chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported that a 28 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 05/27/00. On 05/29/00, the patient  developed a "severe" injection site reaction characterized by an area of redness, and induration measuring 2 inches by 1 inch. The patient was seen by the physician and treated with diphenhydramine, Prednisone, and Cephalexin. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 470-536.
never received a 3rd dose; First dose on 2nd March 2021 and Dose 2 on April 20th 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 20th April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were 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 for 3rd dose was not applicable. The patient received the first dose of Twinrix on 2nd March 2021. The patient received the second dose Twinrix later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacy intern reported that patient never received a 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 41 years, in left arm 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: "Seasonal allergies" (unspecified if ongoing); "hsv2" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Known allergies: Nuts and eggs" (unspecified if ongoing); "Known allergies: Nuts and eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Negative; (04Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received nirmatrelvir, ritonavir (PAXLOVID) from 21Feb2023 to 25Feb2023 as treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
I received a report about patient, subsequently confirmed with phone call, that outlines lip and cheek swelling within 5 min of second dose.  Perhaps some lymph node swelling/tenderness as well.  No wheeze, throat closing, or urticaria.  Took benadryl and resolved that evening.  Had eaten rice krispy treats, no prior issue with this food.
Soreness and redness at injection site, Patient was advised to use cold compress and take NSAID for soreness.
The day of the vaccination, I did feel feverish with chills. The next morning I felt well, but as the day started to progress, I felt: sore arm at injection site, sore throat, dizzy, fatigue, tingling in fingertips of left hand, twinging in internal organs. Those symptoms went away 24 hours later. One week after injection, I developed delayed allergic reaction, with injection site swelling once again, and hives over my  body.
Immunization given in Covid-19 Vaccination Clinic.  Immediately after receiving COVID-19 booster and flu vaccine, pt reported nausea and dizziness. Pt is quickly assisted to first aid cot next to vaccination station, legs elevated and vital signs x3: 10:35: BP: 162/89; HR: 81; 02 sat: 98%; RR: 18; Temp: 98.2  10:45: BP: 153/85; HR: 65; 02 sat: 98%; RR: 18; Temp: 98.2  10:57: BP: 150/85; HR: 57; 02 sat: 99%; RR: 18; Temp: 98.4   Pt had nausea and dizziness immediately following receiving both vaccines today. Vital signs x3, elevated legs, water sips given.  Pt recovered without difficulties. ER precautions given. Pt acknowledged understanding. Pt was observed for another 15 minutes before leaving.
The patient called today complaining of visual disturbances two days after receiving the Janssen COVID-19 vaccine. She did not have headache or other symptoms corresponding with the visual disturbances. I advised her to contact her primary care dr to assess the need for further evaluation or to go to the urgent care/ER if her symptoms worsened.
I had my period like normal from 3/21-3/24. After the second shot, I again got my period from 4/5-4-14. My period is normally very regular occurring near the end of the month & lasts 4 days. It is highly unusual that I got my period again so close to the one I just had at 3/21 & for it to last so long.  My next periods came on 5/8-5/12 & 6/1-6/7.
High fever - 103F Small Hives on face, legs, arms High pitch screaming, irritability Behavior changes, clinginess
At a Covid booster clinic patient/youth presented with a consent to receive the booster. The administering nurse did not verify the last vaccine date prior to administering the vaccine. The patient received a bivalent booster on 10.19.2022 and was not eligible to receive a bi valent booster. The error was not discovered until after administration occurred. The Youth Director advised parents of the vaccine error.
She believes half of the vaccine ran down her arm and clothes; When the HCP did the injection, they were a problem with the needle; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes), SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Covid-19 vaccine (Dose 1, lot number: EL8982) on 29-Jan-2021, Covid-19 vaccine (Dose 2, lot number: EL9267) on 20-Feb-2021, Covid-19 vaccine (Dose 3 and lot number: 33030BD) on 02-Dec-2021; for Vaccination: Flu shot on 19-Sep-2023. Past adverse reactions to the above products included No adverse event with Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine and Flu shot.    On 25-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes), SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes), SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (She believes half of the vaccine ran down her arm and clothes) and SYRINGE ISSUE (When the HCP did the injection, they were a problem with the needle).    Concomitant medication was not provided. Patient stated that when the HCP did the injection, they were a problem with the needle and half of the vaccine ran down her arm and clothes. The HCP that administered the vaccine stated it was just a little bit and not to worry about it. Patient thoughts she might have gotten a quarter of the vaccine. Patient stated she might not be covered since half the vaccine ran down her arm. Treatment information was not reported.
sugar level spikes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting on behalf of the husband reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, 4 days after vaccination, the patient experienced sugar level spikes. The patient was on diabetes medication. Event outcome was unknown. Information on the lot/batch number has been requested.
Initial misuse report received from a healthcare professional on 08 January 2014. A patient (gender and age at the time of event was not reported) had received a dose of Tetanus Toxoid instead of ADACEL vaccine on an unspecified date. No adverse event was reported. Documents held by sender: none.
Patient experienced syncope/fainting episode approx 15 mins after vaccination. Patient stood from chair and complained of nausea, asked for water. Legs buckled, patient fell to knees. Did not fall all the way to floor or experience head/body trauma. Patient was attended to by supervising pharmacist, and subsequently moved into chair with assistance. Pulse and respirations were normal, but patient was pale, diaphoretic, and complained of nausea and dizziness for another 15-20 minutes. No epinephrine or diphenhydramine was indicated or administered. Patient was observed until approximately 8:30pm, at which time he had made a full recovery.  Patient left under his own power, and safely travelled to his home. Pharmacist called to check on patient and spoke with him twice (4/29, 9:50pm...4/30, 4:30pm). Patient reports feeling fine, no residual effects. Is eager to receive his second dose on 5/20/21.
Initial information received from a consumer on 26 November 2013. A male patient (whose age and medical history was not reported) had received a Flu vaccine of unknown manufacturer (batch number, route and site of administration not reported). On an unspecified date, after vaccination the patient developed GBS (Guillain Barre Syndrome). This case considered as serious. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
result was positive; result was positive; Continued feeling ill; Had Pfizer comirnaty booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) at the age of 27 years as dose number unknown (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold like illness", start date: 21Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "Had Pfizer comirnaty booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Dec2021, outcome "unknown" and all described as "result was positive"; ILLNESS (non-serious) with onset 25Dec2021, outcome "unknown", described as "Continued feeling ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) negative, notes: COVID-19 rapid test; (22Dec2021) negative, notes: COVID-19 rapid test; (25Dec2021) positive, notes: COVID-19 rapid test. Began feeling cold like illness 21Dec2021. Took at-home COVID-19 rapid test which was negative on 21Dec2021. Had Pfizer comirnaty booster on 22Dec2021 and took another at home COVID test prior to vaccine that day which was still negative. Continued feeling ill and repeated at home COVID test 25Dec2021 and the result was positive. Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Vaginal bleeding, cramping, high heart rate, dizziness, headache, confusion. Patient is a breastfeeding mother and had given birth one month before receiving the vaccine. Patient?s baby experienced diarrhea following the vaccine.
No adverse events. CDC advised to give everyone Moderna Bivalent vaccine and didn't advise what dose and vial to give until after the vaccine was given.
Patient had general  malaise unknown cause. Onsite EMS was called vitals BP 120/80   HR 62  . Patient refused evaluation/care  and released agianst medical advice.
Fever, chills , body aches,  for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ache. Sore arm. I've recovered from all of that with tylenol.  but I have swelling and tenderness under the arm, lymph nodes?
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 031A21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-337382, MOD-2021-336875.
Lump underneath the collar bone; swelling of the lymph nodes; tenderness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump underneath the collar bone), LYMPHADENOPATHY (swelling of the lymph nodes) and VACCINATION SITE PAIN (tenderness in the arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Lump underneath the collar bone), LYMPHADENOPATHY (swelling of the lymph nodes) and VACCINATION SITE PAIN (tenderness in the arm of the injection). At the time of the report, AXILLARY MASS (Lump underneath the collar bone), LYMPHADENOPATHY (swelling of the lymph nodes) and VACCINATION SITE PAIN (tenderness in the arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non-significant follow up appended with updated reporter address.
Information has been received from a pharmacist concerning a female who was vaccinated IM in the deltoid with a standard 0.5 nl dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R or 650083/0746P). Subsequently the patient developed arm swelling and pain. The pain in her arm caused the patient to fall and break her hip. Unspecified medical attention was sought the patients outcome was unknown. There was no product quality complaint involved. Upon internal review, the patient's hip fracture was considered to be an other important medical event (OMIC). Additional information is not expected.
Full body aches and chill, fever (99 F), skin hurt when touch, headaches the next morning, bloody nose, feeling tired, injection site reaction
Narrative:  Patient received two covid 19 vaccine doses (Jan/Feb 2021). The patient tested positive for COVID 19 on 16 September 2021 and hospitalized with respiratory failure and COVID pneumonia. The patient was treated and discharged on oxygen on 29 September 2021. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
Allergic type rash on arm (inj site) neck, and trunk. Lasts 2 days but better today almost gone. Pt came by to inform me.
pt called and was having swelling in injection site and back pain. called dr and was instructed to ice and take ibuprofen
09/21/22: Pt reported to provider that on 09/20/22 she had new red marks/dot that were flat but now changing to raised like a pimple.  09/23/22: Seen by primary care and dermatology. Per dermatology "Patient has extensive palpable purpura on the examination.  Several raised juicy papules and plaques intermixed with macular lesions.  Her involvement includes the nose, upper back, central abdomen, bilateral lower extremities, and bilateral upper extremities.  She has notable skin breakdown extensively on the bilateral lower extremities from the knee down with open areas of granulation tissue." Diagnosed with  extensive cutaneous small-vessel vasculitis (Dermatology) 09/26/22: patient admitted for significant pain associated with recent vasculitis diagnosis, found to be in acute kidney injury 09/29/22: patient transferred to critical care unit due to increased O2 needs, requiring intubation and pressor support
Fever (102), sinus type headache, joint aching,"knot in throat" - no difficulty with breathing, just a sensation. Next day slight shortness of breath. Seen minor emergency clinic on 5/20/11. Given ibuprofen 400 mg 1 tablet and told to rest.
Received 1st and 2nd dose of COVID-19 vaccine subcutaneous; COVID-19; COVID-19; This is a solicited report from a contactable consumer (patient) via a non-Pfizer-sponsored program, FACILITATED COLLECT, based on information received by Pfizer from  (Manufacturer Control Number: 21K-163-4116265-00).   Solicited report from the USA by a consumer of a 44-year-old female with events of non-serious COVID-19 and entire family caught COVID-19 with Humira (Adalimumab). There was no reported medical history. On unknown dates (2021), the patient experienced COVID-19 and entire family caught COVID-19. In 2021, the COVID-19 and entire family caught COVID-19 resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Feb2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech (subcutaneous). On 01Mar2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech (subcutaneous). Primary reporter contact for lot number information was not available. Relevant laboratory and other diagnostic tests included blood work: blood count came back up in Jan2021; and COVID-19 test: COVID-19 (positive) in 2021. The patient recovered from COVID-19 in 2021.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID-19 and entire family caught COVID-19 with Humira (Adalimumab) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as M034837, expiration date on 18-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit for 70 minutes. Data logger was involved in recording of the temperature excursions. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA009093: US-009507513-1707USA009094: US-009507513-1707USA009095: US-009507513-1707USA009096.
This spontaneous report was received from a nurse referring to a 8 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 23-JUN-2018 (also reported as 23-JUN-2019), the patient was vaccinated with a dose of GARDASIL 9, 1 injection (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse effects reported. No further information provided.
Sore arm, hip and calf left side.  Lump under left arm.  Fever, nausea, metallic taste, chills, worse than when I had covid
18-36 hours after dose (entire next day)- fatigue, generalized myalgia and  joint pain    Arm soreness within 1 hour of dose. Warm, firm, red area below injection site. This area is still tender and raised as well.
9:47pm left sided pain 3/10  spread to left and right  lower back then increased to 6/10 pain until 6:45 am.
Onset redness of (L) arm at vac. site 1 day later. On set hives 1 1/2 week after vaccines.
Pt was given DTaP, Hib, IPV, Prevnar on 3/13/03. On 3/14/03 developed hives and angioedema.
On 05/03/2023 the notified Dr. that she draw and give the wrong vaccine, pt. was in a rush and the MA prepared meningococal vaccine opposed to the Prevnar 13. Pt. was called by both Drs. to explain the situation and assure her that no harm or risk would come o her child.