chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after the flu shot, I awoke with Extreme Weakness which lasted 3.5 days. No other symptoms. Treatment: bed rest, vitamins.
While administering the vaccine "quite a bit" leaked out; A spontaneous report was received from a pharmacist, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and while administering the vaccine "quite a bit" leaked out.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that a vaccine administrator did not attach the needle to the syringe and while administering the vaccine "quite a bit" leaked out and some was administered. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The events, while administering the vaccine "quite a bit" leaked out, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Fever, 101-102.7, a headache, cough, runny nose, sweating, shivering, sore throat, body aches.
The vaccine was administered to the patient with a subq needle; A spontaneous report was received from a pharmacist concerning 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administered with a 5/8-inch (subcutaneous) needle.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot#026L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of needle issue for mRNA-1273, lot # 026L20A. There were no reported AEs associated with this case of needle issue.
Shoulder muscle injury with pain and loss of range of motion 5 weeks after im administration. Cannot lift arm above head with our pain and cannot rotate to full 90 degrees.  Observed poor technique with pharmacy technician standing above and reaching over the counter to administer vaccines.
underlying lung disease; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included prednisone at 5 mg taken for an unspecified indication, start and stop date were not reported. The patient had underlying lung disease on an unknown date. The patient stated that his taking prednisone 5mg. The patient already had the first dose of the vaccine and wanted to know if this will interfere with the effect of the vaccine. The patient states his last Tylenol 16Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No symptoms or side effects, patient left fine. adverse event was that patient was given a Pfizer bivalent dose instead of Pfizer monovalent to replace the Moderna monovalent 2nd dose.
On March 21st Patient received the first dose of Moderna.  On April 2nd he was diagnosed with pericarditis.  He continues to require treatment for the pericarditis.  He received the second dose on April 11th without any new problems.  The vaccines were given at the Vaccine Clinic.
On the evening of 3-25-15, patient experienced redness, swelling and itching and pain with the feeling of heat on (R) upper arm at injection site. This lasted about a week. She applied lotion (BENADRYL) a couple of times for the itching.
This case was reported in a literature article and described the occurrence of uveitis in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced uveitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. This literature article summarizes the results of an open, prospective, observational study that was carried out. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Diarrhea; Abdominal cramp; I had an ache; flu type feeling; Malaise type of feeling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FJ8757) at the age of 47 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: I do have a history of GERD but would not that caused me to have Diarrhea. There were no concomitant medications. Vaccination history included: Flu shot (I took a flu shot I took the flu shot that was may be 2-3 weeks ago. Not sure but I think I took the flu shot on 17Nov2021.), administration date: 17Nov2021; Covid-19 vaccine (Dose Unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "I had an ache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "flu type feeling"; MALAISE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Malaise type of feeling"; DIARRHOEA (non-serious) with onset 12Dec2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN (non-serious) with onset 12Dec2021, outcome "unknown", described as "Abdominal cramp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, influenza like illness, malaise, diarrhoea, abdominal pain.  Additional Information: Facility type was reported as a Clinic. Other products were reported as no. The nurse (patient) stated, "I was calling because I think I might have had the side effects as the result of COVID Booster shot. Well, I took the shot on Thursday and I had the occasional, Thursday morning at like 11:30 11:45, within may be 6 to 7 hours I had an ache and the flu type feeling, the Malaise type of feeling but the thing that kind of concern me was today I started developing Diarrhea, abdominal cramp and Diarrhea." Investigation assessment was reported as no. About treatment: Nurse stated, "It just started today". About causality: Nurse stated, "Do I think this is because of the booster. I would say yes because I wasn't having any problem before and this diarrhea as a side effect."  Follow-up attempts are completed. No further information is expected.
On day 7 after receiving the vaccine, I noticed a small itchy lump in the muscle about 2 inches below the injection site.  I tried to rub the lump out slightly.  Throughout the day and the next, the skin became red and itchy and spread to a circle that is about 3in by 3 in.  Last night, I took ibuprofen and Benadryl.  The redness decreased slightly in the morning but has come back over the past few hours.  It is still itchy.  There is no longer a lump.
FLUZONE HIGH DOSE was given to a 44 year old in error with no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 44 years old female patient who was given FLUZONE HIGH-DOSE in error with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, route, administration site and lot number not reported) for prophylactic vaccination.  On 28-Sep-2022, (latency: same day) the fluzone high dose was given to a 44 year old in error with no reported adverse event (product use issue) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was 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.
rash, pt seen by RN 10Jul90 blisters from rash(2 on face, 1 upper arm) were dry/crusty, rash resolved /wout treatment 2nd dose not given
Pt has a history of CAD, hypertension, and peripheral vascular disease, and complains of a 10-day history of cough, shortness of breath, fatigue, malaise and decreased appetite.  He tested COVID positive.
Redness, swelling and pain. Started the night after vaccine was given. Symptoms started at injection site and spread throughout the upper arm.
Patient came in office to read TB test. While here dad alerted this writer to reaction localized at injection site of varicella #2. It appeared swollen, red, hurt to touch. Checked by MD
Elevated heartrate while cycling, on the subsequent day the Atrial Fibrillation condition occurred. I was treated at emergency room, with electrical shock in hopes it would regulate heartrate. I was prescribed metoprolol tartrate 12.5mg, twice daily. The doctor put in a request for an Electrocardiogram and I have been referred to a cardiologist. My doctor has requested I refrain from strenuous exercise and activities. I am still under doctors care.
Heavy bleeding; High platelet counts; head aches; This is a spontaneous report from a contactable consumer reporting for herself. A 38-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 16Feb2021 (lot number EN6200) at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as none. Historical Vaccine included first dose of BNT162B2 (lot number: EL3247) on 26Jan2021 on left arm for COVID-19 immunization. The patient experienced heavy bleeding, high platelet counts and headaches, all on 16Feb2021. No treatment was received for the events. The outcome of the events were not resolved.
dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Bone cancer.   On 18-Mar-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) (unknown route) dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown. Patient experienced dizziness after the first dose of the two scheduled doses of mRNA-1273.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Bone cancer medication and Blood pressure medication for an unknown indication.
Developed sudden onset of shaking chills and fevers as high as 103.0. She has developed a small circular 5 x 5 area of erythema and firmness at the injection site of her left upper arm.
I began symptoms on 09/07/2022 with a sore throat. I contacted my healthcare provider over their messaging system. Later that day, I did a home test and tested positive. My doctor returned my phone call the next morning 09/08/2022 and they told me that I did not necessarily qualify for any medication because I didn't have any long standing health conditions, but because of my age, they prescribed PAXLOVID. I picked up the prescription on 09/08/2022 and began taking the dosage for 5 days. On 09/09, I had a runny nose. 09/10 and 09/11 I had a dry cough. On 09/12, I felt great with no symptoms at all. I took my last dose of PAXLOVID on 09/13 in the morning. 09/18, I developed symptoms again such as sneezing, coughing and a sore throat. I tested positive again. I took over the counter medication on 09/18 and 09/19. On the 19th, I started to feel somewhat better. On 09/25/2022, I did another home test and tested negative. I had a dry cough for another 10 days after that.
Muscle ache and neuropathy in my hands and lower leg; Muscle ache and neuropathy in my hands and lower leg; wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 15:30 as dose 1, single (Lot number: GH9703) at the age of 68 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "SVT" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2022 at 15:30, outcome "unknown", described as "wrong vaccine administered"; NEUROPATHY PERIPHERAL (medically significant) with onset 30Sep2022 at 23:45, outcome "recovering", MYALGIA (non-serious) with onset 30Sep2022 at 23:45, outcome "recovering" and all described as "Muscle ache and neuropathy in my hands and lower leg". Therapeutic measures were not taken as a result of neuropathy peripheral, myalgia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Blood in urine at 11 pm on Sat  1/9/2021. Blood in Stool at 10 am on 1/11/2021.
Reaction with features of a serum sickness-like reaction. Acute onset painful and itchy erythematous rash- papulovesicular, face and neck swelling, hand swelling . Later with joint pain- knees especially and urticaria. No respiratory symptoms. No fever
Fever of 102.5, body aches, fatigue and a sore arm. This lasted about 24 hours.
1 1/2 (one and one half inches) of redness to upper left deltoid 15 to 20 minutes after injection of vaccine . Per doctor Dytan D 1tsp given at 8:45 am. (11/3/05)
Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details:  Said she felt intense pain at time of injection and she felt her arm feeling numb afterward.
Seriousness criteria: other - medically significant.  Initial report received from a patient on 03 August 2007.  A 55 year old female patient (with a medical history of no known allergies) was not able to "pick up anything with her right arm without severe pain", approximately 2 weeks (approximately on 23 June 2006) after she received tetanus toxoid (lot number U1683AB) intramuscularly in the right arm on 09 June 2006.  She was evaluated and an MRI showed "tears in her right shoulder and elbow".  She had occasional steroid injections in this arm which improved her symptoms for approximately 3 days.  She had been taking 7.5mg po Prednisone daily.  Her arm had improved.  She additionally reported occasional breakthrough low grade fevers of 100F, swelling of the hands and fatigue.  These symptoms continued to persist.  She had seen over 11 physicians but had not been specifically diagnosed, although rheumatoid arthritis was being considered.  No other vaccine was given at the same time.  No illnesses at vaccination time.  At the time of the report, she had not recovered.  Follow-up information received on 11 December 2007 from a health care professional.  The patient had no illnesses at the time of vaccination on 09 June 2006.  14 days post-vaccination, on 23 June 2007, she developed the previously reported symptoms.  It was not reported whether the patient was diagnosed with rheumatoid arthritis.  At the time of this report she had not recovered from her symptoms.
This spontaneous report as received from nurse. Nurse reported that an unspecified number of patients have received Dose 2 of GARDASIL late. Nurse did not have specified dates of when Dose 1 and Dose 2 were administered but she knew some patients have returned to the office late to receive Dose 2. No symptoms reported. Additional information has been requested.
Information has been received from a nurse concerning a male who was vaccinated with all three doses of ROTATEQ at appropriate intervals. In November 2008, 1 week after receiving the third dose, the patient developed high fever, vomiting and diarrhea. The patient was hospitalized for gastroenteritis. Gastroenteritis was considered to be immediately life-threatening. Additional information has been requested.
Initial case received from a consumer on 28 July 2014. A 49-year old female patient had received an intramuscular dose of ADACEL (batch number U4612AA, expiry date 20 September 2015) in the arm on 14 June 2013. She had a medical history of allergies to latex, amoxicillin, LEVAQUIN, mycin's and tomatoes. She has also a piece of metal in her head. On 14 June 2013, immediately after she received the vaccine, she experienced itchy eyes, lips swelled, flu-like symptoms, severe headache, and diarrhea. She felt tired, went to bed and slept 16 hours. She also developed otitis media, sinusitis, inflammation of her eyes, scratched cornea, "systematic inflammation" and vertigo problems on unspecified dates. She reported that she has had ongoing problems since vaccination. She had been evaluated in a clinic and by a neurologist. No information concerning concomitant therapies, complementary investigations or corrective treatment was provided. Outcome was reported as unknown. Document held by sender: none.
Blister above injection site. Dr gave her a Rx for VALTREX 1 gm tid x 10 day.
Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Swelling and tingling occured in tongue, lips and throat. Symptoms began to abate 3-4 minutes after administration of epinepherine (Epineperine 0.3 mg via autoinjector to the pt's left thigh at approximately 1730). Patient was taken to ER by EMS. EMS arrived at approximately 1737.
Redness and pain at injection site followed by malaise, headache, chills, and nausea.  I experienced typical symptoms described after the vaccination, but it was very odd that none of them started until day 8 after vaccination.