chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.).    Concomitant medications were not provided by the reporter. Vial was pulled from the ultra cold on 13-Jul-2022 (no time listed), its used by day was 11-Aug-2022. Based on the count, 13-Jul-2022 was counted as day 1. Vaccine was administered to patient on 12-Aug-2022 before 11 am. Number of doses/vials were 4 infants doses. Vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 13-Jul-2022 Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-628905, US-MODERNATX, INC.-MOD-2022-628903, US-MODERNATX, INC.-MOD-2022-628906 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628905:Infant patient 3 US-MODERNATX, INC.-MOD-2022-628903:Infant patient 2 US-MODERNATX, INC.-MOD-2022-628906:Infant patient 4
PATIENT SAID ABOUT 30 SECONDS AFTER GETTING THE VACCINE, HIS LEFT ARM STARTED HURTING FROM THE SHOULDER TO THE ELBOW. THEN, HE GOT A HEADACHE AND FELT REALLY NAUSEOUS AND SO DIZZY. HE SAID HE FELT LIKE GETTING A HOT FLASH, HIS SKIN FELT REALLY HOT, AND HE SWEAT A LOT. AFTER SITTING DOWN, DRINKING WATER AND REST FOR ABOUT 15 MINUTES, HE FELT BETTER. AFTER 30 MINUTES, HE SAID HE FELT NORMAL LIKE BEFORE GETTING THE IMMUNIZATION WITH NO SYMPTOMS.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Itching, 4 hives, palpitations, headache, ringing in ears, pulse of 92 to 100 for over a week.  Symptoms progressed to chills, fatigue, loss of appetite, loss of taste, congestion, and sinus infection.
Client received CanSino COVID vaccine, no reaction. CanSino vaccine not approved. Pfizer given as an alternative on 09/23/21.
This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the first of eight reports. A patient of unspecified age, ethnicity and gender received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine. Follow-up (16Aug2016): This is a follow-up spontaneous report from a contactable physician. This physician reported for a patient that: Suspect products: TRUMENBA. Adverse events: No new adverse event. Patient Details: Is the patient also the reporter: No. Reporter Details: Is it ok for us to contact you should we have further questions about this report: Yes. What happened: No new adverse event. Products: Suspect products: TRUMENBA. Is this a Pfizer product: Yes. History: Additional Context: Other Reference(s): Forwarded to agency. Additional Context: This is the first report. This is for the first report #. The physician mentioned that he was responding to the mailing he got from the Pfizer asking him to fill out some fax regarding a safety issue for TRUMENBA about which he had called and inquire back in Jul, at that time he indicated to the Pfizer's agent that he did not have any direct information as he was seeing the patient but the vaccine was given by Primary Care Physician and he used to file various reports, so in his understanding it was sufficient and he did not want to do all the reporting as the Primary Healthcare Physician already done that and he also did not have any direct involvement or responsibility with the administration of them. He received multiple page questionnaires. He provided the report# as # and #. The first letter identifies the patient by his initial and second one said unknown but all of his conversations was about the one patient so it was looking like they have generated the second report which was really the same. He wanted Pfizer to stop sending him the letters as it was either helpful or necessary because the paediatrician have administered the vaccine and had already reported all the information. Causality was not available over the call. This case is in cross linked with #. Is there a product complaint to report?: No. Follow-up (16Aug2016): This follow up report contains no new safety information. Follow-up attempts completed. No further information expected.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; 42 Dose administered after 30-day use by date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD). an unknown date, the patient experienced PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date).    Concomitant medication details not reported by the reporter. Vial size was reported as 0.4 ml per vial. Vial was initially stored in refrigerator on 23-DEC-2022. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter. This case contains information about patient 19th out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Patient 1 (Master Case)
Pt developed sudden onset of nausea; drive heaves, chills, anorexia and abdominal pain; She went to the ER and was diagnosed with pancreatitis with elevated lipase, abnormal LFTs and an elevated white cell count.
Normal side effects for 2 days after the shot i.e. pain atound injection site, fever and chills. Two weeks later, high fever and chills for 2 days that lowered with Tylenol. Then rash appeared on abdomen, turned vesicular. For next 2 days more rashes and continued fever, blisters spread to chest, back, face, scalp, arms, legs. Contacted doctor as blisters started spreading. Doctor suspected Chicken pox reviewing pictures of blisters/rash. Started treatment using Valacyclovir. As of reporting, day 6 after adverse reaction started. Advised postponeing second dose for 2 weeks at least.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) 2-3 weeks ago (approximately on 24-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. The physician reported that one week after the vaccination the patient developed shingles on the chest area. No treatment information was reported. The patient sought unspecified medical attention. The outcome of shingles on the chest was reported as recovering. The relatedness for shingles on the chest was not provided for ZOSTAVAX. Additional information has been requested.
lightheaded, headache (everlasting), entire head pounding, short-term memory loss,
This study was received from the investigator in a trial on 02 September 2014. A 27 year-old male subject with past medical history of above normal ECG and dizziness/Fainting spells was found to have angina pectoris 12 days after the subject had received an injection of ACAM2000 (lot number and site of administration not reported) on 23 January 2014. The subject had previously received Anthrax vaccine (manufacturer, lot number, route and site of administration not reported) and Typhoid, ViCPs vaccine (manufacturer, lot number, route and site of administration not reported) on 13 January 2014. On 29 January 2014, the subject presented with an abnormal ECG. He was diagnosed with other and unspecified angina pectoris on 04 February 2014. No other laboratory test results were provided. Troponin I level was not performed. It was not reported whether the patient had received any corrective treatment. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Additional information will be requested from the investigator.
On 3/23/00, the pt presented to a physician with her arm red, swollen, and painful. The red swollen area ran from her shoulder to her elbow.
1 hr p/vax pt screamed a high pitch scream for 2 hrs, fever 101; mom didn't see a MD had fever for 24 hrs; got better fairly fast;
Joint pain, muscle pain, bone pain, vision disorder, aggressive, sleeping disorders, loss of memory and cramps.
MRI showed multiple acute infarcts within left frontal, left parietal, left post central gyrus, left occipital lobe
Patient reports sore arm (could not lift arm at all) for 7 days. Patient lost appetite and could not eat, had the chills, headache, and felt very seriously "sick" for at least 5 days after administration.
Per Dr.   "The patient had an adverse reaction to his first dose 4/30.     Initially, patient at first c/o tingling on the left upper lip, headache and feeling "sleepy."  No e/o angioedema.  He seems to initially be anxious about developing something similar to the prior reaction.  Patient given water and plan to monitor.  Patient has had long covid syndrome from prior dg of COVID in 1/2021.  Reassured patient and told him to stay calm.   While laying in the medical area.  The patient c/o throat tightening and difficulty speaking.  Daughter confirms that his voice has changed.  The patient has had normal vital signs.  No hives.  Activated anaphylaxis pathway.  He is now saying he can barely swallow his saliva.  Patient is objectively handling secretions well.   Epi administered and benadryl 50 PO given."
Patient returns with his mother for evaluation of left arm swelling. He received his Kinrix in the left deltoid about 72 hours ago. Technique was correct. Vaccine was correct. Lot and expiration dates are okay. He developed some tenderness and swelling that evening which has progressed over the weekend. he complains of discomfort, shortness, but no major pain. He is not particularly complaining of itching. It is mostly sore when other people push on it. He has no other symptoms. He specifically denies and his mother also denies sore joints, unusual rash, fevers chills or sweats. He has not had any nausea or vomiting. All vital signs are normal with temperature 99.4.
Fevers of 102, chills, night sweats, body aches, headaches, nausea.
fine for my 15 minute wait. Drove 5 miles to a store, walked in, and all of a sudden my pulse started to race and my head started pounding hard. I wear a FitBit and my pulse was ranging 120-150 on a SLOW walk inside the store.  I rested against a display, got what I needed, drove 10 miles home. My b/p was up because I also got a headache, and the ANXIETY and nausea I experienced was outrageous. My pulse raced throughout the rest of the afternoon into evening, I laid down in bed and rested quietly. Seems like I feel okay today, the anxiety and racing pulse are gone for good. Arm is hot, swollen, red at injection site, could not lie on my left side during the night.
Shoulder pain that just kept getting worse as time went on. Took Advil, but didn't help much. Next day, could even lift arm up without extreme pain. 2 Days later, pain has even worsened.
Patient reported to clinic for Pfizer Covid-19 vaccination.  Patient did not indicate on questionnaire that he had experienced fainting or severe reactions from receiving vaccinations before. About 5 seconds after receiving vaccination patient said he would like to sit for just a minute.  The clinic had a designated waiting area about 25 feet away where patients sit for 15 minutes after receiving vaccination.  My technician and I agreed that patient should stay seated in the same chair he was receiving the vaccination in so we would be right next to him.  After 2-3 minutes I noticed the patient had his eyes closed and then his head began to nod and he started to slump down in the chair.  As I went to patient's side to stabilize him he pushed his chair backwards away from me about 5 feet which caused him to roll to the right side of the chair and fall off hitting his head on the floor. My technician immediately called 911 and EMTs arrived in about 5 minutes.  A bystander who was a nurse helped me roll him onto his back and we propped his legs up with 2 cushions.  We took his blood pressure and pulse. Patient regained consciousness in about 30 seconds and the EMTs cleared him to stand up after about 15 minutes.  After patient had recovered, patient's mother who was there with patient and other siblings stated that the whole family has fainting episodes when receiving vaccinations. I informed patient's mother and patient to please inform any future vaccinators of these fainting episodes so they can be prepared.
Fatigue, stomach pain, fainting spells, anxiety attacks, feelings of pins and needles through legs and arms, shortness of breath, blurry vision.
Narrative: COVID Infection following COVID vaccine series 08/12 Jansseen, dose #1 08/31COVID swab, result: detected 08/31 SARS-COV-2 Variant Sequencing result: pending 08/27 pt cc: chills, cough, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown.
Flu like symptoms; Severe skin pain; Severe dehydration; High grade fever of 102F; Muscle pain; Joint pain; A spontaneous report was received from a consumer, concerning himself, a 29-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, severe skin pain, joint pain, severe dehydration, muscle pain and high grade fever of 102F.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A or 025T20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, four hours after the vaccine administration, the patient started too have flu like symptoms, then after eight hours he experienced fever of 100F and also severe skin pain and joint pain. The following morning, patient went to emergency room (ER) and was confirmed to be have a negative reaction to the Moderna vaccine. However, additionally, patient experienced severe dehydration, muscle pain and high-grade fever of 102F. Treatment for the events fever and dehydration included IV fluid and acetaminophen. No treatment information was provided for the events flu like symptoms, severe skin pain, joint pain and muscle pain.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the experienced flu like symptoms, severe skin pain, joint pain, severe dehydration, muscle pain and high-grade fever of 102F were not reported.; Reporter's Comments: This case concerns a 29 year old, , male patient, who experienced a non-serious unexpected event of influenza like illness, pain of skin, and dehydration, among others, 1 days after receiving mRNA- 1273 (Lot# 025J20A or 025T20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Localized redness, swelling, pain, and itching at injection site that started a week after injection.
24 HOURS LATER HE BECAME RIGID, BODY BEGAN TO DISCHARGE URINE AND BOWELS WITH NOT CONTROL I CALL 911 AND HE IS STILL IN THE HOSPITAL.
COMPLAINTS OF HEART RACING; 126/80; 104HR; 96%; 22 NL OBSERVED ADDITIONAL 15 MIN. REPEATT HR 98 SYMPTOMS RESOLVED
Vesicular lesions around left thigh where vaccine was injected, 2 months previously. Herpes Zoster.
01/07/2022 I had COVID symptoms including dry throat cough, nasal congestion, chest congestion, mild headache, and fatigue. I wouldn't say my symptoms were severe, but it reminded me of common cold or flu. One thing that was peculiar to me was that my rapid test came back positive and at home test came up positive; however, a PCR test I received directly after the rapid test was negative. I think this was a false reading. By the 10th day, all symptoms were completely gone. I also had fever going up to 101. No medical care needed.
Immediately post vax, the pt experienced red arm (shoulder to upper arm) which resolved after one day.
Itchy, red, inflamed rash about 2" in diameter.  Painful to the touch.  Day of injection and day after the injection there was little to no pain.
I got the shingles 9 months after getting the vaccine/ Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 9 months 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 patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that he/she got the shingles 9 months after getting the vaccine. The patient asked if there were any thoughts. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Inappropriate schedule of vaccine administered; no adverse event; This spontaneous report was received from a pharmacist referred to a current 26-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection when the patient was 16 years old, administered as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection at 20 years old, administered as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse events were reported (no adverse event). The patient is now 26 years old and did not get the third dose yet.
Hives 2 days, three days with OTC Benadryl two pills, every 4-6 hours,.  Extreme  pain in left hand at each joint OTC Tylenol, every 4 hours, three days. (I could not bend my fingers due to pain) Residual red  itchy rash on right abdominal to current date 02/27/2021,that started with hives.  Hives went away, rash developed.   Treating with hydrocortisone cream but it will not go away, not sure if it is from the shot.  Waiting Dr. apt for treatment.
3 weeks after vaccine was administered patient had joint pain in knees and back. Jan 2012 - increased back pain with muscle atrophy/weakness Feb/Mar 2012 - difficulty standing and walking. Truncated tremors 4/2012 Dx Allodynia. 6/2012 Dx Chronic Regional Pain Syndrome 8/2012 Large Fiber Neuropathy Dx 4/2013 Small Fiber Neuropathy Dx.
Approximately 10 days after I received the Covid vaccine shot I started noticing a few bumps in my backs that look like pimples. A few days later I noticed it spreads all over my back and that was when I decided to  see a doctor and reported just incase was a allergic reaction to the vaccine.