chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe asthma" (unspecified if ongoing), notes: Other medical history: severe asthma, hypertension, PVC heart issues; "Hypertension" (unspecified if ongoing), notes: Other medical history: severe asthma, hypertension, PVC heart issues; "PVC heart issues" (unspecified if ongoing), notes: Other medical history: severe asthma, hypertension, PVC heart issues; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: walnut" (unspecified if ongoing), notes: Known allergies: walnut; "Known allergies: clove" (unspecified if ongoing), notes: Known allergies: clove. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Severe increase, notes: I had severe increase in blood pressure after the 3rd dose; 150/104, notes: My blood pressure went from 150/104 an hour after the 3rd dose to 220/135 3.5 hours later; 220/135, notes: My blood pressure went from 150/104 an hour after the 3rd dose to 220/135 3.5 hours later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated for COVID-19 with Paxlovid of brand Pfizer from 05Mar2023 to 06Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
9 days post vax, the pt developed a fever of 104.5 and had a seizure. The next day developed a rash. Seen at the ER.
At a routine visit with my gynecologist for an annual exam on 12/13/2021, my blood pressure was the highest it has ever been in my life. It was 125/100 at the time of my appt. My normal blood pressure is 100/70. My doctor was concerned and took it again 30 min later, and it was still 125/100.  She told me to have it taken again later in the afternoon. Three hours later, my blood pressure was read to be 122/89. I had to make an appt with my primary care to have everything else checked out. At my appt with my PCP on 12/17/21, my blood pressure was read at 122/75. NP Butac suggested buying a blood pressure machine and to check it regularly. He also ordered a complete metabolic blood lab. Since then, my blood pressure has remained in the "hypertension - stage 1" level with my diastolic reading above 80.
pt presented today to vaccine site for her second dose and post vaccination began to have jaw pain on the left side and facial tingling. pt states she did have these symptoms with the first dose, and she took Benadryl once home and the symptoms subsided but this time was slightly worse.  Pt given 50 MG of PO Benadryl and felt better after 20 min and had a friend take her home.
expired Meningococcal was administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via Medical Information (Reference number- 00646121) and transmitted to Sanofi on 17-Jun-2021.  This case involves a patient (demographics unknown) who was administered MENINGOCOCCAL VACCINE, produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  The nurse reported that an expired Meningococcal was administered to a patient and asked what were the adverse events (AEs) that they should look out for. Nurse did not provide the name of the vaccine and before she could provide anymore information, she stated that another staff member was reporting the event to another Sanofi agent. No other information was provided.  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 the 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.  There will be no information available on the batch number for this case.
Information has been received from a pharmacist referring to a newborns(numbered 57). Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time= 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 28-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
This literature marketed report refers to a 23 years old female patient with a history of CF (delta 508 mutation), complicated by cirrhosis requiring transplant at the age of 18 followed by standard immunosuppressive therapy with steroids, MMF, and tacrolimus. Over the course of the next 3 months, she had reactivation of EBV and VZV with recurrent disseminations; work-up for PTLD was negative. All immunosuppressive were discontinued 7 months after transplant, with the exception of Prednisone, which was discontinued 2 years posttransplant. She developed an Exophiala dermatitidis pulmonary infection, anti-SS-A positive Sjogren's, and seronegative arthritis. A complete immunodeficiency evaluation was initiated. Results: She was diagnosed with humoral and cellular mediated immunodeficiences characterized by hypogammaglobulinemia, specific antibody deficiency with absent response to PNEUMOVAX, significant CD4 lymphopenia, and markedly diminished response to phytohemagglutinin, pokeweed, and Candida. Antiviral therapy was continued, PCP prophylaxis was initiated, and she was started on replacement IVIg. She had done markedly well, with decreased severity and frequency of infections and resolution of the arthritis. To date, she had no evidence of liver transplant rejection despite being off immunosuppressants. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Monovalent given as booster after CDC recommendations changed on 9/2/22. Bivalent was not yet available at the time of administration.
got infected with COVID-19 and had a very bad time, it was very serious; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (got infected with COVID-19 and had a very bad time, it was very serious) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got infected with COVID-19 and had a very bad time, it was very serious). At the time of the report, COVID-19 (got infected with COVID-19 and had a very bad time, it was very serious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.   Treatment information was not provided.
4/15/04 left arm red swollen where shot given. On  4/17/04 monitor if worsen. Start 4/14/04- 5 x 3 3/4 cm red worse warm area on left deltoid are tender to touch- Treated for local cellulitis with Augmentin for 15 days.
Severe headache started 2 weeks after the vaccine and third week shingles in v1 distribution over the forehead followed by prodromal uri symptoms. Treated with valtrex 1g tid x 10days. Rash resolved, headaches improved with Tylenol. Vague abdominal and joint pains that resolved spontaneously.
Was around someone who exposed me on a Tuesday- they came into where I was at work and was there for about 5 minutes and was close to me and we did not have on masks. That evening my boss from work contacted me that the coworker had tested positive for COVID. Three days later I tested- I did not have any symptoms between the exposure and tested positive. I had symptoms on the 25th but the only thing I experienced was when I was laying flat I could not breathe- so I had to sleep in a sitting position to be able to breath because being flat I could not breath. The next day I was mentally foggy and I worked from home. By Friday the 28th I went and got a PCR test after the home test had showed I was COVID positive. Saturday the 29th I had a virtual appointment with an ER doctor and they advised I no longer test myself and to follow the guidance and stay home.
crying over 3 hrs approx 12 hrs duration t103 R; Seen by MD no tx recvd;
Pain at injection site; Arm soreness; Nausea; Sore throat; injection given too deeply into the muscle; first dose on 2/11/2021 and 2nd dose on 08/19/2021; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 11th February 2021, refer case US2021AMR176934).   On 19th August 2021, the patient received the 2nd dose of Shingrix. On 19th August 2021, unknown after receiving Shingrix, the patient experienced wrong injection technique and drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, pain in arm, nausea and sore throat. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm, nausea and sore throat were not recovered/not resolved and the outcome of the wrong injection technique and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, nausea and sore throat to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, the patient experienced pain at the injection site, arm soreness, nausea, and sore throat after receiving second dose of Shingrix. The arm soreness began immediately after injection, nausea and sore throat began approximately 16 hours after administration. The reporter stated that, pain at time of injection, due to belief injection was given too deeply into the muscle, which led to wrong injection technique. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up. This case was linked with case US2021AMR176934, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176934:same reporter
On 01/8/2021 around 2pm I went into asab it only lasted about 6hrs on 1/9/2021 I started having nausea & it lasted only 1 day.  on 1/8/2021 went to the ER.
SLEEPINESS; FEELING LIKE FREEZING; TIREDNESS; This spontaneous report received from a patient via a company representative through social media concerned a 64 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. Patient reported that they worked a 12 hour shift and had a way of life to blame. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry not reported) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination. Patient reported to be fine and that the vaccine did not bother at all (Dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s booster (Dose number in series 2) (suspension for injection, route of administration not reported, batch number and expiry: Unknown) dose, start therapy date were not reported, 01 total was administered 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, after vaccination with booster, the patient experienced sleepiness, feeling like freezing, and tiredness (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, and feeling like freezing after over a month (dates unspecified), and had not recovered from tiredness. This report was non-serious.
Patient reported pain when needle was inserted. She reported to RPh on duty that when she got home after receiving her flu shot that her arm hurt terribly and she was having trouble moving it. Patient reported concern that she may have received the vaccine "too high up on her arm".
recurrent bowel obstructions; stage 2 colon cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received bnt162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0164) at the age of 53 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Depression/Anxiety" (ongoing); "Depression/Anxiety" (ongoing); "Hypothyroidism" (ongoing); "Restless leg syndrome" (ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism (ongoing); MIRAPEX oral taken for restless legs syndrome (ongoing); ZOLOFT oral taken for depression, anxiety (ongoing). Vaccination history included: bnt162b2 (Anatomical site of injection: Arm (deltoid), Route of administration: Intramuscular, Batch/Lot Number: FR8733), administration date: 26Mar2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: COLON CANCER STAGE II (medically significant) with onset 02Jun2021, outcome "recovered" (16Jun2021), described as "stage 2 colon cancer"; INTESTINAL OBSTRUCTION (medically significant) with onset 25Jun2021, outcome "not recovered", described as "recurrent bowel obstructions". Therapeutic measures were taken as a result of colon cancer stage ii.  Clinical information: Illness/AE: Stage 2 colon cancer, Onset Date: 02Jun2021, Stop Date: 16Jun2021, Pertinent Details: Partial colectomy 16Jun2021. no chemo or radiation. Illness/AE: Recurrent bowel obstructions, Onset Date: 25Jun2021, Stop Date: ongoing, Pertinent Details: Have had 6 obstructions since colectomy. Began after cancer surgery. Received full vaccination course and two boosters, all from Pfizer. Due to cancer history and vulnerable family members, patient hoped my vaccination would help protect her better. Dated: 26Sep2023. The product was prescribed by a healthcare professional and was taken as prescribed. Only taking ongoing maintenance meds. Specific relevant tests for thromboembolic events with thrombocytopenia were none. Pfizer/BioNTech COVID-19 Vaccine Details 3rd dose: Date: 11May2021, Anatomical Site of injection: Arm (deltoid), Route of administration: Intramuscular, Batch/Lot number: Pfizer 301308A (Booster). 4th dose: Date: 30Sep2022, Anatomical Site of injection: Arm (deltoid), Route of administration: Intramuscular, Batch/Lot number: Pfizer Bivalent GN9693. 1st and 2nd dose was at Public Health Clinic/Facility and Vaccine was not administered at Military Facility. 3rd and 4th dose was at Pharmacy or Drug Store and Vaccine not Administered at Military Facility. Booster dose due to a weakened immune system: Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas). Prior vaccinations (within 4 weeks) were none.
pt recv vax 11FEB97 & the following day pt lab test revealed elevated liver enzymes;
it looks like there is some particulate in the syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "it looks like there is some particulate in the syringe". Additional information: The pharmacist had a vaccine that was about to be given to a patient and it looks like there is some particulate in the syringe.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
The patient developed red bumps "hives" all over her body. She is treated with BENADRYL. This started after her 4th Novortis Rabies vaccines on 6/12/13. Before she receives her fourth vaccine on 6/19/13, she will be premedicated with BENADRYL and her epi-pen at home.
At 5pm on Sept 28 I felt body aches come on suddenly,  a temperature of 99.6 with Tylenol began at 7pm. Strong nausea and exhaustion with 99.6 temp continued throughout the night. The next morning I woke up to teach from home and at 5:20am I apologized to my student as my field of vision became narrow and dizziness came over me I passed out on to the floor and my husband found me and gave me water. I stayed in bed from 5:30am until 8pm. I ate two bites of a gluten free waffle at 10am and threw up at 11am and returned to bed. My temperature finally regulated at 9pm on September 29. All symptoms subsided by 10:30pm on September 29. I then began experiencing daily strong heartbeats and a warming sensation under y skin beginning September 30th. This sensation is constant and unusual. Yesterday I went with my family to the zoo and pushing my sons stroller made my heart hurt in my chest, so my husband took over pushing the stroller. I am an active mom and this is very abnormal for me. My resting heart rate is 74 tonight as I'm feeling off.
I received my booster vaccine,  and I went to sleep with a slightly sore arm. I figured if I would get it in the evening i would be able to sleep the soreness off and feel good the next day. The next morning, around the injection site it was red and itchy. Maybe 6 hours later the muscles in my left armpit was sore. This lasted up for about 3 days.
Within 24 hrs after imm pt had shakes, felt "sick", swelling/hives upper deltoid at & proximal to inj. site, had progressively increasing joint & muscle pain. Pt has been alternating acetaminophen/ibuprofen - (see chart note for tx). MOTRIN 400 mg tid, ice off/on for 2 days then heat tid, BENADRYL 25 mg tid for 4 days call if not better then. Rest. VAERS form.
Tinnitus 24/7 high pitch sounds and different frequencies.   Treatment prednisone so far not working and not getting any better.  Reluctant to get second shot not that it's being made easy to even sign up for one.  Why is the CDC not talking about this or letting the public know because people that have had very very mild tinnitus now have it 24/7 which I've been finding out and social media outlets
My daughter developed a high fever that I couldn't reduce for about 5 to 6 days.  She maintained a 103 to 104 to 105 temperature.
moderna covid 19 vaccine given to Left deltoid @1019; at 10:38, pt c/o tingling in her throat and itchiness on her back; no rash found; with her extensive allergy history, administered oral benadryl 50 mg. Patient verbalized improvement in 5-10 minutes from administration of Benadryl. Vs stable and pt was discharged to home with instruction of fluid hydration/rest. If any allergy reaction with throat swelling/difficulty breathing, directed to ER.
Cellulitis (R) thigh 10 X 8 cm. AUGMENTIN 600/5 one tsp PO BID X 1 week.
Tinnitus, continuous in left ear and sporadic in right ear. First noticed June 12, 2021, though it might have been present earlier. Hasn't let up as of this report, March 30, 2022.
Patient describes initial reaction within 4 hrs of receiving vaccine as "palm-sized" area that was red, warm to touch, and firm. On Urgent care date of service, patient presented with spot nearer to elbow which was red, warm to touch, and firm. She denied pain at that time. Today patient describes size of reaction site as "less than 2 fingers" width. She states that there is still warmth, but it is "less than before." Patient states that there is a reduction in firmness. Denies Pain today.  Denies SOB, wheezing; difficulty swallowing; Fever, chills, or other S/Sx of anaphylaxis. Patient is currently taking CLARITIN per PA at Urgent Care. Was icing 20 min on 1-2 hrs off, denies need to ice today.
Allergic reaction - itchy rash appeared the same day of receiving vaccination; lasted for a week. A black spot started to appear on the left side of the lip area. After receiving 2nd dose (10/26/21) allergic reaction happened again. Itching/tingling feeling in the face area.
Started having throat irritation at 15 min obs mark. Transferred to ACC where she then began to c/o chest pain.  Presenting symptoms comment:  Fell some scratchy throat with funny taste after COVID vaccine Severity:  Mild Duration: Just prior to arrival. Prior episodes: Similar episodes when she gets a flu vaccine. Context: medications   Relieved by:  None tried Worsened by:  Nothing
Vaccination site bump; Vaccination site Itching; Swelling at vaccination site; vaccination site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Vaccination site bump), VACCINATION SITE PRURITUS (Vaccination site Itching), VACCINATION SITE SWELLING (Swelling at vaccination site) and VACCINATION SITE PAIN (vaccination site soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006d21a) for COVID-19 vaccination.     Concomitant products included OLANZAPINE for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE MASS (Vaccination site bump), VACCINATION SITE PRURITUS (Vaccination site Itching), VACCINATION SITE SWELLING (Swelling at vaccination site) and VACCINATION SITE PAIN (vaccination site soreness). At the time of the report, VACCINATION SITE MASS (Vaccination site bump), VACCINATION SITE PRURITUS (Vaccination site Itching), VACCINATION SITE SWELLING (Swelling at vaccination site) and VACCINATION SITE PAIN (vaccination site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.