chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the vaccine outdoors in my car at the local fairgrounds.  Within 10 minutes of receiving the vaccine, I briefly experienced a rapid heartbeat.  I could breathe and swallow fine but for several minutes (maybe 20 or so) my throat felt heavy.  My most concerning symptom was blurred vision that would come and go. At times my near sighted vision was completely blurry but far sighted was fine, at times all my vision was so blurry I couldn't see anything and at one point all I saw was a bright white light, I think my vision was trying to adjust to the sunlight when this happened.   All of these symptoms cleared shortly before my 30 minute waiting period was over. After that I just experienced symptoms that I have read about that is common for the vaccine.
Pt recvd vax & was sluggish, irritable & had jaundice; liver & spleen were palpable; MD felt pt had hepatosplenomegaly & cholestatic jaundice; inc liver enzymes; GGT 245; dx infectious hepatitis;
pt recv vax 29APR96 & 12MAY97 pt exp chickenpox w/30 to 40 lesions;
Patient got her first 1 of the vaccine and was observed by a nurse for 15 minutes in the observation area.  After 15 minutes she was okay and left. Few minutes after she came back not feeling well. Patient was nauseous, shaking , and feeling week. She was escorted to a stretcher where our nurse started assessing her.  She was given juice and chocolate to raise her blood sugar. EMS arrived at the scene and she underwent further assessments.  Blood sugar was 84 mg/dl and most likely she was hypoglycemic.  Patient was assessed more and she got more time to rest she felt better after some time but she reported she was still week. EMS advised to go to a hospital, but patient refused. Patient said she will be following with her primary care as she's been experiencing similar episodes and to discuss with her doctor if she will be getting a second dose.
This spontaneous report was received from a nurse refers to a multiple unknown patients of unknown age and gender. The multiple patients' pertinent medical history, Drug Reactions/Allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M037014 and expiry date: 22-NOV-2017) for prophylaxis along with properly stored doses of sterile diluent (lot and expiration date unknown by the reporter). The vaccine was exposed to temperature excursion of 6 Degrees Fahrenheit (°F) to 14° F for 5 hours. There were no previous temperature excursion reported. The call was not due to data logger. No adverse effects were reported. No product quality complaint was filed. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA013329: US-009507513-1709USA001928.
Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 an unknown date, the patient experienced VACCINATION COMPLICATION (Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.). At the time of the report, VACCINATION COMPLICATION (Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
started with tingling in mask like distribution on face.  Waited for 4-5 min to see if would resolve and it didn't.  Throat itchy , but no sob, no hives.  given 50 mg benadryl and it resolved within 10 min. no progression of symptoms
High blood sugar, Fever, Sleepy, Very high resting pulse rate, vomiting, diarrhea, extreme soreness at injection site, intense itching or burning feeling under skin.
She started having horrible cramps and bleeding the morning after the 2nd COVID-19 Shot.; She started having horrible cramps and bleeding the morning after the 2nd Covid Shot.; Also had horrible body aches and a headache; Also had horrible body aches and a headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 13Sep2021 at 18:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included idiopathic cranial pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), duloxetine (MANUFACTURER UNKNOWN) 60 mg and etonogestrel (NEXPLANON) for unknown indication from an unknown date and unknown if ongoing. The patient previously received loratadine (CLARITINE) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Aug2021 at 19:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had nexplanon implant and she was not supposed to menstruate with that. On 14Sep2021 at 08:00, patient started having horrible cramps and bleeding, reportedly the morning after the 2nd COVID-19 shot. The patient also had horrible body aches and a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible cramps, bleeding the morning after the 2nd COVID-19 shot, horrible body aches and headache was not recovered at the time of this report.
12 yo female injected by NP provider against management advice and consent signed by NP instead of a parent/legal guardian. We were advised by a public health nurse to report this as the administration of COVID-19 Janssen vaccine to a 12  year old is considered as a medication error due to the patient being under an unauthorized age group.
presented to ER with progressive shortness of breath. tested positive for COVID-19.Patient has acute on chronic respiratory failure with hypoxia and COPD exacerbation.   O2 requirement improved, down to 2 L nasal cannula   empiric antibiotic,  IV steroids.  home with home health.
DIARRHEA, BLURRED VISION, FEVER, CHILLS, VOMITTING
rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on left arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced RASH (rash on left arm). At the time of the report, RASH (rash on left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided.
Patient said that she was having tightness of chest/slight itching,back tightness  , she stated that she had some allergies that periodically caused this type of reaction.  I gave her 25mg of generic benadryl. she waited a few minutes and said  she felt better but knew that she would have a headache later today.,  I called her at home at about 5pm and  she stated that she was  ok, but she did get the headache she expected.
Pharmacist reported that a 21 years old patient received first and only dose of GARDASIL 9 when she was 14 years old; No additional adverse events were reported; This spontaneous report was received from a registered pharmacist and refers to a 21-year-old female patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On unknown date in 2016 when the patient was 14-years-old, the patient received first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  for prophylaxis (quantity dose, lot #, expiration date and route were not reported) (inappropriate schedule of product administration). No additional adverse events and nor product quality complain were reported.
Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported.
Large welts noted behind both ears and back of neck. Reddened in color, itchiness present.
No adverse event; 2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine).    Concomitant products were not provided. Treatment medication were not reported.  2.5 ml vial was initially stored in the refrigerator on 14FEB2023. It was reported that there was no temperature excursion.   This case was linked to US-MODERNATX, INC.-MOD-2023-710773 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710773:Male child case
Patient was given a Dtap instead of Tdap and when I noticed I stopped patient from leaving and gave Tdap Mom and patient were informed of the mistake.
This case was reported by a healthcare professional (nurse) and described the occurrence of dizziness in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Anti-hypercholesterolaemic. On 4 October 2012 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). On 4 October 2012, 5 to 10 minutes after vaccination with FLULAVAL, the subject experienced dizziness, flushing, rapid heart rate and lightheaded. A pharmaceutical product complaint has been reported. The nurse notes that "she may have a defective batch of FLULAVAL" since this dose was one of the first injections used out of a new vial. The healthcare professional (nurse) reported that all events were probably related to vaccination with FLULAVAL. At the time of reporting the outcome of the events were resolved. The nurse reported another subject receiving FLULAVAL and experienced adverse events. See case A0999490A for details on the other subject. This case was associated with a product quality complaint for FLULAVAL. "A registered nurse reports that she received a suspect batch of FLULAVAL. She notes that she opened a new vial, and the very first 2 patients who received the injection had systemic side effects. Vials were stored under recommended conditions. Nothing looked out of normal when the product was visibly inspected." Quality Assurance (QA) results received on 19 November 2012. Based on the fact that no precise technical problem was reported, and based on the conforming results of the Quality Control visual appearance test, performed on the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Chills, vomiting, fever 104, upset stomach, low energy level, headache
Headaches 2 weeks after second dose with auras and migraines triggered; Headaches 2 weeks after second dose with auras and migraines triggered; Chills without fever; general malaise; yeast infection; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received (BNT162B2, Solution for injection, Batch/Lot Number: en6200), second dose via an unspecified route of administration, administered in Arm Left on 21Feb2021 at 14:45 (at the age of 33 years old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included body mass index from an unknown date and unknown if ongoing other medical history-31 BMI, asthma from an unknown date and unknown if ongoing other medical history-Asthma, blood cholesterol from an unknown date and unknown if ongoing other medical history-Cholesterol, migraine from an unspecified date and unknown if ongoing other medical history-Migraines, anxiety from an unspecified date and unknown if ongoing other medical history-Anxiety. 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 have any known allergic reactions. Concomitant medications included vitamin d3 taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride taken for an unspecified indication, start and stop date were not reported; sumatriptan taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el9264) via an unspecified route of administration, administered in Arm Left on 31Jan2021 at 15:30 (at the age of 33 years old) as 1ST DOSE, SINGLE for covid-19 immunisation. On 22Feb2021 at 14:00 the patient experienced headaches 2 weeks after second dose with auras and migraines triggered headaches, chills without fever, general malaise, yeast infection. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
09/26/2013-1634-pt sitting on exam table, author providing post inoculation edu. Eyes dilated to 7mm, expression went flat, mute and fell back to supine on table. After 30 sec of silence pt blinks, pupils return to 3mm, patient smiles and states "I'm fine". She laid supine for 15 minutes, sits up. Left ambulatory with mom at side. No s/s of acute distress.
Case number PHEH2013US025792 is an initial spontaneous report received from a consumer (patient) on 12 Dec 2013. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: unknown), with first dose on 03 Nov 2013 (day 0) and second dose on 06 Nov 2013 (day 3). He was vaccinated with IMOVAX (other manufacturer, batch number: unknown) intramuscularly as third dose on 11 Nov 2013 (day 7). On the same day, immediately after IMOVAX administration, he felt pale, could not breathe, had arm pain and went to cardiologist who gave him a tetanus shot that helped him to breathe. He was 99.99% sure that it was acute blood poisoning. He insisted that he overheard that the nurse saying it was the first time administering IMOVAX to a patient and therefore he believed that the nurse had caused acute blood poisoning. He received treatment with IV fluids, an HIV cocktail (started the day after IMOVAX), and antibiotics that were taken for the arm pain (starting with CIPRO followed by LEVAQUIN). His WBC level was increased, after IMOVAX administration, compared to the values seen one week prior. He also reported that "his immune system crashed three weeks ago after an exchange of body fluids that occurred" which was treated with TRUVADA, which allowed him to breathe 90% better. He received remaining two post exposure injections with RABAVERT (batch number unknown) on unspecified dates. He stated that he was 99 to 100% sure that he had reported all the events. Outcome of the events was unknown. No seriousness and causality was reported for the events.
Swelling to L upper arm approx. 1/2 size of baseball, reddness noted, warm to touch.
10:45 patient complained itchy uncomfortable feeling in her throat. Was able to swallow and move air. She stated she did not come to clinic with this complaint.  Benadryl 25mg given PO with 16 Oz of water.  Observation per NP and EMS. vs 10:47 190/106/ SAT on RA 99%. 10:55 BP 200/113, HR 75; SAT 99 RA. Lungs clear, moving air, no SOB, no stridor or wheezing. Moved patient on stretcher to more private area with husband.  11:35 - No further complaints of itchy throat.  BP 163/93;HR 75; R 20.  Erythema noted on posterior pharynx. Uvula midline.  Discharged home 11:35.
Qty of (8) Seizure events-(epileptic grand mal type) (1) on Nov-15,  (1) on Nov-21,  (3) on Nov-30,  (2) on Dec-12. She has had a (3) ER visits, (2) ambulance rides, bloodwork each time and suffers with post seizure induced dehydration and bad headaches.  Visit with Neuro-Ped and started taking Keppra at 500mg twice  daily, increased to 1000mg twice daily, now as of 12/13/21 she is up to 1500mg twice daily.
Systemic: swelling of left knee and cramping in left leg -Medium, Systemic: Joint Pain-Medium
Patient described feeling very fatigued, severe headaches and severe arm right pain radiating into her neck. She also described nausea from the pain any time she moved her arm. This started the day after receiving the vaccine. Following up the next day (2 days post vaccination) the patient said the symptoms were resolving though she still had a little pain.
Received ADACEL.  Injection was given high on L shoulder near joint.  Had worsening pain and limited range of motion for a week after the injection before it slowly began to improve.  Now, 3 months later there is still residual pain in the L shoulder when certain movements.
I have had two adverse events since my series of COVID vaccines: Abdominal spasms, many tests, biopsy, result: medication Pantoprozole and regular follow ups.  Multiple Myeloma: no symptoms; regular check up blood test indicated the presence of the disease. Numerous tests: blood, urine, P.E.T./CT scan, bone marrow biopsy.  Confirmed diagnosis - currently on watch protocol with 2 month blood testing
I believe I had a sudden drop in Serotonin levels.  I became very depressed very quickly.  I even had thoughts of suicide surface.  I did not reach out for help because I knew I could manage it.  I have worked in mental health and chemical dependency.  It lasted about 6 hours and then I was fine.  In retrospect, I believe I had a similar reaction with the first injection on February 8th, 2021 at 10 am  with the reaction starting about 7 pm that evening and lasting 24 hours.  I did not connect it to the vaccine at that point.  I have been talking to a therapist since the beginning of the pandemic due to isolation I have been experiencing mild depression that comes and goes but is very manageable.  This was much more intense and more sudden and immediate.  I did not feel at risk even with suicidal ideation, but felt I should report it because if other less experience, educated people experience this it could be dangerous.  It took me so long to report because, in my 70's, I couldn't figure out how until one of my children visited and showed me.
Rt deltoid area swollen since vaccine was given on 1/26/14, bright red rashes, very hard around and at vaccine site, painful to movements of Rt arm pain radiates to my right neck. Heat application only. On Sunday, January 26, 2014, I went to clinic to have a PPD and a TDAP vaccination, a requirement of my school for my upcoming advanced nursing clinical. I received the two vaccines, the PPD in my left forearm and the TDAP my right deltoid. The next morning I felt pain, soreness and swelling in my right arm, at and around the vaccination site. I am aware that these symptoms are usually indicated after most vaccines but my arm had a rash started at and around the vaccine area, it became hard and swollen, pain continues and radiates to my neck. I applied heat compress and applied some BENADRYL cream but it did not feel any better. I went back to the clinic on Wednesday to have my PPD read and spoke with the CRNP that was there; I showed her the vaccine site, she had no explanation for the reaction. Today, the date of this letter is six days, my arm is still as previously indicated, except the rashes are less visible but the redness remains. I have never had the TDAP vaccine before but it 2007, I had the DT booster which was also required by my school for clinical. Following that vaccine, I had soreness, mild pain with red rashes that looked more like red bumps (similar to pox). The CRNP who administered the vaccine let me speak with the physician from (infectious disease). His response was "This is a normal reaction, apply heat and some BENADRYL and in a few days it should be fine". In about four days, the pain, soreness, swelling and red rashes/bumps subsided and I was ok. Unfortunately, the experience with the TDAP is prolonged now to six days with all the above mentioned symptoms and the heat and BENADRYL is not effective in this case. I would like to know, what is the component in this vaccine that causes this reaction. I was given this form to report this problem and will appreciate your feedback as soon as possible.