chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia, and low b12, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s(dose series 1) (suspension for injection, route of admin not reported, batch number: 264B21A expiry: unknown) dose was not reported, 1 total, administered on 13-SEP-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced loss of taste and smell, sore throat, headache, cough, and stuff nose (confirmed covid-19 infection) and also had confirmed clinical vaccination failure for which patient tested Covid-19 positive . On 04-JAN-2022, Laboratory data included: COVID-19 PCR (polymerase case reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210342.; Sender's Comments: V0-20220107787-Covid-19 vaccine ad26.cov2.s-Confirmed Clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD).  Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination.  The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
became very disoriented; seemed to loose their balance; they felt like they were going to fall; felt light-headed; soreness in their arm; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (became very disoriented), BALANCE DISORDER (seemed to loose their balance), FALL (they felt like they were going to fall), DIZZINESS (felt light-headed) and MYALGIA (soreness in their arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DISORIENTATION (became very disoriented), BALANCE DISORDER (seemed to loose their balance), FALL (they felt like they were going to fall), DIZZINESS (felt light-headed) and MYALGIA (soreness in their arm). At the time of the report, DISORIENTATION (became very disoriented), BALANCE DISORDER (seemed to loose their balance), DIZZINESS (felt light-headed) and MYALGIA (soreness in their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication included.
my left arm at the injection site began to feel slightly sore.; This is a spontaneous report from a contactable consumer (patient).   A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL3247) an unspecified route of administration, administered in left arm on 19Feb2021 11:30 (age at vaccination 48 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma. Other vaccine in four weeks was reported as no. The patient had known allergies: seasonal allergies, pets, various foods and dust. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medications included Vitamin D, fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), triamcinolone acetonide (NASACORT) and unspecified multivitamin taken for unspecified indication from an unknown date. The patient reported that on the day of vaccination on 19Feb2021 19:00, towards the evening, her left arm at the injection site began to feel slightly sore. The patient was not received any treatment for event. The outcome of the event was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a patient, describes the occurrence of pain in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain. At the time of the report, pain outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Patient also received Flu shot at same time in left arm.  11/3/2022.  Reaction in just a few hours - bruising, 2nd degree blistering and swelling the size of an orange.  Took over a month for swelling to subside.  Continues now a year later with phantom pain in that arm. Patient wanted another Covid shot 11/13/2023, given Moderna not Pfizer.    She will report back to office if there is any reaction this time.   RN BSN
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling.  Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
Immediately felt dizzy, tired, leg cramps, and headache.  Symptoms lasted two days.   These symptoms slowly resolved over three days. One day following the vaccine began to feel injection site swelling itching, rash, and pain.  Pain lasted three days.  Swelling and rash have continued to this day. One day after receiving the vaccine heavy congestion in my chest began.  This persists to this day.  Continue to have weakness in my arms and legs.  Unable to sleep well.  Continue to feel tired.  Have not received any specific treatment for these symptoms.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 19 March 2008 from a nurse.  A 14-year-old male patient, with past medical history of cyclic vomiting, and who had not received any other vaccinations with four weeks of 18 March 2008, had received an intramuscular, left deltoid dose of Adacel (lot # C2899AA); and an intramuscular, right deltoid dose of Menactra (lot # U2562AA) on 18 March 2008.  Forty-five minutes post-vaccination, the patient complained of abdominal itching, abdominal pain, chest pain, and he had broke out in hives with red blotchy skin in the face and neck area.  The patient also had swelling in the face and neck, and had episodes of diarrhea.  The patient sought medical attention at the local emergency room and was treated with intravenous Solu-Medrol and was released the same day with a prescription of prednisone and Benadryl.  No diagnostic tests were performed.  As of 19 March 2008, the patient was feeling better, but had not fully recovered.
Leakage of vaccine (faulty syringe/ needle) Repeated dose in right arm
I had a breakthrough COVID-19 infection in January 2022. I was having memory issues - I would walk into the room and could not remember why I had gone there. I would then walk away and then remember and then be able to go back and take care of it. It happened many times a day (12-18) in the beginning. It was very upsetting because it happened so often. Now it happens a few times a day but I am able to handle it better. It is much better but may not be daily any longer. I spoke to my neurologist and did a neuro-psyche evaluation and will get the results next week.
I bad body aches after receiving the vaccine for about a day. I had a significant change in my heart palpitations about two months after receiving the vaccine. They changed in frequency and duration. I was concerned and went to see a cardiologist. I had multiple testing and everything was in normal range. I was referred to a gastroenterologist and put on acid reflux medication as they thought that was a contributing factor. About two days later, my symptoms are getting better.
The patient received her vaccine at approximately 10:30am on 8/28/21. Roughly 15 minutes later, the patient began vomiting and sweating. About 15 minutes after that, the patient reported difficulty breathing. The pharmacist who administered the vaccination the instructed a pharmacy technician to call 911 and the pharmacist administered one 0.3mg epinephrine auto-injector at 11:02am into the patient's right anterolateral thigh. EMS arrived and took the patient. The patient was discharged at approximately 4:00pm.
This spontaneous case reported by a patient, describes the occurrence of hyperhidrosis (sweating) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006B21A and 025B21A) for COVID-19 immunization. No medical history reported. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient experienced hyperhidrosis (sweating). At the time of the report, hyperhidrosis (sweating) outcome: unknown/not provided. This case linked to MOD-2021-214472 (patient link).
Right arm began to hurt "more than from a typical flu shot" several days after injection. Increased constant ache in upper arm/neck/shoulder. Activity increased discomfort. Treated with Acetaminophen and 1 dose of Ibuprofen/hot-cold applications. 11/19 arm somewhat better saw doctor who advised to watch it. 11/26/03 continue to ache and in not as strong as he would like-will continue to observe.
Facial numbness to left side of face (same side as injection). Stated reaction stronger and faster than previous reaction with first dose. EE sent to the ED for evaluation.
Patient presented to the clinic requesting the Janssen vaccination.  The location site was offering incentives for those getting vaccinated.  It was later discovered that the patient had completed the Moderna series.
Pfizer, Dose: 5 / Moderna, Dose: 4; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 83 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 at 10:00 as dose 1, single (Lot number: EL9269), in left arm, on 27Feb2021 at 10:00 as dose 2, single (Lot number: EN6203), in left arm and on 01Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing); "Zetia Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer, Dose: 5 / Moderna, Dose: 4". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 11May2023 to 15May2023. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201027 Same patient, different drug, different event.
Very mild itching minutes after the injection. Large red welt  formed later that was hot to the touch at the injection site. Spread down my arm into various other large welts that ached and left behind bruises once they faded. Still have mild itching at the injection site almost 2 weeks after but all other reactions have since faded/stopped.
Initial report received from a health care professional (medical assistant) on 13 Jul 2010: This patient accidentally received a 0.5 ml intramuscular dose of MENVEO (batch no: 027011) that was reconstituted with sterile water instead of lyophilized component on 02 Jul 2010. No adverse events were noted following this administration.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna, vaccine dose number:3; Vaccine brand other: Moderna, vaccine dose number:4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 12:00 as dose 1, single (Lot number: E128733), in left arm and on 26Apr2021 at 12:00 as dose 2, single (Lot number: Ew0175) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 032fz1a), in left arm and on 16Sep2022 at 12:00 as dose 4 (booster), single (Lot number: As7147B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Mild liver disease" (unspecified if ongoing), notes: Mild liver disease; "Autoimmune" (unspecified if ongoing), notes: Autoimmune. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Vaccine brand other: Moderna, vaccine dose number:3; Vaccine brand other: Moderna, vaccine dose number:4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid for COVID-19, Treatment start date was 18Nov2022, Treatment stop date was 22Nov2022. The patient had no known allergies.
Broke out in hives.  They would be there when he awake then disappear then come back throughout the day.  Chronic Urticaria
Hip joint pain, some knee pain relieved with topical medication,  I had some pain previously but not as intense, it got worse , dr had me stop my cancer med,(anastrozole) and pain decreased about 20%.   About 2 weeks ago I started esteste Am trying to decide if pain has increased and why
Information has been received from a physician's assistant concerning a 9 year old white female with no known drug allergies and no illness at the time of vaccination who on 17-FEB-2010 was vaccinated with intramuscularly into the left arm with second dose of VARIVAX vaccine (Merck) (dose not reported, lot number 664616/0971Y). Concomitant vaccination administered on the same date included Influenza A H1N1 vaccine (cold adapted Ann Arbor master strain) (route nasal, lot number 5008499). On 18-FEB-2010 at 06:00 p.m., the patient developed injection site cellulitis the next day after receiving VARIVAX (Merck). It was reported that the patient required a doctor visit. The final outcome was not reported. Additional information has been requested.
Per the patient's mother, one and a half hours post vaccination, the patient started to cry inconsolable for three hours.
5 days after the 1st. Moderna Covid-19 vaccine shot, my left arm started itching that day.  On Friday the itching got worse and the area was sore, when I looked at my arm later that day, my arm had a swollen circle around the injection site about the size of a tangerine.  The area was itching, sore and red.  Saturday morning when I got up the itching and swelling was worse and was very red and hot to the touch and I had developed a rash outside of the circle area.  I called the Drs. office of which they have an acute center on Saturdays.  I was seen about 4:45 pm. that day.  They told me that I had ceullitis (Infection) at the site of the injection on left arm.  They put me on Augmentin for 7 days along with a steroid creme to apply 2x/day for the itching, redness and swelling.   The allergic reaction got to the size of an orange. The medicine was working, by 3 days the swelling and deep redness was gone as well as the heat at that area.  Today is day 6 of being on meds and no swelling, itching, rash or deep red.  You can still see the circular allergic reaction which is still discolored that was about the size of an orange.
Breakthrough Case  **Patient currently pregnant with EDD 02/16/2022 Unknown if pregnant at time of vaccine administration
Day 1, slight pain in long bones (1-2 days) . Sore right arm persists. Day 3 -present -raised, red sore with scabbing. soreness, warmth and red at injection site 2mm diam.
the medical assistant administered third dose of Pfizer vaccine lot # FH8030,  0.3mL IM to patient on 01/08/2022 at 1315 which was a month ahead of the recent CDC eligibility guidelines. The patient had his first dose on 08/17/2021 and second dose on 09/07/2021.
On 01/10/2023  10:50am 17y/o male patient received 5 injections, Polio, Varicella, T-Dap, MMR and Hepatitis B with PPD. Patient tolerated first 3 vaccinations on the left arm well. Last 2 vaccinations were given on the right arm. PPD was place on the right forearm with complaint of pain but was tolerating well. Patient remained sitting while LVN went to print out the shot record. LVN was standing by the copying machine less than 3 feet away from the exam room with door open. Approximately around 10:55am, patient ?s brother called for help. With exam door open LVN observed patient had seizure like symptom, characterize by convulsing, diaphoresis, closing of eyes and pallor. Convulsion was less than 5 seconds, by the time LVN was in the exam room and beside the patient, muscle spasming has already stopped. LVN called for help immediately and advised patient to breathe through his nose and out through his mouth. Oxygen was given @2L/min via nasal canula. Patient was conscious and responsive.  11:00am LVN went to call Dr for assessment. Dr confirmed that it was vasovagal response and advise that patient could leave once he is able to walk with feeling dizzy. BP was taken every 5 minutes. 100/68 @11:00am. Patient was alert and oriented however, appear lethargic, pale and diaphoretic. Lollipop and Kool-Aid 6.75fl oz was given. After further discussion, patient?s brother stated that the patient has not eaten breakfast/lunch.  At 11:07am BP 108/70, O2 was 99% on 2L/min via nasal canula. Color returned and patient stated that he?d felt better with slight dizziness. Patient drank water. BP taken @11:15am 110/72 with O2 discontinued.  11:20am BP 120/78 O2 99% and left the exam ambulating independently. Before leaving LVN advised patient?s brother and father to make sure that patient eats. if further complication arises to take patient to the ER. Patient is scheduled to return on Thursday 01/12/2023 for PPD reading.  01/10/2023 LVN
pt states later in the day her left arm was swelling up.  It is tender to the touch and warm.  she rubbed it down w/ alcohol which seemed to help.  On 3/23/2021 she said her arm is still swollen, but is not as tender and warm to the touch.  Pt will contact her PCP regarding her symptoms.
COVID-19 I received my 4th dose on 04/16/2022. I tested positive on 06/10/2022. My COVID-19 symptoms started on 07/12/2022 in the morning with sore throat ; fever 101; headache; fatigue; I did a tele health with my doctor who me   prescribed in Paxlovid for 5 days. I am still taking the medication. I haven't completely recovered yet.
My left arm pain started the same night of the 2nd dose of Covid-19 vaccine. It is still pain now after 5 week from the shot.
Pt developed chest and throat tightness about 8 minutes after receiving flu vaccine. Epinephrine 0.3cc given.
24 - 48 hours after - Injection site sore;   48 hours - Injection site becoming less sore. 3 days to 7 days out  - swollen bump 2.5 " - 3" adjacent to injection area and skin surface red color. 10 days out - swelling has subsided but red rash area is larger and more elongated down from of arm. Applied topical benadryl to rash area.
This is a non-serious spontaneous case, initially received from other health professional (nurse) on 09-Nov-2018, concerning a patient of unspecified age and gender. On 09-Nov-2018, the patient was administered expired FLUCELVAX QIVc [batch number: 195129, expiry date: 31-May-2018, dose, route of administration and expiry date: not reported]. At the time of this report, no adverse event was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Lot number: GU5342) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Dec2020 as dose 1, single (Lot number: EK5730), on 08Jan2021 as dose 2, single (Lot number: EL1284), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID day 12 with positive rapid COVID antigen testing. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 23Jul2023 to 28Jul2023 (Oral).; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event vaccination failure and COVID 19 cannot be ruled out.