chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 67 year old patient. Medical history and concurrent conditions were not reported. On 13-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Myalgia, Fever, NauseaVomiting, chills, groggy/hazy Narrative:
pneumonia; pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (death, medically significant), DRUG INEFFECTIVE (death, medically significant), outcome "fatal" and all described as "pneumonia". Reporter's mom (patient) got the vaccine and died from pneumonia.  The patient date of death was unknown. Reported cause of death: "pneumonia". It was not reported if an autopsy was performed.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Reported Cause(s) of Death: pneumonia
In the evening I started to have a mild sore throat. I woke up the next morning with a severe sore throat. I took Tylenol, and used honey and hot water to soothe my pain. On the 3rd day I woke up with a rash that started on my upper chest, then spread all over my body. On the 4th day I went to see my doctor, he took a strep test. I never received the results but was prescribed a Z-Pak. My rash and sore throat were gone in about a week.
About 15 minutes after vaccination, I stood up to leave and I felt bad chest pains.  I reported this to the nurse who made me sit down.  My blood pressure was taken at 180/150 and I was told to stay sitting down for 30 more minutes.  After this time, my blood pressure was normal.  I did not have a reaction to the second vaccine, however, I did take 400mg of Benadryl before the vaccine
After five days from the second dose of Moderna Covid Vaccine, I started to have vertigo, dizziness and lightheadedness and pressure on my ears. It is worse when I walk or turn my haead; I am at the day 13 today from the vaccine secon dose, and still have those feelings without any improvement. This has made me unfunctional and unable to walk or do my daily activities. I went to my neurologist 2 days ago and she found nothing wrong with my tests. She finally prescribed otc medication: "meclizine" that has not helped me much. I saw a lot of people are experiencing the same issue, dizziness and vertigo ;Please see thsi forum which shows I am not the only one. /
Rash-small blisters on a red base. Started on abdomen, spread to groin, arms, and legs. Rash is itchy. No pain, no fever.
4/26/2021 Pain at vaccine site.  4/28/2001 Pain gone 4/30/2021 Noticed red , itchy mark on left arm near vaccine shot. 5/3/2021  Red itchy mark almost.gone
The evening after she received the first dose of the Moderna vaccine she developed mild chest pressure and felt itchy. Pt took 25mg of Benadryl and when she woke up the morning after she had moderate hives on her face, neck, chest and arms. Pt took 50mg of Benadryl the morning after the vaccine and then came in to Urgent Care. Pt was prescribed prednisone, instructed to take daily Allegra, Benadryl, and prescribed an epi pen for escalating symptoms. Pt was informed to not receive the second dose until she is cleared by allergy/immunology.
Large local reaction left thigh - edema, warmth, tender to touch localized to entire quadricep. No systemic symptoms. TX: Cold compress/ibuprofen.
Right side of my tongue felt tingly and numb as soon as I arrived to my car about a 2-3 minute walk after 15 minute observation.  It has been  23 1/2 hrs since vaccine and feeling is just going away.
Enlarged area of soreness (felt like large severe bruise) followed by chills and low fever. Some coughing. lasted about 2 hours. Followed by half day of what felt like o=post flu recovery.
Patient suffered an embolic stroke in the Right Middle Cerebral artery requiring thrombolysis and thrombectomy on the morning of 11/10/2021
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Life Threatening Illness. Received Moderna Vaccine on 12/21/2021. Admitted from outside facility to ICU for acute intracranial hemorrhage and suspected immune thrombocytopenia. Presented to outside facility ED c/o HA and sinus pain, acutely developed facial droop and left sided weakness. Stat CT with evidence of intracranial hemorrhage with midline shift. Began vomiting, intubated for airway protection. Initial lab work was significant for platelet count of 1, Hgb 11, Na 140, creatinine 0.8. Received the following interventions: hypertonic saline, mannitol, steroids, and nicardipine drip. Transferred  for higher level of care. Trach placed 1/31/22.   Continued to improve neurologically. Sodium goals were relaxed to normonatremia and neuro checkls relaxed to q4 with q12 sodium checks and transferred to the floor on 02/20/22 with d/c plan to rehab facility.
Saturday night of 1/22/2022 she was just tired. Sunday morning she woke up with a fever. She had a cough, congestion, and her body was aching. On Monday I took her to a doctor's appointment, and she got tested for COVID. It came back positive. She also had a low-grade fever that day. Then the next day on Tuesday her fever was gone and she started feeling better. She was in a house with four other people but she was the only one who got COVID.
Raise rashes scattered all over the body - given PRELONE 15mg/tsp 1/2 tsp BID x 5 days.
Crying, felt cold, & was shaking, temp to 105; Hospitalized for  observation for 2 days; Tx APAP & hypothermia blanket;
Patient received the second dose outside the CDC recommended window of 21-42 days. First dose was administered on 5/30/21, and second dose on 7/23/21 (54 days later).
STRESSED/STRESS ISSUES; PSORIASIS FLARE UP ON OUTSIDE OF LEGS; Flu like symptoms; Fatigue; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), STRESS (STRESSED/STRESS ISSUES), PSORIASIS (PSORIASIS FLARE UP ON OUTSIDE OF LEGS), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COUGH (Cough), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). In May 2022, the patient experienced PSORIASIS (PSORIASIS FLARE UP ON OUTSIDE OF LEGS). On an unknown date, the patient experienced STRESS (STRESSED/STRESS ISSUES). At the time of the report, COUGH (Cough), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) outcome was unknown and STRESS (STRESSED/STRESS ISSUES) and PSORIASIS (PSORIASIS FLARE UP ON OUTSIDE OF LEGS) had resolved.            Concomitant product use was not provided by the reporter. On an unknown date, the patient was stressed/stress issues. In Dec-2021, the patient experienced that booster dose caused flu like symptoms, cough and fatigue. In May-2022, the patient experienced psoriasis flares up on outside of legs. He had stress issues due to family issues and experienced flare ups. He took cream and that helped a lot. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623063, MOD-2022-631087 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Live Follow Up received and updated events outcome.
In addition to developing a fever of 105, she is complaining of pain in each leg.  With each step she takes, she winces in pain.
RN alerted to patient passing out immediately after vaccine dose given. Patient appeared disoriented upon assessment but awake. Patient alert x4. Pt moved to wheelchair and taken to stretcher/observation area. Vitals: BP 116/58;Pulse: 50;02: 98%;Patient denies pain and said he feels "normal". Patient states he passes out when blood is drawn and has a fear of needles. Pt states he did not eat breakfast. He was given water and crackers. Pt has no further concerns and states he "feels fine". RN assessment complete and patient advised to let staff know that he passes out with needles next time he encounters needles. Patient drove himself to clinic today and states he feels 100% okay and fine to drive himself home. Patient discharged from care at 09:08.  Electronically signed:2/1/2022 9:08 AM.
Swollen lymph nodes lower left neck and left underarm; persistent headache; achy joints. Treatment with Tylenol and Advil.
Redness, and warmth surrounding the injection site. Started around 11/3/18. Progressively getting worse.
Vomiting, no fever, 48 hours diarrhea, drowsy, not eating much.
Grandmother put her down for a nap, heard a scream went to check on her and found her having a seizure. Grandmother called 911. Paramedics came to check her and stated she was stable enough to transport by car to ER where she was DX with febrile seizure.
I just feel tired; Light headache; My arm is really swollen up much; Patient received booster shot yesterday; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 3 via an unspecified route of administration on 29Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on unspecified date as dose 2, single for covid-19 immunisation and also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. Patient received booster shot yesterday and experienced mild side effects, patient don't want to be panic. Patient had no fever, and took temperature, didn't had a fever. Patient just felt like tired, headache and arm was really swollen up much and asked are these normal side effects. Patient was stated that It was light headache and I was very much tried. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I woke up approximately 2am 2/5/2021 the night after receiving the vaccination 2/4/2021 (about 13 hours afterwards) with severe chills, shoulder, knees & most joints aching badly, bones in both feet aching with any movements, both arms sore along with severe stomach cramps & nausea, these all lasted through the night and day with a fever of 101 at 7am but by 4pm all but the stomach cramps were replaced by just nausea but severe headache and weakness all over were felt.  I remained in bed until about 4pm 2/5/21 & soaked in a hot bath which relieved the joint pains.  Headache, nausea & weakness continued 2/6/2021 & 2/7/2021 with the headaches coming if any sudden movements such as coughing or standing up too fast & nausea irritated by eating anything but saltine crackers.  Today is 2/7/2021, took sick days from work 2/5, 2/6 & 2/7.
I have never before suffered from edema.   After my first injection I noticed swelling in my legs and feet with an accompanying weight gain.  This was even more pronounced after my second injection.
Shingles of the eye.  Began as a large boil like structure on the bridge of my nose.  It then went to my eyes, especially my rights eye which swelled shut over a period of several days.
Received COVID vaccine in afternoon and then woke at 2 am with diarrhea that lasted for 3 days. And started with a bumpy rash the day after vaccination. Scalp was itching as well.
patient reported widespread itchiness all over the body also red blotchiness/hives. pt saw dr today 5/10 and advised him to take otc allergy medication
Hand/finger swelling/Had arm swelling and couldn't get his wedding band off; normal pain in the arm he got the injection in; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 28Mar2021 10:30 (Lot number: ER2613) at the age of 58 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28Mar2021 10:45, outcome "not recovered", described as "Hand/finger swelling/Had arm swelling and couldn't get his wedding band off"; VACCINATION SITE PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "normal pain in the arm he got the injection in"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "not recovered", described as "arm pain". Therapeutic measures were taken as a result of peripheral swelling, vaccination site pain, pain in extremity.  Additional information: The patient did not undergo any relevant tests. The patient's family medical history included mother was diabetic. The patient had no prior vaccinations (within 4 weeks). The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no history of previous imuunization with the Pfizer vaccine considered as suspect. Clinical course: The patient received first dose of vaccine yesterday morning.  Within 15 minutes he developed hand/finger swelling. In the late afternoon he had arm pain, and later had arm swelling and could not get his wedding band off. He took an Aleve last night and this morning. He also had normal pain in the arm he got the injection in. He took Advil for his arm pain and it was the normal pain. Today it was about the same. He was not dying today. Event onset time for normal pain in the arm he got the injection in was 15:00-16:00. The events did not result to emergency room or physician's office visit. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist (mother) reported same event for two patients. This is the first of two reports. A 14-year-old male patient received, on 17Apr2015, TRUMENBA intramuscularly in deltoid, at 0.5 ml, single dose. Vaccines given on the same date along with TRUMENBA were none. Vaccines given within four weeks of administration of TRUMENBA were none. Relevant medical history and concomitant medications were unknown. On 18Apr2015 at 1:30 AM, the patient experienced fever, chills. In the afternoon of the same day, on 18Apr2015, the dizziness and blurred vision began. Clinical outcome of the events was unknown at time of this report.
Patient states headache immediately after vaccine 2 days ago. Still headache and local reaction with redness to upper Left arm where vaccine injected. No cellulitis noted today area is 2" x 2 ".
Patient received a flu shot at 9am.  At roughly 10:30am, patient reported being itchy on her wrists and chest.  I administered 50mg of diphenhydramine IM in the right deltoid at roughly 10:40am due to patient stating the reaction was getting worse.  At about 10:55am, she stated she was going to go to the hospital due to increased redness and itching on her chest.  At that point, she said her throat was dry and scratchy.  She was talking normally and I did not observe any signs of anaphylaxis so I did not administer any epinephrine.  I offered to sit with her to observe symptoms but she still wanted to drive to the hospital.  I told her she couldn't drive but I did offer to call 911 if she thought that was necessary.  Patient did want 911 called.  The fire department arrived about 3-4 minutes later, they interviewed the patient, looked at her throat and did not visually observe any signs of anaphylaxis.  The ambulance then arrived and the patient stopped talking to the fire department and went over to them.  They put her in the back and were going to administer a dose of diphenhydramine but I spoke up to let them know she had already received 50mg.  They thanked me for the information and then shut the back of the vehicle and proceeded to transport her to the hospital.  Outcome after patient arrived at hospital is unknown at this time.
This 36-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX on 24th September 2018, for prophylaxis. The subject's estimated date of delivery was 28th February 2019. The subject received BOOSTRIX at week 20 of the pregnancy and during the second trimester of pregnancy. On an unknown date, unknown after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The patient received BOOSTRIX (batch number: 33T42, expiry date 1st February 2021). The patient might had given another dose at 28 weeks but the reporter had only information for dose given at 20 weeks. There was some uncertainty about the patient actually receiving another dose at 28 weeks. The reporter consented to follow-up. Follow up information was received from health care professional on 18th March 2019: The reporter's contact details were updated. The patient's demographic details were updated. The patient's past medical history included normal birth (5) and spontaneous abortion (1 spontaneous abortion). Concurrent medical conditions included hypothyroidism, anxiety and LE varicosities. The patient's last menstrual period was on 24th September 2018 and estimated date of delivery was 28th February 2019. The patient received concomitant products such as salbutamol sulphate (Ventolin Hfa), minerals nos + vitamins nos (Prenatal Vitamins). The patient also received expired Xanax and Prozac at 25 weeks gestation. The patient received another dose of BOOSTRIX on 7th December 2018 at 28 weeks gestation. After 137 days, the patient gave birth to a neonate via cesarean delivery. On 18th October 2018, 24 days after 1st dose, the patient experienced placenta previa. On 7th December 2018, less than a day after 2nd dose, the patient experienced placenta previa. On 1st February 2019, 56 days after 2nd dose, the patient experienced placenta previa. Ultrasound performed on 24th September was normal and it confirmed estimated date of delivery. Ultrasound performed on 18th October 2018, 7th December 2018 and 1st February 2019 was abnormal and confirmed placenta previa. It was unknown if the reporter considered the placenta previa to be related to BOOSTRIX.
thinks it is COVID toe; thinks it is COVID toe; an itchy toe/Her toe started itching. It is very red; an itchy toe/Her toe started itching. It is very red; This is a spontaneous report from a contactable nurse, the patient.  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 16Dec2020 at 07:15 (at the age of 49-years-old) as a single dose for COVID-19 immunization.  Medical history was not reported.  Concomitant medications included zingiber officinale root (GINGER ROOT), clonazepam (KLONOPIN), progesterone (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), spironolactone (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), and zinc (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing.   On 18Dec2020 at 02:00, the patient experienced an itchy toe/her toe started itching and it was very red, reported as non-serious. The clinical course was as followed: the patient was at work on the night of 18Dec2020 and was having trouble with her toe. Her toe started itching. It was very red. She wondered if it was "COVID toe" as the picture she found looked exactly the same. The physician she worked with did not know what it was. She took a diphenhydramine hydrochloride (BENADRYL) and sprayed freezing agent on it to stop the itching. The clinical outcomes of the itchy toe, red toe, and "COVID toe" were not recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a possibility that the events are related to BNT162 vaccine. 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.