chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THROAT CLOSED UP; DIFFICULTY SWALLOWING; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a other company (Pfizer, Inc) concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bee allergy, and drug allergy (Acetaminophen). The patient was not a pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in left arm on 03-APR-2021 12:00 for covid-19 prophylaxis. Age at time of vaccination 33 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1) The patient received non-company suspect vaccine tozinameran (Pfizer Biontech covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: FH8027 and expiry: Unknown) dose was not reported, dose 2 administered in left arm on 11-DEC-2021 11:00 for covid-19 prophylaxis. No concomitant medications were reported.  On 2022 (Date and month unspecified), the patient experienced suspected covid-19 infection (Dose number in series: 2). The patient received non-company suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, from 08-AUG-2022 to 09-AUG-2022 for treatment of covid-19. On 09-AUG-2022, the patient experienced throat closed up, and difficulty swallowing (Dose number in series: 2). The patient took treatment with Antihistamine (drug unspecified). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran (Pfizer Biontech covid-19 vaccine) was not applicable, and with Paxlovid was not reported. The patient was recovering from throat closed up, and difficulty swallowing, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Post vaccine heavier menstrual periods.  6 months post vaccine absence of menstrual period for 2 months (May and June).  Next menstrual period on July 19th with heavy bleeding and passing large blood clots no larger than a golf ball size.
Information has been received from a pharmacist concerning a pt who was vaccinated with a 3rd dose of Hep-B. One day, post vax, the pt developed a headache, fever, chills, back pain and drowsiness. The pt sought unspecified medical treatment. Additional information has been requested.
The individual reported on 12/15/21 that he noticed a week after receiving the third dose that the breast tissue in his right breast was swollen and also had a hard lump.  He did also see his PCP and PCP told individual that the lump measures approx. 4cm after his examination as reported to this Public Health by the individual.
Swollen redness and induration on right lateral thigh extending to the anterior mid thigh.
on the 7th and 8th day following the injection, the injection site was very itchy and warm.  no suffering, but the itching was intense.  faded by the end of the 8th day following the injection.  (Injection was on Feb. 20, 2021, the itching was on the evening of Feb. 7th and most of the day on Feb. 8th.)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: 882589) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN 6200) and on 27Apr2022 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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 test: Positive, notes: COVID symptoms with a positive test; Negative, notes: 2 days following negative COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300013169 Same reporter/patient, same drug/different dose, different AE.
Vaccination site reaction. Initial case was received on 13 July 2010 from a healthcare professional. It contains information for a cluster of 9 unidentified patients. Nine unidentified patients ("children" age and gender not reported) received PENTACEL (lot number C3602AB) on unspecified dates. Seven of the patients had uncontrollable crying. Two patients had cellulitis with greater than 3 inch diameter of swelling and redness and had pain and fever. "Several" of the nine patients had local reaction and fever. There were no diagnostic tests or laboratory tests done. The reporter provided no further information. All the patients recovered from the events. Follow-up information was received 14 July 2010 from a health care professional who reported that the events consisted of multiple high grade fevers, local reactions, cellulitis in two cases, and inconsolable crying (previously reported as uncontrollable crying). Patient information was reported as "female". No additional information was reported. Follow-up information was received on 02 August 2010 from a healthcare professional who identified one of the previously nine unidentified patients as an eight month old female. The patient had received on 23 June 2010 a third dose, left leg injection of PENTACEL, lot number C3602AB and a third dose, right leg injection of PCV13 (lot number #52353, manufacturer Wyeth). The next day she developed a temperature >103 which was treated with TYLENOL and MOTRIN. The patient had no concurrent illness at the time of the vaccination. No additional information was reported. Documents held by sender: None.
Refractory chills and rigors without fever, borderline Hypotension, Bradycardia (heart rate approx 50) over 2 days despite rest and Advil 1-2 every 8 hrs prn.
began w/hives (general) including face & chest; woke up 430AM w/chest pains & dyspnea; dx acute allergy w/esophageal swelling;
Body pain going down to abdominal area on left side; Felt pain fool touch on left body side; Swelling of lymph nodes on injection side; Chills; Fever 101 degrees Fahrenheit; Headache; Body pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Body pain going down to abdominal area on left side), TENDERNESS (Felt pain fool touch on left body side), VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph nodes on injection side), CHILLS (Chills) and PYREXIA (Fever 101 degrees Fahrenheit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 101 degrees Fahrenheit), HEADACHE (Headache), MYALGIA (Body pain) and NAUSEA (Nausea). On 18-Mar-2021, the patient experienced ABDOMINAL PAIN (Body pain going down to abdominal area on left side) and TENDERNESS (Felt pain fool touch on left body side). 18-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph nodes on injection side). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, CHILLS (Chills), PYREXIA (Fever 101 degrees Fahrenheit), HEADACHE (Headache), MYALGIA (Body pain) and NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL PAIN (Body pain going down to abdominal area on left side), TENDERNESS (Felt pain fool touch on left body side) and VACCINATION SITE LYMPHADENOPATHY (Swelling of lymph nodes on injection side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101 (High) Fever 101 degrees Fahrenheit.         Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-053174 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Event outcomes were updated.
Chills, Fever, Cough, Sneeze Sore Throat, tired, weakness,   All symptoms occurred over the course of a week following the vaccine
RESIDENT CONTRACTED COVID-19 VIRUS AFTER BEING FULLY VACCINATED ON 9/24/21. RESIDENT PASSED FROM COVID-19 ON 9/28/21.
This spontaneous report was received from a registered pharmacist regarding multiple unspecified patients of unknown age and gender. On an unknown dates the multiple unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006392, expiry: 25-MAY-2016 and Lot# L028279, expiry: 28-OCT-2016). No adverse effects were reported. Additional information has been requested.
Chest pain, sharp pain on the neck and shoulder, light-headed, dizziness, vision changed
Patient reports hardening and redness at injection site along with mild swelling to (R) forearm. Also report feeling like "I was running a temperature". Pt. denies checking temperature. Also reports headache and neck ache on 5/24/12.
This spontaneous report was received from a physician regarding an unspecified number of patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. Between 09-OCT-2015 and 16-OCT-2015, an unspecified number of patients received unspecified doses in the M-M-R II immunization series (dose and route were not provided, Lot number J016232, expiration date 19-DEC-2015, and Lot number K026366, expiration date 15-DEC-2016). Concomitant medications were not provided. There was no adverse effects reported. This is one of several reports from the same source (MARRS #1510USA013291 and 1510USA013292). Additional information has been requested.
pt recv vax 9DEC96 & 24AUG97 pt devel full blown chickenpox;pt presented to MD office;
Patient still hospitalized. HPI: 51 y.o. with a history of TBI, diabetes, and congestive heart failure.   She lives independently.  Presents with abd bloating, epigastric discomfort since Saturday, and diarrhea.  She was weak and family brought her to the ED.     Presented to the ED with these complaints and became hypotensive.  Not responsive to 4 liters of fluids, and 2 additional given and she was started on norepi.  Heart rate unchanged.  CT abdomen showed distal stomach to small bowel, and rectosigmoid colitis, as well as ascites, which was reviewed with general surgery and felt more likely related to her cirrhosis than a diffuse enteritis.  She was placed on norepi for hypotension.  She is also COVID positive.  She denies respiratory symptoms until just shortly after admission where she notes a cough; she is on rom air.  She was started on piperacillin-tazobactam.  She has gotten potassium supplement.  Norepi through port which she has for chronic magnesium infusion.    When asked, she states she is feeling poorly but that the main thing bothering her is her low blood pressure.     She had a recent ED visit for severe hyperglycemia after not taking her insulin.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Initial unsolicited report received from a Nurse on 11-Jun-2018. This case involves two-year-old patient (gender not reported) who was vaccinated with a dose of ADACEL (reported as dose 4, batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event was 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. Documents held by sender: none.
Fine rash to arms and legs. Red, itch patches to abdomen, back, neck and chin. Hot, burning feeling to palms of hands and soles of feet. The rash started 5 hours after receiving vaccine. The rash improved the next day and was gone by 2 days.
Vaccine was administered around 3pm and side effects began around 9pm that evening. Initial side effects were fatigue and muscle aches. From approximately 12am to 5am, I had an elevated heart rate (averaged around 100bpm and went as high as 112bpm), feverish chills, dizziness/foggy head. These side effects seemed to stop abruptly around 5am and was followed by extreme hunger. Heart rate stayed elevated the following day (80s and above), and I also had joint paint. It took about a full week for my body to feel normal again.
Fever, headache, hives, sore/swollen throat, swollen face, behavior changes, light headed/dizziness, cough, rapid heart rate, lethargy.
The next morning i noticed i had a Sore arm and red raised area after vaccination. My heart rate has been higher than usual and I have chills.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) to be possibly related.    No concomitant medication details was reported. No treatment medication details was reported.
Reports face/neck rash beginning 2 days after 2nd Pfizer vaccine, different from her psoriasis rash.  She felt very itchy, with redness of head/neck area with swelling of face and eyes; worst day was 7 days after the 2nd shot.  Saw her rheumatologist 2-3 days after shot and received a steroid shot, Pred-pak and is using topical calamine lotion.  States rash is improving but still present.  Face is now "splotchy" and eyes only swollen in AM.
Patient with longstanding bilateral non-pulsatile tinnitus without associated hearing loss. No dizziness, ear pain, hearing loss or vertigo.He received Moderna vaccine on 3/2 and his tinnitus got much louder. It improved but has not become louder again. He is currently treated with trial of niacin.
Pt developed fever on 5/21/2010 (11 days after MMR vaccine).  She also had some cold symptoms with cough and runny nose. Then, had febrile seizure which lasted about a minute. Brought to E.R.
PATIENT HAD COVID VACCINE PFIZER, ON Dose 1 date: 01/16/2021, Dose 2 date:  01/16/2021, AND TESTED POSITIVE TO COVID
"symptoms of my Lyme disease pop up after 25 years, it "; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE ("symptoms of my Lyme disease pop up after 25 years, it ") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lyme disease (25 years ago).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced LYME DISEASE ("symptoms of my Lyme disease pop up after 25 years, it ") (seriousness criterion medically significant). At the time of the report, LYME DISEASE ("symptoms of my Lyme disease pop up after 25 years, it ") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
I didn't see the pt for the problem until 2 mo after the vaccine. She described local pain and swelling at the injection site. The pain worsened, leading to shoulder pain and limited ROM. She had frozen shoulder by the time I saw her.
Yesterday evening Mom saw swollen entire (L) upper arm. Arm is warm, pt. states feels like a piece of wood and is tender if touched. No fever or other constitutional symptoms. F/U in 5 days.
PATIENT REPORTED TO PHARMACY FOR SECOND DOSE AND MENTIONED REACTION OCCURING TWO DAYS AFTER RECEIVING VACCINE. IT STARTED AS AS PAIN THEN TINGLING AND NUMBING IN THE VACCINATED ARM. PATIENT USES OTC PAIN MEDICATIONS AND  A HEATING PAD WHICH CAUSES SOME REDNESS IN THE AFFECTED ARMS
Patient reported that after receiving the flu vaccine at the flu clinic she developed a large bruise, swelling, and pain in the location of the injection. She stated that she was told by flu clinic to use a cold compress on the area and that it happened because the injection was given too low. Patient reported this to the Patient Safety Officer on 10/11/23 and patient still has a large bruise
A consumer report has been received. The report concerns a 3 year old, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Nov-2012. The patient experienced SENSITIVE EARS, FUSSY, FEVER 103F and RUNNY NOSE which started on 16-Nov-2012. The outcome of the event of SENSITIVE EARS, FUSSY, FEVER 103F and RUNNY NOSE is unknown. The report was considered to be non-serious.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with ROTATEQ (Lot # not provided) (dose, route and frequency not reported). Other suspect therapies included M-M-R II (Lot # not provided) (dose, route and frequency not reported). No concomitant therapy was reported. The reporter stated ROTATEQ and M-M-R II were stored outside of temperature range, that may have been administered to unspecified patients on unspecified dates. Additional information has been requested.
after leaving pharmacy area , patient became very light headed but did not fall.  was able to get on floor.  patient called family  doctor ..  i spoke to patient later in the day. he was feeling fine, believes it happened due to sever fear on injections and watched girlfriend get hers
Blooding from the nose for 3weeks unable to stop the bleeding; Bad headaches; Muscle pain; Pain all over; Chest pain; Difficulties breathing; Blood clots every where in my body; Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 14:00 (54-year-old at time of vaccination) as single dose for COVID-19 immunization.  Medical history included protein C deficiency (protein C and S deficiencies), protein S deficiency (protein C and S deficiencies), PE.s (I've had PE.s in the pasted), allergies (I will need to provide a list I have several). Concomitant medications that the patient received within 2 weeks of vaccination included blood clot meds and a list of other meds daily (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Apr2021, the patient experienced "Blooding from the nose for 3weeks unable to stop the bleeding", bad headaches, muscle pain, pain all over, chest pains, difficulties breathing, "blood clots every where in my body" (medically significant), and stomach pains. The events were serious with criteria of life threatening. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "blooding from the nose for 3weeks unable to stop the bleeding" and included surgery to stop the bleeding. The outcome of the events was recovering.  Information on lot/batch number has been requested.
Large red welt.  Hot and itchy.  Lasted for 6 days.  Mostly better now, still a little itchy.
Rash full body, fever 102.7 3 days after immunizations given. Benadryl given for rash, Tylenol given for fever - relief in 24 hrs.