chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a 21 year old female patient who on approximately 10-JAN-2012 ("approximately two weeks ago"), was vaccinated with  VARIVAX (Merck) (dose, route and lot number not reported). The registered nurse reported, that the patient stated that at the time of receipt of the VARIVAX (Merck) she was not pregnant. At the follow-up visit the patient was tested positive for pregnancy, and further data collection revealed that her last menstrual period was 26-NOV-2011. The patient had a physical exam. The patient was scheduled to be seen by responsible physician 13-FEB-2012. No adverse effect has been reported or observed. Estimated Delivery date would be 01-SEP-2012.  Follow up information has been received from the nurse. The patient delivered a  healthy baby girl on 12-SEP-2102 at 39 weeks' gestation (LMP previously reported as 26-NOV-2011 which would count as 41 week gestational age). The vaginal delivery was without complications. The infant weighed 3203 grams, APGAR scores were 9/9. It was reported there was meconium stained fluid upon delivery. No fetal congenital anomalies were reported. The infant had neonatal jaundice post delivery (captured in Case # 1307USA010527). Additional information is not expected.
Received smallpox vax 2/27/03. Course w/o complaint or Sx's. Scab off 3/31/03. C/o chest pain, mid chest ?? to back intermittent on 4/1/03. No SOB. No fever.
Client felt faint felt some tightness in chest, shortness of breath--reported that the sx resolved w/n 30 minutes but will have an appointment with her provider
Mild pain/ache started in upper arm almost immediately after the shot and is still present to this day.  Not as bothersome during the day however some pain when I lift the arm. Pain worsens after falling asleep. I?ll wake up  in the middle of the night or early morning and my shoulder will be achy and somewhat painful to move.
4/1/21: Per EMS on site, after COVID vaccine administration, client felt a rush of anxiety while in observation. After evaluation and observation for additional 15 minutes client felt better. Client signed Fire Department refusal and accepted all risks and responsibilities of refusal. Client walked out to her car to meet her husband.
numbness and palpitations; palpitations; This is a solicited report received from a contactable reporter(s) (Physician).  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (hospitalization), outcome "unknown", described as "numbness and palpitations"; PALPITATIONS (hospitalization), outcome "unknown".  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5/7: c/o fatigue and headache 5/8: Chest pain, shortness of breath, headache and heart racing 5/9: Worsening left sided chest pain with dizziness.  Presented to an urgent care and then transferred to the hospital.
Heavy Heart Palpitations; Chest Pain; Breath Issues- Heavily Breathing; Chest Feels Heavy; High Blood Pressure; Anxiety; Scared for everything/fear; Dizziness; Head revolving; tension; getting irritated; feel like shout and cry a lot; Sweating in legs and hands inside; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration on 19Apr2021 at 14:30 (at the age of 40-years-old) in left arm as a single dose for covid-19 immunization. The patient previously took Perinorm injection for nausea and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Concomitant medication received within 2 weeks of vaccination included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40) taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: ER8732) on 25Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced heavy heart palpitations, breath issues- heavily breathing, chest feels heavy, high blood pressure, sweating in legs and hands inside, scared for everything/fear, feeling tired, dizziness, head revolving, anxiety was coming for everything like crying a lot so that anxiety was reduced, getting anxiety for work pressure/delivery on time/if miss timelines, any noise/sounds, he got irritated, chest pain, tension and she felt like shout and cry a lot on 20Apr2021 at 22:00. The events were assessed as non-serious. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with aspirin tablets. Post vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures on 22Apr2021 which included SARS-COV-2 (COVID-19) test and RSV by PCR both nasal swab: negative, Influenza A and B by PCR (nasal swab): negative. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Patient experienced rash and swelling on right arm, patient treated with BENADRYL and recommended to visit ER if symptoms worsen.
Pt passed out at first check out desk within 3-5 min or receiving HPV # 1 and flu vaccine in right deltoid. Pt hit left side of forehead on wall and slid to the ground. I did not witness this. Pt taken to exam room #3 by doctors and pt placed in supine position, ice applied to forehead and pt given apple juice. B/P obtained. Pt in supine position for 10 min. Pt felt fine and left the office accompanied by mother and sister. Pt with syncopal episode at front desk. I arrived as she was lying prone and rousing with eyes opening and nodding yes when name called. SI diaphoretic with strong radial pulse of 88. Kept her lying supine for several minutes followed by sitting for several then standing with support. She walked to exam room where she had BP HR check while supine and then sitting drank 2 4 oz cans juice. With second stable BP she was released to leave the office with her mother and sister without further difficulty.
p/vax pt had a serum varicella zoster virus antibody test which revealed negative titers;
This spontaneous report was received from an  office manager via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that the M-M-R II was reconstituted with sterile diluent (manufacturer unknown).  No adverse effects were reported. Additional information has been requested.
approx 13 days p/vax pt devel rash on legs, feet & neck & face. 23mar pt exp an axillary fever of 103f & 4 koplik spots. addl info requested
Information has been received from a registered nurse concerning an elementary aged child who was vaccinated with a dose of Varivax. The RN reported that in February 2006, the patient developed breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.
rash; severe joint pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K) and (batch number XL7RB) for prophylaxis.   On an unknown date, the patient received Shingrix. On 29-JUN-2023, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash) and joint pain (Verbatim: severe joint pain). The outcome of the rash and joint pain were not resolved.   The reporter considered the rash and joint pain to be related to Shingrix.     The company considered the rash and joint pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2023 It was reported that adverse reaction of rash and severe joint pain were currently ongoing. The patient believed that the events were related to the vaccine.
02/01/22 presents to ED for "Fatigue" "Shortness of Breath". PMHx of "non-hodgkin's lymphoma s/p radiation"
Developed a lump under left arm; Pain under left arm; Pain in chest near heart; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in chest near heart), AXILLARY MASS (Developed a lump under left arm) and AXILLARY PAIN (Pain under left arm) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2022, the patient experienced CHEST PAIN (Pain in chest near heart) and AXILLARY PAIN (Pain under left arm). On 19-Jan-2022, the patient experienced AXILLARY MASS (Developed a lump under left arm). At the time of the report, CHEST PAIN (Pain in chest near heart), AXILLARY MASS (Developed a lump under left arm) and AXILLARY PAIN (Pain under left arm) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.
Slight swelling and mild erythema and tenderness for 3 days over left lateral thigh.
Chills; Headache; Nausea; Dizzy; Itching on my arms and legs; Muscle ache; Joint ache; Swollen glands under my arm which bothered then it moved it into opposite side to my breast; Chest tightness; I have Rosacea like flared; Could not sleep at night because my whole body get clammy; Could not sleep at night because my whole body get clammy; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 17Feb2021 (at the age of 75-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included Acid Reflux, Seasonal allergy, Prediabetes and I take PreserVision for my eye. Concomitant medications included metformin taken for glucose tolerance impaired, ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) taken for eye disorder, probiotics, methylcellulose (CITRUCEL) and omeprazole taken for gastrooesophageal reflux disease. On 17Feb2021 the patient experienced chills, headache, nausea, Dizzy, itching on my arms and legs, muscle ache, joint ache, swollen glands under my arm which bothered then it moved it into opposite side to my breast, chest tightness, i have rosacea like flared, could not sleep at night because my whole body get clammy. The patient reported that she received the shot on Wednesday the 17th (17Feb2021) of this month, actually Feb and by that evening she had chills, headache and nausea, which was gone by the next morning but everything returned again by evening and lasted for about 5 or 6 days and she still off and on getting that and this is what she experienced besides the chills, headache and the nausea. She also could not sleep at night because she would get very clammy my whole body get clammy for several nights, she felt somewhat dizzy often during the day she had itching on her arms and legs not extreme but to a slight degree, she had muscle aches and joint aches, she had swollen glands under her arm which really bothered her for 2 days and then it moved it into the opposite side to her breast, swollen a gland in there. She had slight chest tightness but not much, her Rosacea, she had Rosacea like flared, still continue to flare a little bit. The patient was asked if she is still experiencing the problems, she stated Slight now yes, off and on it is very intermediate, intermittent she should say not intermediate, it happens well intermittently. The patient was asked if any treatment for the problem, she answered that No, earlier on when she was having more severe reactions, She did take ibuprofen but only couple of times because she does not like to take lot of that. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
I developed a very itchy rash on my back, hands, feet, arms and what felt like everywhere.  The just today stopped.  The rash lasted about 8-10 days I would say.  It got worse over the course of a week and then started getting better.   Someone suggested I take an anti-inflammatory, because my hands were swelling and it was difficult to work at the computer.  That seemed to help immediately or it could've just started to go away on its own.  Regardless, I've kept the twice daily naproxen for the past 4 days and things seem to be all better now.   My wife suggested I report my reaction.    The small red bumps were scattered mostly on my back, feet and hands.  They looked very similar to shingles but without the big red splotches only the small red bumps.  As they were forming they appeared to be sun blisters and then turned bright red.  Extremely itchy and kept me up scratching at night and scratching all day.
myocarditis with noted chest pain, diffuse ST elevation, and troponin >50.  Received IVIG and IV steroids
Pediatric Pfizer Covid-19 vaccine was not diluted before administration, resulting in a higher than authorized dose.
Wheezing, runny nose, coughing, asthma.  Treated with Albuterol through nebulizer.
Initially just after receiving first dose of pfizer vaccine patient felt "hot spots" all over body that lasted for a couple of minutes. Over the next week and half patient had daily intermittent headaches with pre-syncope episodes that lasted for a week and half following administration of vaccine. Pre-syncope episodes interferred with some activities, for example. he did not want to stand up and cheer  for fear of passing out if he did. Symptoms resolved on own after a week and half.
While in store fell to floor; arched back whole body got stiff, tongue rolled back-unconscious for short period; 911 called pt OK by then; later that evening taken to ER to be checked nothing could be found;
Narrative: Patient received two doses of covid vaccine. patient died a few weeks after second dose. Patient with metastatic prostate cancer/neuroendocrine carcinoma. No details noted of cause of death. reporting per facility instruction.
Death Narrative: Patient with medical history significant for malnutrition and end stage COPD. Patient was on 5 to 6 liters/min of oxygen. On 3/10/21, patient received his first COVID-19 vaccination. On 3/12/21, patient was admitted to Hospice for home hospice care due to worsening of COPD. Per medical examiner, patient passed away on 3/13/21.
Confusion and weakness in muscles upon awakening. Mental status changes as well and achiness in joints. Patient fell but does not remember falling or being on the floor.  Patient reports falling 3 times in 2 days.  These symptoms are all abnormal for patient.
Fever of 103, nausea, redness at site, swelling at site, extreme pain, difficulty moving arm
pt had sz 2-3 mins p/vax given; pt arms & legs rigid, shook all over, eyes rolled back, face was pale, unresponsive; sz lasted 1-2mins; had 1.5 hrs postictal state in ER; no cyanosis, apnea, incontinence; dx grad mal sz;
Pt was seated upright on chair next to a shelf located on his left hand-side. I first administered flumist intranasally. Has hx of Flumist without any problems. He tolerated today's dose well without any issues. Next I administered Pfizer Bivalent Booster 0.3 mL IM to his L deltoid. After administration and applying a band aid I gave him his updated vaccination card and walked back to the pharmacy counter. ~1 minute after, we heard a thud. When I turned around, pt was slumped over on left side on shelf, still seated on chair. Other pharmacist rushed over to hold him up as I called 911. He appeared to be pale and unresponsive for about 10 seconds or so. He eventually came to after a few attempts of trying to wake him up. He appeared to be back to his normal self, alert and oriented however he could not recall what had happened and thought perhaps he "just closed [his] eyes and fell asleep". He also appeared to have urinated on himself during the event. We escorted to a room in the back that was cooler and away from windows. We also gave him some water to drink. Paramedics appeared shortly after to assess the patient. Upon questioning from the paramedics, pt reported he felt a little hot before vaccination was given (he was seated next to window, it was sunny outside, outside temp in 90s, front of pharmacy is typically warmer than the rest of the pharmacy). He also reported only eating a banana that morning. Per paramedics, pt's vital signs were normal. Pt did not want to go with paramedics to hospital for further evaluation and reported he felt okay to go home. He reported his father is a doctor and would consult with him if he had any further concerns.
Within 1-2 minutes of receiving the vaccine, I became tingly all over. I began seeing stars and then completely lost my vision - all I could see was bright white. It was difficult to breath. At the vaccine site, EMS came over to my car and took my blood pressure, which was 70/30. They took my blood pressure again and it was 64/30. They then took me via ambulance to the closest ER. They tested my blood sugar and oxygen levels, which were fine. I started to feel better and gained my vision back after about 15 minutes. Upon arrival to the hospital, my blood pressure had resumed to normal.
14 years old female vaccinated with Moderna COVID vaccine, current minimum age approved is 18 years.  Both Flow Monitor and Vaccinator reported error in providing the vaccine at the request of patient's mother who was the registered homebound patient to receive the vaccine.  Per Vaccinator/nurse he received communication from the stating  ages 12 years and older can now receive their COVID-19 vaccine at home! link for nyc.gov/homevaccine was provided in the text communication which is why he thought it was ok per the mother's request. Patient showed not adverse effect during 30 minutes post vaccine observation period. No adverse response noted or reported on  NP home visit on 7/7/2021 . No Adverse effect reported  by mother on follow call by writer on 7/8.21.
Chills, sweats, joint/muscle aches, itching over entire body. Itching subsided the next day on 02/08, change in taste buds, chest pain and headache.
pyrogenic react suspected due to vax administrered 2 days prior for past splenectomy prophylaxis;
Started to feel queasy, had loose bowel movement, temp went up by 10 pm to 103.6 at that time, took cold shower, was shaking and felt achy all over in joints, etc.  Took Tylenol and also am on antibiotics for salivary gland infect so took usual doses clindamycin as well.  Fever went down to 101 at about 1 am this morning, temp is 99 and I feel much better.
resting heart rate did not go down to where it was before; headaches last night, much better today; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches last night, much better today) and HEART RATE INCREASED (resting heart rate did not go down to where it was before) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (headaches last night, much better today). On 24-Feb-2021, the patient experienced HEART RATE INCREASED (resting heart rate did not go down to where it was before). At the time of the report, HEADACHE (headaches last night, much better today) and HEART RATE INCREASED (resting heart rate did not go down to where it was before) outcome was unknown.      Patient stated that her normal RHR is approximately 70 after doing exercise and her current reading is 96.  Concomitant medications were not reported.  Treatment information has not been specified.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 045L21A and 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2022 at 10:07 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Feb-2022 at 9:43 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 25-Feb-2022 at 9:43 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that 20 doses from 5 vials were used. The vials were initially stored in the refrigerator on 19-Jan-2022. It was reported that the vials did not underwent temperature excursions.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Non significant follow-up information received.
Patient received Moderna (NDC:80777-0273-10) booster. Patient only received half of the adult dose.
child recv vax 10NOV97 & 20NOV97 child father devel varicella & the child had no rash & no rxn to the vax;
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were administered improperly stored oral ROTATEQ (lot # L027719 with expiration date of 28-APR-2017, dose and strength unknown) orally. The vaccines were exposed to 8.5 degree C for 15 minutes. There was no previous temperature excursion. No adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.