chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05May2021 as dose 1, single (Batch/Lot number: unknown) and on 08Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anorexia" (unspecified if ongoing), notes: nervosa; "osteoporosis" (unspecified if ongoing); "osteoarthritiss" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; TRAZODON; ALENDRONATE; TERBINAFINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient was on medications within 2 weeks of starting COVID-19 treatment. Also patient previously had receive a COVID-19 Vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
severe headache; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (Patient) reported that the female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got her vaccine this afternoon (on 06Feb2021) and after 30mins she experienced a severe headache and asking if she can take medicine like TYLENOL. The event outcome was unknown.  Information on the lot/batch number has been requested.
My symptoms happen for about one week a month every month since I received the vaccine. I have a chronic cough that keeps me up at night. I have trouble breathing. I have headaches. When I cough I cough up really think light green phlegm. My asthma overall has worsened overall. Every time it happens, I have been put on different antibiotics, 5 in total. I am also  put on prednisone every time and the doctor changes the amount depending on my symptom severity.
When I woke up in the morning, I felt nauseous and suddenly I passed out, hitting my head and bleeding from my right eyebrow, I called the rescue, but they told me that I should go to an emergency because the wound required suturing.
Had immunization on Friday 9/28/18; woke up 9/30/18, unable to lift arm, Pain with ROM.
Occurred 30 min. after injection. 4cm redness and significant swelling at site of injection. Tender and hot to touch. Numbness Lt pinkie. BENADRYL PO 25mg and ice. Redness and itching resolved 10/19/13.
Patient had a red swollen area on the left arm after Shingrix vaccine.  The area eventually became lighter in color, but continued to spread over a larger area.  Patient went to a walk-in clinic and antibiotic was prescribed.
Patient experienced anxiety-related responses to vaccination and fainted, had pale skin and clammy skin. I placed an ice bag at back of neck for patient and call 911.  Patient was conscience and communicated, after a couple minutes, patient started to recover, skin got color and patient indicated to be thirsty and feel better. Blood pressure was 127/74. EMT came and took over.
Initial report received on 14-Mar-2006 from an investigator participating in the above mentioned trial under the reference number MTA30. A 17 year old female subject developed a one week history of fatigue, increased thirst and urination, variable appetite and weight loss of several pounds. She was found to have Type I Diabetes Mellitus with no evidence of acidosis, 26 days after she had received an administration (route and site not reported) of Menactra, lot number U1892AA, on 20/Jan/2006. The subject had no significant medical history. She also has no family history of Diabetes Mellitus. On 15/Feb/2006, 26 days after receiving the study vaccine, the subject developed fatigue, increased thirst and urination, and variable appetite with a reported weight loss of several pounds leading to hospitalization on 22/Jan/2006. A urinalysis was found to be abnormal. It showed glucose 1000 mg% with moderate blood and 50 mg% ketones. Lab work was completed and her HGB A1C was 10.7% (normal range 4.6-3.0), her random blood glucose was 608 mg/dL (normal range 60-159) and it went down to 307 on 23/Jan/2006, ketone was positive. The patient was positive for varicella-zoster IgG. She was treated with IV fluids for hydration and started on Novolog and Lantus. She was discharged on 24/Jan/2006 with a Glucagon emergency kit. At the time of this report, the events were ongoing. According to the investigator, the event was reported as possible related to the study vaccine. Documents held by sender: hospital discharge summary, laboratory work.
Large red rash & body felt heated 1 hour after. Headache & upset stomach started few hours after. Starting 8 hours after dose, severe body aches & chills - lasted 8 hours after until 30 hours after. Dizzy and nauseous started 36 hours after until 38 hours after. By 48 hours after, only sore and tender arm at injection site lasting until 4 days after.
5 mins post vax reported lightheadedness 15 mins noted rash on neck; c/o of general itchy; w/in 30 mins itching became severe; devel raised rash on back, abd, rt upper arm rash; rt upper arm near inject site;
mom phoned 4 days p/vax to report mild sz episode & shakes;pt fine since;
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff manager). This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289666, 2018SA289688, 2018SA289640, 2018SA289611, 2018SA289702, 2018SA289731 and 2018SA290377, same reporter. This case involves a 9 years old female patient who received vaccine IPOL. The patients past medical history, concomitant medication and family history were not provided. On 18-Sep-2018, the patient received injection of suspect IPV (VERO) lot number- N1K931M, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that IPOL opened reached 32.76 F for 19 hours 44 minutes/ did not freeze, doses were indeed given out of opened multi dose vial of IPOL after temperature excursion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Four minutes or less after receiving the Tdap shot I sense a weird taste in my mouth, like metallic, acid, and like at times is like tasting antibacterial soap. Salty, metallic, acid, and chemical like antibacterial soap or like ear wax. I still have that taste in my mouth.
The patient did not experience any other adverse events / No other AE reported; Caller was supposed to give patient MMR shot but gave them MMR Varicella shot instead; dose of PROQUAD was administered to a 27 year old patient, when the patient was supposed to receive a dose of MMRII; This spontaneous report was received from a medical assistant and refers to a 27-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 29-SEP-2020, the patient was supposed to be vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, vaccination site, route of administration, lot # and expiration date were not provided), but instead was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S03511 (exact dose, vaccination site, route of administration and expiration date were not provided) for prophylaxis. No additional adverse events were reported.  Lot number S03511 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
pt recv vax 2JUL95 & a red streak devel in pt forearm (at the site) which progressed up arm, through armpit & down side of chest;It firs appeared on the day of immun & reached it peak redness 4JUL95;streak was never indurated or warm;
patient fainted after injection while trying  to stand up.  blood pressure ok, pulse ok, breathing ok. All vitals monitored by emt on site.  revived after about 10 minutes.  Refused to be taken by ambulance.  Emt indicated just a sign of anxiety and not from vaccine
This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling, pruritus and feeling hot. On an unknown date, the outcome of the swelling was recovered/resolved and the outcome of the pruritus and feeling hot were unknown. It was unknown if the reporter considered the swelling, pruritus and feeling hot to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient received flu vaccine and experienced swelling, itching and hot fever in her arm. The patient experienced same event when she received Shingles vaccine (refer case US2019GSK079252). The reporter consented for follow up. This case has been linked to case US2019GSK079252, reported by the same reporter for the same patient.
Tingling left arm, dizzy - pr checked VS P 68, B/P 110/78, R 16. Heart irregular beat. Gave juice, snack, layed down. Feels less dizzy still tingling sensation left arm. Went back to class did not want to go home.
1. One week after injection: Site was bright red, and hot to the touch, with a small pus-filled lesion (3mm in diameter). As of 5/19/21, a small hard lump remains under the skin. 2. Despite a very consistent 27-29 day menstrual cycle, I have had no menses since receiving the vaccination.
My heart rate went to 153 BPM and my blood pressure was sky high but I do not remember the numbers. I went to the hospital and they kept me for 2 nights. Ran every heart test you could imagine. Couldn't find anything wrong with my heart but would not allow me out of the bed for anything at the time of hospitalization. Once released, I followed up with a Cardiologist and found nothing but the doctor feels it could be vaccine related.
Allergic skin reaction first on creases of neck for about a month. No treatment.  Followed by similar skin reaction on eyelids with one being significantly worse than the other.  Started 1.5 to 2 months after vaccine and progressively worsened over a 3 month period ending in mid October.  Visited ophthalmologist who concluded allergic reaction to "something".
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L023588 and expiration date 26-JUN-2017, lot # L031066 and expiration date 18-AUG-2017, lot # K003423 and expiration date 06-MAR-2016, lot # K002920 and expiration date 26-FEB-2016 (route of administration and dose were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
2 episodes of syncope while at doctors office after receiving GARDASIL and MENACTRA vaccine.  Was fine prior to getting vaccinated.
The pt received the yellow fever vax on 9/26 and reported to the ER complaining of shortness of breath, flushing, chest tightness and general pruritus. Treated with epinephrine, Solumedrol, Prednisone and then sent home.
Fever after vaccine. No apparent change immediately. Then June 5, 2000 high fever and ear infection, June 19, 2000. ER high fever, ear infection July 21, 2000 fever, diarrhea, ear infection 8/7/00 fever 10/6/03 cough/fever, ear infection. Parents concerned about chronic ear infection pattern developing. 11/6/00 cough, fever, ear infection. Concerned about his effect on hearing w/ problems ear infect. Pattern of illness continued. Tubes in ears Feb. 2001. 12/14/00 concerned with hearing. Diagnosed with autism 5/6/02. Not date specific, but began to be concerned with chronic health, ears and noticing difference in development (hearing and speech) Dec 2000*-/Jan 2001. Not until after his surgery Feb 2001 and no improvements did we feel there was adverse event May-June 2001 time frame. A follow up report received 10/31/2003 adds: (Unable to provide specific onset date). Health decline 19-20 months. Chronic ear infections. Did not notice any developmental concerns, speech regression Dec 2000/Jan 2001 time frame. Tubes in ears Feb 2001. When language did not begin to build upon after Feb 2001 surgery, became concerned more April 2001. The 60 day follow up received on 12/24/03 states pt has high levels of bacteria and yeast in his system. In addition his body is retaining (not naturally detox) the preservatives-toxic metals used in the vaccines in mercury, arsenic, aluminum, tin, nickel, lead, uranium, tungsten, cadium. His immune system has been weak since and he developed chronic allergies to beef, trees, grass, dairy, wheat, gluten, casein, bees and did not exhibit these prior to.
Painful, swollen lymph node under left armpit; Painful, swollen lymph node under left armpit; Pain on left a and injection site; Pain on left a and injection site; This is a spontaneous report from a contactable pharmacist, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient received other vaccine within four weeks prior to the vaccination, which was influenza vaccine (MANUFACTURER UNKNOWN) (reported as Flu vaccine) on 17Feb2021 for immunisation. The patient previously received chloroquine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 10Mar2021, the patient experienced pain on left arm and injection site which persisted 5 days later. On 13Mar2021 at 03:00, the patient woke up with painful, swollen lymph node under her left armpit. It was reported that today on 15Mar2021, the pain had subsided but was still there. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain on left a and injection site and painful, swollen lymph node under left armpit was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initial misuse report received from a health care professional on 11 September 2013. A patient, whose demographics details including initials, age and date of birth was declined, received a dose of FLUZONE vaccine (lot number U4717AA, dose number not reported, subcutaneously in the left deltoid) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was reported that, not sure whether the patient had received the vaccine intramuscularly, may have been administered subcutaneously. It was reported that after receiving FLUZONE vaccine, on an unspecified date the patient had large red, swollen, warm to touch and itchy area at the injection site. Laboratory details and corrective medication was not reported. At the time of this report, the patient was not recovered. Documents held by sender: none.
AT 13;15, CLIENT COMPLAINED OF TACHYCARDIA, BP WAS  167/95, PULSE 75 ABD O2 SAT 100%.  PER PATIENT SHE TOOK PROPRANOLOL AT  0900 AM FOR HTN.  SHE WAS COLD AND CLAMMY AND WERE OBSERVED BY TWO NURSES-LVN. AT 1340, BP WENT DOWN TO 126/88 AND  OF THE FACILITIES WERE INFORMED AND TOOK PATIENT TO THE ROOM.  WE JUST FOUND OUT THAT  CALLED 911 AT 2:30 PM.   PER , SHE SPOKE TO THE PATIENT WHO STATED SHE DOES NOT WANT 911 TO BE CALLED, BUT DID ANYWAYS.  MADE ON 05/15 AND 05/16 TO CHECK ON PATIENT, LEFT A MESSAGE.
About 2 months after the vaccine, I experienced similar leg pain to the second dose but on the left side. It involved the hamstring and calf, but not the lower back or butt. I called my PCP and a physical therapist. I was able to get into physical therapy at the end of December. So, while I waited to see them, I went to my PCP to get treated for the pain. I am still being treated to this day for the pain, and I am still seeing the physical therapist. I was referred to a spine specialist but I am holding off until the physical therapist and I can determine what's going on.
Information has been received from a 74 year old female with no drug reaction/allergies arthritis, heart problems and a history of shingles several years ago who in approximately 2006 "approximately 5 years ago" asked her doctor to give her a first dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included heart medication. In approximately November 2010 "about 2 months ago" the patient started having shingles symptoms again. The patient went to her doctor to see if it was definitely shingles, and he said he didn't know what it was. He gave the patient a cream, but he would not explain to her what it was or what it was for. The rash came and went with this cream, but it was nasty. The pain was severe and it literally had created what looked like a hole in her leg. That section had healed quite a bit, but the rash was nonetheless damaging other areas. The patient went to her pharmacist to ask him about getting another vaccine. No diagnostic laboratory tests were performed. At the time of the report, the patient's status was not recovered. Additional information has been requested.
102.4º fever the evening following vaccination (Saturday PM), fever fluctuating between 99.5-101.8º pretty consistently ever since. Most of the time it's been 100-101.4º. Headaches intermittently. Today is seven days since receiving the vaccine. Have taken acetaminophen fairly regularly - it reduces the fever some, usually not completely, and then it goes right back up.
I have "covid arm" or "Moderna Arm" after thr Moderna Booster vaccine. My upper arm has  a large red oval region(around the injection site but basically cover most of my upper arm) that is painful, itchy, and hot to the touch. Noticed the redness when I looked at my arm two days after the booster. However, I felt the pain and itchy skin and hotness from day one, so the redness may have started the first night. I first looked at it and noticed the redness the morning of day 3.
Rapid heart beat at 110bpm and today was 120bpm; Sore left arm at injection site; A spontaneous report was received from a consumer, concerning herself, a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rapid heartbeat at 110bpm and today was 120bpm and sore left arm at injection site.  The patient's medical history was not provided. Patient had no relevant concomitant medications.  On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (010M2A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, after the second dose of vaccine, the patient experienced sore left arm at injection site and rapid heartbeat at 110bpm. On 29 Jan 2021, the patient's heartbeat was about 120bpm, hence she went to emergency room. Patient had no treatment and co-morbidities.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event's rapid heartbeat at 110bpm and today was 120bpm and sore left arm at injection site were not reported.; Reporter's Comments: This case concerns a 30-year-old female who experienced a serious unexpected event of Heart rate increase along with a nonserious expected event of Vaccination site pain. The events occurred the same day as the second dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt states left arm hurt on injection 10/20/05 and noted swelling that night which lasted with rash until 10/23/05. Pt took Benadryl and ASA.  Reported to Health Department 10/25/2005. No s/s noted.