chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the lt arm where vaccinated is hot, red hand & feet numb, very painful;h/a since 8AM on 21JAN97;c/o nausea since 8AM 21JAN97;did not see MD referred to MD & will see MD @ clinic today 23JAN97;
heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), on 27Jan2021, for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death, hospitalization, medically significant) on 23Feb2021, heart attacks (caused hospitalization, medically significant) on 20Feb2021 with outcome of unknown, collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown, pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown, low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021, shaking on 18Feb2021 with outcome of unknown, extremely cold on 18Feb2021 with outcome of unknown, nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown, his big toe had turned gray on 19Feb2021 with outcome of unknown, his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021, his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away
A 4 year old male pt with exposure to a bat, developed fever, neck pain, sore throat, headache, stomach ache and listlessness following treatment with RabAvert. He received on dose of RabAvert. No visible bites had been seen on the child however, post exposure prophylaxis was started by the local ER staff. On 02Apr04, the pt had two immunizations of Imovax in the arm. Three days later (day 3), he had another dose in the arm. Prior to getting the third dose (day 7), the pt was switched to RabAvert. IM RabAvert was given. On 09Apr04, the pt developed a fever (102F) and stated his neck hurt, he complained of a sore throat, headache, stomach hurting and was listless according to parents. The pt's mother telephoned the pediatrician who said to observe. The next day the pt was perkier, but continued to not be himself. The pt was planned to received the entire series at the pediatrician's office despite the adverse events. Follow up received 10May04: The pt has no symptoms or complaints from previous vaccines or the possible exposure. He received his third rabies vaccine with RabAvert, 1mL, IM in the right deltoid on 09Apr04. Twenty-four hours later, he recovered from the events.
Diarrhea; Coughing; 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 DIARRHOEA (Diarrhea) and COUGH (Coughing) 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 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and COUGH (Coughing). At the time of the report, DIARRHOEA (Diarrhea) and COUGH (Coughing) outcome was unknown.            Patient reported that before patient was administered first dose of shot, patient felt sick. On unknown date, Covid test was performed on patient with negative results.  No concomitant medications were reported.  No treatment information was reported.
Epiglottitis; Allergy to grapefruit and chocolate after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Protein S deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EPIGLOTTITIS (disability), outcome "unknown"; FOOD ALLERGY (disability), outcome "unknown", described as "Allergy to grapefruit and chocolate after the first dose".; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202300148624 same patient, different vaccine dose number and event;PR-PFIZER INC-202300150205 same patient, different vaccine dose number and event;
No reaction to the vaccine. I got COVID several months later, with basically minor symptoms (low grade fever, tiredness for a couple days, sore throat).
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
Patient had balance problems the day after the immunization.  He fell and was taken to the emergency room. He is now in physical therapy and is slowly improving.
hematoma at injection site; slight sensitivity; Skin discoloration; This case was reported by a consumer via call center representative and described the occurrence of injection site hematoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site hematoma, sensitive skin and skin discoloration. On an unknown date, the outcome of the injection site hematoma, sensitive skin and skin discoloration were unknown.   It was unknown if the reporter considered the injection site hematoma, sensitive skin and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient after vaccination experienced injection site hematoma, sensitive skin and skin discoloration. This case has been linked with case US2020AMR039698, reported for same reporter.
occurred at 0800  Immediately following injection, vagal response, white in face felt nauseated without emesis. Patient with parents and waited additional 15 minutes for a total of 30. Mom states ulcerative colitis, gets nauseated.
This case was reported by a consumer via patient support programs and described the occurrence of joint pain in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) for prophylaxis. On 5th December 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intradermal). On 5th December 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced joint pain, injection site wheal, injection site stinging, intramuscular formulation administered by other route and wrong product administered. On an unknown date, the outcome of the joint pain, injection site wheal, injection site stinging, intramuscular formulation administered by other route and wrong product administered were unknown. It was unknown if the reporter considered the joint pain, injection site wheal and injection site stinging to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient went to a clinic today to obtain a TB test. When the nurse practitioner (NP) performed the intradermal test it appeared to be a large amount and it stung. The patient mentioned this to the nurse. When NP went to chart the test, she looked at the box and told the patient she would have to repeat the test since she had used something else which would take two weeks. The patient had to call the clinic back to ask what NP injected since the patient had a large welt on her arm. The NP had given the patient an intradermal shot of FLULAVAL QUADRIVALENT 2018-2019 season instead of a TB skin test, which led to intramuscular formulation administered by other route and wrong product administered. The patient experienced significant joint pain on left knee and hip. Nothing that the patient would normally experience. The patient did receive the skin test on the opposite arm. The patient's concern was for any adverse effects that might be known such as problems at the site of the intradermal injection of an intramuscular substance. The patient would see her primary care physician (PCP) tomorrow. The reporter denied consent to follow up.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Symptoms did not start to develop until next morning. Started with slight fever and aches. Localized back pain severe by afternoon, slightly responsive to ibuprofen. By 4 pm had hives in unusual patterns and places (i.e. quarter sized on left wrist, symmetrically on either side of neck like Frankenstein, and significant swelling of upper lip), itchy and aligned with histamine reaction. Back pain progressed, but mild by second morning. Whole right side of face swollen by morning of 3/25/21. Slowly reduced via ibuprofen and Zyrtec, but still present at time of submission. Odd spikes of intense hunger, and mild cognitive impacts like forgetfulness, distractibility, and some confusion. Tired.
Pt state "about 30 minutes after receiving the vaccine I started having a metal taste in my mouth. About an hour later I started having tingling in my tongue, throat, and, hands. Then I started having head and hands shaking around the same time. About 1 1/2 hours later I started having a burning sensation in roof of mouth then front side of teeth, tonsils, and  gum area. These areas turned red. I did not go to the emergency room and I did not take any Benadryl for this. The upper part of my are where I got the shot it is swollen and hot. This start yesterday and still swollen today. I am still experiencing the head and a little hand shaking today." Encouraged to call md or go to Emergency Room.
3 weeks after second dose, March 20 2021 started with severe hives all over the body, including scalp and face, swelling. Presently on: Prednisone, Levocetirizin-E, Pepcid, Triamcinolone  cream.
Warm uncomfortable left armpit lymph node; Warm uncomfortable left armpit lymph node; third booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, NDC:59267-1000-01) via an unspecified route of administration in the left arm on 05Oct2021 at 15:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified proton pump inhibitors(PPI), unspecified hydrochloride, acetylsalicylic acid (ASPIRIN) and atorvastatin calcium (LIPITOR); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 66-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021, the patient experienced warm uncomfortable, left armpit, lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events warm uncomfortable left armpit lymph node was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 04/08/2022 I did a PCR test on Friday that was Negative. On 04/10/2022 I started to feel achy, my eyes were tired, and I had a sore throat but I assumed it was pollen and allergies. I was exposed at work so I did an At-home rapid test. I had two negative tests on the 10th. I went to an Urgent Care on Monday and those results came back positive. I had no fever, I had no nausea or diarrhea but I had severe head congestion, a sore throat, achy eye, and exhausted. It felt like a very bad cold. I did had congestion no trouble breathing. I am still recovering and have a lingering cough and congestion. I was told to self-treat with OTC medications so I took Afrin and Advil Cold and Sinus. I also used a Symbicort Inhaler. he only side effect I had from Vaccine was 24 hours of fatigue.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies from the patients were not provided. Since 05-SEP-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N01494, expiration date: 11-NOV-2018, and lot # N012135, expiration date: 14-OCT-2018,  for prophylaxis. Concomitant therapies included sterile diluent. The doses were exposed to 6°F to 14°F for one hour. No previous temperature excursion was reported. Data Logger was reported as "Yes".  No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005139.
Varicella like rash 9 days after vaccination. >50 red blotchy macule about 1/10 had pustular 1mm center. Not other wise ill. No treatment just reassurance.
Information has been received from a physician concerning a 14 year old female who on 28-JUL-2006 was vaccinated with HPV rLI 3 11 16 18 VLP vaccine (yeast).  Concomitant vaccination on 28-JUL-2006 included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid.  The patient stated that following vaccination on 28-JUL-2006, she " experienced a great deal of pain at the injection site".  Unspecified medical attention was sought.  At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Left axillary lymphadenopathy: swollen, tender. There was no source of infection, so I had mammogram plus ultrasound done. Multiple suspicious nodes on US. Pathologists recommended a biopsy. Had core bx which failed, so went to OR to have 2 lymph nodes removed for diagnosis on 2/8/09. All path was benign. 3/6/09-records received for DOS 1/28/09-received Gardasil vaccine. No C/O at time of visit.  3/11/09-records received-abnormal lymphadenopathy left axilla. Excision on 2/10/09-
Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 039K20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-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 TINNITUS (Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level). At the time of the report, TINNITUS (Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level) outcome was unknown.            No treatment information was provided by the reporter.
under age 65 years old received a Fluzone HD vaccine with no adverse event; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 62 years old female patient who is under age 65 years old received a influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received a  dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT7743A; formulation, dose, strength and expiry date not reported) via intramuscular route in unknown administration site for (flu vaccine) prophylactic vaccination  On 05-OCT-2022 the patient  under age 65 years old received a fluzone hd vaccine with no adverse event (product administered to patient of inappropriate age).  Action taken : not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
ANKLES SWELLING UP; BODY HURTS, ACHES AND PAINS; CAN BARELY GET UP THE STAIRS; LEFT SHOULDER HURTING ALL DAY; This spontaneous report received from a parent concerned a 22 year old male.  The patient's pre-existing medical conditions included: patient's mother has a history of genetic blood clotting issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 04-MAY-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2022, the patient experienced ankles swelling up, body hurts, aches and pains, can barely get up the stairs, and left shoulder hurting all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ankles swelling up, body hurts, aches and pains, left shoulder hurting all day and can barely get up the stairs was not reported. This report was non-serious.
Body aches, headache, swelling at site, Lt axillary pain, fever, chills x 2 days. 3 IV fluid, Phenergan - nausea, Toradol - headache, given 1g Ancef, Keflex 500 qid, Motrin 800 tid. 12/14/07-records received for DOS 01/21/02/22/07-DX Cellulitis left arm secondary to smallpox vaccine.C/O body aches, headache, increased erythema around smallpox vaccination site, left axillary pain, fever and chills for 2 days. Tachycardic orthostatic.
ichy; sore; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tremor (mild tremor) and red face. Previously administered products included Cortisone (years ago) and Epinephrine (years ago). Concomitant products included simvastatin, etanercept (Enbrel) and potassium nos (Potassium).   On 12th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and an unknown time after starting simvastatin, the patient experienced pruritus, pain and discomfort. On an unknown date, the outcome of the pruritus, pain and discomfort were unknown.   It was unknown if the reporter considered the pruritus, pain and discomfort to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced little achy, sore and uncomfortable. The patient consented to follow up. For tolerance to 2nd dose, refer case US2020012242.
A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 13 month old male vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400020, PJP2004200021, PJP200400022, PJP200400023, PJP200400024.
Patient sweating with chills 3/4/21. No fever noted. 3/5/21 left shoulder and upper arm red, swollen and tender
Administration of Zostavax 9/20/13. Seen in primary care office 9/24/13 with acute outbreak of shingles. Placed on acyclovir and elavil.
Pt devel fever to 103.4 on 23MAY92 progressed to 104.4 on 24MAY, irritability subsequently devel nasal congestion; mom reported discoloration of hands & feet w/fever; devel OM on 27MAY92;
Mother reports seizure activity after vaccine administration.   Did not seek care or report event to PCP until following year.