chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling of fever; Diarrhea; headache like pulling pain on the left side behind the ear; headache like pulling pain on the left side behind the ear; feeling of weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: 30130BA) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination= Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "feeling of fever"; DIARRHOEA (non-serious) with onset Sep2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious), EAR PAIN (non-serious) all with onset Sep2021, outcome "unknown" and all described as "headache like pulling pain on the left side behind the ear"; ASTHENIA (non-serious) with onset Sep2021, outcome "unknown", described as "feeling of weakness". Therapeutic measures were not taken as a result of pyrexia, diarrhoea, headache, ear pain, asthenia.  Additional information: Drug administration time 06:00 PM, adverse event start time: 06:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
The vaccination hurt going into my left arm and within a few hours my arm became extremely painful. Pain and soreness have continued in my arm, impacting my ability to normally use my arm. This has continued for 2 weeks and is not yet resolved.  I have self treated with cold packs, heat, arnica topical and pellets, and rest. Currently (two weeks post-vaccination) the pain is less, though my arm continues to be sore to the point where I cannot function in a normal way.
Miscarriage at 10w 6 days. I have had three healthy and normal pregnancies previously.
large hive at injection site; scattered hives/smaller hives scattered; tightness in throat; thick feeling tongue; bubbled ulcer looking site on his lower left deltoid; left arm soreness; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176), intramuscular on 08Jan2021 at a single dose on the left arm for COVID-19 immunization in the hospital.  Medical history included allergies to penicillin (PCN), sulfa and latex. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient had other vaccines in four weeks. The patient has other medications (unspecified) in two weeks. The patient previously took erythromycin (ERY) on an unspecified date and experienced allergies. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: LEK5230) on 18Dec2020 at 08:00 AM via intramuscular route of administration on the right arm at a single dose for COVID-19 immunization and experienced hives, itching and itchy feeling tongue wherein the patient took Benadryl, 20 mg Pepcid and 10 mg of Zyrtec. After the second vaccine the patient experienced scattered hives, with large hive at injection site and smaller hives scattered on an unspecified date in Jan2021. The patient also had tightness in throat and thick feeling tongue also on unspecified dates in Jan2021. The patient took 50 mg Benadryl, 20 mg Pepcid, 10 mg of Zyrtec and albuterol inhaler with spacer four puffs. The patient also has a bubbled ulcer looking site on his lower left deltoid with left arm soreness eight days later both on an unspecified date in Jan2021. The outcome of the events bubbled ulcer looking site on his lower left deltoid and left arm soreness was unknown while the outcome of the other events was recovering. The patient has not been tested for COVID-19 post vaccination.
Slight fever UNDER 101 degrees F, a lot of body aches, nasal drip, slight sore throat, upset stomach for a couple of hours, runny nose, headaches, very tired.  These symptoms were present for about 3 to 4 days then they began to go away.
Blood count dropped to 7 or 8; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD COUNT ABNORMAL (Blood count dropped to 7 or 8) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 12-Feb-2021. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced BLOOD COUNT ABNORMAL (Blood count dropped to 7 or 8). The patient was treated with Transplant (blood transfusion) for Blood count abnormal. At the time of the report, BLOOD COUNT ABNORMAL (Blood count dropped to 7 or 8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: decrease (Low) dropped to 7 or 8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified  inhaler and stomach medications.  Treatment information was not reported.
My symptoms began in February, mild on day 0. I spoke to the doctor day 0. I started PAXLOVID on day 1. Low grade fever, chills, congestion were the main symptoms. I began to improve after a few days. I also had a tight chest, diarrhea and weakness. Two days after PAXLOVID and tested negative. Then a few days later I rebounded with the same symptoms that now included headache and tested positive. I also lost my sense of smell during the rebound as well as my appetite. This lasted another 9 days. I saw the doctor this time at this time on March 13, 2023. At this time I had chest X--Ray and an EKG. I was prescribed an inhaler ADVAIR.
Nausea; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N).    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided
Vaccines given 11/21/2013, started with sore arm, neck pain, nausea, chills and chest felt heavy. Seen in office 11/22/13.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021, 3/02/2021 and 9/13/2021. Covid+ 12/27/22 rec'd monoclonal antibody infusion 12/27 w/improvement until 1/1/22. Presented to ED 1/4/22 c/o SOB. Admitted for Afib with RVR, Covid and atypical presentation of sepsis. Treated w/steroids, remidisivir, baricitnib, vancomycin and zosyn. Repiratory status continued to decline to acute hypoxemic respiratory failure complicated by metabolic issues in the setting of immuncomprised state and renal failure. DNR status, obtunded and encephalopathic. Expired 1/24/22.
Injection received at 10/18/06 09:45 with no problems. 3 hours after vaccine suddenly developed large swelling, itching and redness at injection site.
Experienced swelling in lymph node of acute left arm pit in pervious IM injections. Bivalent injection has created swelling and throbbing pain of left armpit but has also increased and spread to lymph nodes in left arm (upper and lower) and nearby left breast tissue.
Chills, fever, myalgias nausea vomiting 24 hours after GARDASIL vaccine after each dose #1 11-20-07 #2 1-23-08
Expiration date in system was 5/31/22, but the beyond use date was 5/17/2022.
Within 24 hours of receiving Men B #1, c/o weakness, fatigue, neck rigidity. Went to ER - X-ray, CT scan, lab work completed anti-inflammatories provided with IV fluids. Discharge 8-13-16.
Decedent died one day after receiving the immunizations. He had some congestion and dry cough on that day also.  Mom gave Tylenol (reportedly correct amount) on the day of the immunization. Autopsy report received & complete.
Sore arm at injection site; A spontaneous report was received from a consumer concerning herself, a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm at injection site.   The patient's medical history was not provided. No concomitant medications were reported.   On 20 Jan 2021 8:00 am prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient experienced sore arm at injection site.  Lab details were not provided.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, sore arm at injection site was reported unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Pt reports feeling dizzy and "hot" immediately after injection. Monitoring RN applied ice pack to patient's neck when he reported feeling "like I am going to be sick".  Pt produced significant amount of clear vomit as Fire/EMT arrived. EMTs assumed care of patient, obtained vitals, and provided ongoing assessment. Pt. reported feeling better shortly after vomiting. Color returned & pt. reported "feeling much better" within a few minutes. Pt was reassessed and released from care of Fire/EMS @ 10:15AM. Pt. stayed in monitoring until 10:23 at which time he was free to go, reporting no future symptoms. Pt left POD self ambulating & stating that he left fine.
Rheumatoid arthritis flare up; Cold; Vaccination site cellulitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4241170-00.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single and intramuscular, administration date 15Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Batch/Lot number: unknown) till 2021 and second regimen oral since 2021 (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; VACCINATION SITE CELLULITIS (non-serious) with onset Aug2021, outcome "recovering", described as "Vaccination site cellulitis"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Cold". The action taken for upadacitinib was unknown. In Aug2021, the patient had second dose of Covid-19 Vaccine and for which was also off of Rinvoq during that time to accommodate the vaccine. Cellulitis appeared after the second dose of Covid-19 vaccine at injection site. The reaction she had needed antibiotics after for cellulitis. She had been having flares due to weather in new area and climate. For the ongoing flares, she recently was off of steroids and was just dealing with the pain and severe cold. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq(Upadacitinib) : The reporter's causality for the event(s) of covid second shot reaction/cellulitis at injection site, cold and rheumatoid arthritis flares with Rinvoq(Upadacitinib) was no reasonable possibility.The reporter's causality for the event(s) of covid second shot reaction/cellulitis at injection site was with bnt162b2 (BNT162B2) was possible. The reporter's assessment of the causal relationship of the events cold and rheumatoid arthritis flares with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (INTRANASAL) started on an unknown date for INFLUENZA. Nurse reported at 17 month old patient accidentally received FLUMIST. The outcome of the event of FLUMIST TO A 17 MONTH OLD INFANT is unknown. The report was considered to be non-serious.
Extreme body muscle aches. Head ache so severe I felt like I had a concussion. Felt like my brain was swelling. Couldn?t put my head on pillow because it hurt even more. Symptoms lasted 12 hours. Residual effects.: Memory loss . I have never had any memory loss previously.  I?m 2 weeks post vaccination and still having some memory loss.
Rash developed with itching. Started between shoulder blades evening of 3-6-07. Next day gradually spread to cover whole body. Difficulty sleeping 3-7-07 d/t itching. Mom gave Benadryl 3/8/07 am with no relief. Physician gave rx for Hydroxyzine 25 mg 3-4 times daily PRN.
Child seen 7/12/07 for well visit - was fine. Hep A, Menactra, Gardasil administered. Presented to the office on 7/13/07 with severe diarrhea "too numerous to count" abdominal cramps, and blood in stool. Sx started the night of 7/12/07 - admitted to hospital for IVF and evaluation. 8/27/07-records received for DOS 07/13/07-DX: Colitis.C/O diarrhea since yesterday. Associated with abdominal pain and cramps. No fever no vomiting. This afternoon had bloody stools with large volume of blood. Treated with IV fluids.
feeling really really dizzy, like she is drunk or something; feeling really really dizzy, like she is drunk or something; nausea; really dizzy: getting worse/the nausea is still the same, they have been worsening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0176) at the age of 53 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), FEELING DRUNK (non-serious) all with onset 13May2021, outcome "unknown" and all described as "feeling really really dizzy, like she is drunk or something"; NAUSEA (non-serious) with onset 13May2021, outcome "not recovered", described as "nausea"; CONDITION AGGRAVATED (non-serious) with onset 13May2021, outcome "unknown", described as "really dizzy: getting worse/the nausea is still the same, they have been worsening".  Additional information: Caller received the Pfizer COVID 19 vaccine on Tuesday afternoon and "today" was feeling really really dizzy, like she was drunk or something. She felt very very dizzy and with nausea. Noticed feeling really really dizzy "today", in the morning, at 05:00 AM. Outcome of really really dizzy: getting worse, at 05:00 AM. She did not have nausea. Now she has a lot of nausea, like if wanted to vomit. States the nausea was the same as feeling really really dizzy, they are the same. She did not have any tests, she has not been sick, she was very well.   No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of arm pain in a 37-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  The subject had no relevant medical history.  There were no concurrent medications.  The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events.  On 6 November 2007 at 7:45 a.m., the subject received unspecified dose of Fluarix (unknown, left arm).  The healthcare professional reported that the vaccine was administered into the bone which was the incorrect route of administration.  On 6 November 2007, less than one day after vaccination with Fluarix, the subject experienced arm pain.  At the time of reporting the outcome of the arm pain was unspecified.
had COVID-19; had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1 single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
very sore/painful arm at the injection site, hard bump/knot - advised patient on icing the area and taking ibuprofen as needed
S/ Patient is in with complaint of right upper arm soreness since receiving tetanus booster about two weeks ago. She denies fever, chills, nausea, chest pain or shortness of breath. She also denies injection site swelling, redness, induration or warmth to touch. She reports improvement with Ibuprofen and warm compress.
The initial response was severe pain in arm almost immediately that evening. The next day I felt lethargic and to the  point where I needed to take a power nap but then it was fine. Within 30 days of vaccine I noted some visual distortion in left eye. I was seeing clouds over entire words on close text. I thought it was unusual . I closed one eye . My last eye check with Ophthalmology had improved with age and I was just curious which eye was doing better so I closed one eye to see. I went the next day to eye Doctor and he did the same scan he did in the Fall and that day he said I had retinal vein occlusion which is an eye stroke. He immediately got me into surgeon and they did an extensive scan and there was pooling blood in the back of my eye and field of vision. Best treatment right now is eye injection and I've had 3 so far. I am still being treated. It resolves and then reverts back. The injection is Avastin.
Warm to touch, swollen and very red, itching occurred about 48 hrs after administration.
The patient received the first shot of Pfizer COVID-19 vaccine seven weeks ago. However, 10 days after getting the vaccine he got COVID. He had severe symptoms for week and a half but not to the point needed hospitalization. One week later he was clear and received a negative result. HE was clear now still have minor side effects. He did not feel comfortable getting the second dose of the vaccine at that time. He feel good enough to take the Pfizer COVID-19 vaccine but on him 49 day today. The patient asked the question would the vaccine be effective if he receive it 49 days after dose 1 and would it cause any danger to his health if he receive the vaccine this late. He went to get his vaccine, but they had some advisory at the clinic stating the vaccine could not be given later then 42 days after dose 1. The patient received first vaccine and 10 days later tested positive for Covid; symptoms afraid her because slight increased symptoms; it was dangerous, betrayed and it infected him. The patient stated, he had a very specific question to ask about the Pfizer Covid vaccine just for brief describe, he took the 1st dose of vaccine on 17Mar2021 and after 10 days later he tested positive for Covid and since then he thought recovering from Covid but now he betrayed, but symptoms afraid him, slight increases in symptoms when he had ever been want to go back to get his second shot or feel well enough to go back and get his second shot until now. The point was they gave him first shot and second shot was currently 49 days, was second shot still available for him or it was dangerous or it infected or was there another scenario that comes in private for research was there something secret. Patient was informed about Pfizer Medical information Department. Because it was on 10 days after the first dose, the time frame was significant in that probably the first dose had no impact to when that happening had it been three weeks before or 4 weeks before was probably medical value in that for what do or not, because he want to know if he can get the second shot that was more important if give him that number, would like to call that number. The patient underwent lab tests and procedures which included COVID test: positive (after getting the vaccine I got COVID) on 27Mar2021, negative (One week later I was clear and received a negative result) on Apr2021. The outcome of event was recovered on Apr2021.  No follow-up attempts are possible. Information about lot/batch number has been requested.
No adverse reaction by patient. Recognized after administration of vaccine that this patient had already received a booster of Moderna on 10/27/21, when reviewing vaccine card it appeared as though this dose was a third dose and today's dose would have been the booster dose.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Fever of 102 degrees, severe vomiting, chills, paleness, body aching until 5:00 AM
3/21/12: Patient c/o itching and redness on left deltoid. No warmth, tenderness, induration. Area was outlined in pen RTC in 2 days. 3/23/12 Area of redness increased slightly. ATARAX given.