chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 12 hours, I experienced moderate to severe nausea, vomiting and diarrhea. In addition, within 24 hours I was experiencing fever >100.4, chills, extreme joint pain and swelling along with enlarged and swollen axillary lymph nodes on the L side. I was extremely fatigued and nauseated for more than there days. Since then, I have had abdominal issues including acid reflux and nausea.
Patient developed large indurated erythematous area of entire right thigh with central ecchymosis inferior to injection site with mild bruise just under injection site.
Narrative: Patient was diagnosed with Covid ON 3/20/2020. He was admitted to hospital on 3/20/20 and was subsequently transferred to another hospital where he remained until discharge on 3/29/20. Patient has Crohn's Disease and is currently taking Mycophenolate 1500 mg by mouth twice a day. This is the reason the patient was approved to receive his 3rd Covid shot. He received his 1st Covid shot on 2/23/21. He received his 2nd Covid shot on 3/25/21. On 7/28/21, patient was admitted to hospital with c. diff infection and possible right knee gouty arthritis. It was thought the patient's immunocompromised state led to the c.diff. Patient was prescribed vancomycin oral capsules x 10 days. Patient received 3rd Covid shot on 9/21/21. Patient notified his primary care provider on 9/3/21 that he felt like a "truck hit him." Patient reported a rash on his arm, chest, and back. Patient arrived to the facility on 9/3/21 at 2: 30pm where an urgent care provider noted the patient was dyspneic, and  had a flat, red rash spreading from the site of the 3rd Moderna vaccine. Due to hi risk status (patient was treated for cryptogenic organizing pneumonia in the past at the hospital. Patient was transferred to another hospital were they discharged him that very same day. On 9/7/21, patient was contacted by the facility for follow up and he stated that he was feeling better but that his arm was still a little sore and he still had a rash present.
Call to pt - her temp was 100.3 at the highest and that was last night.  Pt symptoms are : body ache - terrible HA , fever -low grade.  Pt had vomiting yesterday. She has been taking ibuprofen 600 mg every 4-6 hours.  Pt is already trying ice and heat and warm soaks for the discomfort. Pt wanting to know if anything else can be given for pain.
Multiple violent vomiting, gagging/dry heaving just after around 12 hours after injection. For a couple hours. Body aches. Chills/body shaking on an off for 4 hours. General arm soreness.  Back/spine soreness.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling and excessive pain at the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
1/14/10 - H1N1 pt administered 1/17/10 - pt. reported large bruise covering left arm to pharmacist on duty - advised to see MD for eval. 1/20/10 - pt. showed bruise to me - was covering entire upper arm,appeared to be healing 1/21/10-Spoke with nurse at MD office - Dr. expects no further issue
Patient was given expired vaccine. Patient did not report any adverse effects from the vaccine. Patient will be coming in to be revaccinated.
NAUSEA; FEELING  UNWELL; This spontaneous report received from patient concerns a male patient of unknown age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, left deltoid) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination . No concomitant medications were reported.  On 05-MAR-2021, at 11:00 PM, the patient developed nausea and "feeling unwell".  The patient administered home remedies.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the nausea and feeling unwell was not reported. This report was non-serious.
Patient became light headed approximately 5 minutes after injection while listening to this RN answer questions of companion.  Patient encouraged to stay seated, ice pack provided to neck and forehead, coat removed.  Symptoms resolved quickly in approximately 5 minutes.  Patient escorted to observation along with companion.
On 8-30-10 visited doctor for minor cough that I had for 2 weeks - had just finished taking azithromycin - woke up at 3:00 am violent choking attack - phlegm caught in windpipe - for 15 minutes almost could not breathe - thought I would die! Next day went to doctor - sent me to otorhinolaryngologist - could not find major cause - put on antibiotic - now 2 1/2 months later throat larynx starting to feel better- serious cough lasted over 30 days from 8-30-10.
Client states started having right arm muscle and neck muscle pain with numbness to right thumb and index finer around 6/28/04. Stated the soreness was getting worse so he went to a med center on 7/2/04 and was given a shot for pain and was told if it doesn't improve within a couple of days to follow up with his doctor. 7/6/04: saw his / doctor and was prescribed pain pills that client states just made him feel sick to his stomach so he stopped taking the medication. Client then went to chiropractor on 7/8 and 7/10/04. Client reported the above symptoms to health dept on 7/12/04 and states he currently has only a small amount of tingling to thumb/ index finger.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no medical history and no preexisting illness was vaccinated IM into left arm with lot # (671463/1359AA) dose 3 GARDASIL on 12-MAR-2012. There was no concomitant medication. 5 minutes after the injection, patient got up to get water. She started twitching, stiff, some rolling of eyes and fainted. Patient fell and hit her head on the floor. No incontinence. Patient came to in a few min. 2" x 3" hematoma was noticed. Patient had headache and vomiting. CT scan of head was performed, result not provided. The patient visited emergency room. The status of the patient was unknown. The report was considered to be non serious. The original reporting source was not provided. Additional information is not expected.
Passed out in the shower; knock himself out; He is sick; Cannot even get up; Nausea; This is a spontaneous report from a contactable consumer (parent).   A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced passed out in the shower (medically significant), knock himself out, he is sick, cannot even get up, and nausea; all on an unspecified date.  Reporter stated, My son went to the doctor yesterday to get the COVID vaccine. Today he is sick, he passed out in shower, he cannot even get up, and he is sick, nausea. The outcome of all the events was unknown.   Information on the lot/batch number has been requested.
My Herpes flared up within days of receiving the Vaccine.  It has continually come back over the 4 months since.  It will go away and then a few days later, return.
Adverse Event: Guest voluntarily came in and requested Pfizer Vaccine as his first dose. Guest was screened and indicated that he has not received any injections/vaccines in the last 14 days. Upon Checking  out, it was indicated - guest had received  the Moderna Vaccine (04/27/2021),  at a Clinic. Treatment: None - guest has departed facility when this writer was informed of this event. Called x 3 - no answer - message left to call back. No call back as of this date 5/13/2021. Will follow-up with On-Call for next indicated steps as guest has appointment for second dose on 06/05/21 - Pfizer. Outcomes: Unknown
Initial report received on 10 Nov 2005 from a patient. A female patient of no reported age and medical history immediately developed a severe sinus infection and urinary tract infection following flu vaccine at a pharmacy about a week ago. Outcome was not reported.
pt c/o h/a & saw streaks of light p/each inj;called MD next day to say felt better;
2 day, post vax, had nausea and vomiting and dizziness.
Had the shot on 10/7 on a Thursday.  By 10/9 the injection site had developed a blister about 2 cm in diameter. She bumped it and broke it and it drained.  She called the office on 10/9 and was told to apply ice pack to the site.  She returned on 9/20 with an stage ulcer also about 2 cm in diameter.  Borders are erythemic but has eschar. We are seeing her daily to assess the wound.  She is using wet to dry dressings now and will return on Monday.
This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report is in regards to events reported in the patient's past medical history. A currently 68-year-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), at a single dose for immunization, ZITHROMAX, at an unspecified dose for an unspecified indication, gabapentin (MANUFACTURER UNKNOWN), at an unspecified dose for an unspecified indication, and metformin (MANUFACTURER UNKNOWN) at an unspecified dose for an unspecified indication; all via unspecified routes of administration on unspecified dates. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced drug allergies and intolerance to azithromycin, gabapentin, metformin, and pneumonia shot. The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable, for azithromycin was unknown, for gabapentin was unknown, and for metformin was unknown. The clinical outcome of the events, drug allergies and intolerance to azithromycin, gabapentin, metformin, and pneumonia shot, was unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and gabapentin in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder(s) of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and gabapentin has/have submitted the same report to the regulatory authorities.
Resident given expired flu vaccine Influenza Vaccine adjuvanted Fluad Quadrivalent 0.5ml GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
12/15/2020 Around 7:30pm, I started to itch on neck and face. Progressed to scalp, stomach, back and whole body; ears, top of head to bottom of toes. Called critical care healthcare staff; 1 25mg  benadryl  Had nausea, fatigue, hip and joint pain 12/16/2020 Still itchy not as severe as 12/15/2020. Still joint pain and achiness. Nausea was a 8/10.  12/17/2020 feel better. About 80% . Mild itchiness. 'letting it run its course' and haven't taken any other benadryl since 12/15/2020. Joint and nausea has subsided.  Flu shot 09/2020 Second dose of Pfizer shot is scheduled for 01/05/2021
Janssen dose give to 15 year old.  Indicated for 18 and over.
positive immune response 24 hours after injection that increased bodyache and slight elevated temperature; positive immune response 24 hours after injection that increased bodyache and slight elevated temperature; positive immune response 24 hours after injection that increased bodyache and slight elevated temperature; dose 3 on 04Jan2022 and influenza vaccine on 04Jan2022; Patient received Comirnaty booster dose that was >6 hours diluted in vaccine refrigerator; Patient received Comirnaty booster dose that was >6 hours diluted in vaccine refrigerator; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 16 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 04Jan2022 13:30 (Lot number: 330368D) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in deltoid left, administration date 04Jan2022 (Lot number: QFAA2155) as dose 1, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRETINOIN. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: EW0179, administration route: Intramuscular, administration time:13:15), administration date: 09Jun2021, when the patient was 15 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, single, Lot number: EW0170, administrator route: Intramuscular), administration date: 13May2021, when the patient was 15 years old, for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 04Jan2022 13:30, outcome "unknown", described as "dose 3 on 04Jan2022 and influenza vaccine on 04Jan2022"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 04Jan2022 13:30, outcome "unknown" and all described as "Patient received Comirnaty booster dose that was >6 hours diluted in vaccine refrigerator"; BODY TEMPERATURE INCREASED (non-serious), IMMUNISATION REACTION (non-serious), PAIN (non-serious) all with onset 05Jan2022, outcome "unknown" and all described as "positive immune response 24 hours after injection that increased bodyache and slight elevated temperature".  Additional information: The patient did not receive other vaccine in four weeks. Patient did not tested for COVID-19 post vaccination. Patient had not COVID-19 Prior to vaccination. Patient was given .3ml Pfizer booster dose that had been opened and refrigerated for longer than 6 hours. The patient experienced a positive immune response 24 hours after injection that included body aches and slight elevated temperature. This response told us that the vaccine was most likely effective. The patient has reported no other sideeffects since the booster was given.  No follow-up attempts are possible. No further information is expected.  Follow-up (27Jan2022): New information received from a contactable Other-HCP included clinical course and dosage information. Follow-up attempts are completed. No further information is expected.
I had a sore throat and congestion caused by post nasal drip. The congestion was wicked, sick, gross, no body aches or headache but a wet cough maybe. Aa headache for one day and fatigue for a day that progressively went further into my lungs. I had wet cough which has left me with a residual cough and my energy is back but a cough persist. I have developed a sinus infection now or on Friday December second. My right sinus area below my eye is sensitive to the touch  with an ammonia type smell.
Patient has not received the second dose within the appropriated window of time between two doses (first dose received 16Jan2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose within the appropriated window of time between two doses (first dose received 16Jan2021)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose within the appropriated window of time between two doses (first dose received 16Jan2021)). On 16-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose within the appropriated window of time between two doses (first dose received 16Jan2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 28-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2003USA007542: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
Itchy throat, palpitations, sweating. Lasted < 1 hour after Benadryl 50mg administered.
Palpatition/It has gotten worse over the past few days; This is a spontaneous report from a Pfizer sponsored program Pfizer RxPathways via a contactable consumer (patient, self-reported).  A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 01Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient reported that, after having the vaccine, she had noticed palpatition on an unknown date. It has gotten worse over the past few days. The patient asked to have you come across any similar cases and did you have any advice. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Vaccine Error: Vaccine was not mixed correctly. Only the MenCYW-135 Liquid Conjugate Component was administered. Family contacted. Father reported no adverse outcomes at this time.
shivers; cold feeling; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9321), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller was reporting on the COVID vaccine. He received the first shot yesterday (30Dec2020) and had experienced shivers and cold feeling in Dec2020. He wanted to know if this was normal. The outcome of the events was unknown.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject aged between 20 and 29 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included iodine allergy.  On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown manufacturer).  In 2005, a hepatitis B titer was negative.  It was not specified whether  the subject had completed the hepatitis B vaccine series at the time of the titer.  On 5 July 2007, between 08:30 and 09:00, the subject received the fourth dose of Engerix B (20 mcg, unknown, left arm).  She received no concurrent vaccinations on that date.  The subject was 29 years old at the time of vaccination.  On 05 July 2007, less than one day after vaccination with Engerix B, the subject experienced a gradual onset of pain in her injection arm that proceeded to tingling of her fingers of the left arm.  The pain subsequently spread through her entire body.  She later experienced inability to sleep due to the pain, in addition to nausea from the pain which progressed to vomiting.  The subject also experienced muscle spasms in her entire body.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events of left arm pain, tingling in left fingers, and body pain were possibly related to vaccination with Engerix B.
Per parent, pt had nosebleeds occurring twice in 9/16 and once on 9/17. Each episode stopped after 5 min. No previous history of nosebleeds.
Presented with cough and shortness of breath as COVID positive. Treated with remdesivir and dexamethasone starting 8/16
fever, cough, muscles aches, back ache, headache, nausea, shortness of breath, difficulty breathing
Extremely itchy, sore; Lump on collarbone; Lump on left arm; extremely itchy, sore; Lump on left arm; extremely itchy, sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Extremely itchy, sore), LYMPHADENOPATHY (Lump on collarbone), VACCINATION SITE SWELLING (Lump on left arm; extremely itchy, sore) and VACCINATION SITE PAIN (Lump on left arm; extremely itchy, sore) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Extremely itchy, sore), LYMPHADENOPATHY (Lump on collarbone), VACCINATION SITE SWELLING (Lump on left arm; extremely itchy, sore) and VACCINATION SITE PAIN (Lump on left arm; extremely itchy, sore). At the time of the report, VACCINATION SITE PRURITUS (Extremely itchy, sore), LYMPHADENOPATHY (Lump on collarbone), VACCINATION SITE SWELLING (Lump on left arm; extremely itchy, sore) and VACCINATION SITE PAIN (Lump on left arm; extremely itchy, sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.