chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Used sterile water as the diluent for Acthib instead of the 0.4% normal saline with no reported adverse event; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 month old female patient who used sterile water as the diluent for acthib instead of the 0.4% normal saline with no reported adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib) and water for injection (Sterile Water).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); polio vaccine inact 3v (vero) (Ipol)and Rotavirus Vaccine.  On an unknown date, the patient started taking sterile water (water for injection) with unknown dose (route, strength, formulation, frequency, batch number, expiry date, indication was unknown). On 13-Apr-2022, the patient received 0.5 ml dose of suspect hib (prp/t) vaccine (strength, frequency, , formulation was unknown, lot UJ604AA and expiry date: 13-Mar-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 13-Apr-2022, (Latency: same day) stating that an RN(registered nurse) at the clinic used sterile water as the diluent for ACTHIB instead of the 0.4% normal saline with no reported adverse event (product preparation error)   Action taken with water for injection (Sterile Water) and haemophilus type b (hib) vaccine (Act-Hib): not applicable.  Outcome: Unknown    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.
brain fog; dizziness; diarrhea; swollen lymph nodes especially arm pit and neck of theinjection arm; nausea; fever; severe joint pain; Swelling at injection site(covid arm); Rash at injection site(covid arm); This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. The patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the left arm on 15Mar2021 at 09:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 21:00, the patient experienced swelling and rash at injection site (COVID arm), swollen lymph nodes especially in arm pit and neck of the injection arm, fever, severe joint pain, nausea, diarrhea, brain fog and dizziness. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling at injection site, rash at injection site, swollen lymph nodes in arm pit and neck of the injection arm, fever, severe joint pain, nausea, diarrhea, brain fog and dizziness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash going in waves around trunk. Going down thighs today and up inner arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash going in waves around trunk. Going down thighs today and up inner arms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer and Drug allergy (No drug was reported).    On 06-Dec-2021 at 12:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022 at 3:45 PM, the patient experienced RASH (Rash going in waves around trunk. Going down thighs today and up inner arms). At the time of the report, RASH (Rash going in waves around trunk. Going down thighs today and up inner arms) was resolving.            No concomitant medications were reported. It was reported that patient took Pfizer drug as a cosuspect for the treatment of COVID-19 with the start date as 21-MAY-2022 and end date as 25-MAY-2022 It was reported that patient was not the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received COVID-19 treatment. the event reported was Rash going in waves around trunk.Going down thighs today and up inner arms with Device Date as 25-May-2022 No treatment medications were reported.
Soreness at injection site - Commenced about 1 hours after injection and lasted about 48 hours. Headache,  Chills, Body Aches, and maybe slight hypnagogic state started about 12 hours (1:00 am) after injection and subsided about 4 hours later. Fatigue - most of the following day after having a rough night sleeping (as stated above).
always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 0.3 ml single (Lot number: EN6203, Expiration Date: 30Jun2021), in arm for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. Vaccination history included: Bnt162b2 (1st dose: Says Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN5318 , Expiration date: 31May2021 , NDC number: Unknown), for COVID-19 immunization, reaction(s): "always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "always get a sore arm where I get the shot".  Additional Information: Reporter had hip replacement and usually takes 4 antibiotics. She confirmed that her 4 prior doses were all the Pfizer BioNTech COVID-19 vaccine and mentioned that she always got a sore arm where she got the shot.  Follow-up attempts are completed. No further information is expected.
When I got back on June 18, 2022  I felt tired. I thought it was just from traveling and getting up extra early to catch our flights.  We had the test and I took it and it was positive.  then I took another test on the 19th from the Urgent Care and it was positive as well. I felt lightheaded not able to focus and occasionally I would get headaches. The Urgent Care doctor prescribed Paxlovic and I took it as directed. I took the entire 5 day course and I actually tested negative on day 3 but I took the medication until it was all gone.
Sore injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). At the time of the report, VACCINATION SITE PAIN (Sore injection site) outcome was unknown. Not Provided          Treatment information not provided. Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-116661, US-MODERNATX, INC.-MOD-2021-116616, US-MODERNATX, INC.-MOD-2021-116619 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116661:Case for second dose US-MODERNATX, INC.-MOD-2021-116616:Case for daughter US-MODERNATX, INC.-MOD-2021-116619:Cluster case for other people having spinal pain
pt recv vax 9OCT95 & pt devel warmth & a pink area around the inj site;no tx necessary;pt recovered;
No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
Unknown which RSV vaccine. But received it on OCT17 and has a hematoma approximately 3 x 3 cm which is still present 2.5 weeks later.
PT GIVEN PFIZER BIVALENT BOOSTER AS A PRIMARY DOSE (1ST DOSE) INSTEAD OF PFIZER MONOVALENT.
Dizziness; shortness of breath; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (shortness of breath) and DYSARTHRIA (Slurred speech) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Dec-2020. Concurrent medical conditions included Drug allergy (Codeine-Vomiting), Blood pressure high and Anxiety. Concomitant products included AMLODIPINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 26-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Dizziness), DYSPNOEA (shortness of breath) and DYSARTHRIA (Slurred speech). At the time of the report, DIZZINESS (Dizziness), DYSPNOEA (shortness of breath) and DYSARTHRIA (Slurred speech) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2020, SARS-CoV-2 test: positive (Positive) Nasal swab. On 26-Mar-2021, Blood glucose: 73 (Inconclusive) Blood sugar drop.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had EEG and MRI. Treatment includes Juice and Candy.   This case was linked to MOD-2021-101869 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021; Reporter's details updated, Patient's demographic details, Patient medical history, Lab data updated. Concomitant medications updated. Event details and outcome updated. On 02-Jul-2021: Follow-up received and contains non significant information. On 19-Jul-2021: Follow up received and contain non significant information.
LITTLE EFFECT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20210947115.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
patient came into the clinic for PPD tuberculin skin test but their medical assistant drew up 0.1 ML of IPOL and administered it to the patient with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient came into the clinic for TUBERCULIN TEST (ppd tuberculin skin test) but their medical assistant drew up 0.1 ml of  IPV (VERO) [IMOVAX POLIO] and administered it to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Oct-2023, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and also received started taking tuberculin ppd (TUBERCULIN TEST) Unknown dosage unknown route unknown (with an unknown formulation, strength, expiry date, batch number) for Skin test. The information on batch number was requested.  On 24-Oct-2023 the patient came into the clinic for ppd tuberculin skin test but their medical assistant drew up 0.1 ml of ipol and administered it to the patient with no reported adverse event (latency : same day) (wrong product administered) following the administration of TUBERCULIN TEST and IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient came into the clinic for ppd tuberculin skin test but their medical assistant drew up 0.1 ml of ipol and administered it to the patient with no reported 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 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.
Patient started having fever, and shakes the night after receiving the vaccine. Went to a clinic and was treated with ADVIL, but temperature still went up and ended in ER and then hospitalized due to high fever, extreme high blood pressure and pain. He received three vaccines total on 5/11/2018 (PNEUMOVAX 23, ADACEL and SHINGRIX) but the infectious disease doctor from the hospital thinks it was most likely due to SHINGRIX adverse reaction. He was hospitalized for a few days, and treated by flashing treatment and strong pain medication (morphine).
Vaginal bleeding starting the day after both vaccines; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an intramuscular route of administration in the left arm on 31Aug2021 at 14:00 (at the age of 33-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an intramuscular route of administration in the left arm on 21Sep2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant 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 medications within two weeks of vaccination. On an unknown date in 2021, the day after both vaccines, the patient experienced vaginal bleeding. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal bleeding was resolved on an unknown date in 2021.
Red, raised, itchy rash 2?x2? Appeared 8 days after 1st shot Lasted 5 days
After the shot given to him I asked him to sit down and wait for 15 minutes. While he was sitting suddenly he fell from to chair to the floor. His nose started to bleed. We helped him with bleeding and called 911. After waited for 15 minutes for paramedics they took him to the hospital. He said he felt very dizzy and fell.
Within a minute after having received the final shot, I began feeling very nauseous, dizzy and weak. Within seconds, all of these feelings escalated and I collapsed. I never lost consciousness totally that I'm aware of. There were nurses and physician assistants standing by who responded immediately. They propped my feet up and monitored my vitals while I layed there. They also put ice behind my neck, gave me water and M & M's to eat. Several hours later, although I was fully functional, I still had brain fog & tingling in feet. Signs & symptoms (dizziness & nausea) didn't last long after I collapsed... perhaps just a minute or so. I felt fairly weak, however, for at least 10 minutes. My eyes remained "glassy" for several hours after the event. The brain fog & tingling feet lasted several hours also. Around 5 p.m. I felt pretty normal, and after a good night's sleep I returned to work next day c/o any complications.
Pt has severe pain at injection site. Pt still cannot sleep on the side the shot was received in. Pt states that the pain is so severe that it makes her almost cry when she picks up her grand daughter.
Information has been received from a nurse concerning a female with medical history unspecified who on unspecified date was vaccinated a dose with GARDASIL (Lot # was unspecified). Concomitant therapy was unspecified. Subsequently, the patient experienced fainting. The patient sought unspecified medical attention. The outcome of the AE was unspecified. No further information is available.
2/1/23 I woke up with a sore throat. I tested positive with an at home COVID test. As the day went on, I started to not feel overall good and had a severe headache which lasted 3-4 days. I had a fever later that afternoon. The next day, I could not get out of bed. I had flu like symptoms and felt horrible which lasted about 2-3 days. Then I began coughing and had a little bit of a runny nose. I was sick for a good 10-12 days. I tested positive for 14 days. During that time, around day 5 or 6, I was having trouble breathing and had a telehealth appointment. I was prescribed a Z-PAK and albuterol inhaler. I still did not feel good after finishing the Z-PAK. I had a chest x-ray which came back negative. It was three to four weeks, before I felt better. At times, I would have trouble getting my breath. My allergies are now magnified. I can't touch anything with the chemical in it.
Redness, swelling, itching at PCV 13 injection site x 1 day. Advised ice to area, 1/2 tsp BENADRYL p.o for Rxn per doctor.
Patient presented to emergency department on 10/1/2021 for worsening shortness of breath. He was found to be COVID-19 positive on 9/14/2021 during a vacation where he was hospitalized and treated with remidesivir. He was discharged on home oxygen and returned home. His symptoms worsened and he presented to hospital and was admitted for further management. He was found to be positive on PCR test on 10/5/2021 for COVID-19.  Patient's condition improved and was discharged home on 10/9/2021.
Mixed manufacturer: Pt had already received John & Johnson Covid vaccine in March 2021 and did not disclose it upon receiving Moderna vaccine today as her first dose. Therefore pt received another dose of Covid vaccine of Moderna.
Pain behind knees down back of legs into calves, arms weak, headache started around 2200 on evening of vaccine and continues to 8-13-2008 at 9:35 am time of MD visit.  MEDICATION PRESCRIBED: Analgesic antipyretics, also stay home 8-13-08 and 8-14-08  11/04 Phone call w/reporter reveals patient had completely recovered from rash by 9/2008. No further evidence of any AE.