chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sounding like she has a case of Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix .5 ml. In January 2020, less than 3 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but it could be 72 or 73 years old. The patient received vaccine in left deltoid. The patient received 1st dose of Shingrix vaccine. As per reporter the patient had possible Shingles at the time of reporting. The reporter was concerned whether that was just a coincidence or there was increased risk for triggering an outbreak with the immunization. The reporter consented to follow up.
This case was reported by a physician and described a subject of unspecified age and gender who had a decreased response to immunization with hepatitis B vaccine recombinant Engerix B. The physician reported that an unspecified number of patients experienced a decrease response to Engerix B, however, no subject identifies were provided. Medical history included human immunodeficiency virus infection. On an unspecified date before June 29 2005, the subject received a dose of Engerix B (dose number not provided). At an unspecified time after vaccination with Engerix B on an unspecified date on or before 6/29/2005, a hepatitis B surface antibody titer indicated that the subject had a decreased response to immunization with Engerix B. The physician reported that, my HIV patients have a poorer response rate to Engerix B then my immuno competent patients.
Prior to receiving the J & J vaccine, I was at the end of a failed IUI (fertility treatment).   My HCG was low and very slow rising so my Doctor had me stop my progesterone medication (Crinone Gel and Progesterone In Oil).   My HCG levels were: 3/24/2021 15.73 mIU/mL 3/26/2021 22.27  mIU/mL **STOPPED MEDICATION 3/29/2021 11.51  mIU/mL Had my period 4/1/2021 RECIEVED VACCINE 4/5/2021 5.93  mIU/mL 4/12/2021 63.07  mIU/mL 4/13/2021 116.37  mIU/mL * Ultrasound showed no abnormalities/anything of concern  4/14/2021 170.09  mIU/mL * Ultrasound showed no abnormalities/anything of concern 4/14/2021 Methotrexate Injection  4/16/2021 282.66  mIU/mL 4/20/2021 281.53  mIU/mL 4/20/2021 Methotrexate Injection
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, more than 2 months before the 2nd dose). On 2nd September 2018, the patient received the 2nd dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness and back pain. On 3rd September 2018, the patient experienced unable to walk. On an unknown date, the outcome of the fatigue, spasms, walking difficulty, sleeplessness and back pain were not recovered/not resolved and the outcome of the injection site erythema and chills were recovered/resolved and the outcome of the unable to walk was recovering/resolving. It was unknown if the reporter considered the fatigue, spasms, walking difficulty, injection site erythema, chills, sleeplessness, back pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: This adverse event report was collected directly from the patient. The patient had no history of having back pain. The patient received SHINGRIX on the left arm. On the same day of vaccination, the patient started to develop the symptoms. The patient experienced fatigue, back pain, spasms in the back. The patient clarified that the back pain and spasms in the back are on the same side of the body where he received the SHINGRIX. The patient had difficulty walking due to the SHINGRIX. The patient's side effects were worse than what his wife experienced. The back pain was so severe that he was unable to walk on Monday or Tuesday. He could barely walk with the assistance of a walker on date of reporting. The patient could not walk a long distance either, he immediately had back pain. The patient could not sleep because of the muscle spasms in the back. He had severe cramping in his hip and last night he had leg cramps (4 days after vaccination). The patient stated that, all the symptoms happened on the left side where he got the vaccine. He also had a huge red circle at the injection site. The patient also experienced chills. He recovered from these two symptoms on an unknown date. The patient was upset because he had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient had been prescribed a muscle relaxer and that did not help at all. This is 1 of 4 cases, reported by the same reporter.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 12-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1536 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
10/1/05 onset swelling R face with tenderness. Exam showed mild swelling from pre auricular area to undermath mandibular rim right face, associated and mild tenderness, induration. No redness neck nl. Lab: WBC 10.2, Hgb 11.3, ESR 24, strip neg. No treatment. Had received MMR 9/2/05.
Temp has been up & down every day, itching on the lower forearm & back; feel OK
Squeezing her chest; Really bad headache; Hurting to breath/can't take a deep breath without it hurting; Headache which turned to migraine; Everything aches to touch, move; nauseated; Vomiting; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hurting to breath/can't take a deep breath without it hurting), CHEST DISCOMFORT (Squeezing her chest), MIGRAINE (Headache which turned to migraine), PAIN IN EXTREMITY (Soreness in arm) and MYALGIA (Everything aches to touch, move) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Heart disorder.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 10-Sep-2021, the patient experienced DYSPNOEA (Hurting to breath/can't take a deep breath without it hurting), MIGRAINE (Headache which turned to migraine), MYALGIA (Everything aches to touch, move), NAUSEA (nauseated) and VOMITING (Vomiting). On 11-Sep-2021, the patient experienced CHEST DISCOMFORT (Squeezing her chest) and HEADACHE (Really bad headache). At the time of the report, DYSPNOEA (Hurting to breath/can't take a deep breath without it hurting), CHEST DISCOMFORT (Squeezing her chest), MIGRAINE (Headache which turned to migraine), PAIN IN EXTREMITY (Soreness in arm), MYALGIA (Everything aches to touch, move), NAUSEA (nauseated), VOMITING (Vomiting) and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.  Treatment drugs :Cold ,Flu , Acetaminophen
swelling at the back of my mouth and top of my thoart lasted abot ten minutes saw the Dr on monday was okay at that time
other people with the same problem in her support group,tinnitus,swoshing sound in ear; hardly sleep; she is freaking out really bad; can barely hear out of the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (other people with the same problem in her support group,tinnitus,swoshing sound in ear), INSOMNIA (hardly sleep), FEELING ABNORMAL (she is freaking out really bad) and HYPOACUSIS (can barely hear out of the ear) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced TINNITUS (other people with the same problem in her support group,tinnitus,swoshing sound in ear), INSOMNIA (hardly sleep), FEELING ABNORMAL (she is freaking out really bad) and HYPOACUSIS (can barely hear out of the ear). At the time of the report, TINNITUS (other people with the same problem in her support group,tinnitus,swoshing sound in ear) had not resolved and INSOMNIA (hardly sleep), FEELING ABNORMAL (she is freaking out really bad) and HYPOACUSIS (can barely hear out of the ear) outcome was unknown.        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 Concomitant medications were provided by the reporter. No Treatment information was reported.
Client came to vaccination table today requesting COVID card to be updated. Per records, client was vaccinated by team public health nurse (PHN), on 5.25.2022 with 2nd dose of COVID Moderna, 0.5 ml Lot # 054A22A at 9:11 am in the left arm. Client's record indicated that he received 3 total doses of COVID Moderna vaccine (02/05/2021, 03/05/2021, and 01/26/2022.) The PHN looked up client in records, which forecasted only the doses given on 1.26.2022 and 5.25.2022. The PHN, discussed the other doses with client, whom stated "he doesn't remember mentioning them" when he came for his vaccination on 5.25.2022, and documentation was not provided. The PHN texted the doctor at 10:01 the situation, requesting to condense COVID vaccine cards and add 0.5 ml dose on booster line of COVID vaccine card and to complete a report. Doctor agreed. The PHN added dose given on 5.25.2022 to COVID vaccine record client provided today.
Headache within 15 minutes; fatigue 2-3 hours later, soreness at injection site for 2-3 days
PT RECEIVED VACCINE AT AROUND 11:05AM. PT REPORTED FEELING ITCHING AT BOTH ARMS THAT SPREAD TO BACK  AND TORSO AT 11:20AM. SHE DID NOT HAVE ANY BREATHING PROBLEMS. SHE WAS GIVEN DIPHENHYDRAMINE 50MG/1ML, 1 ML IM INTO RIGHT DELTOID. SHE REPORTED ITCHING GETTING BETTER AND REDNESS LESSENING. AT 12PM, WHILE BEING OBSERVED AND WAITING FOR HER SON TO ARRIVE TO DRIVE HER  HOME, SHE NOTICED THAT THE ITCHING INCREASED. SHE WAS GIVEN DIPHENHYDRAMINE 50MG/1ML, 1 ML IM INTO RIGHT DELTOID AGAIN. I SPOKE WITH HER ON THE PHONE AT 5:20PM. SHE FELL ASLEEP WHEN SHE GOT HOME AND WOKE UP LATER, GETTING ITCHY AGAIN. SHE NOTED THAT IT WAS TIME FOR ANOTHER BENADRYL 25MG DOSE (SHE WAS INSTRUCTED TO TAKE 1-2 CAPS (25MG TO 50MG) BY MOUTH EVERY 4 TO 6 HOURS FOR AT LEAST 1 TO 2 DAYS OR UNTIL THE RASH RECURRENCE STOPS). SHE TOOK THE ORAL DOSE AND SAID THAT THE ITCHING WENT DOWN.
Clinical Summary Patient is a 76 y.o. male with a history of HFrEF, Atrial fibrillation, chronic left heel osteomyelitis  who presented to ER 11/27/22 with shortness of breath, transferred to alternate hospital 11/27/22 for ICU care. Course complicated by septic shock, (+)COVID, HAP with MDR-organism, and intubation. Medical Care assumed care 12/2/22 on transfer. Hospital course further complicated by progressive debility. Medical Care consulted 12/2/22 to assume care upon transfer.   1. Acute hypoxemic and hypercapnic respiratory failure: In the setting of COVID-19, HAP and left lung atelectasis. Chest x-ray 11/28/2022 with left hemothorax opacification. S/P bronchoscopy 11/28/2022. S/p inhaled thromboxane. Extubated 12/1/2022, weaned to 2-3L NC by 12/5/22.  2. COVID-19 Infection: Fully vaccinated, symptom onset 11/26/22, (+)test 11/27/22. Completed 10 days of Decadron end date 12/7/22 and out of isolation since 12/8/22. 3. HAP: BAL cultures 11/28/22 with MDR actinobacter. Completed Unasyn 12/6/22.  4. Septic shock: Likely related to above. Transiently required pressors in ER, resolved by 12/1/22. 5. Acute metabolic encephalopathy: Suspect metabolic from above. CT head 11/27/22 non-acute. Resolved. 6. Chronic left heel osteomyelitis: With diabetic neuropathy and PVD. Follows with Dr. (podiatry). Hospitalized at local facility on 10/2022 and placed on IV daptomycin and Invanz. Antibiotic course completed 11/28/22.  7. AKI on CKD3: Follows with Dr. (Nephrology) Baseline Cr 1.9, Cr 2.2  on admit due to septic shock. CR improved by 12/2/22 8. Persistent Hyperkalemia: due to AKI on CKD, added Lokelma 12/5/22.  9. CAD: S/p DES mid-LAD 5/2022. Continued asa, plavix and lipitor. 10. Chronic HFrEF: Ischemic CM, EF Nadir 35% (5/2022). Euvolemic on admit, last TTE 8/4/22 (at local facility) EF 50%. Initially held home Toprol XL due to hypotension, restarted 12/6/22. 11. Paroxysmal atrial fibrillation: AC stopped due to hx of recurrent GI bleeding in 11/2022 admit. Follows with Dr. who is considering LAA closure device in the future. Home BB and Propafenone restarted 12/6/22 12. Melena/recurrent GI bleed admitted 11/18 to 11/20/2022.  S/p blood transfusion.  EGD 11/19/2022 negative for bleeding. 13. Diet Controlled T2DM: Hgb A1c 5.9% on 5/13/22. Not on home medications. Stopped insulin 12/2/22. 14. Abnormal chest imaging: 3 cm right lower lobe calcified nodule on CT/5/16/2022.  Outpatient follow-up with repeat CT in 3 to 6 months. 15. Code status: DNR-CCA/DNI-Spouse. Palliative medicine following and has had multiple goals of care meetings.  16. DVT Prophylaxis: lovenox
In process of injecting Tdap vaccine when pt slumped in chair. She was unresponsive for 5 seconds. Laid pt down and placed cool cloths on head. BP - 112/78, Pulse - 90. Pale. Feeling "fine" in 15 min. Pt and mother wanted to continue with immunizations. Gave meningitis vaccine and HPV vaccine after 15 min.  Observed another 15 min with no symptoms of distress. Called mother 6/30/11 - patient had no other symptoms or problems after immunizations.
This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19vaccine) for COVID-19 immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On Jan 14, 2021, patient experienced maternal exposure during pregnancy. On Jan 14, 2021, maternal exposure during pregnancy resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided. Sender's comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
SEVERE neurological complications; This case was reported by a consumer via interactive digital media and described the occurrence of neurological symptom in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was unknown.   It was unknown if the reporter considered the neurological symptom to be related to Tdap Vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Tdap vaccine and experience severe neurological complications.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
This case was reported by a pharmacist via other manufacturer and described the occurrence of generalized rash in a 69-year-old male patient who received BOOSTRIX (batch number 3Z27B, expiry date unknown). On 22nd September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 25th September 2016, 3 days after receiving BOOSTRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by a registered pharmacist. The age at vaccination was not reported. The patient's medical history, diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities and obesity were not reported. No any adverse event reported previously. There was no illness at the time of vaccination. The patient did not receive any concomitant medications. At 1:58 pm, the patient received BOOSTRIX in left arm. After receiving BOOSTRIX, the patient experienced rash on trunk and on body. The adverse events did not require an emergency room or physician visit. The patient was not hospitalized. No treatment or tests were required. The event did not occur after re-administration.
Guillain-Barre with Miller-Fisher variant: abdominal pain and constipation x1wk prior to 11/17/19, L facial droop, abnormal gait on 11/16/19
hives; headache; low fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: FA6780, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 08Jun2021 12:00 (age at vaccination: 44-years-old) as dose 2, single for covid-19 immunization. Medical history included hypothyroidism, allergy to dust, mold, gluten, penicillin allergy, food allergies, allergies to medications. Concomitant medications included levothyroxine sodium (TIROSINT), received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in arm left on 17May2021 12:00 (age at vaccination: 44-years-old) as dose 1, single for covid-19 immunization and the patient had hives after dose 1 however it was unclear if the hives are from my external and food allergies or the shot. The patient started taking antihistamines prior to dose 2 and the hives cleared up and also had a sore arm after dose 1. On 12Jun2021, the hives appeared again after shot 2 and also had common reactions of headache, low fever, and body aches from about 24 hours after to 60 hours after. Therapeutic measures were taken as a result of all reported events and treatment included Claritian, which was continuing for 2 weeks. The seriousness was not reported. Outcome of the events was not recovered.
Intense exhaustion, to the point of impaired function, long before normal bed time. I reported this same symptom after the previous injection.
Painful swollen lymph glad I under right arm. Lasted that evening very uncomfortable then not as bad the next day?by third day only hurt if pushed on.
Redness at the injection site; Injection site itched; Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th September 2019, 1 days after receiving Shingrix, the patient experienced chills. On 19th September 2019, the patient experienced injection site erythema and injection site itching. On 19th September 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site itching were recovering/resolving.   It was unknown if the reporter considered the chills, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient experienced chills, redness the size of a baseball at the injection site and it itched. The chills were gone when the patient woke up on Thursday, September 19, 2019. On 20th September 2019, the patient noted that both the redness and itching were less. The patient gave permission for his physician to be contacted.
Acute vaginal bleeding (pregnancy); diagnosed with subamniotic hemorrhage of unknown etiology.
I went to administer the vaccine and the plunger would not move.  I tried a second shot with the same result.  While I was in the pharmacy trying to put a needle on a third vaccine, the child fainted in his dad's arms.  He came to about 10 seconds later.  We applied a cool compress to his head and had him lay down on a bench.  After  a few minutes he was able to walk away on his own two feet.  No vaccine made it out of either syringe into his arm.  Parent's stated he has a fear of needles and has passed out before.
concomitantly received VARIVAX and PROQUAD; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant drugs included Hepatitis A Vaccine, Inactivated (VAQTA). The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were not reported.   On an unspecified date, the patient concomitantly received 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: w025273, expiration date: 10-AUG-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis and 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot#: w028566, expiration date: 06-MAR-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (overdose). No additional AEs (adverse events) were reported (no adverse event).