chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from an approximately 26-year-old female patient with no drug reactions/allergies regarding herself. Current conditions included high risk for labor. On an unknown date in 2012 the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route not reported). No concomitant medications were reported. Subsequently, the patient became pregnant with a Last Menstrual Period (LMP) on an unknown date in April 2012. The trimester of exposure was first and second. The patient stated she was vaccinated with GARDASIL before she had the knowledge of knowing that she was 5 months pregnant. She found out that she was 5 months pregnant on an unknown date in September 2012. Treatment was given for the event, she was prescribed some unspecified pills. No laboratory diagnostic tests were performed. Patient sought medical attention, she went to Emergency Room. Follow up information was received from the physician. The physician details were updated. The physician stated that he is a radiologist and the patient who reported the adverse event was not affiliated with his practice. He requested no further contact regarding the adverse event. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  The Pharmacist reported administration of an expired  Moderna vaccine to patients of around 490 to 500 people on the date last 20 Oct 2021 to 29 Nov 2021.  Reporter has provided lot Number of vaccine as follows, 006C21A (10-10-2021), 026B21A (09-17-2021), and 031B21A (9-22-2021).  Reporter stated that vaccines were stored in freezer and used one to two vials which were placed in fridge each day as needed.
Small rash and redness; Small rash and redness; This is a spontaneous case initially received from pharmacist via Med Communication (case ID: SEQ19-04542) on 11-Oct-2019, concerning a 59-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   On 10-Oct-2019, the patient was administered Flucelavax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid left arm, batch number: 261210 and expiration date: 30-Jun-2020] for influenza prophylaxis.   On 11-Oct-2019, the patient experienced small rash and redness. Pharmacist advised to place ice on the area.   On an unspecified date in 2019, the events were resolved.  The reporter assessed the case as non-serious, but did not provide causality assessment.  Follow up information received from pharmacist via Med Communications (reference number: SEQ19-06239) on 22-Nov-2019) included: The outcome of the events was provided and changed from not resolved to resolved. Additional number was added. The narrative was amended accordingly.  Company comment: Events were assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: The reporter assessed the case as non-serious.; Sender's Comments: Events were assessed as related to Flucelvax Quadrivalent.
Expired doses administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include nasal spray.  No treatment medications provided.  Patient did not experience any events.
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 52-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Concomitant medication(s) included: PREDNISONE, start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (22Jul2022) Negative, notes: Tested neg on day six and 7; (23Jul2022) Negative, notes: Tested neg on day six and 7; (25Jul2022) Positive, notes: On day 9 tested positive and had symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Jul2022 to 21Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5/7/13 Administered Yellow Fever, Tdap, Hep B, PPD. YF administered at 0830 remaining shots 30 min later. Pt experienced whole body itching and hives approx. 8 hours later. Went to urgent care facility and got meds.
suspected vaccination failure; still get them; 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 provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine years ago from the date of reporting. After receiving Shingles vaccine, the patient still got shingles. The patient reported that, if you were one of those unlucky folks who got the Shingles vaccine multiple times, the shot only minimized their chance of getting it again. 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 were not provided.
Pt recvd 2 doses of Engerix-B & exp swelling @ inject site, arms, hands & wrists swollen, hives, itching & hives covering wrists, ankles & mouth same day all sx had cleared by 18JUL92;
This spontaneous report was received from a registered nurse and refers to unknown number of patients from a group of 5 patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M038226, expiration date: 07-SEP-2018; and lot # reported as M033902, expiration date: 20-JUL-2018), reconstituted with properly stored sterile diluent (lot # and expiration date unknown), for prophylaxis (dose, frequency and route of administration, were not reported). No adverse effects were reported. The doses of the vaccines were exposed to a temperature of 6 degrees Fahrenheit (°F) to 14°F for a time frame of 21 hours. There were no previous temperature excursions. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1704USA013521.
Saw pt. in ER less than 24 hours after immunizations; patient had fever (controlled by ibuprofen), also c/o snakes crawling over his legs / chasing him, pain or discomfort in feet and legs.  Normally very independent but constantly running towards / jumping on mom for comfort.  Consolable.  ? paresthesias.
Headache, Myalgia, NauseaVomiting, CHILLS, INJECTION SITE PAIN Narrative:
itchy, raised rash on forearms.  More severe on arm that injection was put in (left).
Skin and stomach felt on fire Felt light headed Broke out in blotchy rash, but went away and did not itch a week out. Light headed
12/22/2021 01:00 am, I had flu like symptoms, but what was concerning was a very rapid resting. Heart was in the 90s normally 65 to 67. Fever and chills for 24 hours. Rapid heart rate for 48 to 54 hours.
About 12 midnight after the vaccine I developed chills and was achy all over and had a headache for about 24 hrs. I felt really drained for about 5 days and was back to normal after that. 7/27 I began having feeling lousy. Developed the most uncontrollable diarrhea and felt worse through the day so I contacted my PCP via phone who advised COVID testing. On 7/29 I went to the Urgent Care and was tested and was COVID positive on 7/30.
hit by a truck; neuromuscular symptoms; tingling; burning; shortness of breath; tachycardia; very fatigued; This spontaneous case was reported by a physician and describes the occurrence of PAIN (hit by a truck), MUSCULAR WEAKNESS (neuromuscular symptoms), PARAESTHESIA (tingling), BURNING SENSATION (burning) and DYSPNOEA (shortness of breath) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (hit by a truck), MUSCULAR WEAKNESS (neuromuscular symptoms), PARAESTHESIA (tingling), BURNING SENSATION (burning), DYSPNOEA (shortness of breath), TACHYCARDIA (tachycardia) and FATIGUE (very fatigued). At the time of the report, PAIN (hit by a truck), MUSCULAR WEAKNESS (neuromuscular symptoms), PARAESTHESIA (tingling), BURNING SENSATION (burning), DYSPNOEA (shortness of breath), TACHYCARDIA (tachycardia) and FATIGUE (very fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  No treatment information was provided.
Patient states that he was at the Janssen COVID-19 Clinic on 3/13/21 hosted by Pharmacy and received his single dose of the vaccine.  Two weeks later, he noticed leg pain and numbness in both arms. He went to the  hospital and then to see his regular practitioner with no answers. Patient is convinced that these symptoms are due to the vaccine and would like some answers.
Information has been received from a registered nurse concerning a 12 month old patient who was vaccinated SC with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported that after vaccination the patient had a breakthrough of chickenpox. The patient had less than 50 lesions of chickenpox. Unspecified medical attention was sought. a product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Pt. started having redness of the left deltoid this morning. She had swelling of the legs deltoid for several hours. She complained of tightness in her throat and hives on her face and neck. She has 5x6 cm tenderness on her left deltoid.
Breakthrough case admission after 2 vaccines Pfizer 5/1/21 Lot# Ew0185;  Pfizer 6/3/21 Lot# Ew0191
Patient receive 2 vaccines (BOOSTRIX and ENGERIX-B) and passed out/fell. She was taken to the ER but was fine.
Two days after shot I started to feel terrible with difficult breathing, wheezing, paleness, weakness, ears plugged bad, dizzines, depression, light fever, chills, cold sweating, back pains,light skin irritation, nose congestion.  Today 12/05/06 after more than 4 weeks and three medical visits I still have some of the symptoms described.
Red spot started on right hand and face on 03/23/03.  03/24/03 red spot on bicep and another on face.  Pt was not given meds or actual diagnosis.
Developed an autoimmune pleva on her entire body.  To date this has not cleared up.  This developed after a sinus infection in which she took antibiotics.
Recvd DPT/OPV/HBOC 28Nov90. grandmother reported child cried "the whole time" & was unconsolable. Excessive crying /wout being consolable lasted @ least 3 hrs. Seen in the ER @ 9:00pm, & noted to be pale, irritability resolved, exam-neg
Shingles - Zoster- Appeared on patient's left arm extending linearly from the left clavicle to the left wrist two weeks after vaccine administration. The vaccine was administered to the thigh.
stiffness neck, h/a x 5d;chest pain, nausea, malaise;
Pt recieved Moderna for first 2 doses through Human Services. Here today for booster, per CDC protocol administered Pfizer booster .
got Shingles from the vaccine/Suspected vaccination failure; shingles sores; nerve pain; sores; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got Shingles from the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles sores), nerve pain (Verbatim: nerve pain) and skin ulcer (Verbatim: sores). The outcome of the vaccination failure was unknown and the outcome of the shingles and nerve pain were not reported and the outcome of the skin ulcer was resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the nerve pain and skin ulcer to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the nerve pain and skin ulcer to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient  interactive digital media. The patient stated un-imaginable. The patient stated nerve pain lasts after the sores were gone.  The patient got shingles from the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
10/26 11 pm Very sore upper right arm - used extra strength TYLENOL. 10/27 7 am Low grade fever - 100 with nausea and headache - used extra strength TYLENOL. 10/27 5 pm Headache, fever, nausea continue.
patient was pregnant and received the first dose of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (patient was pregnant and received the first dose of vaccine) in a 33-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-May-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (patient was pregnant and received the first dose of vaccine). On 22-Jan-2021, EXPOSURE DURING PREGNANCY (patient was pregnant and received the first dose of vaccine) 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 did not provide any causality assessments.   Concomitant products were not reported.  No treatment information was reported.  Number of fetus was reported as 1, previous pregnancies as 3 and gestation period as 27 weeks.
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left 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: "Heart failure" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Coronary heart dz" (unspecified if ongoing); "Some antibiotics" (unspecified if ongoing). The patient took concomitant medications. 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: Negative, notes: I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for COVID-19 treatment from 26May2022 to 31May2022. Patient was taking many different meds for heart disease and heart failure from 01Jan2019 to 01Jun2022 (lot number was Unknown).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
rash to both forearms, thigh and private area/developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy/rash now is flat, red, and pinkish; rash to both forearms, thigh and private area/developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy/rash now is flat, red, and pinkish; rash to both forearms, thigh and private area/developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy/rash now is flat, red, and pinkish; This is a spontaneous report received from a contactable nurse (who is also the patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date unknown), intramuscular in left deltoid, on 19Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported she received the COVID-19 vaccine on Saturday (19Dec2020). Everything was fine all day on Saturday and when she took a shower on Sunday morning (20Dec2020), she noticed she developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy, and she still has the rash on the arms. She called her primary care provider and was instructed to use Benadryl at bedtime and Zyrtec in the morning to help. She was wondering because in 20 some odd days she is to get the second shot and wants to know if she should expect this type of adverse reaction. She mentioned that the rash now is flat, red, and pinkish. She stated she has never had COVID-19 testing or symptoms. Just this rash from the vaccine. The reporter assessed the events as non-serious. The outcome of the events was not recovered (reported as ongoing).
I had neck pain for about a month at the end of October 2022. My orthopedist and he believed it to be arthritis. On November 30th I noticed right calf pain that continued for about a week. I had a formal ultrasound, and I had a clot in my leg. I had more lab work and an EKG. They more abnormalities. I then had more tests and found more small clots in left upper and right lower lobe. I had no other symptoms than the calf pain.
Inflammation, swelling/hardness, redness, soreness at injection site. Strong fatigue. Onset of symptoms did not occur until a full week after the vaccine was administered. Diagnosed as cellulitis and treated with antibiotics.
not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of breath); arm feeling weak (arm felt weak); This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140, expiration date 31Mar2021) via an unspecified route of administration on 08Jan2021 at a single dose in the left arm as Covid-19 vaccine due to being a front line worker. Medical history included ongoing pre-diabetic from 2015. There were no concomitant medications. The patient received the vaccine today on 08Jan2021.  Within 15 minutes (also reported as 15 minutes after the vaccine), she experienced not feeling good (felt like crap), dizziness (really dizzy), weakness, shortness of breath (short of breath), and arm feeling weak (arm felt weak) on the side where the injection was received. It's the weirdest thing, she never had issues with vaccines before. She was asking if this was normal. The outcome of the events was unknown. The nurse reported that the events were related to the suspect product.
she had covid 19; she had covid 19; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer covid vaccine on 19Mar2021 and she was due to get the second dose on 10Apr2021 and she asked if she should get the second dose because she had covid 19. The outcome of the events was unknown.  Information about lot and batch number was requested. Follow-up attempts are completed. No further information is expected.