chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO APPETITE; LOOSING WEIGHT; ABDOMINAL PAIN FELT LIKE STARVING; FELT MISERABLE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced no appetite. On 2021, the subject experienced loosing weight. On 2021, the subject experienced abdominal pain felt like starving. On 2021, the subject experienced felt miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the no appetite, loosing weight, abdominal pain felt like starving and felt miserable was not reported. This report was non-serious.
Had flu shot; c/o severe pain later that eve 10/12. When awoke 10/14 has 5-6cm sharply demarcated erythema with 2cm induration in center, very hot and tender. Rx with Duricef x 7 days.
Hepatitis B and ADACEL given at 1130 AM. Patient c/o chest fullness, headache, lightheadedness and shortness of breath at 1356. She was sent to Emergency Dept where she was treated and released. She felt much better following ED visit.
Patient began to have visual and audio hallucinations.  She was unable to focus on the conversation she was having.  The walls appeared to be moving.  Her eyes were unfocused and she was awake but not responsive.  This lasted for about 2 hours.
loss of smell; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. A customer got the first dose of the Pfizer covid vaccine on Monday. She experienced a loss of smell after receiving the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported in a literature article and described the occurrence of exacerbation of pseudotumor cerebri in a 18-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). Concurrent medical conditions included pseudotumor cerebri and scoliosis. On an unspecified date, the subject received an unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). 30 days after vaccination with HPV vaccine, the subject experienced pseudotumor cerebri exacerbation. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unlikely to be related to vaccination with HPV vaccine. This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI) and to provide an advice about AEFI to practitioners, assigning potential causality, and contributing to an improved understanding of AEFI. Cases were referred by practitioners, health departments, or CDC. The diagnoses were accepted as given by providers without independent verification. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination according to CISA investigator modified criteria of WHO causality assessment criteria. Recommendations regarding future immunizations were relayed back to the referring physicians. CISA investigators reviewed 76 cases between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. On 22 August 2011, following GSK review, the event has been changed to pseudotumor cerebri instead of condition aggravated. The case has been therefore upgraded to serious as it was assessed as medically serious by GSK.
Information has been received from a physician concerning a 26 year old female patient who on 18-DEC-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot# 0294Y) IM in the left deltoid. On 18-DEC-2009 after vaccination, the patient experienced pain at injection site, abdominal pain, left shoulder aches and pain, nausea and dizziness. The patient was examined in the Emergency Room on 19-DEC-2009 but was not admitted. She was discharged on the same day. The name of the hospital was not known. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a health care professional and medical records concerning a 26 year old female patient with no illness at the time of vaccination and no known allergies who on 18-DEC-2009 11:30 A.M. was vaccinated with the first 0.5ml dose of GARDASIL (lot# 0294Y) IM in the left deltoid. There was no concomitant medication. On 18-DEC-2009 the patient experienced pain at the injection site, abdominal pain, nausea and dizziness. On 19-DEC-2009 the patient visited the emergency room with complaint of pain at the vaccine injection site on her arm. There was no erythema or swelling. The physical examine was within normal limits except for tenderness at the left shoulder. The pain assessment showed that the patient had a 10 pain score. The patient had aching of the upper arm with radiation of pain to the left shoulder. The physician's assessment noted local myalgia. The patient was treated with MOTRIN, tablet, 800mg, PO. At the time of the report, the patient recovered on an unspecified date. Additional information is not expected.
Adacel, which is approved for 7 years old and older was given to a 2 year old female.  No known reactions
Fever, chills , muscle pain , nausea , and painful swelling of left lymph nodes
Child had syncopal episode, pt complained of feeling dizzy and then fainted in mom's arms.  Upon placing an oximeter on the child oxygen sat was 96% and heart rate was 43.  Child was alert and complained of being dizzy, however appeared pale and diaphoretic.  Apical pulse was 52.  I left to call doctor and two other nurses stayed with pt, while I was gone oxygen dropped to 83% and heart rate 62.  Physician stated for her to come to his office.
This spontaneous report received from a nurse referred to a currently 7 month old male patient. The patient's historical condition included rash and concurrent conditions included fever and moderate petechia. On 13-JAN-2017, the patient received a dose of M-M-R II (lot: L043702, expiry date: 03-NOV-2017) for an unspecified indication. The patient was seen in the office on 10-MAY-2017 and received a dose of VARIVAX (lot: M037643; expiry date: 01-SEP-2018) subcutaneously for an unspecified indication. The patients mother called the office on 30-MAY-2017 stated, a couple of days prior the patient developed multiple blisters in his groin area and under his arms that were then crusting over. When asked the current status, the nurse stated that he was doing well. No treatment was given to the patient. Outcome of blister was resolving. Causality assessment was not reported. This is one of the two reports received associated with the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001656:
Within a hours, severe muscle tightening from hips to neck, threw spine out of place. Severe pain. Has been to several doctors, including chiropractor and message therapist. Inflammation in hip, legs, and knees. Couldn't walk for three days. Now able to walk with cane. Was extremely physically active prior to the shot.
Patient complained of unsteady gait, numbness and tingling  of upper and lower extremities more pronounced on the left side where received vaccine.  Patient was seen in ED on 1/11/21 and did not receive any treatment, was evaluated and later discharged in stable condition.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 29May2021 as dose 2, single (Lot number: Ew 0186), in right arm and on 14Dec2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 55 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes (onset)" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Allergy to Strawberries" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (01Jun2022) Negative, notes: He tested negative on the 1st of June; (05Jun2022) Negative, notes: tested negative again on the 5th of June; (10Jun2022) Positive, notes: Retested on the 10th of June, tested positive. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient tested negative on 01Jun2022 and tested negative again on 05Jun2022. Stated that, the patient returned to work on 06Jun2022 and re-tested on 10Jun2022, tested positive. Stated that, no fever. Acting his usual self. Retested due to travel plans. Therapeutic measures included anti-viral details: Product COVID 19 Treatment, Brand: Paxlovid, Treatment started on 28May2022 and stopped on 05Jun2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6MAR96 5PM mom noticed gen pink blot chest that gradually turned red; pt reportedly exp intense itching that kept pt up most of noc;consulted w/MD by phone-told rash d/t immun
Initial HCP report received on 06 Jan 2010: The patient was vaccinated with H1N1 (batch: 102149P1) 0.5 ml intramuscular, for immunization, on 05 Jan 2010. On 06 Jan 2010, at 5.00 am, the patient discovered that her left thumb was numb. The outcome of the event was reported as, not subsided. The causality of the event was not reported.
Client reported S & S began in afternoon, Wed, 3/5/03, and reported to hospital contact at 11:30 a.m. on 3/6/03. C/o temperature at 99 deg F on 3/5/03 that increased to 100.4 deg F on 3/6/03. Client was advised by hospital contact to take pondri paretic c/o of swelling and muscle pain in arms and shoulders.  A 15-day follow up report received 05/20/2003 adds no new info.
Patient had a syncopal/near syncopal episode shortly after vaccine given, becoming very lightheaded/dizzy. Had a very short period of unresponsiveness, approximately 5 seconds.  He does report having a similar situation after flu vaccine in the past. He was placed in supine position, cool compress applied to forehead. After several minutes was able to consume water and lollipop. He was made to remain in the treatment area for 30 minutes post vaccination, at which time he recovered without any further treatment and was able to leave with his mother, ambulating steadily without assistance.
This case was reported by a physician via other manufacturer and described the occurrence of injection site rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site rash and vesicular rash. On an unknown date, the outcome of the injection site rash and vesicular rash were not reported. It was unknown if the reporter considered the injection site rash and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient has been captured as adult as per schedule of SHINGRIX. After receiving the SHINGRIX dose, the patient experienced asymptomatic vesicular rash at the area of injection. The reporter did not wish to be contacted for follow up.
Heart Palpatations for month + Increased rate at different times during the day Frequency has lessened but sporadically happens out of the blue
This spontaneous report was received from a medical assistant concerning to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as M041514, expiration date: 11-OCT-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 46 Fahrenheit degrees for 4 hours and 15 minutes and then  53.6 Fahrenheit degrees for 14 hours and 15 minutes. No previous temperature excursions were reported. Data logger was involved. The patient's concomitant therapies included sterile diluent lot # reported as M045717, expiration date 31-MAY-2019. No adverse effects were reported. Additional information has been requested.
I contracted COVID-19 and began experiencing symptoms on 4/09/22 of congestion, cough, myalgia, fever, shortness of breath, fatigue, chest pain/tightness, scratchy throat, and swelling in my hands. I was ill for 17 days before all of my symptoms resolved. I have lingering fatigue, congestion in my throat, and lack of concentration. I received Monoclonal Antibodies 04/13/22 and was also prescribed Decadron 7 day round of steroids, and increased my Pulmicort dosage.
Hospitalization for  COVID-19 symptoms of cough, shortness of breath, fever, and dirarhea on dates  6/17/2022-6/22/2022.  Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Area of injection became swollen within hours. Swelled to 13cm X 6cm area, was reddened and warm. Temperature of 100F and developed a dry cough which later became productive. Also had chills. Placed on antibiotics and is improving.
Exhausted; Body aches; Coughing; Fever; chills; Congestion; Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and kidney disease. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), benzalkonium chloride, sodium chloride (ALIVE), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EXT5318) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 15:00, the patient experienced exhausted, body aches, coughing, fever, chills, congestion and chest pain. Since the day the patient got the vaccine he had the symptoms at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhausted, body aches, coughing, fever, chills, congestion and chest pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
20-30 papules-scattered on trunk wk post vax-no other sx probable vaccine assoc varicella-no known exposure to wild type varicella;
This is a spontaneous report from a contactable consumer reporting on herself. A 67-year-old female patient received PREVNAR 13 (Lot # R12280) via an unspecified route of administration at 0.5ml, single on 29Dec2016 for pneumonia. Medical history included ongoing blood pressure abnormal, ongoing blood cholesterol abnormal. Concomitant medication included lisinopril (20 mg, 2x/day for blood pressure, fenofibrate 145 mg, 1x/day for Cholesterol, both ongoing. On 29Dec2016 the area that patient got shot in started to bruise about two inches around and then further out, it became blazing hot and it was at least 6 inches around that came to be really hot and swollen. It lasted a week and finally went to the doctor. On 29Dec2016 the patient also experienced little patch, where it has swollen and turned red, the colour was not returned to normal. When she was in so much pain, she could not sleep I took couple of TYLENOL. The doctor prescribed a cream, Triamcinolone for the itching when the swelling had come down and the pain had started to go away. The patient stated she recovered completely, the only thing that showing on arm write was a red patch where it has swollen and turn red and the colour has not returned to the normal.
Patient called stating she had quite a reaction to the SHINGRIX vaccination, that the day of the vaccination she developed a 50 cent piece size reddened and swollen area at site of vaccination. Also stated that it is very sore. She said today, (4 days post vaccination), that it is now a darker red, and the swelling goes down her arm. Did not state what treatment she has tried for relief.
Post vax, pt's left thigh became "splotchy" at about 14:30 to 15:00, right after Comvax given, per mother. She noticed bruising at the site. The mother noted that other family member (not a sibling) had also had bruising and shot nodule formation from having Comvax. Due to numerous reports of reactions locally to Comvax, information is being forwarded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: mollusks" (unspecified if ongoing), notes: known allergies: mollusks. Concomitant medication(s) included: ZOCOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient received second Pfizer COVID-19 vaccination on 1/7/2021. On 1/8/21 developed nausea, flu-like symptoms, dizziness. While walking down stairs became dizzy and fell, injured R shoulder. Presented to urgent care 1/9/21 for shoulder workup, all symptoms of vaccine reaction had resolved. No OTC medications taken for vaccine reaction.
Patient received their first Pfizer peds covid vaccine.  Patient had waited for their brother to get the shot and got a toy in the office and was acting normal, this time span had been over 5 minutes. The father, brother and patient went out to schedule their second shot when the father was going over information with the technician. There was a noise where the kids were behind the father and the child was on the ground.  The dad asked the patient what he was doing and the dad tried to pick the up the kid and the dad said he was "limp as a noodle" in his dad arms.  I then went out to the front of the pharmacy and pulled the patient into the office with the dad and the patient was bleeding from his nose. We grabbed facial tissue and applied to the nose and I called medical emergency and nursing staff came to help. Patient was clammy to touch and pale.  After about 15 minutes in the pharmacy, he coloring had returned and bleeding had stopped. The patient was seen by one of our providers in clinic due to the bump on his nose. The mother came into the pharmacy after the event while we were attending to the patient and she stated that she faints with all her vaccines.  I called security to have them review the footage and the security dispatch said he didn't trip or fall on anything but looks like he fainted.
sore arm  1st day, swelling, itching.    Itching increasing  third day, and area turning red and increased swelling.  Treated with hydrocortison and pain salve.  Itching less and swelling and redness less.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of unspecified age and race/ethnicity received PREVNAR 13 (Lot# lot R33240), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient broke out with rash all over her body on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Point of turned blue increase to size of $.50 area around turned red  and continued towards elbow with swelling and temperature increase over period of 3 hours. Condition somewhat same last 48 hours.
Inject site swollen & inflamed 8x6cm, incessant crying began 6hrs p/inject, irritability; Tx ice & APAP;