chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph node in neck, slightlyleft of adam's apple. Size of small wafer; Cool to touch; Dose 1 and Dose 2 administered on 08Mar2021; Dose 1 and Dose 2 administered on 08Mar2021; This is a spontaneous report from a contactable other HCP (Nurse).   A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199) dose 1 via an unspecified route of administration, administered in left arm on 08Mar2021 09:30 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in right arm on 08Mar2021 as dose 2, single (at the age of 50-year-old) for covid-19 immunisation. Medical history included hypertension, hyperlipidemia, gout, depression and anxiety from an unknown date and unknown if ongoing. Patient received unknown other medication in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date of Apr2021, the patient experienced swollen lymph node in neck, slightly left of adam's apple, size of small wafer, cool to touch, no redness. Persistent since Apr2021-not reduced in size. No treatment was given for the events. At the time of reporting, outcome of the event Dose 1 and Dose 2 administered on 08Mar2021 was unknown and rest events was not recovered.  Follow-up attempts are completed. No further information is expected.
Lightheadedness dizziness hypotension with BP 80/40  thought to be vagal but persistent  given Epi.
Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer (reporting for son)  A 14-year-old male patient received BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date (this past Saturday) at the age of 14-year-old, as dose number unknown, single, for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient was currently experiencing chest pain and shortness of breath. It just started in the early hours on 28Jun2021 (reported as this morning). Both started about 3:00 this morning and has stayed the same. Treatment: None, that is what re-porter was trying to figure out, if she should take him to the emergency room and stating she was going to take him to the ER. The outcome of the events was reported as not recovered.    Information about batch/lot number has been requested.
Swollen eye lids, red eyes. Worse on right side. Diagnosis was chemosis . Treated with antibiotics, steroids, antihistamine, compresses and it still continues.
the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; intense arm pain; injection site pain; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/ lot number was not reported) via an unspecified route of administration on an unspecified date, as a DOSE 1,SINGLE (at the age of 62-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the caller mentioned that they have been holding campaigns at their clinic and one of the clinic nurses brought to his attention that 3 doses were drawn out of one vial of the Pfizer BioNTech COVID-19 vaccine. Caller mentioned that the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used. Caller mentioned that one dose of that reconstituted vaccine was given to a female patient. Confirmed that 0.3ml of 3 doses, equivalent to 0.9ml was drawn out of that vial of the vaccine. Caller wanted to know what the adverse reactions are for being given an overdose of the Pfizer BioNTech COVID-19 vaccine. Caller also asked if it was the patients first dose, if that would change anything on the recommendations. On 12Aug2021, stated that he spoke to a representative who said do not repeat the dose, and he asked for clarification on that as to whether or not to give the second dose, as this was the patient's first dose. Caller also mentioned that more intense arm pain/injection site pain for the patient was something he should watch for. The outcome of the events were unknown.   Information on lot number/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made.   Follow up (12Aug2021): This is a spontaneous report from a contactable other health care professional. New information include, caller also mentioned that more intense arm pain/injection site pain for the patient was something he should watch for.    Information on the lot/batch number has been requested.  Follow-up (30Aug2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Updated information: At risk classification removed, age at vaccination added.  Follow-up attempts completed. No further information is expected.
Patient states that about 1 day (Thurs) after receiving vaccines she had hives/pruritus. Went to ED & received BENADRYL, steroids.
Pt. periods have all been 10x as painful and as heavy as they have ever been.
Developed cellulitis. Hospitalized 2 day and received IV antibiotics. Discharge summary states staph infection. msv
got fever but never passed from 100°F; chills; head ache; both didn't get much sleep on Friday and Saturday night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got fever but never passed from 100°F), CHILLS (chills), HEADACHE (head ache) and SLEEP DISORDER (both didn't get much sleep on Friday and Saturday night) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (got fever but never passed from 100°F), CHILLS (chills), HEADACHE (head ache) and SLEEP DISORDER (both didn't get much sleep on Friday and Saturday night). At the time of the report, PYREXIA (got fever but never passed from 100°F), CHILLS (chills), HEADACHE (head ache) and SLEEP DISORDER (both didn't get much sleep on Friday and Saturday night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Pyrexia: (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Dull aches to the left site of the injection site (side of thigh); Anatomical Site of injection- Left quadricep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient received BNT162b2 (BNT162B2), on 06May2021 as dose 2, single (Lot number: EW0179) and on 15Feb2022 as dose 3 (booster), single (Lot number: FJ5683), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hormone replacement" (unspecified if ongoing); "Sleep aid" (unspecified if ongoing). Concomitant medication(s) included: ESTROGENS CONJUGATED; METHYLTESTOSTERONE oral taken for hormone replacement therapy (ongoing); PROGESTERONE taken for hormone replacement therapy (ongoing); TRAZODONE taken for sleep disorder (ongoing); CALCIUM (ongoing). Vaccination history included: BNT162b2 (Dose 1, single; Batch/ Lot number- ER8733; via Intramuscular route in Left deltoid), administration date: 27Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Dull ache", "Her arm never stopped hurting/continuous arm ache", "burning sensation". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06May2021, outcome "unknown", described as "Anatomical Site of injection- Left quadricep"; VACCINATION SITE PAIN (non-serious) with onset 06May2021, outcome "recovering", described as "Dull aches to the left site of the injection site (side of thigh)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Anatomical site of injection was Left quadricep for dose 2 and dose 3. Patient was taking multivitamin tablets; Progesterone 100 mg and Trazodone 50 mg at present. Relevant tests included Ultrasound with negative results in Apr2021 and Physical therapy assessment with negative results in Apr2021 and with comments as no loss of stomach or range of motion or flexibility noted. Patient received the 2nd and 3rd dose in my left quadriceps, also have dull aches to the left site of the injection site (side of thigh). The pain has subsided somewhat over time, but it has never completely gone away.
I had a rash on my belly and back, it was not itching or painful I was thinking I may be having an allergic reaction to something. I made an appointment with my doctor. He knew immediately upon looking at my rash what it was. He prescribed three different medications and I started on them immediately. I have recovered from having shingles. Not long after this I started vomiting and had pain on my right side. I went to the emergency room. They did a CT scan and found that I had gallstones and I need to have my gall bladder removed. I was admitted to the hospital for two days and given antibiotics to help clear the infection. I am awaiting a date to get in for a gallbladder removal.
My mother was given the vacine at 1:00 and was told she could leave immediately.    She shopped around the store with my younger brother and began to feel funny.  SHe then told him he needed to driver her home.  She started to feel dizzy,  right arm felt funny, speech became slurred.  Once she arrived at home, she tried to lay down.  She called me at 4pm and she sounded horrible.  I was unable to communicate with her as her speech was so impaired.  I drove over and found her unable to talk or walk as her whole right side was not working.  We rushed to the hospital and was told she had a stroke.  She was a perfectly healthy woman.   No history of high blood pressure or any leading factors of a stroke.  We have now been in the hospital for 17 days as she is having to learn to speak and walk again.  She still has no movement in her right hand.
Patient received Fluzone vaccination of October 29th (Saturday).  Started noticing joint pain ("like arthritis" per patient) on Sunday.  The pain is all over the body and patient complained that he "can't move."  He called in the symptoms on Thursday (November 3rd).  Patient called from work and had not contacted his doctor. He wanted to know if the symptoms could be due to the flu shot or if it was arthritis or something else.  I encouraged the patient to contact his physician first thing in the morning.
Had body aches; chills; arm swelling; Got / shot in 11/2019, got 2nd shot yesterday; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On 23rd March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd March 2021, less than a day after receiving Shingrix, the patient experienced general body pain, chills, swelling arm and drug dose administration interval too long. On an unknown date, the outcome of the general body pain, chills and swelling arm were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.  It was unknown if the reporter considered the general body pain, chills and swelling arm to be related to Shingrix.  Additional details were reported as follows: A day before reporting, the patient received 2nd dose of Shingrix and experienced body aches, chills and arm swelling. The patient received 2nd dose later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
severe abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ABDOMINAL PAIN (severe abdominal pain). At the time of the report, ABDOMINAL PAIN (severe abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
The next morning I had site pain and swelling and rash at the site. I had pain up my neck stabbing pain in right shoulder blade. The next day after my lymph node in right armpit swelled up the same day I started getting pain in right arm to hand. Within a few days my right breast swelled up and my lymph nodes swollen in left armpits got tender. I was having horrible hot flashed continuing as a fever. About a week in I got a rash over my whole body. My eyes and ears started to itch really bad. Within that day my whole body had a rash on it. My scalp as well. I took Benadryl through out the night to help sleep. In the period of time I went to see my doctor and all of my issues with my achilles tendon had become inflamed. My old injury from Sept 2021 became super tender as if I became injured again. I started getting more pain in hand and thumb as if I had joint pain. On and off during this whole experience I was getting headaches.
RECEIVED SECOND PFIZER DOSE TOO SOON.  RECEIVED PFIZER FIRST DOSE ON 08/04/2021.  RECEIVED THIS SECOND DOSE ON 08/18/2021.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 4 decade old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was 01-Mar-2021 for prophylactic vaccination. The patient experienced arthritic pains/pain in elbows, back pain, pain in fingers and plaque psoriasis (Dose number in series 1) when treated with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).The patient not recovered from arthritic pains/pain in elbows, recovering from plaque psoriasis and outcome of back pain and pain in fingers was not reported. Risankizumab (Skyrizi) (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported on an unspecified date for an unspecified indication. The patient previously received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total, start therapy date was unknown date in 2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with risankizumab was not reported. The outcome of off label use, inappropriate schedule of vaccine administered was not reported. The patient received additional dose of MRNA 1273 (Moderna) (Elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number and expiry was not reported) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following administration of MRNA 1273 (Moderna) (dose number in series 3). This report was non-serious. This case, involving the same patient is linked to 20220246704 (Dose number in series 1).
Painful and swollen axillary lymph nodes on the same side as the vaccine; This is a spontaneous report from a contactable other hcp (patient). A 29-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the right arm on 17Dec2020 15:00 at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) and ibuprofen. The patient did not receive other vaccine within four weeks prior to COVID vaccine.The patient experienced painful and swollen axillary lymph nodes on the same side as the vaccine on 25Dec2020 10:00. The event led a clinic visit to the doctor or other healthcare professional office. It was unknown if treatment was given. Outcome of the event was not recovered. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19.  Information on the Lot/Batch Number has been requested.
No additional AE/no PQC; Medical assistant reported AE related to an adult patient that received a pediatric dose of RECOMBIVAX HB.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (incorrect dose administered) intramuscular injection, strength: 5/0.5 mcrg/ml (lot number W025817 was determined to be valid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date has been established as 21-MAY-2025), administered for prophylaxis (route of administration was not provided). No additional adverse was reported.
Information has been received from a licensed practical nurse concerning a 7 year old Caucasian male patient who on 09/22/95 was vaccinated with the first dose of Varivax in the right arm and the first dose of MMRII in the left arm. On 12/26//01, the patient began to break out with chicken pox lesions, and on 12/28/01 was seen in his pediatrician's office with approximately 25 to 30 lesions all over his body. The child had no other complications. The child subsequently recovered from the event. No further information is available. The licensed practical nurse also reported that an 8 year old female developed varicella  following vaccination with varicella virus vaccine live. (WAES0201USA00235)
the patient had redness and swelling from their deltoid to elbow; the patient had redness and swelling from their deltoid to elbow; This spontaneous report was received from a physician via company representative and refers to a 54-year-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On an unspecified date in 2019 (reported as within the past month), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent (PNEUMOVAX23) lot # S012246 has been verified to be a valid lot, expiration date was not provided, but upon internal validation established as 10-FEB-2021, intramuscular, injection (strength and dose were not provided) for prophylaxis. On an unspecified date in 2019 (reported as after an unknown amount of time), the patient experienced redness and swelling from their deltoid to elbow. The patient sought medical attention and visited the doctor's office. The patient required treatment with antibiotics (unspecified).   The outcome of the events was reported as recovered (on unspecified date in 2019). The relatedness between the events and the vaccine was not reported.
3 x 1-2 cm erythematous plaques on chest consistent with hives. Sleepiness. Pruritis. No local injection reaction. Total duration of adverse effect was about 30 minutes. No respiratory or other systemic symptoms.
swelling started by 1PM; sore & discomfort; stiff was sewing got progressively worse; 7PM decided to go to ER: rt arm swelling from shoulder to below elbow; was red, hot & very painful;
Subsequent to receiving one dose of Lymerix, the pt complained of soreness in his fingers and hands, outcome unresolved. In June, 2000 the pt received second dose of Lymerix and the soreness in his fingers and hands continued. The most recent information reports the outcome of the event is unresolved.
Information has been received from a mother concerning her 13-year-old daughter who had no medical history or allergies who on 08-DEC-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant therapy. The patient's mother reported that on 12-DEC-2007, her daughter developed an allergic rash all over her body. The patient was seen in the Emergency Room (ER) because of the rash. No laboratory/diagnostic tests were performed. At the time of this report, the patient's allergic rash persisted. No further information is available.
Spasms in right arm. Vitals wnl, O2 sat 99%.
morphea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MORPHOEA (non-serious), outcome "unknown", described as "morphea".  Additional Information: On an incoming call from the patient she stated "She was prescribed Eucrisa for morphea which is off label". The patient also stated "this occurred after her fifth Pfizer vaccine just so you know."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300068455 Same reporter/patient, different drug/AE.;
This spontaneous report as received from a nurse (mid wife) refers to a three adult patients, over the age of 20 years, of an unknown gender. On an unkonwn dates, the three adult patients were inadvertently administered PROQUAD (Merck) 0.5ml, subcutaneous (lot # and expiration date were not provided). No adverse effects reported. Additional information is not expected because the reporter did not agree on further contract.