chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to a male patient of unknown age with concurrent conditions of asthma, benign prostatic hyperplasia, gastroesophageal reflux disease, irritable bowel syndrome with diarrhoea, seasonal allergies and hyperlipidaemia. The patient is allergic to unspecified statins, niacin, unspecified sulfa drugs and red yeast rice. The patient's medical history included prostatitis, tinea cruris and fibromyalgia. The physician also reported that the patient has a history of unspecified allergy to unspecified statins (manufacturer unspecified). It was unspecified whether these unspecified products were Merck products. On 09-JUL-2015, the patient was vaccinated with ZOSTAVAX vial of dose 0.65 ml once (lot number, route and site of administration not reported). Concomitant therapies included SINGULAIR, albuterol, omeprazole, AVODART, TYLENOL EXTRA STRENGTH and probiotics (unspecified) (PD-8). The physician reported that within 10 days (on 19-JUL-2015) after vaccination the patient developed generalized burning sensation all over the body. The patient also developed urine dysfunction and painful penile erections in 2015 and the physician felt that this could be related to pre-existing prostatitis. The patient sought for the medical attention and visited the office. On 27-AUG-2015, urinalysis was performed which showed as negative. The patient was treated with CIPRO for the adverse events. The reporter adverse events were not recovered. The causality of the  generalized burning sensation, urine dysfunction and painful penile erections were not reported. No additional information regarding these adverse effects was provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 26 year old Caucasian female with reaction to codeine (nausea and vomiting) and had no illness at the time of vaccination who on 06-OCT-2008 was vaccinated with her first dose of GARDASIL vaccine (lot number 661703/0651X) 0.5ml IM into deltoid.  Concomitant therapy included MICRONOR.  On 07-OCT-2008 the patient woke the day after the vaccination feeling nauseas and had flu-like symptoms.  As the day went on, nausea increased.  The patient developed mild headache.  By 5pm, the patient felt mild to severe nausea, chilly, headache.  Symptoms entirely gone by 08-OCT-2008.
No adverse reaction noted Pt received a Hep B at birth 9/7/16. Pt received PEDARIX on 11/11/16. He was administered PEDARIX on 1/25/17. Hep B should have not be given until 3/3/17.
TRAP MUSCLE AND NECK MUSCLES LOCKED UP; MUSCLE CRAMPS; COULDN'T MOVE NECK AND NOT EVEN ABLE TO LIFT UP ARM; NECK PAIN OFF AND ON; SORE ARM; SEVERE HEADACHE/ OFF AND ON HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced neck pain off and on. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced severe headache/ off and on headache. On 25-MAR-2021, the subject experienced trap muscle and neck muscles locked up. On 25-MAR-2021, the subject experienced muscle cramps. On 25-MAR-2021, the subject experienced couldn't move neck and not even able to lift up arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and severe headache/ off and on headache on APR-2021, and had not recovered from trap muscle and neck muscles locked up, muscle cramps, couldn't move neck and not even able to lift up arm, and neck pain off and on. This report was non-serious.
Patient called 3 weeks later and was asking if we had another other helpful tips to help her arms soreness.  She had spoken to her Chiropractor and he suggested she developed Bursitis from the vaccine.  She described a lot of discomfort and much difficulty raising her arm for a week or so after. She now could raise her arm however, it continued to be tender.  She was doing physical therapy type exercises to work on strengthen the muscle. She had taken ibuprofen to help with the pain. She also had used ice and heat. Discussed to continue with arm exercises and ibuprofen as needed. Also, to continue with ice or heat as needed.
Consistent chest pains for four days, then sporadic chest pains tapering off for the following few weeks
This is my fifth dose of COVID vaccine, I did not get the second booster because I had COVID. I am neurodivergent, I have epilepsy and essential tremor. With each dose, my side effects have gotten worse. This round of vaccines was the worst. I had the shot on a Thursday, my left arm began burning immediately at the injection site. Thursday night I experienced a slight seizure. I spent most of Friday asleep, with a low-grade fever, sore all over, and my entire left arm sore and swollen; my legs felt like lead walking around the block was difficult. In the hours I was awake Friday I had severe neurological symptoms: balance problems, my tremor was worse, and I had trouble completing simple tasks including putting peanut butter on a bagel. I did not seek medical treatment, knowing from past experience that the symptoms would most likely subside by the next day and all an urgent care center would do is give me Tylenol and send me home. The next day, Saturday was indeed better; the neurological side effects were gone along with the fever and body soreness, but only my arm continued to hurt. Today, Sunday I am much improved only a swollen and painful arm remains the problem, from past experience that will not be fully healed for a week - 10 days. My concern here is the neurological symptoms I have never had that severe from a vaccine. Previous COVID shots have caused seizures, but the cognitive problems were a new and scary side effect, and should be reported. In addition although my seizures are under control with medication I am warned by my doctor that it will only take one seizure to cause permanent brain damage, the fact that vaccines can cause seizures should not be overlooked.
INJECTION SIGHT WAS SORE; This spontaneous report received from a patient via a company representative of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on AUG-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 an unspecified date, the patient experienced injection sight was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection sight was sore. This report was non-serious.
Headache for 1 day, less than 50 spots, treated with Zovirax 200 2tsp QID for 5 days, Benadryl, Calamine.
Dry cough; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix and an unknown time after starting Ventolin and Flonase, the patient experienced dry cough. The patient was treated with salbutamol sulphate (Ventolin), fluticasone propionate (Flonase), omeprazole (Prilosec), benadryl (nos) (Benadryl), cough cold preparations nos (Cough Syrup) and codeine. On an unknown date, the outcome of the dry cough was not recovered/not resolved.   It was unknown if the reporter considered the dry cough to be related to Shingrix.  Additional information was provided as follows: The reporter reported for her mother. The patient received Shingrix and within a week after vaccination her mother started experiencing dry cough and it continued.  The patient had to clear her throat more often now. Patient had tried prilosec, ventolin, benadryl, Flonase and cough syrup with codeine. Nothing had helped and she was still experiencing the cough. The reporter did not consent to follow up. No further details were provided.
I have had right arm/shoulder pain when moving my arm since getting the first vaccine over two weeks ago.  It is NOT pain at the injection site.
This spontaneous report as received from Healthcare student refers to a 28 year old patient of unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The reported stated that the patient was accidentally administered ZOSTAVAX instead of VARIVAX (merck) on an unknown date. No adverse effect reported. Additional information is not expected.
2/28/2021 about 9 am.  Unable to get out full words or sentences, says she felt like she had marbles in her mouth.  No other symptoms and it is slowly improving.  3/1/2021 my mother called me at 1:38. She speaks very slowly, has a difficult time getting certain words out and definitely has a problem completing thoughts and sentences.  Her speech is somewhat slurred. She seems "out of it."  Her primary care doctor encouraged her to go to urgent care.  My father is taking her there now. It is currently 3:07 pm.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (lot number, expiration date, dose and route were not reported). No concomitant medications were reported. On an unknown date, (reported as "within two days of dose"), unspecified number of patients complained of injection site pain. The outcome of injection site pain was not reported. The relatedness between injection site pain and (Oka/Merck) VARIVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: =============================== Patient is experiencing the following at the injection site: Patient is experiencing chills. Patient is experiencing fever greater than 100.4 degrees F (>38 C). Patient is experiencing fatigue or tiredness. Patient is experiencing a headache. Patient is experiencing nausea
Starting around hour 12:  my arm was sore and I had an intense headache and felt feverish.  24 hours later: Felt very feverish and I experienced nausea and vomiting. No appetite. Body aches and headache. Fatigue.  2 days later: 101.2 fever/chills. Nauseous. Faint/light-headed. Fatigue.  3 days later: Temperature around 99. No headache or arm ache. Severe diarrhea. 4 days later: Still feeling a bit warm and moderate diarrhea.
Insomnia; Body aches; Fever; Chills; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW976) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 06May2021 at 03:30, the patient experienced insomnia, body aches, fever, chills, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia, body aches, fever, chills, headache and nausea were recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; swelling of rt arm to fingers day of vax p/ dose 4; lasted 4 days;
I did not have a reaction to the vaccine.  I tested positive for COVID-19 05/18/2022. Symptoms: headache, sore throat, cough and fatigue.  I took a home test and sent it to my doctor- and they said I had COVID-19. They prescribed the monoclonal antibodies.  The antibodies did not help me. I emailed my provider regarding my symptoms and I had to see the doctor.  It was determined I had a sinus infection with a cough. I was put on another antibiotic. I took several vitamins during the duration of my illness for my symptoms.
dry mouth; covid arm; a red welt that was kind of swollen where the injection was; a red welt that was kind of swollen where the injection was; tiredness; felt kind of off; brain foggish; like I was coming down with a cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold), DRY MOUTH (dry mouth) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety (Because of patients symptoms she is struggling with the decision between receiving and not receiving the second dose. Patient states that this decision is causing her anxiety.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold) and FATIGUE (tiredness). On 11-Mar-2021, the patient experienced DRY MOUTH (dry mouth), TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (a red welt that was kind of swollen where the injection was) and VACCINATION SITE SWELLING (a red welt that was kind of swollen where the injection was). On 12-Mar-2021, MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold), DRY MOUTH (dry mouth), TYPE IV HYPERSENSITIVITY REACTION (covid arm), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (a red welt that was kind of swollen where the injection was) and VACCINATION SITE SWELLING (a red welt that was kind of swollen where the injection was) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include regular vitamins, prebiotic, a protein shake and greens drink which are all a normal process for her.  Patient reported water as treatment.
The patient presents for swelling and tenderness at site of flu injection. No fevers, but area has increased in size in the last 2 days. Patient denies fever, vomiting, diarrhea, cough, congestion or sore throat. Normal po/uop. Normal activity.  Skin: tender, swollen left thigh with warmth and erythema--no fluctuance good pulses of left leg
Patient received Moderna Vaccine on 07/07/2021, pt came in today for second dose of vaccine, pfizer vaccine was administer after being okayed by provider.
2 hrs p/receiving the vax pt began having inconsolable crying that lasted for 6 full hours; Also had temp above 103;
I mostly have problems with my vocal cords, I was having a loss of my voice. I went to my doctor, the attending physician agreed with me that it was more than the GERD I have, sent me to an ENT and Speech and Voice Pathologist. I had a nasal endoscopy that helped the ENT determine that mucus was built up on my vocal cords causing my problem. This was caused by long COVID-19 symptoms, I was given MUCINEX to help thin the mucus, but it is a constant battle to keep the mucus down.
Not severe problem with her heart; Heart beating faster; Normal side effects; 2nd dose 20 March 2021 which is 24 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Not severe problem with her heart), TACHYCARDIA (Heart beating faster), VACCINATION COMPLICATION (Normal side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20 March 2021 which is 24 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 661azia) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEFLUNOMIDE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20 March 2021 which is 24 days). On an unknown date, the patient experienced CARDIAC DISCOMFORT (Not severe problem with her heart), TACHYCARDIA (Heart beating faster) and VACCINATION COMPLICATION (Normal side effects). The patient was treated with CARVEDILOL for Adverse event, at a dose of UNK, bid and HYDROCHLOROTHIAZIDE for Adverse event, at a dose of 25 milligram. On 20-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20 March 2021 which is 24 days) had resolved. At the time of the report, CARDIAC DISCOMFORT (Not severe problem with her heart), TACHYCARDIA (Heart beating faster) and VACCINATION COMPLICATION (Normal side effects) was resolving.            Following vaccination briefly after the 2nd dose patient experienced the events. Patient received diagnosis but everything was coming OK. Concomitant medication reported included hypertensive medication. Treatment medication includes medication to slow down her heart.
Tingling feels like electric shocks inner left foot through toes. Happens sitting standing and walking.
Patient stood up after injection, walked to closed door, slumped forward & said he didn't feel well, then threw his head back, went stiff & fell over unconscious.  He came back to consciousness w/in 1 min & remained weak for 20 mins.  He has never done this before & it happened 1 min after vaccine was administered.
Patient developed bursitis in the arm she received her vaccination in. Dr told patient it was because the injectino was given to high on the arm.
Ran a fever; 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 PYREXIA (Ran a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Ran a fever). At the time of the report, PYREXIA (Ran a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Itchiness, bumps at injection site and at armpit (post vaccine 36 hrs.) Fever starting 6 hours after, lasting 48 hours  Tight chest, pain in shoulder starting about 36 hours after Headache starting post vaccine 6 hours  Sweats at 48 hours
pt recvd vax & w/in a few hrs of vax pt devel severe swelling, heat, pain & redness in the shoulder joint area above the deltoid muscle wher pt recvd vax;
The vaccine was administered with an insulin syringe so received subcutaneously, not intramuscular
This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a physician concerning a 4 month old male with gastrooesophageal reflux disease who on 12-SEP-2006 in the morning was vaccinated with a first dose 0.2 mL oral dose of ROTATEQ (lot # 654392/0578F). Concomitant vaccination administered that morning included a 3rd IM dose of PEDIARIX (AC21B034AA), a 3rd IM dose of PREVNAR (lot # B18634A) anda 3rd dose of ACTHIB (lot# UE852AA). There was no illness at the time of vaccination. Subsequently, on 12-SEP-2006 at 10:50 pm the patient developed severe vomiting for one week. On 13-SEP-2006 the patient developed a fever of 102.3 and was fussy. Unspecified medical attention was sought. The patient recovered "by 19-SEP-2006". There was no product quality complaint involved. Additional information is not expected.
Per home conversation, developed "Welts on both arms and rash in the area between her knees and ankles on both legs. She saw a dermatologist on 9/18/08 and he prescribed some medication, she doesn't know the name. Rash is getting better.
myocarditis; Patient received 2nd dose 23 days after the first; a little sensitivity if she touched the injection site; heavy pressured feeling on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST DISCOMFORT (heavy pressured feeling on her chest). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first) and VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site). At the time of the report, MYOCARDITIS (myocarditis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first), VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site) and CHEST DISCOMFORT (heavy pressured feeling on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was given. Patient had on allergy pills as concomitant medication.  Company Comment: 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-2021-237410 (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.