chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt terrible and I thought that I should take a COVID 19 Test. I was really sick to my stomach with no energy and a terrible headache. I did the at home test on September 15, 2022, and it was positive. I called the doctor and they had me to come in. He prescribed Paxlovid and I took that, and I felt much better. It took a full month for my energy to return but I have since recovered from all my symptoms.
a history of high blood pressure and says she went to the hospital due to experiencing high blood pressure; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  Medical history included high blood pressure. The patient's concomitant medications were not reported.  The patient received her first injection of the Pfizer covid 19 vaccine and was supposed to receive her second injection on 07May2021 but she missed the appointment because she was in the hospital. The patient reported a history of high blood pressure and says she went to the hospital due to experiencing high blood pressure and dizziness on 07May2021. She was kept overnight and treated with blood pressure medication and a medication for dizziness and a vitamin. She reports being fine now. The outcome of the event was recovered on 07May2021. The patient does not feel like her high blood pressure and dizziness were due to the Pfizer covid-19 vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded.  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.
reduction in lactation; Metallic taste; Short term memory problems; Head ache; Pain at injection sight; Slight blurred vision; Both arm muscle twinge; Warmth in breasts; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 04May2021 at 16:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, fibromyalgia, fatigue, attention deficit disorder/ attention-deficit hyperactivity disorder (ADD/ADHD), anxiety, depression and obsessive-compulsive disorder (OCD). Concomitant medications included paracetamol (TYLENOL), omeprazole (OMEPRAZOL), prenatals and mitragyna speciosa (KRATOM) all for unknown indication from an unknown date. Medical history included known allergies to Nicolen, antidepressants. Prior to the vaccination, the patient was not 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 vaccination. On 04May2021 at 20:00 the patient experienced warmth in breasts, reduction in lactation, metallic taste, short term memory problems, head ache, pain at injection site, slight blurred vision and both arm muscle twinge. The clinical outcomes of the events warmth in breasts, reduction in lactation, metallic taste, short term memory problems, head ache, pain at injection site, slight blurred vision, both arm muscle twinge was unknown at the time of this report. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended past drug event, Relevant Med History, event coding, treatment received and narrative. drug allergy" was coded for "Past Drug Event: Nicolen" 2. A new slide "Relevant Med History" added for "known_allergies: antidepressants" 3. "VITAMIN D NOS" was removed from product tab and left in narrative only. 4. Event updated from "Sore breasts" to "Feeling hot" per MedDra. 5.  "Treatment Received? No" was ticked for all events. 6. "No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care." added in narrative. 7. "The patient previously took aluminium phosphate gel; magnesium trisilicate; sodium alginate (NICOLEN) and antidepressants." removed and updated to "Medical history included known allergies to Nicolen, antidepressants."
rash on palms of hands, tops of hands, arms, some nausea, headache or lightheaded
erythemia extending to upper forearm w/mod swelling around inject site-swelling noted total circumfrenace of arm 3.5 cm larger than lt arm;
I was not able to move my arm without pain in my shoulder joint for weeks afterwards. Now, 2 months later, I have more range of motion but still have pain in the joint and upper arm muscle when I open my arm wide.  The injection site was higher than usual and they used a 1 in needle,  I weigh 120 lbs.  When I went for my 2nd vaccine I mentioned it to the person who administered the shot and she did it lower on my arm and also didn't go in all of the way, there was only 1 in needles available.   I have not seen a physician about this as I'm hoping it will go away.
9:29 am 8-2-05 Recd Pediarix vaccine left anterior thigh. PM 8-3-05 in afternoon begin to notice swelling and fever at site on left anterior thigh. PM 8-3-05 concerned parent took to ER for evaluation. Recd Benadryl and Tylenol in ER on 8/3/05.
tingling in both hands; sore arm; chills; "stomach thing"; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 55-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 3rd December 2020, the patient received Boostrix. On 10th December 2020, 7 days after receiving Boostrix, the patient experienced tingling of extremity. In December 2020, the patient experienced pain in arm, chills and gastric disorder. On an unknown date, the outcome of the tingling of extremity, pain in arm, chills and gastric disorder were unknown.   It was unknown if the reporter considered the tingling of extremity, pain in arm, chills and gastric disorder to be related to Boostrix.  Additional details were provided as follows: The patient reported for herself. The patient received Boostrix vaccine and a week later had some tingling in both hands. In December 2020, less than 2 weeks after vaccine administration, the patient had sore arm which to the patient was normal, chills and a stomach thing. The reporter consented to follow-up.
4 y. o received varicella vaccine on 4/21/09.  Developed edema of R arm extending from deltoid to mid forearm erythema over deltoid.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced injection site cellulitis. The outcome of the injection site cellulitis was unknown. The relatedness between injection site cellulitis and therapy with pneumococcal vaccine (manufacturer unknown) was not reported. Additional information is not expected because the reporter did not consent further follow up.
Experienced very itchy eyes approximately 25 minutes after the injection which lasted for about 3 hours.
A week after receiving my first shot, my arm got very sore again, my lymph nodes in my arm pit were swollen and sore and my entire body started to hurt. After the first day I noticed my body was hurting worse and I had become very tired and week and had no apatite. After about 3 days my body stopped hurting but I was not able to do anything except sleep because of how tired and week I was. I went to the local hospital and they tested me for all sorts of sicknesses and couldn't find anything wrong. They had me on monitors and did an IV of fluids.  2 days later i went to the doctor still very tired and week, they did more test and found nothing out of the ordinary.
About 1 hour after the injection I began to feel like I was getting the flu.  I was freezing, but no spike in temperature.  Immediately,  diarrhea started.  Diarrhea did not subside until Thursday mid-morning when the last bowel movement was soft, but not diarrhea.  I was very tired and had zero energy.   I had no appetite.  All symptoms subsided by mid-afternoon  Thursday.  I contacted my daughter who is an NP,  Level 1 Trauma and she said to continue to hydrate and complete this form ASAP.  It is currently Thursday evening and all symptoms are gone.
Numbness and weakness on left side of entire body, Sensitivity on left side, reoccurring migraines on left side of head ongoing from April. Numbness in right leg staring in May with shoulder pain and weakness in right arm and legs. Swelling in legs all symptoms are still present to date
As a result of a routine thyroid ultrasound two weeks after my March 3, 2021 dose of the Moderna vaccine, it was discovered that my cervical lymph nodes were enlarged. One month later, I was seen my Dr. an ENT,  who had me go to Hospital for a sonogram guided fine need aspiration to determine if I had lymphoma. At this appointment, the technician discovered that my lymph nodes had shrunk to a normal size. The radiologist then came in to do the imaging himself and he concluded that there was no longer any suspicious lymph nodes to biopsy as they were not suspicious any longer. This doctor stated he suspected I was having a reaction to the COVID-19 vaccine.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/27/2021. PATIENT FULLY VACCINATED ON 07/10/2021.
Atrial flutters which are continuing. EKG confirmed. Increaed Carvedilol medication to 50mg/day from previous dose of 25mg/day. Added blood thinner Elequis.
Information has been received from a nurse with a Bachelor of Science in Nursing concerning a female who on 07-JAN-2011 was vaccinated orally with a third dose of ROTATEQ (lot # 668334/0515Z, expired date 21-APR-2012). On 07-JAN-2011 the patient started screaming but received the complete dose. No treatment was given for this adverse event. Patient sought medical attention which happened in office. At the time of reporting, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
9-16-11 Redness came up on left shoulder & moved up to face. 9-19-11 Raised red spots came up & have scabbed over on face & only left side from shoulder up. Itching began 9-16-11. Applied > Triamcinolone 0.5%.
As per mom allergic reaction from vaccine. As per provider: Right upper arm erythema edema indurated 9cm x 9cm
Thyroid is still high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), outcome "not recovered", described as "Thyroid is still high". Relevant laboratory tests and procedures are available in the appropriate section.      Additional information: The patient had a severe reaction about that thing, her thyroid was still high now, she doesn't know what.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
INFECTION DEVELOPED APPROX 3 DAYS POST VACCINATION CAUSING SORENESS IN LEFT ARM. PT SOUGHT TREATMENT AT A WALK-IN CLINIC AND WAS PRESCRIBED 2 ANTIBIOTICS, NAUSEA MEDICATION AND PAIN MEDICATION. THE PROVIDER DID NOT ATTRIBUTE HER SYMPTOMS TO THE VACCINATION NECESSARILY.
Almost received vaccine when breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Almost received vaccine when breastfeeding) in a  neonate of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Almost received vaccine when breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Almost received vaccine when breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported  Treatment information was not reported
Patient received vaccine on the afternoon of 01/11/21 and began feeling ill around 8 PM on that evening. Patient reported "big red splotch" around the injection site, as well as bilateral pain in both arms, as well as the neck and shoulders that required icing and pain relief. Additionally, the patient reported increases in both heart rate and blood pressure during this time. The appearance of the area resembled a large bee sting. As of 01/15/21, the patient is reporting a return to normal, aside from a continued mark around the vaccine site.
consistent diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 08:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 10:00, about 1 hour after the vaccination, the patient began having consistent diarrhoea that lasted approximately 12 hours, otherwise, the patient had no other adverse effects. No therapeutic measures were taken as a result of the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the event diarrhoea was recovered on 01Apr2021.   No follow-up attempts are needed; information about the lot number cannot be obtained.
ZOSTAVAX given twice 8/15/12 & 9/24/12.
This case was reported by a physician via sales rep and described the occurrence of lethargy in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than year after receiving SHINGRIX, the patient experienced lethargy, pain in arm, erythema of extremities and tiredness. On an unknown date, the outcome of the lethargy, pain in arm, erythema of extremities and tiredness were unknown. It was unknown if the reporter considered the lethargy, pain in arm, erythema of extremities and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient had 2.5 days of severe arm pain with redness and the patient also felt tired and lethargic. The physician did not feel it was outside of the pain reported labeling adverse events.
The patient called and said she is having "Covid Arm". She said the symptoms started 9 days after the 1st dose and she was having itchiness, soreness, redness at the injection site. She described the injection site reaction as being "as big as a baseball" I encouraged her to go to urgent care or to her PCP.
Child ok til 90 min after shots went dizzy and pale 20 - 30 seconds with slow recovery to normal over 1 - 2 hours.
No adverse effects reported; patient received improperly stored dose of vaccine; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medications, medical history and drug reactions/allergies were not provided.   On 23-SEP-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant Human albumin)) (lot # S009756, expiration date 27-SEP-2020; vaccine dosage detail and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (product storage error). Current temperature excursion was -14 Celsius degrees to -10 Celsius degrees (-13 Celsius degrees) for 3 days. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products and Treatment medication were reported.   This case was linked to MOD-2021-200231, MOD-2021-245676, MOD-2021-245668 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up received, contains gender updated, dosage regimen details updated and race updated.
This spontaneous report was received from a pharmacist concerning a 70 year old male patient. On 17-SEP-2012, the patient was vaccinated with an expired dose of 0.5 milliliter PNEUMOVAX 23, intramuscularly. Lot number was reported as 669579/0595AA and the expiry date was reported as 30-AUG-2012. No concomitant medications were reported. No other adverse effect was reported. Additional information has been requested.
Patient stated that a few hours after she recieved vaccine, she felt nauseous, dizzy, extreme fatigue, and just an overall uneasy feeling. Patient had a bruise about 4 in x 4 in on her upper left arm where she received the vaccination. Patient had received flu shots and other vaccines in the past and has never had an issue until this vaccine. Symptoms started on 9/10 after patient received vaccination, and resolved on their own by 9/11 in the afternoon. Advised the patient to use tylenol for pain relief if needed, ice pack for bruising. Patient stated she had no reason to seek medical care, just stayed in bed all day.
Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg on day 5-6, 10 mg on day 7-8, 5 mg on day 9-10. Prescribed on 1/20/2021. Then on 3/3/2021 prescribed prednisone 20 mg tablets TAKE 1 TABLET 3 TIMES A DAY FOR 7 DAYS, THEN 1 TABLET 2 TIMES A DAY FOR 4 DAYS, THEN 1 TABLET D FOR 4 DAYS, THEN 1/2 TABLET D FOR 4 DAYS. Currently still has hearing loss and ringing in the ear.
Immediate pain and itch as injection was going in my arm like the first injection.  Followed by, like the first injection,  mouth and throat numbness less than 2 minutes after.  Following day arms was red, hot and swollen as to be expected, however redness kept increasing with itch and severe pain.
Extreme shortness of breath, wheezing and fatigue which she has never had before. Dad called to tell me mom had Covid. She had not been out of the house for weeks so I bought a covid test  and administered it and it was NEGATIVE. I said you don?t have covid. She said she knows her body and had never felt like this before   I said I was taking her to see her PCP. Dr  listened to her Lu gas and heart and immediately ordered a EKG where they  confirmed she was in AFIB. He instructed us to go immediately to ER and when we arrived they had EKG from  and started triage immediately putting her on a blood thinner to prevent clots and IV Diltiazem. 48 hrs later still in AFIB. Dr choose not to do trans esophageal shock due to some fluid in lungs and around heart
April 19, 2022 (~ 2:30pm) received Moderna Booster shot .  Typical malaise experienced for ~ 24 hours. April 21, 2022 (11:30am) abdominal pain began on right side of abdomen.  Over the counter  Beano and Peptobismol taken.  Warm compresses given.  Pain continued and intensified.  At 3pm went to ER.  Lab work drawn.  CT scan done at 6-6:30pm.  Results showed Acute Appendicitis.  Emergency surgery done at ~ 8:30pm.
C/o swelling under chin & throat & felt like speech was sluggish & just didn't feel herself starting the A.M after vaccines were administered reports symptoms lasted 2 days felt ok & symptom free by Sat. the 30th of Oct.
Blood Clot on brain. Taken by ambulance from home at 11:? to Hospital. CT Scan, Injected with blood thinner on steroids, Life flighted to  Hospital. Surgery to remove blood clot. 5 days in hospital.
w/in 18hrs of shots pt developed erythema multiforme rash; no fever, no mucosal lesions;
Skin rash; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Skin rash) in a 62-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE: Moderna COVID-19 vaccine induced skin rash. Vis J Emerg Med;25:101108     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Skin rash) (seriousness criterion hospitalization). At the time of the report, RASH (Skin rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered RASH (Skin rash) to be related.    No concomitant and treatment medication were reported.  Company Comment: This literature non-study case concerns a 62-year-old, male patient with no reported medical history, who experienced the unexpected, serious (hospitalized) event of Rash. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non-study case concerns a 62-year-old, male patient with no reported medical history, who experienced the unexpected, serious (hospitalized) event of Rash. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.