chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Strange chemical or metallic odor; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 23Mar2021 at 16:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotos thyroid, menopausal symptoms and arthritis. The patient had allergic to unspecified medications, food or other products. Concomitant medications included vitamin d(MANUFACTURER UNKNOWN), Estradiol (ESTROGEN), levothyroxine sodium (SYNTHYROID), progesterone(MANUFACTURER UNKNOWN) and cele (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Mar2021 at 12:00, 2 days after the shot the patient experienced a strange chemical or metallic odor which occurred on a regular basis which did not depend on location, air movement, or temperature and was not affected by sense of taste but only by smell. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event  metallic smell was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a male patient of unknown age. The patient's medical history included heart issues and shingles. The patient's concurrent condition included diabetes. The patient was allergic to several drugs. On 16-JUN-2016 (reported as "last Thursday") the patient received ZOSTAVAX (dose, Lot#, Expiration date and route not reported) and pneumococcal 13v conj vaccine (PCV 13)(dose, Lot#, Expiration date and route not reported) in the back of his right arm. Since the patient received the vaccines, he had been very weak and his blood pressure and sugar had been up an down. The patient did see his HCP on 19-JUN-2016 (reported as "yesterday") and was advised his blood pressure was too high and his sugar was up to 500 (unit unknown) and the patient also had low sodium. No treatment was given for the adverse events. The outcome of the events was unknown. Reporter's causality was not provided. Additional information has been requested.
Right arm below elbow was swollen, firm, raised, warm to touch.  Patient complained of pain and itching in area.  Arm extremely reddened in color.
Information has been received from a registered nurse concerning a child who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (lot # was not available).  The nurse stated that the patient developed a rash and a possible outbreak of chickenpox within 48 hours after receiving VARIVAX.  The patient sought unspecified medical attention.  The patient's outcome is unknown.  Additional information has been requested.
Headache, chills, fatigue, tiredness, blurry vision, and sleeplessness; was not able to fall asleep the night after the dose. Lots of pain and soreness at injection site. Had a severe headache the next morning (relieved with acetaminophen), and had a difficult time seeing up close for about two hours despite using my corrective lenses, which made the headache worse.
Asthma symptoms (wheezing, difficulty breathing, irritation in throat), headache, soreness at injection site. No treatment. Symptoms mostly alleviated after 1 hour, but still present to a lesser extent.
Kind of tired for a couple of days after the first dose of the Covid Vaccine; This is a spontaneous report from a contactable consumer. This case is related to first dose. This consumer (patient) reported herself that a 66-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EN6200, NDC number/ Expiry Date: Unknown), via an unspecified route of administration in left arm on 26Feb2021 (at the age of 66-years-old) as single dose for COVID-19 immunisation. The patient took Covid Vaccine because she feels everyone should get it. The patient's medical history was stenosis in back and arthritis had these condition for years and were ongoing, spinal fusion this was done about 13 years ago. In November and December of 2020, she had COVID 19. Concomitant medications were not reported. The patient received Influenza vaccine (No product details known by caller, batch/lot number not provided), via an unspecified route of administration on an unknown date as historical vaccine for Immunisation and experienced little stroke, lost use of left side and fell after Flu Vaccine (states was about 25 years ago). Additional no other vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). In Feb2021, the patient experienced kind of tired for a couple of days after the first dose of the Covid vaccine. Stated it might have started the evening of the vaccine or the next day, she cannot remember. The patient underwent lab tests included: Blood test with result WBC's elevated and x-ray with unknown result. The outcome of the adverse event "Kind of tired for a couple of days after the first dose of the Covid Vaccine" was recovered in Feb2021.  No follow-up attempts are possible. No further information is expected.
pt recv comvax & hep B instead of ped hib & hep b vax; there was product confusion;
On the 6th i notice a increase of my vertigo, it is still occurring even now its minor and manageable. Its mainly on the left side or left ear area. this does not change my feelings about the shot more as a service.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 54 year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 04Oct2021 (Lot number: FF2593)at the age of 54 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rosacea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergy to chemicals" (unspecified if ongoing), notes: Known allergies: Sulfates and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications were not reported. Past drug history included: Robitussin, reaction: "Drug allergy", notes: Known allergies: robitussin.  The following information was reported: VERTIGO (non-serious) with onset 06Oct2021, outcome "not recovered", described as "On the 6th i notice a increase of my vertigo, it is still occurring even now its minor and manageable. Its mainly on the left side or left ear area. this does not change my feelings about the shot more as a service". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient also received bnt162b2 (BNT162B2), administered in right arm , administration date 25Oct2021 (Lot number: FF8839) at the age of 55 years as dose 2, single for COVID-19 immunisation.
monomorphous eruption w/grouped lesions over cheeks,trunk & extremities w/almost urticaria-like eruption on insteps of feet.Rxn occurred day following vax. Tx w/Aveeno bath,Aquanil lotion,benadryl 1/2 t bid.poss Gianotti-crosti synd
Patient given HEP A and VZV vaccines.  Complained of stomach pain, became flush, tongue tingling.  Patient given Benadryl.  At 4PM patient taken by parent to MD as symptoms increased with facial swelling and nasal congestion.  Given Prednisone and referral to allergist.
Swollen neck lymph nodes causing neck and back pain.  Five months since the one vaccine.  Now beginning treatment for lymph node cancer diagnosis. Take daily steroids.
Child awoke and had red spots over upper body, including under and on arms, chest, stomach, neck, under breasts. Spots were about the diameter of a pencil eraser. They can be felt with fingers. Not fluid filled. Over weekend bumps became greater in number.
Information has been received from an office manager concerning a female "couple" of patients who on an unspecified date were vaccinated with GARDASIL (lot # not reported). On an unspecified date the patients experienced syncope and the patients said that the vaccination "hurt". The patients sought unspecified medical attention. Follow up information has been received from a physician concerning a 13 year old female patient who on an unspecified date experienced prolonged pain brachial neuritis for 3 plus weeks. It was noted that the patient's nerve factor was okay motor function was okay. At the time of report, the patient had totally resolved on treatment with MOTRIN. There was no work-up performed. Additional information is not expected.
Dizziness,nausea,tiredness,blurry vision, muscle pain, chronic aches, and chills, as well as chest pain and a extreme dip in left arm sight of the vaccine
Sensorineural Hearing loss right ear - moderate to severe Urgent care ddx possibly otitis media -march 2021 Dx with SNHL May 2021 by ENT - MRI to r/o intracranial mass - imaging unremarkable. Attempted oral steroids with no effect. Second opinion by another ENT confirmed SNHL and attempted 3 intratympanic kenelog injections. No effect. Permanent mod-severe SNHL
10/26/22 I developed a sharp pain below my right rib cage. It made it impossible to sleep. I went to the emergency room on 10/27/22. I had a CT scan for the lungs and a Doppler imaging on my leg. I was diagnosed with a blood clot in the lower right lung and thrombosis in the left calf. I had a COVID test which was negative. I had bloodwork and genetic testing came back negative. I was in the hospital for two days and was put on a blood thinner, ELIQUIS. The blood clot in my lung has gone away. I continue to have blood clotting in my leg. I continue to see my physician for this.
Patient's advocate called to say that patient has a rash and thinks it is from the shingles vaccine. Patient was referred to physician for treatment. Rash is mostly on his back but did not seem painful. Itchiness was mild.
In the minutes following the vaccine: heat in the back of the head, 'electricity' in jaws About 5-8 hs later: huge fatigue and beginning of fever That night: fever over 104 degrees for 3 days In the 4th day and for the rest of the week: huge headache Following weeks: pain in neck and 'electricity' in lower jaw
patient was given a 0.5ml, expired, dose of Menactra/no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11-year-old male patient who was given a 0.5ml, expired, dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and PHENYLEPHRINE, TROPICAMIDE (T-P).  On 20-Apr-2021, the patient received a dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6543AA, expiry date-unknown) via an unknown route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.   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.
PATIENT CAME IN ON 9-3-2020 TO PICK UP A PRESCRIPTION FOR PREDNISONE 20MG TO TAKE 1 DAILY FOR 5 DAYS AND STATED THAT HE HAD A FLU VACCINE ON 9-1-20 AND BROKE OUT IN HIVES ON 9-2-20 ON THE ARM, CHEST AND LEGS
pt recv & 4 days p/vax pt devel Henoch-Schonlein purpura, w/edema of the ears & scalp, vesicular lesions, fever, swollen, lt leg & swollen rt hand;No further details were provided;
About 3 months after my booster shot I had a routine tele-visit with my doctor where he told me that I have tested positive for Kidney Disease. On a grade scale of 0-6 I was at a 3. I have an intermittent pain on my left lower back.
66 YO received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 66-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 17th October 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: HCP states that a 66 year old immunocompromised patient was administered Bexsero. She classified the immunosuppressed patient as HIV. No lot number or expiration date available.  The reporter did not verify what that meant.  The reporter consented to follow up via postal. Additional Supportive Information: The 66 year old immunocompromised patient was administered Bexsero, which led to inappropriate age at vaccine administration.
Redness, induration, warmth at site 6x4cm.  Responded well to Keflex.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. This is the first of two reports. A 16-year-old female patient of an unspecified ethnicity started to receive TRUMENBA, via an unspecified route of administration at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced 2 to 3 cm swollen area on an unspecified date with outcome of unknown. Follow-up (12OCT2016): Follow-up attempts are completed. No further information is expected.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered Covid vaccine at 11:05 AM. patient began feeling nauseated  at 11:15 AM, obtained Vitals : Temperature: 97.6  BP: 130/80mmHg    Pulse: 86   SpO2: 97% provided patient with water for hydration.  Patient was assessed by doctor and was given Ondansetron Tablet 4 mg for nausea.  Monitored patient for an additional 30 Minutes. Vitals Taken at 11:53 AM Temp: 97.7 Pulse: 68   Spo2: 99%   BP: 120/74mmHg Notified doctor, Per patient symptoms subsided. Per Dr. okay to release. Notified patient if symptoms returned and/or worsen may to to ER and/or may follow up with her PCP and/or contact our office for additional assistance.
28AUG98 pt sweeping the floor when the cap cam off the top exposing a piece of metal;finger was cut;p/shot had severe allerg rxn;
Redness and swelling at site. Fever since 4/30/13. Location in (L) deltoid.
This spontaneous report as received from a healthcare professional refers to a 4 year old patient of unknown gender. On 28-MAY_2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported) instead of second dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Swollen and painful under arm pit, (not sure if its a gland that is swollen) very sensitive when moving arm and radiating to hand. Lasted about 5 days, now only mild tenderness.
I developed Dermatographia (itching + hives) after the Moderna booster for COVID19.
A non-serious spontaneous report of tested positive for influenza, fever, vomiting and headache was received from a nurse concerning a six year-old male subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Nov-2008. The next day the patient's mother reported the patient experienced fever, vomiting and headache. The child also later tested positive for influenza. The events of fever, vomiting and headache lasted for two days and then resolved.
I TO GET THE CHILLS AND WENT INTO BED AND STARTED TO COUGH, MUSCLE ACHE, SORE THROAT, HEADACHE, FELT WEAK, DIFFICULTY BREATHING, WHEEZING, PALENESS, FAST HEART BEAT AND VOMITING
Fever; sore (arm was sore); achy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (sore (arm was sore)) and PAIN (achy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vitamin D deficiency (low vitamin D level), Hepatic failure (liver failure) and UTI. Concurrent medical conditions included Type 2 diabetes mellitus, Sjogren's, Psoriasis, Neurogenic bladder, Brain lesion, Spinal cord injury (Spinal Lesion), Scarring (Liver Scarring), Paralysis, Hypercoagulability, Hypercholesterolemia and Spinal hemangioma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced PYREXIA (Fever), MYALGIA (sore (arm was sore)) and PAIN (achy). At the time of the report, PYREXIA (Fever), MYALGIA (sore (arm was sore)) and PAIN (achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported  No treatment information was provided
Tingling, numbing feeling in front part of tongue to tip of tongue. Metallic taste. These symptoms are still coming and going on 4-3-21. Some days no symptoms, next day full symptoms are back.  Also, starting on 4-1-21, redness and itching at the injection site and rash on back of both hands. As of 4-3-21, redness at site has tripled in size but no itching. Rash on hands is diminishing.
Rash on forehead 10 minutes after vaccines, BENADRYL given, patient assessed before and after BENADRYL discharged home with mother.
Patient was administered the Pfizer bivalent as the first dose in the primary series.  No adverse reactions were reported.
2hrs p/immun,on way home in car,child became rigid, threw head back & eyes rolled; Episode lasted only secs-Went to Peds MD;t103.3 (ax);Pediprophin & APAP adm; 1hr later t98.7;Sent home w/instructions to use APAP. Pt fine today.Plan:Peds DT
Patient complains of pain throughout her shoulder and neck area.  She did report that she never experienced redness, swelling, or heat at the injection site.
No adverse symptoms or signs at this time but patient was given a PROQUAD and a varicella vaccine instead of a MMR and a varicella vaccine that was ordered by the physician.
Shot was a little achy next day but he says more achy today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shot was a little achy next day but he says more achy today) in a male patient of an unknown age 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 PAIN (Shot was a little achy next day but he says more achy today). At the time of the report, PAIN (Shot was a little achy next day but he says more achy today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Experienced heavy bleeding coming out of the vagina this morning.; This is a spontaneous report from a contactable consumer or other non hcp.    A 63-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 81 mg for an unspecified indication. Medical history included and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced heavy bleeding coming out of the vagina this morning on 24Apr2021 07:00 with outcome of recovered with sequelae. No treatment was received.  Follow-up (24Jun2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer reported for the female patient in response to Non-HCP letter via follow-up letter which included the information.  Follow-up attempts are completed. No further information is expected.