chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain / aches; Nausea; Normal levels of discomfort; Mild muscle aches in neck and back; tiredness; This case was reported by a consumer and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (20 years ago), cytomegalovirus infection, chickenpox (recurring monthly for 25 years) and post-traumatic stress disorder. Previously administered products included Antiviral (took a few monthly doses of an antiviral to manage breakouts of Post-traumatic stress disorder (PTSD)).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain, nausea, discomfort, muscle pain and tiredness. The patient was treated with acyclovir. On an unknown date, the outcome of the pain, nausea, discomfort, muscle pain and tiredness were unknown.   It was unknown if the reporter considered the pain, nausea, discomfort, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine resulted in the normal levels of discomfort, pain, aches, tiredness, and nausea. The patient's mother had rheumatoid arthritis (RA) the patient had the factor but it's not active. The patient had been battling recurring monthly trunk located chicken pox for 25 years after an initial stressful PTSD event for which the patient taken a few monthly doses of an antiviral to manage breakouts. Symptoms were lifting with medication for pain. She had recurrent viral attacks (Shingles) on right hip from a stressful event 20 years ago.  The patient was taking acyclovir to manage the outbreak as done for 20 years.  It was her hope the vaccine would prevent future breakouts since the acyclovir in her case seems like a life long medication.  It's odd, in her case it's almost a monthly occurrence about 30 days apart and also in between with added stress of any kind both physical and emotional. Most doctors were sort of baffled, her original diagnosis was cytomegalovirus for which the patient was told there was no cure. Following up with a specialist, she just looked at me and said he did not have that.  Her family Doctor prescribed acyclovir as a prophylaxis for breakouts but she only take it until symptoms disappear and until the next occurrence. She just thought it odd the vaccine, being recombant, through the severity of side effects ( she had the g3 level of all the side effects for 48 hours and then fortunately bounced back with the usual Shingles rash on her hip and back to taking acyclovir to manage as usual. It was her hope and prayer she never get a full blown event like the symptoms from the shot again after receiving the full vaccine or the actual severity of the classic Shingles, the type that wraps around the torso and effects the whole body.  The patient just hope that whatever she have eventually goes always completely. For tolerance in 2nd dose refer case US2020AMR211620.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211620:same patient, 2nd dose
Significant swelling of arm. Extensive redness. More than 'typical'. Fever like symptoms (more than first dose). Syncope.
Started with severe nauseanand quickly progressed where I had pins and needles in both arms and then I lost feeling in my arms and could not move either of my hands and they were spasming. I got up for help and collapsed and was seeing black patches. Went to ER right away.
After receiving the vaccines (days following) the patient pain in left jaw and ringing in left ear. Pt had tests done w/50% hearing loss in lft ear by a physician. MRI was clear.
vaccine 4/29/21 5/4/21 left arm red, painful, swollen and indurated
Describes "tingling" sensation, a burning pain, arm "feel's heavy", edema, bruising
started w/erythema of upper chest & lt arm 15mins p/inj;approx 30mins later c/o tightness of throat;contacted family MD, DPH given;
HPV was given in Right deltoid IM. Immediately after administration he slumped over, clenched eyes tight and his fists and left arm jerking for 2 seconds. Drs. came to room. Pulse ox 99 % on Room air, BP 90/58, Heart rate in the 50's.  Patient does not remember incident. Patient sat in room for 10 minutes, alert and able to leave office in stable condition.
A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 03-Dec-2013. The patient was inadvertently given an expired dose of FLUMIST which started on 03-Dec-2013. The outcome of the event of inadvertently gave an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Info has been received from a health care worker concerning a 38 year old female with reaction to aspirin who was vaccinated (date unknown), with MMRII. There was no concomitant medication. Subsequently, the pt failed to seroconvert after 3 vaccinations. The first when she was a year old, the second before starting college and a third before starting a job as a teacher after college. The pt sought unspecified medical attention. It was reported that the pt had a titer test. At the time of the report, it was unknown if the pt recovered. Additional info has been requested.
Patient developed painful genital ulcers two days after the second dose of her COVID-19 vaccine series. She was treated with pain control and symptoms self-resolved. She then developed recurrent genital ulcers in November 2021. She was again treated with pain control and started on Valacyclovir though HSV testing was subsequently negative.
Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer.   A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation.  Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration).     The patient's concomitant medications were not reported.  On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle.  On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown.   Information about lot/batch number has been requested.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 48 years old male patient who experienced was inadvertently given 0.5 ml vaccine MENACTRA (lot US5916AA and expiration date 27-Jun-2019) via subcutaneous route in the right deltoid on 31-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLULAVAL for Immunisation. It was a case of actual medication error due to inappropriate route of vaccination. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age. From 07-OCT-2013 to 16-DEC-2013, the unspecified number of patients might have vaccinated with doses of RECOMBIVAX HB (lot number unspecified) (dose, route unspecified) that were exposed to temperature outside of the prescribed information which were not supported. No adverse effects were reported. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
14JUN91 c/o nauseous about 1130AM; slept from 3PM 930PM woke up nauseated & sweating; given Panadol & Entex; slept from 935 to 730AM; @ 730AM t101 orally, vomiting, h/a, would not respond; 17JUN91 eyes hurting;
Vaccine at 12:00 pm, by 4:30 pm she had developed a tic of pulling at her shirt sleeves, one side then the other. This has been going on for six days now, it has not lessened. When she has to pull at her shirt sleeves she loses concentration on whatever she was doing and is fully engrossed in adjusting her sleeves. When asked if she has an itch, or why, she replied with my brain is telling me my body is uncomfortable. The same night she received her vaccine she had the biggest tantrum I have ever seen. The next day at school her teacher pulled me aside after class and told me today she was unlike she had ever been, was angry and mean to other kids.
Information has been received from a nurse practitioner concerning a 69 year old female with diabetes, hypertension, unspecified allergies and penicillin allergy who on 30-JUN-2008 was vaccinated subcutaeously with the single dose of ZOSTAVAX (lot no. 659408/0300X) into the left upper arm. Concomitant therapy included glyburide, ACTOS, quinapril HCl, propranolol HCl, simvastatin (manufacturer unknown) and ZYRTEC. On 03-JUL-2008 the patient developed a red, itchy, macular "hand-sized" rash at the injection site of the left upper arm. On the same day, the patient was seen in the clinic and was prescribed BENADRYL. At the time of this report, the patient's red, itchy, macular rash at the injection site persisted. Additional information has been requested.
Had Hep B # 3, DTaP # 4, PCV # 4 and MMR # 1 on 12/4/08. At 8pm that night, pt had seizure with 104.2 temp. Went to medical center ER. TX with TYLENOL/MOTRIN, sent home. At 6am 12/5/08 had another seizure at home mom took her to ER. DX with seizure, sent home, per mom.
This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 09-AUG-2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (exact dose and route not reported) lot # L003228 which expired on 30-JUL-2016. It was reported that this was supported. No adverse effects were reported. Additional information has been requested.
Severe burning sensation and inflammation of the whole upper left arm. The arm was also swollen badly.  Asked patient to treat with cold compresses and an nsaid for a couple of days
rash (about the size of a half-dollar coin) on the arm and wheezing that required treatment with albuteral & steroid inhaler
arm was somewhat sore; mild headache; felt mildly tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was somewhat sore), HEADACHE (mild headache) and FATIGUE (felt mildly tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 042L20A) for COVID-19 vaccination.     The patient had no other chronic or long-standing health conditions. The patient had no history of anaphylaxis, hypersensitivity reactions, hives or urticaria, asthma and hay fever.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was somewhat sore), HEADACHE (mild headache) and FATIGUE (felt mildly tired). At the time of the report, PAIN IN EXTREMITY (arm was somewhat sore) had resolved and HEADACHE (mild headache) and FATIGUE (felt mildly tired) outcome was unknown.            The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had these events after her second dose. Her arm was somewhat sore for two days. The events did not cause her to seek medical care. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-027542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027542:First dose case
Flu symptoms: chills, diarrhea , headache, sore left arm (injection site)
Information regarding PREVNAR was received from a healthcare professional regarding a 3-year-old male patient who experienced pneumococcal cellulitis and mastoiditis.  The patient received a dose on an unspecified date.  On 22-Dec-2009 the patient experienced pneumococcal cellulitis.  The patient also experienced mastoiditis on an unknown date.  These events involved or prolonged hospitalization.  Treatment consisted of unspecified Intravenous antibiotic therapy.  The patient has recovered from the pneumococcal cellulitis but the outcome of the mastoiditis was unknown.  No additional information was available at the time of this report.
Pt began to cough with edema and blueness under eyes. No SOB or tightening of throat. Epinephrine was given SC in left deltoid. Signs and symptoms cleared in 10-15 minutes.
Sudden cardiac arrest 11/30/2021 with ACLS resuscitation and return of circulation, ventilator for 12 days DVT 12/01/2021 Extreme fatigue  and muscle weakness 12/11/2021 and still ongoing
This spontaneous report as received from a licensed practical nurse refers to a 45 year old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 26-JUN-2014 the patient was vaccinated with a dose of expired MMR II, lot # H011898, expiration date 25-JUN-2014 (dose, site and route of injection not reported). The patient did not report or demonstrate any adverse effects. Additional information has been requested.
1.5cm pruritic induration to lt arm. Hydrocycline HCL 25mg 1 q 6 hrs. Triamcinolone 0.01% cr-apply tid.
Pt received full dose of Moderna 0.5ml instead of 0.25 ml on 10/25. I called Moderna on 10/26 to receive vaccine information through email. I called patient on 10/29. She stated that she did experience fever and nausea after getting the vaccine.
On 07/01/2022 in the morning I started with a sinus infection. I had extreme fatigue. On 07/02/2022 I went to my doctor's office just to see what was happening and I didn't want it to go to my upper respiratory. My doctor did a COVID-19 test which was positive. My doctor advised me to drink plenty of fluid and rest. I took TYLENOL for 1 day. I didn't developed any fever at all. I was just exhausted. I isolated myself for over 1 week. My doctor said if my sinus gets worse to contact him.
Mild Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 12:30 (Lot Number: EL3247) as single dose (at age of 43-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medication in two weeks included salbutamol sulfate (VENTOLIN HFA) inhaler. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild diarrhea on 05Mar2021 06:00. No treatment was received. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination, on 05Mar2021 underwent polymerase chain reaction (PCR) test (Nasal Swab): unknown result (pending). Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient presented to the ED and was subsequently hospitalized with chest pain within 6 weeks of receiving COVID vaccination.
5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 5 patients under the same suspect product(s). This is 4 of 5 reports.  A patient of unspecified age and gender received unknown dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The reporter reported that five people in his church got Covid after being vaccinated with Pfizer. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received both Pediarix (first dose) and Engerix-b (second dose) on the same day; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 2-month-old patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B pediatric, the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The pharmacist reported that the patient received both Pediarix (first dose) and Engerix-b (second dose) on the same day. HCP had no further information about the situation. The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix and Engerix-b on the same day which led to overdose.
Numbness to left side of the face, drooping ness of left eye and eyebrow, not able to smile with left side, swelling of right side of the face.
Fever of 102F on and off for about 36 hours. Severe muscle fatigue, headache, and nausea
Blood present in stools during bowel movement. Never before have I had this problem. And I've had a colonoscopy in the last five years with no problems at all. Never seen blood in stools before this vaccine!
Patient received ZOSTAVAX on 7/26/2011. Patient developed cellulitis at injection site (right tricep). Patient placed on KEFLEX, and is fine.
Mild muscle aches; This is a spontaneous report from a non-contactable consumer reporting for herself. A 45-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EJ1685, and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 at 14:15 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced mild muscle aches on 04Mar2021 19:00. The patient did not receive any treatment for AE. The outcome of the event was resolving.   No follow-up attempts are possible. No further information is expected.
Rhythm was off; Hard to swallow; Shortness of breath; Fever; She also had a laceration linear scab, hardlike erythema at the injection site; She also had a laceration linear scab, hardlike erythema at the injection site; She also had a laceration linear scab, hardlike erythema at the injection site; Ulcer in the back of her throat; Sore arm; Can't lift her arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Can't lift her arm), HEART RATE IRREGULAR (Rhythm was off), INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site) and SCAB (She also had a laceration linear scab, hardlike erythema at the injection site) in a 44-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.     No medical history was reported by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MOBILITY DECREASED (Can't lift her arm). On 09-Apr-2021, the patient experienced INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site), SCAB (She also had a laceration linear scab, hardlike erythema at the injection site), ERYTHEMA (She also had a laceration linear scab, hardlike erythema at the injection site), PHARYNGEAL ULCERATION (Ulcer in the back of her throat) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced HEART RATE IRREGULAR (Rhythm was off), DYSPHAGIA (Hard to swallow) and DYSPNOEA (Shortness of breath). At the time of the report, PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Can't lift her arm), HEART RATE IRREGULAR (Rhythm was off), INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site), SCAB (She also had a laceration linear scab, hardlike erythema at the injection site), ERYTHEMA (She also had a laceration linear scab, hardlike erythema at the injection site), PHARYNGEAL ULCERATION (Ulcer in the back of her throat), DYSPHAGIA (Hard to swallow), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) 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.   Treatment included Tylenol.
Pt received an improper dose of Pfizer Covid Vaccine. His age, 10 yo, dictated that he should get the 5-11 yo Pfizer Pediatric Covid Vaccine but he received the Adult Pfizer Covid vaccine in error. It was injected into the left deltoid.  Patient had no complaints of any ill effects during the 15 minute holding pool time that he was here after the injection.