chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 16:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 16Nov2022 as dose 1, single; PREMPRO LOW DOSE oral. Vaccination history included: Bnt162b2 (Dose 3, single, lot number: 33130BA, vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever"; Bnt162b2 (Dose 2, single, lot number: EN6207, vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever"; Bnt162b2 (Dose 1, single, lot number: EN6205, vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever". The following information was reported: PAIN (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022), described as "Body Aches"; CHILLS (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022); FATIGUE (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022); PYREXIA (non-serious) with onset 06Dec2022 at 04:30, outcome "recovered" (Dec2022), described as "Fever". Therapeutic measures were not taken as a result of pyrexia, chills, pain, fatigue. Additional information: The seriousness of the events was reported as non-serious. The patient had no COVID prior vaccination and not tested COVID post vaccination. The patient had no known allergies. Fever, Chills, Body Aches, Fatigue began approximately 12 hrs post dose and continued for 12-16 hrs.; Sender's Comments: Linked Report(s): PFIZER INC-202201359444 same patient/AE, different vaccine dose; PFIZER INC-202201359445 same patient/AE, different vaccine dose; PFIZER INC-202201359446 same patient/AE, different vaccine dose.
states she has a device that detects ethanol content of her blood and after she received the vaccine; This is a spontaneous report from a contactable other health care professional (patient) via medical information team. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated she had a device that detected ethanol content of her blood and after she received the vaccine her device showed a reading, which to her, was unexpected. Reporter was asking if ethanol was an ingredient in the Pfizer BioNTech Covid-19 Vaccine. Reporter asking how the ethanol was removed. The patient underwent lab tests and procedures which included blood ethanol (ethanol content of her blood) resulted as unexpected on an unspecified date. Outcome of the event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
vertigo nausea / vomiting diarrhea low-grade fever pain at injection site
Patient became Pale, Diaphoretic, clammy, Experienced N/V, and Dizziness. Patient vomited x1 , given cold compress and escorted to cot. Vital signs obtained P: 67 , R: 18,  B/P: 90/60, O2 sat 98% on R/A. Patient monitored for 30 minutes and symptoms improved , no medication required. Vitals P: 79, R: 18 , B/P: 102/70, O2 sat 98% on R/A. Patient color pink, lungs sound clear, no further distress noted, patient stated he felt better. Father advise to have second vaccine give with PCP.  Discharged home.
Pt experienced an injection site reaction characterized by red, swollen, and warm to touch area.  Area was also firm to touch.
Area around injection site is raised, red and warm to the touch. PCP stated it may be cellulitis.
Couldn't lift left arm for a couple of days.  Very painful, swollen, weakness and numb.  Numbness persists and weakness when overhead motion used.
Patient from homebound vaccination program received a Janssen vaccine for the first dose on 04/07/21. Due to a scheduling oversight on our system and 2 different spellings of the same name, this patient also received a first dose of Moderna through the same program on 04/22/21. The patient has had no adverse reaction to receiving these 2 vaccines.
PATIENT IS 17Y 10M  TOLD MOM I ONLY HAD MODERNA, SHE UNDERSTOOD. I ADMINISTERED VACCINE AND WHEN I WAS FILLING OUT HIS CARD REALISED HE WAS ONLY 17. I WENT OUT AND LET MOM KNOW HE WAS TOO YOUNG TO GET MODERNA. HE NEEDED PFYZER. WOULD CALL HEALTH DEPT FOR ADVISE. WAS TOLD TO REPORT ON VAERS AND HE SHOULD GET MODERNA AS SECOND DOSE. NO REACTION TO COVID VACCINE ABOUT 20-30 MIN AFTER ADMINISTRATION.
I received my second COVID-19 booster on 5/4/2022. Within two days, I had mild symptoms of fatigue, body aches, and general malaise. This lasted for maybe a day. For the remainder of the week, I was fine. The following week, though, I had the mild symptoms again, and they lasted a little longer. I then felt fine again. On 5/21/2022, I had a fever of 102. I also had severe headache, chills, sweats, fatigue, malaise, and body aches. I was alarmed enough to seek medical attention, so my husband took me to the emergency room. At the ER, I was put in a hospital bed and given a COVID-19 test, which yielded a negative result. I also underwent bloodwork, and I was given intravenous fluids and possibly acetaminophen. I was under observation for maybe six to eight hours. The doctor told me that I had tested negative for COVID-19. He told me that I had likely had an acute immune response to the booster I had received, which he said sometimes happens. He also advised me that I was likely to have a strong reaction to any future immunizations I received. He told me that I could treat my symptoms with acetaminophen and to take it every four hours, if necessary, and that I should also drink plenty of fluids. He then released me, and I went home. I followed the doctor's orders. I rested, and my situation remained stable. I was able to operate at a satisfactory level by 5/23/2022.
One week and approx. 7 hours after injection, an existing mild tinnitus in the right ear became noticeably worse. Three days after that, a bilateral higher frequency buzzing tinnitus (that presents over the head rather than in the ear) appeared. Prior existing tinnitus levels were previously unnoticeable throughout the day (able to successfully ignore and forget about) but now  both are noticeable throughout the day and take quite a bit of effort to distract myself from.
This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included lap band surgery. The patient had an allergy to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine(SULFA). On 10-APR-2017, the patient was routinely vaccinated with a dose of ZOSTAVAX injection, 19400 Plaque-forming units (PFU), subcutaneously in the left arm (lot # reported as M038863; expiration date 12-DEC-2017; dose was not reported) which was reconstituted with Merck sterile diluent (lot # reported as M046371; expiry date 06-JUL-2019). Concomitant therapies included terbinafine (LAMISIL) and vitamin B12. On 11-APR-2017 (reported as 24 hours after the ZOSTAVAX was administered), the patient started to experience pain, swelling and erythema at the injection site. The patient drew a circle around the injection site reaction on the left arm at that time. The patient's swelling grew to about twice the initial size after 24 additional hours (12-APR-2017). The patient sought medical attention and had an appointment with her physician on the morning of 12-APR-2017 and was prescribed oral clindamycin 300 mg, three times a day for 7 days for an unspecified diagnosis. The physician was unsure if the patient had a bacterial infection and left if up to the patient to decide if she should take the antibiotics or not. At the time of the report, it was unknown whether or not the patient took the clindamycin. At the time of report, the patient was experiencing muscle pain in her left arm from her elbow to her shoulder, and was unable to lie on the arm. No lab diagnostic studies were performed. A product quality complaint was not involved. The outcome of all events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
severe arthritis pain in her feet; could not get out of bed for 5 days.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; apixaban (ELIQUIS; Batch/Lot number was not reported), via an unspecified route of administration from 01Oct2017 at unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving the Pfizer COVID-19 vaccine, she experienced severe arthritis pain in her feet on an unspecified date. She noted that she could not get out of bed for 5 days. No further information provided. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ran a fever of 100.9. Sore throat fatigue. Had a breathing problem.
asthma; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer. This consumer (patient mother) reported for a 21-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 08Apr2021 at 19:00, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 08Apr2021, the patient hard arm soreness. On 20Apr2021, Tuesday, the patient had tested COVID-19 positive which was asymptomatic. On an unknown date, the patient had asthma so he wanted them to all get tested again since allergies can be like COVID-19 and her son was a crazy person about COVID-19. Patient must be asymptomatic, they have no symptoms, she doesn't feel anything. The reporter stated that they had a family member that passed away last Tuesday, and around that time was when they contracted and tested positive for COVID-19, for which they have been quarantined. She says that there had been a lot of people in and out of where they were after her mother-in-law passed, and some were wearing masks, and some were not. On 04May2021, the patient will complete his quarantine period. On 20Apr2021, the patient underwent lab tests and procedures which included COVID-19 PCR test, result was positive. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed temp of 103.0F & broke out w/urticaria rash on lower extremities bilat rash lasted 1-2hrs & then began to resolve;
Guillen Barre symptoms; diplopia; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Arexvy and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced guillain barre syndrome (Verbatim: Guillen Barre symptoms) (serious criteria GSK medically significant) and diplopia (Verbatim: diplopia). The outcome of the guillain barre syndrome and diplopia were not resolved.   The reporter considered the guillain barre syndrome and diplopia to be possibly related to Arexvy.     The company considered the guillain barre syndrome and diplopia to be possibly related to Arexvy.   Additional Information: GSK receipt date: 02-NOV-2023 The physician thought that patient was experiencing Guillen Barre symptoms and diplopia. The physician thought it could be Arexvy causing the symptoms. It was unknown if the reporter considered the guillain barre syndrome and diplopia to be related to Flu vaccine. The reporter consented to follow up.
swollen injection site; sore injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter was the patient,wanted to remain anonymous and refused to answer questions. The nurse patient reported that, at the time of reporting to the clinic, they told her that they had other patients, had the same reaction of severely sore and swollen at injection site. This case has been linked with US2019AMR128561 and US2019127856 reported by the same reporter.
Discomfort stomach; low energy; Watery mouth; Her head was hot; Body ache; Nausea; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth) and HEAD DISCOMFORT (Her head was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth), HEAD DISCOMFORT (Her head was hot), NAUSEA (Nausea) and FATIGUE (Very tired). At the time of the report, PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth), HEAD DISCOMFORT (Her head was hot), NAUSEA (Nausea) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
at 0200 on 12/1/21 (vaccination @ 1500 on 11/30/21) pt reported waking up to go to the bathroom and when she was washing her hands looked in the mirror and noticed a large swelling  on her forehead above her left eyebrow.  She woke her husband up and asked him to look at it and he saw it as well .  She reported discussing with her husband what could have caused it and was certain she had not had a fall and bumped her head there.  She stated that otherwise she felt of so she went back to sleep.  In the early morning upon waking to begin her day she noticed that her entire left eye was swollen shut and was black in color.  She then reported going to the ED (Attending Doctor signed her discharge papers at 0501 on 12/2/21).  She was discharged advising how to treat a contusion (apply cold and take tylenol).  She was given no steroids or antihistamines.  When this was reported to me upon arriving to work today (12/3/121) I called the pt (she came to the store 12/2/21 to show the pharmacist her eye and that pharmacist reported this  situation to me).  When I called the pt 12/3/21 she told me of the above reported events and when I further inquired she said that now her right eye was becoming involved.  I advised her to seek urgent medical attention  of which she is currently doing upon writing this information.
Rash and tenderness where injections was given. Started a little over a week after getting the injection.
Pt. stated she got a headache a minute after she got vaccinated.  It was a sharp pain at first and then it was dull.  Pt. also reported a metallic taste.  Vitals signs taken at 11:45 am:  BP 148/69, HR 87, O2 Sat 98%, R 18.  At 11:57 am pt. stated she is feeling better, headache is almost gone, she wants to go home.  Pt. went home at 12:02 pm.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX (Lot# and exp date unspecified) subcutaneously "about a year ago" in approximately 2011. No other co-suspects were reported. No concomitant medications were reported. "About a year ago" in approximately 2011, the patient experienced pericarditis. The patient had performed unspecified lab diagnostics (result not reported). The outcome of pericarditis was reported as recovered/resolved "for about 6 months" in approximately February 2012. The patient has sought unspecified medical attention. Additional information is not expected.
Patient was given Pfizer COVID 19 vaccine at 11 years of age.  No negative outcomes at this time
5 minutes after the vaccine, I experienced shortness of breath and tightening of the throat and then fainted in the clinic. When I woke up I was told that I had a possible seizure.  I was injected with an epipen and made a full recovery before the paramedics arrived. My vital signs were checked and I was not allowed to return home for an hour. I was not given the last two injections of the Gardasil vaccine.
June 2021- painful left ear lobe, erythema and abscess, treated at home with warm compresses, lanced small abscess, topical triple antibiotic ointment  resolved in 1 week  June 2021 - 1 week later - painful right ear lobe, erythema and abscess, treated at home with compresses, lanced small abscess, topical triple antibiotic ointment resolved in 1 week.  June 2021  - 3 weeks later - redness on right side of neck at the collar line extending from the angle of the mandible to chin associated with a large grape-sized lesion.  Treated with warm compresses, 2 weeks of Keflex, currently on Bactrim
I developed hives on my torso (front and back) and arms approximately 36 hours after the vaccine. The symptoms that appeared after my 12-23-21 vaccine persist today (12-28-21).
Arthralgia Chest pain, SOB. Injection site red, warm and swollen Jan 10 Narrative:  referred to PCP  Other Relevant History:
17 patients administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Date the vial was initially stored in refrigerator was 28Sep2021. Date of administration of vaccine was on 28Sep2021 and 30Sep2022. The patient did not reported any adverse events.   This case was linked to MOD-2022-489458 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypo thyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "reflux" (unspecified if ongoing); "depression" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "vitamin d deficiency" (unspecified if ongoing); "high cholesterol but quit taking for ten days" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Sep2009; LEVOTHYROXINE, start date: 01Mar2009; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: 01Mar2019; PRAMIPEXOLE, start date: 01Mar2015; SERTRALINE, start date: 01Aug2018; VITAMIN D [VITAMIN D NOS], start date: 01Jun2018. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Erythromycin, reaction(s): "Known allergies: erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures included Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 09Nov2022 and stopped on 14Nov2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 days of chills and sweating - I stayed in bed, drunk some water but didn't eat anything. Mouth dry - managed to sleep for an hour or two at a time (wound up losing 12 pounds).
Patient came in today on 1/13/19 and stated she has had a very severe large bruise since she received the SHINGRIX vaccine on 12/27/18. She showed me the very large bruise - it encompassed almost her entire deltoid region of her arm. It was very black and purple still even after almost over 2 weeks since the vaccination occurred. She said it was painful and swelling.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had a knee replacement in the past. On 15-OCT-2012 the patient was vaccinated with a single dose of ZOSTAVAX (lot # reported as H012523, expiration date reported as 09-OCT-2013). The patient had experienced discomfort in that knee since administration of ZOSTAVAX. The patient sought medical attention by calling the pharmacy. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information is not expected.