chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre syndrome; This spontaneous case was received on 14-Dec-2020 with an additional information received on 15-Dec-2020 (being processed together) from other non-health professional via Med Communications (reference number: SEQW20-05768) and concerned a 21-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 13-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number was 279831 and expiration date was 30-Jun-2021.  On an unknown date in 2020, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced Guillain Barre syndrome. It was the first time that the patient got an adverse event.  The outcome of the event of Guillain Barre syndrome was not reported.  The reporter did not provide a causality assessment.  The event of Guillain Barre syndrome  was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: The patient developed Guillain-Barre syndrome after receiving the suspect product, Flucelvax Quadrivalent. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Based presented findings, causal relationship between the suspect product and the event is assessed as possibly related (defaults to "related" in the safety database for reporting purposes). Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.; Sender's Comments: The patient developed Guillain-Barre syndrome after receiving the suspect product, Flucelvax Quadrivalent. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. Based presented findings, causal relationship between the suspect product and the event is assessed as possibly related (defaults to "related" in the safety database for reporting purposes). Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.
CP, SOB, weakness, fatigue, cough, HA, and was treated in ER
Headache; Stif arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced headache, stiff arm on an unspecified date. The patient also verbally stated that she has cataracts in both of her eyes. It was verbally stated as she do not have the mobility she had before. The patient also stated that she will be getting a blood transfusion, and she sees both a cardiologist as well as a kidney doctor. The events were assessed as non-serious. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
pt recvd vax & exp fever, also had local react consisting of redness, swelling & tenderness @ the site of inject;
A major high akin to smoking marijuana; which I never did. I wanted to fly  Dizzy Headache  Muscle pain on opposite hand w swelling Throat closing up; itching  Hives
Could hardly walk; Almost falling backwards like someone who has cerebral palsy; His back hurt bad/back pain is ongoing/back pain is improving; His neck really hurt; Out of work for the week so far/missed 3 days of work; His neck has weak spots; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (His neck has weak spots), GAIT DISTURBANCE (Could hardly walk), FALL (Almost falling backwards like someone who has cerebral palsy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Administered on Fall 2021.Route of administration- Intramuscular) in 2021 and J&J (First dose). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII and J&J. Concurrent medical conditions included Hypercholesterolemia (No change in status such as improvement or worsening recently.). Concomitant products included SIMVASTATIN for an unknown indication.   On 09-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced NECK PAIN (His neck really hurt). On 11-Apr-2022, the patient experienced GAIT DISTURBANCE (Could hardly walk), FALL (Almost falling backwards like someone who has cerebral palsy) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving). In April 2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (His neck has weak spots) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work). At the time of the report, MUSCULOSKELETAL DISCOMFORT (His neck has weak spots), FALL (Almost falling backwards like someone who has cerebral palsy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Out of work for the week so far/missed 3 days of work) outcome was unknown, GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (His back hurt bad/back pain is ongoing/back pain is improving) was resolving and NECK PAIN (His neck really hurt) had resolved.            Patient received second booster dose on 09-Apr-2022 afternoon. The manufacturer of the second dose patient received was unknown. No treatment medications were reported.   This case was linked to MOD-2022-539764.
Sore throat, cough, sore throat, fever (temp was 99), body aches, loss of taste, loss of smell, nasal congestion, sinus congestion. starting 12/18/21
4/30/13 swelling and redness and pruritus left upper arm 3.5 cm x 4.5 cm. Week after 4/29/13 pain both legs with constant need to move, decreased exercise tolerance, pain preventing sleep.
Guillian-Barre Syndrome Information received from the annual follow up states patient last visit was 8/17/07, diagnosed with hepatic cancer.
Patient was supposed to receive Tdap. Patient was given Dtap. Patient did not have any reaction to the vaccine at that point in time. I advised Mom to monitor, if patient had a reaction to call us immediately.
Moderate lethargy for 24 hours after vaccination.  Redness and pain at the injection site. (approx. 6 in x 3 in. area). No swelling .  Redness and pain started 24 hrs after injection.  Almost resolved as of 8/5/2019.
Low iron and phosphate; Low iron and phosphate; Loss of bladder control/Cannot hold urine at all/Often urinate in my clothing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 15:00 (Lot number: EW0179) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stiff neck", start date: 1998, stop date: 1998, notes: Pinched nerve in neck, Onset date: 20Apr2021; "Pinched nerve in neck" (unspecified if ongoing); "Knee pain", start date: 2003 (ongoing), notes: Twisted knee/continued pain/X-rays. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Time: 15:00, Anatomical site of injection: Left arm , Batch/lot no: ER8729), administration date: 10Apr2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "Lower body numbness", "Very poor balance", "Pain in my legs", "Pain in my legs and abdomen", "cannot walk up steps or stairs", "muscle spasms/Leg spasms". The following information was reported: URINARY INCONTINENCE (non-serious) with onset 19May2021, outcome "not recovered", described as "Loss of bladder control/Cannot hold urine at all/Often urinate in my clothing"; BLOOD IRON DECREASED (non-serious), BLOOD PHOSPHORUS DECREASED (non-serious) all with onset 25May2021, outcome "unknown" and all described as "Low iron and phosphate". The event "loss of bladder control/cannot hold urine at all/often urinate in my clothing" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urinary incontinence. Therapeutic measures were taken as a result of blood iron decreased, blood phosphorus decreased.  Additional information: Patient often urinate in clothes if patient cannot get to a bathroom immediately, Once starts, patient cannot stop it.  Follow-up attempts are completed. No further information is expected.
Vaccines received on Monday 10-22-01, pt. c/o soreness. Tues p.m., Wed. am 10/24/01 left arm swollen, red and warm to touch from shoulder to elbow. Child responsive but didn't want to get out of bed. Mom state "didn't want to be bothered' Child feverish, temperature not taken, but given Motrin and warm compresses. seen by MD Wed. am. No other treatment prescribed. Better Wed. pm 10/24/01, Recovered and return to school 10/26/01
FATIGUE, NUMBNESS IN SHOULDERS, AND HANDS. LIGHT HEADINESS.  PRESCRIPTION FOR LIGHT HEADINESS.
Temperature 102.9F, within 24 hours, post vax, lasting 6-8 hours.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015), single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the (23-valent) PNEUMOVAX had a temperature excursion for 40 and 72 hours, with the lowest recorded temperature was 28F (-2.222 Celsius) and the highest 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Pt was given Flublok rather than Fluzone Quad. No adverse reaction from patient noted. Prescriber and family notified.
Bilater swollen knees; pain, could be related to Osteoarthritis; This case was reported by a physician via call center representative and described the occurrence of swelling of knees in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis.   In November 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling of knees and pain. On an unknown date, the outcome of the swelling of knees was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the swelling of knees and pain to be related to Shingrix.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment:  The reporter reported that a friend received Shingrix on November 2022 (not exact date provided) and developed bilateral swollen knees after it. Symptoms abated 1-2 weeks after the episode. The patient remained with pain but could be related to Osteoarthritis (patient had Osteoarthritis before receiving Shingrix but was not under treatment)  The facility of administration unknown. The reporter did not consent to follow up.
Patient fussy 3/12/07 pm at bedtime. Awoke at 200am with fever 103 degrees which rose to 103.8 was seen in ER. Treated with Motrin and steroid. Follow-up with pediatrician who dx as due to vaccines.
After the first day, I started to have minor arm pain at the injection site. I periodically used and ice pack and I took some advil.  2 days later, I woke up several times in the middle of the night with chest pain and shortness of breath. I felt paralyzed and just went back to sleep a few times. Around 6am,  I woke up and changed to sleeping in a chair in a sitting position as I felt a little less pressure on my chest while doing so. After I finally woke up a couple of hours later, my symptoms were more bearable although I did still feel chest pressure and slight shortness of breath, it did not seem like an emergency any more. These symptoms continued on into the next couple of days and started to go away with time.
Pains across my chest, ribs, ovaries, and legs. Felt like a corset was around my rib cage, fever off and on for over two-three weeks. Infection/rash on legs that brought on open soars on my legs by day 5 post injection. Infection was identified by primary care NP, and an antibiotic was given. Felt a skin crawling like reaction all over my arms and legs, making sleep very difficult. rash continued to appear off and on.  Subsequent doctors appointments due to continued symptoms above:  lab work showed, high spike protein results, inflammation markers on my labs, and that some blood clots were at some time present. Continued to doctor, Infectious Disease Doctor evaluation requested by Primary Care. Oct 26th I was diagnosed with Myocarditis as a result of the COVID vaccine.  Was told there was no treatment other than a series of steroids. Took a 6 day steroid treatment, which produced broken blood vessels in my eyes and face.  Echocardiogram schedule for Nov 23rd, which was four weeks out due to staff shortage and influx of patients.  Continued pain in my chest and rib cage area, with intermittent pain in ovaries. Nine week post immunization, suffering from chest, rib and ovarian pain...knife like sharp pains. left frontal eye pain this week, running into my jaw, which i communicated to my physician
On 4/6/21, the 16 y/o patient received the Moderna vaccine at the vaccination site.
I have a large circular rash at the injection spot now being called "COVID arm." It's mildly itchy, red, and a little bit tender to the touch. It's about 3 inches in diameter.
Period stopped. Have not had a period since 2nd COVID Vax dose 40+ days ago. Periods are usually regular
MODERNA COVID-19 VACCINE EUA Large red, itchy rash area around injection site that increased in size a couple of days before started looking better.
Patient was scheduled for second dose of Pfizer vaccine on 7/29/2021. Second dose of vaccine was given 6 days early.  Second dose of vaccine was due to be given on 8/4/2021.
"Bumps" noted 12/23/05 on Abdomen/back (approx 20) with red vesicles, resolved in 1 day. 12/29/05 4 vesicles noted at vaccine site.  Some with oval red background.
This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions. drug reactions/allergies and concomitant medications were not reported. On unspecified dates since 10-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M028323, expiration date:26-SEP-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of - 1.7 Celsius degrees for 4 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013313: US-009507513-1703USA013314: US-009507513-1703USA013202:
Left upper arm at injection site started to itch 1/21, and became swollen, hard, red and painful to touch 1/22.
Pt says she got the shot on 8/28 tohether with her husband. Husband is okay with no reactions, but she got some bruising and a throbbing pain on the site where she got the shot. Pt said she could not sleep and at work she had to stand upright. It was weekend and she hasn't spoken to her PCP yet and pt said she was hopping it goes away.
Fever over 100, chills, body aches, headache. After 1 week this was joined by redness of the skin which spread and itched intermittently. After 2 weeks, the chills stopped, but fever, aches, headache and red "rash" (no bumps) continued. On 07/29/2011 the body aches turned into severe muscle and joint pain in arms and shoulder, legs, feet, neck, jaw, and back (though not all at the same time--one day leg and arms, two days later leg pained lessened but intensified in wrists and elbow, then that lessened and moved to feet, and so on). In the joints was severe swelling with the pain.  As of 08/05/2011, a low grade fever, headache, muscle and joint pain and rash (though not as severe as before) still continue.  As an aside, I had muscle pain/soreness at the site of the injection for 3 days after the injection.
Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on Feb2021 as dose 1, single, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 01Mar2021, the patient had shortness of breath upon getting back in bed and lying down. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
By end of day painful at injection site. Increase pain in moving arm that night. 7/27 at work headache, aching in joints, pain arm left work early. 7/28 made informal visit to Health office and then came to clinic to have PPD read, left arm had minor swelling and redness at site. 7/29 pain decrease, more swelling and redness at site. 7/30 minimal red spot at site.
Information has been received from a health professional concerning a 12 month old male with no medical history and no allergies who on 16 February 2006, was vaccinated intradermally in the left forearm with a dose of varicella virus vaccine live (Oka/Merck) (lot#649741/0222R). There was no concomitant medication. On 16 February 2006, the same day, the patient experienced redness at the injection site. Unspecified medial attention was sought, but no labs were done. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Seizures (1st episode) around 18 hours after shots x4 with hypotonic/hyporesponsive episodes post-ictal. Hospitalized for 3 days with negative evaluation. On day of subsequent seizures one month later.
Major chills, body aches, headache and fatigue.  Slept 17 hours within a 24 hour period starting at 26 hours after injection.  Symptoms improved about the 48 hours mark following injection
Pregnancy and received 1st dose of Moderna COVID 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy and received 1st dose of Moderna COVID 19 vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Mar-2021, the patient experienced PREGNANCY (Pregnancy and received 1st dose of Moderna COVID 19 vaccine). At the time of the report, PREGNANCY (Pregnancy and received 1st dose of Moderna COVID 19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported   No treatment medication reported
This spontaneous report was received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history was not reported. On an unknown date these unspecified amount of patients were vaccinated with M-M-R II (lot #, dose and route were not reported), that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported.   Follow up has been received from nurse who stated that the lots numbers involved in the case for the M-M-R II was: J011332, expiration date: 13-SEP-2015.   Follow up information was received from the nurse. After temperature excursion vaccines were verified as stable. On 21-AUG-2014 at 16:19, multiple patients were vaccinated with M-M-R II (lot number J011332, expiration date: 13-SEP-2015, dose and route were not reported. No adverse reactions were observed or reported. This is one of several reports received from the same reporter. Additional information is not expected.
Pt. was crying and blotchy all over body. Administered 3ml children's BENADRYL. Lasting seconds, then disappearing.
Patient received Moderna vaccine on 4/7/21 and on 4/19/21 woke up to facial paralysis and left facial drooping.
6 pm chills 10 pm tired, needed to sleep 2 am awoke with extreme headache, nausea, fever, chills.  lasting 2 hours, husband wanted to call 911,  thought I was going to die,  was able to take 2 Advil then sleep in 30 minutes,   slept till 11 am
Day of vaccine itching and redness where bandaid was applied. One week after vaccine swelling and sadness and itching around site. Approximately 4" x 4" circular swelling noted. Tenderness and warmth around swelling. Benadryl and ibuprofen taken before bed and some swelling decreased, however the swelling and warmth slightly descended down arm.  and area not as large but some redness still noted. Ice applied and not much help provided.
pt recv vax 21MAY96 & 21MAY96 evening exp urticaria & a fever;21MAY96 the urticaria was described as one big mass of red raised skin covering body w/some individual hives;cheek red & puffy, lips & hands were swollen;knuckles on hand bluish
dizziness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient's wife).  A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 16Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Feb2021, the patient experienced dizziness and has been lying in bed. The reporter stated that she was calling for her husband. He received the vaccine Tuesday 16Feb2021 and was experiencing dizziness and has been lying in bed. The reporter enquired, how long are these symptoms supposed to last. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.