chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bumps all over her arms and shoulders, primarily on right arm and back of right shoulder and 4 bumps on left arm; noticed first bump on injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (bumps all over her arms and shoulders, primarily on right arm and back of right shoulder and 4 bumps on left arm) and VACCINATION SITE SWELLING (noticed first bump on injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SKIN SWELLING (bumps all over her arms and shoulders, primarily on right arm and back of right shoulder and 4 bumps on left arm) and VACCINATION SITE SWELLING (noticed first bump on injection site). At the time of the report, SKIN SWELLING (bumps all over her arms and shoulders, primarily on right arm and back of right shoulder and 4 bumps on left arm) outcome was unknown.            Reporter did not allow further contact
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness.  I have not been to work this week.
rash like itchiness on face neck and arm. taking benadryl does not seem to help
symptoms: fever, chills, headache, dizziness, swollen lymph node in the left armpit treatments: no outcomes: fever, headache, dizziness lasted for about 1 day, swollen lymph node in the left armpit is still ongoing.
Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter
3RD DOSE MODERNA COVID VACCINE GIVEN 11/27/2021, LOT #004F21A; Pt resides at Senior Living; had a positive COVID test on 12/27/22; follow up in facility showed O2 not required; oral intake good; no chest congestion; on steroids for edema associated with the brain tumor; pt on hospice; DNR; hospice provider; pt passed away in the facility
General discomfort, that lasted for 3 or 4 days; Bone pain, that lasted for 3 or 4 days; Felt like she had fever, but she had not , that lasted for 3 or 4 days; Chills, that lasted for 3 or 4 days; Headache , that is not usual for her, that are worse at night; Nasal congestion, that is worse than previous time when she had them, and are worse at night; Fast heart beat, after the vaccine is worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse), BONE PAIN (Bone pain, that lasted for 3 or 4 days) and PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ04) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, ATENOLOL, ATORVASTATIN, LOSARTAN and TRIAMTERENE for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse) and HEADACHE (Headache , that is not usual for her, that are worse at night). On an unknown date, the patient experienced VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), BONE PAIN (Bone pain, that lasted for 3 or 4 days), PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days) and CHILLS (Chills, that lasted for 3 or 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (General discomfort, that lasted for 3 or 4 days), NASAL CONGESTION (Nasal congestion, that is worse than previous time when she had them, and are worse at night), PALPITATIONS (Fast heart beat, after the vaccine is worse), BONE PAIN (Bone pain, that lasted for 3 or 4 days), PYREXIA (Felt like she had fever, but she had not , that lasted for 3 or 4 days), HEADACHE (Headache , that is not usual for her, that are worse at night) and CHILLS (Chills, that lasted for 3 or 4 days) outcome was unknown.
12/28/21 presents to EC ED for "altered mental status". PMHx of "hypertension dementia"
TINGLING IN THE FACE AND AROUND THE INJECTION SITE APPROX. 2 HOURS AFTER VACCINE ADMINISTRATION. NO NUMBNESS OR PARALYSIS. TINGLING IS STILL PRESENT 24 HOURS LATER. HAS NOT SEEN A PROVIDER FOR TREATMENT.
Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F; Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient; patient received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F) and PRODUCT STORAGE ERROR (Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No allergies to food and other products.     On 08-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F) and PRODUCT STORAGE ERROR (Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were undergone temperature excursion by maximum 44.6 degree F and minimum by 38.8 degree F) and PRODUCT STORAGE ERROR (Vaccine expired on the 20jan2022 were put in the freezer and from 23feb2022 until the12may2022 administerto patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Unknown whether the patient ever had COVID + test or diagnosis. On 20JAN2022, the vial was initially stored in the refrigerator.  The vial undergone temperature excursions. Excursion duration: 3 months. Patient did not seek medical care for the AE. Unkown if the patient symptoms improved or worsened. Treatment information was not provided.
Total loss of taste on the tongue. The (very few) taste buds in the other areas of the mouth remained minimally functional. For a point of reference, I can barely taste anything when I swish mouthwash around in my mouth.  Pre-existing minimal chest pain (related to history of vaping) flared up to an extreme extent the night of the day I was vaccinated. Hurt more than the joint pain or headache I also have (but those are common side effects).
Excelerated heart rate, light headedness, hot flashes, sweating, extremely blood shot eyes, difficulty taking a deep breath.
8/22/06 RA injection site itched immediately, swelling 1 hr later, 3 hrs later redness on right arm. 8/24/06 redness/swelling to chest, back, neck. Came in for eval at urgent care.
pt recvd vax 27APR93 & 28APR93 pt exp flu-like sx & a sore arm; the following day exp severe h/a, fever of 103.8, pain in knees, back of legs, in back, & joints; pt presented to ER; noted lost ten pounds;
Chief Complaint: Fall.   .  Diagnosed with COVID yesterday.  COVID-19 NAAT Test Result: Positive.  Dexamethasone 6 mg daily due to tachypnea and O2 requirement. Interestingly no PNA on CXR O2 to keep spo2> 93%
Measles antibody negative; Mumps antibody test negative; Rubella antibody negative; Antibody test negative; This spontaneous report as received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and historical drugs  was not provided.       In January 2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  In February 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, frequency, route of administration,lot number and expiration date were not reported). Concomitant therapies included the sterile diluent.     The patient reported that when she got the blood test done, it did not show any antibodies to both of these vaccines (measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative) therefore, the reporter would like to know if this patient should be revaccinated. The outcome of measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative was unknown.      The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and  varicella virus vaccine live (oka/merck) (VARIVAX) and the reported events was unknown.
I woke up with an extremely sore throat. As the day went on it started to feel better. The second day I woke up with a worse sore throat, headache, sneezing, runny nose, lower back pain, and a fever of 103. I took two ibuprofen to reduce my fever. The next day I took a COVID-19 test at home that came back positive. I talked to the doctor and they gave me PAXLOVID. My symptoms lasted for about 4 days.
When injecting the pre-filled fluzone syringe into the patient's arm, approximately 80% of the liquid squirted from the connection of the barrel to the luer-lock connected needle.  Discussed the incident with the patient and agreed the best course of action would be a second injection. A new prefilled syringe and needle were used at a second injection site 1.5 inches from the original without incidence. Patient has not reported feeling any adverse effects at this time.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (June 2020 miscarriage first few weeks "standard miscarriage") in June 2020 and Raynaud's syndrome on 01-Dec-2014. Concurrent medical conditions included Pregnancy (Pregnancy is current condition). Concomitant products included CARBASALATE CALCIUM (CARBASALAATCALCIUM CARDIO) from 12-Oct-2020 to 20-May-2021 for Anticoagulant therapy, DOCUSATE SODIUM from 12-Jan-2020 to an unknown date for Constipation, DOCOSAHEXAENOIC ACID (PRENATAL DHA) for Multi-vitamins deficiency, CALCIUM from 20-Nov-2020 to an unknown date for Supplementation therapy.    On 24-Mar-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 14-Sep-2020 and the estimated date of delivery was 23-Jun-2021. On 24-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 24-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      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.   No treatment information provided. Lab tests: Ultrasounds - 9 ultrasounds total-  28Oct2020 confirmed pregnancy/03Feb2021Anatomy Scan, Blood work - 22Mar2021: Checked Gall Bladder. Estimated date of conception is Sep 27 2020.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non significant follow up
7 days after injection: Itchy, red rash about 2" x 3" in area of injection.  12 hours after rash sharted: rash increased to 3" x 5" - hot, swollen in tricep area for about 36 hours before swelling and hot feeling started to disipate. Rash has not subsided or changed. Muscle is tender almost to elbow.
Expired daptacel was administer to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 26-Jul-2021 from pharmacist via global medical information (GMI) (Reference number- 00697188) and transmitted to Sanofi on 26-Jul-2021.  This case involves a patient of unknown demographics who was vaccinated with an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, past medical treatment, vaccination, family history and concomitant medications were not reported.  On an unknown date in Jul-2021, the patient received a 0.5 mL (once) [total] dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date 17-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "pharmacist is looking for information regarding precautions on administration of an expired product".   It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event was reported.  Event outcome was unknown.  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 the 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.  There will be no information available on the batch number for this case.
Approximately 8 days after receiving the vaccine in the deltoid area the patient states that she developed a large (3" diameter) red, itchy area at the site of the injection.  This eventually cleared. without incident.  She received her second dose today of lot #EN 6204 in the same arm.
pt recv vax 8OCT96 & 30min p/vax pt exp itching & flushing of upper head, neck & face, red blotches on arms & legs, a small red rash around the eyes;tx w/DPH;pt did not have SOB;
PAIN FROM UPPER LEFT ARM (WHERE I GOT THE FLU SHOT) GO UP THE LEFT SHOULDER. I TOOK ADVIL BUT THE PAIN IS STILL THERE FOR ALMOST A MONTH NOW.
Patient stated that she received the wrong vaccine.  Reports that she was supposed to receive HBV and received HPV instead.  No adverse events reports.
TRANSIENT CEREBRAL ISCHEMIA 3/12/2023  --  HYPOTENSION
Got the first dose of the Moderna vaccine on 02Mar2021 and has not got the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 02Mar2021 and has not got the second dose yet) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa).    On 02-Mar-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 PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 02Mar2021 and has not got the second dose yet). The patient was treated with PARACETAMOL (TYLENOL) in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 02Mar2021 and has not got the second dose yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Heart rate: rapid (High) Rapid heart beat recovered after an hour and a half.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.
1.   severe headaches that are not going away  2.  severe abdominal pain that is not going away 3.  Swelling in legs & belly 4. nausea (but not throwing up) 5. Diarrhea (comes & goes) 6  100.3 temp (today) 7. body itching all over comes & goes
I broke out in a rash and it was diagnosed as shingles. I was given a prescription for steroid pills. The rash was very painful.
Pt presented 7 days early for 2nd . Vaccine given on day 21, instead of day 28. Multiple attempts to contact pt without success.
Bad symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031521A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad symptoms). At the time of the report, VACCINATION COMPLICATION (Bad symptoms) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
12/22/2020: Site sore for 2 days, small lump.  12/29/2020: site began to itch, felt sore again, became erythematous, warm  and raised, approximately 2.5 inches diameter. By the evening erythema spread and darkened, became larger to 3 inches diameter, warmth and swelling continued, mild itching.  12/30/2020: erythema continues, mild warmth, raised area.  No analgesics taken, applied triamcinolone cream 12/29/2020 evening. No significant change in skin noted.
history of aversion needles and lightheadedness, has recurrence of lightheadedness immediately after receiving the vaccination. No itching, shortness of breath, tongue swelling, facial swelling.
PATIENT REPORTED APPROXIMATELY 24 HOURS AFTER RECEIVING VACCINE SHE DEVELOPED REDNESS ABOUT 3 INCHES IN DIAMETER THAT WAS SWOLLEN AND HOT TO THE TOUCH. PATIENT WAS INSTRUCTED TO MONITOR REDNESS AND REPORT BACK IF REDNESS DID NOT IMPROVE OR WORSENED.
herpes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes" (unspecified if ongoing), notes: herpes because she's been suffering for 10 years now. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, he took three shots of the Covid-19 vaccine from Pfizer), for COVID-19 immunization; Bnt162b2 (Dose: 2, he took three shots of the Covid-19 vaccine from Pfizer), for COVID-19 immunization.  The following information was reported: HERPES VIRUS INFECTION (non-serious) with onset 2022, outcome "recovering", described as "herpes".  Additional information: it was reported that the patient was begging Pfizer to make a cure for herpes because she's been suffering for 10 years now. She took three shots of the Covid-19 vaccine from Pfizer and it worked very well for her, she felt good about them.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Pt received monovalent for the third dose instead the new bivalent 6m-4year dose.  No reaction noted. Pt will not repeat third dose with bivalent vaccine per CDC guidelines. PCP notified.
Patient is having swelling  in his left elbow, 2 weeks after getting the vaccine. He thinks the swelling is related to the vaccine and wanted it reported.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Patient complains of redness/ swelling at injection site that radiates down arm. She went to another CVS and was told shot could have been administered too low. I counseled patient that the dose was administered in the correct shot and this was a normal reaction. Counseled to ice and take ibuprofen. Patien will contact md if pain persists
This case was reported by a nurse to a sales representative and described the occurrence of an injection site reaction in a patient who received hepatitis B vaccine recombinant Engerix B. The nurse reported that quite a few patients experienced an injection site reaction following the administration of Engerix B, however, patient identifiers were not provided. On an unspecified date, the patient received a dose of Engerix B (lot AHBVB004BA, dose number not provided). At an unspecified time following the administration of Engerix B, on the same day, the patient experienced an infection site reaction characterized as burning. the outcome of the event was not reported. The nurse stated that the injection site burning occurred with this particular lot of Engerix B. She also reported that this practice, had not had a problem with other prefilled syringes of Engerix B they have used in the past. The nurse considered the injection site burning to possibly be related to vaccination with Engerix B.
Rash, itching left are (same arm as vaccine). spread for 2-3 days then subsided