chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took Paxlovid tested negative. Then a few days later tested positive and symptoms started again; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Took Paxlovid tested negative. Then a few days later tested positive and symptoms started again) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unknown drug).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Took Paxlovid tested negative. Then a few days later tested positive and symptoms started again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Took Paxlovid tested negative. Then a few days later tested positive and symptoms started again) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Took Paxlovid tested negative.         No information on concomitant medication was reported. Few days later after taking Paxlovid, on 01-Jun-2022, the patient tested positive and symptoms started again. The outcome for "tested positive and symptoms started" was recovering/resolving. No treatment medication given for "tested positive and symptoms started" post treatment with Paxlovid.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious  event of Covid-19. The event occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Patient tested negative. However few days later symptoms started again. No other information surrounding the event was reported. The outcome of the event was reported as resolving. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected non-serious  event of Covid-19. The event occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Patient tested negative. However few days later symptoms started again. No other information surrounding the event was reported. The outcome of the event was reported as resolving. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Child had swollen eyelid on left eye and pain similar to a headache behind her swollen eye. Treated with OTC eye drops, ibuprofen for pain, and a cool pack on the eye. The swelling lasted for five days, and subsequently resolved. Parents declined to continue the vaccine series fearing a more significant reaction with a second  dose.
SEVERE PAIN IN LEFT ARM, FOR A YEAR, CAN'T SLEEP ON THAT SIDE, MEDICATIONS NAPROXEN, X-RAYS.
sore injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore injection site shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore injection site shoulder). At the time of the report, ARTHRALGIA (sore injection site shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-138767 (Patient Link).
4 kidney stones in 3 weeks.  Never had kidney stones before,  have not had any since.
After the second vacination I started to get ringing in my ears and was diagnosed with Tenitis.
Sight is hard and continues to be red and the circle is getting bigger.   Bad headache, body/joint aches, chills,  fatigue.
Severe welts on both arms torso breasts legs. These lesions are extremely itchy and lumpy. They have spread to cover most of my body.
For two days I experienced fever and chills with the highest at 99.7, headache, tiredness. Stomach felt like someone had punched me.
shingles; itchy rash over left breast, shoulder, back and abdomen; "red ring" around the site of injection,which doubled the size the next day; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), RASH PRURITIC (itchy rash over left breast, shoulder, back and abdomen) and INJECTION SITE ERYTHEMA ("red ring" around the site of injection,which doubled the size the next day) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA ("red ring" around the site of injection,which doubled the size the next day). On 10-Feb-2021, the patient experienced RASH PRURITIC (itchy rash over left breast, shoulder, back and abdomen). On 19-Feb-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles), RASH PRURITIC (itchy rash over left breast, shoulder, back and abdomen) and INJECTION SITE ERYTHEMA ("red ring" around the site of injection,which doubled the size the next day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication for shingles steroids
Within 12 hours, severe muscle pain and limited range of motion in neck and upper back; lasted the first time 24 hours, 2nd dose, it lasted just about 14 hours before subsiding;  the 2nd dose landed me in bed all the next day with severe pain, feeling lethargic, at least one time, extremely diaphoretic and needed assistance back to bed.   The muscle/soft tissue pain was the most severe pain in may entire life.
DTaP given 1:30pm 4/28/04. Tylenol given 3 times in first 24 hours. Mild fever present each time (99-100 degrees approx). At 1:30am, pt woke me up crying. Temperature taken under arm 105.8 (Thermometer read 104.8). Gave Tylenol and let him hug a cool cup of water. Also placed wt washcloth on his head. Comforted and eventually fell asleep. I woke up at 4am and pt had normal temp (99 degrees). Continued to have mild fevers for another day. Tylenol controlled them. No inflammation at injection site.
Mother states child developed temperature > 102F. Rash noted on torso but resolved within 24 hours. Child was irritable for 1 week, post vax. No reaction from 1st set of shots.
A little tenderness in the arm; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported a side effect that she experienced after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine, with the first dose she stated she never get a reaction to the vaccine only a little tenderness in the arm. She received the second dose of the Pfizer-BioNtech Covid-19 vaccine (today) on 05Feb2021. She has not experienced any side effect to the second dose. She would like to know if this means that her immune system is not developing a strong immune response as in someone who has a reaction to the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vasovagal response, EMS monitoring for 15 minutes. Discharged home AAOx3, states feeling fine now.
Extreme pain in my right shoulder and upper right back began while I was sleeping.  Pain continued for about 1 week then I had a loss of strength in the arm and shoulder and winging of my right shoulder blade.  The condition was diagnosed as Parsonage Turner Syndrome.
Brief episode of throat tingling. NO other symptoms. No wheeze or stridor  on exam. Vital signs P 84, R18, BP 125/76, RA O2 Sat 99%. Patient observed for 30 min. NO worsening or return of symptoms and discharged from the observation area at the vaccination site.
BlurredVision, Dizziness, Tachycardia,  PATIENT REPORTED 'TUNNEL VISION, HEARING CHANGES, AND A CLAMMY/SWEATY FEELING'.  Narrative:  PATIENT WAS AT THE END OF 15 MINUTE OBSERVATION TIME (APPROX 7:59 AM) WHEN SHE REPORTED FEELING, SWEATY, CLAMMY, LIGHTHEADED, AND DIZZY. SHE REPORTED EXPERIENCING TUNNEL VISION AND HEARING CHANGES. PATIENT WAS MONITORED UNTIL 8:35AM. PATIENT AMBULATED ON HER OWN WITHOUT ASSISTANCE AND STATED SHE FELT BETTER BEFORE LEAVING THE CLINIC. VITALS WERE AS FOLLOWS. 8:02AM 128/90 98% 97P 8:09AM 117/85 98% 96P 8:15AM 126/80 97% 94P 8:20AM 122/84 97% 97P
I have recently been diagnosed with MS; Lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0689) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. No other vaccine in four weeks and other medication in two weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Right), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Right), administration date: 23Apr2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FF2593, Location of injection: Arm Right), administration date: 23Oct2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant) with onset Apr2022, outcome "not recovered", described as "I have recently been diagnosed with MS"; SYSTEMIC LUPUS ERYTHEMATOSUS (disability, medically significant) with onset Apr2022, outcome "not recovered", described as "Lupus". The events "i have recently been diagnosed with ms" and "lupus" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2021) Negative, notes: Nasal Swab; (Jun2022) Negative, notes: Nasal Swab; (Oct2021) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of multiple sclerosis, systemic lupus erythematosus.  Clinical course: Patient had recently been diagnosed with MS and also possibly Lupus. Stated that why would these two autoimmune diseases suddenly come on her at that stage of her life. Patient wished she had never gotten vaccinated. Her life, as she knew it, was over. No covid prior vaccination. Patient was covid tested post vaccination. No other vaccine in four weeks.  No other medication in two weeks.   No follow-up attempts are possible. No further information is expected.
patient developed a fever which lasted for a day; 1st dose:23May2021/2nd dose:06Jun2021; 1st dose:23May2021/2nd dose:06Jun2021; This is a spontaneous report from a contactable consumer.   An adult female patient of unknown age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 06Jun2021 as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: unknown) dose 1 via an unspecified route of administration on 23May2021 as, single for covid-19 immunisation. On 07Jun2021 (One day after the second dose of vaccination), the patient had fever which lasted for a day. The outcome of the event was resolved on 08Jun2021.  Information about lot/batch number has been requested.
09/4/2021- skin sensitivity, skin pain in back, nerve pain. 09/10/2021- blisters and rash and pain from left shoulder around breast. 09/10/2021 Went to the doctor.
Information has been received from registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient fainted, at the doctor's office, after being vaccinated with GARDASIL. The patient was monitored by the doctor and then released. At the time of this report, the patient had recovered. It was reported that the patient may have fainted because she had not eaten. No further information is available.
Sore arm; Fatigue; Nausea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0151) via an unspecified route of administration on 08Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced sore arm, fatigue, nausea and headache. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. The clinical outcome of the events sore arm, fatigue, nausea and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
swelling in the vaccination area, pain in the vaccination area the first day then pain in the whole arm up to the hand, pain in the body and head, soft stools but no diarrhea. duration 5 days.  Google translate was used
Information has been received from a dentist, via a company representative, referring to a female patient of unknown age. Her medical history, concomitant therapies and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot/batch, expiration date, dose and route of administration were not provided) for prophylaxis. On an unspecified date, the patient developed a rash. It was not specified how long after receiving ZOSTAVAX the patient developed the rash. It was reported that the patient sought medical attention (spoke with an unspecified physician). At the time of the report the outcome of rash was unknown. The reporting dentist did not rate the causality assessment between the rash and ZOSTAVAX. Additional information is not expected dentist refused to be contacted.
Night of Sep 6 body froze up-could not get out of bed w/o help. Could not left arms above head. Dr ordered brain scan to rule out stroke await results. Chiropractor. Scheduled appt w/neurologist upcoming.
101.9-degree fever, chills, and headache; fever continued for 24 hours and declined with periodic administration of Tylenol.
Patient received 2nd dose of Jannsen. Patient reported that he had not received 1st dose when 2nd dose was given. It was only when patient 2nd dose was registered into system that it was found that patient had already received a 1st dose.
Teammate had vaccine on 9/19/23, initially site was sore. Today, 9/21/23, woke up with grapefruit sized red, warm-to-touch, hardened, painful area around injection site. States pain is improving some throughout the day. Does not feel needs to be seen in OH at this time.
48 hours after the injection, patient reported feeling warm and having temperature of 99.8 orally.  Pt was extremely fatigued and  bedrest.  Patient treated self with ibuprofen.  No nausea, vomiting or diarrhea.  Arm was sore with no redness.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/5/21 (lot NA) Pfizer Dose 2 2/26/21 (lot NA) COVID Positive 11/2/21  11/2/21: This is a 66-year-old female with history of scleroderma, interstitial lung disease, pulmonary hypertension, chronic kidney disease stage 4 and chronic hypoxia on 3 L of O2 who presented with dyspnea. Patient has been having worsening shortness of breath along with fever, bilateral ear aches and productive cough for the past week. History was limited as patient is currently lethargic. According to ED staff, patient denied abdominal pain, chest pain or recent swimming. Patient has interstitial lung disease secondary to history of scleroderma and follows with pulmonology as outpatient. Patient was vaccinated against COVID-19.   In the emergency department, patient was found to be hypoxic and tachypneic and she was put on BiPAP with FiO2 of 75%. Patient tested positive for COVID-19. Labs showed a sodium of 132, creatinine of 3.69, proBNP of 1474, troponin of 0.04, WBC count of 12.1 and a D-dimer of 0.72. Chest x-ray showed extensive bilateral pulmonary fibrosis. Lung perfusion scan was negative for acute thromboembolic disease. Patient was given p.o. Tylenol, nebulizer treatments, dose I IV Levaquin, Solu-Medrol, lorazepam and IV fluids.  11/23/21: Patient is a 66-year-old female with history of scleroderma, interstitial lung disease, pulmonary hypertension, chronic kidney disease stage 4 and chronic hypoxia on 3 L of O2 who presented with dyspnea on 11/02/21.  Patient admitted for bilateral COVID 19 pneumonia and acute on chronic hypoxic respiratory failure. Hospital course complicated by worsening respiratory status status post intubation on 11/07/2021.  Patient continues to be critically ill.  Patient was treated with IV antibiotics, bronchitis, Solu-Medrol and Flolan was started.  Patient continues to be critically ill.  Goals of care was discussed with family and patient was made comfort care.  Patient deceased, time of death 11/23/21 17:39. Family was at the bedside.
This spontaneous report as received from a 71 year old male patient, reporting on his wife, who on 05-APR-2013 was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On an unknown date his wife experienced a small red rash around the injection site "for a few days after which has since disappeared". This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a female who was vaccinated with a dose of Gardasil.  The patient after receiving the vaccine fainted.  The patient came to and was fine.  It was unknown whether medical attention was sought.  The patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007.  Information has bee received from a health professional concerning a female who was vaccinated with the first dose of GARDASIL (lot# 658558/1061U).  The patient fainted within 10 minutes after receiving the vaccine.  The patient recovered well after resting.  No treatment required.  No product quality complaint was involved.  Additional information has been requested.
Initial symptoms (11/27/2021): 1. Urticaria on scalp, ears, neck, arms, chest, back, stomach, legs, genitals, perianal area, hands, and feet. 2. Arthralgia in arms, hands, and feet. 3. Pain 6/10. 4. Edema of feet and hands.  Initial treatment (11/27/2021): Diphenhydramine q 4 and 20 mg prednisone per day for 4 days.  Pain, edema, and arthralgia worsened on 11/28/2021. Updated treatment (11/28/2021): Prednisone 60 mg per day for 4 days, then 40 mg per day for 4 days, then 20 mg per day for 4 days, then 10 mg per day for 4 days. Betamethasone ointment to be used sparingly on most painful areas. Diphenhydramine, Famotidine, and Cetirizine daily or as needed. December 1 symptoms: Urticaria mostly resolved, edema resolved, pain improved, arthralgia in arms persists, and the onset of difficulty swallowing, dizziness, lightheadedness, and mild altered mental status. December 10 symptoms: Urticaria mostly resolved, edema resolved, arthralgia resolved, difficulty swallowing resolved,  pain resolved, dizziness resolved, lightheadedness resolved, and mild altered mental status mostly resolved.
Rec'd dose of ZOSTAVAX on 6/28/11. Broke out in shingles type rash on 7/18/11 - thoracic area. Notified & saw PCP. Called our agency to report.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient got both his COVID vaccine and flu shot and after getting up and putting on his coat he become lightheaded and fell to the floor. He hit his head on the floor and cut his face. He was going in and out of consciousness so we called an ambulance. he was taken via ambulance to make sure he did not have a concussion.
PCR test: Positive; PCR test: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single and administration date 17Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab; (05Jan2022) negative, notes: Nasal Swab.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported SARS-COV-2 TEST POSITIVE after COVID-19 immunization is considered VACCINATION FAILURE of BNT162B2, and the Company cannot exclude the possible causality between the reported event and BNT162B2 administration.
NONE THAT AWARE OF PATIENT WAS GIVEN MMR IM WHICH SHOULD HAVE BEEN SUB Q.