chrisvoncsefalvay/vaers-outcomes huggingface dataset:
contracted Covid after vaccination; contracted Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "contracted Covid after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pain scale of 8; Swelling of joints/ ankle/ wrists/both elbowPelvis; Swelling of 4th and 5th finger on Right Arm/feet/ behind ears/limbs are quite swollen; Feels like its killing me; Inflammation levels are elevated; Low grade fever: 100F for 24hours/ sometimes low grade fever of: 100F for a couple of days; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain scale of 8), JOINT SWELLING (Swelling of joints/ ankle/ wrists/both elbowPelvis), PERIPHERAL SWELLING (Swelling of 4th and 5th finger on Right Arm/feet/ behind ears/limbs are quite swollen), FEELING ABNORMAL (Feels like its killing me) and INFLAMMATION (Inflammation levels are elevated) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 04OA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Monoclonal gammopathy, Rheumatoid arthritis, Sjogren's syndrome, Latex allergy, Allergic reaction to antibiotics (tetracycline), Allergic reaction to analgesics ( morphine), Drug allergy (statins) and Autoimmune disorder. Concomitant products included CARISOPRODOL (SOMA [CARISOPRODOL]) for Pain, LORAZEPAM for Sleep difficult, AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), VITAMIN D NOS, THYROID, GABAPENTIN, VITAMIN C [ASCORBIC ACID], Vitamin B6, VITAMIN B12 NOS, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), EVOLOCUMAB (REPATHA) and SECUKINUMAB (COSENTYX) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Pain scale of 8), JOINT SWELLING (Swelling of joints/ ankle/ wrists/both elbowPelvis), PERIPHERAL SWELLING (Swelling of 4th and 5th finger on Right Arm/feet/ behind ears/limbs are quite swollen), FEELING ABNORMAL (Feels like its killing me), INFLAMMATION (Inflammation levels are elevated) and HEADACHE (Bad headache). 13-Apr-2021, the patient experienced PYREXIA (Low grade fever: 100F for 24hours/ sometimes low grade fever of: 100F for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 mg every eight hours. At the time of the report, PAIN (Pain scale of 8), JOINT SWELLING (Swelling of joints/ ankle/ wrists/both elbowPelvis), FEELING ABNORMAL (Feels like its killing me), INFLAMMATION (Inflammation levels are elevated), PYREXIA (Low grade fever: 100F for 24hours/ sometimes low grade fever of: 100F for a couple of days) and HEADACHE (Bad headache) outcome was unknown and PERIPHERAL SWELLING (Swelling of 4th and 5th finger on Right Arm/feet/ behind ears/limbs are quite swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment also include Motrin 600 mg.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Outcome of event updated for peripheral swelling.
Sudden onset of significant acquired torticollis about 6 hrs after injection requiring an inability to sleep due to pain, significant pain.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with ROTATEQ (dose, lot# were not reported) which were exposed to temperature excursion of 59F for 15 hours. No Product Quality Complaint (PQC) was involved. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
immed p/vax pt exp hives face;hives lasted 1/2hr;no resp diff;MD on call notified & instructed for mother to give pt DPH
The day after receiving the 2nd Moderna shot, the injection site and surrounding area started itching, and upon inspection noted a red bumpy, slightly raised rash had formed that was approximately 8 inches by 4 inches in size. It had a raised edge. Today it is much better but still noticeable, just not as itchy.
I started having sore throat, postnasal drip, fever (100-101), runny nose, cough, body pain and bone discomfort. I went to urgent care, and they were closed then I went again on Monday. I was given albuterol inhaler, azelastine, benzonatate, lidocaine, prednisone, and ipratropium. It is helping and I started recovering over the course of three days. I am surprised that I got COVID-19 30 days after getting the vaccine.
I think it is unrelated to the vaccine, but provide this information out of an abundance of caution. Around 10 days after received vaccine, developed pain around rib case and a rash that resembles mild case of shingles, and that is in same location and with same symptoms as with prior bouts of shingles that I have had over the years.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergic to erythromycin. On 20-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date, indication not reported, 0.65 ml, subcutaneously). On 20-JAN-2014, patient began vomiting every 20 minutes for two days, losing 4 pounds and necessitating a visit to her local emergency room. The reporter had no information regarding treatment provided at emergency room. The patient had had continuing headaches in January 2014 and had missed work. The patient's physician told her that should not have been administered the ZOSTAVAX as she had noted allergy to erythromycin. The outcome of the events was unknown. Additional information has been requested.
oral Lichen Planus; I have Lichen Planus (LP), an autoimmune disorder.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 1, Left arm), administration date: 04Mar2021, when the patient was 38 years old, for Covid-19 Immunization, reaction(s): "muscle pains", "muscle tinglings in the left arm bicep and both feet area". No other vaccine in four weeks. No covid prior vaccination. The following information was reported: LICHEN PLANUS (disability) with onset May2021, outcome "not recovered", described as "I have Lichen Planus (LP), an autoimmune disorder."; ORAL LICHEN PLANUS (disability) with onset Oct2021, outcome "not recovered", described as "oral Lichen Planus". The events "i have lichen planus (lp), an autoimmune disorder." and "oral lichen planus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: (May2021) lichen planus (lp); (Oct2021) oral lichen planus; sars-cov-2 test: (22Jan2022) negative. Therapeutic measures (Oral treatment) were taken as a result of lichen planus, oral lichen planus. Clinical course: The patient started observing several changes in his body. Around the end of May2021, the patient started observing some black spots on his face under the beard. He went to dermatologist for biopsy and found that he had Lichen Planus (LP), an autoimmune disorder. Around early October, the patient started feeling some burning sensations in his mouth. Later symptoms started getting worse and he was unable to eat even very very mild spicy food. Analysis of biopsy sample showed that he had oral Lichen Planus. The lot number for bnt162b2 was not provided and will be requested during follow up.
Extremely painful arm at injection site. Hives around the injection site. Extremely painful Gland under arm of injection site. Extreme Tiredness. Swelling of arm at injection site. Hot skin at injection site. Red raised rash at injection site.  Lasted about one week.  Took Ibuprofen and Amoxicillin 250mg. 3 times a day.
Tired for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired for 24 hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008F21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired for 24 hours). In December 2021, FATIGUE (Tired for 24 hours) had resolved.            Concomitant product information was not provided Treatment information was not provided   This case was linked to MOD-2022-441862, MOD-2022-441948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow up received and contains no new information
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. On 05-DEC-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose unknown) (lot # L026414, expiration date 15-OCT-2016) subcutaneously for prophylaxis. No adverse effects were reported. Additional information has been requested.
Nose extremely runny, slurred speech, short of breath, high blood pressure 190/100, 2 months after had 2 AFIB attacks (closer than usual)
fever; chills; nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A 53-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL9267; Expiration Date: May2021), intramuscular, administered in Arm Left on 10Feb2021 11:30 ,at the age of 53 years old,as dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever, chills and nausea on 11Feb2021 03:00. Therapeutic measures were taken as a result of fever, chills and nausea.Additional Context: Received a call from consumer or patient herself who reported regarding the Pfizer COVID vaccine. She took it yesterday and she had a fever all night, chills and nausea. Her fever went to 102. She took Motrin twice. Nothing seems to be helping. She did not provide a dose, lot or expiration for the Motrin. She would like to know how long this process will last. The chills are unbearable.The patient provided the details of the 2nd dose of Pfizer covid19 vaccine.She also provided number # on the vaccine card as well. Vaccination facility was reported as specialty hospital.The patient previously received her 1st dose of Pfizer covid19 vaccine on 20Jan2021,Lot EL9261, expiration May2021.The outcome of the events was not recovered. Follow-up (11Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that patient age was reported to be 53 years old,weight 108.86 kg,Height (cm): 175 and gender female.start date of reaction was reported to be 11 feb2021.The patient reported about the events chills,nausea and fever.The patient also provided her 1st dose of vaccination date.The patient also reported about product complaint that is : She took Motrin twice and nothing is helping. She still has a fever, chills and nausea. No further details provided. additional lot no,product packaging details was unknown.  Follow-up (12May2021): Follow-up attempts are completed. No further information expected.
experiencing a high fever of over 101 degrees and he is being having that from most of the day, most of today; having trouble getting out of bed; Dizzy; feels like he is going to fall over if he walks; Chills; Headache; loss of appetite; her husband was very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 14Oct2021, outcome "unknown", described as "experiencing a high fever of over 101 degrees and he is being having that from most of the day, most of today"; MOVEMENT DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "having trouble getting out of bed"; DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Dizzy"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "feels like he is going to fall over if he walks"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; DECREASED APPETITE (non-serious) with onset Oct2021, outcome "unknown", described as "loss of appetite"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "her husband was very sick". The patient underwent the following laboratory tests and procedures: body temperature: over 101 degrees.  Additional information: Reporter stated that her call was about her husband who was 34 years old who go the second COVID vaccine and he just got the second Pfizer COVID Vaccine last night about 24 hours ago, he was experiencing a high fever of over 101 degrees and he was being having that from most of the day, most of today. So for just probably just after under 12 hours, he was having trouble getting out of bed, he was dizzy, he felt like he was going to fall over if he walks, he was having chills and headache and loss of appetite. The reporter was wondering if he was in good health over all and if someone would have any medical advice on how to deal with this because the patient was considering going to the hospital. Probed for LOT number: Reporter stated she did not have time to talk about anything but how to deal with this right now, her husband was very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 04-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Pt reported to the school nurse with rash that had started on her back and had spread to trunk, arms and legs.
This case was reported by a pharmacist via call center representative and described the occurrence of trigeminal neuralgia in a 76-year-old male patient who received SHINGRIX. On 23rd March 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced trigeminal neuralgia. The patient was treated with prednisone and antibiotics. On an unknown date, the outcome of the trigeminal neuralgia was not reported. It was unknown if the reporter considered the trigeminal neuralgia to be related to SHINGRIX. Additional details were provided as follows: The patient had a family history of trigeminal neuralgia. The patient experienced a gradual onset of trigeminal neuralgia pain. The patient did go to see his physician and was being treated at the time of reporting with antibiotics and Prednisone for the trigeminal neuralgia pain. The pharmacist said she was still unsure if the patient was actually diagnosed with trigeminal neuralgia. The pharmacist was unsure if vaccine was related to symptoms. The pharmacist did not have any additional details at the time of reporting.
Possible cellulitis of right upper arm 4 days after the administration of the vaccine.  Patient presented in the Emergency Department and complained of redness and pain at the injection site.  A 5x4 cm red area was noted on the right upper arm.  She was ordered on an oral antibiotic. She subsequently had 5 additional visits for this issue, 4 in the Emergency Department and one with her Primary Care Provider. A culture taken on 12/6/06 was negative for growth.  She reports that she has residual scar tissue in the are of the injection.   The individual reported that she had received the vaccinations in the same arm.  Medical record documentation indicates that she received the Influenza vaccine in the left deltiod and the Pneumovax vaccine in the right deltiod.
PT stated that when vaccine given it burned "alot". Experience no reaction at site. The following morning he reported to his mother he did not sleep well due to rapid heart rate and c/o pain in (L) chest and arm for 1 - 2 hrs. that AM. (PT did drink 1/4 bottle  mountain dew also) contacted family doctor next day - advised to file this even though he drank soda as he felt the rapid heart rate sensation before was not normal response. This inject was #1 and other are suspended. PT also experienced some SOB and fatigue after and has since had no other complaints.
Noticed irregular periods after my vaccination. My  regular cycle is 26 days. After my first dose my period is delayed by 7 days and after my second dose got an early period, with 18 days cycle. Periods are heavy and cramping is painful.
Emesis - no other symptoms reported - denied fever - recommended seeing walk-in care and to drink plenty of fluids
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-MAR-2013, the patient was vaccinated by a physician at office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUN-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Chills; Fatigue; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Long grade fever; This spontaneous report was received from a Registered Nurse and refers to a 64-year-old female patient. Information about the patient's medical history, concurrent conditions, or concomitant medications was not provided.   On an unspecified date, the patient had received an initial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   On 21-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramuscularly, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administration was not reported) for the prevention of pneumococcal disease.   After vaccination, the patient contacted the registered nurse to report that, on approximately 21-AUG-2020, her arm was red, hot, and swollen from elbow to collarbone.  was painful to touch and to move.  The patient also reported having a low-grade fever, chills, and fatigue.  It was mentioned that all the symptoms lasted "48 hours after vaccine".  The patient did not seek medical attention or receive any treatment for the aforementioned symptoms.   At the time of the report, the patient was recovered.  The reporter did not provide the causality between the aforementioned events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002598:
Started with a rash all over body on 04/28/04 and continues with the rash today May 2, 2995. The diagnosis has been MMR reaction. There is a rash that is red and itchy.