chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a lot of swelling collarbone up to sides of neck; trouble swallowing; esophageal swelling; voice distortion; This is a spontaneous report from a contactable consumer (reported for herself). A 53-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150/Batch number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 at 12:30 (age at vaccination was 53 years) as dose 2, single for COVID-19 immunization at Temporary Injection Site. The patient's medical history included asthma, antiphospholipid antibodies and raynaud's phenomenon from an unknown date and unknown if ongoing. The patient has known allergies. The concomitant medications included gabapentin, pantoprazole, cetirizine hydrochloride (CETRIZINE), vita and acetylsalicylic acid (ASPRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. The patient previously received Vioxx and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown) via an unspecified route of administration, administered in arm left on 17Mar2021 at 13:00 (age at vaccination was 53 years) as dose 1, single for COVID-19 immunization. On 11Apr2021, the patient experienced a lot of swelling collarbone up to sides of neck, trouble swallowing, esophageal swelling and voice distortion. No treatment was received for the adverse events. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Patient received the vaccination on 23OCT2019. Tested positive for pregnancy on 06NOV2019. LMP 12OCT2019, patient was likely pregnant at the time she received the vaccination. Other than the expected vaccinia lesion, she has experienced no other adverse events.
This non-valid spontaneous report was received from a doctor of pharmacy referring to a multiple unspecified dialysis patients of unknown age and gender. The patients' medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (strength, dose, route, anatomical location, lot # and expiration date were not provided), for hepatitis B protection. On unknown dates, after receiving RECOMBIVAX HB, the patients did not show antibodies (hepatitis b surface antibody negative). It was unknown if the patients received any treatment. At the time of reporting, the outcome of hepatitis b surface antibody negative was unknown. The causal relationship between the event and the RECOMBIVAX HB was not reported.
p/vax pt devel a lesion on rt cheek that looked like a pimple, got a little red, but w/in24hr went away;since then pt devel 1-2 lesions in varying degrees each day;7 lesion were big & obvious w/white center which left a brown patch & scar;
C/O numbness lips and tongue.  Cleared to leave @ 1215  Pt denies SOB or swallowing difficulty.  Discharged at 1232.
the client died yesterday; This is a spontaneous report from a non-contactable other healthcare professional (hcp) from a Pfizer-sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on 08Apr2021.  The cause of death was unknown. It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes.     The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: the client died yesterday
After the patient received the 2nd vaccine dose on 03/17, he became weak and unable to walk. He also experienced headache, nausea, and diarrhea. On 03/18, he was sent to the emergency department where we received a diagnosis of acute on chronic hypoxia related to the 2nd dose of COVID-19 vaccine. He required up to 2 L of O2 during the night time. He was given his regular home medications and Lovenox 40 mg SQ QD for DVT prophylaxis.  On 03/21 he was discharged as his SpO2 improved. His hypoxia returned to his baseline level upon discharge.
Acute Asthma attack requiring ER visit. Received neb treatments x2 to bring O2 saturation into the mid 90's.  Given Prednisone, Tamiflu and Albuterol inhaler at time of discharge.
Mom stated child was fine until 5:30 PM when she noticed infant had broken out in hives all over body and was running a temperature of 102.3. She then immediately called the infant's PCP, who prescribed over the phone TYLENOL and Amoxicillin x 5 days. Mom stated infant's hives cleared in 3 days. No other symptoms reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 11-OCT-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 24-JUN-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This is an administration error report. This client received the J&J vaccine on 03/29/2021 through his place of work from us at the health department. We went back out to this clients place of employment for a vaccine clinic on 07/07/21 and the place of work sent out a text reminding people who signed up for the vaccine clinic and this client responded to the employers text saying "I think I will get Moderna today." The clients employer or the health department did not catch that the client had J&J vaccine on 03/29/2021 until after we gave the Moderna vaccine first dose on 07/07/2021. This error was caught after administering the first dose of Moderna. Client was having symptoms of headache, dizziness and just not feeling well.
A delayed large localized skin reaction beneath the injection site aka delayed cutaneous hypersensitivity. The rash lasted 4 days and was 101.6mm by 98mm at it's largest. It was severely swollen, red, itchy, and painful. I had minor pains down my arm and muscle spasms around the rash. Every time it was touched it made it worse. I treated by washing it in warm water with a mild soap before applying anti-itch cream, took half doses of asprin, wore a compression sleeve to keep it from touching my clothing, and iced it several times every day.
Patient presented to the clinic with father with a red, raised bumps varying in size that were itching. Majority located in a cluster on right proximal posterior arm. Small clusters noted around waist line and on back of bilateral legs.
Sore arm; Slight headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache) 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 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.
because of COVID, have not received 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, because of the shingrix not being available and then COVID, the patient had not been able to receive the second dose of Shingrix, which led to social problem.
3/17/2022- Presents to ED, SOB and R sided chest pain x 1 week. DX Covid + 3 days ago at pre-op for a esophagus dilation procedure and He was treated with Augmentin,  doxycycline and Paxlovid for pneumonia seen on CXR. Chest CT: Mild R lower lobe emboli, Small R effusion and atelectasis. Spo2 89% on RA.  Extensive bronchiolitis. Heparin drip ordered. D-dimer:345. ABG:7.44/41.5/59/28.2/3.7 91% on RA. Admit pulmonary embolism with severe respiratory syndrome s/t Covid. Start IV decadron, Rocephin and azithromycin.  3/18/2022- No c/o cp or SOB. Vitals stable.  3/19/2022- Discharged to home. Eliquis for 6 months. Dexamethasone and azithromycin ordered.
Vasovagal Syncope -- Pt. was moved to a prone position and feet were elevated. Total time of syncope was approximately 10 seconds. Pt.'s position was maintained for about 5 minutes. Pt. was alert and oriented x 3 within 2-3 seconds after return to consciousness. After 5 minutes pt. was raised to semi-Fowlers position and provided a glass of water. BP was checked: 93/65. Semi-Fowlers position was maintained for another 5 minutes, during which time pt. was provided another glass of water and a small snack. Per pt's report that she felt "fine", she was raised to a sitting position. BP was rechecked: 105/65. Pt. stated that she felt she could stand without difficulty and so was assisted off the exam table. She was escorted to the reception area where she remained under observation for another 10 minutes before she left in stable condition.
Got my vaccine and then I actually contracted COVID; Got my vaccine and then I actually contracted COVID; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer stated that, I just have a question. So, I got my vaccine and then I actually contracted COVID (PC Filed conservatively) but I haven't received my second dose. Do you think it would be okay if I did went to receive my second dose, I've been in quarantine for 8 days. The outcome of the events was unknown.
a low grade fever of 99.2, 99.3; rash; got chills and went into shaking; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), CHILLS (got chills and went into shaking) and PYREXIA (a low grade fever of 99.2, 99.3) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient is a breast cancer survivor and has been "8 years out now".).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced RASH (rash) and CHILLS (got chills and went into shaking). On 10-Feb-2021, the patient experienced PYREXIA (a low grade fever of 99.2, 99.3). The patient was treated with PARACETAMOL (TYLENOL) on 08-Feb-2021 for Pyrexia, at an unspecified dose and frequency. On 09-Feb-2021, CHILLS (got chills and went into shaking) had resolved. At the time of the report, RASH (rash) and PYREXIA (a low grade fever of 99.2, 99.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.13 (High) Fever. On 09-Feb-2021, Body temperature: 99.2 (High) Low grade fever of 99.2. On 10-Feb-2021, Body temperature: 99.3 (High) Low grade fever of 99.3. On 09-Apr-2021, Carcinoembryonic antigen: 3.7 (High) CEA test is 3.7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported   This case was linked to MOD-2021-080882 (Patient Link).
was vaccinated and still got it/ suspected vaccination failure; still got it. Brakout was triggered; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still got shingles. The reporter stated that the breakout was triggered. So please educate yourself on the triggers and take better care of yourself. No need for vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Mother refers that on the night of Thursday, January 23, 2020 she noticed that the minor started complaining of aches and itchiness on the area where the vaccine was administrated. The area was red, warm to touch and had some edema.
Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression symptoms; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 39-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in arm left on 17Mar2021 08:30 (at the age of 39-year-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Patient's relevant medical history noted dairy allergy and covid-19. Concomitant medication was not reported. Prior to vaccination, the patient was diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Ew0162) via an unspecified route of administration, administered in arm left on 14Apr2021 as dose 2, single within four weeks of vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 13:00, patient experienced severe menstrual bleeding and cramps; very significant change in mood and depression symptoms when patient had never had an issue before. The patient did not receive any treatment for adverse events. The patient did not seek medical attention because she felt embarrassed and was not confident in her doctor or insurance. Outcome of the events was recovering.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101422825 same reporter/drug, different patients.;US-PFIZER INC-202101422824 same reporter/drug, different patients.;US-PFIZER INC-202101422823 same reporter/drug, different patients.;US-PFIZER INC-202101422826 same reporter/drug, different patients.
This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Feverish, chills, severe myalgia, severe headache, nausea , fatigue
Patient experienced pain all over her body within 15 minutes after receiving the vaccine. She was unsteady and unsure if she could drive home.
1St dose of Shingrix was administered in 2019 and never receied 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. The patient never received the 2nd dose of Shingrix, which led to incomplete course of vaccination. No reactions were reported. The reporter did not consent to follow-up.
After 30 minutes in waiting area, pt c/o headache.  BP 170/108 P 70.  Pt taken to Observation area to lay down.  Pt denies history of hypertension.  BP 162/90.  Pt left w/o assistance.  Instructed to see Primary Dr about BP.
606 doses were given after expiration date; Expired vaccine was placed in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was placed in refrigerator) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was placed in refrigerator). On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was placed in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP said that 606 doses were given after expiration date. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  On 29-Oct-2021, vaccine was placed in refrigerator. Patient had no adverse events and also reported that there were no temperature excursion.  Patient was given booster dose.
Approximately 12 hours after the injection, I developed significant lethargy and chills. I had to leave work about 1 PM as I could not function at work. My teeth were chattering, although I did not feel febrile nor take my body temperature. I slept for about 2 hours when I arrived at home, leaving from work. My left arm was mildly sore and I developed a mild fine pinpoint maculopapular rash about the size of a half-dollar. The next day I felt significantly improved, although not 100%. I was able to return to work the following day. The total duration of this adverse effect, until completely resolved, as 2.5 - 3 days.
Left shoulder, neck and left upper chest wall discomfort upon awaking in afternoon and which became worse when going to work the night shift later on same day as vaccine.
The following week after the vaccine I noticed shortness of breath and sort of like an asthma attack. I was having jaw pain. That continued through 8/14-8/16 it was less but still there. I had intermittent coughing. I was tested for covid twice and both negative. I contacted my primary care office, my advair dosage was increased and my nebulizer has been used as needed. I have never had an asthma attack in the summer before.
Itching and hives on chest and abdomen: developed the day after receiving the shot and is spreading in distribution, but severity of rash is improving. I am giving her Benadryl for sx's and recommending against any further vaccinations with the anthrax vaccine in the future. She reports no other allergies to foods, drugs or latex that she is aware of.  I have contradictory recommendations from the patient info pamphlet (hives considered serious reaction and contraindication to further vacc) and from the vaccine packaging insert (anaphylactic or anaphylactic like reactions are contraindications). Localized swelling, warmth and pain: common reaction, but the warmth concerns me a little so she agreed to follow up in the morning for reevaluation. I rx'd ibuprofen for these sx's for now. Skin is otherwise intact, non-fluctuant. I expect it to improve quickly.
A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I got a round red spot on my arm at the injection site. It continued to spread and get bigger
Information has been received from a pharmacist referring to the patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On 07-MAY-2016 the patients were administered doses of improperly stored ZOSTAVAX (0.65 ml, lot# M0001745, expiration date 07-APR-2017) subcutaneously. No adverse effects were reported. On 01-JUL-2016, the reporter reported another temperature excursion of ZOSTAVAX (lot# M001745, expiration date 07-APR-2017) after the previous one. The vaccines were improperly stored on 30.6 degree Fahrenheit for 14 hours. No doses were administered after this excursion. Additional information has been requested.