chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive; Fell and hit her head and hit her back; Face was bruised all on the side and she "was all messed up"; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus and Multiple sclerosis (primary progressive multiple sclerosis). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive) (seriousness criterion medically significant), FALL (Fell and hit her head and hit her back) and CONTUSION (Face was bruised all on the side and she "was all messed up"). At the time of the report, MULTIPLE SCLEROSIS (She further stated that "it was like the vaccine just kicked up (her) MS and took her legs from under her" positive), FALL (Fell and hit her head and hit her back) and CONTUSION (Face was bruised all on the side and she "was all messed up") outcome was unknown.            No treatment details reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-291888 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient presented to the pharmacy on 10/11/2017 stating on 10/10 he had a low grade fever of 100 and redness covering whole upper arm.
On Saturday about 10:30 am noticed rash on her stomach and continued to get bigger and redder. Today has an irritated flat red rash over both sides of abdomen. None noted elsewhere.
slightly headache; Minor fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in left arm on 18Mar2021 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and depression. The patient was allergic to drug DEMEROL. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration left arm on 25Feb2021 at 12:15 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), losartan (MANUFACTURER UNKNOWN), Liothyronine (NP THYROID), vitamin D (MANUFACTURER UNKNOWN), strontium (MANUFACTURER UNKNOWN) all started from an unknown date and for unknown indications. On 19Mar2021 at 05:30, the patient experienced slight headache for 36 hours and minor fatigue for 12 hours, both started about 12-14 hours after second dose. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache and fatigue was resolved with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
11-11-13: PNEUMOVAX 23 shot given. Few hours later arm sore and couldn't lift. 11-12-13: After an eye doctor appt stopped in and RPh told him to go to doctor. Went home, changed clothes, noticed arm was red and swollen. Went to doctor. Put on antibiotic and antihistamine. 11-14-13: Getting better. 11-19-133: Doing well.
This spontaneous report as received from a pharmacist via company representative refers to a 78 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # M041086, expiry date: 31-JAN-2018) (route: subcutaneous) reconstituted with DILUENT (unknown Lot/Exp). On an unknown date, (reported as 2 weeks later), the patient experienced itchy rash that looked like dermatitis on one side of his back. VZV packet not offered. The patient did not seek any medical attention. The outcome of the events was reported as not recovered. The causality of the events was unknown. Additional information has been requested.
major infection; molar abscess; This is a spontaneous report from a contactable consumer reporting on behalf of her friend. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included oral surgery. Concomitant medications included clindamycin hcl taken for an unspecified indication, start and stop date were not reported; glucose, metronidazole (METRONIDAZOLE & DEXTROSE) taken for an unspecified indication, start and stop date were not reported. The patient experienced she was having major infection on an unspecified date. Clinical course reported as: Patient had an oral surgery done and had a implant placed on March 17, she was on antibiotic and on March 24 she received her first dose of the Pfizer covid vaccine. Patient was having problem her implant, it had to be removed, she was having major infection, had to drain the abases in the moth. She had another molar abscess that would be extracted. Outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hot like you can cook on it; Her arm is red, black and blue; Feverish; Her arm is swollen; Red to her elbow, her arm is red, black and blue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (Hot like you can cook on it), INJECTION SITE DISCOLOURATION (Her arm is red, black and blue), PYREXIA (Feverish), INJECTION SITE SWELLING (Her arm is swollen) and INJECTION SITE ERYTHEMA (Red to her elbow, her arm is red, black and blue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot like you can cook on it), INJECTION SITE DISCOLOURATION (Her arm is red, black and blue), PYREXIA (Feverish), INJECTION SITE SWELLING (Her arm is swollen) and INJECTION SITE ERYTHEMA (Red to her elbow, her arm is red, black and blue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Hot like you can cook on it), INJECTION SITE DISCOLOURATION (Her arm is red, black and blue), PYREXIA (Feverish), INJECTION SITE SWELLING (Her arm is swollen) and INJECTION SITE ERYTHEMA (Red to her elbow, her arm is red, black and blue) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included Ice.
No adverse reaction. Patient stated she only felt small bump on are where vaccinated and soreness on arm. No other symptoms.
severe itching; very severe rash on both arms, neck, and chest; started breaking a rash with blisters; tingling in arms and legs; skin was sensitive to the water of the shower; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arms and legs), SENSITIVE SKIN (skin was sensitive to the water of the shower), PRURITUS (severe itching), RASH (started breaking a rash with blisters) and RASH (very severe rash on both arms, neck, and chest) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Injection. On 01-Mar-2021, the patient experienced PARAESTHESIA (tingling in arms and legs), SENSITIVE SKIN (skin was sensitive to the water of the shower) and RASH (started breaking a rash with blisters). On 02-Mar-2021, the patient experienced PRURITUS (severe itching) and RASH (very severe rash on both arms, neck, and chest). On 01-Apr-2021, PARAESTHESIA (tingling in arms and legs), SENSITIVE SKIN (skin was sensitive to the water of the shower), PRURITUS (severe itching), RASH (started breaking a rash with blisters) and RASH (very severe rash on both arms, neck, and chest) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
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.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood Pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Rebound covid; (09Sep2022) Positive, notes: Rebound covid Positive test three days after completeing Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Adverse event: Rebound covid Positive test three days after completeing Paxlovid treatment. The patient did not have Known allergies. Patient did not receive any Other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning her 2 year and 9 month old daughter who was "previously" vaccinated with a dose of VARIVAX (Oka/Merck).  It was reported that the patient developed pustules and a mild case of chicken pox after her sister received her injection of VARIVAX (Oka/Merck).  The outcome of the patient was not reported.  The patient's sister developed a mild rash after receiving VARIVAX (Oka/Merck) (WAES 0811USA02164).  Additional information has been requested.
Fatigue, loss of appetite, muscle pain in legs and hips.  Pain and spots in vison in left eye, still happening three weeks later.
UNPLEASANT BUT NOT TOO BAD; PERSISTENT HEADACHE; SEVERE ACHE; SEVERE FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 28-APR-2021, the subject experienced severe ache. On 28-APR-2021, the subject experienced severe fever. On 29-APR-2021, the subject experienced unpleasant but not too bad. On 29-APR-2021, the subject experienced persistent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe ache, and severe fever on 29-APR-2021, had not recovered from persistent headache, and the outcome of unpleasant but not too bad was not reported. This report was non-serious.
itching at site of injection; 3 and a half by 3 inch red swelling area " at site of injection; (area)swelling; extreme itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at site of injection), INJECTION SITE ERYTHEMA (3 and a half by 3 inch red swelling area " at site of injection), SWELLING ((area)swelling) and PRURITUS (extreme itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced INJECTION SITE PRURITUS (itching at site of injection), INJECTION SITE ERYTHEMA (3 and a half by 3 inch red swelling area " at site of injection), SWELLING ((area)swelling) and PRURITUS (extreme itching). At the time of the report, INJECTION SITE PRURITUS (itching at site of injection), SWELLING ((area)swelling) and PRURITUS (extreme itching) outcome was unknown. Not Provided      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.
89 y.o. female with a history of TIA, hypertension,     and breast cancer who presents with fatigue onset on 9/23/2021 She received her COVID vaccine at 10AM on 9/22/21 Husband states that the patient "collapsed" while walking with him. No     history of Parkinson's disease. She did not obtain any injuries. Reports that     she has has a similar collapsing episode about 2 years ago. Denies chest pain,     shortness of breath, nausea or vomiting.
Redness, swelling, pain, itching, and hives. No treatment needed as it is resolving on its own.
Dizziness, then redness and pain at injecion site, later in the day progressed to severe headache and neck and back pain, spreading to ribs and it hurts to breathe.  I am still having a lot of pain and headache. They gave me the Flu vaccine for age 65 and older.
Red big spot at site of injection, kind of hard in the center; no pain but Itches at the red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red big spot at site of injection, kind of hard in the center) and INJECTION SITE PRURITUS (no pain but Itches at the red spot at the injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red big spot at site of injection, kind of hard in the center) and INJECTION SITE PRURITUS (no pain but Itches at the red spot at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red big spot at site of injection, kind of hard in the center) and INJECTION SITE PRURITUS (no pain but Itches at the red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient did not use any treatment medications for the symptoms.
Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (pain in my lower left stomach) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (pain in my lower left stomach). At the time of the report, ABDOMINAL PAIN LOWER (pain in my lower left stomach) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
passed out immediately after dose administered and began to seize. bubbling at mouth and stuttering. seizure lasted ~1 minute and she became unsconcious. EMS was called. arrived 15 min later
Developed tremor 24 hr after receiving vaccine. Pt seen 1/15/15 and reports tremor improving.
Patient presented to the ED and was subsequently hospitalized for complete intestinal obstruction within 6 weeks of receiving COVID vaccination.
Approximately 48 hours after administration, patient noticed a red bump at the injection site. She drew dots around the red area, and the next day, it had expanded about 11/2 inches up to the size of a hockey puck. It was red, burning, and painful. She consulted on online prescriber who prescribed Cetirizine 10mg. Bump is still sore today but has decreased in size by half.
First ever complex migraine with aura including right visual field deficits, tingling of the right hand and and right side of the mouth and difficulty speaking over the course of an hour that then resolved and was followed by a severe migraine headache when nausea.  My migraines have never been associated with aura, paresthesias, etc., before.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Within 24 hours entire upper arm was erythematous, swollen and area around injection site was hard to palps - No fever. By about 36 hours erythema had extended down forearm and into chest.
reaction to her first dose of Moderna COVID19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to her first dose of Moderna COVID19 Vaccine) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to her first dose of Moderna COVID19 Vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to her first dose of Moderna COVID19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported
ON 9/24/2020 PATIENT CONTACTED THE PHARMACY AND SPOKE WITH PHARMACIST TO REPORT HER ARM HAS "NO RANGE OF MOTION" AND "FEELS FROZEN." PATIENT STATED THE PHARMACIST "GAVE THE SHOT TOO HIGH" UP IN THE ARM. PATIENT ALSO STATED SHE HAD A CALL INTO HER PHYSICIAN.
Child in health center with brother who is being seen today. Mother mentioned area of redness on child's thigh at injection site of 8/6/03. Area is red, indurated, cool to touch, about dime size. Does not appear painful to touch.
Prolonged crying episode with fever about 3-4 hours after given 3 shots, Pediarix, Hib, Prevnar.
This case was reported by a consumer and described the occurrence of injection site pain in a 82-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (Refer case US2018GSK165025). On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On 9th September 2018, the patient experienced malaise, nausea, myalgia, chills, sweating and fever. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the injection site swelling, malaise, nausea, myalgia, chills, sweating and fever were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, malaise, nausea, myalgia, chills, sweating and fever to be related to Shingrix. Additional details were provided as follows: The patient experienced pain at injection site, redness, swelling. The patient used ice externally. On 8th September 2018, the pain and redness remain at injection site. On 9th September 2018, 2 days after vaccination, the patient experienced malaise, nausea, myalgia in extremities, chills, sweating, fever with body temperature of 101.4 degree F. Swelling and redness at injection site was continued and remained unrelieved with topical ice.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # L008574, expiration date 22-NOV-2016 or lot # L027719, expiration date 28-APR-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of minimum 34 degrees Fahrenheit for 12 hours and a maximum 50 degrees Fahrenheit for 12 hours. It was reported that the patients sought unspecified medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Within less than 24 hours after the first injection, patient went into tachycardia with heart rate 117 -120 for 2 weeks. After the second dose which patient was encouraged to get from their clinic, his heart rate went in excess of 139 for 1.5 weeks and he ended up in hospital for one week. Per patient's report, despite all treatments, they were only able to get his heart rate back to around 117. He was discharged home in tachycardia. Then, without change, 6 weeks after his second dose and being perpetually in SVT, patient's heart rate dropped into the 50s and has remained bradycardic. These have been the first changes in patient's last 5 years of daily heart rate logs since being diagnosed with paroxysmal a-fib in 2016. This has been unlike patient's history and a frank change in his heart rate and lots. Patient also reports having multiple whelps all over his lower abdomen since the injections.
Started experiencing pains in my left buttock and sometimes shooting down the outer left thigh a little bit.  Went to the doctor today and he said it was the left side sciatica nerve.   I have never had this problem in my life and had no recent injuries to cause this.   And it was very coincidental that it came on the afternoon of the day I received the vaccine