chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dermatomyositis; muscle weakness/ muscle weakness in the arms and leg; a red skin rash around the eyelids and red bumps around the joints; This case was reported by a lawyer and described the occurrence of dermatomyositis in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than a month after receiving Shingrix, the patient experienced dermatomyositis (serious criteria GSK medically significant), muscle weakness and rash. The action taken with Shingrix was unknown. On an unknown date, the outcome of the dermatomyositis, muscle weakness and rash were unknown.   It was unknown if the reporter considered the dermatomyositis, muscle weakness and rash to be related to Shingrix.  Additional details: The patient received Shingrix first dose unknown and second dose was approx. December 2019. On approx. January 2020 patient experienced Dermatomyositis was an autoimmune condition that causes skin changes and muscle weakness. Symptoms can include a red skin rash around the eyelids, red bumps around the joints, and muscle weakness in the arms and legs.
Chills; her body got real hot; Stomach ache; vomiting like dry heaving; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's wife) that:  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; FEELING HOT (non-serious), outcome "unknown", described as "her body got real hot"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; VOMITING (non-serious), outcome "unknown", described as "vomiting like dry heaving".  Additional information: Reporter stated he is calling about the COVID 19 vaccine. Reporter stated he is calling about his wife. Reporter stated his wife took the second shot yesterday at about 11 o'clock and around 4:30 yesterday his wife started having chills, her body got real hot, kind of had like a stomach ache and has been vomiting like dry heaving. Reporter asked how long is that going to last and when should he start to get worried.  Reporter Communication: Full details not obtained as reporter declined to proceed with report at this time. Informed reporter that Medical Information may be able to speak to if these symptoms are reported side effects from the vaccine but for medical advice a doctor may be the best person to contact.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1/11/2021 vaccination 28 hours later, I was sitting on the couch, and everything starting shifting to the left and spinning. Lasted a 1-2 minutes, HR increase, and became diaphoretic. Stayed in bed rest of the day; lightheadedness. I called my PCM the next day and I said is this something I need to be seen? Informed to cb if still felt this way.  2/19rd recurred episode with same symptoms.  2/22 I saw the Dr; ordered on MRI *have had a couple more episodes since; occurring on Left side.
MA gave an expired HepB vaccine on 04/06/2022. MA did not looked at the expiration date before giving the vaccine she notice the expiration date when she was documenting the vaccine on the patients chart. After MA gave the expire vaccine she inform me about the incident. I talked to MA about the importance of always following the seven rights: 1. Right patient 2. Right vaccine/diluent 3. Right route 4. Right time 5. Right site 6. Right dosage 7. right documentation. I also reminded MA the next step to take after the incident. The next step after the incident is to call the parent of patient and inform her patient was given an expire vaccine and she will have to bring patient in for revaccination. MA called parent to schedule patient for revaccination, parent gave verbal understanding of information given and stated she will call back to schedule appointment.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.   This case was linked to (Patient Link).
Fever, N & V, cough, itching, sneezing, wheezing about 3 hrs after shots respiratory symptoms gradually improving.
2 red itchy blotches that looked like an allergic reaction that appeared under the injection site.  The areas were extremely itchy and they burned.
First vaccine. Arm had 3 large hive like spots that were swollen and red and itchy. Started Thursday March 4 and completely disappeared by Monday  March 8.
I have also developed arthritis in my ankles, knees and wrist since that time; Schambergs Capartis on both legs.; rash to both legs; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Mar2021 (Lot number: EN6205) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Problems", start date: 2014 (ongoing); "Contrast Dye" (unspecified if ongoing); "Hypertension" (ongoing); "chest pains" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "triple bypass", start date: 2015 (unspecified if ongoing); "back pain", start date: 1979 (ongoing); "fell-ruptured lumbar disc" (unspecified if ongoing). Family history included: "breast cancer" (unspecified if ongoing), notes: Grandmother+3 sisters diagnosed with breast cancer,; "stroke" (unspecified if ongoing), notes: Father died as result of stroke. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=Em9810,, lot unknown=False,, administration date=11Feb2021, dose number=1, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 11Feb2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; RASH (medically significant) with onset 07Jun2021, outcome "recovered", described as "rash to both legs"; ARTHRITIS (non-serious) with onset 15Aug2021, outcome "not recovered", described as "I have also developed arthritis in my ankles, knees and wrist since that time"; CHRONIC PIGMENTED PURPURA (non-serious) with onset 15Aug2021, outcome "not recovered", described as "Schambergs Capartis on both legs.". The events "joint pain", "rash to both legs" and "i have also developed arthritis in my ankles, knees and wrist since that time" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia. Therapeutic measures were taken as a result of rash, arthritis, chronic pigmented purpura.  Clinical information: The patient did not receive any medication within 4 weeks prior to vaccinations. The patient did not have covid prior to vaccination. The patient did not test positive for Covid post vaccination. The patient received 3rd dose (Batch/Lot: Pfizer booster 33030BN) of injection on 26Nov2021 administered in Left Arm.   No follow-up attempts are possible. No further information is expected.
Two days after vaccinations, was seen in the office complaining of chills, headache and fever as high as 104 degrees about 24 hours after vaccines. Symptoms resolved about 12 hours later. He also had redness at the injection site.
PT HAD SWELLING OF SHOT AREA WITH REDNESS AND SOME WARMTH. PT APPLIED ICEPAK AND SOME BENADRYL ALSO SUGGESTED SOME IBUPROFEN.
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL.  The patient had been hospitalized four times after receiving GARDASIL.  No further information is available.
Redness, itching, and swelling at injection site; soreness of arm that began the evening of the date of vaccine and grew more intense until beginning to subside 4 days after vaccine. I continued to use my arm normally as much as possible and took Tylenol at night. Today, the 8th day after receiving the vaccine, the injection site is still slightly sore to the touch.
@0825am received Dose #2 of Pfizer, resting/lying  on the gurney. (due to the experience/adverse reaction from Dose #1), water offered. @0835am pt C/o HA, ice pack offered w/ mild relief. still lying on the gurney.  @0845am noted pt's voice changed, + coarse/weak, + episode of dry coughing, + "weird feeling inside throat but breathing fine", + HA, + severe fatigue, but denies Dizzniess/N/V/epigastric pain.  VS: 36.8(o), 85, 151/95, 20. 99%RA, no s/s of resp distress/swelling/rash noted. pt continue to resting/lying on gurney   @0900am pt 's voice slowing returning, coughing less, + HA,  continue to deny N/V,dizziness,epigastric pain. pt states "feeling a bit better but very tiring". VS: 36.8(o), 79,140/93, 20, 99%RA, no s/s of resp distress/swelling/rash noted. pt continue to rest on gurney.   @0915am pt asleep, no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 77, 139/93,18,98%RA  @0930am pt asleep,  no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 76, 138/91,20,97%RA  @0945am pt asleep,  no coughing noted. no s/s of resp distress/swelling/rash noted. VS: 79, 130/90,20,98%RA  @10am pt woke up and claimed feeling a lot better, no more HA, no more weird feeling inside throat. + tiredness, but much better. VS: 78, 138/92, 20, 98%RA RN recommends pt to rest at home. strict return precaution explained and discussed.
This case was reported by a consumer (also the subject) and described the occurrence of swelling at injection site in a 31-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), TETANUS vaccine (Unknown manufacturer). A physician or other health care professional has not verified this report. The subject's medical history included seizure disorder. Concurrent medical conditions included high blood pressure. Concurrent medications included Blood pressure medication. On an unknown date in January 1998, approximately 1988 and 1984 the subject received unspecified doses of TETANUS vaccine (details unknown). On 19 November 2007 at 14:00 the subject received a dose of BOOSTRIX (unknown route, right arm). One hour after vaccination with BOOSTRIX, the subject experienced swelling at injection site that was approximately 1.5 inches tall and 3 inches round. The injection site reaction remained for approximately 4 weeks. One week after vaccination with BOOSTRIX, the subject experienced joint stiffness in every joint of his body, pain in all joints, muscular fatigue and muscle aches. The swelling at injection site resolved in December 2007. The joint stiffness, joint pain, muscular fatigue and muscle pain were unresolved at the time of reporting. The consumer reported that all blood work remains negative and no diagnosis has been made. The consumer also reported that he had experienced similar reactions after previous tetanus vaccinations in 1984, 1988 and January 1998, but that this reaction has been the most severe. He stated that he was hospitalized after previous tetanus vaccinations due to these symptoms. The consumer reported that he now has daily scheduled appointments with his doctor but has not been hospitalized.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Large red shingles appearing rash measuring approximately 8" down arm, very painful but not blistering. "Road rash" appearance at four days post injection. Fever accompanied symptoms for 3 days. Unable to work due to rash and fever presence and possibility of transmission.
Became almost bed ridden for two days. Headache, neckache. weak. Unable to walk very far without  sitting down and catching breath on oxygen due to COPD and Emphysema. Breathing much worse. Tested my self for Corona Virus and that was negative. Unable to sleep as well also. Started to recover a little on the fifth of Oct. Am feeling much better today on the Seventh of Oct.
Shortly after vaccination, patient became itchy on arms, neck, back and legs. No hives or swelling noted. No difficulty breathing. 5:45 pm 50 mg BENADRYL given with good effect. 5:48 pm BP 142/96, P 84. 6:02 p, BP 142/80, P 82. after approx 30 mins, patient was feeling better and left for home with daughter at 6:15pm.
Tightness in the chest; Throat itchiness; Tongue itchiness; Night flashes; This is a spontaneous case reported by other health professional to Med Communications (Case: SEQ19-04742) and initially retrieved on 15-Oct-2019, concerning a 63-year-old, female patient.  Patient's medical history included egg allergy and no concomitant medications were reported.  On 01-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 259811 and expiration date: 30-May-2020] for prevention of influenza.   On 02-Oct-2019, the following day after vaccination, patient experienced the following symptoms: tightness in the chest, throat and tongue itchiness, and night flashes.  The outcome of the events was not reported, at the time of the initial reporting.  The reporter assessed the case as non-serious, but did not provide causality.  Non-significant follow-up reported by other non health professional from Med Communications [reference number: SEQ19-05587] on 14-Nov-2019: Additional Med Communications reference number added. No changes in narrative.  Company comment: The patient experienced chest discomfort, throat irritation, oral pruritus and night sweats after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
The patient received both Moderna 4th dose and Pneumovax 23 on 4-18-22 and she complained about her left upper arm hurting on that evening and again on the following day , husband is saying that he left her for couple pf hours and came back home found her whole body shaking especially her arms "she was waving them fast and out of control" she ended up at ER
H/A, Myalgia, Chills, Weakness, Redness at injection site that spread up arm, Nasal congestion.
Lost strength on his arm. Started to get a lot worse after getting the booster shot; Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-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 MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot). At the time of the report, MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot) had not resolved.            No Concomitant information was reported. No Treatment information was reported.  It was reported that arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone and it's been months. The pain is constantly there during the day and it becomes more intense during night time when he is resting.  Started a couple of days after the 2nd dose and it started to get a lot worse after getting the booster shot.   This case was linked to MOD-2022-474346 (Patient Link).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent diseases, drug allergies/reactions and concomitant therapies were not reported. On 30-JAN-2019, the patient received a dose of ROTATEQ lot # N012757, expiry date: 27-JAN-2019; given orally for prophylaxis. Patient had no known adverse effects. Product quality complaint was not involved.
I've had diarrhea for 10 weeks since receiving my latest booster; I've lost 13lbs in the last 10 days. I have an appointment with my physician to find a diagnosis and proper resolution. They conducted stool tests which all came back negative for any pathological infections or parasites.
Fell in the kitchen; Bruise on her arm; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell in the kitchen) and CONTUSION (Bruise on her arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FALL (Fell in the kitchen) and CONTUSION (Bruise on her arm). At the time of the report, FALL (Fell in the kitchen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: There is not enough information to assess the relationship between the event of fall and the administration of mRNA-1273.  Critical details such as the patient's medical history and latency from onset of the event to vaccine administration is lacking.  the bruise resulted from the fall and is assessed as unlikely related to product use.  All events are confounded by the patient's advanced age.
The physician told the field employee that a patient experienced syncope after receiving her second dose of GARDASIL 9; This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.     On 11-JUN-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, strength, lot # and expiration date were not provided) for prophylaxis.         The physician stated that, on the same date, the patient experienced syncope. The patient recovered on the same date after "seconds or a few minutes" later. The patient sought for medical attention, however it was unknown if any treatment was provided.  The physician spoke with the patient's family on 14-JUN-2021 (reported as "yesterday"), and the informed the patient was doing fine. Causality between the reported event and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, syncope was determined to be medically significant.
Patient was very nervous (crying) before vaccinations began. After last vaccination, patient appeared to begin to faint in chair--color faded in face, sweat broke out on forehead. Wet paper towels and cold packs were applied by nurses, cold water was given to patient to sip and lollipop which patient kept in mouth by holding with hand. Patient remained seated in treatment room for >45 minutes. Offered to call 9-1-1 but parents refused. Mother and stepfather were with child entire time. After patient stated he was feeling better, nurse walked him out to waiting area where he remained seated with parents nearby. After approximately 5 minutes in waiting room parents walked with him out to vehicle where family entered vehicle and left without incident.
knot in her arm around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (knot in her arm around the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A214) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE INDURATION (knot in her arm around the injection site). At the time of the report, VACCINATION SITE INDURATION (knot in her arm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI- contact info provided