chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having symptoms and one of the symptom is trophic lateral sclerosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "Having symptoms and one of the symptom is trophic lateral sclerosis". Clinical information reported that on reporter was calling on behalf of her cousin (consumer), who took the Vaccine in Aug that was Pfizer COVID-19 Vaccine and since then she (further not clarified) was having symptoms and one of the symptom was trophic lateral sclerosis (event captured as per verbatim), number and number of COVID-19 Vaccine was unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
she started losing her taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (she started losing her taste) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AGEUSIA (she started losing her taste). At the time of the report, AGEUSIA (she started losing her taste) outcome was unknown. Not Provided          No concomitant medication reported. No treatment information reported. A week after the second dose patient started losing her taste. Patient  wanted to know it is on and off  if this was normal.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: FU attempt made, consent declined by patient
INSOMNIA W SLEEP APNEA 3/27/2023 DIZZINESS AND GIDDINESS
headache for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache for 3 weeks) in a male 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 HEADACHE (headache for 3 weeks). At the time of the report, HEADACHE (headache for 3 weeks) outcome was unknown. US      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No new information received.
Pt was hospitalized with COVID-19 Pneumonia. Admitted on the 25th of January and treated with Remdesivir. Discharged to home on February 1st.
Adverse Event: patient came in on 01/03/2023 for a routine clinic visit and it was called to the medical assistant that patient was due for a booster dose vaccine which was already given during 10/14/2022 office visit. Which was documented into patients chart erroneously.
8 days after shot, a raised and itchy circle, appeared under shot site on my left upper arm. I checked internet and believe it is what is being allied Covid Arm.  I have applied a topical inti-itch lotion made by Aveeno.
Pt woke up this am with redness to inj. site, warm to touch and states that area is tender.
left side of my face got numb; injection site arm developed a rsh; arm was flaming red from shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (left side of my face got numb), VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (It was in that same arm.) in 2017. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PARAESTHESIA (left side of my face got numb), VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (left side of my face got numb) had not resolved and VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medications include an ANTIBIOTIC, and a ANTIHISTAMINE prescribed by the doctor.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Updated outcome of event left side of my face got numb. Consent to FU denied.
Patient with history of atrial fibrillation, oxygen-dependent COPD, ESRD.   Patient brought to the ED by EMS on 11/11 for shortness of breath for the past two days. He uses O2 at baseline, but was at 45% upon EMS arrival. EMS placed the patient on 15L via rebreather mask, sating him to 93%. In the ED, patient also reported fever, chills, myalgias, and cough, and notes he tested positive for COVID on 11/9. Patient was also tested for COVID in the ED on 11/11 and was positive.  Ultimately patient admitted 11/11/2022 - 11/14/2022 for acute on chronic hypoxic respiratory failure from COVID-19 pneumonia and possible superimposed bacterial pneumonia, as well as fluid overload from missing HD. He initially required BiPAP and eventually weaned down to 3 liters (baseline).  Patient has received the COVID primary vaccine series and one booster.
Onset of severe arm pain prohibiting movement within 2 hours. Next AM, when awoke had 5cm area of redness down arm from injection site. Redness lasted 4 days. Headache and fatigue starting 8-9/17. Lasting 1 week.
On 11/19/14 pt was administered the flu shot. Patient informed me on 1/13/15 that her arm was still sore when she moved it. I recommended she see her MD.
Patient was into the clinic yesterday for his first COVID vaccine.  Patient had no contraindications for the vaccine.  Vaccine was administered to right deltoid.  Patient then was asked to sit in the waiting room for 15 minutes for observation.  Patient was sitting in waiting room and developed shortness of breath and dizziness.  Patient vitals signed were obtained blood pressure was elevated 150s/100, heart rate 120s, oxygen level upper 90's on room air.  Patient was brought to an exam room where he could lay down via wheelchair.  Multiple vital signs were taken during the duration of his time at the clinic.  Blood pressure did come down to 140s/90s, sats remained in  upper 90s, heart rate came down to 70-80.  Patient remained dizzy the entire time.  Patient states that he has a history of idiopathic angioedema as well as a heart stent.  Patient goes on the explain that at different times he can have swelling internally.  He has had this happen several times in the past to his abdomen, saliva glands, tongue, as well as extremities.  Patient and his wife called his primary care physician and MD advised if episode did not resolve to go to the ER.  After waiting in the clinic for around 45 minutes the patients wife decided it would be best to go to the ER.  EMS was notified. Ambulance responded.  Patient was transported via ambulance to ER.    Patient wife was called the afternoon of the incident.  She states that patient was admitted to the hospital for observation.  He was treated with Benadryl, Pepcid, Decadron; CT of head was normal; blood pressure was still elevated; and they were not sure what was the cause of the episode.  I called the patient's wife on 1-29-21 to check on patient again.  His wife stated that he was been discharged home.  They were unsure what caused the episode and to follow up with primary physician in one week.  She states that at one week follow up visit they would discuss the need/desire for second COVID vaccine.  .
Ten days after the vaccine I noticed that my arm was aching. I had a big red circle coming up around the site of the shot. It was very hot to the touch. It started at the top of the injection site and went most of the way down to my elbow. My upper arm was still swollen. It was a little itchy. I took some Benadryl. It lasted for eight days but went down slowly until that time. I had the second dose and got it in the other arm and had no swelling or redness.
On 08/05/2022, started to feel sick and tested positive for COVID-19 with a home test; talked to my Doctor and because of my health issues, I wasn't prescribed anything, but told to take a decongestent, Vitamin C and zinc and rest; I became disoriented on 8/20/2022 and taken to Hospital where they discovered that I had Guillain-Barré syndrome (GBS); On 08/25/2022,   right foot was severly effected by this and the front part of the foot near the toes had to be amputated; After surgery, started to have slight paralysis and was in the ICU for a week; Transferred from hospital to Medical Center; Became almost fully paralyzed for 72 hours; The only places I wasn't paralyzed was in my head, throat and chest area's;  Stayed in that hospital for over a month, then was transferred to Hospital; Was there for 3 weeks, receiving Speech Therapy, Physical and Occupational Therapy; Still partially paralyzed but was able to come home and goes to an Outpatient Clinic for Rehabilitation three days a week;
20 minutes after vaccine administration, eyes began to ear and face began to flush - BP 138/80, P 88.
Patient said the injection itself was excruciating.    She had swelling about the size of a softball with redness and fever around the injection site.  Patient also stated that she pain all over and was in bed for over 48 hours.  This was the patient's second shot in the series and she stated that it was much worse than the reaction to the first shot.
On 4/3/2021, I awoke to most of my upper left arm swollen tight, hot, itchy, and red. My right arm reacted to the first injection after many days...this is much worse. I went by urgent care and Dr advised Benadryl, topical Cortisone cream, and ice. Yesterday, I had fever and chills. 1st shot, I felt much worse. 2nd shot, reaction at injection site noticeably worse.
Information has been received from a licensed practical nurse concerning a 6 month old male with a history of respiratory syncytial virus infection and no drug allergies, who on 23-FEB-2007, 27-APR-2007 and 29-JUN-2007 at 13:50 was vaccinated with the first, second and third (Lot# 655317/0980F) 2ml oral does of Rotateq. There was no illness at the time of vaccination. Concomitant therapy included PEDIARIX. On 01-JUL-2007 the patient experienced mild vomiting and diarrhea. Unspecified medical attention was sought. No labs or diagnostic studies were performed. No treatment was required. Subsequently on 02-JUL-2007, the patient recovered. There was no product quality complaint. Additional information has been requested.
Suspected vaccination failure; got shingles a couple months later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a couple months later). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-SEP-2023 The case was received from the consumer interactive digital media. The reporter stated that two people (patient) in the neighborhood got the shingles vaccine and they were also the only two people in the neighborhood who got shingles a couple months later. The reporter stated that people were starting to wake up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR128156, reported by same reporter.
On 9/11/21 I started to experience chest pain at approximately 2330 hours thinking it may be heartburn. At approximately 0030 hours I took 4 Rolaids and nothing changed. At 0100 hours I took one Pepcid Complete and the pain did not go away. At approximately 0215 hours the pain was increasing and I have never felt this type of chest pain before. I went to hospital ER and an EKG, chest x-ray, and two blood tests were completed several hours apart. I was given morphine for pain and Zofran. I was told that everything checked out alright and I should follow up with my doctor.   Throughout the day on 9/12/21, the pain started to come back and I took 12 ibuprofen and 4  acetaminophen due to the pain throughout the day. During the early morning hours on 9/13/21, the pain was just as severe, if not worse, as it was the night of 9/11/21. I then went to hospital. An EKG, chest x-ray, and blood tests were completed.  The ER doctor diagnosed me with pericarditis. I was prescribed anti-inflammatory and pain narcotics.   I followed up with my primary doctor on 9/14/21 and he confirmed that I had pericarditis and that it was a result of the Pfizer covid-19 vaccine (first dose).
Day 1 - muscle soreness within 2 to 3 hours after injection; pain became bad enough at night to impact my sleep Day 2 - significant muscle soreness and weakness remains, plus having chills, lethargy Day 3 - chills and lethargy gone, but significant muscle soreness and weakness remain Day 4 - significant muscle soreness and weakness remain - I've never had this continue for so long after a flu shot. Is this considered adverse? How much longer should this pain and weakness continue? Even typing  or driving a car hurts like crazy.
First & 2nd Hep A local erythema induration (-)   (-) drainage.
Sensation of chills and shivering began approximately 15 hours after injection.  Symptoms worsened and broadened to include generalized body aches, headaches, loss of appetite, and overall listlessness which persisted for approximately 30 hours but were ameliorated with Tylenol.  Reddened area appeared on left upper arm, approximately 10cm long by 8cm wide and separate from the site of injection.  The closest point of the reddened area to the site of injection was separated from it by approximately 2cm.  The reddened area was neither painful nor manifested itching.  Gradual reduction in redness and swelling noted as time progressed, but is still visible five days post-injection.
pt seen 11JUL93 for laceration given tetanus shot;pt returned 15JUL93 @ which time 4cm round raised area noted lt deltoid; pt given Claritin; pt sx resolved;
Within one minute after the vaccine was administered I felt unable to breathe and was very light headed. I took 25 mg. of Bendryl which helped with the breathing. I felt very faint and experienced episodes of high blood pressure which lead to  uncontrollable shaking. I broke out in hives accross my arms and chest.  I laid with my feet elevated for one hour at which time symptoms subsided and I was able to leave the pharmacy. I had no further allergy type symptoms after leaving the site.
Redness & swelling at site of injection with a pimple-like raised area at the actual injection site.
Patient was to receive Hepatitis B vaccine.  In error, the patient received a 4th dose of HPV instead of Hep B
I had 3 serial injections of rabies vaccine: on 7/16/13, 7/23/13, and 8/13/13. All were into left upper arm. The first two were uneventful. The third injection felt different- with the sensation that it was "spreading out" during the injection. I also noted that the bandaid over the sight was a bit higher and more anterior than usual. Beginning after the injection and over the next several days, instead of getting the usual deltoid tenderness, I had increasing pain over the anterior shoulder, and with abduction, anterior flexion, arc. Over the 2 weeks since the injection the pain has been increasing, and range-of-motion of my Left shoulder is decreasing. I was evaluated by orthopedic shoulder specialist's office. They think that the 8/13/13 vaccine injection probably went into my subacromial space, and is causing intense inflammation of my rotator cuff. Please note: I do not currently have information re brand/manufacturer. The clinic will have this.
Fatigue; Joint Pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ARTHRALGIA (Joint Pain) and PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Joint Pain) and PYREXIA (Fever). At the time of the report, FATIGUE (Fatigue), ARTHRALGIA (Joint Pain) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Interchange of Vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6200) and on 26Mar2021 as dose 2, single (Lot number: ER2613), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), on 28Sep2021 as dose 3 (booster), single (Lot number: SO1358A), in left arm, on 16Sep2022 as dose 5 (booster), single (Lot number: AS7147B), in left arm and on 10Jul2023 as dose 6 (booster), single (Lot number: AS718SB), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 027L21A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of covid-19, drug ineffective, patient took Paxlovid from 10Sep2023 to 14Sep2023. Clinical course was reported as follows: patient had four negative Covid-19 at home tests starting 15Sep2023 through 22Sep2023.
Sick stomach; Cramps; Diarrhea; Chills with a possible high temperature; Chills with a possible high temperature; Neck pain; This spontaneous case from the was received on 24-Oct-2020 from other non-health professional via The Agency (reference number: SEQW20-04206) and concerned a 73-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks.  On 22-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 23-Oct-2020, one day after receiving Fluad Quadrivalent, the patient developed neck pain.  On 24-Oct-2020, two days after receiving Fluad Quadrivalent, the patient experienced sick stomach, chills with a possible high temperature (not checked), cramps and diarrhoea.   At the time of initial reporting on 24-Oct-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  This case is linked to the case 202005446 (same patient).  Company comment: A 73-year-old female patient was administered Fluad Quadrivalent vaccine. One day after receiving vaccine, the patient developed neck pain. Two days after receiving Fluad Quadrivalent, the patient experienced abdominal discomfort, chills, pyrexia, muscle spasms and diarrhoea. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks. With information available, causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: A 73-year-old female patient was administered Fluad Quadrivalent vaccine. One day after receiving vaccine, the patient developed neck pain. Two days after receiving Fluad Quadrivalent, the patient experienced abdominal discomfort, chills, pyrexia, muscle spasms and diarrhoea. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks. With information available, causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.
Injection site became red, mildly swollen and mildly itchy. No dizziness, no shortness of breath, no nausea no vomiting. Skin intact, no pealing no rash. Reported mild pain at site of injection. No other body system involvement. The symptom started within a day of the injection and peaked the evening of 7/22/23 (about 30 hours after injection). The symptoms have reportedly improved 7/24/23 but are still present.   Patient has followup appt on 7/27/23
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Red rash about 2-3 inches in diameter at the injection site. Itchy and swollen. Appeared after a week and seems to be this
Covid arm.  Skin rash And hard area Surrounding injection site, red  skin, warm to touch, itchy And mildly sore to touch. Circumference was about 4 inches.  Symptoms resolved In 60 hours.
PATIENT RECEIVED VACCINE AT 10:30AM AND WITHIN 5 TO 10 MINS HE BECAME FLUSHED AND NAUSEATED AND BEGAN TO SWEAT.  PHARMACY CALLED 911 AND IN THE TIME BETWEEN CALL AND ARRIVAL OF EMS, THE PT BEGAN TO RETURN TO NORMAL. HE WAS CHECKED OUT BY FIRE DEPT AND DECLINED GOING TO HOSPITAL. PHARMACIST CALLED PATIENT AT 1:00PM AND HE STATED HE WAS DOING FINE.