chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report as received from a licensed nurse practitioner refers to a female patient of unknown age. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1 (lot number 0841AA, expiry date 08-APR-2013) and 2 (lot number 1291AA, expiry date 12-APR-2014) of GARDASIL, both on unknown dates. The anatomical location and route of administration were not reported for the doses. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant. The LMP and EDD is not known. The amount of weeks at which initial exposure to GARDASIL took place was unknown. It was reported that the patient delivered a baby, without further details. No treatment information was reported. The reported relatedness for the fact that the patient received the first and second dose of GARDASIL and then got pregnant is unknown for GARDASIL. Additional information has been requested.
Information has been received form an office manager concerning 8 patients who were vaccinated with PNEUMOVAX (lot # 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that one of the patients was a female who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports from the same source. Additional information has been requested.
New information was received regarding use of Ethyl Chloride. Information regarding PREVNAR was received from a physician regarding a patient who experienced very painful injection. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication of PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1dose 1 time per day. Concomitant therapy included Ethyl Chloride. The patient experienced very painful injection on an unknown date. Outcome is unknown. Ethyl chloride is used as skin refrigerant or anesthesia to prevent pain at injection site. No additional information was available at the time of this report.
Pt came into pharmacy and stated that she thinks she got left arm and some time (R) arm pain, as well as left and (R) knee joint pain, and pain in her groin in (R) side, after getting pneumonia shot. She says the pain is still there thru now since she got the shot.
pt recv vax OCT95 & pt devel knee pain in one knee;pt went to ER but was never adm to the hosp;
Body aches, fatigue, extreme swelling of left arm/shoulder; severe spine, right hip and lower back pain.
This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with attention deficit disorder. On 07-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date: 04-APR-2014, 0.5 ml, intramuscular in the right arm) as she had started working in a hospital. Concomitant therapies included ADDERALL tablets for attention deficit disorder and she was also on an unspecified birth control medication. On 08-NOV-2014 the patient experienced injection site swelling and tenderness and she visited physician on 10-NOV-2014. No treatment had been prescribed. Action taken with PNEUMOVAX 23 was not reported. The outcome of the events was reported as not recovered/not resolved. No additional information was provided. The causality was unknown. The reporter requested for lot check for PNEUMOVAX 23, lot # K008409, expiry date: 04-APR-2014. She indicated that she was not comfortable using any more this lot of PNEUMOVAX 23, due to these two adverse events. This one of several reports received from the same reporter. Additional information has been requested.
Patient received 0.25cc of influenza vaccine on 10/21/03. Developed fever that night which increased to 104 degrees that next night.
Nausea onset approx. 1 hr post vaccine. Nausea / vomiting / diarrhea x 3 days. Increasing abdominal pain - MD visit then ED - hospitalization x 3 days. 12/18/09 Medical records received for date 11/13/09. DX: abdominal pain. Chief c/o RUQ pain/cramping, NVD. Pt states received vax and felt this way since. Assessment: BS diminished, RUQ direct tenderness. 12/23/09 DC summary received for dates 11/13/09 to 11/15/09. DX: abdominal pain. Pt was admitted and given NG tube. Sx improved over two days and pt dc home stable.      11/2/5/09 Medical records received for DOS 11/13/09  CC abdominal pain. C/O abd pain. Cramping. Swelling. Nausea. Previous vomiting, diar. Worsened by eating or coughing. CT abn.  NG tube placed.  Improved. D/C to home full liquid diet.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008861: US-009507513-1707USA008862: US-009507513-1707USA008793: US-009507513-1707USA008819: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008838: US-009507513-1707USA008863: US-009507513-1707USA008864: US-009507513-1707USA008794: US-009507513-1707USA008795: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008839: US-009507513-1707USA008865: US-009507513-1707USA008866: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008840: US-009507513-1707USA008867: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008827: US-009507513-1707USA008841: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008828: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008842: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA008799: US-009507513-1707USA008831: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008845: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008834: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008789: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008853: US-009507513-1707USA008854: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA008855.
for the 2 dose again my blood pressure rose to 168/109  and the back of my throat began to itch , I was then taken to the emergency room for treatment for my adverse reaction, while in the emergency room my upper body began to itch my right began to hurt and got a slight headache, I was discharge after receiving treatment.  While at home I have chills and was tired.
5 days post vaccination I experienced sudden onset of generalized hives associated with itchiness. After use of benadryl the hives became more red, less raised, and resembled a confluent measles rash. From association with hives I experienced ear pruritus, sore throat, nausea. And fatigue. Hydrocortisone creme was used on the rash.
On the night 12/15 exp body aches typically  how you feel when having a virus, no fever, no gi symptoms. The following day I had fatigue and one point had chills, body aches. Then took Motrin on night of 12/16 and felt better on 12/17.
Patient only received half of the J+J dose secondary to vaccinating RN reporting needle and syringe separated during administration. RN will be re-educated.  No adverse reaction reported by patient.
This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm, swelling arm and fasciitis. On an unknown date, the outcome of the erythema of extremities, pain in arm, swelling arm and fasciitis were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm, swelling arm and fasciitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported via online chat. The patient received SHINGRIX and had a severe localized reaction that made her entire upper arm red, swollen and painful above the elbow. The doctor who saw her thought it was fasciitis. The doctor asked whether this had been reported before and if there was any concern about the patient getting the second SHINGRIX shot in 6 months.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/18/2022 CKD STAGE 3B (GFR 30-44)  ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/18/2022 URINARY RETENTION
Patient received his 2nd dose of the COVID-19 vaccine on 4/12/21 being fully vaccinated.  Patient presented to the testing clinic on 8/26/21 with symptoms of congestion and tested positive for COVID-19.
L hip bursitis; Pain in my hip; If she tries to walk then that is when it hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 93 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Oct2021 13:30 (Lot number: 301250A) at the age of 93 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hip replacement" (unspecified if ongoing), notes: One hip replacement was about 10 years ago and the other one was about a year ago, Pertinent Details : Bilateral hip replacements; "Chronic leukocytosis" (ongoing), notes: Illness/AE: Chronic leukocytosis, Stop Date : Ongoing; "Hypothyroidism" (ongoing), notes: Illness/AE: Hypothyroidism, Stop Date : Ongoing; "Hypertension" (ongoing), notes: Illness/AE: Hypertension/Hyperlipidemia, Stop Date : Ongoing; "Hyperlipidemia" (ongoing), notes: Illness/AE: Hypertension/Hyperlipidemia, Stop Date : Ongoing. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose number: 1, Date/Time: 26Jan2021, Time : 11:30AM, Anatomical Site of Injection : Left deltoid, Route of Administration: Intramuscular, Batch/Lot number : EL8982), administration date: 26Jan2021, when the patient was 92 years old, for COVID-19 immunization; Bnt162b2 (Dose number: 2, Date/Time: 16Feb2021, Time : 11:30, Anatomical Site of Injection : Left deltoid, Route of Administration: Intramuscular, Batch/Lot number : EM9810), administration date: 16Feb2021, when the patient was 92 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 04Oct2021, outcome "recovering", described as "Pain in my hip"; PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "If she tries to walk then that is when it hurts"; BURSITIS (non-serious), outcome "unknown", described as "L hip bursitis". The event "pain in my hip" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Treatment of adverse event with Steroid shot Tylenol arthritis No follow-up attempts are possible. No further information is expected.
We received on 05 OCT 2007 from a nurse the following information: A female patient (birthday unknown) was vaccinated with Fluvirin, batch no. 78480 on an unknown date. She developed an anaphylactic reaction on 03 OCT 2007. The outcome is unknown. Company assessment: Seriousness criterion: medically significant. Causality: possible. Expectedness assessment according to SPC: Anaphylactic reaction is expected after vaccination with Fluvirin. No change in benefit risk-ratio. No measures necessary.
Johnson/Johnson vaccine 5/6/21 at  2 PM.  About 7 hours later, body aches gradually worsening.   Around 9 AM 5/7/21, developed substernal CP aching/sharp quality, 6/10, accompanied by SOB.  He notes mild increased SOB/CP with exertion.   EKG was abnormal with inverted t waves V1-4, III, he was admitted over night and diagnosed with pericarditis.  Stress echo showed no abnormality.  Negative troponin.  On follow ekg changes normalized, he improved with ibuprofen alone
Information has been received from a Registered nurse, for GARDASIL, a pregnancy registry product, concerning a 23 year old female patient, with no pertinent medical history, drug reactions or allergies reported, who on 11-JAN-2011 was vaccinated intramuscularly, with her first dose of 0.5 ml, GARDASIL (Lot #: 666597/0768Z, Exp: 17-OCT-2012). Concomitant therapy included prenatal vitamins. Registered nurse reported that patient found out she was pregnant "soon after" she received the GARDASIL. The patient's last menstrual period was on 30-JAN-2011. No adverse effects were reported. A prenatal exam, a blood work and an ultrasound were performed (results not provided). Follow up information has been received via telephone call concerning the patient, who on 04-NOV-2011 at 39 weeks 5 days of gestation delivered a healthy baby boy. The baby was delivered via C-section due to (labor) failing to progress. The baby weighed 9 lbs 11 oz and had no reported congenital anomalies. There were no reported complications with delivery or the pregnancy. Upon internal review the baby was delivered via C-section was considered to be an other important medical event. Additional information has been requested.
Discharge Physician: MD Primary Care Physician: MD  Date of Admission: 2/24/2023 Discharge Date: 2/28/2023 Room Number:  PRESENTING PROBLEM: Pneumonia of right lower lobe due to infectious organism Pneumonia due to COVID-19 virus COVID-19   Patient is a 61 y.o. male past medical history down syndrome, achalasia and dysphagia with feeding tube in place, anemia, elevated LFTs and GERD who presents with cough and weakness. Hospitalized from 1/31-2/2 with abdominal wall cellulitis and pneumonia and completed 5 days of  Azithromycin and rocephin.   In the Emergency Department, he was noted to have hypoxia down into the 80s at times and required 2L NC. He tested positive for COVID in the ER. Per report other residents at his AFC and care givers also positive. His procal was elevated at 0.62 and CXR showed concern for worsening of right lung with multifocal pneumonia. He had normal lactic acid and WBC and did not meet sepsis criteria. He did have some softer blood pressures in the ER but improved with IVF. He was noted to have hyperkalemia and elevated LFTs but LFTs were similar to recent admit. He was given IVF and started on azithromycin and rocephin in the ER but switched to cefepime on admit. He was admitted to the hospitalist team for COVID, respiratory failure and pneumonia.    Patient was able to wean oxygen. He was continued on antibiotics (and discharged to complete 5 day coarse of antibiotics) and decadron during admit. His labs improved, vitals and lung sounds improved. Patient was able to ambulate out of bed the day of discharge. Patient is clinically improved and hemodynamically stable for discharge.  Discussed plan of care for discharge with AFC and guardian including outpatient follow-up with PCP within 7 days.  They voiced understanding and were agreeable with plan of care for discharge.
Pt recv vax in 3/99; 6 hr post vax pt exp urticaria & angioedema
Started with severe backache, in 3 days progressed to severe headaches, and major flu like symtoms, high fever, severe chills and tremors,and body aches. High white platelets jumped to 638,000, then to 900,000, and became amemic. Have been sent to hematologist on 22nd. Waiting for results-appt on Nov 1st.
Approximately 24 hours after receiving second vaccination (1000 am 4/21/2021), I developed a temperature (99.6 degrees), body aches - primarily low back/kidney area, and feeling tired. Took 2 Excedrin Migraine. Slept most of the day and temperature remained. Approximately 10:00 pm I took 2 more Excedrin Migraine.  Awoke at 3:30 am, temperature reduced to 97.9 degrees (approximately 18 hours after onset of first experiencing  symptoms). All symptoms gone by 3:00 pm 4/23/2021.
chills, lethargy, body aches, low grade temp. started on day 5 after vaccine administration.
Client developed redness, warmth, hardness, pain at injection site.  No fever reported.  Redness and pain remained 4 days later.
administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered from an expired vaccine) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 04-Nov-2021. The vial did not undergo any temperature excursions. It was reported that the patient had no adverse event (AE) and was monitored. Some of the vaccines were administered on 05-Nov-2021 and some on 12-Nov-2021.  No concomitant medications were reported.  No treatment information was reported.
Swollen, Red neck. No trouble breathing, treated in ER, given Benadryl and Keflex.
This initial spontaneous case, was received from other health professional on 14-Nov-2017, concerning a 41-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195242, expiry date: 01-Jun-2018 and anatomical location: left deltoid). On the same day, after 2 hours of vaccination, the patient experienced numbness in her lips and gums and no treatment was received. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious.
Information has been received from a medical assistant who heard from a physician's assistant concerning some patients who were vaccinated with unspecified doses of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patients became blind and paralyzed. At the time of this report, the patient's outcome were unknown. Follow up information has been received from a physician's assistant who stated that one of her patients stated that she did not want receive GARDASIL because she had heard someone became paralyzed after receiving GARDASIL. Upon internal review, being paralyzed was considered to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
admitted 5/5/21 with increased sob/cough/aches and pains. Dx with COVID 19 pneumonia on 5/1 . temp 98.3
After injectable vaccination felt hot and lightheaded. G3 P2 x 21 wks. Prob vasovagal. Sx's resolved with lying down, ice pack and drink. 11/10/09 OB record received from date 10/19/09. OB record. Pt 20 weeks gestation. 11/5/09 Pt. seen in OV c/o body aches, fever cough. DX: pharyngitis. Flu A/B(-). 11/10/09 Pt. c/o feeling faint. pt. states not sure if having rx to H1N1 vax.
Large wheal at site about 6 cm with erythema, fatigue, HA, nausea, chest tightness and pain opposite arm.
Narrative:  Recieved Janssen vaccine 0.5ml dose at 1150, at 1200 he reported nausea & vomiting. VS stable: HR 65, P.Ox 97%, BP 97/65mmHg. Stated that he always vomits after vaccinations. Continued observation for 30 minutes, no further adverse symptoms reported by patient. Not treated with any medications.
About 24 hours after injection, red, warm patch at injection site (oval 5.2 x 2.8 cm). Vomiting, malaise, fatigue,  nausea,  progressive pain/soreness in arm and upper shoulder/neck muscles. Rash on elbow(distal to shot) ?? related.
injection site pretty sore; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6207) via an unspecified route of administration on 16Apr2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, COVID-19. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), loratadine; pseudoephedrine sulfate (CLARITIN-D) and amlodipine besilate (NORVASC) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration on 02Mar2021 at 10:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 06:00, the patient experienced injection site was pretty sore that morning. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event injection site was pretty sore that morning was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
The evening that I got my third dose of the vaccine, I got a pounding Migraine. After the first dose, I had a mild headache. I do not get headaches or Migraines normally. I went to the Urgent Care on the third day, after and the Toradol shot, and it did help. I returned to the ER the next day and they gave me a cocktail of painkillers. It did not really help the pain. The migraine finally subsided on 10/17/2021. When I woke up that morning, I had flashing lights in my vision. I now have a variety of vision problems after a month.  I have since had a two-hour eye exam and an MRI of my Brain. All tests have been negative, except that that they want to test my vision angles, which could have been due to inflammation. I see flashes of light, and I am very sensitive to light, as well as flashing lights at the edge of my vision. It does not seem to be improving.
Became pregnant in between vaccination #1 and vaccination #2. Estimated delivery date was 10/28/2021.  Pregnancy was ectopic and was removed 03/26/2021
Presented with SOB, fever, body aches, fatigue, productive cough x 2 days; admit with Covid 19 PNA; tx with  remdesivir, maxipime, steroids, doxycycline, zinc, Vit C, Vit D