chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began to feel lightheaded, experienced blurred vision, clammy skin, eyes dilated, 10 minutes following IM dose of Pfizer vaccine, about 2pm. Dose was administered at 1:45pm Mother asked pharmacist to call 911 because her daughter was feeling dizzy. Medical first responders arrived at 2:08pm, took her blood pressure, O2, and blood sugar, temperature. All were within normal ranges. O2=100, BP 114/60mmHg . Even though all vitals were normal, first responders recommended patient should follow up with primary care provider. First responders told mother response was likely due to nervousness or anxiety about new vaccine.
Sore arm, sore neck, general weakness, chills, joint pain, nausea
Moderna on 1/26 and 2/19. Positive on 8/3 admitted 8/12-8/13
1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral paresthesias 1046 Evaluated by medical control; vital signs include BP 160/90, pulse 55, respirs 14/minute, O2 sat 98% RA.  With smile right side of mouth lower and asymmetric compared with left, confirmed by husband.  Nonfocal neuro exam otherwise with normal neurosensory and eyebrow/forehead motor 1055 Reevaluated with similar findings 1100 Ambulance called 1115 Ambulance arrived for transport
Red rashes  itching all over body hands chest stumoch leg swsollen face with red rashes bumps.
Approximately 7-9 hours after shot I had an achey pain in both armpits. The next morning (day2),  I woke up with a swollen left armpit (same side as shot) which was achey and tender to touch. Nothing on the right armpit. The next day (day 3)it became a bit larger (half a lemon size?) Today, Day 4, the swelling began to go down.    No other adverse side effects other than tiredness on Day 2.
Pain; Left side eye twitching; Rash on lip; Runny nose; This case was reported by a consumer via call center representative and described the occurrence of pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received Shingrix. On 12th February 2020, 87 days after receiving Shingrix, the patient experienced pain, blepharospasm, rash lips and runny nose. On an unknown date, the outcome of the pain, blepharospasm, rash lips and runny nose were not recovered/not resolved.   It was unknown if the reporter considered the pain, blepharospasm, rash lips and runny nose to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain left side eye twitching and rash on lip and runny nose. The patient wanted to know how long the vaccine could last. Reporter consented to follow up.
Unilateral left conjunctivitis began 1/5/2021, began presumptive treatment with antibacterial eye drops 1/6/2021.
Immediate severe irritable crying, autism-severe social delay, sleeplessness, severe speech delay, pervasive developmental delay, gaze aversion, stumming, mild spaslicity. The 60 day follow up received on 9/5/03 states continues to have severe communication delay-speech apraxia (severe), approx 3 yr delay in language acquisition, vocab of 2 yo, decrease use of expressive speech. Does not look at and play with other children. No pretend play. Excessive repitition, mimicky, rigidity, memorizationn. Does not comprehend rudiments of social relationships, oblivious to aspects of other personhood.
Today I had a nosebleed. The same thing happened about 3 weeks after I received the first Janssen injection (11/23/2020) in a clinical trial. But, I also started HCTZ at the time, so I thought HCTZ was the culprit. I stopped taking HCTZ in July because my BP went down after I stopped working nightshift. The nosebleeds from the first injection continued until 8/20/2021. Initially, they occurred about once a month, then gradually increased. I started keeping track of them in May:  May 15; July 7, 16, 19; August 3, 7, 20. April 22, my platelet count was 265. On Oct. 22, it was 239.
Immunizations provided 1/11/06 Mother called 1/13/06 stating that child had a red, swollen area on his left arm.  She felt that it was larger today than when she first noted it 1/12/06. Encouraged mom to have child seen. Could also apply some topical benadryl and cool compresses for comfort.   Mom did have child seen at the office, red area 95x80mm non-tender.  Reinforced comfort measures, and to call if any further concerns.
redness around injection site started on 7/24, grew larger on 7/25, induration is approximately 3.5 inches, when touched, felt lumpy.
Anaphylaxis, Fever, CoughWheeze & Rash Narrative:
On date of injection, later that afternoon, patient reported feeling lightheadedness and shortness of breath, but it went away.  Arm was sore later and thru today, 11/6/19, of which patient contacted pharmacy to let us know that arm was still hurting.  There is no redness, though.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     It was unknown if the patient had any acute illness, chronic or long standing health or was taking prescription, over the counter medication, dietary supplements, or herbal remedies at the time of vaccination.  Previously administered products included for Product used for unknown indication: Pfizer (FIRST DOSE) on 27-Feb-2021, Pfizer (SECOND DOSE) on 27-Mar-2021 and Pfizer (FIRST BOOSTER) on 02-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 26-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    It was unknown if the patient was diagnosed with or had any COVID-19 positive test previously.   No concomitant medications was reported.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow-up received, updated suspect drug information and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015 - 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting/treatment with AFLURIA the patient experienced Fever (oral temperature of 101 Degree F), Headache, Nausea, Vomiting. For relevant test results see appropriate report section. Reporter's assessment:
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-AUG-2016, the patient was inadvertently administered a dose of improperly stored ZOSTAVAX (lot# M020071, expired date 18-JUL-2017, dose unknown) subcutaneously. The vaccine was exposed under 46 Fahrenheit degree (F) for 11 hours. There was no previous temperature excursion. Digital date logger was not involved. No adverse effect was reported. Additional information has been requested.
? at injection site Left deltoid  Pink with tan halo 10mm circumference. Erythema, increased heat, tender 3 3/4cmx 4cm. Mild induration. No flatulence.
Vasovagal response. Patient arouse from his chair in waiting area after vaccination and while conscious, fell to the ground. Patient was assisted with ambulatory back to exam room and laid on the exam table. Feet were raised above the level of heart and he stated that he felt much better within 5 minutes of this maneuver. Over a 45 minute period, patient positioning was slowly elevated from laying to sitting, then to standing, and was escorted in a walk around the store. Patient performed all of these tasks without incident. Called patient the next morning to check on status. Patient reported that he did just fine getting home and had no other incidents since vasovagal response.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 44 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Patient received Pfizer -BioNTech COVID-19 vaccine in the  clinic. At check out, patient reported 'heart racing, dizziness, and feeling flushed" ED Proceed Out called. Patient evaluated by ED team. Patient transported to ED for further monitoring.  In ED, patient complained of  mild throat tightness which was resolved by Benadryl. patient was monitored for 4 hours and was discharged home on benadryl
extreme L  side numbness/weakness: arm pain, L side of neck pain, L side of face/L orbital headache, L earache, symptoms started to fade away by 9/25. Injection site still remains sore at this time-9/28.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Nov2021 14:15 (Lot number: F63527) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Severe headache" (unspecified if ongoing); "Covid-19", start date: 06Jan2021, stop date: 26Jan2021, notes: Thought I had flu; "CLL", start date: 2018 (ongoing), notes: Not taking medications. , Green tea only. Concomitant medication(s) included: TYLENOL EXTRA STRENGTH taken for headache, start date: 08Nov2021, stop date: 11Nov2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Date: 29Mar2021, Time: 17:15, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/ Lot number: ER8733), administration date: 29Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "Virus symtoms returned", "Diffculty Breathing", "A temperature above 99 F"; Bnt162b2 (DOSE 1, SINGLE, Date: 08Mar2021, Time: 14:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/ Lot number: EN6198), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "Virus symtoms returned", "Mind fog", "Headache", "Body ache", "night sweating", "Inability to concentrate", "Sense of balance", "loss of appetite", "general feeling of exhaustion". The following information was reported: IMMUNISATION (non-serious) with onset 07Nov2021, outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Nov2021 23:00, outcome "recovered" (10Nov2021), described as "virus symptoms returned". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness.  Additional information: Prior Vaccinations (within 4 weeks) was reported as none. It was reported that after each vaccination, virus symptoms returned at no time did the patient have Difficulty breathing or a temperature above 99 F.  No follow-up attempts are possible. No further information is expected.
Four weeks after 2nd vaccine. Definite flu-like symptoms. Fever, headache, muscle aches, severe fatigue. Duration 48 hrs.
Breakthrough case admission after 4 vaccines Pfizer 2/26/21 Lot# EN6202;  Pfizer 3/19/2 Lot# EN6204;  Pfizer 9/28/2 Lot# FF2589;  Pfizer 6/23/22 Lot# FM0173;
Patient tested positive on 12/20/2021.  No charting of symptoms or pre-existing condition in ODRS.  Patient died 12/28/2021
A report was received from a health professional on 12Nov01 concerning a 5 year old female pt who experienced an injection site reaction 2 days after receiving Fluvirin on 25Oct01. The pt had previously received an influenza vaccine (brand unspecified) in Nov 2000 without any adverse sequelae. The pt is a near drowning victim who is now medically compromised receiving 29 medications on an as needed basis (list unavailable by the reporter at the time of the call). On 25Oct the pt received Fluvirin 0.5ml IM. the pt did not received any concomitant vaccines. After 48 hours, a 5x9cm reddened are with 15-20 white dots developed at the site of injection. Twenty four hours later, the area developed into 2 dime-sized blisters. The physician diagnosed the reaction as a chemical burn. The pt is currently being treated with silver sulfadiazine and oral cephalin. The reporter assessed the relationship to the injection site reaction as probable.
Redness, inflammation, and tenderness at injection site and radiating down left arm all the way to wrist. Resolved after 3-4 days. Patient is post-transplant and was directed by oncologist to receive a 2nd PNEUMOVAX (unknown when first dose given but at least 5 years prior).
Raised red lesion on Lt deltoid, tender, 8cm in diameter, hard knot at center.  Patient was brought in for an appointment for evalu. day she called 9/23/10.  Told to apply warm compress and follow-up if not better.
received an expired dose of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date 3rd April 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of Boostrix, which led to expired vaccine administered. The reporter consented to follow up.
Patient states she started experiencing tingling and numbness on the left side of her body about 10 minutes after administration. I advised the patient to remain seating for a few more minutes. She stated it started feeling a little bit better, but was concerned regarding the numbness. I informed the patient that she could go to emergency room or follow up with PCP.  Patient did inform they were going to the ER.
A report has been received from a Physician concerning, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. Expired drug administered. The patient experienced RECEIVED EXPIRED FLUMIST which started during 2014. The outcome of the event RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
11/03/10 Headache, 11/07/10 nausea, vomiting, diarrhea. 11/08/10 numbness of left side of face, left hand, stiff neck. 11/20/10 seeing double. 11/23/10 papillo edema diagnosed per optometrist. Seen by PCP, referred to ER. Transferred to Hospital for neuro consult.
Patient got vaccine & waited onsite 15minutes.  Stated thought her throat felt a little funny but wasn't sure; denied any other symptoms.  Continued waiting as requested.  10-15minutes later while nurse was tending to two other patients, patient approached crying & stating concern may be feeling worse.   Monitored  along with the two other patients.  Conversed with other recovering patient & calmed & laughed.  States she thinks she was just anxious.  BP130/86.  Left ambulatory @2:50pm.
Client reported palpitations beginning within several hours of administration and lasting for 2 days. Client reports no underlying cardiovascular illness nor any cardiac related medications.
DT given in lt deltoid in ER on 10JAN92 when pt presented w/2nd degree lt thumb burn from hot liquid; 14JAN92 devel warmth & broad area of erythema @ inject site;
approx 3yrs p/vax pt exp moderate varicella w/approx 30-60 lesions that were generally disseminated.
Client had yellow fever vaccine on 11-13-12 & had Hep A B #1 on 11-13-12. States she started itching to (R) arm at injection on site on 11-15-12. The area was red & had bruised according to client. The redness remains at the site is lighter per client - area measured appeared 25 mm L x 25 m W on 12-11-12.
Due to Covid, I waited to get my second/ after I received my Covid Vaccines. Now I am ready/ It's been 11 mos.; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in august 2020). Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by the patient himself. The age vaccination was not applicable for this report. The concomitant medication included covid 19 vaccine. The patient received first dose of Shingrix and due to Covid waited to get the second dose, which led to social problem. The patient was ready for the second Shingrix vaccine and enquired if it was too late as it had been 11 months.
Patient given expired dose of Moderna. Vial opened on 8/9 and expired 8/10. Vial should have been discarded. Vial kept refrigerated appropriately. It had not been punctured more than 20 times. Patient experienced no adverse reactions.
Swelling, tenderness and redness at site of injection starting at 24 hours; now 3 days later firm, warm tender, no abscess palpable 6 x 6 cm anterior thigh; followup was observation, ice, Benadryl as needed and reevaluation at pediatrician in 48 hours
elevated t103.2 approx 1 1/2 hrs p/DTP w/shakey & irritability; taken to ER; poss allergic rxn to med; high temp, shivering, crying, became pale, had chills, rhinorrea
patient developed a large saddle pulmonary embolism and is currently in hospital receiving standard treatment for such
NAUSEA STARTED WITHIN 30 MINUTES THEN BECAME UPPER ABDOMINAL PAIN AND SWELLING OVER THE NEXT DAY.  WAS STARTED ON PREDNISONE AND THEN FELT LIKE SHE BEGAN TO EXPERIENCE FACIAL FLUSHING AND SWELLING.  SHE STARTED NAC SUPPLEMENT BUT THESE SYMPTOMS CONTINUED FOR ONE MONTH BEFORE BEGINNING TO RESOLVE. NOW SHE IS FEELING WELL.
While seated at my desk, I experienced a feeling of blood draining from my head followed immediately by a total visual blackout for several seconds.  I did not lose consciousness.  My heart was pounding randomly, which I stopped by coughing,  and seemed to be missing beats every 10 seconds or so for the next few days.  Extreme light headedness, shortness of breath, heart flutters and pounding continued.  My daily walks for the next month had to be shortened as I felt I might faint.  I had a monitor.  They found I have supraventricular irregularities and PVC's .  I did not have this before.  The heart condition continues now.
Began with burning sensation in throat & esophagus and by noon legs broke out in hives. By the next day, hives covered body and then began BENADRYL. Dr increased to 2 every four hours.
Developed Kawasaki disease-fever started 6/1/03. Rash started 6/2/03. Hospitalized-IVIG given 6/3/03-discharged 6/5/03 with symptoms resolved.
Expired dose administered; This was the patient's fourth DTaP and IPV dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired product administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 09-MAY-2023, the patient received the 4th dose of Kinrix. On 09-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired product administered (Verbatim: Expired dose administered) and inappropriate schedule of vaccine administered (Verbatim: This was the patient's fourth DTaP and IPV dose). The outcome of the expired product administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-May-2023 The nurse reported that the patient received a dose of Kinrix, which had an expiration date of 07 May 2023.  This was the patient's fourth DTaP and IPV dose.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient was administered an expired fourth dose of Kinrix, which led to expired vaccine used and this was the patient's fourth DTaP and IPV dose which led to inappropriate schedule of vaccine administered.