chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". 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: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. Other medication in two weeks was Tylenol. No COVID prior vaccination. COVID tested post vaccination. Patient took PAXLOVID for covid-19 treatment.  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 available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Pt had throat and tongue swelling. Presented to the ER given 2 doses of epinephrine. Which reversed the reaction. Pt was held for observation. Total treatment time about 5 hours.
Aches and joint pain, followed by fever/chills and shaking. Lasted 12 hours. Lingering headache and tiredness.
warm tender red arm sensitive to touch at injection site.  Seek relief with antihistamine and ibuprofen and if not resolved by monday please call md
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 03-OCT-2012, the patient was vaccinated with a dose of 0.5 milliliter PNEUMOVAX 23, intramuscularly and another dose was given on 04-OCT-2012 (lot number unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Thé day after his second shot my son woke up with a back ache and with three veins popping horizontally on his back.
Pt recvd vax & became very lethargic, hypotonic, difficult to arouse occurred 30min p/shot; Last approx 15min; No treatment necessary;
Client reports L deltoid area has been sore and achy since shortly after receiving vaccine. No swelling, bruising, lumps/bumps noted. No infection noted.
Patient was given 1 dose 0.5 mL expired vaccine. Vaccine expired 2/26/2023.
1 day after vaccination pt reports swelling, rash, redness, heat, down to antecubital on right arm. Pt tried Ibuprofen, TYLENOL, and CLARITIN with no relief. Reported to clinic 2 days after vaccination.
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a female patient who received ENGERIX B. Previously administered products included TWINRIX (dose 1) and TWINRIX (dose 3). On 8th July 2013, the patient received the 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced wrong vaccine administered and inappropriate schedule of vaccination administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administration were unknown. Additional information received.
Aggrevated ankylosing spondylitis; Sickness; Fatigue; Joint Pain; Headache; Fever; This spontaneous case was reported by a physician and describes the occurrence of ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MELOXICAM and ADALIMUMAB (HUMIRA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced ILLNESS (Sickness), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis) (seriousness criterion medically significant). At the time of the report, ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis), ILLNESS (Sickness), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ILLNESS (Sickness), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and PYREXIA (Fever) to be probably related and ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis) to be not related.    Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  Company comment: This case concerns a 39-year-old female with a serious unexpected event of ankylosing spondylitis exacerbation, and no serious unexpected illness, and expected pyrexia, fatigue, headache, arthralgia. Event onset the same day as after second dose mRNA-1273. Events resolved. 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.   This case was linked to MOD-2021-082546 (Patient Link).; Sender's Comments: This case concerns a 39-year-old female with a serious unexpected event of ankylosing spondylitis exacerbation, and nonserious unexpected illness, and expected pyrexia, fatigue, headache, arthralgia. Event onset the same day as after second dose mRNA-1273. Events resolved. 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.
devel zoster on lt side of body from umbilicus to spine along T12 dermatome;devel approx 2 1/2months p/vax;
Breakthrough case admission after 4 vaccines: Moderna 1/30/2021 batch/lot# 007M20A; Moderna 2/27/2021  batch/lot# 010A21A; Moderna 9/16/2021 batch/lot#045C21A; Moderna 4/10/2022 batch/lot# 066K21A.
Information has been received from a nurse practitioner concerning a 12 month old female twin who was vaccinated on an unspecified date with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). On 5/10/2006, the patient developed a varicella like rash. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The reporter indicated that the patients twin sister experienced an adverse event following vaccination WAES0605USA02016. Additional information has been requested.
12 hrs after vaccine developed red, swollen area 10cm in diameter. Indurated tender. Fever, chills.
Narrative: Positive COVID test in fully vaccinated, asymptomatic patient admitted for orthostatic hypotension
Menstrual periods changed following 1st and second dose of the Pfizer vaccine. 2nd dose was taken 4/6/2022, lot EW0150. Previous menstrual cycles were between 21-30 days. Following the vaccines, the cycle was 137 days and the resulting menstruation was very light compared to normal cycles.
Around 5-10 minutes after the injection, patient began to feel faint. Patient turned pale and diaphoretic and passed out.  Patient was lethargic and confused when coming back. Patient then began to remember where he was and started to feel better for about 2 minutes. Patient then fainted again and was able to regain consciousness with tactile and verbal stimulation. Medics were called for the patient. Patient's blood pressure was 80/55. When medics arrived, the patient had started to feel better and refused ER treatment. Medics left patient without doing vitals or assessments. Patient stayed at the vaccine clinic for another hour and then left after feeling better.
No pain at the time of injection, but fainted after returning to sit outside.  After about twenty minutes, with fluids and a snack kindly provided by the pharmacy staff, recovered quickly.
Side of face particularly in right ear lobe's lymph glad was swollen; The skin felt tight; It was like very freaky; Side of face particularly in right ear lobe's lymph glad was swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Side of face particularly in right ear lobe's lymph glad was swollen), SKIN TIGHTNESS (The skin felt tight), FEELING ABNORMAL (It was like very freaky) and LYMPHADENOPATHY (Side of face particularly in right ear lobe's lymph glad was swollen) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], SIMVASTATIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced SWELLING FACE (Side of face particularly in right ear lobe's lymph glad was swollen), SKIN TIGHTNESS (The skin felt tight), FEELING ABNORMAL (It was like very freaky) and LYMPHADENOPATHY (Side of face particularly in right ear lobe's lymph glad was swollen). The patient was treated with CLINDAMYCIN at a dose of 150 mg. At the time of the report, SWELLING FACE (Side of face particularly in right ear lobe's lymph glad was swollen), SKIN TIGHTNESS (The skin felt tight), FEELING ABNORMAL (It was like very freaky) and LYMPHADENOPATHY (Side of face particularly in right ear lobe's lymph glad was swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: negative (Negative) Negative.         Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was  received and the event outcome was updated.
Had vaccine at 4PM 12/12/2003; by morning of 12/13/03 had chills, fever about 102 degrees, complained of muscle and/or joint soreness, and was listless.  Fever varied between 101 and 103 until pre-dawn 12/15/2003. Midnight dose of ibuprofen on 12/14/2003; and midnight dose of aceteminophen on 12/15/2003.
swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional information was reported as follows: The patient received a dose of Shingrix on the right arm. Additional information was not provided. The reporter did not consent to follow-up. For tolerance to 2nd dose refer linked case, reported by the same reporter.
swollen lymph node under left arm associated with soreness; This is a spontaneous report from a contactable consumer  reporting for herself.     A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Mar2021 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; fluconazole (FLUCONAZOLE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, cyanocobalamin, nicotinamide, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (T-VITES) taken for an unspecified indication, start and stop date were not reported.  The patient experienced lymphadenopathy on 13Mar2021 10:30 with outcome of not recovered.    Course of the event On second morning after second dose, I woke up with swollen lymph node under left arm, vaccination was also given in my left arm. It looks fatty/ swollen and has soreness/ pain associated with it.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
pt recv vax 8AUG95 & 21OCT96 pt devel chickenpox consisting of a generalized rash consisting of approx 50 lesions & a fever of 103;
on 8/8/07 mother called the HD stating her child developed a red warm swollen area to LDT where shot was administered. Mother took the child to the ER. DX. cellultis. TX.Keflex and Benadryl,ane tylenol.
freezing to death, she was absolutely freezing; she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather; it even hurt her to walk; during night her feet started cramping real bad.; she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather; it was so bad she could not trust herself to drive.; this was way beyond chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.) and NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 004M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.), NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it was so bad she could not trust herself to drive.) and CHILLS (this was way beyond chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.), NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it was so bad she could not trust herself to drive.) and CHILLS (this was way beyond chills) outcome was unknown.            No concomitant medications were reported.
Pt is a 37 y.o. female with HbSS sickle cell anemia who was admitted 9/14/2021 due to fevers, rhinorrhea, congestion and found to be COVID+. She is s/p COVID vaccination: dose 1 on 2/22/2021 and dose 2 on 3/15/2021. Went to an indoor concert 5 days prior to admission, developed URI symptoms 2 days later.  No dyspnea or chest pain, but went to urgent care when she developed fevers at home to 101. At urgent care patient desatted to 88-89% while walking, so was directly admitted for further management. Labs on admission demonstrated hgb 7.1 (baseline 7-7.5), platelets 484, WBC 11.4K. Strep/legionella negative. CXR without any focal opacities On exam she remained well-appearing, in no acute distress, not in any pain. Remained on room air and passed walk test upon admission here. Lungs remained CTAB, heart sounds normal, regular rate and rhythm, no murmurs. Patient received 1 dose of dexamethasone overnight, discontinued given stable respiratory status. We recommended 5d of remdesivir to prevent complications from COVID however patient stated she felt well and agreed to receive 3 doses.
Left upper arm very painful to move. I cannot raise my arm above my head, reach behind my back or shoulder, painful to reach over under my right arm to apply deoderant, it wakes me up when I am asleep. I tried ice, heat, massage, using my arm, resting my arm, taking 400mg of Ibupro. After giving it several months to get better, to no avail. In May I went to see my doctor, she said she thought it was a "sterile abscess".  I gave it more time (June) and it is still not any better so I "GOOGLED" "sore arm months after getting H1N1 shot" and found a blog of people that have the same issue.  I am quite concerned now as it is very painful to do my job at work.  I am a CNA and lift, move, and shower patients.  I am very concerned that I take ibupro. on a regular basis.  I try not to, but sometimes it is the only way I can make it through my workday.
Day after vaccination she broke out in rash on both legs and arms. C/O itching with rash. Symptoms have progressively gotten worse despite use of cortisone cream. Referred to MD.
This spontaneous report as received from a registered nurse refers to a few of patients. Specific number of patients was unspecified. The patients was vaccinated with VARIVAX (Merck) (lot number not provided) on an unknown date. No other co-suspects were reported. NO concomitant medications were reported. On an unknown date the patients broke out rash after VARIVAX (Merck) was given. The outcome of adverse event was unknown. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
congestive heart; renal failure; very weak; This is a spontaneous report from a non-contactable consumer.  A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Feb2021 at single dose for COVID-19 immunisation at the age of 75-year-old. Medical history and concomitant medications were unknown. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at single dose for COVID-19 immunisation at the age of 75-year-old. On 07Feb2021, patient became very weak; the patient was hospitalized with renal failure and congestive heart. It was unknown if any treatment was administered due to the events. The patient did not recover from the events. The patient did not have Covid-19 before vaccination; it was unknown if Covid was tested post vaccination. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
On 11/21 left upper arm red/hot to touch and sore. Awakened with SOB and wheezing "not normal for her". Note: 11/26 discussed with staff. Had baseball size hard lump, cellulitis look like it. No hives. I instructed her consider this an allergic reaction, do not take in future.
Information has been received from a physician concerning a female patients between 20 - 25 years old who was vaccinated with Gardasil. Subsequently all the patient experienced abdominal cramping "like premenstrual related symptoms". Subsequently, all the patient recovered from abdominal cramping "like premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several from the same source.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 216 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
Moderate erythema on left thigh (10 cm), no induration, slightly mottled appearance, non-tender, small knot at injection site.
Developed headache similar to when I got my initial shot in March. Headache is sporadic throughout the day but has been consistent since day of injection of booster. It originally resolved within two days when I received my first shot.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, concomitant medications and past therapies were not reported. On 02-APR-2018, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N013268, expiry date: 25-OCT-2018 for prophylaxis whose dose and route of administration were not reported. The PROQUAD administered was reconstituted with properly stored sterile diluent (MERCK) of unknown lot number and expiry date. On an unspecified date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live was subjected to a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit (9 degree Fahrenheit) for the time frame of 2 hours which was noted from a data logger. No adverse effect reported. It was reported that there was no previous temperature excursion. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA002406.