chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 036A21A, 018B21A and 070H21A) for COVID-19 prophylaxis. The patient had not diagnosed or tested positive for COVID-19. On 05-Mar-2021 at 12:06 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021 at 3:21 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Dec-2021 at 4:34 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:34 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). No concomitant medications was reported. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The used vials were placed in the refrigerator on the same day of administration 07-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications was reported.
Numbness in the extremities and joints of my hands and feet and pain in back. Styled callus formation on the left hand, uncontrolled high blood pressure.
A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 30-Dec-2013. It was reported that the patient had expired FLUMIST QUADRIVALENT administered which started on 30-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Patient states night of 9/25/07 starting feeling ill pain in joints, feeling of pressure in legs, exhaustion, hot flashed, moist skin and hard to think f/u with 9/26/07.
PATIENT EXPERIENCED HIVES/RASH AROUND SHOULDER AND DOWN FOREARM 5 DAYS AFTER RECEIVING SECOND DOSE OF VACCINATION.
Low grade fever (Not Measured) after 2nd dose; Body aches after 2nd dose; Chills after 2nd dose\chills for 1 day.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever (Not Measured) after 2nd dose), MYALGIA (Body aches after 2nd dose) and CHILLS (Chills after 2nd dose\chills for 1 day.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037K20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included LOSARTAN for Blood pressure management.On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced PYREXIA (Low grade fever (Not Measured) after 2nd dose), MYALGIA (Body aches after 2nd dose) and CHILLS (Chills after 2nd dose\chills for 1 day.). On 24-Feb-2021, PYREXIA (Low grade fever (Not Measured) after 2nd dose), MYALGIA (Body aches after 2nd dose) and CHILLS (Chills after 2nd dose\chills for 1 day.) had resolved. No Treatment information was reported.This case was linked to MOD-2021-383015 (Patient Link).
Noticed 3 days after second injection; low grade temp...then followed by sore throat.....And 2-3 weeks later change in speech pattern. Initially attributed to seasonal allergies; but have seen PCP, Endocrinologist, and Neurologist with DX: Dysarthria. The s/s have precipitated for 4 months..
Patient called pharmacy to report having a slight fever (100.2) the night she received the vaccine (9/25/19) and injection site swelling as well as redness of her entire arm from shoulder down to elbow that presented 9/25/19 in the left arm (the arm in which she received Shingrix). The redness got progressively worse that day, and has subsided and appears to be resolving today (9/27).  She works in a facility with a nurse available who evaluated her and advised her to contact us so that we could report reaction.  She'd had several shots before but never had a reaction.  We called her PCP to advise as well, though the patient didn't think that was necessary.
The shot was given on 10/19/05. In the afternoon he became ill  that same day. Fever ran up very high, loss his appetite, he slept constantly, he missed 4 days out of school, there was vomiting. He was fine when I took him in for the shot, after 4 days I took him back to the doctor his condition was diagnosed as pneumonia.
The patient developed unspecified swelling at the injection site; This spontaneous report was received from a nurse referring to a 42-year-old female patient. Her pertinent medical history included hypertension (considered concurrent condition). On an unspecified time in the past, the patient received lisinopril (LISlNOPRlL) (considered an historical drug), to which she developed an unspecified drug reaction (also considered a concurrent conditions) (captured on MARRS # 1909USA005728). The patient had no concomitant medications.  On 10-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular route for prophylaxis (strength and dose were not provided; lot number S021740 has been verified to be a valid number; expiration date 25-MAR-2021, and upon internal validation established as the same date).         On 12-SEP-2019, the patient developed unspecified swelling at the injection site (injection site swelling). The outcome of injection site swelling was reported as not recovered. The patient stated that she sought for medical attention and was treated by the physician with diphenhydramine (BENADRYL) 25 milligram (mg) tablet and Acetaminophen (TYLENOL) (unspecified dose). Laboratory diagnostics or studies were not performed.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the injection site swelling was not reported.  This is one of two same patient cases.; Sender's Comments:  US-009507513-1909USA005728:
low grade fever, chilled within a couple of hours. Then went home early. Over weekend became achey and didn't feel well. Saw personal MD on 10/26, he called it Hyperimmune Response to the vaccine. Unknown if patient has recovered
Donor was due for her second vaccination and disclosed to nurse that she experienced moderate abdominal cramping for 1.5 hours, sharp chest pain for 1-2 minutes and minor yellow vision for one minute. All symptoms resolved and did not reoccur until 2 days later.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 12-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient presented with mom to the clinic for her booster covid vaccine.   No adverse reaction at this time.  Mom was called and notified of this error in administration.
LETHARGIC; ARM PAIN/SORE ARM; FEVER; HURT WHEN WAS INJECTED; FELT HAVING FLU; FELT HEAVINESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt having flu. On APR-2021, the subject experienced felt heaviness. Laboratory data included: Body temperature (NR: not provided) 99.5 F, 98 F. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced arm pain/sore arm. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced hurt when was injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and fever on 11-APR-2021, had not recovered from arm pain/sore arm, and the outcome of felt having flu, felt heaviness and hurt when was injected was not reported. This report was non-serious.
wiped out; low grade fever ranging from 100-100.5°F; she had left arm injection site pain; chills; knee and ankle pain; she felt wiped out the next day; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expiry Date: unknown), via unknown route of administration on 10Feb2021, as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 in the month of Aug2020 (minus loss of taste and smell). Concomitant medications were not reported. After vaccination, on an unspecified date, the patient had experienced left arm injection site pain, chills, low grade fever ranging from 100-100.5'F, knee and ankle pain, and she felt wiped out the next day. In Aug2020 she has tested positive for COVID antibodies and she has been donating convalescent plasma. She had underwent lab test which included SARS-CoV-2 antibody test: positive in Aug2020, body temperature: low grade fever ranging from 100-100.5'F on an unspecified date. The outcome of events was unknown.   Information about lot/batch no has been requested.  Follow-up attempts are completed. No further information is expected.
Red,pain,swelling and warm at injection site for 7 days. Body aches for 3 days following the day of injection. Rash developing on 4/16.  Welts started on both arms the night of the 16th and continued to get worse through the day 4/17. Welts started to improve at about the 24 hours mark. Itching and redness still persistent on extremities, inside the ears, and head. Took 200mg total of benadryl first 12 hours. Other antihistamines as well.   Continuing to take benadryl every 4 hrs of 50-75mg. Message out to my PCP, but no response yet.
Dose administered from a not fully thawed vial; A spontaneous report was received from a nurse, concerning a 67 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in dose administered from a not fully thawed vial (incorrect dose administered).   The patient's medical history was not reported. Concomitant medication reported was simvastatin.  On 28 Jan 2021, prior to the onset of the event, the patient received female first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  It was reported that the vials were stored in the refrigerator. After that, one of the vials was punctured and a dose was administered to a patient. Also, syringes were pre-filled with doses of the same vial (vials still contain some doses). The healthcare professional visually observed the vials and noticed that the suspension was not fully thawed to the patient on 28 Jan 2021. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the even, dose administered from a not fully thawed vial was recovered on 28 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Employee woke up with welts at injection site the following day after vaccine administration.  Within several hours the rash spread to her elbow as well as her chest.  She developed a fever of up to 101.5 for the next three days.  She was advised by her physician to take OTC Benadryl and given a prescription for 2 antibiotics (Septra DS and Keflex).  Symptoms resolved by Sunday 9/19/2021
Pt received vaccine BUD. Vaccine expired 7/7/22, given to patient on 7/9/22
Pt was administered H1N1 Flu Mist instead of injection at parents' request.  Pt was less than 2 years old at time of administration.  No adverse reaction occured, no tx administered.
15 minutes after injection, employee felt hives welt on injection site, with intense itching. Hives did not spread systemically.  Later she started vomiting with diarrhea prn over 3 days.
At that time my PSA was 0.26 this was 8Oct. As of 01Apr22 my PSA is 0.11. I got my booster on 08Oct. Your Covid vaccine may be responsible; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "prostate cancer", start date: 2009 (unspecified if ongoing), notes: i have been fighting prostate cancer since 2009; "my cancer metastasized to my bones", start date: 2013 (unspecified if ongoing), notes: Anyway in 2013 my cancer metastasized to my bones. Concomitant medication(s) included: LYNPARZA, start date: Dec2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN DECREASED (non-serious) with onset 01Apr2022, outcome "unknown", described as "At that time my PSA was 0.26 this was 8Oct. As of 01Apr22 my PSA is 0.11. I got my booster on 08Oct. Your Covid vaccine may be responsible". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Patient had to many treatments to count on all fingers. Anyway, in 2013 patient cancer metastasized to bones. Patient cancer was from 11Sep was a first responder. Anyway, cancer was NEVER IN REMISSION. Last Dec, Patient was taking Linprazza and various other drugs. Patient's oncologist took off the linprazza. At that time patient's PSA was 0.26 this was 08Oct. As of 01Apr22 patient's PSA was 0.11. Patient got booster on 8Oct and reported that Covid vaccine may be responsible.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Have 38.6 degree C; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have 38.6 degree C) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced PYREXIA (Have 38.6 degree C). At the time of the report, PYREXIA (Have 38.6 degree C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Body temperature: 38.6 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported. No concomitant medication information was reported.  The reporter reported that, after taking vaccination on 06Jun2021, the patient had 38.6 degree C.
Chills, body ache, sore arm.  LOSS of BALANCE.  Fell three times on way to bathroom.  Seems related to sudden head movement.  Lingering as of AM 28 March.  Only sore arm with 1st dose.
Sick with the Flu. Sore throat, running nose, slight fever, chills, cough pains in all joints for 5 days now. (11/3)
Chills; fever; with the bivalent I had a little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (Dose 1, Dose 2), for COVID-19 immunization, reaction(s): "Chills", "Fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "with the bivalent I had a little sore arm".  Additional information: It was reported that, patient got the new omicron booster, patient had all regular and all boosters Most had chills fever But with the bivalent, patient had a little sore arm Maybe tired Did it work.  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.
two years ago got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-DEC-2020.  This case involves a patient of unknown age and gender who reported that two years ago got the flu (Influenza), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that the patient got a flu shot every year and two years ago got the flu !! Just one bad day... so thankful for the flu shot (Influenza).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
ACUTE RESPIRATORY FAILURE 1/12/2022 ATRIAL FIBRILLATION, UNSPECIFIED HYPOXIA 1/14/2022 ATRIAL FIBRILLATION, UNSPECIFIED
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (unknown drug).   On 15-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Treatment details was not reported by the reporter.  It was reported that patient has taken Pfizer on 19 May 2022 for the treatment of COVID-19 and experienced the event- Metallic taste after taking the first dose ,on 19 May 2022 12:00  and the outcome was unknown.  The device date was reported as 20-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the second dose of mRNA-1273 vaccine. It was reported that patient has taken Pfizer on 19 May 2022 for the treatment of COVID-19 and experienced Metallic taste after taking the first dose of Pfizer. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the second dose mRNA-1273 vaccine. It was reported that patient has taken Pfizer on 19 May 2022 for the treatment of COVID-19 and experienced Metallic taste after taking the first dose of Pfizer. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Left thigh with a 3mm erythematous area of induration, a light 2cm circumferential area as well, slightly tender; immune reaction vs. cellulitis. Treated with KEFLEX.
On 4/27/2021, I received my first dose of the Pfizer vaccine. I almost immediately noticed that there was the sound of blood rushing in my ears. I also had some of the usual side effects, such as the queasiness, fatigue, and sore muscles. About 10 days after the vaccination, I developed moderate to severe tinnitus. It was very distressing, and it was so loud that I had trouble sleeping. I had to go to an otolaryngologist, who told me that many other people were also experiencing tinnitus after receiving mRNA vaccines. He said that the tinnitus would probably get better after several months, but there was nothing that could be done for it. Since the mRNA vaccine was the apparent source of the tinnitus, I was advised by my doctor to get Janssen/Johnson and Johnson vaccines afterwards. Since then, I have received two of the J&J vaccines.  I continue to have tinnitus and pulsatile tinnitus at the time of this writing, but they are slightly less severe now than they were in the beginning. They are in the moderate to high moderate range currently. It is possible that the Johnson and Johnson vaccines have contributed to them to some extent, but not nearly as much as the Pfizer. Since it has already been a year since I developed this issue, I'm worried that I may have permanent damage. I'm a scientist, and I feel absolutely certain that the Pfizer vaccine is the culprit.