chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIT HER HARD; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (HIT HER HARD) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (HIT HER HARD). At the time of the report, VACCINATION COMPLICATION (HIT HER HARD) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
3:00pm sudden chills, felt extremely cold and shivering, muscle ache and fatigue  3:30 pm lightheadedness/dizziness to the point of almost fainting 5:00PM continued symptoms with added naesua  9:00PM extremely hot , 101.8 degree fever   Following day felt much better except for headache and fatigue. Continued to have some much aches and pains  Currently on day 3 and have some aches and lains, arm tenderness still, but no lightheadedness or naseau since the first day  Treated with Tylenol, rest, ibuprofen
Headache, Myalgia, Fever, fatigue, stuffy nose, itchy eyes Narrative:
I am pregnant and I got the Covid vaccine.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she was pregnant and got the covid-19 vaccine on an unspecified date. The outcome of event was unknown.   Information about lot/batch number has been requested.
This study case was received from the investigator in a trial on 19 September 2012. A 22-year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) an an unspecified amount of time later was found to have on 20 January 2011 an elevated Troponin, central laboratory level of 0.27 ng/ml (also with as reported date of 26 January 2011). The subject had a rapid Troponin I level on 20 January 2011 that was within normal limits (negative). The subject denied chest pain and shortness of breath. Vitals included: BP 136/79, HR 80, RR 16, T 99.1, HT 68 in, WT 155 lbs, SpO2 98% and BMT 23.57. On 27 January 2011, an ECG was normal and Troponin I was <0.10 ng/mL. Concomitant medication included doxycycline. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
This case was reported by a consumer and described the occurrence of seizure in a 3-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included bone marrow transplant, chronic skin disorder, immune deficiency, reflux unspecified and seizure. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on 6 June 2007. Concurrent medications included KEPPRA, PRILOSEC, CLARITIN, Vitamin D, Selenium and ZINC. On 6 June 2007 and 30 October 2008, the subject received 1st dose and 2nd dose of PEDIARIX (unknown, left thigh). On 6 June 2007, 5 minutes after vaccination with PEDIARIX, the subject experienced tremors of hands and lips. On 11 June 2007, 5 days after vaccination with PEDIARIX the subject experienced seizures, then again on 16 June 2007. On 30 October 2008, 5 minutes after vaccination with PEDIARIX, the subject experienced tremors of hands and lips and inappropriate schedule of vaccine administered. This case was assessed as medically serious by GSK. The immunization series was delayed, and symptom recurred following subsequent administration. The subject consulted a healthcare professional. The reporter stated the subject received PEDIARIX on 06 June 2007, and approximately five minutes after the injection he experienced hand tremors and lip tremors lasting approximately 10 to 30 seconds. On 11 June 2007, he experienced a seizure and on 16 June 2007, he had two additional seizures. The subject has a history of seizure and is taking seizure medication KEPPRA. On 30 October 2008, the subject received 2nd dose in the series of PEDIARIX (inappropriate schedule of vaccine administered) and again experience tremors of the hands and lips approximately five minutes after the injection lasting for 20 to 30 seconds. The subject was 3-years old at the time of the initial injection and 4-years old at the time of the most recent adverse event. On 30 October 2008, the events were resolved.
10/8/19 Patient reports 24 Hours after receiving vaccinations swelling, redness and throbbing on left arm where she believes the pneumovax-23 shot was given. Patient has a circular pattern swelling across width of arm. She stated she will contact a doctor at an urgent care to examine local reaction.   10/9/19: Patient came in to Pharmacy for Arm evaluation & Left arm at pneumovax injection site swelling has resolved as well as pain & throbbing. Redness still persists and appears more red than day before (10/8/19). If redness continues to worsen patient will Follow-up with DR on 10/10/19. Patient is otherwise feeling well.   10/10/19 Pt presents - swelling resolved - redness towards Innerside of upper arm almost to elbow/crease - slightly warm to the touch - No tenderness @ site/No itching   -10/11/19 Patients - symptoms have resolved.
JOINT PAIN; FEVER; HEADACHE/LIGHT HEADACHE; This spontaneous report received from a patient concerned a patient 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 not reported) dose, start therapy date were not reported 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 joint pain, fever, and headache/light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and joint pain, and had not recovered from headache/light headache. This report was non-serious.
Pt experienced an eruption of vesicles. Pt was seen in physician's office with symptoms of red pimples on face and trunk. Pts temperature was 96 degrees axillary. Pt was diagnosed with mild varicella eruption and treated with calamine lotion and Benadryl for pruritus.
Pt experienced nausea and vomited 2x. This occurred 15 minutes after vaccination.
warm to touch; itching; Vaccination site burning; Vaccination site swelling; Anxiety; flushing; blood pressure drop; pale as a ghost; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), VACCINATION SITE WARMTH (warm to touch), FLUSHING (flushing) and PRURITUS (itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (dyes and fillers, morphine, generic acetaminophen, zoloft). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Allergy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), FLUSHING (flushing) and ANXIETY (Anxiety). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), PRURITUS (itching), VACCINATION SITE PAIN (Vaccination site burning) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), VACCINATION SITE WARMTH (warm to touch), FLUSHING (flushing), PRURITUS (itching), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE SWELLING (Vaccination site swelling) and ANXIETY (Anxiety) had not resolved. 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.   Patient reported after 20 mins  of vaccination events flushing, blood pressure decreased, pallor got resolved.  Concomitant product include steroid eye for allergy.  No treatment information was reported.   Reporter did not allow further contact
she had diarrhea that lasted for weeks; seemed confused all the time; her confusion was from the exhaustion caused by the weeks of diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:00 (Lot number: EN6204) at the age of 71 years as dose 1, single for covid-19 immunisation. Family history included: "High blood pressure" (unspecified if ongoing), notes: she had high blood pressure for 10 years or more. high blood pressure was an issue in her family. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 10-MAR-2021 15:00, outcome "unknown", described as "she had diarrhea that lasted for weeks"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "seemed confused all the time"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "her confusion was from the exhaustion caused by the weeks of diarrhea". The events "she had diarrhea that lasted for weeks", "seemed confused all the time" and "her confusion was from the exhaustion caused by the weeks of diarrhea" were evaluated at the physician office visit.  Additional Information: Reported 5 hours after she had her first COVID-19 Vaccine, she had diarrhea that lasted for weeks. She clarified she had already called Pfizer after her first inoculation because she had enough of the stomach issues (diarrhea). She said she seemed confused all the time, and she thought her confusion was from the exhaustion caused by the weeks of diarrhea. She said she was a healthy eater and was making sure she kept her diet well after having the diarrhea for so long. She said her diarrhea was so bad at times, she almost did not make it to the bathroom. She said it was just draining to go through having diarrhea for that long. She said being older, too, probably didn't help with her recovering as quickly.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia,  Fatigue, pain/swelling at injection site Narrative:
This spontaneous report as received from a pharmacist via field representative refers to several patients of unknown demographics. The pharmacist reported that in approximately October 2013 (reported as over past 2-3 weeks), she had several patients vaccinated with PNEUMOVAX23 via (dosage, lot and expiry date were not reported) who had experienced serious local reactions after vaccination including swelling and redness. The reporter (pharmacist) knew of 2 patients who had these e vents (linked case 1311USA004105). The outcome of events was unknown. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
1/2 hour post vax, the pt developed arm pain at the injection site and then progressed  over the whole arm, red and blotchy to the elbow. The pt experienced a headache, and fever approximately 2 hours post vax.
Worst headache of life with nuccal rigidity and vomiting culminating 27Feb. Follow up headache and nuccal rigidity resolved 2 March 2003. He was given the vaccination via 15 jabs of bifurcated needle.
18FEB: Noticed rash around smallpox vaccine seen in ER and dx as cellulitis tx SEPTRA 800/160 1 tab 2x day 10 days. 24 FEB: Rash had spread to hands seen in ER and dx contact dermatitis tx w/ MYCOLOG TID and ATARAX 1 tab QD. 4 MAR: Rash had spread to bilateral arms, hands, chest, face and neck tx w/prednisone 20 mg 1 tab 3x day 10 days.
temp began 7 days p/vax;range of R temp 103.6 to 105 R @ 9 days later;intake dec-24hr-very fussy;used Ibuprofen 3 days;seen in office 8MAR97;
HERPES ZOSTER, RASH, SHINGLES AND NEURALGIA.
Patient started with swelling underneath left eye which has persisted for several hours, not associated with eye pain , itchy, redness or discharge.  noted by staff and sent home due to symptom.
Blisters  inside and outside her mouth; Sores inside and outside her mouth; mild headache; Nausea; Fatigue; dizziness; Body ache; Fever; Pain; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blisters  inside and outside her mouth), STOMATITIS (Sores inside and outside her mouth), HEADACHE (mild headache), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 68-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 information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (Body ache), PYREXIA (Fever) and PAIN (Pain). On 14-Feb-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters  inside and outside her mouth), STOMATITIS (Sores inside and outside her mouth), HEADACHE (mild headache), NAUSEA (Nausea), FATIGUE (Fatigue) and DIZZINESS (dizziness). At the time of the report, ORAL MUCOSAL BLISTERING (Blisters  inside and outside her mouth), STOMATITIS (Sores inside and outside her mouth), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Body ache), PYREXIA (Fever) and PAIN (Pain) outcome was unknown and HEADACHE (mild headache) and DIZZINESS (dizziness) had not resolved.             No  Concomitant medications were reported.   The treatment medications were reported as acetaminophen and ibuprofen    Reporter did not allow further contact
Information has been received from a female nurse who since about two years ago, in approximately 2009, had been vaccinated with 3 doses of MMR II (lot numbers not provided) in less than 2 years. The nurse reported that she still did not have protective antibody levels for mumps. It was unspecified if the patient sought medical attention or if any treatment was given. At the time of the report the patient's outcome was unknown. No further information is available.
Shingles outbreak; This case was reported by a consumer and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix and it was time for 2nd dose. The patient experienced a mild shingles outbreak. The patient asked, could he go ahead with the 2nd shot
I had sneezing, coughing, running nose, low grade fever, sore throat with slightly swollen glands, fatigue, and sinus headache. I tested positive for COVID-19 at home. My doctor prescribed me PAXLOVID. I started to feel better and get more energy. I still have COVID-19 and I still have post nasal drip, cough, and lack of concentration.
Throat closed up, eyes swelled shut, couldn't breathe; happened 1-2 hrs p/vax;  would not provide details;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy on 22-JUL-2016, for routine health maintenance and for the prevention of shingles. The zoster vaccine live did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient began to experience feelings of numbness, tingling and joint pain, accompanied by a burning sensation concentrated in her left shoulder and the midsection of her body. In response to these complaints, on 28-OCT-2016, the patient presented to her primary care physician and was diagnosed as suffering from neuropathic pain. The patient's complaints did not improve. Accordingly, the patient was referred to a neurologist who diagnosed her as suffering from small fiber neuropathy. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, 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. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of live, physical impairment and injury. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster, joint pain, and neuropathic pain/small fiber neuropathy were considered to be disabling. Additional information has been requested.
Administered H1N1 injection and H1N1 flumist simultaneously.  Mistakenly thought H1N1 injection was seasonal injection
got shakey & very sleepy: like a hypoglycemia episode: On multiple medications for various types of conditions was exposed to kenya; 20SEP93 f/u not seen by MD for above sx; No other complications known p/addtl doses;
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 23-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562 and expiration date 08-PR-2017, lot # K016966 and expiration date 10-MAY-2017, exact doses and route of administration were not reported). It was unknown which of the lots of the vaccine were administered on that date, so all lots for the product were listed. No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt. reports throat tightness and facial flushing after 5th Anthrax dose. Pt. returned to clinic and was given 50 mg BENADRYL medication. VS monitored closely for 45 minutes. Pt. reports symptoms resolved after medication. Pt. educated to call 911 if symptoms returned.
pt recv vax & devel a inj site rxn;no further info was available @ date of this report;this is 1 of 6 pt from this facility to devel an inj site rxn p/vax;
grandfather brought child to clinic today because he has a red, inflamed, warm spot in the area where he received his MMRV booster on 5-1-07 (about 1" by 2" area on back portion of (R) arm). GF seemed to think child may have scratched it. too. Nurse practitioner recommended ice pack 20 min on then back on when skin warms up and pediatric Benadryl.
Patient immediately felt facial flushing and blotchiness to the face only.  Lasted about 1 hour. Patient was monitored on site at the vaccination center.
I am not convinced that this came from the vaccine but for research I am filling out this report. About a couple of months after the vaccine I started having Afib symptoms. My cardio doctor monitored and upped my dose as my condition was indeed worsening. Heavy chest, pain, hard to breathe, uncontrollable heart rate. My tinnitus has also been a problem, and after the 3rd vaccine I have had this insistent ringing in my right ear. Again I do not think it is related to the vaccine as I am 68 going on to 69 and have had heart problems before, but I am documenting this as I did have them under control for the last 3 years until I had the vaccines.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 06 November 2013. A 46-year-old male subject received the an injection of ACAM2000 (lot number not reported) on 17 July 2013. On 19 July 2013 the subject had an abnormal ECG and an abnormal echocardiogram. The subject was diagnosed with cardiomyopathy in other diseases classified on 23 July 2013 and other primary cardiomyopathies on 01 August 2013. Troponin I results were not available. The subject had a past medical history of high blood pressure, elevated cholesterol, cardiomyopathy and abnormal ECG. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Reaction to first dose was nil.  Below is reaction to the second dose: Same evening: slight fever and chills Next day: Stomach upset, dizziness, mild headache, nausea. One fainting episode at 8PM followed by vomiting. Heartrate: 55-63. The day after: Another fainting episode at 11:AM, followed by vomiting. Heartrate: 55-60.
Administered 2m vaccines, mom states the rota (ROTATEQ) vaccine induced vomiting. However 4m vaccines administered minus ROTATEQ ended on same results. Mom wanted to be report as adverse reaction.
This is a spontaneous report from a contactable consumer who reported for his/her brother, via Pfizer-sponsored program. A male patient of an unspecified age received his second single dose of PREVNAR, on unspecified date for immunization. Medical history and concomitant medications were not reported. Previously, on an unknown date, the patient received the first dose of the vaccine. The patient died on an unspecified date, 4 months after getting the second pneumonia shot. It was unknown if autopsy was performed. It was reported that patient was up to date on all the pneumonia vaccines available at the time (2009). Reported Cause(s) of Death: patient died 4 months after getting a pneumonia shot.
Approximately 3 minutes post injection the patient began hyperventilating 2/2 SOB.  RR notified .  Patient placed on 4L o2.  Pt fully recovered.
My arm is swollen, red and warm. It?s been hurting so much I couldn?t lift it. It?s even swollen under my arm. For 48 hours i was exhausted and didn?t eat. My arm is still sore but I?m back to eating. Advil has worked well. The only time it?s hard is trying to go to sleep and get comfortable.