chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was really sore; Muscle soreness; This is a spontaneous report from a contactable Consumer (Patient).  A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 03Feb2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medicines were not reported. Patient stated that she had to take Tylenol 3 times yesterday (on 03Feb2021, on the day of vaccination) for muscle soreness and her arm was really sore, so she took, Tylenol three times yesterday (One day before this report, 03Feb2021) and a friend of her told that they read online that once you get the vaccine then you should not take the Tylenol. Patient was asking that will that Acetaminophen decrease the effectiveness of the vaccine.
Slight sore throat.  Aches & pains in joints whole body.  Started with symptoms with in 1 1/2 to 2 hours after vaccine.  Took TYLENOL (symptoms lasted 3 days.
On Friday 1/22/21 9:30 pm patient reports sudden onset of visual changes such as double vision with vertigo. He presented to Hospital to the emergency room. Treatment CT (negative) -blood work then transferred to healthcare facility via ambulance where he had an MRI (negative) and a CTA (negative). He was diagnosed with Lateral Sixth Nerve Palsy. He was intructed to follow with ophthamalogy and neurology and priamry care providers.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 2nd dose01/27/21 Diagnosed covid positive:09/10/21 Symptom onset:09/06/21 Exposure:Home Symptoms:cough, muscle aches,runny nose
This spontaneous report as received from a 82 year old male consumer. On 01-NOV-2012 the patient with no drug reactions/allergies was vaccinated with ZOSTAVAX (lot number was not reported) developed a severe itching rash on his legs the same day. There was no concomitant therapy. The rash progressed quickly and has maintained its severity. The patient explained that the rash became so severe at times that he was unable to sleep, sometimes for 2 night stretches. The patient had sought medical attention with 3-4 dermatologist who associated the rash with Eczema, however the Vascular physician who also evaluated the patient did not feel that Eczema was an accurate diagnosis. The patient treated with OTC topical creams. Biopsy completed and confirmed to rule out scabie infection. The outcome of event was unknown. The patient received unspecified flu vaccine 1 week after ZOSTAVAX vaccination. Additional information has been requested.
I need to know if I can take the booster when I was allergic to Moderna; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (I need to know if I can take the booster when I was allergic to Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced ALLERGY TO VACCINE (I need to know if I can take the booster when I was allergic to Moderna). At the time of the report, ALLERGY TO VACCINE (I need to know if I can take the booster when I was allergic to Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication 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.
Fever; headache; skin sensitivity; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162), via an unspecified route of administration in the left arm on 10Apr2021 at 17:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 13:00, the patient experienced fever, headache, skin sensitivity and joint pain. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events fever, headache, skin sensitivity and joint pain was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Symptoms started developing shortly after receiving first dose of Moderna COVID-19 vaccine including cough, myalgia, and body aches. She was experiencing worsening shortness of breath and presented to the emergency department on 4/18/21. She was found to have COVID-19 and was admitted to the hospital for further management.
Patient tested positive 1/12/22, treated with oxygen, steriods, remdesover, Toci-monoclonal antibiodies. Developed acute kidney injury on 1/19/2022 and family made patient comfort care. Expired on 1/20/2022
Clinical Summary Patient is a 82 y.o. female with a history of Afib, HTN, provoked PE who presented to the ED with cough, shortness of breath, found to have COVID 19 with hypoxic and was transferred to the ICU 12/15/2022 for further care and required HHFNC. Another HCF assumed care out of ICU.   1. Acute hypoxic respiratory failure: secondary to COVID 19. CTPA was negative for PE, with pulmonary edema and small Rt pleural effusion. Was initially on NRB then HHFNC and now weaned to RA. S/P diuresis. Home O2 evaluation completed no need for home o2.  2. COVID 19 pneumonia: vaccinated. Symptom onset 12/14. Positve on 12/15/22. Continued dexamethasone (started 12/15/22).  3. Afib: with brief episode of RVR on admission. Secondary to MR. Continued BB (pt stated she is not sure if she will continue this at home as how it makes her feel). Not on AC or antiarrythmic, stopped taking 1 year ago recommended continue AC and discuss with her PCP prior to stopping pt stated she is not sure if she will take it. Continue to monitor.  4. HTN: Per history. BP stable. Continued current medications (on half of home dose BB). Continue to monitor as outpatient 5. Hypokalemia: K 3.2. monitor and replace as needed. Resolved 6. Hyponatremia: Na 130. Improving. Resolved. 7. Elevated troponin: suspected demand ischemia secondary to hypoxia. Denies chest pain. Down trended. No further ischemic evaluation at this time 8. Reported weight loss: 10-12 lbs in the past year. May consider OP work up.  9. Incidental finding: Aortic root dilation seen on ECHO mild 3.5 cm. Recommend OP follow up with ECHO.
Mother states fever 100.5 for 1 1/2 days (since injection) Rt side shaking and staring for 30 seconds thinking it was a seizure.
Arm is little sore; This is a spontaneous report from a contactable consumer (Patient's husband). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485; Expiration Date: Oct2021), via an unspecified route of administration, administered in arm on 05Aug2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization.  Medical history included asthma. The patient had no concomitant medication.  The patient after her 1st dose had little sore in the injection area. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
The first thing I noticed was sore throat, lymph nodes on my neck (both sides) was swollen. It felt like I had the mumps and this was the worse sore throat I ever experienced could barely swallow water. I had a low grade fever went to clinic for Covid,Strep (results negative). My symptoms lasted for 36 hrs.
Patient fainted after getting up right after receiving 2nd vaccination.  He hit his head on the wall on his way down and I was unable to catch him since he was 6' - 220 lbs+.
Patient reported lightheadedness, dizziness and spreading myalgia within 30 mins of receiving the 3rd dose of the Pfizer vaccine
Swelling 4.5cm x 4.5 cm, erythema, warmth at injection site.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021.  No treatment information was provided.
This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a adult female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced near death experience (serious criteria GSK medically significant) and feels awful. On an unknown date, the outcome of the near death experience and feels awful were unknown. It was unknown if the reporter considered the near death experience and feels awful to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that, Tdap vaccine surely did her and it was horrible. The patient was trying to protect her grand babies and stated Dtap vaccine almost killed her. The patient stated that she did not care what anyone said.
Information has been received from a nurse, via a company representative, concerning "a  number of patients" who were vaccinated with a dose of PNEUMOVAX 23 (dates, and lot # not provided), and developed cellulitis. Follow up information received from a healthcare professional identified a 58 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 (lot #654977/0888F) and subsequently developed "redness that radiated down her arm from the injection site." Therapy included VICODIN. At the time of this report, the outcome of cellulitis was unknown. Attempts to obtain additional identifying information to distinguish the individual patients mentioned in this report, resulted in two additional reports of patients who developed cellulitis following vaccinations with PNEUMOVAX 23 (lot #654977/0888F) (WAES #0709USA03917 and 0709USA03918). Additional information has been requested.
Case previously recorded as MA2009-5159. Initial case report received from a physician via MedCom on 19 NOV 2009. A patient 1-year-old female was vaccinated inadvertently with S-OIV FLUVIRIN (batch no. 102124P1) once i.m on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Symptoms started about 3 weeks after the last shot 4/5/22, and continued to worsening over the next 5-6 months. In early December symptoms started to abate but are still debilitating. Symptoms include:Extreme fatigue Muscle weakness especially in legs and arms A sense of being choked, difficulty swallowing Sense of pressure in my sinuses and swelling in my neck Headaches Feeling faint, that resulted in two separate ER visits (6/11/22 and 8/2/22)
Suspected vaccination failure; I know 6 people that got the shot and then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The reporter reported that, he/she knew the patient who received Shingles vaccine and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of singles were not provided.    This was 1 of 6 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161267:Same reporter. Pt. 1/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6
Left arm sore for 3-4 days after first dose. One week after first dose, experienced a erythema, induration & pruritis at vaccine site on left arm for about 36 hours, AKA "Covid Arm".
My lymph nodes in my left armpit were engaged.  It felt and looked like I had a small water balloon in my left armpit.  It was painful to lay on my side.   After 7 days, the swelling is gone but putting deodorant on is still tender.   in addition, my energy levels went up and down over a 7 day period.  Some days getting through work was challenging, even though I was working remotely.   Almost 10 days out, I don't feel 100% of where I was before the vaccine.
LUMBAR RADICULOPATHY; NUMBNESS ON BOTH ARMS; TINGLING ON BOTH ARMS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies, patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced lumbar radiculopathy. On 28-MAR-2021, the subject experienced numbness on both arms. On 28-MAR-2021, the subject experienced tingling on both arms.  On 30-MAR-2021, Laboratory data included: X-ray (NR: not provided) Lumbar radiculopathy diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumbar radiculopathy, numbness on both arms, and tingling on both arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
6 cm Bartholin's abscess developed approximately 4 weeks after second dose, abscess lanced, drained and a word catheter placed.
Joint pain in  left hand fingers shortly after; Muscle spasms in my upper left arm only; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EX0584 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 03Aug2021 at 11:00 hours (at the age of 33-years old) as dose 2, single for COVID-19 immunisation. The patient medical history included neuropathy peripheral, allergies to sulfa, eggs and dairy and COVID-19 (prior to vaccination) (all from an unknown date and unknown if ongoing). The patient's concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EX0584 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on an unspecified date in 2021 (at the age of 33-years old) as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On 04Aug2021 at 23:00 hours, patient experienced muscle spasms in her upper left arm only and joint pain in left hand fingers shortly after. Patent received no treatment for the events. Patient did not hospitalize for the events. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
headache; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on the left arm on 21Sep2020 at a single dose for immunization and influenza vaccine (FLU VACCINE), via an unspecified route of administration on the right arm on 21Sep2020 at an unspecified dose for immunization. Medical history included pneumonia from an unknown date and unknown if ongoing.  There were no concomitant medications. It was reported that the patient received the pneumococcal 13-valent conjugate vaccine and flu vaccine 21Sep2020 and on 22Sep2020, the patient has had a headache ever since. She wanted to know what she can do about the headache and is it safe to take the COVID-19 vaccine or wait until the headaches stops. She has had this headache since she got the pneumococcal 13-valent conjugate vaccine and she has seen several doctors and had a MRI, she's had head scans and chest scans and everything they could think of, the doctors are stumped. Sometimes, she takes Advil and it will go away sometimes it will not go away. She was wondering if others have had that experience and what they have done about it. She does not have any dose information for the pneumococcal 13-valent conjugate vaccine. She said it was the first dose of pneumococcal 13-valent conjugate vaccine. She understands there are 2, you get the first one and later you get a second one. When asked for the indication, she stated that with the COVID virus many people her age was dying from pneumonia. She had pneumonia 40 years ago so she figured it would be a good idea to get the pneumonia vaccine first and then see if it is compatible with the COVID vaccine but she does not want to get the COVID vaccine if she still has a headache. She did not know what the name of the flu vaccine was. She just knew they gave the flu vaccine in the right arm and pneumococcal 13-valent conjugate vaccine in the left arm and she said they would not counteract each other, they were safe, so she took her word for it. Indication for flu vaccine: The doctor wanted her and her husband to get it, he is 88 and she is 80 so the doctor wanted them to get it to protect them through the winter. He wanted them to get it in Sep before the flu season hit. No further information provided. She says there is no other medicines medical conditions or lab results to add. That is what has stumped her. She has been in excellent health for her age. The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain , feels like heavy, elephant sitting on chest. . No trouble breathing. And fever from vaccine