chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Arm, elbow and hand pain at night; Arm, elbow and hand pain at night; Pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 22Apr2021 at 14:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 23Apr2021, the patient experienced nausea and even arm, elbow and hand pain at night. On 23Apr2021, the patient also experienced pain in armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, arm, elbow and hand pain at night and pain in armpit were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb
The pt developed a circumscribed area of erythema on right thigh; no drainage associated.
Developed painful, swollen red arm (at site of injection) by the next morning. Area worsened and unable to sleep due to pain in his arm. Seen on 9-13 at 1:15 PM. Area 10 x 11 cm, hot, erythematous and very tender to touch. No streaking. Full range of motion of arm. Started on KEFLEX 750 mg BID x 1 week.
Patient received the [1st] COVID vaccine (Pfizer Lot # ER8732). RN 1 reported to RN 2 that client had a reaction within the 4 hours following administration of first dose. RN 2 responded. Client report experiencing fatigue, dizziness and that the "floor looked funny" approximately 5 minutes after vaccination. Client reports she was offered EMS and client denies. Today she admits to some shortness of breath that lasted about 1 minute and that she does not fully recall what the EMTs and Nurses were telling her. RN 2 consulted with medical team who determined that this client is not eligible for Pfizer as 2nd dose. Medical team determined client can be offered Janssen as 2nd Dose. RN 2 reported to client that her name and phone number would be sent to our scheduling team for her second dose Janssen. Client verbalized understanding. Client denied additional concerns.
Pinpoint rash on torso, belly, back, neck, chin, and cheeks.
Arm pain first day. By the morning of the second day, I was having pain throughout my body with nausea and dizziness and a low grade fever of less than 100. This lasted for the next three days with remnants for about a week. I've never had a reaction to the flu vaccine like this. I usually just have a sore arm and light fatigue the following day.
Patient started feeling week, dizzy, panicky, and like her heart was racing immediately after leaving the room after receiving the shot. She sat down and then I had her lie down on the floor.  She was given a bottle of water and then after about 1 min lying down on the floor she decided she felt ok to sit back up.  After a couple of minutes sitting (<5 min) she felt ok to stand back up.
Received the Moderna COVID 19 vaccine after manufacturer date of expiry; Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Drug allergy (Hydrocodone), Drug allergy (Morphine) and Drug allergy (codeine).   On 14-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired.  On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  The patient did not report any side effects.  No treatment medications were reported.
Immunization given (Pneumovax) not recommended for children <age 2 years.
maculo papular skin lesions over trunk posteriorly & abdo epigastic to suprapubic anteriorly;
Large, size of orange, red, slightly raised area at injection site which was there for a week or two after shot. Was gone, and has now reappeared months later and persisted for several weeks already.
This spontaneous report as received from a Doctor of pharmacy refers to a 64 year old female patient. On 02-FEB-2013 the patient was vaccinated with a 0.65 ml dose of live ZOSTAVAX (Lot # H019040 expiration date 17-JAN-214) subcutaneously in the left upper arm. The pharmacist reported that on 02-FEB-2013, during the administration of live ZOSTAVAX, the needle started to leak and the patient did not receive the full dose of the medication. The patient was not experiencing any adverse events. There were not Lab diagnosis or studies performed. Additional information has been requested.
Patient's wife called on 09/27/21 stating that patient's arm is red, swollen, and a little bruised at the injection site but not itchy.
Administered a dose reconstituted with sterile water; Administered a dose reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA724Z, expiry date unknown) for prophylaxis.   On 28th September 2022, the patient received Menveo. On 28th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter reported that the medical assistant administered a Menveo vaccine to a patient that was reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate. The expiry date was not recorded. At the time of the reporting, the repeat dose was not administered. The vaccine administration facility was same as the primary reporter. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Information has been received from a 26 year old female who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL. The patient had a menstrual period on 06-AUG-2008 and next period on 30-AUG-2008. Her periods are normally regular. The patient did not seek medical attention. Additional information is not expected.
Developed severe herpes zoster on right lower back.  Was ill for 8 days (missed 6 days of work). Did not receive any antivirals. (Pt. works at Health Dept and reported this in conversation, dates may not be correct.  He'll ask his physician to submit a full VAERS)
wide local reaction (R) ant thigh, red, raised, sl warm 7 x 5.5 cm No tx
COVID rebound; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; METFORMIN; NOVOLOG; ADVAIR; MULTIVITAMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 03Sep2022, outcome "unknown", described as "COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical Course: Patient received Covid-19 treatment with Paxlovid from 23Aug2022 to 28Aug2022. Known allergies: No. COVID rebound on 03Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sister had break through varicella rash on 4-23-06 - had been imm. on 02-25-00.  Broke out in a few spots on 04-27-06.
minor injection site discomfort; Joint pain; achy all over; weakness; little bit of fever; chills; no appetite; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL82982), via an unspecified route of administration on 02Feb2021 15:00 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: HIV positive, high blood pressure, shoulder replacement, hip replacement and knee replacement. The patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient received first dose of bnt162b2 (Lot Number: EL 3246) on 12Jan2021 at 03:15 AM as SINGLE DOSE in Arm Left for covid-19 immunization and had minor injection site discomfort. Concomitant medications included: dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY), hydrochlorothiazide and rosuvastatin. Prior to the vaccination the patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00, the patient experienced minor injection site discomfort, joint pain, achy all over, weakness, little bit of fever, chills and no appetite. This lasted 1.5 days. The patient did not receive any treatment. The outcome of events recovered on 05Feb2021.
Patient briefly fainted. She urinated on herself, eyes rolled back in her head, and she got very hot. We called EMS, got her an ice pack, and monitored for consciousness/breathing. She did not go with EMS, they released her to her mother.
Initially had self limiting Neck pain, fever and chills. Day or two later later she developed skin rash on her left arm, which eventually spread to diffusely over her body. Rash spared palms, soles, genital region and face.
the night after receiving this 2nd COVID vaccination, I returned to active Afib and started in  active Afib status for 9 1/2 days.  Since then I have had 2-4 days where no Afib (irregular heartbeat) was recorded, but the past week irregular heartbeat has been recorded each time I took my blood pressure (using an Omron series BP monitor).I can feel my heart flutter often and I am very short of breath, where I cannot walk over a block without getting out of breath.
My husband developed severe COVID symptoms, despite testing negative for COVID via pcr tests on Sunday 3/21 /21 and Tuesday 3/23.  He was hospitalized on 3/28 due to low blood oxygen levels.  Was diagnosed with COVID and pneumonia.  Treated with remdesivir and a steroid, then monoclonal antibodies.  Despite making progress to the extent doctors were cautiously optimistic on 4/9/21 he would be discharged on 4/16/21, he instead was transferred to ICU on 4/10/21, placed on a ventilator on 4/11/21 and died on 4/15/21.
Received Janssen vaccine dose, complained of feeling dizzy and lightheaded. Vital signs taken twice, normal both times. Patient lay down for a short time and then reported feeling better. Refused further treatment or transport.
Typhoid vaccine was intended as the second vaccine today, but instead Imovax was mistakenly administered the second time.; instead Imovax was mistakenly administered the second time; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who was second time vaccinated with 1.0 ml RABIES (HDC) VACCINE [IMOVAX RABIES] (formulation: Powder and solvent for suspension for injection) (lot number not reported) via unknown route in unknown administration site.instead TYPHOID VACCINE and RABIES (HDC) VACCINE [IMOVAX RABIES] on an unknown date. On 05-Apr-2019, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot: N1K303M) via unknown route in unknown administration site  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered and vaccine overdose (Typhoid vaccine was intended as the second vaccine today, but instead Imovax was mistakenly administered the second time).  It was unknown whether the patient had any adverse 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 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.  List of documents held by sender: none.
Resident reported a headache along with back pain around 2330.  Resident was provided PRN oxycodone and PRN Tylenol primarily for the back pain. Resident was noted to be sleeping throughout the rest of the night. Resident has a history of headaches and has taken medication in the past for this. She also reported not eating dinner due to the back pain which may have contributed to the headache.
About 12 - 15 hours after the shot, I started to have mild contractions. My body went into labor like symptoms for a period of about 3 hours. The mild contractions were not consistent and I knew they were a side effect. I was sore, the baby was very active and felt similar to labor - but on a much reduced level.
3rd dose of Moderna was given by mistake only had record of first dose given on 05/04/2021 and could not verify that second dose was given daughter has vaccine record card in her possession and claimed that patient already received 2nd dose of Moderna 28 days after 1st dose patient signed consent form stating that she did not yet receive 2nd dose reporting just in case
"Throat itchy, can't swallow, throat swollen"  Cough observed Epi-Pen administered at 4:24 pm x1.  02-99%, HR 80-90 EMS called- Assessment, refused transport.  Left facility with husband (had unused epi pen when left building). Patient later reported was going to hospital.
Patient reports a pauple-sized area of redness, swelling , soreness, and pain at injection site eleven days after receiving vaccination. Also reports left torso soreness. Advised to use antihistamines, home care, and carefully monitor.  After showering on the evening of the eleventh day after vaccination noticed a quarter-sized localized reaction: was diagnosed with vaccine reaction and seconday cellulitis.  Prescribed antibiotics.
immediately following the shot, patient developed left shoulder pain and bruising. she stated that the shot was the most painful vaccine she had ever received. the swelling and pain initially resolved, but then she had persistent pain over the left shoulder and bicep tendon. she is unable to lift her arm and pain is severe on some days. she is using Tylenol and declines stronger meds. also does not want any invasive interventions
Soreness which is to be expected, but it's now 2/2013 and her arm is still sore can't do anything strenuous e.g. lift wts/exercise. Complains of off and on pain.
Initial information received on 30-May-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 42 years old patient who experienced patient who received a dose of MENACTRA (lot U5948AB, expiry date not reported) via intramuscular route (frequency once) vaccine instead of MMR vaccine (lot number and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered. Laboratory investigation was not reported. It was not reported if the patient received a corrective treatment. 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 and Module VI of the 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. List of documents held by sender: none.
This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported) in the arm. Other suspect therapies included Influenza Virus Vaccine (manufacturer unknown) (lot #, expiration date and route not reported) in the same arm. No concomitant medications were reported. After this, on an unknown date the patient experienced cellulitis on the arm where the injections were given. The outcome of the event was unknown. It was unspecified whether lab studies were performed. The patient sought medical attention by calling the pharmacy. It was unspecified whether treatment was given for the patient. Additional information has been requested.
Recipient felt lightheaded after receiving vaccine. Did not lose consciousness but did lay himself on the ground. He stated this happens each time he receives shots but did not inform anyone of his condition. 911 was called and he was evaluated but refused to go to the ED.
Very itchy rash on insides of arms and legs and on torso.  It started in the evening and was gone by the next morning.  When it started i took an antihistamine, Claritin D, and used triamcinolone acetonide ointment.  About 10 days later the same thing happened again 2 more times with the same  treatment and results.  I have had no symptoms in the last 3 days.
itchiness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nonstop itchiness in her hand post vaccination on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
high fever for 2 days; Light headedness; couldn't breath; Felt like face was bloating and felt hot; Felt like face was bloating and felt hot; This is a spontaneous report from a Pfizer-Sponsored program from a contactable consumer (patient). A 23-year old female patient received the 2nd dose of bnt162b2 (BNT162B2) via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high fever for 2 days (non-serious) on an unspecified date with outcome of recovering, light headedness (non-serious) on an unspecified date with outcome of unknown, couldn't breath (non-serious) on an unspecified date with outcome of unknown, felt like face was bloating and felt hot (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: high on unknown date.    The information on the lot/batch number has been requested.
Vaccines were kept frozen until they are ready for administration; Administered Moderna vaccines beyond the use date and or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
Severe pain in left arm and shoulder. Saw my doctor after 2 weeks of severe pain. She referred me to a specialist. He prescribed pain medication (Tramadol HCL 50 mg on 12-13-16. Still very painful to move left arm (appt. to see another specialist on 1-6-17.