chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 72 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and tingling to right upper and lower arm.  Also c/o pain to mid forearm.  She denied hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching and tongue swelling. When walking to the emergency bay reports some lightheadedness and generalized weakness Denies facial drooping or weakness.  No loss of strength and normal ROM to hand and arms   This provider was notified of patient reaction and she was then assessed in the emergency bay area.     Monitored patient for severe reaction symptoms, including: rapid progression of symptoms, respiratory distress with dyspnea and increased work of breathing, hypotension and chest pain   Review of Systems     Objective   Vitals Vitals:   12/18/20 1023 12/18/20 1025 BP: (!) 175/93 (!) 182/85 BP Location: Left arm Left arm Pulse: (!) 115 (!) 112       Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: She is not ill-appearing.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Cardiovascular:     Rate and Rhythm: Normal rate.     Pulses: Normal pulses.  Pulmonary:     Effort: Pulmonary effort is normal.     Comments: Initially with slight shortness of breath After 3-4 min was able to return to normal rate of breathing SpO2 remained 99-100% for duration of observation Musculoskeletal:     Right shoulder: She exhibits tenderness (where identified). She exhibits normal range of motion, no swelling, no effusion, no deformity and normal strength.       Arms:     Comments: C/o generalized tingling and mild weakness to right arm. Point tenderness where identified. Grip strength equal bilaterally Full ROM Injection site to right deltoid covered with bandaid  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert.       Assessment/Plan    Treatment included antihistamines.  Zyrtec given po at 1025 Follow up response to treatment:no change Patient discharge:  Transported by ambulance   Report provided for Medical Record Patient reports some improvement in arm tingling, but pain to forearm and weakness remains   APRN Electronically Signed 12/18/2020 11:31 AM
Headache- migrane, chills, muscle soreness, lethargy/ tiredness, lack of appetite/ nausea
Around 5:30pm, pt fainted after a few minutes of getting the vaccine. EMT transport to hospital. Faint because gotten severe dehydrated from academy physical training not because of Flu vaccine.
Received H1N1 on Dec 16, 2009. Developed chronic dry cough for several weeks. Developed flu like symptoms and couldn't urinate. Thereafter was paralyzed from chest down.
After receiving the first dose, I started to have minor headaches. After receiving the second dose, the headaches became  constant. Some days, I would take one aspirin and some days I would have to take three. There are also days where I don't have to take any at all.  Also, I now I have high blood pressure. I had experienced a bit of stress with the passing of my husband in 2019 and my son moving to another state in 2020, so I'm not sure if this is from the vaccine or not. I want to add that when I received the vaccine, it didn't hurt at all.
Swelling, bruises, hard spot in center and fever 101 degrees, itching and pain lasted about 3 weeks. Arm still bruised and lump still present 2 months later. Scheduled follow up with doctor August 2, 2018. Refused second injection until after I see the doctor.
Health Department let us know that their was a excursion with our refrigerator and the vaccine was nonviable
5 days after the second vaccine, experiencing significant dizziness and vertigo throughout the day - sometimes while moving and other times just when laying down still.  This is something I've never experienced before in my life... and it is accompanied by soreness in the neck area (back and sides of neck) as well.
Red glassy eyes, fever of 104F, discomfort, crying for 5 hours.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 12:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 12:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.03.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient presented to the ED with evaluation of cellulitis changed to his right foot. Patient had recently had extensive surgeries to both feet. Patient was discharged 2 days later in stable condition.
no additional AE; inadvertently administered a 4th GARDASIL 9; This Spontaneous report has been received from a nurse via company representative regarding a 28-year-old female patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 31-AUG-2021, the patient was inadvertently vaccinated with a forth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. No additional adverse event.
ANXIETY TYPE FEELING IMMEDIATELY AFTER INJECTION; SLIGHT SORENESS AT INJECTION SITE; LITTLE NAUSEA IMMEDIATELY AFTER INJECTION; FATIGUE; LOW GRADE FEVER FOR 24 - 48 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced anxiety type feeling immediately after injection, slight soreness at injection site, little nausea immediately after injection, fatigue, and low grade fever for 24 - 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade Fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety type feeling immediately after injection, slight soreness at injection site, little nausea immediately after injection, fatigue, and low grade fever for 24 - 48 hours. This report was non-serious.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
Patient had the menactra vaccine on 7-29-09.Her arm was very sore,on 8-1-09 at approx 6 pm she complained of sore lymph nodes in her neck radiating into the collerbone area, in another 30 minutes she was having shooting pains in her neck and head, these seemed to subside somewhat, within another 20 minutes her whole side where she had received the vaccine was very painful including her ribs with all over stiffness her breathing was labored due to the pain and numbness in her arm and legs.We took her to emergency room they looked at her and determined it was a reaction to the vaccine.We were instructed to give her ibuprofen, her pain subsided and she still has soreness in the arm and shoulder.
Patient began having left sided chest discomfort, racing heart beat, and numbness/tingling in left arm starting Saturday Feb. 20th, 2021 in the morning.
Erythemic flat blanchable redness developed 24 hours after KINRIX vaccine given to right upper thigh. 24 hours later (48 hrs after vaccine) area doubled in size. Ice was applied and erythema improved. Some pain noted to area, mild ecchymosis noted.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: PT received vaccine and sat in waiting area chair, within 5 min, said "excuse me, I think I'm going to pass out" Went out to pt, was very pale, asked if he ate, said no, offerred water and chocolate said food made him nauseous, got orange juice, color came back to lips when drinking but faded, his Aunt brought him in and called both parents, she refused our request to call ambulance, said dad was emt and on his way, mother arrived and he left with her after several glasses of oj, color returned
pt recv vax; uncontrollable crying x 7 hr w/ cramping; MD prescribed ped DT;
Temperature excursion; No further AE details; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from Pharmacist and refers to a 15-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 07-JUN-2023, HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE details/No PQC.  Lot Number W0252273 is NOT valid for V210 and does not match any Company product.
I experienced dizziness, lack of energy and my pulse rose to 160. I also felt like my heart was about to come out of my chest.
Patient was vaccinated on 4/19/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and was advised and he got re-vaccinated with Pfizer#4
At around 12:00 AM the morning after the vaccination, I woke up with a mild fever. I had extreme thirst that could not be quenched and was unable to go back to sleep. The entire day after the vaccination my stomach was slightly upset, but mostly I felt bad the rest of the day due to the lack of sleep. After work that day, I came home and went to bed around 6 PM. The symptoms went away after getting some sleep and were overall minor, but the extreme thirst was something I had never experienced before.
Fever, chills, malaise, generalized muscle pain, moderate to severe, confusion, felt like a zombie. Had to lie in bed for duration of night. Tylenol extra strength seemed to help. Had a hallucination while lying in bed. Felt better next day but then, late in day same symptoms  came back, not as severe. Back in bed.
I am experiencing lower back pain and muscle spasms she. Standing for longer than 10-15 minutes.  I did not include it in my vsafe check in because it wasn?t constant and I didnt think it was related to the vaccine.  It wasn?t until I was making a note of when it started to make an appointment with my doctor that I realized that  the first instance was within hours of me getting the vaccine.
This is a spontaneous report from a contactable nurse and from a contactable physician. A 20-year-old female patient received first dose of TRUMENBA (Lot# J28923), intramuscular in left deltoid, on 21May2015, at 0.5 ml single. Relevant medical history included borderline factor 7 deficiency that did not require medications or treatments. Concomitant medication included ORTHO CYCLEN, oral, at 1 DF 1x/day, for oral contraception. The patient experienced really red swollen arm, about 4 inches swollen, a lot of pain and fatigue on Jun2015. The patient was treated with ice packs and TYLENOL either 650mg or 1000mg tablets by mouth 3 times a day as needed with good effect and relief. No other treatments were required. The events were assessed as non-serious. The events recovered. Follow-up (16Feb2016): New information received from a contactable physician includes: vaccination details. Follow-up attempts completed. No further information expected.
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*.  By 21 hours I had a temp of 102*.  My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*.  Finally I took some Tylenol at 34 hours so I could sleep from the back pain.  Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*.  I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction.  My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
After the vaccination I got sick and had symptoms of fatigue, body aches, and fever and it lasted for a day. The next day my heart condition got worse and I had to go see the doctor and they diagnosed me with ventricular tachycardia.
the night of vaccine Started feeling bad all over about 7 pm aching and chills all over. went to bed early because i felt so bad a little nauseous. about an hr later i got up and threw  up. i took 1 tsp of pepto, before i threw up and after.  I only weight 89 pounds so i feel like it affected me differently.  the next day (today) had nausea when i woke up but am starting to feel a little better. able to keep down a little yogart.
This spontaneous report was received from a 77 year old female patient, reporting on herself. The patient did not have pertinent medical history. The patient's drug reactions or allergies included aspirin and oxycodone (PERCODAN), Aspirin, penicillin, and an unspecified medication that used to be used as anesthesia. On 16-DEC-2016, the patient was vaccinated in the physician office with PNEUMOVAX23 (which had the lot # M013156, expiration date unknown) route "injection", to prevent pneumococcal disease (dosage information was not provided). Concomitant medication was reported as "other unspecified". The patient experienced shooting pain around the injection site "quickly, right after the shot". Additionally, her "range of motion" began to decrease about "two days after the shot" and got "progressively worse" (mobility decreased). The patient also said that when she was sleeping, the pain "woke  her up and bothered her". The patient had not seen her physician for treatment, but she was self medicating with unspecified acetaminophen (TYLENOL) and pain cream reported as "methyl salicylate (BENGAY) kind of stuff". It was also reported that laboratory tests were not performed. The patient did not seek medical attention. And there was no product quality complaint. At the time of reporting, the outcome of mobility decreased, vaccination site pain and sleep disorder was not recovered. The causality assessment between the reported events and therapy with PNEUMOVAX23 was not provided. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 06-DEC-2017, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N001488, expiration date 12-JUL-2018 (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006828: US-009507513-1801USA002138: US-009507513-1801USA002137.
On 1/8/21 notice red, warm, raised, , swollen hardened area to upper arm, around site of injection
Twenty-four hours post vax, developed cold symptoms. Returned to physician's office following day, child appeared to be disoriented - 'out of it.' Physician dx bronchitis and gave Biaxen. Went to ER that day - child was unresponsive (hypotonic). Admitted to hospital and received dx of leukodystrophy. Genetic testing nml.
Breakthrough case admission after two vaccines: Pfizer 4/22/2021 batch/lot# EW0164; Pfizer 5/13/2021 batch/lot# EW0183.
10 hours after receiving the vaccine (1st dose) he reports a seizure.  Was seen in the emergency room for care.  No prior history seizures
Patient reports she had swelling in her hands, feet and felt like she was having difficulty breathing. This has since improved and denies difficult  breathing. Reports fever 102.7 with chills, body aches, and nausea. Encouraged patient to seek emergency care if rash, swelling, difficulty breathing occur. Advised to take BENADRYL.
Area of approx. 2 inch x 2 inch diameter of erythema to (Lt) upper arm with mild edema, tenderness & warmth. (Mild-moderate local reaction). No hives or rashes; positive fever per mom.
Positive for Covid-19; Positive for Covid-19; This is a spontaneous report from a contactable other healthcare professional (nurse). A 33-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021), via intramuscular route, administered in Left arm on 04May2021 at 06:30 as dose 2, single (at the age of 32 years) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021) via intramuscular, administered in Left arm on an unspecified date in Apr2021 at 06:30 as dose 1, single (at the age of 32 years), for covid-19 immunization, at clinic. Relevant medical history, concurrent conditions and relevant past drug history was unknown. It was unknown if the patient had received any other medications within 2 weeks of vaccination (concomitant medications unknown). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that, on 30Jul2021, the patient was positive for Covid-19. The event was reported as non-serious. The event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no hospitalization. No treatment was received. The outcome of the event covid-19 was recovering at the time of report.  Product complaint investigation conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
I had very heavy fatigue, muscle aches, moderate fever of 101.5F, nasal congestion and coughing at night a month ago. I had trouble sleeping and decided to test for COVID-19. I decided to take an at-home COVID-19 on 5/10/2022, and it came back positive. So I decided to go to a pharmacy and got PCR tested on 5/13/2022, but it came back negative. So I waited some days and got retested on 05/16/2022 with another PCR test, and this one came back positive. I called my doctor and told them in which he prescribed me medication, but I never called to get it filled. So I took ibuprofen daily until I got better.
7 days ( March 4)  after vaccine I felt a hive at vaccination site, by next morning (March 5) it had tripled in size . By March 8th, 2/3 of upper left arm was red, hot, itchy and inflamed. Treated with hydrocortisone topically, oral Benadryl and topical ice packs.  Nothing ultimately helped any of the symptoms. By morning on March 11, itching was gone, area is still warm but not hot and most of redness has disappeared but skin is still slightly discolored.
After DTAP, HIB, Pev 7 #3 on 12/27/2002; patient report that the baby was irritable and "lethargic"-lost interest in playing-withdrawn regressed developmentally for about a month.  She has pale and dark curves around her eyes, lost muscle mass right away.  Diapers child felt "scratchy" ears, pulling out hair.  F/R fontanelle blury for six days.