chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from Pregnancy Registry from a 19 year old female patient who on 08-MAY-2007 was vaccinated IM with a first dose of GARDASIL and received a second dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Patient reported that she discovered that she was one month pregnant after getting the second vaccination. She stated that she is "one of the rare people who get their period when they are pregnant. "Patient reported that on 10-JUL-2007 she developed soreness at the injection site. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested.   This is in follow-up to report(s) previously submitted on 10/12/2007, 1/7/2008.  In follow up it was reported that concomitant therapy included ORTHO TRI-CYCLEN.  Patient reported that she discovered that she was one month pregnant after getting the second vaccination.  She stated that she is "one of the rare people who get their period when they are pregnant."  Patient reported that on 10-JUL-2007 she developed soreness at the injection site.  Unspecified medical attention wsa sought by the patient.  The outcome was unknown.  A follow up telephone call was made to get pregnancy outcome information.  Patient informed that she had not yet returned for "her third shot".  No further information available at this time.  Additional information has been requested.
Information has been received from a Licensed Practical Nurse via a field representative referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the third and final dose of GARDASIL 9 (dose, route and lot# were not reported). Information regarding concomitant medication was not reported. The date of the first and second doses given was not provided. After taking the third and final dose of GARDASIL 9 the patient developed muscle weakness and a fever. The patient sought medical attention. TYLENOL was given for the adverse events. The outcome of the events and the causality were not reported. Additional information has been requested.
Suspected vaccination failure; shingles; shingles / They are so painful; itch something awful / have used everything on them and still itch; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles. The patient stated that, they were so painful and itch something awful. The patient had used everything on them, had taken the required medication but still itch and nothing had helped till the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Injection site redness; Swelling of the lymph nodes in her armpit,  half an inch in size; Extremely itchy; Rash around vaccination site; Painful lymph nodes in armpit; Hurts to lower arm, sore; Feel sore and tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Extremely itchy), FATIGUE (Feel sore and tired), VACCINATION SITE RASH (Rash around vaccination site), AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced FATIGUE (Feel sore and tired) and VACCINATION SITE PAIN (Hurts to lower arm, sore). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Extremely itchy), VACCINATION SITE RASH (Rash around vaccination site) and AXILLARY PAIN (Painful lymph nodes in armpit). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. On 09-Jan-2021, AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) had resolved. On 10-Jan-2021, VACCINATION SITE PRURITUS (Extremely itchy) and VACCINATION SITE RASH (Rash around vaccination site) had resolved. At the time of the report, FATIGUE (Feel sore and tired) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up information was added on 16 April 2021. Second dose information and a new events (injection site erythema, injection site rash and injection site pruritis), race, ethnicity, event treatment, event outcome was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
At second dose appointment, patient reported "Covid-Arm" (redness, itching, nodule spanning whole upper arm) starting approximately 8 days following first COVID vaccine. Symptoms have since resolved.
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 50-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Kiwi" (unspecified if ongoing); "Intermittent asthma" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Dilated cardiomyopathy" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: COVID 19 Treatment; Positive, notes: home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: symptoms again (body aches, fatigue, runny nose, sore throat) and next morning positive home antigen test. The patient received ADVIL (ibuprofen) on 10Aug2022.
Pt recv vax on 1/19/99; 6 - 8 hr post vax pt exp labored breathing, stiff arms & legs w/ blue hands & feet x 1 min
This spontaneous report was received from a registered nurse, referring to unspecified number of patients of unknown age and gender. From 01-MAY-2017 to 11-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number M009767, expiration date 23-FEB-2018; lot  number M032495, expiration date 05-JUL-2018; lot number M038858, expiration date 14-SEP-2018; lot  number M041080, expiration date 06-OCT-2018; lot number M049126, expiration date 15-DEC-2018; lot number N012134, expiration date 17-APR-2019) for prophylaxis. Concomitant therapies included sterile diluent. The data logger registered a temperature range between minus 9 to 8 grades Celsius (°C) during 88 hours and 45 minutes. There was no previous temperature excursion. No adverse effects were reported.
Fever 2/17 - PM 101 - Rt leg extremely swollen with mild rash - inner thigh no edema or redness at knee.
Myalgia, Fever, restlessness, injection site pain Narrative:  Tylenol relieved discomfort
received first dose on 05Feb2021 and then tested positive for covid on 26Feb2021 and was quarantined until 01Mar2021; received first dose on 05Feb2021 and then tested positive for covid on 26Feb2021 and was quarantined until 01Mar2021/Received the first Covid vaccine; Contracted Covid; This is a spontaneous report from a contactable consumer. A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  There were no relevant medical history and concomitant medications. Mother, calling on behalf of son, who received first dose on 05Feb2021 and then tested positive for covid on 26Feb2021 and was quarantined until 01Mar2021. The earliest available date for his second vaccine was scheduled for 30May2021, the mother is asking if it's too late or does he have to restart the vaccination series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Feb2021. The outcome of the events was unknown. The case was assessed as serious (medically significant).    Information on the lot/batch number has been requested.
Rash on Torso and arms; This is a spontaneous report from a contactable consumer (patient). This 54-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9265) via an unspecified route of administration on 19Feb2021 at 14:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included high blood pressure and cholesterol medication. The patient did not have any allergies to medications, food, or other products. On 19Feb2021 at 18:00 the patient experienced a rash on torso and arms. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of rash on torso and arms was not recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Pt noted right upper arm with redness, warmth, pain and swelling on the same night as vaccines were given.
The day after I received dose 4 in October 2022, I experienced swelling at the injection sight and nausea that lasted about 2 weeks. Also, I tested positive for COVID-19, April 7, 2023. I have experienced fever, runny nose, shortness of breath, nasal congestion, loss of appetite. I began taking PAXLOVID and the side effects gave me diarrhea and muscle cramps. As of today, I still have diarrhea, runny nose, coughing, fever and headache.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2019SA077321 (same reporter). This case involves a 11 years old male patient received a first 0.5 ml dose of ADACEL (lot U6217AA and Exp. Date 21-Mar-2021) via unknown route in the left deltoid on 18-Mar-2019 at around 3:00 pm, that may have been frozen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE for Immunisation. It was an actual medication error case due to incorrect product storage. No adverse reactions reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
she developed blood clots in her lungs, legs and all over her body; 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 75-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to a lot of things" (unspecified if ongoing), notes: she is allergic to a lot of things. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (states last year, she had a flu vaccine that was 'mixed' together with a Pfizer covid vaccine and developed blood clots as well), administration date: 2022, reaction(s): "blood clots". The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "she developed blood clots in her lungs, legs and all over her body". Additional information: Reporter States she wants to know the ingredients as after she took the pfizer covid vaccine, she developed blood clots in her lungs, legs and all over her body. States she almost died. States she has respiratory problems (unclear of timing) and needs to take the 'lung vaccine." States she is allergic to a lot of things. She is not sure that she wants to take the Pfizer RSV vaccine as states pfizer has ingredients in their vaccine (covid) that is not good for her." Upon further clarification, caller states she had 2 Pfizer covid shots and one pfizer booster for covid and after every shot, she developed blood clots.  Also states last year, she had a flu vaccine that was 'mixed' together with a pfizer covid vaccine and developed blood clots as well. Attempted to clarify further however caller unable to clarify. states she is 75 years of age.     The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312116 same patient, same event, different dose of vaccine;US-PFIZER INC-202300312117 same patient, same event, different dose of vaccine;
BODY ACHE; FEELING LIKE HANDS ARE TIGHT; FEELING TIRED; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, osteopenia, fibromyalgia, hypothyroid, insomnia, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. The patient experienced drug allergy when treated with gramicidin/neomycin sulfate/polymyxin b sulfate, and bacitracin/polymyxin b sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020,  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body ache. On 13-MAR-2021, the subject experienced feeling like hands are tight. On 13-MAR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, and feeling tired, and had not recovered from feeling like hands are tight. This report was non-serious.
arm was very swollen; red; itchy; This is a spontaneous report from a contactable consumer, the patient. A 35-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 arm right on 24Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol sulfate (PROAIR), ethinylestradiol, levonorgestrel (SRONYX) and ibuprofen (MOTRIN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 03Mar2021 (at the age of 35-year-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 24Mar2021 the patient experienced arm was very swollen and felt like there was a knot right under the injection site for a week and it was also red and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm was very swollen, red and itchy was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Narrative: Patient received two doses of covid vaccine. Per notes, patient was on home hospice after cancer reoccurrence. No other details of death reported. Reporting per facility instruction.
Runny nose since 5/29/08, headache off/on since 5/30/08, fatigue since 10:00 AM today, no energy since shot, sore throat, itchy throat 10:00 AM today, thirsty today, sneezing once or twice on 5/30/08, just noticed while on phone that left eyelid with redness and swollen, phlegm to chest since 5/24/08, phlegm color is yellow, chest pressure between nipples from coughing.
Hives on forearms, armpits, trunk, thighs. Lethargic and very tired. Sick and night sweats for the past week. UP & Down fever
I put BD Safety Glide needle 08290-3059-16 lot REGW1122 on the Fluad PFS and pushed out the air. When I was giving the patient the shot, the plunger on the Fluad would not advance. I had to remove the needle from the patient's arm and swap with another of the same type of needle of the Fluad.
Whole body maculopapular rash with two days of fever up to 100.8.
fever of 102.1 onset 12 hours after second dose. he took Tylenol
Pain at injection site, headache, chills, nausea, lightheadedness, fever up to 103.1 degrees F, joint and muscle aches and diarrhea that lasted approximately 24 hours.  Took ibuprofen 600mg tablets
Started to feel sick to stomach,  weak, faint. Then really bad headache,  fever, shakey,  couldn't walk, nausea and vomiting. Took to emergency room
pt recvd vax 17NOV93 & on the same day devel redness & soreness in upper arm & axilla area; No further details were provided;
It was reported that on 12/2/00, the pt complained of "redness, swelling, hard and raised area, the size of a golf ball with darker red appearance". It was also reported that on 12/3/00, the pt complained of "itching (wearing a wood sweater)". From additional correspondence received on 3/12/01, it was reported that the pt recovered from this experience. Additional lab data, vaccine and responsible facility information were also provided. The pt was given an antibiotic prescription (Keflex) X 1 week. From follow up received on 3/12/01, it was reported that the pt recovered from this experience. Additional lab date, vaccine and responsible facility info were also provided.
This spontaneous report as received from a other health professional refers to a male patient of unknown age. The patient received a dose of (Merck) VARIVAX injection. The healthcare worker reported that one dose of (Merck) VARIVAX injection (lot # K011082, expiration date 08/08/2016), which was exposed to a temperature outside of the recommended range, was administered to the patient yesterday, on 22APR2015. No adverse effect has been observed or reported. The outcome of incorrect storage and no adverse event is unknown. No additional information was provided. Additional information has been requested.
negative titers; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, one dose (valid lot number W036194, expiration date 29-SEP-2025), administered intramuscularly for prevention of hepatitis B virus (anatomical location and vaccination scheme was not provided).  On 26-OCT-2023, the patient declined their dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), he was scheduled to receive a second booster dose of the vaccine after he had "negative titers" (hepatitis B surface antibody negative). The outcome of the event hepatitis B surface antibody negative was not provided.  The causal relationship between the event hepatitis B surface antibody negative and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Received vaccine at 9:45 AM and advised due to anaphylactic reaction in the past due to bee stings, advised to stay 30 minutes.  At 10:03 AM husband stated wife was not feeling well.  10"05 called EMS.  Blood pressure 197/88, chills, heart racing, and SOB.  10:10 ambulance here.  Checked out patient and at 10:22 EMS dismissed patient.  Vitals 140/98, HR 88, and Pulse Ox 97%.