chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine and was instructed to sit for 15 minutes as required for monitoring. About five minutes in, another patient who received the vaccine together with patient told us the patient had fainted. Patient was slumped over to the side when I came to check on patient. I called the patient a few times and patient started to come to. I asked the patient how he was feeling and if he had any difficulty breathing to assess for anaphylactic shock. Patient was breathing normal, but was sweating and a bit confused. Patient reported feeling dizzy. I explained to patient that he fainted for a few minutes and instructed to sit as I did not feel comfortable having patient lay down in the state he was in. Patient was given water and a fan to help cool him down and legs elevated (patient reported feeling much better with the fan blowing on him). Patient sat at the pharmacy for over 30 minutes before heading to the bathroom. At this point, patient were no longer dizzy and I instructed him to get up slowly and assessed that patient was no longer dizzy before letting him go to the bathroom.
Swollen gums/blisters; Fatigue; Fever; Chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), GINGIVAL SWELLING (Swollen gums/blisters), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0088B21-21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). On 04-Apr-2021, the patient experienced GINGIVAL SWELLING (Swollen gums/blisters). On 09-Apr-2021, DIZZINESS (Dizziness), GINGIVAL SWELLING (Swollen gums/blisters), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included gargling salt and water.   This case was linked to MOD-2021-245545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up received updated outcome of events and patient details.
Patient was given Hep A, Vaccine was Expired Date Jan. 16,2023  . Patients mother was notified .
This non-serious spontaneous case, was initially received from a physician on 14-Aug-2017, concerning a 04-year-old male patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was sixth of 10 reports. On 24-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as: 185586), expiry date: 31-May-2017, dose, route of administration and anatomical location: not reported). On 24-Mar-2017, the patient was vaccinated after multiple temperature excursions. First excursion occurred on 02-Mar-2017 (47-degree F, 14.7h), second on 03-Mar-2017 (47-degree F, 16 h) and third on 04-Mar-2017 (47-degree F, 19.75 h) which was characterized by incorrect storage of drug and drug administration error. The outcome of the events was not reported. Non-significant case correction received 14-Aug-2017: Batch no. (185686) was captured in the case form and narrative was amended accordingly.
Redness on arm and spreading. Hot to touch, child could not move arm said it felt numb. Swollen
pt recv vax & exp lower lobe pneumonitis & was treated as an outpatient;pt became hyponatremic & hypokalemic;pt was hospitalized & treated w/IV ATB;
2 days later noticed red and swollen. Resolved some then on days 4-5 was in the sun all day. Increased red flare, swollen, and itchy.
sporadic itching mostly on chest and some on legs and arms; slight sore at the Injection site.; itchy eyes; slight redness in the corner of her eyeballs.; This is a spontaneous report from a contactable consumer or other non hcp. A 73-year-old female patient started to receive BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: Unknown), via an unspecified route of administration on 13Jan2021 at 10:00 (at the age of 73-years-old) as a single dose for Covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 15Jan2021, the patient experienced itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site. The clinical outcome of the events itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site was resolved on 17Jan2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
pt recv vax 1980 & in OCT95 lab eval revealed pt had no antibodies;pt recv 4th dose of vax;
Pinkish ring around where the shot was; A week later I have a swollen lip; Itcy spots on my upper thigh; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 week after receiving Arexvy, the patient experienced injection site erythema (Verbatim: Pinkish ring around where the shot was), lip swelling (Verbatim: A week later I have a swollen lip) and localized itching (Verbatim: Itcy spots on my upper thigh). The outcome of the injection site erythema, lip swelling and localized itching were not resolved.   It was unknown if the reporter considered the injection site erythema, lip swelling and localized itching to be related to Arexvy.     It was unknown if the company considered the injection site erythema, lip swelling and localized itching to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2023 A week later patient has a swollen lip and itchy spots on upper thigh. Also, still a pinkish ring around where the shot was given. Follow-up would not possible as no contact details were available.
Local reaction started 1 hr after HPV/MENACTRA in left arm worsening to 12 X 14 cm 2 d later.
Information has been received from a through Merck pregnancy registry and a Certified Medical Assistant (C.M.A.) concerning a 16 year old female patient with a history of bacterial vaginosis who on 15-MAY-2007 was vaccinated with a dose of GARDASIL.  On 16-MAY-2007 the patient discovered that she was pregnant.  The outcome was not recovered.  On 11-JUN-2008, a follow up telephone call was made to get the pregnancy outcome for the patient and a message was left at the patient's doctor's office.  On 20-JUN-2008 the health care provider returned the call and reported that the patient was delivered by primary cesarean section at term, and had a normal and healthy female baby.  The baby weighed 7 lbs 10 oz, after spontaneous onset of labor.  No further information was available.  Upon internal review patient having "spontaneous onset of labor" which required cesarean section considered to be an other medical event.  Additional information is not available.
Chicken pox vaccine breakthrough. Had Varicella vaccine 4/12/04. Diagnosed with chicken pox in our office on 10/19/05 by doctor. Multiple papules and some vesicles on trunk, arms and face. Rash started 10/16/05. No fever. One scabbed lesion on back of head.
Pain from top of my shoulder down my tendon. I could not lift my arm without severe pain. I could not lift or push anything. Sleeping was very difficult, as pain got worse at night. I have been going to physical therapy and received a cortisone shot from one of my doctors. Cortisone was the only thing that has helped.  I am currently still not able to fully lift my arm, or use my arm to lift anything with any weight without pain.
Numbness of left side of face. Muscles will not work. Not able to eat without biting tongue and lips. It got progressively worse over the weekend. I went to my Neurologist on Monday 11/1/10 and was diagnosed with Bell's Palsy.
As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask so not sure f that had anything to do with that feeling. I sat down in the wait area for the required 15 minutes and left. while walking towards my car I was nauseous and drank some water to help ease my stomach. When I got home my stomach felt like if I had a nod at the top of it as well as it got a little upset. I noticed I had blotchy arms the following morning.
3/10/23  I started not feeling good. I had a sore throat, drainage, a lot of congestion and a headache. I took an At Home COVID test and it was negative.  3/12/23 I felt horrible and took another At Home COVID Test which was positive. On 3/13/23 I had 100.9 temperature, my normal temperature is 97.9,  and it stayed that way for three days. I had a lot of congestion, my voice sounded like I had laryngitis. I had a lot of drainage and mucous, my head hurt, and a cough. I also had very bad night sweats. I had a telehealth on 3/15/23 and was prescribed Prednisone for 12 days. She also prescribed an Albuterol Inhaler and Benzonatate.  I began getting better, still had the headache and sinus pain. The cough got better.  I continued to have night sweats. I am 99.9% better. I still cough some. I spent 2 weeks of feeling really rotten.
11/22/21 presents to ED for "worsening shortness of breath". PMHx "COPD"
Patient began with weakness shortly after the vaccine, and then seen in the ER on 1/10 and then by his primary doctor on 1/11 with worsening weakness.  He was then seen by me in the ER at Hospital on 1/15/2022 with diffuse sensorimotor loss, and areflexia.  Presumably Guillain Barre, and transfered to Medical Center ICU for IVIG and neurology consult.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F for 492.6 hours for a total of 839.3 hours (35 days); in November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # J006236, exp. date: 25-FEB-2016) (route, dose and strength 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.
Redness and swelling on left arm, tender and warm to touch . Started morning after vaccination continued to expand over 4 days following vaccination, resolved on day 5. Extended from surrounding injection site to nearly patient's elbow.
31OCT95 AM pt had no sxs just had a very fast rise in temp which was followed w/staring spell/sz;pt taken by amb to hosp where cont to have szs-kept in ICU overnoc;hospitalized until 2NOV-had high fever & rash;
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms included severe fever, headache, nausea, lack of appetite, chills, fatigue, joint paint beginning approximately 12 hours after administering of dose and continuing for about 18 hours after onset of symptoms. Treatment involved two acetaminophen every 12 hours after onset of symptoms for about 36 hours, a total of 3000mg of acetaminophen.
Around 5:30 pm in the evening following my vaccine I started having chills, headache, nausea, and fever of 101. Chills got worse, whole body was shaking and shivering. Nausea progressed into constant dry heaving. Head was pounding with the worst pain I have ever felt in my life, worse than natural child birth and worse than running marathons. The nausea was so bad and I could feel my fever burning and getting worse. I was about to vomit so got out of bed to go to the toilet to vomit and the whole room started spinning completely out of control. My heart was racing and I could hear it and feel it pounding rapidly through my ears. I couldn?t walk and was so disoriented I crawled to the bathroom to throw up in the toilet. My husband heard me and came and picked me up off the bathroom floor and carried me to our bed. As the night progressed fever got worse, head was in almost unbearable pain, severe body aches over my whole body, heart racing and horrible nausea and dry heaving.  I made it through the night. For two days after I had a headache and fever  and nausea and body aches and couldn?t get out of bed to care for my children. By the third and fourth day I was able to get out of bed at times and still felt fatigue, nausea, headache and body aches. Anytime I would stand up for 10 days after the vaccine it felt like I was rocking on a boat. I am almost at 2 weeks and still feel fatigue and dizziness at times. On April 15th, 9 days after my vaccination I had symptoms of a blood clot in my leg. I went to the Emergency Room and was diagnosed with a superficial blood clot of the leg as well as swelling in the vein. I am thankful to be alive!
This spontaneous report as received from a nurse refers to 13 year old adolescent. Gender was not reported. Medical history and concurrent conditions were not reported. In 06-MAR-2007, the patient was vaccinated with first dose of VARIVAX (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Patient would like to received a second dose of VARIVAX. No adverse symptoms were reported. Additional information has been requested.
sore throat, brown and excess sputum, cough, feverish and slight fever of 99.F (usually 97F), woozy, fatigue,  ongoing. Today still have cough, sore throat, feverish.  I am not absolutely certain of the type of flu shot and RSV shot that I received, but I did get both in the right arm.   Sore arm, to be expected
Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point; Expired 5 doses of Moderna Covid-19 Vaccine had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses of Moderna Covid-19 Vaccine had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022 at 3:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jan-2022 at 3:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses of Moderna Covid-19 Vaccine had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses of Moderna Covid-19 Vaccine had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Moderna vaccine was pulled from the freezer on 16 Dec 2021. The beyond use date was 15 Jan 2022 printed in red and taped to the top of the boxes. On 26-Jan-2022, it was noted that the vaccine was still in the fridge and expired 5 doses had been given at that point.   On 31-Jan-2022, Moderna responded that revaccination not required.  The patient were notified of the error and that a repeat vaccination was not required. Patient denied any adverse effects.  No treatment medications were reported.
Pt developed hives about 1 hour after vaccine on 12/05/06. Hives on face, arms, neck, chest and back. Resolved in 24-48 hours. Treated with Benadryl cream. Received flu vaccine many times previously, no problem. Pt has history of eczema and rhinitis.
Pt received vaccine, started to experience throat tightness and difficulty swallowing. Vitals taken, MD notified. Pt escorted to exam room. Benadryl 25mg IM ordered and administered. Patient feeling much better. Second set of vitals taken. No SOB, or throat tightness, vitals stable. Pt discharged home.
Donor complained of pain radiating from left to right of shoulder back to shoulder blade after given tetanus immunization. She stated shot was placed between deltoid/shoulder bone area. This has caused pain with inflammation along with restricted ROM of shoulder. Sees PCP for treatment and taking meloxicam for inflammation. Will start physical therapy 2/7/18. Shot was given on 1/6/18 and this event was reported to medical staff on 2/4/18.
6 month old into ER, via aunts arms gasping for breath then becoming unresponsive approximately 15 minutes prior to arrival. On admit to ER, patient lethargic with slow shallow respiration weak, crying effort, reported vomiting at home. EKG reported ventricular hypertrophy, rapid irregular rate with PVCS. Patient transferred to a location. Patient coded/died in route to hospital.  2/8/07 Received medical records from hospital which reveal patient brought to ER on 1/22/07 day of vax after experiencing vomiting, SOB then becoming unresponsive w/eyes rolling back in head.  Patient was lethargic w/shallow slow breathing & weak cry on admit to ER.   Patient transferred to higher level care hospital but expired en route.  6/15/07 Received Autopsy Report which reveal COD as: Changes consistent w/vaccination related death.  Pathologic findings: cerebral encephalopathy; thymic enlargement; & visceral congestion.  Manner of death: consistent w/accidental.
Pt developed fever (103°), headache, abdominal pain 2 days after 2nd MMR. H/O vomiting on the 3rd day. H/O Rt knee pain. H/O pain and redness at the injection site.
Vaccine on 6/5/18 - Felt nausea, headache and body aches for 2-3 days afterward. The symptoms resolved. Patient was counseled to have 2nd part of the vaccine.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Expiration date. Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp. date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp. date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Patient received booster dose vaccination time was given as 10:43:10. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported.
Received VZV vaccine on 2/4/08.  Had tactile fever on 2/12-2/13.  On 2/14/08 developed diffuse erythematous maculopapular rash on abdomen, chest, back, neck, cheeks.  Afebrile in clinic.
sz 3 hrs p/vax pt active, alert & nl exam 30 mins p/recovered from sz; temp in office was 99.5;
This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender received a single dose of  PREVNAR 13, on an unknown date for immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Sep (unspecified year), the patient developed a severe site reaction resulting in cellulitis, needing antibiotic treatment. The outcome of the event was unknown. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Tongue began tingling and became numb for about an hour. Sneezing, full feeling in ears.
Patient called with concern of rash that started to appear on his back few days after receiving 3 vaccines on 10/14/2020:  Shingles vaccine(Right arm), Tdap+Fluclvx Quad (Left arm)  Patient also stated rashes are itchy and painful and he assumes its shingles infection. He did use Hydrocortisone cream and Tylenol for pain relief but haven't contacted his doctor yet.  Patient seemed upset about why would he get a shingles like rash/infection if he got a vaccine for Shingles and why wasn't he informed to watch out for any rash like side effect/reaction during vaccine administration? Upon further asking, patient also informed the pharmacist that he did some yard work/gardening few days after receiving the vaccine. Pharmacist advised patient to consult his doctor as reason of rash appears to be unclear.
This spontaneous report was received from a medical assistant and refers to a 37 year old non-pregnant female patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD). Concomitant medications included ranitidine. She had none drug reactions or allergies. On an unspecified date, when the patient was a child, she was vaccinated with an unspecified vaccine for measles, mumps, rubella and varicella. On 21-DEC-2018, the patient was performed the titers count laboratory test for measles, mumps, rubella and varicella all with negative results (values not provided) (measles antibody negative, antibody test negative, rubella antibody negative, and mumps antibody test negative). It was specified that the patient sought medical attention and received treatment for the events. On 03-JAN-2019, the patient was vaccinated with PROQUAD 0.5 mL (lot # R006213, expiration date: 28-AUG-2019), administered subcutaneously in the right arm, once for prophylaxis (product administered to patient of inappropriate age, off label use). The vaccine was diluted with a sterile diluent (lot # and expiration date were not reported). The outcome measles antibody negative, antibody test negative, rubella antibody negative, and mumps antibody test negative was reported as not resolved. The causality between the events and PROQUAD was not reported.