chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not feel well; Lump on the arm where he got the shot; A little nodule (which maybe a lymph node) on his right temple in front of his ear; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (A little nodule (which maybe a lymph node) on his right temple in front of his ear), MALAISE (Did not feel well) and VACCINATION SITE MASS (Lump on the arm where he got the shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21, 013L20A and 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Did not feel well). In September 2021, the patient experienced NODULE (A little nodule (which maybe a lymph node) on his right temple in front of his ear) and VACCINATION SITE MASS (Lump on the arm where he got the shot). In September 2021, MALAISE (Did not feel well) had resolved. At the time of the report, NODULE (A little nodule (which maybe a lymph node) on his right temple in front of his ear) and VACCINATION SITE MASS (Lump on the arm where he got the shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Patient  did not feel well and this lasted for a day or so. 2-3 days after he noticed a lump on the arm where he got the shot and a little nodule (which maybe a lymph node) on his right temple in front of his ear.
Patient said started running a fever and chills and arm got red so she went to ER... they tested her for flu but it was negative. Patient says today arms is still red and sore and she is supposed to go see primary care in 3-4 days.
Nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Feb2021 (Lot number: EL9266) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "over weight" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "heart trouble" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 20Feb2021, outcome "recovered" (Mar2021), described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not have any problems with the first dose except nausea. She was feeling nausea the whole time until the week before she went to get the second shot. The week prior to getting the second shot, it seemed to end so she felt like he had nausea for about 2 weeks.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303335 same patient and product, different dose and events
Double vision and severe dizziness. I also have high fever and injection site pain which I expected. The dizziness is so severe that I cannot move without falling down.
Pt experienced his first general clonic tonic seizure on 1/7/22 @ 2am, while sleeping.   He had a second seizure at the local Hospital ER at aprox 5:20am.   Pt has no previous seizure history, no family history and no other sickness or triggers were identified.
About a week after my first Moderna shot, my arm began to itch around the injection site. I ignored it, but noticed the following day that there was a rectangle around the injection site that was swollen and itchy.
Patient began running a low grade fever the first two days after immunizations given which resolved. Patient began having swelling and redness of the upper left arm the evening of 11/04/2004. Immunizations had also been given in the right arm on the same day with no reaction. Swelling and redness increased and patient was seen in the office 0n 11/05/2004.  Area effected was a 7cmX5cm area with warmth and tenderness. Swollen area was circled to monitor progression and treatment instruction given to apply ice to effected area. Patient grandmother instructed to call back if patient becomes febrile or effected area increases in size or severity.
He was also tired for a long time; Caller states his stool was green and he was pooping; he got sick; On the 2nd day, he experienced vomiting.; her son lost 5 pounds; he experienced fever; diarrhea; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/Lot number and expiration date: not reported), dose 1 via an unspecified route of administration in Arm Left on 19May2021 (at the age of 12-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 on an unknown date in Oct 2020, allergy to animal (cats) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. Patient's mother mentioned that day after his shot, he experienced fever and diarrhea (on 20May2021) which lasted for 7 days. Caller states the fever was more like 8 days and the diarrhea was at least 8 days, she would have to ask him when it completely went away. Caller states her son lost 5 pounds (on 20May2021) when he got sick on an unspecified date, he was 90 pounds currently, he was 95 when he got the vaccine. She states he kept losing weight over the week. Caller states his stool was green and he was pooping everything out, it was gross on an unspecified date.  On the 2nd day, he experienced vomiting (on 21May2021). He was also tired for a long time on an unspecified date. Caller states her son had been staying at his dad's house when he was sick. She states she would've taken him to be seen earlier because after 5 days of fever, he needed an IGG drip in case it was his heart or similar to Kawasaki. She requested him to get an IgG Drip because, according to her, any child who has a fever for 7 days might have the virus that causes Kawasaki disease. This is based on her experience with her daughter who has Kawasaki disease. The son was not given the IgG drip because the doctors were not sure. They also tested his stool, but he did not have anything wrong. She mentioned that her son had COVID in October, the one that got sick for a week, then goes away, and comes back again. He was sick for a while with all the symptoms, and it was proven that he had it. Caller states when he got sick, they wanted to rule other things out, so they tested his feces for a bunch of things, but he was negative for everything. As of calling, the son had recovered but she was requesting for him to have an ultrasound of the heart. She was asking if he should get the 2nd dose. The events resulted in physician office visit. The patient underwent lab tests and procedures which included culture stool negative on an unspecified date. The outcome of the event fever, lost weight was recovered on 28May2021; vomiting recovered on 21May2021; diarrhea, fatigue recovered on an unspecified date; and the outcome was unknown for faeces discoloured and illness.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received ENGERIX B adult (batch number 92M2J, expiry date 3rd November 2017). On an unknown date, the patient received ENGERIX B adult 1 ml. On 8th June 2015, 6 hrs after receiving ENGERIX B adult, the patient experienced fever, felt faint, ringing in ears, decreased appetite, headache and dizziness. On an unknown date, the outcome of the fever, felt faint, ringing in ears, decreased appetite and dizziness were not recovered/not resolved and the outcome of the headache was unknown. The reporter considered the fever, felt faint, ringing in ears, decreased appetite, headache and dizziness to be possibly related to ENGERIX B adult. Additional information provided: the patient was checked for titers for hepatitis B. Patient titers was low so a booster shot of ENGERIX B was given on 08 June 2015. The reporter stated that the patient has no significant medical issues.
FELT DIZZY; COULDN'T STAY AWAKE; FATIGUE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. Concomitant medications included dupilumab for allergies.  On 03-NOV-2021, the patient experienced felt dizzy. On 03-NOV-2021, the patient experienced couldn't stay awake.  On 03-NOV-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizzy, couldn't stay awake, and fatigue on 05-NOV-2021. This report was non-serious.
slight swelling with itchy rash that lasted about 3 days and spread to two large spots
Fever (100F), chills: Started 12 hours after injection, lasted 3-4 hours. No medication taken. Muscular ache, fatigue: Started next day. Ibuprofen 600mg taken, effective at relieving ache and fatigue.
Extreme stiffening of fingers and hands and resulting in "trigger finger" and "trigger thumb" which did not resolve itself over time.
Information has been received from a physician via telephone call about a conversation he heard concerning a teenage female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported). On an unspecified date the patient had a stroke. At the time of the report, the patient's outcome was unknown. Upon internal review strokes were considered to be an other important medical event. It was unknown if the patient sought medical attention. This is one of several reports received from the same source.
Information has been received from a health professional concerning a 9 year old white male (65 pounds, 50 inches) with no pre-existing allergies, birth defects, or medical conditions who on 07-JAN-1999 was vaccinated SC in the left arm with a first dose of Varivax (Lot# 628246/1655H). There was no illness at the time of vaccination. That same day the patient was also vaccinated with MMR (lot # 628895/1541H) subcutaneous in the right arm. On 15-JAN-2007 at 9:30AM the patient started with a few red bumps and then progressed to a total of 15. The location was right clavicle area/shoulder and upper arm in various stages of red pustulae with center scabs. No relevant drug tests or lab data were required. The patient recovered on 24-JAN-2007 (also reported as the rash lasted for 3 days). Additional information is not expected.
2nd dose was minor aches & pains. By end of August 2021 began seeing small growth on shin, rapidly growing
Chills, fever, headache,  body aches, upset stomach, pain in arm of vaccine
Shingrix first dose reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number T5J32, expiry date 20-AUG-2024) for prophylaxis.   On 14-SEP-2023, the patient received the 1st dose of Shingrix. On 14-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix first dose reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 Pharmacist reported that a nurse administered to a patient Shingrix first dose reconstituted with sterile water, which led to wrong solution used in drug reconstitution. The reporter consented to follow up. Follow up accepted to Long Term Care facility.
Pt recvd 2nd of Hep B vax on 2MAY91 & exp malaise, h/a, dizziness & upset stomach despite prophylactic use of APAP;
Bad headache  chills. Body aches and all over muscle soreness  and sore throat
Patient has fear of needles so was vaccinated in MAR area. Pt asymptomatic BP 120/72; HR 79; Resp 18; O2 Sat 100%; Temp 98.2.
Arm hot Day 2 until Day 10; Swollen and hard but not cellulitis; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 11Jul2021 12:00 (at age of 55-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included inflammatory bowel disease, systemic lupus erythematosus, sulfanilamide from an unknown date and unknown if ongoing. Patient had known allergies to Sulfa medications and Azithromycin. Concomitant medications included mesalazine (ASACOL), atorvastatin calcium (LIPITOR), montelukast sodium (SINGULAIR) taken for an unspecified indication. The patient previously took azithromycin and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 14Jul2021 19:00 the patient experienced arm hot day 2 until day 10 and swollen and hard but not cellulitis. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of event was recovered on an unspecified date.  The lot number for the vaccine [Pfizer/BioNTech COVID 19 Vaccine] was not provided and will be requested during follow up.
Headache, Myalgia, inj site pain/red/swelling; chills, body ache Narrative:
Per patient's husband--had pain in side starting about 1 hour post first vaccine. woke up the next morning, had blurred/double vision (pain in side has subsided). Has been diagnosed with Myasthenia gravis. Per husband-doctor does not believe that it was caused by the vaccine, but may have caused her body to show the above symptoms.
Accidental administration of Moderna vaccine given to 16 yr female.  RN switched from Pfizer vaccine
None from flu vaccine. Pharmacist said that several other patients who had only the Covid19 Bivalent Moderna Vaccine, had the same symptoms.
Rhabdomyolysis Malaise, fatigue, arthralgias, myalgias
Approximately 3 weeks after the vaccine my hair being to fall out in large patches. Hair began to rapidly turn grey.
Rash/ raised red area the is warm to the touch. Also small black spot in the middle
3 days after the shot,  1/3, I started to feel soreness under my tongue.  I've felt this before when starting to feel sick.  It progressively got worse, appearing to have peaked on 1/5.  It is painful all the time, but really hurts to extend my tongue and swallow.  While it hurts on both sides, it seems to be worse on the left side.  When I lift my tongue and look in the mirror, it looks like the tissue is swollen some on the left.  I scheduled a visit with the ARNP at my doctor's office, who I mentioned earlier.  She couldn't determine an exact cause.  She believed it could possibly be an immune response to the vaccine or something viral.  If it gets worse or doesn't go away after a week she asked that I call back.   The pain is unresponsive to 400 mg of Ibuprofen.  If I take 800 mg I do get some relief, but can definitely still feel it.
COVID-19; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a other company (AbbVie) concerned a 48 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total (1 in 1 once) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received additional dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total (1 in 1 once) administered on 15-MAR-2022 for covid-19 prophylaxis which was Off label dosing frequency (Dose number in series: 1).  The patient received non-company suspect drugs upadacitinib (Rinvoq) (form of admin unknown, oral, batch number and expiry was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced 103.4 (unspecified unit) of fever and had covid-19 (Dose number in series: 1). Laboratory data (dates unspecified) included: Body temperature 103.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib (Rinvoq) was withdrawn. The outcome of the covid-19 and off label dosing frequency was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total (1 in 1 once) administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination covid-19 vaccine ad26.cov2.s (Dose number in series: 2). This report was non-serious. This case, involving the same patient is linked to 20220928222.
Every bone in his body aches; Aches everywhere, but specifically mentioned hands, knees and legs; Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs; muscle pain/can't work because body aches; Tired and Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in his body aches), PAIN IN EXTREMITY (Aches everywhere, but specifically mentioned hands, knees and legs), ARTHRALGIA (Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs), MYALGIA (muscle pain/can't work because body aches) and FATIGUE (Tired and Fatigued) in a 63-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Every bone in his body aches), PAIN IN EXTREMITY (Aches everywhere, but specifically mentioned hands, knees and legs), ARTHRALGIA (Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs), MYALGIA (muscle pain/can't work because body aches) and FATIGUE (Tired and Fatigued). At the time of the report, BONE PAIN (Every bone in his body aches), PAIN IN EXTREMITY (Aches everywhere, but specifically mentioned hands, knees and legs), ARTHRALGIA (Elbow that hasn't hurt in 25 years is hurting/Aches everywhere, but specifically mentioned hands, knees and legs), MYALGIA (muscle pain/can't work because body aches) and FATIGUE (Tired and Fatigued) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 10:00 as dose 1, single (Lot number: 6N6199) and on 31Mar2021 at 09:00 as dose 2, single (Lot number: EP6955) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 071F21A), in right arm and on 18Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 0U8L21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: 09Jun2021; LOVASTATIN, start date: 01Apr2019, stop date: 28May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient had no known allergies. COVID 19 Treatment with Plaxlovid from 28May2022 to 01Jun2022. It was reported 3 days after stopping the paxlovid patient had symptoms of flu and tested positive. Patient reported that he still have symptoms today. .
Injection went normally, at about 3 hrs after injection noticed itching and hives on R arm and part of body.  Took Benadryl and started feeling better.  When woke up on 11/3 arm was swollen and hot from shoulder to elbow.  The swelling progressively got better through the day. On 11/4 it is still hot to touch and swollen with joint pain.
Constant high pitched  ringing in ears approximately 6 to 7 days after second dose.  Ongoing after a week.  My physician stated he doubted from vaccine, but he really can't say.  But the ringing correlates with the vaccine being administered.
This spontaneous report as received from a physician refers to a 25 years old female patient with no drug allergy. The patient was vaccinated with VARIVAX (Merck) (lot # reported as G007690, exp date 05-AUG-2013, route unknown) on 05-NOV-2012. No other co-suspects were reported. Concomitant medications included multivitamin (unspecified), vitamin D (unspecified) and progesterone pill. On 26-NOV-2012 the patient experienced broken out in varicella rash about 3 weeks after received VARIVAX (Merck). The treatment information was reported as acyclovir. The patient had sought medical attention via office visit. The outcome of broken out in varicella rash was unknown. Additional information has been requested.
No other adverse effects were reported in the patient.; patient received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-MAY-2020, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml, (route and frequency not reported. Lot No. R029816 was reported and has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent. Expiration date reported and validated as 09-MAY-2020) for prophylaxis. No other adverse effects were reported in the patient.