chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I fell asleep and  3 1/2 hours later awoke with a mild headache that did go away without any medication and flu-like ashiness. During the remain 5 hours, I had very restless sleep being away at least 75% of the time. I was very tired and groggy while drinking my morning coffee around 6:00 am. My husband said I had fainted (syncope diagnosis by ER doctor) and was out for 30 to 45 seconds. When I came to, I threw up my morning coffee, broke out in a cold sweat and continued to feel extremely tired and somewhat achy. My husband contacted my primary care physician who directed us to Emergency at local hospital. Important information - I had just gotten over a cold and was experiencing spring allergies.
Patient received an expired dose of the Moderna COVID-19 vaccine from a previously unpunctured vial that had been in their refrigerator since 04 Jun 2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine from a previously unpunctured vial that had been in their refrigerator since 04 Jun 2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine from a previously unpunctured vial that had been in their refrigerator since 04 Jun 2021). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine from a previously unpunctured vial that had been in their refrigerator since 04 Jun 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
This spontaneous report as received from a mother reporting on her daughter of unknown age. On 26-JAN-2015 the patient was vaccinated with a second dose of GARDASIL (dose, route and lot # was not provided). The reporter stated that after first dose of GARDASIL (date unspecified) her daughter did not experienced adverse effects. However after second dose, patient's menstrual period which was normally on time had not yet started. By the time of the report (reported as "yet") the event was not resolved. Relatedness between the event and GARDASIL was not specified. Additional information is not expected as the reporter did not wish to provide specific information.
Left deltoid swollen, red and hot to touch. No fever. Swollen area firm - 3" in diameter. Treated with heat, Ibuprofen. Recheck as needed.
Sept 5, I noted elevated heart rate that didn't miss any exertion level or stress level. It was a single event and I was able to back it down with rest and then it resolved itself. Then on Sept 12, I had another tachycardia event where heart rate was up in the 120s and then I couldn't get it back on September 12 - but I could get it back down into the low 100s. It now continues and comes and goes. It could be another medication that caused it - most likely Dethamexazone -I was taking a pill in August something. And then I got a a first infusion of it in an  IV infusion of it. I started getting infusions that included Dethamexazone of it in September 15th and I got it for five days; I  don't know.
Extreme pain in new knee replacement so much so almost falling. Pain non stop. Hurts to stand. Feels weak. All joints extremely painful but knee replacement worse. It?s 5 months old
Pt c/o recurrent right deltoid muscle pain. Pt. seen by family physician on 20110211 and by clinic physician. Pt. diagnosed with deep tissue/bone bruise. We will continue to follow up with patient.
Mom called pharmacy on 1/16/2022 stating patient received her first dose of Pfizer pediatric on 1/14/2022. She developed a rash on her face that evening. On 1/15/2022, patient was itchy on her arm and belly. Upon inspection from her mom, it was discovered the patient had hives on her belly and arm. There was no difficulty breathing but mom gave patient Benadryl. The patient was better on 1/16/2022. The mom wanted to report the AE and asked if patient should get the second dose.
This spontaneous report as received from a certified medical assistant refers to an 8 year old female patient. In approximately 209, "approximately 4 years ago", the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) IM two months prior her ninth birthday. No adverse experienced was reported. The patient did not seek medical attention. Additional information has been requested.
No symptoms. Friend and has mother tested positive and she tested on 11/8/21 and received positive results 11/9/21
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Almost exactly 24 hours after receiving the second injection, I had a tonic-clonic seizure. This is my first seizure in >2 years and they have been well-controlled with Lamictal which is prescribed by my neurologist.
rash/rash over sun exposed areas; This case was reported by a physician via call center representative and described the occurrence of solar rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced solar rash. On an unknown date, the outcome of the solar rash was unknown.   It was unknown if the reporter considered the solar rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient developed a rash over sun exposed areas 1 week after the vaccination.
Patient complained of feeling cold, nauseated when getting up in the morning and stated that he had felt cold all night long and could not get warm.  Appearance was pale.  Dressed in multiple layers of clothing.  Rode with me in the car as to not leave him alone.  While sitting in the car he became more nauseated and vomited.  When he leaned back onto the car seat he began to seize biting his tongue and then stopped breathing.  Pulse was present.  911 called.   Breathing gradually returned.  EMS took him to the hospital where he remained for 4-6 hours.  He was released from the hospital after the post distal stage passed and he could function.  He was so weak that he did not return to work for 10 days.
Initial report received from a consumer who is also a health care professional on 14 Dec 2009. This patient received Fluvirin(H1N1 influenza virus vaccine) first dose for immunization against swine flu on 30 Oct 2009. The patient reported that three days following vaccination, the patient developed serious reactions like general weakness, gait abnormality and loss of balance. The patient did not have any medical history of asthma or immunosuppression. The patient contacted his ENT specialist to inquire whether it was related to ear ache or vestibular nerve damage. The ENT specialist prescribed Methyl Prednisolone (manufacturer unknown) and ear drops with Diazepam (manufacturer unknown). The patient's condition improved for a few days but the symptoms reappeared again with loss of balance (gait problems), because of which he could hardly walk without support. The patient contacted a neurologist who assessed that the reaction as related to the swine flu vaccine. The patient's condition remained the same for almost four weeks. Recently the patient also presented with mild headache on both side of tempo parietal region. The patient also reported that because of the illness he switched to part time job. The  patient expressed his concerns for immediate treatment since he may develop neurological deficits if untreated.
Ten days after vaccination I broke out in hives and a rash. The rash and hives spread to cover entire body and persist four days later.
Weakness for 2 days after 2nd shot; Nausea after for 2 days 2nd shot; Headache for 2 days after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness for 2 days after 2nd shot), NAUSEA (Nausea after for 2 days 2nd shot) and HEADACHE (Headache for 2 days after 2nd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced ASTHENIA (Weakness for 2 days after 2nd shot), NAUSEA (Nausea after for 2 days 2nd shot) and HEADACHE (Headache for 2 days after 2nd shot). In June 2021, ASTHENIA (Weakness for 2 days after 2nd shot), NAUSEA (Nausea after for 2 days 2nd shot) and HEADACHE (Headache for 2 days after 2nd shot) had resolved.            No concomitant product information was provided. No treatment information was provided.   This case was linked to MOD-2022-437599, MOD-2022-437623, MOD-2022-437623 (Patient Link).
Patient  had a reaction to the Covid 19 vaccine. Patient lost consciousness  and he fell to the side, the body was tight, he felt dizzy and his eyes were half open. He had not eaten any food prior to immunization.    Patient was given water to drink, Orange juice was given to the patient as well. Patient started feeling better after given orange juice. Patient fully recovered, Advised upon discharged.
5-6 minutes post vax, the pt experienced dizziness, elevated heart rate and diarrhea. A clinic visit was required. Her symptoms resolved in 24 hours. The hepatitis B vaccine was discontinued. As of 08/02/2000, the outcome of the event is resolved.
warm on arm around injection site; itchy on arm around injection site; red on arm around injection site; rash on arm around injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm on arm around injection site), VACCINATION SITE PRURITUS (itchy on arm around injection site), VACCINATION SITE ERYTHEMA (red on arm around injection site) and VACCINATION SITE RASH (rash on arm around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm on arm around injection site), VACCINATION SITE PRURITUS (itchy on arm around injection site), VACCINATION SITE ERYTHEMA (red on arm around injection site) and VACCINATION SITE RASH (rash on arm around injection site). At the time of the report, VACCINATION SITE WARMTH (warm on arm around injection site), VACCINATION SITE PRURITUS (itchy on arm around injection site), VACCINATION SITE ERYTHEMA (red on arm around injection site) and VACCINATION SITE RASH (rash on arm around injection site) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MODERNATX, INC.-MOD-2021-060987 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-060987:friend case
Within 40 mins I started feeling dizzy and light headed with brain fog as well as numbness from my knees to feet. Then within 4 hours I started getting numbness from my elbows to hands as well and in this time frame I developed chest heaviness, SOB, stabbing chest pains and facial flushing. The numbness is on and off all day long every day for the last 7 days as well as the flushing of the face. I have not had any relief from the chest pain/tightness/SOB/stabbing pains/pounding of the heart since I received the vaccine. 3 days after the vaccine i did have an episode of heart fluttering..   On Tuesday 11-16-21 I did make an appointment to see my PCP for today 11-19-2021 at 2pm to discuss my symptoms. I had waited a few days thinking my symptoms would resolve but they have not and the chest/heart issues are getting worse.
Information has been received from a consumer concerning her father who is in his "early sixties" who was diagnosed with PARSONAGE-TURNER syndrome by a physician several years ago after receiving the influenza virus (unspecified) (manufacturer unspecified), who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, several weeks after receiving the zoster vaccine live (Oka/Merck) vaccination his symptoms of PARSONAGE-TURNER
Throat burning; continued to swell like my glands were swelling.; arm is little sore; throat was burning in pain; It was very sore and painful; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (throat was burning in pain), PAIN IN EXTREMITY (It was very sore and painful), THROAT IRRITATION (Throat burning), LYMPHADENOPATHY (continued to swell like my glands were swelling.) and PAIN IN EXTREMITY (arm is little sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), OMEPRAZOLE, ALLOPURINOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (throat was burning in pain), PAIN IN EXTREMITY (It was very sore and painful), LYMPHADENOPATHY (continued to swell like my glands were swelling.) and PAIN IN EXTREMITY (arm is little sore). On an unknown date, the patient experienced THROAT IRRITATION (Throat burning). On 07-Feb-2021, OROPHARYNGEAL PAIN (throat was burning in pain), PAIN IN EXTREMITY (It was very sore and painful) and LYMPHADENOPATHY (continued to swell like my glands were swelling.) had resolved. At the time of the report, THROAT IRRITATION (Throat burning) and PAIN IN EXTREMITY (arm is little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Motrin, Hot tea with honey & lemon.   Reporter did not allow further contact
Within 15 minutes chest felt like it was burning, then chest pain, felt short of breath, and tachycardia. Notified monitoring staff. Hooked up to a bf cuff, pulse ox, heart rate. HR elevated and can't remember bp. Started to feel better then chest pain worsened, felt faint. Thought I was vasovagalling so I laid down and put feet on a chair. Same symptoms continued occur in a cyclic fashion, continuing to worsen. Brought to ER waiting area then left arm went numb, hand turned white, and began spasming. They rushed me back to an er room. Ekg normal, waited an hour and released me home. The doctor said it may have been a vasovagal triggering panic attack in a cyclic runaway manner. Not a clear explanation. I continued to have chest pain and elevated heart rate /anxiety issues for weeks that I did not have ever before. I also experienced chest pain and shortness of breath after the first round in the middle of the night and I assumed it was just heart burn. Then experienced the same symptoms but exponentially worse with the 2nd shot 15 minutes after.
Atrial fibrillation at 11:45pm on 4/14 resulting in carioverson at 2:00am in 4/15
Patient contacted the clinic on 6/21/21 with symptoms of an upper respiratory infection. Patient tested negative several times for COVID-19. He was treated with multiple courses of antibiotics with no improvement. Patient went in to the ER for shortness of breath and was diagnosed with Guillain-Barre Syndrome.
GBS;severe back pain, leg cramps/fingers & toes numb;finally couldn't walk, facial paralysis, half smile;couldn't roll over w/o help;hard time swallowing couldn't close eyes;p/2mo in hosp had to learn to walk again but legs feel heavy;
1 inch x 3 inch raised, painful, heated. Treated with NSAIDS. Resolved in 1 weeks.
Narrative:  Fever chills, fatigue, nausea. Started feeling poorly before bed, fever started overnight I believe. Slept nearly the whole day afterwards. Chills happened when fever broke, went away when fever returned. Still felt a bit nauseous on the 14th, but this may have been d/t not eating much on the 13th
Covid symptoms reappeared on 14Jun2022; Covid symptoms reappeared on 14Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 14Dec2021 at 15:45 as dose 3 (booster), single (Lot number: 330308D) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Covid symptoms reappeared on 14Jun2022". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0162 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 EW0162, fill lot EP8695,and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. A complaint sample was not return ,and photographs were not received.   Conclusion of Previously Completed Investigation: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 33030BD was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 33030BD. No quality issues were identified during the investigation. There is no impact on product quality.  No follow up attempts are needed. No Further information is expected.
Nausea/vomiting requiring ER visit. Sent home after ER visit.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter (consumer) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Mar2021 (lot number: EL3247) at the age of 26-years as dose 2, single and administration date 10Feb2021 (lot number: EL3247) at the age of 26-years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset 05Jan2022, outcome "not recovered" and all described as "Tested positive for Covid." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2022) negative, notes: Nasal Swab; (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure and COVID-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Reviewed with patient how he would like to receive the vaccine; and confirmed he has personal epi pen with him; reviewed allergy list and completed screening questionnaire;    Patient lying down, using breathing techniques and administered vaccine in left deltoid; had immediate feeling of pain and burning at the site of the injection, more than he expected; the patient remained alert throughout course of administration; remained supine for approximately 15-20 minutes after injection; pulse remained strong and steady 75-80 bpm; moved to sitting position on his own; given cold pack for injection site; states he has sharp jabbing pain in ribs under left arm    About 45 minutes post injection stated he was tired; denies any s/s of allergic reaction; injection site unremarkable; sipping on a sports drink   @ 1116 c/o slight dizziness, nausea and abdominal cramping; improved with ambulation   @1145 c/o tight feeling around his chest similar to jabbing pain he had earlier in ribs under left arm; comes in waves; no SOB, no diaphoresis; in no apparent distress   @ 1215 states nausea and abd cramping has resolved; rechecked BP; 132/85 P 64; reviewed follow up care with his friend who accompanied him to the appt;    Discharged to home with appt scheduled in 2 months for booster.    12/16/21;  But immediate thing for me is how awful I feel right now - esp pain in legs.  I'm doing/trying everything I know to do - long Epson baths on days I can; taking more RED MM for pain than I ever have ... at least once a day where if I took 1 or 2 a month that was rare & putting RED MM pain balm on my legs during day & at night to try help get to sleep, heating pad & ice packs on me constant.  See you next Tues.
severe itching. swollen eyes, feet, lips, and tongue     2-3 days  antihistomines, steroids
Measles-like rash all over body along with watery nasal discharge and dry mucus membranes within 10 days following MMR vaccine. Mild fever, otherwise, well child.