chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 21, 2021 I had a positive pregnancy test. We were preventing conception and were very surprised. On 5/27/21 at 12:30 pm I started having vaginal bleeding and went to Hospital ER where I was told I was having a miscarriage. I have had two pregnancies and 2 lives births, no previous miscarriage
This spontaneous report was received from a nurse via a company representative and refers to a 70 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 03-OCT-2017 (reported as yesterday), the patient was vaccinated with an expired dose of ZOSTAVAX injection, 1 dosage form (reported as one shot) (route and site of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. No further information was provided. Product quality complaint was not involved.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Pt's mother reported chills and hives 30 mins after administration. Eyes swollen shut, hives, "extreme" swelling in (R) arm for 48 HR. Dizzy, vomiting sxs started 48 Hr after administration. Pt seen at ER dept and received MRI and CT scan. Pt released from hospital 10-2-13 6 AM. Event reported to Pharmacy at 1:30pm 10/4/13 by patient's mother.
There has been no treatment at this time (February 15 2021). I?m just reporting this now to you to start a conversation. After having recieved the vaccine and after approximately 18 hours I developed pain on my left lower side close to area of kidney. It is a dull pain but persistent in occurrence. There is no prior history of this type of pain in this area. It is sensitive to the touch. ?
administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received HBV (Engerix B) (batch number 3727z, expiry date 16th October 2020) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   On 23rd September 2021, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On 23rd September 2021, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that, the patient received an expired dose of Engerix-B, which led to expired vaccine used. No further events or details were reported. The health care professional agreed to be contacted through their email address for follow-up.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient experienced significant cellulitis at the point of the shot, arm swelling, arm redness and soreness in arm on an unspecified date with outcome of unknown. The doctor attributed the significant cellulitis to PREVNAR 13. Follow-up (07JUL2016): Follow-up attempts are completed. No further information is expected.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Trouble in breathing at night with stridor lasting for four seconds.  He never had asthma.  He was getting these episodes 2-3 times a wk.
Pt recvd. series of 3 vax & failed to respond to the vaccine.
(Severe fatigue then & now & after shot). (3A Mon 3-8-2011). I awoke with bad Lt hip pain. Upon standing I had pain full back (neck to coccyx) muscles, joints, both arms, forearms, both shoulders, elbows, wrists, hands, fingers. Full upper body & upper extremity severe pain. Rx pain meds, prednisone, antidepressants, antibiotics Lt ear infect. 6-8-2011 3 wks to heal.
I had experience of muscle cramps of left calf muscle  in Feb / march and observed 3-4 times over a period of 2 months . I was thinking  that could be due to dehydration . On   03/ 14 /21 morning , I got severe left leg pain and could not able to walk. I took pain killers and did not subside and that end up going to hospital emergency . I was diagnosed with 2 blood clots in left leg  . I do not have family history of clots nor any h/o major medical issues . All my previous and recent blood reports normal . I am currently in use of blood thinners
This spontaneous report as received from a consumer refers to a 13 month old female patient with no medical history. On approximately 15-MAR-2013 the patient was vaccinated with (Merck) VARIVAX. Other suspect therapies included M-M-R II and hepatitis a vaccine (manufacturer unspecified). Concomitant therapies included PREVNAR. In March 20123, couple of days after vaccination, the patient developed a fever, achiness and runny nose. On approximately 22-MAR-2013, approximately 1 week after vaccination, the patient developed a measles like rash. On 24-MAR-2013, the patient was taken to an unspecified urgent care facility for medical attention. The outcome of runny nose, fever, measles like rash and achiness is unknown. Additional information is not expected.
Information has been received concerning a pt who on 6/26/00 was vaccinated with the first dose of varicella vaccine. On 07/02/00 the pt experienced two puruitic, erythematous, macular lesion on the right posterior shoulder. The pt also developed a lesion on the upper lip and on chin, nose, left knee, and right inguinal fold, all of which were reported to be puruitic. The physician saw the pt on 07/06/00 and as of that date, she had four lesions remaining. These lesions were throbbing with pain. The pt reported that the lesion on her nose was draining slightly serous fluid. As of 07/06/00 the pt did not have any vesicular lesions. All the lesions left were macular papular. These 2 lesions resolved within 48 hours. In July 2000, the pt experienced headache and mild nausea. The physician discussed the case with another physician and they both felt that the rash was not a typical varicella rash, though neither know exactly what the rash was. F/U 6/17/02 revealed there was no record of this pt. However, it was noted "to date all pts experiencing adverse reactions to varicella virus vaccine live, through this clinic, have recovered fully". No further info is available.
Initial misuse report received from a healthcare professional on 07 March 2014. A patient (No information was provided regarding the patient) had received a dose of YF VAX (Lot number, expiration date, site of administration was not reported) to patient intramuscularly on an unspecified date. i.e. inappropriate route of administration. This case is of medication error. No adverse event was reported. List of documents held by sender: none.
Narrative:  Pt is a 90y.o. male who died on 04/02/2021 w/ h/o AFib, HLD, Past stroke, Colonic polyps. Pt received Moderna Covid-19 Vaccination 2/2 on 02/08/2021. Pt died on 04/02/2021 at Hospital. Unlikely Moderna Covid-19 Vaccine caused/contributed to pt death.
Malaise; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; Itchy; nausea, could not eat; Fever; Nausea, could not eat; Headache; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), DECREASED APPETITE (nausea, could not eat) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00UM20A and 013C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), PYREXIA (Fever), NAUSEA (Nausea, could not eat), HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday). 16-Feb-2021, the patient experienced DECREASED APPETITE (nausea, could not eat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PYREXIA (Fever) had resolved. On 21-Feb-2021, MALAISE (Malaise), DECREASED APPETITE (nausea, could not eat) and NAUSEA (Nausea, could not eat) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) and PRURITUS (Itchy) had resolved and HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient is on medication centromine.  patient has received Tylenol and advil after both doses.
I took the 2009 H1N1 influenza vaccine (LAIV which is sprayed into the nose). After taking the vaccine, I have fever, cough and other symptoms as H1N1 flu.
12/3/03 within few hours post injection became "cranky." 12/4/03 blotchy rash around injection site. Still "cranky." 12/5/03 rash gone. Still cranky. Appetite decreased. 12/6/03 am-still cranky. Not eating much. 12/6/03 put in her room by parents. Door closed. Few minutes later, family realized they hadn't heard her. Went in, found her under her bed, unresponsive, eyes rolled back, fists clenched. Some jerking of upper extremities. Respirations absent. Cyanotic, cold and clammy. AFter some rescue breathing by family. Started breathing on her own and crying. Stayed alert-to hospital by ambulance. Follow up on 01/12/04: "Pt is a 15 month pt who was admitted last night because of a significant apneic event and possible associated seizure.  Pt is usually healthy.  She did get her influenza vaccine on 12/03.  Yesterday, 12/06, she was a little whinier than usual but had no fever.  Maybe wasn't eating quite as good as usual.  Apparently sometime in the evening she went into her bedroom and closed the door.  Things sounded too quiet so the parents checked on her and found her still partially under her crib.  She wasn't wedged.  When they pulled her out initially apparently she was limp but her upper arms were flexed and maybe there were a few twitches of her distal upper extremity.  This was bilateral.  Her head might have been turned to one side.  She was blue and was seemingly unresponsive.  Her grandfather was in the house and he came and gave her some artificial breaths.  They had called 911.  Sometime during that call then she did start crying.  Initially when she started coming to she seemed to be somewhat dazed but then seemed to be relatively appropriate for the circumstances thereafter and not clearly post-ictal.  She did not wet her diaper.  In the ER she was afebrile and had normal vital signs, and there was no focal findings of any concern on her exam.  Chest x-ray was obtained which was unremarkable.  Basic metabolic panel, magnesium level, and CBC were also obtained and were unremarkable.  They were going to get a urinalysis but she had some labial adhesions so that was not obtained at the time.  It was decided to admit her overnight for observation.  Because of the apneic episode, and IV was placed.  A bag and mask were put at her bedside ready in case it was needed.  She was put on a continous pulse oximeter.  Overnight she did well.  There were no further events or concerns or new concerns.  Basically healthy child with primary apneic event which may or may not have had with it seizure activity.  If not clear what is the cause of this.  The family wonders about the influenza vaccine, that it had occurred more than 72 hours prior to this, and she has no ongoing neurologic symptoms.  She was not tightly wedged under the bed.  The parents stated that there is no bar or any other structure where her head was right there were she could have hit her head.  She did not have coughing or choking subsequent to the apnea.  She had a normal chest x-ray and normal O2 sat, so there is nothing that suggests foreign body aspiration. The medical record received on 1/12/04 states apnea.
Last week I had the new shingles vaccine. Here's what's been happening: 1. Tuesday- flu like symptoms 2. Wed- Headache, fatigue, and a new herpes blister,itchiness on the extermeties (little red dots on my arms), plus PHN...killer pain. 3. Thurs -PHN, less itchy, another blister 4. Fri. - PHN subsiding 5. Sat. - New Blister! 6. Sun.- normal(?) 7. Mom.- New blister.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 18-AUG-2017 the patient was vaccinated with M-M-R II lot # L028273 for prophylaxis. Concomitant therapies included sterile diluent. On 18-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to M-M-R II.
Itchiness; A spontaneous report was received from a healthcare professional concerning a 88 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pruritus/itchiness.  The patient's medical history was not provided.  Products known to have been used by the patient were blood pressure meds and tramadol.   On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced  itchiness all over the body starting from the right shoulder.  Treatment details included Benadryl. No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, itchiness was unknown.
I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 NEUTROPENIC FEVER, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 NEUTROPENIC FEVER, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 BRONCHIECTASIS    PERIPHERAL T-CELL LYMPHOMA, UNSPECIFIED TYPE, MULTIPLE LN SITES I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 FEVER I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 1/25/2023 HX OF CUTANEOUS T CELL LYMPHOMA
Information has been received from a physician concerning a patient with liver disease (unspecified) who was vaccinated IM with a dose of 0.5 ml PNEUMOVAX in the left or right deltoid "within the last 2 months."  The physician reported that the patient experienced a severe injection site reaction which impaired the use of the injection site arm (could not lift for 3 to 4 days).  The patient sought medical attention and contacted the physician.  At the time of the report, the patient recovered.  The reporting physician considered injection site reaction and impaired use of injection site arm, (could not lift) to be disabling.  This is one of several reports received from the same source.  Additional information has been requested.
Severe itching, irritation, took oral Benadryl, proceeded to nearest Emergency Room
This is a spontaneous report from a contactable other healthcare professional. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the arm right on 18Jan2021 as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. The patient did not take any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the right arm on 28Feb2021 as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021, the patient was diagnosed to have thyroid nodule on both sides of the neck. The patient have slight sore throat from it but it went away but it came back last Month and it hurt to swallow; during ultrasound the patient was diagnosed to have thyroid nodule on both sides of the neck: they recommended to do biopsy for right side as it was big. The patient did not have any family history of cancer or thyroid problems and was otherwise healthy individual. The patient could not think of anything else that caused sudden development of nodule except COVID 19 vaccine. She was scared and worried. Therapeutic measures were taken as a result of the event which included treatment with Diagnostic tx. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event thyroid nodule on both sides of the neck was not resolved at the time of reporting.
couldn't sleep at all; she was rushing, she had a lot of energy and she couldn't settle down; extremely fatigued; shaking; diarrhea; doesn't feel well / She doesn't  feel well and she wants to know if she is okay; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Sep2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. Historical vaccine included Flu vaccine in 1998 (23 years ago) for immunization which she had an adverse reaction. The patient's concomitant medications were not reported. The patient stated she got the first dose of the vaccine on Wednesday night (01Sep2021) and was having some issues and wanted to talk to someone because she was alone and doesn't feel well (Sep2021). She was fine with no pain or side effects all day yesterday. Thursday she was fine. Friday (03Sep2021), well last night, she couldn't sleep at all. It was like she was rushing, she had a lot of energy and she couldn't settle down. She didn't sleep an hour and now was extremely fatigued today. On an unknown date in Sep2021, she has been shaking, didn't sleep, had diarrhea and was fatigued but has no pain at the site of the injection. She can't tell if these are normal things. She just can't tell if it was from the vaccine or what was going on and thought someone should be told. She said she consulted the doctor about her symptoms and they referred her. She stated because she had an adverse reaction to a flu shot many years ago, where she had an immediate reaction with that, she just didn't feel right and wanted to make sure the symptoms she has were normal and she stated it does not say anything about how long they last in the paperwork she received. She also wanted to know how soon a bad reaction would occur after the vaccine, if it was within an hour. She didn't feel well and she wanted to know if she was okay. She stated she was fine and she was expecting a reaction early and didn't have anything and said that it was good to hear [regarding when severe allergic reactions usually occur vs side effects] and made her feel a little calmer. She stated she will keep sipping water and rest as much as she can. She stated if she did get worse she may not be able to call anybody. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
PATIENT IS 16 YEARS OLD RECEIVING MODERNA WHICH IS ONLY APPROVED FOR 18 YEARS AND UP.  AFTER 20 MINUTES OF VACCINATION, PATIENT REPORTED NO SIDE EFFECTS.
fully vaccinated (moderna, 2/17/21, 3/17/21); onset of symptoms 7/22/21
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown dates, the patients have received improperly stored VARIVAX (doses and routes of administration were not reported; lot # L023587, expiration date: 26-JUN-2017; lot# L012038, expiration date: 07-APR-2017; lot# L003774, expiration date: 04-FEB-2017). No symptoms were reported. Additional information has been requested.
For flu vaccine - redness, itchiness, swelling, sore arm, feverish, achy, headache. For SHINGRIX- redness, swelling, sore arm.
I contracted COVID-19 on 06/16/2022 with symptoms of fatigue, sore throat, congestion, cough, loss of smell and taste, headache, and fever of 101 at highest point. I was prescribed Paxlovid on 06/18/2022, but I was called back and instructed not to take it due to being on Estradiol. I was prescribed Guaiatussin and a cough pill as an alternative to Paxlovid. My symptoms began to improve after 5 days, but I am still experiencing lingering symptoms of cough.