chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHE; SORE THROAT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 08:00 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAR-2021, the subject experienced body ache. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, nausea, and sore throat, and had not recovered from headache. This report was non-serious.
Arm is numb since the injection. Severe left arm pain. Chest pain on the left side
Patient admitted to Hospital with positive covid-19 breakthrough case.  O2 saturation 89 % on room air on arrival. No other compliants. Patient from assisted living facility with multiple positive staff and patients.  Currently on 4 L NC.
Patient developed a generalized, vesicular rash that was similar in appearance to a primary varicella infection.  Skin biopsy showed a spongiotic dermatitis with eosinophils. The patient had pruritis, but was not clinically ill. (We have photographs if you or the manufacturer would like them.)
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. On 26-DEC-2016, the patient was treated the same physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages. The outcome of the events was unknown. Causality assessment was related.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: barbiturates" (unspecified if ongoing); "Known allergies: allergy to Milk" (unspecified if ongoing). Patient had no other medical history.The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: negative tests; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Developed pain in my left chest that extended to my left shoulder, fever, vomiting, difficulty breathing, weak and very tired. Went to DR on 10/29 and again on 11/2, tested my heart, looked for blood clot, pneumonia, could find nothing. Dr. felt like it was "pleuritic" in nature, but I had fever and vomiting and was fine before the shot. Hospitalized on 11/2 overnight. given pain medicine for chest pain.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 35-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th NOVEMBER 2018). Co-suspect products included TWINRIX adult (batch number 2BA47, expiry date 27th SEPTEMBER 2018). On 21st JUNE 2016, the patient received BOOSTRIX (intramuscular) .5 ml and TWINRIX adult (intramuscular) 1 ml. On 21st JUNE 2016, 6 hrs after receiving BOOSTRIX and TWINRIX adult, the patient experienced headache, spots before eyes, influenza-like symptoms, fatigue and stiff neck. On an unknown date, the outcome of the headache, spots before eyes and stiff neck were recovered/resolved and the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue was unchanged. The reporter considered the headache, spots before eyes, influenza-like symptoms , fatigue and stiff neck to be probably related to BOOSTRIX and TWINRIX adult. Additional details were provided as follows: The patient was vaccinated at 8:30 with BOOSTRIX and TWINRIX adult respectively in the left and right deltoid. The call was transferred to medical information. The case was erroneously considered as "Exclude from Pader".
BODY ACHES; HEADACHE; NAUSEA; LOW GRADE FEVER; MUSCLE ACHE; BURNING AT INJECTION SITE; LEFT ARM SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. gatorade since symptoms appeared with minimal improvement.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022, and batch number: 1085022) dose was not reported, administered on 19-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 19-MAR-2021 07:15, the subject experienced burning at injection site. On 19-MAR-2021 07:15, the subject experienced left arm soreness at injection site. On 19-MAR-2021 15:30, the subject experienced body aches. On 19-MAR-2021 15:30, the subject experienced headache. On 19-MAR-2021 15:30, the subject experienced nausea. On 19-MAR-2021 15:30, the subject experienced low grade fever. On 19-MAR-2021 15:30, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site on 19-MAR-2021, and had not recovered from headache, body aches, nausea, low grade fever, left arm soreness at injection site, and muscle ache. This report was non-serious.
Fever less than 12 hours (unmeasured), fatigue and congestion in 36 hours from second dose . Resolved by 48 hours.
Patient admitted for stroke, incidental COVID-19 discovered. Asymptomatic. Provider's discharge note "acute thalamic stroke. Plan for 21 days of ASA and Plavix, then Plavix monotherapy thereafter. Incidental COVID-19+, asymptomatic (tested positive 7/22/2022). She and family declined additional services at this time. She will discharge for ongoing care post-hospitalization."
Altered Mental Status. Confusion. Lasted about 12-24 hours. Occurred about 24h after vaccination. Pt found by daughter speaking gibberish and acting oddly.
Right upper thigh area about 4cm diameter edematous, red reaction warm to touch. Tx: Benadryl and ice and observe.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE], start date: 05May2022, stop date: 07May2022; DAYQUIL, start date: 06May2022, stop date: 08May2022; SIMVASTATIN, start date: 04Jan2010, stop date: 04May2022; CALCIUM, start date: 03Jan2000; METOPROLOL, start date: 01Sep2008; BABY ASPIRIN; MAGNESIUM; POTASSIUM; VITAMIN C [ASCORBIC ACID], start date: 08Apr2020; ZINC, start date: 08Apr2020. Past drug history included: Cipro, reaction(s): "Allergy", notes: known allergies: Cipro. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details [product for COVID 19 Treatment, brand was Pfizer, treatment start date was 09May2022, treatment stop date was 13May2022, lot number was GA1188, indication for Treatment of COVID-19. The patient previously received a COVID-19 Vaccine. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient received Coricidin (brand: Bayer), DayQuil (brand: Vicks), Calcium & Multivitamin (brand: Equate) along with other concomitant medications.
Treatment of COVID-19; Treatment of COVID-19; Tested positive 5 days after Paxlovid course; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "not recovered", described as "Tested positive 5 days after Paxlovid course"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative for the last 4 days; (unspecified date) Negative, notes: Tested negative for the last 4 days; (unspecified date) Negative, notes: Tested negative for the last 4 days; (unspecified date) Negative, notes: Tested negative for the last 4 days; (28Aug2022) Positive, notes: Tested positive 5 days after Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial unsolicited report received from a physician on 04-Oct-2017. This case involves a 69-year-old male patient who was vaccinated with a single dose of FLUZONE QUADRIVALENT (batch number: UI850AA, expiry date: 30-Jun-2018) in left deltoid via intramuscular route on 02-Oct-2017 in afternoon. The patient's medical history and concomitant medications were not reported. On an unknown date, few hours following the vaccination, the patient developed uncontrollable rigors, temp 100 F, and malaise around midnight. The patient's laboratory data was not reported. Corrective treatment includes Tylenol. On 03-Oct-2017, the patient was recovered from events. List of documents held by sender: none.
GOUT ATTACK THAT CAME 1 WK PRIOR WAS HEALING AND RECOVERED 1 DAY PRIOR, AND AFTER VACCINATION, GOUT ATTACK EXACERBATED AND HAVE BEEN PROLONGED OVER A WEEK. STILL IN PAIN.
Received a BOOSTRIX vaccine (R) arm 10/30/08. Seen on 11/2/08 area red swollen, hot to touch.
Vaccine given after manufacturer beyond use date exceeded by 1 day (product expired on 9/8/21 and give on 9/9/21).  No ADRs noted by pt.
Patient's mother reports that in the evening her daughter started to complain about soreness in her left arm and has generalized arm pain since. Mother also notes that she has been nauseous as well. Reaction discussed with PCP Dr. He suggests ice and Ibuprofen.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-311212, MOD-2021-311337 (Patient Link).
ADMINISTERED PER PROTOCOL IM INJECTION ICD-10 Z23 CPT 91300: 30MCG/0.3ML INTO LEFT DELTOID AROUND 11:40 AM. Patient in vaccine room with pharmacist post injection for about 5 minutes then moved to waiting room and about 5 minutes later patient started experiencing shortness of breath and used 2 puffs of Proair HFA. She knocked on pharmacy door expressing shortness of breath. Pharmacist evaluated  no swelling on body, no rash, no bleeding occurred at injection site. Patient was given 3 tablets of 25mg Diphenhydramine.  Pharmacist also noticed her hands were really cold as she was attempting to help calm patient. Technician immediately dispatched EMS as patient was expressing increased difficulty in breathing. Patient blood pressure was assessed about every 3 minutes 1st reading 137/118 pulse 78; 2nd time 153/92 pulse 126; 3rd time 150/97 pulse 138.  EMS showed up at showed up about 7 minutes later 12pm. Patient was escorted to the hospital by EMS for 24 hour observation.
The patient reported that from 4/26/2023-5/18/2023 she experienced heavy menstrual bleeding that did not align with her regular menstrual cycle. The patient reported that her menstrual cycle was supposed to start on 5/5/2023, but instead started on 4/26/2023.
FEVER and RED RASH by next morning.  treated with Tylenol and Aleve: FEVER went away after approximately 24 hours. RASH HAS REMAINED STILL (minor itching only) RASH has faded from the torso but remains on the legs and feet, Rash does seem to be fading a little every day
MODERNA - 1st dose  "COVID arm" - itchy & sore at injection site for 24 hrs about a week after the injection. Now have a red spot the size of an egg on my arm but no more soreness.
swelling in right elbow (size of a gulf ball), with slight pain and a lot of black and blue around the elbow and up my forearm
Pt received PREVNAR 13 vaccine on 11-6-14. She noticed redness with inflammation to her (lt) arm. Pt came to office on 11-11-14 and see dr. Erythema noted to lt arm. Lt arm painful and warm to touch.
On 2/20/00, the pt developed shingles. The pt sought unspecified medical treatment. The reporter stated "I am very concerned because I have another child who in immunocompromised." Additional information has been requested. Follow up data states on 3-20-2000 patient developed a vasicular rash on the left shoulder and upper arm which was consistent with herpes zoster. On an unspecified date the patient recovered. No additional information is available.
10days p/ vax pt devel a herpes zoster rash. rash had devel as a unilateral vesicular, papular rash. f/u info low back pain 15sept. treated w/famvir
Patient discharged after (3) days inpatient admission. Documentation of home health in patient chart following discharge. Patient is an 82 year old female with PMH of CAD, DCIS, HTN, OSA, COPD, CKD4. Over the past year, she has had multiple courses of antibiotics for UTIs. She presented with stinging with urination and chronic urinary urgency. She has undergone uterine suspension in the past. In addition, she reported 4-5 days of cough, congestion, and sore throat. Her husband had tested positive for COVID 19. The patient has been fully vaccinated but has not yet received her booster. She was admitted for a UTI and COVID 19. She received monoclonal antibody treatment. She did not require any additional COVID therapies as she remained on room air.    She was started on Ertapenem given hx MDR infections. ID consulted and felt the distal part of her urinary tract is likely colonized with ESBL K.pneumoniae due to significant antibiotic use over the past year. Urinary urgency noted to be longstanding problem, and did not demonstrate significant improvement with appropriate antibiotic therapy. Antibiotics discontinued after 4 days. Recommend outpatient follow up with urology for possible structural abnormality causing her urinary complaints.    PT/OT evaluated and recommended discharge home with HHC. This was arranged and she was discharged home in stable condition. She was advised to follow up with her PCP and urology.
First of all, Patient was given a shot and the vaccinator claimed the plunger mal functioned. She quickly threw away the syringe. A large amount of blood, probably mixed with vaccine, was running down his arm. Another vaccinator got another syringe and he was stuck a second time. We were a group of 4 getting vaccines and patient is the only one who is sick now, so he probably got more than just the second dose. He has been very sick all night with chills, malaise and general flu-like symptoms.
Around noon started to get tired on 04.07.21. Then around 5pm I started to experience nausea and  chills throughout the evening . This continued to the afternoon of 04/08/21
Patient presented roughly 25 minutes after receiving vaccine with itching of face and a blotch below right eye. Pt was given 2 25 mg Diphenhydramine tabs and had no further complaints.
Did the adverse event start after the first or second vaccination?   Fatigue after first, more symptoms after 2nd (Around 6pm the day of receiving vaccine starting having chill, and the rest of the symptoms progressed after) Date and time of vaccination: (list both if they received both shots):   02/14/21 11am 2nd dose
Moderna COVID?19 Vaccine EUA  After one week of receiving the second shot of Moderna Covid-19 vaccine, i started to develop muscle pain and stiffness in my left hand. After a day I started to see some rashes all over the arm and then some blisters in the rash areas all over the left arm. The pain in the arm started to develop much so that i have to go to see a doctor, who prescribed to take Cyclobenzaprine (FLEXERIL) and MethylPREDNISolone (DOSE PAK). Even after taking that for 2 days , its not getting better and the pain is increasing along with the rash and blisters in the left arm only.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old female patient who was given diluent without the lyophilized powder portion of vaccine ACT-HIB Diluent Lot: U6073AA and Exp. Date: 14-Nov-2019 via unknown route in the left deltoid, on 11-Jan-2019. Powder: Lot UI913AA exp: 22-Nov-2019, Package: Lot number UI913AAA exp date: 14-Nov-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was diagnosed with Immunodeficiency with Predominant Antibody defects. Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration, off label use and product preparation issue. It was reported that the 39 years old received dose given off label due to - Immunologist requested she have this because of a diagnosis of Immunodeficiency with Predominant Antibody defects. The diluent was given without the lyophilized powder portion. No adverse events were reported. 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 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. Documents held by sender: none.
R shoulder hemichorea/progressed to R foot/eventually R arm/shoulder/leg/foot hemichorea; R arm weakness; This is a spontaneous report from a contactable consumer reported for herself. A 65-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6206) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included allergies PCN, HLD (hyperlipidaemia), GERD (gastrooesophageal reflux disease). Concomitant medication(s) included acetylsalicylic acid (ASPIRIN); omeprazole; simvastatin. The patient previously took the first dose of BNT162B2 (lot EL9267) on 14Feb2021 in left arm for COVID-19 immunisation. The patient experienced right (R) shoulder hemichorea/R arm weakness started 30Mar2021 and progressed to R foot restlessness, and eventually R arm/shoulder/leg/foot hemichorea in the next week.  Seen by Neurology and started on Valbenazine with some relief but no etiology found. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient hospitalized for 6 days. The patient received trial of Amantadine inpatient as treatment but did not help. The patient had Nasal Swab PCR, on 08Apr2021, with negative result. The outcome was not recovered.
AFTER ADMINISTERING THE SHOT BY 2 SECONDS PATIENT HAD SYNCOPE AND LOST CONSCIOUS FOR FEW SECONDS AND IN 10 OR 15 SECONDS HE START TO REGAIN CONSCIOUS . PATIENT WAS OBSERVED AFTER THAT FOR 20 MINUTES HE WAS DOING OK AND WAS PROVIDED COLD WATER . NO SHORTNESS OF BREATH OR ANY SIGNS OF SWELLING . PATIENT REJECTED HELP FROM 911 SO 911 WAS NOT CALLED ( PT REGAIN CONSCIOUS AS WELL )
pt called next day w/ c/o delayed swelling, heat, pain, nausea;
My mouth got sore and I had a headache.  Now I have several sores in my mouth and my right cheek is sore.  It is uncomfortable to eat.
pt recv vax;17 days later exp flare-up of malaria w/ fever,muscle aches,abd cramping&HA;sx were intense;hosp for 4-5 days;resolved;