chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fall (collapsed due to stress and infection, the patient was on respirator). Previously administered products included SHINGRIX (on 23rd May 2018 vaccinated with the 1st dose). Concurrent medical conditions included rotator cuff tear and carpal tunnel syndrome (causes numbness in hands and fingers). On 22nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling, injection site induration and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site swelling, injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The patient after vaccination with SHINGRIX, experienced redness, hardness, and swelling at the injection site about the size of palm of her hand. The symptoms were mostly resolved except for some soreness if the patient pushed herself firmly. It took a few weeks for the symptoms to resolve. This case was linked with case US2018165433 (1st dose), reported by the same reporter for the same patient.
10 days post vax pt exp high pitch scream/cry, dec feeding, fussy, Seen by MD sx of URI w/poss gastroenteritis;
Headaches; Left eye jumping/ eye jumping other than its something like a twitching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), administration date: 14May2021, for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: HEADACHE (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Headaches"; MUSCLE TWITCHING (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Left eye jumping/ eye jumping other than its something like a twitching".  Additional Information: Reporter unable to clarify further on eye jumping other than its something like a twitching. States has lots of health problems. Asking for more information on her side effects including duration and whether it is related to the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I lost the ability to get out of bed or a chair, balance so I could not walk.  Lasted about 15 hours.  May have something to do with detrol.
Patient had normal major response to vaccine no fever, no CAD, no pustules, no erythema - had associated blister.
itchy; Burning skin; This is a spontaneous report from a contactable other HCP (nurse). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route, administered in left arm (Left Deltoid) on 30Jan2021 at 10:15 (Batch/Lot Number: EL3246) as SINGLE (age at vaccination was 39-years-old) for covid-19 immunization. Medical history included seasonal allergies and urticaria. The patient's concomitant medications were not reported. On 31Jan2021, at 06:00, the patient was itchy. On an unspecified date in 2021, the patient experienced burning skin. On 23Feb2021, at 12:30, patient received second dose of bnt162b2 via intramuscular route, administered in left arm (Batch/Lot Number: EL3302) as SINGLE for covid-19 immunization. Therapeutic measures were taken for both the events (Benedryl/ topical steroid). The outcome of pruritis was unknown whereas, burning skin was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
No additional AE information; e received GARDASIL 9 on 2/24/2023 at the age of 49; This spontaneous report was received from a consumer and refers to a 49-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 24-FEB-2023, the patient was vaccinatedwith hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event information was provided (no adverse event).
His arm was sore for 2 days after receiving 1st dose; He felt little tired on 2nd day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm was sore for 2 days after receiving 1st dose) and FATIGUE (He felt little tired on 2nd day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (He felt little tired on 2nd day). On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (His arm was sore for 2 days after receiving 1st dose). At the time of the report, PAIN IN EXTREMITY (His arm was sore for 2 days after receiving 1st dose) and FATIGUE (He felt little tired on 2nd day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment taken was not reported concomitant medications were not reported
Pt developed a maculopapular rash and irritability which started on day #15 following her MMR injection. She did not have fever. She was examined on day #18 and had what appreared to be a mobilliform rash on the trunk.
after recieving my third vaccine (booster) I started having hives and brain fog. Its been over a month and I am still suffering.
pt arm became swollen & sore w/in 8hr of vax;arm inflamed from shoulder area to elbow including axillary;pt used cool compresses & OTC Ibuprofen to reduce pain/inflammation;5JAN97 pt visited clinic had brown pigmentation spot;some itching;
I woke up the day after receiving my second vaccine with severe hot/cold feeling. I was shivering but had a very high fever. I spent the day sleeping and feeling very achy and tired. I had spikes in my fever off and on for two days and was still achy going into day three. I felt much better by day four.
My heart stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm right on 06Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 40-year-old. Medical history was none. The patient had first dose of bnt162b2 on 06Mar2021 at right arm at age of 40-year-old. Concomitant medication in two weeks included omeprazole (PRILOSEC). No other vaccine took in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient heart stopped on 10Apr2021and she died at home, her husband brought her back to life, then she died in the ambulance they brought her back to life. Then in the Hospital trauma room they sent her to CT scan she died again for 5 minutes they saved her again. The patient was admitted for 6 days and received treatment for the event. The event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was recovered with lasting effects.  Information regarding the Lot/Batch number has been requested.
Whole body rash with intense itching. Hives on back from shoulders to buttocks.  Dermatographia all over body.  Initially tried prednisone five day course but had no effect. Primary then tried to treat for scabies with prescription strength permethrin but this had no effect either. I tried different OTC anti-histamine drugs. Due to my job, I can only take Claritin or Allegra. Two 180mg Allegra a day keeps all symptoms, except dermatographia, at bay.
Adverse Event: Right shoulder pain, decreased range of motion  Chiropractic 3 visits (first visit end of October 2021), 11/5/2021; 11/10/2021 - referred to Physical Therapy Physical Therapy twice weekly starting  11/22/2021 (still attending twice weekly) Steroid injection R shoulder joint 11/30/2021 (Orthopedics) Steroid injection R shoulder bursa  1/11/2022 (Orthopedics)
body aches/ Pains; sick; Not feeling good; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches/ Pains"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown", described as "Not feeling good".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 7-2-09 at 10pm father noticed eye lids swollen + red. Taken to ER - Benadryl liquid given.
12-year-old patients that received the fluzone high-dose quadrivalent accidently with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA443951.  This case involves a 12 years old and unknown gender patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] accidently with no reported adverse event t inappropriate age.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.7 ml dose once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( formulation and lot number: unknown) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 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.
Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.
FRIDAY, SAT, SUN - BAD HEADACHES; BODY ACHES SUNDAY - MONDAY - BAD PAIN INJECTION SITE; RED SWOLLEN, HOT TOOK TYLENOL AND IBUPROFEN.
On 5/11/00, telephone call from father stating pt's left arm is red, swollen, warm to elbows from site of injection and arm is almost twice as big as the other arm. Father was advised to take to MD. On 5/12/00, spoke to father, who stated pt was put on antibiotics and is better today.
Pt received J&J COVID 19 vaccination at 12:22 8 minutes later while in observation area Pt started complaining of nausea, feeling faint, and dizziness. Pt vomited and complained of feeling like she was going to pass out. Instructed patient to take deep breaths. Pt having SOB placed on 15 L/min O2. Pt VS were stable O2 99 and BP 81. After a few minutes of O2 removed from patient and continued to monitored patient for 20 minutes without O2 patient stated she felt better and requested to leave. Instructed patient if she felt that way again take deep breaths and pull over.
Had Tdap #1 & MCO #1 left arm 3/20/13, developed some swelling & redness at site that AM & increased in size so seen at ER 3/22/13 and dx allergic reaction to immunizations - was already on AMOX --> changed to Clindamycin, ORAPRED & BENADRYL.
deep vein thrombosis left leg/Vascular u/s showed clot from the ankle to the groin in left leg; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at the hospital. Medical history included prediabetes, relapsing polychondritis, obesity, intolerant to gluten and cow's milk protein, and penicillin allergy. The patient is not pregnant at the time of report and vaccination. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included fish oil; ergocalciferol (VIT D); methylfolate; metformin; and desvenlafaxine succinate (PRISTIQ). On 12Jan2021 at 19:00, the patient's left ankle swelled double normal size. On 13Jan2021, left leg swelled. On 14Jan2021, patient knew it was a deep vein thrombosis left leg based on pain and swelling and past experience but waited till her day off on 15Jan2021 to seek medical care. Vascular u/s (ultrasound) on 15Jan2021 showed clot from the ankle to the groin in left leg. Sent to emergency department and started on Zarelto x 6 months for long term anticoagulation. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose on 01Feb2021 at 16:45. Outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deep vein thrombosis and the suspect drug.  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  Committees, and Investigators, as appropriate.
Entire back hurt; Left arm sore; Left armpit swollen a bit; Cold; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 03:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously took shellfish. Prior to the vaccination, the patient was 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 01May2021 at 00:15, the day after shot, the patient experienced that his entire back hurt, on a pain scale it was 6/10, had left arm sore, left armpit swollen a bit and cold most of the day. The clinical outcome of the events entire back hurt, left arm sore, left armpit swollen and cold was resolved on an unknown date on May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had odd symptoms with left ear. Described as ear pain, pressure, buzzy feeling on and off. Patient also experienced dizziness, chills, aching and diarrhea.
I woke up with a tender, sore and swollen right supraclavicular lymph node. Tenderness and soreness resolved after about 2 days but it has continued to be palpable/ swollen to present time.
Pressure in ears, ringing in ears, dizziness. Started two days after vaccine. Still present
Patient's mother alerted us that patient was feeling nauseous. Patient is an 8 year old male only medical history reported by mother of asthma and allergic reaction to amoxicillin (reported side effect of nausea/vomiting). Mother also reported symptoms of nausea with the first dose but no vomiting related to anxiety. Patient received his second dose of 0.2ml of Pfizer in the left arm, with no symptoms for the first 10min noted. Mother reported to the nursing staff that patient wanted to vomit, patient vomited 200cc of light brown emesis. Staff nurse assessed patient was A&Ox4, no loss of consciousness, no signs of SOB, rash, or hives. Patient was cyanotic and clammy, patient was lowered down to the ground with his legs elevated on a chair. First set of vital signs with no reading, second set after lowering him on the ground was B/P: 98/58, P:80, R:20, O2 sat: 98% RA. Second blood pressure reading was B/P: 78/40, P: 68, R:24, O2sat: 98% RA.  Reassessed airways, no SOB or tongue swelling. Patient was given a lollipop to keep him stimulated and alcohol pads were placed under his nose to have him breathe. No onset of SOB, swollen tongue, stayed with patient at all times. 911 was called and fire engine responded. EMS took vitals at 1419 with 108/72 79 HR, and 100% oxygenation. Patient was taken to Hospital by ambulance with permission of the mother.
Watery/Mucus diarrhea 9-10 times a day  lasting 17 days. Symptoms started 5 days after MMR vaccine.
The pt broke out in papular vesicular rash on 03/24/2002 also adenopathy and local site reaction.
Patient started experiencing severe pain, patient went to ER and was later diagnosed with Shingles after vaccine was administered. Patient had nerve pain and active rash. Patient was treated by PCP.  Shingles is still not fully cleared.
Injection site reaction developed after Zostavax administered. Patient was instructed by MD to monitor size and to take hydrocortisone or Benadryl if itching.
Discomfort at inj. x 1 week. No swelling, redness, not warm to touch.
went to get a booster dose from Moderna and got a full dose of 0.5ml.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (went to get a booster dose from Moderna and got a full dose of 0.5ml.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 088D21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (First dose, lot EN6206, expiry date 30-JUN-2021, Injection) on 09-Mar-2021, Pfizer (Second dose, lot EP6955 and expiry date 30-JUN-2021) on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, GOLIMUMAB (SIMPONI), MESALAZINE (PENTASA), LAMOTRIGINE (LAMICTAL), FUROSEMIDE (LASIX [FUROSEMIDE]), OMEGA-3-ACID ETHYL ESTER (LOVAZA), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), FAMOTIDINE (PEPCID [FAMOTIDINE]) and SODIUM for an unknown indication.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (went to get a booster dose from Moderna and got a full dose of 0.5ml.). On 17-Jan-2022, ACCIDENTAL OVERDOSE (went to get a booster dose from Moderna and got a full dose of 0.5ml.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported This case pertains to the caller. Patient had 3 doses of primary series (first and second were Pfizer, third was Moderna)   This case was linked to MOD-2022-455754 (Patient Link).
3-8-22 - racing heartbeat, chills, dizziness, shortness of breath 3-9-22 - increased dizziness and shortness of breath 3-10-22 - progressing dizziness, diagnosed vertigo, weakness in body 3-12-22 - headache, dizziness, vertigo 3-15-22 - extreme headache, vertigo, weakness progressing (left side) 3-20-22 - excruciating headache, vertigo, nausea, weakness, barely walking 3-24-22 - extreme headache, pain all over, left side numb, SOB could barely open my eyes, couldn't see, heart racing, didn't ear for 3 days, could not function at all. Same day was sent to Emergency at hospital and was admitted or six (6) days.  I am still awaiting for my medical records and am willing to send them when I obtain them.
Severe explosive diarrhea cannot control. I have been taking up to ^ imodiums a day  gas ex and charcoal tablets.
From onset for about 24 hours extreme fatigue, also even though temp was 98.6, the feeling that of having a fever.
Edema presented shortly after vaccine was administered. Cold compress on site applied for about 30 minutes and patient was monitored for about an hour. No systemic symptoms noted.
Information has been received from as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's son experienced mercury poisoning and neurological disorder. Upon internal review. neurological disorder and mercury poisoning were considered other important medical events (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/13/04.
I received the vaccination in my left arm at a Clinic .  I received next Pfizer vaccine 3/25/21 at a pharmacy  on 3/25/21, Lot No. EP7533.  I received the  Pfizer booster also at a pharmacy.
Felt faint 5 minutes after vaccination. Profusely sweating, ears ringing, blurred vision. Needed to lay on the ground immediately for fear of fainting. Ice pack and water was given to me