chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number Bg92z, expiry date 04-JUL-2022) for prophylaxis.   On 25-APR-2023, the patient received Engerix B. On 25-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2023 The Pharmacy technician reported that an expired dose of Engerix-B was administered on the day of reporting.  The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow up. The patient was administered with expired vaccine which led to Expired vaccine used.
On friday night 4/9, pt started to have swelling and redness on arm with soreness. pt presented today with same symptom with warm to touch. Pt marked arm with sharpie to determine if spreading was occurring. in about 3 hours time, the redness spread about 3/4" out of the sharpie marked area with further discomfort felt by they patient. the pt will see medical evaluation and further care if needed.
Patient appeared to be dozing off then waking up - BP + Pulse ox tested OK per Nursing home. I had them call EMS As a precaution.
After receiving the vaccine, had stomach pain. The pain is going down to elbows in both arms., across shoulders and upper back. Still has a big lump in arm. White blood count stays up since having the vaccine. Getting more pain from it all the time. Did not go the hospital.
decrease in fetal movements; body aches; decrease in fetal movements; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is the mother report.  A 30-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 22Mar2021 at 5:30, the patient experienced decrease in fetal movements, body aches and had a slight headache. The mother reported she became pregnant while taking bnt162b2. The mother was 37 Weeks pregnant at the onset of the event. The mother was due to deliver on 10Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326788 same report/drug, mother/child case
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The reporter was calling for medical information and availability of SHINGRIX (refer case US2018151043). While discussing this reporter mentioned her friend experienced flu-like symptoms and was really ill. The reporter was not asked further probing details since she just mentioned that in conversation and that was not the reason for her calling. This case has been linked to case US2018GSK157011, reported by the same reporter.
Moderna vaccine expired on 03/11/2023 and accidentally given on 03/13/23
I was positive for COVID-19 on 26DEC2022, I had a cough sore throat and nasal congestion like I was having a cold. Plus I was very tired all the time, I spoke to the nurse practitioner she gave me PAXLOVID. But I never took it I started feeling better 24 hours later.
Admitted for COVID pna. Fully vaccinated. Treated with O2/Bipap, cefepime, azithro, steroids, lovenox, zinc, vit-c and d, singulair, toci. Progress to intubation/vent support. Added remdesivir. Condition continued to decline. Pt coded 11/20 and expired.
Patient told us at time of Injection that he had never had a COVID Vaccine before, this was his first dose.  He was administered J&J - we went to bill the vaccine, and his insurance said it was too soon for further doses - we looked him up in the state Registry and he had received a Pfizer vaccine on 7/8/2022 at a pharmacy.
Developed pain, soreness, swelling that afternoon. Mom states thigh area appeared to have welts in evening & may have slight fever. Con't w/pain, swelling & tenderness in whole thigh. Seen by MD x-ray done. Still fever 100-101.
The vaccine administered on 10/5/23 was Comirnaty 12+ (Covid) 23-24 SDV, 0.3 ML, at the same time with Fulcevax PF INJ 2023-24 0.5 ML.  Patient had a big red and hot spot on her upper arm at the site of the injection, about 3 inches in diameter.  She  started feeling ill on 10/11/23, with nausea, fever, sore throat.  Fever subsided on 10/13/23, but sore throat and congestion continued, which led to coughing.  On Monday, 10/16/23, visited a Urgent Care Center to get some relief for coughing.  Patient was found to have fluctuating blood oxygen saturation, varying from 83%-84% to 90%-92%, and was sent to the ER.  All the tests came back negative, and she spent 2 days in the hospital under 24/7 monitorization for her heart and lungs, with no apparent cause for low oxygenation.  Started on 2L of oxygen on 10/16/23, raised to 6L on 10/17/23, when the doctor expressed a high risk of ARDS, and lowered again to 2L on 10/18/23.  Was discharged from the hospital on 10/18/23 with a diagnosis of acute hypoxemia respiratory failure and ordered to be on oxygen support 24/7.  Follow-up visit with primary care Dr. on 10/23/23 showed all signs of ARDS were gone, and breathing was restored.  We are waiting to follow-up with a pulmonologist on 11/8/23 for further reviews/test
Patient was given the shot and after he got up to look on his sister getting shot, he stepped away from vaccination area and fell on floor. Dad picked him up and he was stiff per dad. he started crying and i checked his breathing which was rapid i called 911 after consulting with mom. I grabbed epipen when he was on the floor but he was breathing so i did not adminster it, Mom says he has not had a flu shot since he was a baby. EMT came over he had conversation with parents and checked him out, parents declined to go to ER with child.
not feeling well; chills; 102 Fahrenheit fever; sore arm; very very very cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING COLD (very very very cold), MALAISE (not feeling well), CHILLS (chills) and PYREXIA (102 Fahrenheit fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING COLD (very very very cold), CHILLS (chills) and PYREXIA (102 Fahrenheit fever). On 17-Mar-2021, the patient experienced MALAISE (not feeling well). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING COLD (very very very cold), MALAISE (not feeling well), CHILLS (chills) and PYREXIA (102 Fahrenheit fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Pyrexia: 102 (High) 102.         Concomitant product use was not provided by the reporter.   Treatment information was not provided
Generalized itching and irritated sensation of skin across face, neck and shoulder. Persistent skin irritation and pruritus along head and neck, which was also associated with redness/ flushing of face and puffiness of his cheeks. Symptoms began approximately 3-4 hours after injection.
large (3" diameter) rash around inj site;mild soreness; (no itching); rash appeared 24 hrs p/vax, disappeared p/ 4 days
Swollen for about 4 days; pain and redness in the site; pain and redness in the site; It feels a little hard but it's just blood in that area; This is a spontaneous report from a contactable Nurse.  A 19-year-old female nurse reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), on 07Jan2021 in the left arm at single dose for COVID-19 immunization. The patient had not any medical history and did not receive any concomitant drugs.  The nurse reported that she had got this shot in her left arm and it is not too swollen but it has been swollen for about 4 days and there is still pain and redness in the site as well. It feels a little hard but it's just blood in that area. The nurse took a Tylenol (LOT# EK9231) or 2, but it didn't really do much. At the time of reporting the patient had not recovered.   Information about lot/batch number has been requested.
Patient is 76 Years Old Female.  Here for f/u of rash after flu vaccination, now the rash is subsiding. No cp, no sob, no n/v.
I have had migrane/ headaches since my second Pfizer dose. Followed with swollen lymph nodes on breast and arm pain for 3 weeks. I have also had insomnia, hot flashes, and hand nerves tingles.  I have had nausea and loss of appetteti. I'm now having to seek medical help for side effects and costing me alot of money.
This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (got COVID-19 from a new strain even after being vaccinated) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID-19 from a new strain even after being vaccinated). At the time of the report, COVID-19 (got COVID-19 from a new strain even after being vaccinated) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. It was reported that a woman that the reporter knew and the husband of that woman (both were vaccinated), along with other people who went to a graduation, got COVID from a different strain than the previous ones. Reporter only knew that the woman and the husband were older adults. Treatment medications were not provided. Company comment: This spontaneous case concerns a male patient of unspecified age with no reported medical history who experienced the unexpected non-serious adverse event of special interest suspected COVID-19 (described as got COVID-19 from a new strain even after being vaccinated) which occurred at an unknown interval after receiving the a dose of mRNA1273. The reporter in this case stated that the patient got COVID-19 from a different strain although the patient was vaccinated. Latency cannot be established since vaccination details were not mentioned. Further details regarding the clinical course, additional diagnostic or imaging test done, concomitant medications and treatment were not provided. The ongoing pandemic of COVID-19 remain as a confounder in this case. Information regarding other COVID-19 vaccine were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-630495 (E2B Linked Report). Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no reported medical history who experienced the unexpected non-serious adverse event of special interest suspected COVID-19 (described as got COVID-19 from a new strain even after being vaccinated) which occurred at an unknown interval after receiving the a dose of mRNA1273. The reporter in this case stated that the patient got COVID-19 from a different strain although the patient was vaccinated. Latency cannot be established since vaccination details were not mentioned. Further details regarding the clinical course, additional diagnostic or imaging test done, concomitant medications and treatment were not provided. The ongoing pandemic of COVID-19 remain as a confounder in this case. Information regarding other COVID-19 vaccine were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-630495: Wife case.
she got a rash; on her left leg there were some of the red spots that were sores that she has suddenly inflamed up; one spot that is still itchy; jillion tiny red dots on her arm, the arm she got the shot in; could have been an allergy; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6200 and expiry date not reported), via an unspecified route of administration, on 24Feb2021 (at the age of 86-year-old), as dose 2, single, for COVID-19 immunisation. Patient had no medical history. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318 and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. It was reported that, on 26Feb2021, 2 days after the vaccine she got a rash, it was like a jillion tiny red dots on her arm, the arm she got the shot in, and it completely covered her arm with it and on her left leg there were some of the red spots that were sores that had suddenly inflamed up. It was reported that, they resolved before the vaccine, but they reared their ugly head and were inflamed again then the next day they began to subside (as reported). The reporter clarified this happened after the second dose. It was resolved except for one spot that was still itchy other than that, all the jillion little dots were gone. She was a little concerned about that it could have been an allergy and did not know if she should have had her take something for it like Benadryl. The outcome for rash was recovered and the outcome for one spot that was itchy was not recovered and the outcome for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Headache; raised rash - red 2" x 3+" - itching, hot; fever off and on since before sunup, aches. The arm which got the shingles vaccine has the large raised rash. Later developed pruritus in ears, eyes, throat.
Throat: sore, red, and swollen; looks like cobblestone throat Nose: running and sneezing Headache Congestion Fatigue
Within 30 -40 mins of administration of Pfizer EK9231 started developing slight numbness on right side of the face, mainly right cheek and under right eye. Took Ibuprofen 400mg still was feeling the numbness and took another Ibuprofen 200mg  around 1400 for the still felt slight numbness.  Took 25 mg of Benadryl around 1700 because I still was feeling the slight numbness on right side of face. In the morning was not noting any improvement in the facial numbness and was feeling that the cheek muscles were tighter on the right side and causing subtle facial asymmetry.  I got worried and went to the ED. I was assessed,  diagnosed with facial paresthesia.  I was offered an MRI, I declined as I did not feel that I needed it at the time. Provider prescribed 40 mg of prednisone daily for 5 days, valacyclovir 1000mg  3 times a day for 7 days. After starting prednisone facial muscle tightness I was feeling improved, still felt slight numbness more so in the mornings the next 2 days. I took the full course of prednisone, I am no longer feeling the facial symptoms. I stopped taking valacyclovir on day 3, since I felt that the prednisone was what is helping and it was harder to evenly take it 3 times a day.
No adverse reactions noted at this time. Patient received first dose of Moderna and was previously vaccinated with both doses of Pfizer vaccine.
the night of the 2nd day, and during the 3rd day I got vicious headaches; I had a heavy nosebleed which left me extremely exhausted for 2 days; I had a heavy nosebleed which left me extremely exhausted for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 17:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included alopecia areata. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included malus spp. vinegar extract (APPLE CIDER VINEGAR) for unknown indication and ethinylestradiol/levonorgestrel (ALTAVERA) for birth control; both from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021, the patient underwent COVID test (Nasal swab) and the result was Negative. On 23Jan2021, the patient underwent COVID test (Nasal swab) and the result was Negative. On 10Feb2021, the patient underwent COVID test (Nasal swab) and the result was Negative. On 14Apr2021 at 07:15, the patient experienced heavy nosebleed which left the patient extremely exhausted for 2 days. On 16Apr2021, the night of the 2nd day, and during the 3rd day, the patient experienced vicious headaches and the 3rd day, the patient started feeling better. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely exhausted for 2 days was recovered on 16Apr2021 and of the events heavy nosebleed and vicious headaches was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy to NSAIDs" (unspecified if ongoing), notes: Known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144177 Same patient, different product, different event;
The pt's mom picked the pt up from daycare. Arm swelling, warm to the touch and was acting unusual noted.
Patient received the Pfizer covid vaccine, and had no symptoms but a sore arm.; This is a spontaneous report from a contactable consumer. A contactable consumer reported different events for 5 patients. This is 4 of 5 reports. This consumer reported for a male patient (reporter's brother) that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via unspecified route of administration on an unspecified date in 2021 as dose number unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer covid vaccine, and had no symptoms but a sore arm on an unspecified date. The reporter stated that the patient had received the Pfizer covid vaccine within the last two months. The outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested.
2 days p/vax pt exp dizziness & lightheadedness when rolling over in bed;pt was unable to focus on clock, which appeared to be spinning;pt exp these sx on arising for the next 3 days;once out of bed, had no sx;
J18.9 - Left upper lobe pneumonia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia
Patient complained of itchy rash on legs/arms for 3-4 days. She presented 2 days after the shot with raised hives on legs, feet and hands. She was placed on Medrol dose pack, Atarax, 100 1 qd
Abdominal tightness with lower chest with tightness briefly lower chest that resolved with juice. Pt did not eat before coming out to vaccination center with pt feeling better on DC. Vitals stable
Father of the patient called office. Patient slept several hours post vaccine. Awoke with severe headache and vomiting. TYLENOL no help for headache. Instructed to give sips of water every 5 minutes for 30 minutes and then call back. Patient did improve and was recovered later that evening.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/14/21, 3/6/2021, and 9/19/2021. Covid + 1/8/22, Presented to ED 1/13/22 c/o SOB. Placed on HFNC in ED, admitted for acute hypoxemic respiratory failure due to Covid PNA transferred to ICU 1/14/22 due to O2 needs. Intubated 1/15/21. Developed staph epi bacteremia and fungemia during admission. Treated with remdesivir, baricitnib,zosyn, tobramycin, vancomycin, ambisome, micafungin, corticosteroids. Extubated on 1/25/22 leading to respiratory distress but pt declined reintubation. Status changed to DNR on 1/26/22. Expired on 1/27/22.
TWO MINUTES AFTER GIVING VACCINE PATIENT HAD A VASOVAGAL RESPONSE
30APR92 pt recvd 1st HIB vax & 1 hr later exp lower abd discomfort & diarrhea; 4JUN92 recvd 2nd HIB vax abdominal cramping recurred, more severe w/more diarrhea; connected sx w/shots p/2nd episode;