chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US019090 is an initial spontaneous report received from a pharmacist on 20 Sep 2012 with a follow-up received on 28 Nov 2012: This case refers to a 20-years-old male patient. He was given only Men A component of MENVEO vaccine (batch number: unknown) reconstituted with sterile diluent, intramuscularly on 19 Sep 2012. No adverse reaction reported following this administration error. He was vaccinated with a correctly re-constituted MENVEO on 24 Sep 2012. Follow-up received from the pharmacist on 28 Nov 2012: Updated patient demographics, date of vaccination and information about re-vaccination.
Febrile seizure 3/22/10. Patient found dead on morning of 4/2/10, per parents febrile to 102 t bedtime with URI but no other sx. Autopsy and toxicology were negative.
Information has been received from a registered nurse concerning an 8 year old patient who on 26JUL2001 was vaccinated iwth a dose of varicella virus vaccine live. On 26JUL2001 concomitant therapy included diphtheria toxoid/pertussis vaccineteta, poliovirus vaccine and measles virus vaccine live+mumps virus vaccine live+rubella virus vaccine live, respectively. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications", no treatment was required and patients were not seen by the nurse , but were reported by parents as explanation of an absence. It was also noted that the child was part of six cases that took place over the last school year from 9/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 9 years of age. The nurse also reported that five other children developed mild chickenpox. Additional information has been requested.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 05-Nov-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
First reported to provider on 11/03/2017- localized reaction to left thigh with small nodule and large area of dimpling/indentation to left thigh. Follow up 12/15 no improvement, no pain or weakness.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 25Feb2021 14:15 (Lot number: EN6202, Expiration Date: Jun2021) at the age of 82 years as dose 2 single for covid-19 immunisation. Relevant medical history included: "COPD", start date: 1965 (unspecified if ongoing), notes: Stop date: Ongoing; "Removal of cancerous from lung", start date: Aug2006 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 04Feb2021, Time: 12:30 P, Anatomical Site of injection: arm, Route of administration: Intramuscular, Lot#EL9262 (Exp. May2021)), administration date: 04Feb2021, for COVID-19 Immunisation, reaction(s): "Headache"; Bnt162b2 (Dose: 1st), for COVID-19 Immunisation, reaction(s): "Tired", "Sweating", "General malaise", "Muscle aches", "Fever". The following information was reported: HEADACHE (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Headache".  Additional information: Headache the next day- lasted several hours and was gone. No other side effects.Prior vaccination (within 4 weeks): None.  No follow-up attempts are possible. No further information is expected.
Vaccine administered on 7/24/23, 3 days beyond BUD (7/21/23)
2 days after dose #2: headache, muscle/joint ache, chills, loss appetite,swollen lymph glands, brain fade. Every other day for over 2 weeks.
pt ran a low grade fever, front thigh ( inject site) swelled from groin to knee to almost double.  Bright red in color, cried uncontrolled for 2 hr. only cold compresses & APAP was suggested. swelling  & redness went away in a few days.
itchy; Redness at site; tender; A spontaneous report was received from a consumer who is a 76-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at site, itchy, and tender.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, aspirin, ascorbic acid, vitamin D and fish oil.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026-L206A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the same day as the vaccination, the patient reported she had redness, itching, and tenderness at the injection site and it measured approximately the size of a half dollar.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events of redness at site, itchy and tender was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Right side of face paralysis, Right side of mouth pulling to the left. Loss of blinking function in right eye. Went to urgent care clinic on 11/25/09 at 5:00PM per Dr's orders. Full exam and CAT Scan. Diagnosis: Bell's Palsy. Given 60mg prednisone/dy for 7dys on a taper on/off schedule.  11/30/09 Medical records received, service date 11/25/09. Assessment - Bells Palsy. Patient presents with sudden onset facial droop. Change of taste, right droop of lips and difficulty closing right eye. Dizziness, headache, vertigo.
Flu like Symptoms; Dizziness; Low fever; Body Aches; Tenderness in shot area; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like Symptoms), DIZZINESS (Dizziness), PYREXIA (Low fever), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Tenderness in shot area) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     Patient reported no allergies and never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: Pfizer (Patient received previous dose from pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Ankylosing spondylitis (Patient has ankylosing spondylitis for years, but does not take immunosuppressant medications.).    On 26-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like Symptoms), DIZZINESS (Dizziness), PYREXIA (Low fever), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Tenderness in shot area). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like Symptoms), DIZZINESS (Dizziness), PYREXIA (Low fever), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Tenderness in shot area) outcome was unknown.            On 27Sep2022 in the afternoon he had low fever, body aches, dizziness, tenderness in shot area and flu like symptoms  Patient received concomitant medication but patient does not feel comfortable providing this information. No treatment information were reported by the reporter.
Chest pain, disorientation, dizziness, nausea, brain fog, muscle spasms, inflammatory response in prior surgical sites (from 6 months to 2 years old), and fatigue
Immediately after receiving the vaccine, I started to feel sick as expected and it took a week to feel better. I haven't had any complaints since then. But heartburn was getting a lot worse so I saw my doctor and they prescribed me famotidine 20mg daily. And that was working quite well. But over the past several months it was becoming less effective. I reached out to my doctor and they said to increase the dosage. And I was also taking Tums for heartburn. That's something I've needed to take in combination to manage. My heartburn has been triggered by stress, and it's been a stressful time. I'm not sure if it's in relation to the vaccine but it's just a really stressful time. With symptoms: heartburn happens regardless of my diet, drinking water causes heart burn, it's a very intense uncontrollable heart burn. Doing things like bending down and just general job activities have been unbearable and impossible.
Patient presented to the ED on 4/13/2021 for syncope. Patient presented to the ED and was subsequently hospitalized on 4/23/2021 for bradycardia, AV block. These visits are within 6 weeks of receiving COVID vaccination.
Started with sore arm. Soreness continued to go up neck & into back & patient had severe muscle spasms. Had ER visit.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 26Jan2021 as dose 2, single (Lot number: EJ1686), in right arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF88839) at the age of 68 years, in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 17Jun2022 as dose 4 (booster), single (Lot number: 0554A22A), in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Jun2022, outcome "unknown", described as "Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (31Oct2022) Positive, notes: Positive test with symptoms 5 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report received from a patient concerned a 53-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose series was 1) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, route of admin, and batch number were not reported) dose and frequency were not reported from an unspecified date to 15-OCT-2021 for psoriatic arthritis. No concomitant medications were reported. On 24-NOV-2021, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine was not applicable and action taken with adalimumab was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220117270 -Covid-19 vaccine suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
tested positive for Covid on Aug 25th; tested positive for Covid on Aug 25th; feeling sick; weakness; fever; slight cough; dizziness; feeling not good; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 07Aug2021 (age at vaccination 54-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on Aug25th and feeling sick, weakness, fever, slight cough, dizziness, feeling not good on 21Aug2021. The clinical course was reported as she works for the school system. She had her first Covid vaccine dose on 07Aug2021. She started feeling sick on 21Aug2021 with symptoms including weakness, fever, slight cough, dizziness, and feeling not good. She tested positive for Covid on 25Aug2021 and missed her second dose which was supposed to be on 28Aug2021. She has been symptom free since 04Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 25Aug2021. The clinical outcome of the event tested positive for covid was unknown and other events was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive COVID-19 test with symptoms". The patient was very sick for 5 days, coughing, fever, diarrhea and lethargic. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed large, itchy raised hives in trunk, legs, arms approx 8-9 hours after receiving vaccine. Partially relieved by Benadryl 25 PO every 6 hours. Hives continue to persist and have exacerbated 48 hours after flu vaccine administration.
Headache; swollen lymph nodes in right underarm and right breast with pain; swollen lymph nodes in right underarm and right breast with pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) Nurse. The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 13:00 (Lot number: FH8030) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy to Penicillin" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 21Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Right, Vaccine Administration Time: 12:00), administration date: 16Feb2021, when the patient was 45 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Arm Right, Vaccine Administration Time: 12:00), administration date: 26Jan2021, when the patient was 45 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 22Oct2021 17:00, outcome "unknown", described as "Headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 22Oct2021 17:00, outcome "unknown" and all described as "swollen lymph nodes in right underarm and right breast with pain". The events "headache", "swollen lymph nodes in right underarm and right breast with pain" and "swollen lymph nodes in right underarm and right breast with pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, lymphadenopathy, lymph node pain.  Additional information: if covid prior vaccination No. if covid tested post vaccination was yes  No follow-up attempts are possible. No further information is expected.
Weeks after I went to the dermatologist office, and was diagnose with my auto immune system inflamed with my ANA TITER reporting on 06/26/2021 high on the 1:640 H from my blood work, the physician assistant said that this is a possibility I may have different kinds of Lupus.
SORE ARM, REDNESS, SWELLING FIRST FEW HOURS..THEN FEVER & CHILL AT NIGHT.. SYMPTOMS SUBSIDED AND WENT AWAY NEXT DAY..BUT SORENESS STAY X1 WK.
Pt received first dose of pfizer vaccine lot number EL9262 on 02/23/21. Pt began developing SOB and feeling tired. Second dose of vaccination 03/18/21 Lot EN6208.  Pt went to ER on 3/17/21- negative CXR. Sent home on steroids. No cardiac history. Returned to hospital 4/2/21 with worsening SOB- ECHO revealed estimated EF of 25% with diffuse hypokinesis. Pt c/o weight loss and fatigue. CT chest negative for PE. Was found to have small pericardial effusion with a large left pleural effusion.  Started on Lifevest, entresto, furosemide and potassium.
Pt having swollen area around site, low grade fever, nausea for 48 hours post vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of Meniere's disease aggravated in a adult female patient who received FLUARIX QUADRIVALENT (batch number 2F5P4, expiry date 30th June 2016). Concurrent medical conditions included Meniere's disease. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced Meniere's disease aggravated (serious criteria GSK medically significant and other: as per reporter) and ringing in ears. On an unknown date, the outcome of the Meniere's disease aggravated and ringing in ears were unknown. The reporter considered the Meniere's disease aggravated to be almost certainly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the ringing in ears to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter stated that patient received the FLUARIX vaccine and believed that the vaccine flared up the Meniere's disease. The sales rep reported that the patient developed ringing in ears after vaccination with FLUARIX.
Started with Swollen Lymph Nodes in my clavical area on both sides. Feels like I am being choked.  Then the extreme pain set in from neck to lower back and all in between. Rash started in my torso area and then traveled up my chest into neck.  Eventually started to travel down my arms and legs.  Stabbing jolting pain in my breast, more on my left side.  Lasted for about 2-3 weeks. Was put on Prednisone and Rash medicine.
Shaking of arms and head, decline in gross motor skill function, all over body trembling that lasted approximately 24 hours.
Headache,   chills,  swelling,  redness, pain, joint pain, tirednesd
dizzy/ her head was swimming so bad, she could hardly get her head off the pillow; car sick; weak; nauseated; This is a spontaneous report from a contactable consumer (patient). A 95-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via an unspecified route of administration on 13Feb2021 at 13:00 (at the age of 95-years-old) in left arm as dose 1, single for covid-19 immunisation. Medically history included that years ago, she took smallpox vaccination and got really sick, fever, ached all over. She was healthy and wasn't like this before vaccine. She was in very good health and was walking a mile every day before she had the covid-19 Vaccine. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks, adverse events following prior vaccinations, family medical history relevant to adverse events were reported as none. The patient's concomitant medications were not reported. The patient reported that she thought she had food poisoning. She clarified she felt like she was car sick. She said she wanted to throw up but could not. She said she had no diarrhoea. She said her head was swimming so bad, she could hardly get her head off the pillow. She said she took Ibuprofen, and eventually was alright. She said she has not had any dizzier spells and was walking with her cane now.  The patient asked if it was OK for her to get her second COVID-19 Vaccine since she had a side effect to the first COVID-19 Vaccine. The patient was nauseated in Feb2021. Since she had the dizziness, she had not felt as strong. She said what she experienced has left her body weak. She said she took her cane out, so she has her cane with her when she walks just in case, she needed the cane. She said she felt so bad when her dizziness started that she didn't know what was going on. The adverse events do not require visit to emergency room or physician office. It was reported that she took probably a total of 3 Ibuprofen 600mg tablets from last week into this week. She said she took only 1 Ibuprofen 600mg tablet on a given day. She said the Ibuprofen 600mg tablets are a prescription that are dispensed in a pharmacy bottle with no NDC, lot and expiration date listed.  Relevant tests were reported as none. The outcome of the event asthenia was not recovered, for nausea was unknown and for all other events was resolved in Feb2021.  No follow-up attempts are possible. No further information is expected.
First dose of COVID-19 shot in upper left arm.  Less than 24 hours later, hardness at injection site and 1 inch diameter redness
I got the vaccine on 9/24/21 at 9:35 AM.  At 7:30 PM that night, I started to get ringing (tinnitus) in my left ear.  The ringing has been constant and has not gone away. It has only gotten worse and is now in my right ear as well. This side effect from the vaccine has increased my anxiety exponentially.  I have a difficult time going to sleep at night because of this.
Information has been received from a physician concerning a 15 year old, (previously reported as a 16 year old), white female student,  who on 09-AUG-2006 in the pm. was vaccinated with the first dose of Gardasil in the right arm.  On 03-NOV-2006 in the pm. was vaccinated with the second dose of Gardasil in the left arm.  On 23-FEB-2007 in the pm. was vaccinated with the third dose of Gardasil in the right arm (previously reported left arm) it was reported at the time of the vaccine the patient had nausea and severe malaise.  Unspecified medical attention was sought.  On approximately 27-APR-2007, the patient recovered from flu like symptoms extreme nausea, and severe malaise.    Additional information is not expected.