chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was injected with an empty syringe... I apologized and informed her of the mistake made and injected her again with the syringe with vaccine.  I explained to her of the error and told her that I wanted her protected and injected her again.The reason was that patient needed a different needle length and I  was unfortunately distracted by my conversation with her.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, single), for Covid-19 immunization; Bnt162b2 (Dose: 2nd, single), for Covid-19 immunization; Bnt162b2 (Dose: 3rd, booster single), for Covid-19 immunization; Bnt162b2 (Dose: 4th, single booster), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: It was reported that all of the patient's shots including the 3 boosters were all Pfizer. The patient had absolutely no complications and only a sore arm after each shot. That made the patient want to always use the same pharma company going forward.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035212 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;
PATIENT TESTED POSITIVE FOR COVID 2 DAYS AFTER  GETIING VACCINATED. PATIENT SURVIVED.
delayed cutaneous hypersensitivity reaction Narrative:  onset one week after 1st vaccination dose. Rash resolved after 2 days.  Other Relevant History:
Patient reports that on 10/2/21 his right hand and fingers lost feeling and function and had no strength.
This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: Field representative states that he saw an email that was sent to one of his customers. The age at vaccination was not reported. The reporter stated the patient was hospitalized after receiving SHINGRIX. No other information was provided. The representative did not have the email himself. He was going to try and follow up with the person who sent the email to get more information.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, Developed fever, nausea, diarrhea, HA, and myalgias 10 hours after 2nd COVID 19 vaccine which caused her to miss work the next day.  Narrative:  Developed fever, nausea, diarrhea, HA and myalgias 10 hours after 2nd COVID 19 vaccine which caused her to miss work the next day.
Lt arm swollen, red, feverish 24 hours after injection, parent gave Tylenol for discomfort, med helped alot 2/7/07 swelling and fever has resolved.
Date of Admission: 9/20/2021   Date of Discharge: 9/28/2021
Tinnitus in both ears in the form of ringing.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO180) in the left arm on 24May2021 at 18:30 (at the age of 40-years-old) as a dose for COVID-19 immunisation and patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO217) in the left arm on 14Jun2021 at 18:45 (at the age of 40-years-old) as a dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included mefenamic acid (ADVIL); for unknown indication from unknown date and unknown if ongoing. 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 28May2021 at 21:00, the patient experienced tinnitus in both ears in the form of ringing. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event tinnitus in both ears in the form of ringing was not recovered at the time of this report.
pt c/o dizziness and slight lightheadedness, V/S 99% RA 100bpm 19cpm 157/111 mmhg
44yo patient presents to the emergency room the following day after receiving a pneumococcal vaccine. The patient reported fever (101), chills and tenderness with swelling at the injection site (right arm). Dizziness, wheezing and pain made it hard to sleep. The pain radiated from the site of the injection to the patient's back and shoulder Stiffness and pain in the neck was also reported. The upper arm showed mild confluent blanching erythematous maculopapular rash and reduced range of motion due to pain. Patient received diphenhydramine 50mg IV and morphine in the ER with improvement. On discharge patient received pain medication and diphenhydramine capsules and was instructed to apply warm compresses. No further event noted.
Pt c/o itching and burning at injection site. Observed an area about 1 inch in diameter. Red and swollen, warm to touch. Gave 1 Benadryl 25mg tablet PO for swelling and itching. Recommended ice to area and to return if not better in 24 hrs for a recheck.
This prompted her to test for COVID, which came back positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (This prompted her to test for COVID, which came back positive) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (dose 1, lot no. 004M10A) on 12-Feb-2021, Moderna COVID-19 vaccine (dose 2, lot no. 0011321A) on 13-Mar-2021, Moderna COVID-19 vaccine (dose 3, lot no. 024D21A) on 22-Oct-2021, Moderna COVID-19 vaccine (dose 4, lot no. 008W214) on 12-Apr-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (dose 5 and lot no. AS7164B) on 30-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 03-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (This prompted her to test for COVID, which came back positive). At the time of the report, COVID-19 (This prompted her to test for COVID, which came back positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  The patient stated that on 14-Nov-2023, she woke up with her throat feeling terrible. Her head hurt with a pounding headache. She was sneezing and blowing her nose and had a whole body ache. This prompted her to test for COVID, which came back positive. She also felt like a sloth and did not want to move at all. She says that she was still coughing and her throat still felt sore, but it was not as bad as before. She also still had a headache but that too, was not as bad as before. She felt like she was on the "uptick" with her symptoms. She said that it felt like COVID was more prevalent than the flu, but goes unnoticed because people were only doing home tests.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750144 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750144:Daughter case
10/3/2018 3:00 AM WEAKNESS COULD NOT GET OUT OF BED WITHOUT HELP, SORENESS  AT INJECTION SITE, NO RASH, CHILLS, SHIVERING, FATIGUE BY 4:00 PM SHE SAID SHE WAS FINE.
On 12/03/2022 it started with coughing, low-grade fever. I then sought care from a local clinic (urgent care), and they performed an MRI and I was diagnosed with a lung infection. Provider prescribed LEVAQUIN. I am still short of energy.
Initial unsolicited misuse report received from a non healthcare professional (medical assistant) on 23 March 2016. This case involves two patients (gender was not provided) who were vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U4939AA, expiry date:8 January 2017, dose number and site of administration was not reported) intradermally instead of a dose of TUBERCULIN PPD (PPD) (batch number, dose details, route and site of administration were not reported) on 21 March 2016. The patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 23 March 2016, two days following the vaccination, the patients came for a PPD vaccination however they were vaccinated with Adacel. When they returned, this error was discovered. Both patients had redness around the injection site, one the size of a baseball and the other the size of a softball, a hard pea size nodule at the injection site. Both patients stated the injection site felt itchy at first and then redness and swelling appeared. It was a case of wrong vaccine administered, wrong route of administration and product use issue. Patients required ER/doctor visit. Lab data and corrective treatments were not reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
macular popular rash at injection site with mild itching. 30 minutes of dizziness. Resolved. Happened approx 1 hr post vaccine
Arm with aching within one hour of injection followed by 2 days of debilitating fatigue and muscle weakness.
Product leaked out and dripped down her arm; Product leaked out and dripped down her arm; A spontaneous report was received from a healthcare facility staff member  who was a 44-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the product leaked out and dripped down her arm.   The patient's medical history was not provided. Concomitant product use was not provided.   On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 0011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, some of the product leaked out of the syringe and dripped down the patient's arm during vaccination. She denied experiencing any side effects. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, product leaked out and dripped down her arm, was not provided.   The outcome of the events, product leaked out and dripped down her arm, was considered recovered on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure via skin contact for mRNA-1273 (Lot number: 0011J20A). There were no reported AEs associated with this case.
Horrible neck pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 70- years-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 01Feb2021 at 10:45 (age at the time of vaccination was 69 years) as dose number unknown, single for covid-19 immunisation. Medical history included lupus from an unknown date and unknown if ongoing and known allergies were reported as no. Concomitant medications included azathioprine sodium (IMURAN) taken, isosorbide mononitrate (IMDUR), hydroxychloroquine sulfate (PLAQUENIL), levothyroxine sodium and estradiol all taken for an unspecified indication, start and stop date were not reported. The patient did not have covid prior vaccination. On 15Feb2021, the patient experienced horrible neck pain. Therapeutic measures were taken as a result of horrible neck pain which included treatment with Pain meds. The patient was not covid tested post vaccination. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from an RN concerning a 24 month old Asian Indian female with no known allergies and no pertinent medical history who on 4/19/00 was vaccinated SC with a 1st dose of varicella virus vaccine live (lot 632616/1688J). Concomitant medication on that day included a 3rd dose SC of Hep-B vaccine recombinant (yeast) (lot 634991/0154K), a 1st dose SC of MMRII (lot 634036/1711J) and a 3rd dose SC of IPOL (lot R0506). There was no illness at the time of vaccination. On 4/7/01, the pt developed a varicella rash on her bilateral thighs, right foot, left shoulder and back. The rash was also described as erythematous papules with vesicles, approx. 20-30 lesions. The pt was afebrile and the rash was not pruritic. It was reported that the pt was seen in the office on 4/9/01 and no lab tests were done. After a few days, the pt recovered.
Patient started to feel chest tightness and tingling in his left arm. It then started to travel down his left leg. His arm was cold and numb at one point. He was concious but very confused and could not think straight. He had someone drive him to the ER. They did a CT scan, EKG, and other routine lab tests and all were normal. They attributed it to the vaccine.
This is a spontaneous case initially received from a pharmacist on 15-Nov-2018, concerning a 63-year-old, adult female patient. On 14-Oct-2018, the adult patient was administered FLUAD (TIV) [batch number: 250789, expiry date: 31-May-2019]. At the time of this report, no adverse event was reported. This case is linked to (201805586) due to same reporter. The reporter assessed the case as non-serious.
This is a spontaneous report from a contactable Nurse.  A 27-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EJ1686), via intramuscular route administered on Arm Left on 25Jan2021 10:00 AM (27 year-old at the time of vaccination) as single dose for COVID-19 immunization. Patient relevant medical history included anxiety, depression, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder and allergies to PCN, Bactrim, Biaxin, Ceftin, Ceftezole. No other vaccine in four weeks, None other medications in two weeks. No covid prior vaccination, Yes covid tested post vaccination. There were no The patient concomitant medications were not reported. On 26Jan2021 at 08:00, the patient experienced lymph node swelling on affected side, fever, lethargy/fatigue, body aches, bruising and rash to bilateral lower extremities, migraine, nausea/vomiting. The patient underwent lab tests and procedures which included sars-cov-2 test(Nasal Swab) was negative on 28Jan2021. The patient did not receive any treatment for the events. The outcome of event was recovered. Follow-up attempts are completed. No further information is expected.
Had a routine mammogram except that they had seen a suspicious growth two years prior - they had wanted me back in six months later  for another mammogram but the Pandemic hit and I didn't go;  so I went on May 27, 2021. They came up with two growths and did the biopsies and one is benign and one was estrogen receptive. When the surgeon got in there - there was a third one that hadn't showed up on the mammogram. She removed  the two that were cancerous  - Estrogen receptive positive/HER2 negative. Left the one that was benign. I've had a lumpectomy. Now we are trying to decide what follow up to do after this.
Information has been received from a nurse practitioner concerning an 81 year old male patient with arthritis who in 1998 was vaccinated with a dose of PNEUMOVAX 23, in October 2007 was re-vaccinated with PNEUMOVAX 23 and on 10-MAR-2009 received a third dose of PNEUMOVAX 23. Concomitant therapy included sulindac (MSD). It was reported that the patient experienced a very bad reaction of redness and swelling that started in his upper arm and moved to the forearm. The patient outcome was not reported. It was reported that there was no death, hospitalization or life threatening effects. Follow-up information has been received from a nurse practitioner concerning the patient. It was reported that the patient had redness and excessive swelling in arm given in. Afterwards, the patient checked his records and he realized he had PNEUMOVAX 23, 2 years prior. At the time of reporting the patient had recovered. No further information is available.
Face is swollen; specially under my throat part it looks like I got two faces; Face is swollen; specially under my throat part it looks like I got two faces; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), PHARYNGEAL SWELLING (non-serious) all with onset Nov2023, outcome "unknown" and all described as "Face is swollen; specially under my throat part it looks like I got two faces".  Additional information : Patient had the covid shot the previous day that was Comirnaty and just noticed because patient was looking in the mirror trying to do hair, that patient's face was swelled, specially under throat part it look like patient got two faces  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
redness few inches in size; itching arm; red arm; arm red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness few inches in size), VACCINATION SITE PRURITUS (itching arm), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE ERYTHEMA (red arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm red). On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (red arm). On an unknown date, the patient experienced ERYTHEMA (redness few inches in size). On 22-Mar-2021, VACCINATION SITE ERYTHEMA (arm red) had resolved. At the time of the report, ERYTHEMA (redness few inches in size), VACCINATION SITE PRURITUS (itching arm) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
headache; Sinus Pressure; fever; Injection site was red; Lump at injection site; A spontaneous report was received from a consumer concerning a 58-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, sinus pressure / paranasal sinus discomfort , fever/pyrexia, injection site was red/injection site erythema, lump at injection site/injection site mass.  The patient's medical history include diabetes. No relevant concomitant medications were reported.  On 4 Mar 2021, approximately 2 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced the event(s) headache, sinus pressure, fever, injection site was red, lump at injection site.  Treatment details included acetaminophen, Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), headache, sinus pressure, fever, injection site was red, lump at injection site was unknown.
22APR93 mom came to discuss pt having rash-wet pustules 3 days p/vax; pt had a skin infection; pt was also irritable;
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-SEP-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 72 hours (Highest recorded temperature was 9 F (9 Celsius) and 48 hours (Lowest recorded temperature was 1 F (1 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
After the vaccine, I felt bubbles in my veins; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the vaccine, I felt bubbles in my veins) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (After the vaccine, I felt bubbles in my veins). At the time of the report, FEELING ABNORMAL (After the vaccine, I felt bubbles in my veins) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient was terrifying because patient figured out how reaction has stopped and started again. It was reported that It may be either with vaccine plus a chemical additive in the product which a patient used  a (strange combo phenomenon) that's causing bubbling or  a new chemical additive was manufactured with the same product. No treatment medications were reported.
Low grade fever between 99-99.8 daily from time of vaccine until today. Treatments: Over the counter fever reducers (aleve), basic home remedies, rest, drinking a lot of water, vitamin C. The fever has not gone away and continues to occur daily these last 3 1/2 months.