chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID?19 Vaccine EUA Arm is very red at the injection site two days later. It is hot to the touch. There is a lump under the injection site. It is painful to touch.
Mom noted small amount of redness at the vaccine site on his left thigh on 5/11/18. On 5/12/18 mom took the band aid off of the vaccine site on his left thigh and notes a reddened, tender, raised area the size of a deck of cards. Mom gave ibuprofen and BENADRYL and the site began to improve. Mom contacted the office on 5/14/18 to notify us of the reaction and she said that the reaction had almost resolved by that time.
Tested positive on 25Apr2021, her 1st dose on 15Apr2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Apr2021, the patient experienced tested positive on 25Apr2021, her 1st dose on 15Apr2021. Caller called to say that she tested positive on 25APR2021. She wants to know if this will affect her second dose of the vaccine which is scheduled on 06MAY2021. Were any unaddressed medical questions referred or forwarded to Medical Information? Yes: Customer and/or medical inquiry forwarded or referred to MI. On 25Apr2021, the patient underwent lab test which included covid test: positive. The patient did not receive any treatment for the events. The clinical outcome of the tested positive on 25Apr2021, her 1st dose on 15Apr2021 was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TETANUS VACCINE from 01-Jun-2021 to 01-Jun-2021 for Tetanus immunization.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.). At the time of the report, OFF LABEL USE (I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       Concomitant product information was not provided.  Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2013 the patient was vaccinated with ZOSTAVAX, dosing information was not reported. On an unknown date in 2013 the patient experienced inflammation and redness at the administration site. The outcome of inflammation at the administration site and redness at the administration site is unknown. This case is lined by same reporter link to case #1308USA014147 on a 77 year old male who on 28-AUG-2013 had a really red area on his upper left arm after ZOSTAVAX vaccination. Additional information has been requested.
Patient had several strokes on both sides of her brain, atrial fibrillation and major GI bleeds, all causing 2 trips to the hospital.  She has been given 2 transfusions, as the GI bleed has made her blood count go down.  She is currently is in the hospital, they are trying to get her stabilized.
Very mild soreness at the injection site; Very Mild fatigue; This is a spontaneous report from a non-contactable consumer (female patient). A 78-year-old female non pregnant patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: em9809) via unspecified route of administration on left arm, on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 for COVID-19 immunization. It was reported that the patient experienced very mild soreness at the injection site and very mild fatigue on 08Feb2021. The patient administered most recent COVID-19 vaccine at doctor's office/urgent care, had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (unspecified) within 2 weeks of vaccination (as reported). The patient didn't receive treatment for the adverse events. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient was given Boostrix in our shot room appeared fine afterwards.  She stayed in the store not far from the shot room  looking at tylenol products with her sister when she became dizzy, her sister was there and happened to catch her when she started to fall, she did fall into the shelves a little bit but did not hurt herself.  She was given water and sat in the waiting area.  She admitted she hadn't had much to eat or drink that morning and it was a very hot humid day (90's).  After waiting for about 20 minutes she felt well enough to leave with her father who came to pick her up.
2nd dose: Around 6pm of the same day of the shot, I started feeling nauseous, throwing up, body aches, severe headache, fever. The next morning around 6am, I was bleeding out of my nose and butt, feeling worse than the night before. Monday evening, 5/10/21, I started having pain on the left side of my neck and chest pains and my left arm was going numb and was rushed to the ER. An EKG was done and I was checked by the Dr, which he said my neck was swollen and my arm was most likely numb from a pinch nerve. The EKG showed normal. Was sent home to rest and take Tylenol. I continued to feel sick the rest of the week. I noticed my lower part of my legs were then turning purple, which by the end of the following week has spread up to my thighs. It looks like honeycomb under my skin from my butt to my thighs dow n to my legs and my arms are faintly purple. The temperature does not make a difference.
3 x 5 cm area of redness, slight warmth surrounding DTaP shot . No tenderness or induration
Patient broke out into hives 1 hour after treatment. Hives were relieved completely after 12 hours.
Redness at injection site (approx. 2 inches in diameter), intense pain from shoulder to fingers in injected arm, numbness in elbow and wrist
pain and weakness in both arms after having the vaccines; I also having a shaking feeling in both upper arms; pain and weakness in both arms after having the vaccines; Blood pressure increased; Diarrhea; Recurring headaches; Slight dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jul2021 10:00 (Lot number: EW0164) at the age of 65 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 09:00, Anatomical site of injection:  Left arm, Batch/lot number: Unknown EW0197, Event required visit to: Physician Office, Seriousness: Important medical event, Treatment: no), administration date: 15Jun2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "pain in both arms", "weakness in both arms". The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 2021, outcome "unknown", described as "Blood pressure increased"; DIARRHOEA (medically significant) with onset 2021, outcome "unknown", described as "Diarrhea"; HEADACHE (medically significant) with onset 2021, outcome "unknown", described as "Recurring headaches"; DIZZINESS (medically significant) with onset 2021, outcome "recovered" (Sep2021), described as "Slight dizziness"; MUSCULAR WEAKNESS (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 13Jul2021 10:00, outcome "not recovered" and all described as "pain and weakness in both arms after having the vaccines"; TREMOR (medically significant) with onset 13Jul2021 10:00, outcome "not recovered", described as "I also having a shaking feeling in both upper arms". The patient visited family physician due to continued pain and weakness in both arms after having the vaccines. The patient was also having a shaking feeling in both upper arms and sometimes indicate to his chest. The patient underwent the following laboratory tests and procedures in 2021 included blood pressure measurement: increased.  No follow-up attempts are possible. No further information is expected.
get two bumps under each arm pit but they went away a couple days late; fever; This is a spontaneous report from a contactable consumer (patient herself).  A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247; Expiry date: unknown) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunization. Medical history included mammary duct ectasia from 1999 to an unknown date. Patient had not received any other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 01Feb2021 for COVID-19 immunization. The patient's concomitant medications were not reported. Caller stated that she was calling to report not an adverse event, just the opposite, wanted to report an additional benefit to the Pfizer COVID vaccine, caller was a Pfizer employee, stated she also wanted to report that after she had her oldest daughter in 1999 she had a clogged breast duct under her right arm pit, and there has been a bump that comes and goes with her period under her right arm pit since then, saw a doctor many years ago and did so many tests, CT and ultrasounds, they were not concerned. Caller stated she had the first dose of the Pfizer COVID vaccine on 01Feb2021, then second dose was on 22Feb2021, stated she was not really paying any attention. She saw that article and then looking at her past three periods the bump did not bother her, it had not been an issue since the doses of the vaccine. Caller stated after the second dose, on Feb2021 she did experience a fever the whole next day, states she did initially get two bumps under each arm pit but they went away a couple days later, exact dates was unknown. Reporter seriousness for bump under right arm pit has disappeared and not bothered her was unspecified. The outcome of events was recovered on Feb2021.
mom noted while in the arms of uncle that lips turned red & was pale;no history of t/c movement;no fever;
Severe lymphadenopathy cervical with difficulty breathing and pain. Necrotic lymph node with inflammation spreading into the deep neck spaces and mediastinum
SORE ARM; ACHY; BRAIN FOG; HEADACHE; This spontaneous report received from a consumer . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pain in arm. On MAR-2021, the subject experienced ache. On MAR-2021, the subject experienced brain fog. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, ache, brain fog, and headache on MAR-2021. This report was non-serious.
Follow-up case was received from a healthcare provider (nurse) on 05 AUGUST 2013. The additional information provided includes patient identifiers for two cases. This case now pertains to one of the thirteen patients. Information for the other patients is captured in case number 2013-008318 and 2013-06998. This case involves of a cluster of thirteen unidentified patients who had received intramuscular injections of IMOVAX, lot number D1177-1. This 23 year old female patient was vaccinated with the first dose into the left deltoid, the second into the right deltoid and the third into the left deltoid. Dates of administration were not reported for this patient Titers were checked on 14 MAY 2013 and 15 MAY 2013 and were low. Laboratory test results were not reported. The patient had received a first dose of Tdap batch U4088A intramuscularly into the left deltoid on 14 SEPTEMBER 2013. The patients pre-existing allergies and medical conditions were reported as UKDA, Lutera, Alopecia Areata. No further information was available at the time of this report. The patient outcome was reported as unknown. Documents held by sender: none
About 2 weeks after 2nd shot I woke up unable to walk with intense pain in my joints. I am now going to see Rhomatiod specialist asap.  Been to emergency room twice with same problem.  Prednisone ( two regimines one 5 day one 10 day) and pain returned within 24 hours after prednisone runs out.  Please help me! The pain is overwhelming! Totally decapacitating!  I am willing to be in any research programmes you may have that will help me to walk again and find out why this is happening.
Two days post vax the pt experienced numbness and tingling on her right side and a droopy right eyelid. The symptoms were treated with aspirin, and Engerix B was discontinued. The most recent information received reports the symptoms are resolving and there is some residual in her right finger.
body aches; sleepy; nausea; Felt ill like flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt ill like flu), PAIN (body aches), SOMNOLENCE (sleepy) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 prophylaxis.     The patient had not COVID + test or diagnosis. Concurrent condition included High cholesterol.  Concurrent medical conditions included Allergy to antibiotic (Allergy to Tetracycline), Allergy to antibiotic (Allergy to Erythromycin), Sulfonamide allergy, Penicillin allergy, Blood pressure high (Start Date: 10 years ago), Rheumatoid arthritis (Start Date: 3 years ago), Egg allergy and Environmental allergy. Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure high, ROSUVASTATIN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, 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 experienced INFLUENZA LIKE ILLNESS (Felt ill like flu), PAIN (body aches), SOMNOLENCE (sleepy) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Felt ill like flu) had resolved and PAIN (body aches), SOMNOLENCE (sleepy) and NAUSEA (nausea) outcome was unknown.            The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  After 1st and 2nd dose, the patient experienced the same symptoms felt ill like flu for 24 hours, felt nausea, body aches and sleepy.  No treatment medications were reported.   This case was linked to MOD-2022-608554 (Patient Link).
Hot and Cold Spells/Fever, Chills, Nausea, Chronic low platelets started not long after and never had incidence of it before.
Discomfort in Left upper arm when applying pressure. No redness or swelling. Patient was evaluated at outside clinic.
EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal discomfort s/p getting the covid
A report was received from a health professional on 20Nov01, concerning a 58 year old female pt who experienced a maculopapular rash, 1 day after receiving the Fluvirin vaccine on 16Nov01. On 17Nov01, the pt developed a maculopapular rash and pruritus on her abdomen, 1 day after receiving the Fluvirin vaccine. On 20Nov01, the pt was seen at the reporter's clinic for treatment of the rash, which had expanded from the abdomen to the breast and pubic area. The pt did not have a fever or any signs or symptoms of infection. The pt received previous influenza vaccinations in 1999 (Flushield brand), 1998, and 1997 without incident. At the time of report, the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as unclassifiable.
lump the size of a goose egg; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 64-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, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The health care professional received the first dose of Shingrix around 4 months ago and called to inquire about the intensity of reactions compared to the first dose reactions.  Health care professional presented a lump and was in the size of a goose egg for some weeks. No exact dates were provided by health care professional regarding her own symptoms, resolution of the event or first dose administration. Reporter consented to follow-up by email.
Some of the vaccine leaked out while administered; Some of the vaccine leaked out while administered; A spontaneous report was received from a nurse concerning a 31-years-old, male patient who experienced some of the vaccine leaked out while administered.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 07 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number 011m20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 07 Feb 2021, the patient experienced some of the vaccine leaking out while being administered. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event some of the vaccine leaked out while administered was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose  and Syringe connection Issue for mRNA-1273 [Lot number 011m20a]  with no associated AEs.
POTENTIALLY EXPIRED VACCINE ADMINISTERED; INCORRECT PRODUCT STORAGE; This case, from the same reporter is linked to 20210704358. This spontaneous report received from a pharmacist concerned a 64 year old male. 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: 1816022 expiry: 15-AUG-2021) dose was not reported, administered on 01-JUL-2021 11:50:00 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced potentially expired vaccine administered. On 01-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potentially expired vaccine administered and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210704358.
Fever for 8 days.  Fever ranging 100.4 - 104 axillary.
administration date 12Feb2021/administration date 26Jan2021; administration date 12Feb2021/administration date 26Jan2021; had breakthrough bleeding for the first time ever. Periods were significantly heavier with massive clots; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration, in left arm, on 12Feb2021 10:00 (at the age of 37-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history was not reported. Patient has no known allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No concomitant medication (reported as "patient received no medications within 2 weeks of vaccination"). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 26Jan2021 (at the age of 37-year-old), at single dose, for COVID-19 immunization. In Feb2021 and Mar2021 patient had breakthrough bleeding for the first time ever. Periods were significantly heavier with massive clots. Patient saw OBGYN, but no reason found except vaccine side effect. Event result in doctor or other healthcare professional office/clinic visit. No treatment received. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
It started with the welts at the injection site and now, they look like mosquito bites.  It started on the  right arm then spread to the neck and now it's all over her chest, back and down both arms.
Fever developed after 7-10 hours from injection. Fever presisted for nearly 24 hours after first sign of symptoms.  Slight nausea and weakness, chills, bedridden for the duration of the fever. Fever broke after 24 hours or so, weakness and chills persisted and gradually diminished over a further 24 hours. Full recovery at 72 hours from first symptoms.
Irregular heartbeat which after had EKG and Holter monitor was diagnosed to be Tachycardia.
This spontaneous report was received from a nurse and refers to a 1 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 23-JUN-2017, the patient was vaccinated with improperly stored first dose of VARIVAX, one unspecified dose in the left thigh (lot # M047622, expiration date and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide.; Sender's Comments:  US-009507513-1706USA009938: