chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weight on my head; chills; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head). At the time of the report, CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter considered CHILLS (chills), PYREXIA (Fever) and DISCOMFORT (Weight on my head) to be related.    Reporter did not allow further contact
Initial report received on 19 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL on the following dates: 03 December 2009, 11 March 2010, 11 May 2010 and 28 December 2010 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 07 July 2012, approximately 19 months after the last dose. On 17 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 20 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Within 5 minutes of injection my eyes begin burning, my head started swimming and I could not focus my vision ,my heart was racing. I had no breathing issues and was able to get through it as it only lasted 6 to 7 minutes. But I'm very concerned as to taking the second dose? Please advise as to getting second dose
About a half hour after getting vaccination, it seemed like I was having trouble swallowing.  A few hours later, it seems to be resolved.
Headache, Fever, EE presenting with Body aches, fatigue, 100.4 temp, & a slight headache. Narrative:  Got vaccine yesterday, morning around 7am Today, EE presenting with Body aches, fatigue, 100.4 temp, & a slight headache.
pt recv vax & devel inj site rxn of redness,swelling,tenderness & a lump. Tx w/ice.
The evening of the 2nd dose he experienced bilateral tinnitus, generalized itching, and left hand numbness and weakness.
Diarrhea (started day after shot), 102 Fever started 4 days after shot.
This complaint for caller only has the injection itself. Whoever gave the last one threw out the box. The only thing that she has is the broken vial for PREVNAR 20; The initial case was missing the following minimum criteria: Other-info not qualifying for AE reporting-Product complaint. Upon receipt of follow-up information on (27Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2604) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "This complaint for caller only has the injection itself. Whoever gave the last one threw out the box. The only thing that she has is the broken vial for PREVNAR 20".  Additional information: Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for caller only has the injection itself. Whoever gave the last one threw out the box. The only thing that she has is the broken vial for PREVNAR 20V PFS SUSPENSION 0.5MLX10 is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. Product used for treatment.
body aches; Fatigue; diarrhea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache".  Additional information: The patient got his 1st dose on 24Mar2021 and 2 days after, he experienced adverse events such as fatigue, diarrhea, headache, and body aches. He wanted to know if he should still get the 2nd dose and or what will be the efficacy of the vaccine if he did not take the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered) outcome was unknown.        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.   No concomitant medications were reported. No treatment related information has been reported. Reporter did not allow further contact.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia.    The patient's medical history was not provided. concomitant product used not provided by reporter.   On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak).  On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body).  On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant).  On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs).  The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported.   The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Dizziness and fainting the morning following the 2nd vaccination dose.  Red and swollen blotch at injection site.
Where I got my shot in right arm I have never recover from severe pain, it hurts to touch both my arms , can hardly lift the right arm. Noticed the night I got the shot the bottom of my feet were beet red and still are. Went to ER with breathing problems. Had a meeting with My lung specialist and we both decided no 2nd Moderna Vaccine. I have been to my family Doctor and she gave me prednisone and told me to take Tylenol for pain.
Initial unsolicited report received from a consumer on 01 October 2014. A 69 years old female patient, whose medical history involves bronchiectasis and permanent ileostomy and concomitant medications were not reported had received intramuscular dose of FLUZONE HD (Batch number and expiry date were not reported) in the right deltoid on 30 September 2014. On 30 September 2014 on the same day after vaccination, the patient began to have pain in her right arm. She felt like they hit the bone when the vaccine was administered. The patient had symptoms of headache, malaise and stiffness in her joints. Later in the evening, it was difficult for her to raise her right arm up and down. At the time of this report she has a low grade temperature. Illness at the time of vaccination was not reported. The patient does not have any corrective treatment and laboratory data to report. At the time of this report the patient was not recovered. List of documents held by sender: none. Follow up information received from a consumer on 01 May 2015. No new additional information received. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 02 June 2015. Lot number was reported as U5023BA. It was reported that, primary care physician was not vaccine administering physician to the patient. List of documents held by sender: none.
I had the flu vaccine in the afternoon of 11/07/2013.  When I awoke on 11/08/2013 both eyes were completely bloodshot, swollen and extremely sore.  They got worse through out the day.  The next morning there was no sign of improvement so I went to the ER.  I was seen at facility.  I was treated for conjunctivitis.  Conjunctivitis does not appear this severely in both eyes over night.  I feel this was an allergic reaction to the flu vaccine.   Conjunctivitis can be allergy related.  I was given an ointment to use in my eyes and advised to take 50 mg of Benadryl.   After a week this has started to clear up.
@ 4 mo visit, mom reported following rxn to 2mo shots-4 hrs following shot pt awoke from nap very pale & limp; lasted approx 5 min, then returned to normal activity;
Mother stated on 2/4 - grandson started running a fever of 102, still running a 100ish with medicine. Has rash on buttocks, palms, genital area, legs, around mouth & in mouth. Client states itches. Saw Dr on 2/5/13. 2/06/13 Grandmother says Dr ran blood tests & consulted (infection disease doctor) & sent pictures to him. Grandmother also sent me pictures. She stated she is giving the child oatmeal baths, BENADRYL faithfully & TYLENOL for fever. 2/7/13 Spoke with grandmother again. She states he has been fever free since last night & "looks like rash is starting to clear up".
Info has been received from a medical assistant concerning a male pt who on 12/05/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644103/0710M). On 12/07/2002 the pt developed cellulitis and was treated with injections of ceftriaxone sodium (Rocephin). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. It was also reported that another male pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644103/0710M) and developed cellulitis (WAES #0306USA02719). Additional info has been requested.
Right thigh red, swollen, "size of grapefruit" warm to touch. Treated with ice pack and prednisolone.
This spontaneous report as received from two pharmacists refers to a 13 year old male patient. On 19-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001009 and expiration date: 24-APR-2014) (dose and route were not reported). The pharmacist stated the 13 year old grandson of a patient who was vaccinated with ZOSTAVAX developed chickenpox. At the time of reporting, the outcome of chickenpox was unknown. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8736), in left arm and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Acetaminophen" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient didn't taken other medication in 2 weeks. Patient received Paxlovid as treatment for Covid-19, started on 06Sep2022 and stopped on 11Sep2022.  No follow-up attempts are possible. No further information is expected.
Fever; Chills; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included virus 3-4 weeks ago in 2020 prior to getting the vaccine. The patient's concomitant medications were not reported. The patient had the virus 3-4 weeks ago and received the vaccine yesterday (11Jan2021). She experienced fever and chills for a short time after the vaccine. The reporter wanted to know "Is that more prominent after you have had the virus? Are we getting reports of patients who had Covid 19 prior to getting the vaccine having more side effects? If since his sister got those reactions, can she be more contagious." The outcome of events was unknown.  Information on the lot/batch number has been requested.
Severe swelling over olecranon quite distal to area of injection on deltoid.  Swelling of lips, numbness in feet.  Acceleration of hypertension.  11/14/08 Reviewed hospital medical records of 10/3-10/4/2008. FINAL DX:allergic inflammatory reaction to pneumo vaccine; cellulitis; paresthesia; & left arm swelling Records reveal patient experienced LUE warmth, erythema, pain & swelling at pneumo injection site which worsened progressively restricting LUE movement.  Temp on admit 99.  Tx w/IV antibiotic & steroids.  Progressed well & d/c to home on continued oral antibiotics & tapering steroids.
Information has been received from a health professional concerning a 60 year old female, with no medical history, who on 11-NOV-2005 was vaccinated with a 0.5 ml intramuscular dose in the right arm of pneumococcal 23v polysaccharide vaccine (Lot#650082/0691P).  Concomitant therapy on the same day included an intramuscular dose in the left arm of methotrexate.  It was reported that the patient was seen by a physician on 18-NOV-2005 complaining of a little swelling where she received her vaccine.  The patient was currently seen by a physician.  It was reported that the patient was recovering.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012 the patient was inoculated with the ZOSTAVAX vaccine at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-OCT-2016, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
chills, sweats, body aches, headache & nausea - lasting about 20 hours completely recovered the next day
cough; nasal congestion; back pain; body ache; chills; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), NASAL CONGESTION (nasal congestion), BACK PAIN (back pain), COUGH (cough) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 27-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 PAIN (body ache), BACK PAIN (back pain), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain). On 19-Mar-2021, the patient experienced NASAL CONGESTION (nasal congestion) and COUGH (cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (VICKS NYQUIL) for Nasal congestion and Cough, at an unspecified dose and frequency. On 02-Mar-2021, PAIN (body ache), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved. On 14-Mar-2021, BACK PAIN (back pain) had resolved. At the time of the report, NASAL CONGESTION (nasal congestion) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Overnight  fever of 101, soreness and pain in the injection area with a duration of 2-3 days.
w/in hr of inj had uncontrollable screaming-finally  required Phenobarb coma to stop;now little activity on EEG-tube feeding-only sl responsive;on rehab service;
Received 2 mo old immunizations in morning & by afternoon well-defined purple black in color over anterior 1/3 of tongue - increase with crying.
Patient was given her firs dose of Pfizer, after waiting her 15 minutes she started feeling  She describes a sensation of feeling unwell with a headache.  she was found to be hypertensive with a systolic pressure in the 190s.  She then began feeling somewhat lightheaded, flushed and has sensation of tingling in her upper lip.  She was given 25 mg of Benadryl and an EpiPen injection.  She was sent to the emergency department for further evaluation.
This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (having some irritated skin, heating and swelling at the injection site.), VACCINATION SITE WARMTH (heating at the injection site) and VACCINATION SITE SWELLING (having some irritated skin, heating and swelling at the injection site.) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced SKIN IRRITATION (having some irritated skin, heating and swelling at the injection site.), VACCINATION SITE WARMTH (heating at the injection site) and VACCINATION SITE SWELLING (having some irritated skin, heating and swelling at the injection site.). The patient was treated with CELECOXIB (CORTAX [CELECOXIB]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (having some irritated skin, heating and swelling at the injection site.), VACCINATION SITE WARMTH (heating at the injection site) and VACCINATION SITE SWELLING (having some irritated skin, heating and swelling at the injection site.) was resolving.        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.   Concomitant medication details were not reported by the reporter. Treatment included cold compresses.
I had headaches, fever coughing, sore throat for a week but I did not test positive. I went to my family doctor at a local HCF who could not find what I was positivity for so work asked that I stay home for five days and I took amoxicillin for five days. I much better now.
Hepatitis B Vaccine administered 07/17/2006 Left deltoid. Within 6 HR had dull ache in shoulder. By 12-16 hr patient noted swelling, induration, warmth, pain, mild erythema over left deltoid.
Extreme kidney pain. Left kidney. I do have a cyst in kidney and I have passed kidney stones in past. I?m experience covid symptoms waiting for results. Pain In left kidney again.