chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 09:45 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1, location: Right arm, date/time: 16Apr2021 14:00), administration date: 16Apr2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08May2021, outcome "unknown", described as "severe headache". The event "severe headache" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 08May2021 she developed a severe headache which has continued and not resolved. She had an MRI which showed no abnormal findings. She wants to know if this has been reported and how long to expect this side effect to last. Consumer stated that she wanted to report a side effect. She was just actually at the hospital and stated that she was advised by the hospital staff to report this after she had a clear brain MRI. She said that she has had a severe headache going on 6 days now. she stated that it has gotten a little better but is definitely persisting. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) Covid-19 Vaccine, Right arm, No lot or expiration date info available. The patient visits to emergency room and no physician office. She was sent to get a MRI at the hospital by the physician.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information haws been received from a physician assistant concerning a 19 year old patient who on 15-MAR-2008 was vaccinated SQ with a second dose of 0.5ml of VARIVAX (Oka/Merck). the first dose was administered on 27-SEP-1997. It was noted that based on titer results on 07-FEB-2008 (no response) and on 29-APR-2008 (unequivocal) the patient did not seroconvert. No other symptoms were noted. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
On February 9, my right arm began to itch and when I went home at lunch, I looked and there was a small rash forming. On February 10, the rash was larger, so I went to my workplace walk-in clinic. They suggested Benadryl, Zyrtec, and prescribed an antibiotic. The rash got larger - almost from my shoulder to elbow. After 3 - 4 days, the rash started to go away. My skin was yellowish for 3 - 4 more days before it finally cleared to normal around February 17, 2021.  On February 19, I woke up and had a rash over my entire body with the exception of where the earlier rash was on my right arm. That spot was perfectly clear. About 2:00 I went to Urgent Care. I received a steroid injection, was prescribed prednisone and levocetirizine and told to take Benadryl, soak in oatmeal baths and use Aveeno lotion. MD said it was hives. It worsened Sunday, February 20, and then gradually began to fade Monday and through the week. Today, March 1, 2021, I still have splotches on my skin but it is mostly clear.
CDC reports: 17 mo child developed fever 104 & local rxn at inject site following DTP/OPV/MMR immun. Duration of illness 4 days. Dx as ear infection.
Dry cough, fatigue from lack of sleep due to cough. Slight fever (99.9) first evening only.
Apparent percarditis.    Heart palpitations, chest pain, trouble breathing ( due to chest pain). Worse when lying down.  NSAIDs helped.   Waited in ER lobby for an hour ( approx hour 6 after onset of symptoms when symptoms began to dissipate). Only intake triage performed at hospital. 10 hours duration
Patient called the pharmacy complaining of a rash the day after his second dose occurring on the side of vaccination combined with swelling x1 day. The patient also endorsed aches and pain in his finger tips. He endorsed the rash was not getting bigger .
Low fever, chills, fatigue, muscle soreness, vomiting, severe headache Started at 10:00 pm at night and ended at 4:00 am. The headache continued into the next day and lasted a total of 12 hours.
severe headache, body ache, severe back pain, left arm thru clavicle pain fatigue, nausea, chills, fever 103 F,  first post day,     2nd post day sweats, diarrhea, nausea, decreasing headache and aches, pains as day progressed, fever lasting around 40 hrs.  This is first injection.
Awoke with breathing difficulty (Asthma Attack) which lasted about 20 minutes I was able to take my inhaler and a cup of hot herbal tea to calm the symptoms. Afterwards, tried to sleep again, but awoke with chills.
Shortness of breath Leg swelling Hypertension Diarrhea Cough
Pt recvd DTP/OPV in AM 5MAR92 @ 8PM pt devel rash on body, large red raised area; rash more pronounced on side of body vax recvd; large red area @ inject site; pt taken to MD who gave pt shot & cream for rash on back;
Drug rash eruption within 24 hours of intranasal H1N1 vaccination.
Date of Admission: 11/29/2022 Date of Discharge: 12/1/2022   Active Hospital Problems   Diagnosis o NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) o Fall, initial encounter o COVID-19 o Transient loss of consciousness o Primary hypertension o Coronary artery disease involving native coronary artery of native heart with unstable angina pectoris (CMS/HCC) o 3-vessel CAD o Hyperlipidemia with target low density lipoprotein (LDL) cholesterol less than 70 mg/dL
Redness and swelling where I got the shot in my arm.  Feels bruised.
Anxiety. Warm, swollen, itchy,  bleachable rash Left deltoid
Per conversation with patient 8/18/17: - Muscle pain at injection site after shot, documented report to the pharmacy of "muscle tightness" on 9/30/16 - Pain, tingling, numbness in entire left arm and hand persistent for about 3 to 4 months, but then tapered away - Reports that she continues to have "aches" before storms now.
Arm felt tickle. After about 1 min. started tunnel vision. Felt lightheaded, dizzy. Passed out for about 30 sec & came to. Called 911, they check vitals, everything ok. Will follow up w/PCP.
I started having chills, dizziness, and fatigue by the third day. I then started having a lot of head pressure, along with the dizziness. I am scheduled to see an ENT doctor on 12/07/2021.
Pain at the injection site; Swelling, hardness, redness and heat at the injection site; Immediately felt itching at the injection site; Swelling, hardness, redness and heat at the injection site; Swelling, hardness, redness and heat at the injection site; Swelling, hardness, redness and heat at the injection site; She was very upset; This is a spontaneous case initially received from other non-health professional (consumer) via agency (reference number: SEQ19-07498) on 17-Dec-2019, concerning an over 65-year-old female patient.   The patient's medical history was not provided. The patient's historical vaccine included Flucelvax (QIV) last year and the year before without any adverse reaction. The patient's concomitant medications were not provided.   On 22-Oct-2019, the patient was administered Flucelvax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, after vaccination, the patient immediately felt itching at the injection site. About an hour after the vaccination, the patient developed swelling, hardness, redness and heat at the injection site.   On the same day, the outcome of the event vaccination site itching was resolved.  On 23-Oct-2019, one day after vaccination, the patient developed pain at the injection site. The patient was very upset.   On 24-Oct-2019, the outcome of all events which occurred at the injection site was resolved. However, it was not reported whether the patient still was upset. It was unknown whether the patient received any corrective treatment for the events.  The reporter assessed all the events as non-serious and did not provide causality assessment to Flucelvax (QIV).  Company comment: The patient developed vaccination site warmth, anxiety, vaccination site pruritus, vaccination site swelling, vaccination site induration, vaccination site erythema, vaccination site pain on the same day after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.; Sender's Comments: The patient developed vaccination site warmth, anxiety, vaccination site pruritus, vaccination site swelling, vaccination site induration, vaccination site erythema, vaccination site pain on the same day after Flucelvax (QIV) was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.
24 hours after receiving FluMist patient noticed dark brown urine. Next day CK level found elevated. Did have afebrile URI symptoms starting 2 days prior to receiving FluMist. Received IV fluid therapy for 48 hours after 24 hrs of oral therapy until CK < 5000. No other complications.  11/27/2007 MR received DOS 10/13-16/2007.  Pt reported dark brown urine 1 day following Flumist vax.  Pt had 5 day hx of afebrile URI prior to receiving vaccine.  PE (+) for pharyngeal erythema and nasal discharge. Diffuse aches noted in arms and back.  DX:  Rhabdomyolysis (likely due to viral illness, possibly Flumist). TXd with IVF.  Normal urine color noted 10/16/2007. Resolution of Lab abnormalities noted on 10/16 as well.
Severe left arm pain, numbness and immobility that began 24 hours after incident. Patient also experienced fevers.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 year old female pt who received DTAP (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the local health department. On 04/17/03 the pt received the 5th dose of Infanrix in the left arm. On the same date, she received an injection of inactivated IPV in the left arm and an injection of MMRII in the right arm.  On 04/18/04, 24 hours post-immunization, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt's left arm was stiff. The pt also experienced irritability and low-grade fever. The events resolved on 04/20/03.  The nurse considered the events were related to vaccination with Infanrix.
Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  In or around July 2016, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using it. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). The reporter considered the event to be disabling.
PATIENT DEVELOPED DIFFUSE SWELLING OF THE DELTOID WITH ONLY MINIMAL DISCOMFORT AND ERRYTHEMA.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Date of refrigeration of vial was 7 May 2021.   This case was linked to MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
515 PM - PT COMPLAINED OF DIZZINESS, FEELS OUR OF IT. DENIES OTHER S/S  HR 64, 99%  124/80 WATER GIVEN CRACKERS. 524 PM DIZZINESS STILL  BP 124/80  534 PM DIZZINESS STILL NO OTHER S/S  535 PM DIZZINESS STILL THERE IF I LOOK DOWN.  MORE CRACKERS AND WATER GIVEN 545 PM DIZZINESS SL IMPROVED, GAVE TEAM MEMBER BOX LUNCH  610 PM FEELING BETTER DIZZINESS GONE  FELT OKAY TO LEAVE MOM WAS COMING TO TAKE PT HOME NO OTHER S/S
Patient is a healthy 18 year old male with no history of Covid-19. Received 1 dose Moderna vaccine 5/8/21. Felt malaise, febrile to 103.5 that evening, 5/9/21 began experiencing chest pain. 5/11/21 presented to emergency department. Diagnosed Myopericarditis of unknown origin. Cannot exclude inflammatory response from vaccine as etiology.
Moderna COVID-19 Vaccine EUA WED, 3/17 - itch begins and small hives appear in left & right ("L&R") ankles, feet, and toes.  Began antihistamines.   THUR, 3/18 - itch intensifies to severe level.  Hives spread to entirety of feet, ankles, and hands/palms (L&R).  By mid-day, hives had spread to upper thighs.   FRI, 3/19 - severe itch continues non-stop, primarily on feet, hands, and elbows.  Hives now spread from toes to upper thigh (L&R) and fingers to biceps (L&R).  Dr visit - received steroid shot and doubled up on antihistamines.  SAT, 3/20 - hives lighter in color, with severe itch remaining in feet and hands.  Swelling of hands and fingers (L&R, but primarily left), and joint pain in hands.   SUN, 3/21 - hives hives almost completely gone, redness still noticeable.  Slight itch still present in feet but much less severe.  Hands extremely swollen and painful in morning (primarily left).  By end of day, swelling almost gone.  Joint pain primarily in hands but also in legs and backside.   MON, 3/22 - symptoms minimal.  Slight itch remains in feet and slight joint pain in hands.
4-14-21 telehealth visit complaining of sore throat, body aches, diarrhea started on 4-13-21. 4-10-21 had heavy arms. 4-11-21 noted some sneezing
This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix-B immunizations series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
Injection 11/10/2003 received flu vaccine.  Next day, felt run down lightheadness (Tuesday).  Friday in PM had diarrhea and nausea and felt like tongue was swelling.  Went to ER diagnosis with panic attack.  Also had one 9 days later just feels like she is getting the flu.  2nd time she had flu shot, 1st time felt bad all winter.
pt recvd vax MAY92 6-8 hrs p/vax exp severe gastrointestinal upset of nausea & diarrhea; treated w/rest;
This spontaneous report was received from a nurse practitioner and refers to a 16 year old female patient. The patient's current conditions, medical history and concomitant medications were not reported. On 22-JAN-2016, the patient was vaccinated with GARDASIL 9 injection 0.5 ml, lot # L027282 (expiry date 21-SEP-2017) intramuscularly. On 25-JAN-2016, the patient developed a headache. Treatment was not given for the event. Lab diagnostic studies were not performed. The patient sought medical attention. On 28-JAN-2016, the patient saw nurse practitioner for the ongoing headache. Product quality complaint (PQC) was not involved. No further information was provided. The event was not resolved. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 24 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt given KINRIX (L) upper arm. Went to ED on 11-27 Dx with cellulitis. Discharged with clindamycin suspension. Had vomiting associated with med. Continued fever. Returned to ED 11/28 and was admitted and started Clindamycin IV. At discharge 11/29 was afebrile and had small induration at site and mild swelling well within previously drawn borders.
fatigue Narrative:  after 1st vaccination day 2 generalized and localized myalgia; day 3 headache and diarrhea; day 4 fatigue.
Low grade fever on 2/05 and 2/06. Right upper arm (where vaccine was administered) swelled (from just above elbow to below shoulder) from 2/05-today (2/08), with the swelling reducing incrementally day by day. It is still slightly swollen today.
In May of this year, I  tested positive for Covid-19.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (In May of this year, I  tested positive for Covid-19.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (In May of this year, I  tested positive for Covid-19.). At the time of the report, COVID-19 (In May of this year, I  tested positive for Covid-19.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as first booster dose.  Unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    Treatment information was not provided.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious COVID-19  after receiving the 1st booster dose of mRNA-1273 vaccine. The exact onset date of event and vaccination date were not reported. Patient had 1st booster dose about 6 months ago and reported that in May this year (2022) COVID test was positive. Clinical course and treatment details were not reported. The outcome of event was reported as recovered. There was no information provided regarding the first 2 doses of vaccination.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious COVID-19  after receiving the 1st booster dose of mRNA-1273 vaccine. The exact onset date of event and vaccination date were not reported. Patient had 1st booster dose about 6 months ago and reported that in May this year (2022) COVID test was positive. Clinical course and treatment details were not reported. The outcome of event was reported as recovered. There was no information provided regarding the first 2 doses of vaccination.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Rebound bout of COVID; Rebound bout of COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 25Feb2022 as dose 2, single (Lot number: EN6203), in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FE 3590), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "surgery for melanoma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Allergies to soy" (unspecified if ongoing); "Allergies to pine" (unspecified if ongoing); "Allergies to dust" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for hypersensitivity, asthma; CLARITIN [LORATADINE] taken for hypersensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound bout of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive.
Extreme soreness at injection site, lasting overnight and into the next day. Fatigue and headache.
Seizure - 11 AM 4/28/09 - taken by ambulance to E.R. In-patient 2/28/09 - 4/29/09 - high fever. 4-30-09 - Back to Dr. office, severe diarrhea.  5/18/09 Hospital records received DOS 4/28/09 to 4/29/09. FINAL DIAGNOSIS: Febrile seizure, questionable left perihilar infiltrate on x-ray Post vaccination: febrile seizure, fever, cough, congestion of nose, loose stools, erthema of injection site on thigh. Skin hot pink dry. Fussy ICD-9: 780.31 Febrile Convulsions (Simple), Unspecified