chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness on the injection site; This is a spontaneous report received from a contactable female consumer from a Pfizer sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 10Mar2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose on 07Apr2021. Medical history and concomitant medication was not reported. Caller, on behalf of her Boss asking if it was okay not having any side effects after getting the second dose of the vaccine today, 07Apr2021 and if receiving the second dose of the vaccine 4 weeks later from the first dose given on 10Mar2021 instead of getting it in 3 weeks and which was not as expected based from what they heard about the second dose side effects, considering also her Boss had some side effects after the first dose of the vaccine. She mentioned the side effects of her Boss felt after the first dose of the vaccine which was arm soreness on the injection site on unspecified date in 2021. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained
tingling sensation on toes; A spontaneous report was received from a consumer (medical student), reporting on self and concerns a 26-year-old male patient who received Moderna's COVID-19 Vaccine and experienced tingling sensation on toes.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 02 Jan 2021, approximately 2 days prior to the onset of symptoms, the patient received his first of two planned doses of mRNA-1273 (Lot number 026L20A) through an unknown route in an unknown arm  for prophylaxis of COVID-19 infection.  On 03 Jan 2021, the patient had tingling sensation on toes. Treatment information for the event was not provided.                                                           Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event, tingling sensation on toes was unknown.; Reporter's Comments: This case concerns a 26-year-old male who had a nonserious unexpected event of paraesthesia, described as tingling sensation on toes.  Event onset occurred 2 days after the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the paraesthesia, a causal relationship cannot be excluded.
Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling.  Tingling, numbness.  Next day intense pain at injection site, but swelling had gone down.  Trouble sleeping first 3 nights after vaccine.  Pain at injection site lasted until 4 days later when right shoulder joint began to hurt causing limited mobility.  7 days after vaccine lymph nodes very swollen and tender in left armpit and large swollen nodule next to right ear on scalp appeared.  9 days after vaccine still having pain and mobility issues with right shoulder.  Have been generally fatigued, harder to exercise in the days after the vaccine.
was hospitalized from 8/30/21 - 9/8/21 for COVID; positive test on 8/30/21; had fever, cough, and increasing SOB; treated with steroids, bronchodilators, DVT prophylaxis; was dc'd to home where (per death certificate) she died; Causes of death:  recent GI bleeding, ESRD, inoperable large cardiac and aortic aneurysms, recent COVID illness
red itchy bumbs started first on left arm, then to my right. later in day to the top of my feet and then to my hands.
Patient received flu shot 10-30-2020 after stating that she has already received the flu shot for this season on 10-7-2020
Patient signed up for a flu vaccine at the pharmacy. She filled out the consent form and was counseled by the pharmacist.  After receving the vaccine, she stated that she also received the flu vaccine at her doctor's office 1 month ago. The patient's doctor was notified. No adverse reactions have been observed .
I got the J&J vaccine. Didn't see a choice above. Janssen? Intense chills. Fever, Severe Headache, Cold-Sweats, Vomiting , Diarrhea for about 36 hours. Low grade fever fro about 48 hours
ITCHY RASH ON ARMS; RASH; RASH/HIVES ON BOTH ARMS FROM WRIST TO SHOULDER; SCRATCH EYES OUT; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816024, and expiry: 29-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for heart disorder. On AUG-2021, the patient experienced scratch eyes out. On AUG-2021, the patient experienced rash. On AUG-2021, the patient experienced rash/hives on both arms from wrist to shoulder. On 06-AUG-2021, the patient experienced itchy rash on arms. Treatment medications (dates unspecified) included: camphor/diphenhydramine hydrochloride/zinc oxide, prednisone, betamethasone valerate, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rash on arms, and rash, had not recovered from rash/hives on both arms from wrist to shoulder, and the outcome of scratch eyes out was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 31Mar2022 at 10:00 as dose 4 (booster), single (Lot number: 046L21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "heart valve repair", start date: 28Jan2022 (unspecified if ongoing), notes: Other medical history: heart valve repair 28Jan2022. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 as the patient received Paxlovid treatment on 30Dec2022.
After the second Moderna Covid shot patient had fatigue, malaise, his symptoms never improved they became worse. Since then he has been light headed, dizzy, some peripheral eye issues. He falls asleep in less than two minuets. He was told to give it some time that these were side effects from the Covid shot. He made an appointment with his primary doctor on June 10th, had several blood test done, many came back with extremely abnormal results. He was sent to an oncologist, the bone marrow aspiration revealed PH+Chronic Myloid Leukemia. Patient was very healthy prior to this, had had blood work within the previous year that was 100% normal at that time!!
extremely, horribily itchy hives/rash/welt areas that pop up sporadically at random places on torso (front and back), arms, fingers, hands, neck, head, eyelid, ears, and legs.
Severe constipation, which has never happened before. She is normally regular and was not dehydrated. She was crying and sweating and sat on the toilet for over an hour. We had to give her a laxative chew. She potentially developed hemorrhoids from pushing so hard.
Headache  Chills Temp  (101.6) Body aches Skin hurts to touch Soreness in arm  (injection site)
3 days of fever to 102 degrees. Redness spreading through left shoulder. Soreness remaining after 2 months.
Patient felt nausea and could not breath so he stood up and took a breath. When he stood up he lost consciousness and fell. Patient hit his fore head and started having a seizure. The seizure lasted about 1-2 minutes before he regained consciousness. Patient was taken away by the EMS
Chills; stabbing headache; low grade fever (100.4F); body aches; dry cough; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, Lot number: EN5318) via unspecified route of administration, on right arm, at 08:15 on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included childhood asthma, lymphomatoid papulosis, small fiber neuropathy, canker sores on tongue, allergies to penicillin, eggplant, quinoa. The concomitant medication was not reported. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced chills followed by stabbing headache, low grade fever (100.4F), body aches, dry cough and fatigue at 21:00 on 29Jan2021. It was reported that symptoms lessened within 24 hours and after 48 hours only cough and fatigue remained. It was reported that as of 01Feb2021, the patient had only occasional cough and some fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had not received any treatment for the events. The events were reported as non-serious. The patient had not diagnosed with COVID-19 prior to vaccination and had not been rested for COVID-19 since the vaccination. The outcome of the events chills, stabbing headache, low grade fever (100.4F), body aches was recovering, while for fatigue and dry cough was not recovered.
Patient received Tdap on 3/23/09. Came into office today 3/30/09 arm slightly red, small lump at site. Patient states "it is much better than it was. Arm was red, lump and warm to touch. Shoulder to mud upper arm. Patient using hydrocortisone cream. Improving.
On Friday 11/12/21 she took her first dose of COVID vaccine (Pfizer). The following day she started having sharp pain in her left arm and left chest, and could not take a deep breath due to discomfort in her chest.
This happened for first and second doses. Same symptoms: chills, fever, joint pain, numb legs, full body pain, loss of appetite. She had covid in September 2020.
Pt is in a Moderna trial at school, today presents to clinic with hives scattered on body and severe muscle and joint pain
Left anterior thigh 13x17.5 cm erythematous , edematous tender. Treatment: Keflex, Benadryl
pt states that she has been experiencing extreme fatigue and body aches.  she has swelling and soreness in left arm around the injection site.
1604: 1st dose Pfizer vaccine administered 1609: Syncope episode- Client appeared limp and sliding out of chair. Pallor appearance. NP and MA witnessed event and placed client on floor before she fell out of chair. Did not hit head. Feet were immediately raised. Client was vocal but disorientated. ice packs used.   Client A&Ox4 within seconds. Gatorade and water offered.  1611: BP: 122/ 68 HR: 94 RR: 18. After syncope episode, mother stated that client has history of vasovagal syncope with needles.  Client still laying on floor with feet raised. NP sitting on floor with client and her mother for observation. 1645-Instructed mother to follow up with pediatrician. Complexion returned to normal.  Client stated that she feels fine. Mother and client left site without no further incidents.
On 10/29/02 had five pink bumps on stomach, 3 on back, one on head, one on arm, one on face. Did not see physician. School nurse sent her home.
Seven hours later got violent shakes, very cold body, ice cube hands. Took ibuprofen went to bed, couple hours later shakes turned to small trembling. Middle of the night had severe headache around the crown of head /like it was put in a vise. Joint and body aches, fragile stomach, fever, off-balance. Stayed in bed for about 37 hours. Blew two big clots out of each nostril. Took about a week to feel ?normal? and not waking up with bad headache.  The site of my injection and arm was never really sore.  Almost went to ER .  My first injection went well only had a slight metallic taste for a few hours and sore arm.
Headache, vaccine site pain, nausea, weakness, anorexia, dry cough, myalgia, joint pain. My spouse had onset of symptoms at the same time post-vaccination (about 11 hours).  He has malaise, myalgia, partial anorexia, acute recurrence of shingles with generalized stabbing pains. Age 78. We are now 31 hours post vaccination and our symptoms have not improved.
pt recv vax; subsequently devel generalized varicella like rash w/ 10-15 lesions & slight T of 99;
Local erythema, swelling, pain at site of injection of Varicella and Tdap which were both given together at same area at Public Health- left tricep area
Information has been received from a pharmacist concerning a female in her early 20s who was vaccinated with the first two doses of GARDASIL at a different clinic. Subsequently the patient tested positive for HPV. The patient come tot he office for a yeast infection and is currently being prescribed DIFLUCAN. She was tested for HPV at the office visit for the yeast infection. The pharmacist did not know if she was tested for HPV prior to the start of GARDASIL. As of 04-SEP-2007 the patient had not recovered. Additional information has been requested.
Infant was given MMR and Varicella vaccines prior to 12 months of age. DOB was entered incorrectly in the EMR and staff did not verify patient's DOB on arrival. Therefore he was given vaccines normally given to 12 month old. MMR of course can be given prior to 12 months under special travel circumstances (but this patient was not traveling). Varicella has no indication prior to 12 months of age. Incident was caught when patient followed up for routine well visit  2 months later. Family is aware of error and they reported no adverse events when he received the vaccines at 10 months of age.  They are also aware he will need the MMR and Varicella repeated, now that he's over 12 months old.
pain at the injection site; tired; Headache; Muscle ache; Chills; Joint pain; Fever; Nausea; Feeling unwell; Covid vaccine booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 12:00 (Lot number: FG3527) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, 04Mar2021, Lot: EN6204), administration date: 04Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "tiredness", "fever"; Bnt162b2 (Dose 2, Second: Given on 25Mar2021 Lot: ER2613), administration date: 25Mar2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Covid vaccine booster shot"; VACCINATION SITE PAIN (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "pain at the injection site"; FATIGUE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "tired"; HEADACHE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Headache"; MYALGIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Muscle ache"; CHILLS (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Chills"; ARTHRALGIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Joint pain"; PYREXIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Fever"; NAUSEA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; MALAISE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Feeling unwell".  Additional information: Report is  related to a study or programme. No investigation Assessment.Primary Healthcare: declines as he is ok now. The caller clarifies this all lasted 2 days, all of Sunday and all of Monday and then he was ok. AE did not requires to visit to emergency room and physician office. No prior vaccination within 4 weeks. No AE's following prior vaccination. No relevant test's.  Follow-up attempts are completed. No further information is expected.
received a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number y537x, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09th September 2020) and Shingrix (received 2nd dose on 11th November 2020).   On 15th February 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 15th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient inadvertently received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
WARM TO TOUCH, 11X9 CM LIGHT ERYTHEMA LEFT UPPER THIGH
Shingles; Leg swelling, foot swelling; Numbness; 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 HERPES ZOSTER (Shingles), PERIPHERAL SWELLING (Leg swelling, foot swelling) and HYPOAESTHESIA (Numbness) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles), PERIPHERAL SWELLING (Leg swelling, foot swelling) and HYPOAESTHESIA (Numbness). At the time of the report, HERPES ZOSTER (Shingles), PERIPHERAL SWELLING (Leg swelling, foot swelling) and HYPOAESTHESIA (Numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
On 11/15/01 at 01:00, pt was fed and laid on her back. At 03:00, checked baby and determined that she was not breathing. There was no response and no pulse. Called 911 and CRP was performed. Ambulance came and transported to the hospital.
headaches - 1 hour after injection  injection site pain - 5 1/2 hrs after injection body aches & fatigue - 5 1/2 hrs after injection and continuing, Tylenol helps suppress the severity  of body aches and fatigue chills - 20 hrs after injection reddish/purple spots or bruising on left (same side as injection) ribs, almost underarm. Bruise is approximately 2 inches in length and 1 in tall. noticed this evening (4/26/21)
Pain and swelling in R deltoid, took child to ER at 10pm on 11/5/02. Dr stated child had cellulitis and put him on antibiotics.
Patient was given a booster dose (0.25mL) of Moderna instead of a full dose (0.5mL) as this was patient's 2nd dose. Patient was notified and returned to the clinic to receive another 0.25mL dose of Moderna. No reactions or adverse event from receiving 2 injections.
Pain in left arm started approximately 7:00 pm the day of the shot (Feb. 17).  The next morning approximately 7:00 am I started getting a headache but it was gone by around 10:00 am.  Felt fatigue all day on Thursday (Feb. 18).  Pain in left arm was worse Thursday (Feb. 18).  Couldn't raise arm out to the left or to the front.  Arm pain was still there on Friday, but was minor.  Didn't take any medications, just rested on Thursday, Feb. 18.
Swelling under both eyes, first noticed when I woke up the morning after vaccine, gradually decreased over the next few days; swelling left cheek, gradually decreased over the next week; chest tightness, started the day after vaccine, intermittent throughout day, decreased in frequency & severity 8 days post vaccine. Currently 14 days post vaccine and still have mild chest tightness, intermittent throughout day.
He has extreme aching and soreness in both hands.  Still has the symptoms, 2 days after vaccination.  Unable to improve symptoms with tylenol and ibuprofen.
ED visit for closed fracture of right hip. She underwent right hemiarthroplasty on 3/5/2022. Prior to discharge, she started on apixaban 2.5mg BID for DVT prophylaxis, but developed a GIB requiring transfusion and transfer to the ICU. Discharged. Hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Redness, firmness, and slight itching at injection site 2 days after injection.  'Covid Arm'
Event: Received the Influenza vaccine on 9/22/21 in right shoulder, which hurt when received it. Later that night the pain became worse. Every day and night since has had to take Tylenol and ibuprofen alternating every 4 hours. Wakes during the night and has to take Aleve. Has used ice and heat. All therapies have helped with some relief. Describes pain as dull ache but when moves is a "pulls my muscle off bone - tearing feeling." Pain is felt in anterior and lateral portion of right shoulder. Rates pain a 3/10 but when moves it can be an 8/10.   Tx: Will start meloxicam and tizanidine. May use tylenol every 4-6 hours as needed. Discussed use of ice/heat in addition to topical analgesics/patches.
Pain and redness of ankle, couldn?t walk on ankle, Severe cellulitis resulting after a few days. Trip to ER and resulting emergency surgery for potential necrotizing fasciitis.
A nurse practitioner reported that a 38 year old female received a dose of Flu Shield on 12/06/2001 and immediately experienced neck discomfort and stiffness. The symptoms improved within approx 15 mins. At the date of the report, no further info was available. This is 1 of 2 patients from this facility who experienced an adverse reaction following receipt of flu shield. (2001-2002 formula) lot 4018041. FOLLOW-UP information received from the reporter on 02/05/2002, provided physician information, time of vaccination and stated that, within 24 hours post-immunization, there was no residual effect. (See related HQ9313710DEC2001)
Felt like vertigo about 20 min after vaccine, irregular blood pressure. Lasted 1 hour of monitoring until I felt safe to drive away.