chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is sore at the injection site; Raised rash, below the injection site; red, below the injection site; had to use 3 vials of Shingrix to mix the dose; had to use 3 vials of Shingrix to mix the dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On 5th November 2021, the patient experienced injection site pain, rash and erythema. On an unknown date, the outcome of the injection site pain, rash and erythema were not recovered/not resolved and the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the rash and erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose of Shingrix in right arm.  2 days after receiving Shingrix, the patient experienced a rash that was raised and red about 1 inch below the injection site. Her arm was sore at the injection site.  The patient wanted to also report that, she was not comfortable with the immunizer at her pharmacy as he looked confused when mixing the Shingrix vaccine.  The immunizer told the patient that, he had to use 3 vials of Shingrix to mix the dose which led to inappropriate reconstitution technique and it made her felt like she did not get the correct vaccine which led to inappropriate dose of vaccine administered. The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up.
Patient presented to the ED complaining of upper quadrant abdominal pain, headache, fever and chills after receiving 2nd vaccine the previous day. She also blacked out on the same day as receiving the vaccine and did not remember how she got home.  Patient was discharged same day in stable condition.
Began vomiting intensely on evening of 11/26/02. Aspirated and then went to ER.
LOCALIZED REDNESS AT SITE, RASH DEVELOPMENT ON UPPER TORSO.
Sore arm for 3 days., followed by nothing for 3 days.  On the 8th day, sore arm returned and a localized rash developed.  Called primary physician and he advised taking Benedryl.  Rash is beginning to fade on day 16.
Pt reported 48 hrs of fever above (101.6), pain, redness, edema at site of injection. Decreased range of motion with left arm. Fatigue X 3days.
PATIENT RECEIVED VACCINE AND WAS WAITING  IN POST VACCINATION AREA. ABOUT 5 MINUTES AFTER THE VACCINE HE FAINTED.  HE WAS PLACED IN SUPINE POSITION, WITH FEET ELEVATED. PT REGAINED CONSCIOUSNESS IMMEDIATELY. PATIENT CUT HIS EYEBROW DURING FALL. AMBULANCE WAS CALLED IN AND PT WAS TAKING TO THE HOSPITAL.
8/19/09 mother called clinic stating child developed "upper respiratory infection 1 week after administration of vaccine" was treated with antibiotics as prescribed by her pediatrician. blood tests are pending.
gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        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 medications were reported. No treatment medications were reported.
Patient reported tingling in her tongue 5-7 minutes after receiving the vaccine. Pt requested to get Benadryl since that ?usually helps?. She mentioned her physician talked to her about the possible side effects and duration for someone with her medical history, as listed below. Patient mentioned she has a ride waiting for her in the parking lot and someone to stay with her for the next three days, per physician?s recommendations. 2pm: BP 129/91 HR 73 RR16 SpO2 96 normal pain level for her, A&O x4 2:30pm: BP 123/90 HR 64 RR16 SpO2 99 Temp 98.4 normal pain level for her, A&O x4. Patient taken into medical tent, vital signs taken, patient reported feeling normal otherwise. Allergies to Amitriptyline, Calcium Channel Blockers and Lidocaine. Took her usual medications before visiting our vaccine site: Fludrocortisone, Valtrex, Zyrtec, and Pepcid. History of Mast cell activation syndrome, P.O.T.S. - Postural orthostatic tachycardia syndrome, and an undiagnosed neurological condition that causes pain, decreased pain sensation and tingling. Patient requested a half dose, she decided on 25mg. Administered 25mg of Benadryl PO liquid, 10ml, 5ml = 12.5mg. Released back to the 30 minutes observation area. At 2:30pm patient taken into medical tent, vital signs taken, she reported feeling better and felt less tingling after Benadryl administration. Repeated vital signs, as reported above. ?I appreciate you taking my concern seriously?. Escorted out of the building by observations staff.
PT WAS GIVEN ADULT DOSE OF HEP A WHICH WAS 20MCG, WHEN HE SHOULD HAVE BEEN GIVEN 10MCG.
Colleague received 2023 flu vaccination on 10/8/2023 at 1pom. She did not notice she had had a reaction until 10/10 at 11:00. She went to scratch her RUE as it was itchy and found the site to be slightly raised and red and hot. The area is approx 2 " in size and barley raised. It is warm and pink.
Child was here for his well checkup and was offered the HPV9. I had the patient lay down, administered the HPV, advised to wait 15 minutes. Patient got up and felt nausea and dizzy. Dr. came and checked on him. Was given orange juice. Monitor until better.
arm is sore; did not sleep well; nagging headache; feeling real tired, fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is sore), POOR QUALITY SLEEP (did not sleep well), HEADACHE (nagging headache) and FATIGUE (feeling real tired, fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), POOR QUALITY SLEEP (did not sleep well), HEADACHE (nagging headache) and FATIGUE (feeling real tired, fatigue). At the time of the report, PAIN IN EXTREMITY (arm is sore) and POOR QUALITY SLEEP (did not sleep well) outcome was unknown, HEADACHE (nagging headache) had not resolved and FATIGUE (feeling real tired, fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she did drink some coffee and the fatigue eased up a little.  No concomitant medications were reported.  Treatment information was not provided.
(approx .10 cm) Received VARIVAX (L) upper arm SQ on 9/26/2013, Larg area of induration (R) upper arm. Diag w/cellulitis 9/28/13. Developed fever after vaccines. Started Clindamycin Palmitate 75mg/5ml TID.
Reports to PCP on 2/12/21 that she has been having fatigue and "ringing in ears" (tinnitus) which started 1 day after her vaccination on 2/4/21.  Pt was seen in-clinic at urgent care on 2/13/21. Ear exam was normal. Pt was referred for audiology exam and then follow-up with ENT for referral.
2/1 vaccination at 9am; 10AM same day, spiked fever of 101.6. Lasted for several days. Tylenol did not ease fever nor symptoms. Fatigue, chills, extreme HA, and face was flushed. Symptoms lasted the whole 3 days. Fever broke that Friday morning. **COVID + 07/2020; lingering symptoms
Approximately 24 hours post vax, pt's deltoid became edematous, erythematous, hot and tender. Pt proceeded to local ER. Started on Keflex.
Arm is sore and red around vaccine site. Symptoms started after the morning after the vaccine was administered.
This case was reported by a healthcare professional and described the occurrence of injection site lump in a 4-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX in an unknown leg. At an unspecified time after vaccination with KINRIX, the subject experienced injection site lump (golf-ball size knot at the injection site) described as a "bad reaction." At the time of reporting the outcome of the event was unspecified. Follow up received from the healthcare professional on 03 February 2012. Concurrent medical conditions included asthma. On 20 December 2011 the female subject received a dose of KINRIX as the 1st dose in series (.5 unknown, unknown, right thigh) in the series and experienced wrong vaccine administered. KINRIX is indicated as the 5th dose in the DTaP series and the 4th dose in the IPV series. The reporter noted that this was the 1st dose of KINRIX administered to the 4-year-old subject. also on 20 December 2011, the subject received unspecified dose of MMR vaccine (Non-GSK) (details unknown), 1st dose of PREVNAR 13 (.5 unknown, unknown, right thigh), unspecified dose of VARIVAX (details unknown). On 22 December 2011, 2 days after vaccination with KINRIX, MMR vaccine (Non-GSK), PREVNAR 13 and VARIVAX, the subject experienced injection site lump. The healthcare professional noted that the events could have been associated with KINRIX, MMR vaccine, PREVNAR 13 and VARIVAX as all were given at the same time, but left relationship to GSK product as unknown. The healthcare professional considered the events were clinically significant (or requiring intervention). On 20 January 2012, the events were resolved.
Patients states she felt a "pushing" feeling in the middle of her back along with dizziness. Two days later, she noticed a 3"x1" raised lump at injection site.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had not resolved.            No concomitant medication were provided by the reporter.   This case was linked to MOD-2021-148711 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received included no new signification information. Correction made in initial document, processed as second dose case, first dose events removed.
head and body/aches; body/aches; fever; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7642B and 055F22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  After each of my 6 COVID vaccinations, I have experienced head and body/aches, fever, and fatigue for approximately 36 hours.  Patient would like to know was it unusual to have fevers, a few aches and fatigue after having the Moderna Spikevax vaccine. She reported it packed more of a punch this time. This one hit her pretty hard. She was feeling well last night and then started feeling achy and had a fever but not high. She was really sick on Sunday night after she got the vaccine and typically has a fever. She was just concerned since it was 36 hours after the vaccine that she was still experiencing these reactions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743743 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Live follow up received contains reference number added. On 23-Oct-2023: Live Follow up received: Events added, Batch number updated, Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743743:Bivalent case
I got out of work went home, started having sharp pains in my chest, and on my arm, I got worried nothing like this has happened before with the chest pain, I was already having back pain, shortness of breath, and headaches
Itchy red rash on my inner left elbow, with scattered raised bumps. They appeared to be over scars from blood donations I've contributed over the past four decades.
Information has been received fro a 62 year old female with "Charcot Marie tooth", a type of muscle, never disease and drug reaction to AUGMENTIN who "a week ago last Monday" on 20-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # was not available). Concomitant therapy included DILACOR (DIGOXIN), LIPITOR, NEURONTIN, clonazepam, baclofen and isosorbide. "The following morning after receiving ZOSTAVAX (Oka/Merck)" on 21-OCT-2008 the patient experienced an allergic reaction. The patient had swelling on the face, back of the neck, mouth and chin, horrible headache, elevated blood pressure and difficulty swallowing. The patient was brought to the emergency room last Wednesday (22-OCT-2008) from 7 pm until 2 am but was not admitted in the hospital. The patient was treated with corticosteroids, anti inflammatory drug, pain medication, and BENADRYL. As of 28-OCT-2008, the patient still had swelling around her mouth and pain inside her mouth and had not recovered. Additional information has been requested.
Rash on both shoulders/ a little on stomach/ on his back/ on the thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on both shoulders/ a little on stomach/ on his back/ on the thighs) outcome was unknown. Not Provided          No concomitant medications were reported.  On 31-Jan-2021, the patient had a rash on both shoulders and a little on stomach. It was spreading more and more. It was also on his back and thighs. It was looking like mosquito bites.     Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: only e-mail address provided
RAT testing positive; RAT testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 16May2021 as dose 1, single (Batch/Lot number: unknown) and on 25Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. 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 "RAT testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (07Jun2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient symptoms resolved with paxlovid tested negative RAT on 07Jun, symptoms returned 13Jun and RAT testing positive. COVID 19 Treatment with Paxlovid. Treatment start date from 02Jun2022 to treatment stop date 07Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHING DIFFICULTIES
No adverse event; Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was reported by the patient that he had only received 1 dose but states that he was fully vaccinated due to this "2 in 1" vaccine. No treatment medications were reported.   Reporter did not allow further contact
5NOV93 episodes of vomiting start in AM cont throughout day; 6NOV93 taken to ER saw MD for dehydration; 7NOV92 sl elevated temp noted, some episodes of vomiting; 8NOV93 seen by MD no dehydration noted-MD stated viral not vax related;
Patient began to feel flushed in her legs and feeling spread to her chest and arms after approximately 5 minutes.  Patient was assessed and found to be slightly hypertensive but no other abnormal vital signs.  Patient felt comfortable contacting her doctor and leaving the facility on her own.
Patient reported itching and redness at the injection site along with the skin being hot. Said this started Saturday morning and he has been experiencing the warmth ever since. I instructed him to take BENADRYL and MOTRIN and apply ice to the site.
I had a cerebral stroke; some times my speech gets a bit slurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Stroke" (unspecified if ongoing), notes: I had one 7 months ago. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 03Feb2022, outcome "unknown", described as "I had a cerebral stroke"; DYSARTHRIA (non-serious) with onset 03Feb2022, outcome "unknown", described as "some times my speech gets a bit slurred".  Clinical course: The patient Called to check on mothers enrollment status. During the call, it was stated that it was unclear if the patient had a stroke in June, it has nothing to do with vaccine. The patient had a cerebral stroke and some times speech got a bit slurred.The following information was not confirmed during the call, but retrieved from the system: Reporter phone No.,The following information was not provided during the call: Patient gender. On 7Feb2022, during the phone call, the patient confirmed that, the stroke was not related cause to the stroke that had been one 7 months ago. It was also stated that the patients date of birth was not provided on the phone call.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine failure, dx with varicella 1/24/06 total of 5 crusted vesicles 3 on thighs, 1 on pubis, 1 adjacent to clitoris.
received vaccination at 6 pm. At 10 pm chills, fever, night sweats, frequent urination (hourly), shortness of breath (severe), no sleep. Sleep about 4 am until 8:30 am.
Fly headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Fly headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 030M20A and 039FZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Fly headache). At the time of the report, HEADACHE (Fly headache) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-375493, MOD-2021-375498 (Patient Link).
Pt vax w/ 3 hepta B; testing after 3rd indicated 3rd dose titer neg.  Given 2 boosters 1 month apart.
Very bad fever chills,  headache, sore jaw and eyes, swollen lymph nodes, metallic taste in mouth