chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy can't stand up.  Nausea from room spinning.  11/25/09 Hospital records service dates 11/20/09 to 11/25/09. Assessment: Ataxia/dysmetria, demyelinating disease. Transferred from another facility, with a history of dizziness and tremulousness. Admitted for possible MS vs Wilsons disease vs reaction to H1N1 vaccine. Photophobia, tremors worse with movement, gait instability, ataxia. Intention tremor/dysmetria upper extremity. IVIG administered.  12/01/09 Additional lab records received service dates 11/20/09 to 11/25/09.  12/11/2009 Hospital records, transfer summary received, service dates 11/13/09 to 11/20/09. Assessment: MRI White matter lesions of unknown etiology. Patient presented with ataxia and dizziness. Weak in lower extremities. Nausea. Lethargic. Unable to walk. Tremor. Transferred to another facility per family request.  12/17/09 Rehab D/C summary for 11/26-12/14/09 received. FINAL DX: cerebellar ataxia Pt admitted to rehab w/comorbidities of cerebellitis, vertigo, nystagmus, nausea & hepatitis B.  Slow & steady improvement.  D/C to home w/walker & continued PT/OT.  12/22/09 Received PCP office note & vaccine record of 11/4/09.  Pt had dry cough x 2 wks which had resolved.  Exam revealed allergic rhinitis, cough & nasal congestion.  Tx w/meds
Patient was administered Adacel on 16-Feb-2021 that expired on 13-Feb-2021 with no adverse event; Initial information was received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from an other health professional (nurse) via call centre in the United states.  This case involved patient (with unknown demographics) who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number: C5566AA] via unknown route at an unknown administration site for prophylactic vaccination on 16-Feb-2021 that expired on 13-Feb-2021 (expired product administered). (Latency: at the same time of vaccination)  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error due to expired vaccine used.   It was reported that, the reporter questioned about required re-vaccination.  After outbound call on 18-Feb-2021, the nurse stated that she already spoke with someone and they sent her the information about expired doses also reporter verbally reviewed the information from the Expired product Sanofi Pasteur and had no further question at the time of reporting.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
STROKE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered, start therapy date were not reported 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 an unspecified date, the patient experienced stroke. It was reported that ""I got vaccinated and still lost my job due to the stroke the vaccine caused me to have. Would have much rather lost it from not getting vaccinated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220624066-Covid-19 vaccine ad26.cov2.s-Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
She had no history of anaphylaxis from any cause, she had no history of reactions to vaccines or components.  After about 5 minutes I checked on her and she said she was feeling very dizzy.  I called management for assistance and got her ice packs for neck and forehead. I took her blood pressure and it was 150/90, HR 73. We laid her down and elevated her legs.  She said that she felt some pressure in her chest but she had pulled a muscle there the day before and wasn't sure if it was related.  She said the room was spinning as she continued to lay on the ground and it was not improving.  Her blood pressure was taken about 5 minutes later and it was 143/85 HR 73.  She said it is usually low.   She had no signs of local reaction, hives, or swelling.  She complained of nausea.  After a few more minutes she said she was not feeling any better and was having pain in her throat and difficulty breathing.  I asked her to try to take a deep breath and she was gasping for air, unable to breathe deeply.  I administered epinephrine (one dose) and called 911.  I rechecked blood pressure while waiting for paramedics and it was 125/80.  She was taken to hospital when they arrived.  Her mom arrived shortly before the ambulance and went with her.  Pt never lost consciousness.  Management followed up with patient this evening and patient is home and well, but the ER did classify the event as an allergic reaction.
the morning p/3rd dose had onset of stiff neck & generalized myalgia; had a flaccid paralysis of the lt arm & leg which persisted 36 hrs but was not seen by a MD; saw MD on day 3 w/rash suggestive of erythema nodosum & inflammed pharynx; ra
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 at 14:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's hypothyroidism" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: Initial Covid positive test 28Jun; (05Jul2022) Negative, notes: testing negative Tuesday 05Jul; (11Jul2022) Positive, notes: tested positive for Covid 11Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Initial Covid positive test 28Jun. Prescribed and began Paxlovid 29Jun. Paxlovid rebound occurred after testing negative Tuesday 05Jul (completed medication on Sunday 03Jul). Developed symptoms again Sunday 10Jul and tested positive for Covid 11Jul. Other medication in 2weeks product: Levoxyl, other medication in 2weeks start date: 20Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
welts on her back; vaccination site burning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts on her back) and VACCINATION SITE PAIN (vaccination site burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (welts on her back) and VACCINATION SITE PAIN (vaccination site burning). At the time of the report, URTICARIA (welts on her back) and VACCINATION SITE PAIN (vaccination site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Patient received Pfizer Covid-19 Booster and fainted.  She  fell off bench and I immediately came to her assistance.  Patient was alert and responsive.
Initially 102 degrees fever that lasted from 1/18/2021 5:00pm to 1/20/21 9:00pm.  On 1/19/2021, pain on left arm that over time went up to my shoulder to neck and now down to right arm.  Currently neck and right arm hurt more than injected arm.  Pain feels muscular and nerve like (similar to when I had shingles).  Pain is not relieved by Lidocaine 1% patch or with Ibuprofen or Tylenol.  I am not sleeping and am in pain all day.
sweating and limp, Still responsive but slow. Treated her with cool packs and laying her down. BP 60/48 HR 38 SpO2 99% at first. After 30 mins BP 90/48, HR 40 - which is normal for her. SpO2 99%. Gave her 2 chewable diphenhydramine.  Was able to stand on her own with out any dizziness or feeling light headed. Both parents here when she was dismissed to their care.
Projectile vomiting 2-3 times per day for 7 days, no vomiting on day 8, 3 times on day 9 - began Zantac on day 9, ended Zantac on day 10, began Pepcid on day 11. Excessively loose stool. Severe diaper rash from loose stool requiring prescription diaper ointment.
Starting on 12/11/17 paralysis developed paralysis of left facial nerve, diagnosed with Bell's palsy. He continued to have symptoms including facial droop, unable to close left eye, severe pain and diminished/altered taste. He was treated with MEDROL dose pack x 5 days with improvement but 2 days following completion of the dose pack, symptoms worsened and he was prescribed prednisone daily again x 5 more days. He also used eye drops and eye covering. Was seen by ENT also on 12/28/2017.
She is in such pain that she cannot use her arm; Knot in arm; A spontaneous report was received from a consumer concerning his wife, a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a knot in her arm, and such pain that she couldn't use her arm.  The patient's medical history was not provided. Concomitant product use was not provided.  On 27 Jan 2021, the patient received her dose of mRNA-1273 (Lot number unknown) in the right arm for prophylaxis of COVID-19 infection.   On 31 Jan 2021 she had a knot in her arm.  She was in such pain that she couldn't use her arm.  Treatments of these events included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown.; Reporter's Comments: This case concerns a 77 year old female patient who received her dose of mRNA-1273 (Lot number unknown) in the right arm for prophylaxis of COVID-19 infection  and experienced a non-serious listed event of "knot in her arm" and non-serious unlisted event of  "such pain that she couldn't use her arm". Treatment included Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are possibly related to the vaccine.
Pt received vaccination and had left facility and was driving away from the center when she developed red skin, was pale, huge pupils, and throat felt thick and full. She stated she was "about to pass out". Returned to center and was further evaluated. At 1832 BP 124/71, HR 98, 99% on Room Air; 1826 104/72, 112, 99% on RA. At 1828 she received 50 mg Benadryl in her Left Arm via IM injection. At 1838 131/79, HR 92, 100% on RA. Pt stated she felt better and was wheeled out of the facility at 1850 accompanied by significant other. Pt was advised to get rest and monitor symptoms.
SHARP CHEST PAIN; COULD NOT CATCH BREATH (HARD TIME TAKING A DEEP BREATH); EXTREME BACK PAIN; BAD CHILLS THAT WONT GO AWAY (FEELING OF FREEZING COLD); FEVER; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced sharp chest pain. On 20-AUG-2021, the patient experienced could not catch breath (hard time taking a deep breath). On 20-AUG-2021, the patient experienced extreme back pain. On 20-AUG-2021, the patient experienced bad chills that wont go away (feeling of freezing cold). On 20-AUG-2021, the patient experienced fever. On 20-AUG-2021, the patient experienced headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not catch breath (hard time taking a deep breath), extreme back pain, bad chills that wont go away (feeling of freezing cold), fever, and headache on 21-AUG-2021, and had not recovered from sharp chest pain. This report was non-serious.
I had to take a test to fly home after a cruise. I could have had tiredness in the two days beforehand but I had also been on vacation and that made sense. The night before I was tested I did have a cough that kept me up that night but that is normal for me. My spouse also tested positive as well. We had to stay on the ship for ten days and the cough got worse. I having body aches, I was very very tired and slept almost all day for a few days. I was having a runny nose and post nasal drip, the cough calmed down and was not as persistent. We were released to fly home after the ten days and were able to travel home. Since being home I have been tired but also had flown for 17 hours internationally and it was a long flight and that made sense. At this point I am only having a cough and it is much less frequent. On the ship I had been given NYQUIL nighttime to sleep by the medical staff and I also used ibuprofen as well.
Soreness at injection site, not much worse than flu shot. Lymph node in under arm area swollen and very sore. Soreness goes down in to elbow.
The patient received her H1N1 vaccine at her place of work on October 16, 2009. On 11/3/2009 she died at home. The cause of death is unknown. The autopsy results were unremarkable. Labs and frozen sections are pending. She is alleged to have had a seizure disorder and neurologic records are being subpoenaed by the Coroner.
On Friday, December 3, 3-4 minutes after receiving the booster shot, I lost consciousness for a few seconds. I was sitting, slumped to my left, and my head shook. A bystander described it as a ?mini seizure.? Paramedics came and took my pulse-60 BP-70/40, sugar-130. My vision was blurry, skin was clammy and sweaty. I drank cool water and gradually felt better. 30 minutes later I was fine. My pediatric anesthesiologist wife believes that it was a vasovagal reaction. I have an appointment with my primary care doctor on Wednesday 12/8 at 9:20am eastern time to follow up.
Limp and pale approximately 10 minutes after vaccines.  Throughout the following 9 hours he awakened intermittently and stared, was passive/not very active.  Regained normal activity and behavior after almost 9 hours.  Mom said he had fever also.
Pt received IPV, DTaP, MMR and Prevnar in late AM. Mom called at 4:00 PM stating pt with urticarial rash to trunk and LE (blanches to touch). Benadryl 25mg IM given to pt once pt returned to clinic 4:30 PM. No respiratory distress, itchy. Hives disappearing.
This is a spontaneous report from a contactable consumer reporting for herself. This 74-year-old female consumer received PREVNAR 13 on 26Jan2016 at single dose for immunisation. Medical history and concomitant medications were not provided. She stated she did not have diabetes. After vaccination, since an unspecified date, she had been experiencing fatigue, muscle pain, joint pain, decreased appetite, tenderness in injection site and it itched and there was a lump there. On an unspecified date in 2017 her blood glucose came back very high and was labeled off the charts. She stated she felt like this vaccine was ruining her health. Events outcome was not provided.
Sore throat; Mild congestion; Mild fever; Headache; Mild flu like symptoms for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms for 48 hours), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Mild congestion), PYREXIA (Mild fever) and HEADACHE (Headache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms for 48 hours). On 24-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Mild congestion), PYREXIA (Mild fever) and HEADACHE (Headache). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Sleep disorder, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu like symptoms for 48 hours), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Mild congestion), PYREXIA (Mild fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable
Pt has Induration, erythema, warmth, and pain on the same arm where she received the anthrax immunization. Pt has limited range of range of motion. The area of erythema has gotten larger over 48 hours.
No adverse effect reported.; a patient was inadvertently administered a dose ofMMRll via the intramuscular route; Information has been received from a pharmacist, referring to a 25 years old patient of unknown gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.     On 29-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (a dose, lot number R031629, expiration date 01-NOV-2020) Albumin status rHA (recombinant Human albumin)  via the intramuscular route for prophylaxis (Incorrect route of product administration). No adverse effect was reported.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Patient provided us a different name, which did not come up in database.  Having no record of any covid vaccination, we provided him the requested vaccine.  A worker of the housing came to us approximately 10 minutes after the injection and told one staff member his last name according to their records.  When we pulled up the database record for that name, we found he had one moderna dose administered.
Fever of 102.4 to 99.5,  all over body aches, mild headache, nausea and physical exhaustion for roughly 3 days.
Head Infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Head Infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Head Infection). At the time of the report, INFECTION (Head Infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided
Chills, diarrhea,  lower back pain,  upset stomach--all continuing today!  21 days since the vaccine!
redness & mild itching w/inc temp @ the site of Td inj; 10x12cm;
Began vomiting about 2 hours after administration of vaccine. Vomited 6 times, later had small amount of diarrhea. No fevers. Treated with Zofran 4mg ODT. Note: Patient's mother and sister developed same symptoms within 12 hours of vaccine administration to this patient only.
The right leg has elevated erythema, induration, heat, pain, and some surrounding urticaria.
Pt states pain in left shoulder and back began next day after injection and lasted 1 1/2 - 2 weeks. Now she states approximately 1 week ago she noticed a dark spot (4 3/4" down from shoulder, 2mm x 2mm) with a lump (7mm x 4mm) underneath at site of injection. Pt appears to be extremely tender at this site. She was refered to health department on 02/02/2000. She also states parestheisa is noted at and around site.
Ran a fever afterwards and feeling achy all over headache and went to the bathroom at 2 am to be sick and passed out.