute distress; had a single 1.75 cm raised pink blanching urticarial lesion on his R upper thigh; no other rashes or hives present; no shortness of breath; no vomiting; applied cold compress to site x 15 min and upon re-examination, lesion was smaller and no new lesions; child was observed in office an additional 15 min after which time the hive had resolved (there was some faint residual pinkness to site); child discharged home to parents; on 11/27/12 child developed a new rash at same site of R upper thigh; started as single raised bump with surrounding redness; by next day, had 5-6 similar lesions;  seen in office on 11/29/12 and diagnosed with immunization reaction from varicella (had a cluster of small papulovesicular lesions on R upper thigh on a base of erythema); not indurated, warm, or tender; no pustules.
Itchy on left arm and around mouth. Assessed and stood by with epi pen. Symptoms eased and patient returned to normal and released
UrticariaPruritus Chills, fatigue, nasal congestion Narrative:  Other Relevant History:
feel sick; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel sick) and PYREXIA (fever) 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 MALAISE (feel sick) and PYREXIA (fever). At the time of the report, MALAISE (feel sick) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
no additional AE reported; the patient did not come back until now to get her 2nd dose; This spontaneous report was received from a pharmacy tech and refers to a 21-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 28-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  The patient did not come back unit 24-NOV-2020 (reported as now) to got her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse events reported.
Patient called pharmacy 7/19/17, stated that she received a PNEUMOVAX IMZ yesterday in the afternoon, and in the evening she developed a low grade fever, as well as her arm where injection was administered was hot and swollen. Patient stated that she took some ibuprofen over the counter and used an ice pack, however, it did not seem to help much. Advised patient this morning via phone call 07/19/17, to seek medical care. Patient stated she would contact her PCP.
fever (101.8 F); chills; full body aches; joint pain; brain fog; lymph node swelling (armpit of injection site arm); injection site pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 10:00 (Lot number: FF 8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS; "PCOS" (unspecified if ongoing), notes: PCOS. Concomitant medication(s) included: INFLUENZA, administration date 27Oct2021; KARIVA. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EL 3249, Location of injection: Left Arm), administration date: 26Jan2021, when the patient was 22 years old, for COVID-19 Immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Left Arm), administration date: 16Feb2021, when the patient was 22 years old, for COVID-19 Immunization, reaction(s): "Low-grade fever (100.4 F)", "body aches", "headache", "bruising injection armpit", "injection site pain", "lymph node pain and swelling", "lymph node pain and swelling".  The following information was reported: PYREXIA (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "fever (101.8 F)"; CHILLS (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "full body aches"; ARTHRALGIA (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "joint pain"; FEELING ABNORMAL (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "brain fog"; LYMPHADENOPATHY (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "lymph node swelling (armpit of injection site arm)"; VACCINATION SITE PAIN (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "injection site pain"; HEADACHE (non-serious) with onset 12Nov2021 18:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, feeling abnormal, lymphadenopathy, vaccination site pain, headache.  Additional information: The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Client reported immediate pain shot down right arm to finger tips. Later that day it was sore but she could use it both Friday and Saturday. Sunday she couldn't lift her arm past her waist. She alternated 2 Tylenol or 2 Advil every 4 hours. Monday night she was unable to sleep, difficulty lifting arm. She had to sit in recliner all night. Her husband took her early April 2nd to hospital Downtown. She stated that the nurse practitioner ask her where she got the shot and she stated "the shot was too high". She was given a prescription for Tramadol 50 mg for pain and she was referred to an orthopedic doctor. The patient saw Dr. at the Center on Wed., April 3rd. Doctor stated "the shot was too high on the rotator cuff" per client. She was ordered a physical therapy evaluation for PT for 4-6 weeks. She reports the pain was better April 4th and is able to move her shoulder. Today, April 5th she state "it feels so much better" able to move arm freely, but slightly sore.
Within 30 min the patient started noticing itching all over his body. He did not notice obvious welts or hives. This itching was present when I saw him for an appointment the following day as well. He was stung by a mosquito approximately 3 hours after the vaccine and his whole right arm swelled up for several hours in addition to the full body itch. He used warm showers to alleviate his symptoms.
Extremely Painful Back Pains; Arms and Legs feeling very weak and tired; Arms and Legs feeling very weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Extremely Painful Back Pains), MUSCULAR WEAKNESS (Arms and Legs feeling very weak and tired) and FATIGUE (Arms and Legs feeling very weak and tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Extremely Painful Back Pains), MUSCULAR WEAKNESS (Arms and Legs feeling very weak and tired) and FATIGUE (Arms and Legs feeling very weak and tired). At the time of the report, BACK PAIN (Extremely Painful Back Pains), MUSCULAR WEAKNESS (Arms and Legs feeling very weak and tired) and FATIGUE (Arms and Legs feeling very weak and tired) outcome was unknown. Not Provided          No concomitant medications provided. Patient stated that he was seeing an physician and would be having an MRI. No treatment information provided.
Both arms were sore, just pink around the sites.  A few hours after the injections developed a headache, neck hurt, had a fever all night.  Legs were weak,  stomach upset, but never vomited, anorexia.  Stayed home from school the following day.  Still had a headache and neck hurt for the following two days, but attended school.
Information has been received from a registered nurse concerning a 12 year old female with anxiety disorder and reflux oesophagitis and no drug reactions/allergies who on 03-JAN-2007 was vaccinated with a first dose of GARDASIL 0.5 mL IM.  Concomitant therapy included LEXAPRO and PREVACID.  On 01-MAR-2007 the patient was vaccinated with a second dose of GARDASIL in her pediatrician's office.  The patient has not received a third dose.  On 15-MAR-2007 the patient developed persistent recurrent vaginitis, severe dysuria with itching and redness in the genital area.  Medical attention was sought.  On an unspecified date urinalysis and vaginal cultures were negative.  The patient was treated with multiple courses of oral DIFLUCAN, MYCOLOG cream, MONISTAT cream, an estrogen vaginal cream and one of course of VALTREX.  The symptoms recurred when treatment was discontinued.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided.  Additional information has been requested.
Seizure (first occurance) lasting 10 minutes, not treated with medication, required ER evaluation.
I?ve had a severe fever, headache, chills,  and heart palpitations. I was surprised that I was getting heart palpitations. The symptoms were starting to reside.
My hearing in both my ears decreased significantly after having the immunization series. No treatment completed; just hearing testing and verifying levels.
as soon as I got the vaccine I felt a small shooting pain on my right leg. the  first 2 days I felt nothing out of the ordinary. Chills, sleepy.  as days progressed I started to feel something that was more that chills, uncomfortable teeth feeling, some shooting tingling in feet and fingers, then on it started to feel uncomfortable to specially at night and early morning. Doctor said it was paresthesia and  that a nurse said she had seen other paitients with similar symptoms. April 6 and 7 I had a fever all day long. Still have chills all over but it feels more than that, it's more like a paresthesia kind of thing. Very  uncomfortable and I have been so worried. I have a 6 year old daughter so not getting 2nd shot.
8/30 Pt presented to Ed with syncope. Known COVID exposure. He was found to be positive for SARS-CoV-2 and he had sats in the 80's on RA and had a patchy infiltrate on CXR. He was started on oxygen,  Decadron and IVF. Within 48 hours he was feeling better and was off O2. He as discharged to home with instructions to hold daily prednisone until done with Decadron taper.   Pt returned to the ED on 9/6 by squad. He had called EMS due to weakness and was found to have a RA pulse ox in the 60's. CXR showed worsening infiltrate. He was admitted and remains hospitalized as of today (9/23/2021) During his current hospitalization, the pt has required O2 with vapotherm and HFNC. He is wearing BiPAP at night and with naps. He finished a prolonged Dedadron course on 9/16. He complete 14 days of baracitinib on 9/20. Sugars have been labile and difficult to control. Pt has required several rounds of diuresis
12 hours after injection, body aches , fatigue  30 hours after injection, sore lymph node in right armpit 36 hours after injection approx. 6 hours of chills and low fever 48 hours after injection lymph node is still sore 72 hours after injection lymph node is still sore
Vaccine given (R) arm IM-immediately stated "feels like cold going down arm". C/o numbness ("Icy/hot feeling)-Numbness and cold. -Lasted greater than 30 mins. inner portion of (R) arm form-Axilla and decreased thru fingers.
Black and blue arm; Fever; Chill; Sore arm/Hurting from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/Hurting from shoulder to elbow), INJECTION SITE BRUISING (Black and blue arm), PYREXIA (Fever) and CHILLS (Chill) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M2OA.) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/Hurting from shoulder to elbow), PYREXIA (Fever) and CHILLS (Chill). On 11-Mar-2021, the patient experienced INJECTION SITE BRUISING (Black and blue arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (Fever) and CHILLS (Chill) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm/Hurting from shoulder to elbow) had not resolved and INJECTION SITE BRUISING (Black and blue arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes eczema cream.
NOSEBLEEDS; SORE ARM; CHILLS; FEVER; BODY ACHES; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional nosebleeds, migraine, seasonal allergy, allergic reaction to steroids, and concerned about citric acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nosebleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleeds on 11-APR-2021, chills on 07-APR-2021, and fever on 10-APR-2021, and the outcome of sore arm and body aches was not reported. This report was non-serious.
bad enough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: bad enough).  The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-Mar-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her shingles vaccination was bad enough. The follow up would not be possible as no contact details were provided.
Woke up around 4 AM the morning after the vaccine. Had pains are crossed my entire trust and felt as if I was having a heart attack. Got up I had a couple glasses of water and a couple of ibuprofen and it seem to clear up after about 30 minutes. Next day I was very lethargic and had increased stomach issues. Injection site very sore
received a positive COVID test, after being fully vaccinated; received a positive COVID test, after being fully vaccinated; This is a spontaneous report from a contactable consumer (patients' mother). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter became aware last night on 21Jul2021 that a friend's son, Name withheld received a positive COVID test, after being fully vaccinated with Pfizer's COVID Vaccine BNT162B2. He had severe cold symptoms, body aches, sore neck, burning nose and loss of smell and taste. His mother, Name withheld states that he felt better now and can be reached for further information. The patient had covid test positive on 21Jul2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
dizziness; feeling unwell; low grade fever; joint pain; cloudy in head; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Box # 18) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced dizziness, feeling unwell, low grade fever, joint pain and cloudy in head. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the events dizziness, feeling unwell, low grade fever, joint pain and foggy feeling in head were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient was set-up to receive the COVID-19 Bivalent vaccine. Patient was interviewed as to when the last dose was and if they had had COVID within the last 90 days. Vaccine was administered and when the information was entered into database the pharmacist realized that the patient had already had the Bivalent vaccine on 9/21/22. Patient was called to inform her of what had happened and to report any major adverse events. None were reported.
Itchy area confined to injection site 1st noticed on  12/11 during the day.  No need for any treatment, and continues off and on through today. 12/15/21 6:45 a.m.  Itchy red area with bumps observed on both legs, in the  outer top of thigh being the worse area, with intermittent red itchy spots from mid-thigh to knees, and occasional red itchy spots between knees and ankles .   Itchy red areas not observed anywhere else on my body.  No treatment as of 4:30 pm 12/15/2021.
Fainting spell.  Patient felt dizzy and almost passed out.  His heart rate was elevated and his breathing became rapid. 911 was called immediately.  His blood pressure was 102/80 and heart rate was 92.  After about 5 minutes he was feeling fine.  EMS determined it was a vagal response.
4 patients received IPOL from the opened multi-dose vial after it was punctured  with no reported adverse event; several cold temperature excursions occurred.The total excursion time was for 20 hours and the lowest temperature reached was 0.7C with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves  4 patient of unknown age and gender who received IPV (VERO) [IPOL] from the opened multi-dose vial after it was punctured  with no reported adverse event and several cold temperature excursions occurred. the total excursion time was for 20 hours and the lowest temperature reached was 0.7c with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  It was reported that there was a several cold temperature excursion occurred between 29-Apr-2022 and 27-May-2022. The total excursion time was for 20 hours and the lowest temperature reached was 0.7c with no reported adverse event (product storage error) involving IPV (VERO). Reporter was not sure of the cause of the excursions because they all occurred overnight while the facility was closed and believes that it may have been due to a fluctuation in electricity. The products involved were one punctured multi-dose vial of IPOL that was punctured on 03-May-2022. This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data  On 03-May-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot V1A121M and expiry date: 15-FEB-2024) via unknown route in unknown administration site for Immunization.  On 03-May-2022 the patient developed a non-serious event of 4 patients received ipol from the opened multi-dose vial after it was punctured  with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  No further information provided by the reporter  Action taken : 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.