chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a 14 month old female patient. There was no information about the patient's medical history and concurrent condition reported. On 13-AUG-2015, due to the staff error, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot#, dose and route unknown) and a dose of (Oka/Merck) PROQUAD (lot#, dose and route unknown) (overdose). No adverse effects were reported. Additional information has been requested.
Patient called over standing by EMS provider EMS, vitals were obtained. Patient stated that he felt his throat was closing. Patient was awake and talking . Transported by EMS to ER.
Dizzy; Vertigo; Feeling sick; Nausea; her arms were super itchy; A spontaneous report was received from a 46-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling sick, nausea, vertigo, itchy arms, and dizziness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 026L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient took the first dose of Moderna COVID-19 vaccine on 31-Dec -020 and on 8-Jan-2021 she started feeling sick. She became nauseous and had vertigo. She reported that her arms were super itchy, and she felt dizzy. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced feeling sick, nausea, vertigo, itchy arms, and dizziness were considered unknown.; Sender's Comments: This case concerns a 46-year-old female who experienced non-serious events of unexpected malaise, dizziness, vertigo and expected nausea, pruritus.  Event onset occurred 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Rash from neck to pubic bone started 12/23 at 5am. Called and spoke with patient this am, 12/24 at 11am. rash is subsiding and she feels fine.
I received the Shingrix vaccine at about 2p, and when I got ready to shower at 7p that evening I noticed that my L upper arm was red and had a cellulitis appearance to it. The whole arm wasn't red, but I would say about 3/4. (I'm a nurse). The rash was raised as well, connected, and snaked around most of my arm down to my A/C joint. It wasn't hot to touch. I just drew a line around the rash to make sure that it didn't spread. It started about 1/2 down from my injection site.
Information has been received from a physician referring to a 35 year old female patient. The patient had a history of smoking and no drug reactions/allergies. The patient's concurrent conditions included overweight, attention deficit/hyperactivity disorder, genital herpes, acne and mild eczema. Concomitant therapies included ADDERALL, valacyclovir hydrochloride, spironolactone, piroxicam and hydrocortisone (manufacturer unknown). On 12-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscular, lot # was reported as M033080; dose and expiration date were unknown) (patient requested the vaccine). The physician stated later in the day on 13-OCT-2016, the patient developed a large, red, warm, tender spot at the injection site that was 3 by 4 inches and a 101.3 Fahrenheit degree fever. She had achy joints in her hip and rib cage and was in mild to moderate distress and she just wasn't comfortable. The physician stated the patient took ibuprofen at home on 13-OCT-2016 as treatment however it didn't really help. The physician stated the patient was seen on 14-OCT-2016 and had a full blood count (CBC) and Comprehensive Metabolic Panel (CMP) performed which showed her white count was 29700 (unit unknown), neutrophils were 21000 (unit unknown), bands were 3861 (unit unknown), metamyelocytes were 891 (unit unknown) and her monocytes were 2376 (unit unknown). The physician stated they gave the patient TYLENOL and intravenous (IV) fluids as treatment on 14-OCT-2016. The physician stated the patient was seen in the office on 15-OCT-2016 for re-evaluation and had another CBC and CMP performed which showed her white count was 27000 (unit unknown) and her neutrophils were 24000 (unit unknown). The patient also had blood cultures grown on 14-OCT-2016 and 15-OCT-2016 which showed no growth. The physician stated the patient was admitted to the hospital on 15-OCT-2016 due to her symptoms. The physician stated "the hospital gave her a preliminary diagnosis of cellulitis but she did not have cellulitis, she had a reaction to the PNEUMOVAX 23". The physician stated the patient was still in the hospital. The outcome of the events was unknown. The physician considered the events to be significant disability as the patient could not do routine work. Upon internal review, cellulitis was considered to be medically significant. Lot number M033080 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
fever, low grade if anything; Sweaty; Cold; Stomach upset; Nausea; Headache; She said that she also was maybe a little short of breath.; kind of allergies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jul2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller was a consumer who reported that, she had the first dose of the Pfizer Covid vaccine. Stated that, she had no reaction for 2-3 days after the dose. The caller stated that, she had no fever, well she never checked it, but stated that, it was low grade if anything. Stated that, she was sweaty kind of cold and it was mild. Stated that, she got stomach upset, nausea and headache. Stated that, it was time to take her second dose, was it safe to take the second one. Stated that, just on the other side of feeling better, she has felt ok for a couple of days, how long can she wait or can she go ahead and get the second dose. Stated that, she also was maybe a little short of breath. Stated that, the caller had nausea, headache and kind of allergies but the caller was get that. Not enough to even call the doctor. Stated that, she was ready to get her second dose, wondering whether it was ok. First dose was on 26Jul2021 and when can she get it. The caller stated that, her daughter was going to go get her second vaccine and she wanted to go with her. The caller declined to complete a report as she was in a hurry and wanted to have her questions addressed. On an unspecified date, the patient underwent lab tests and procedures which included fever (body temperature), resulted as low grade, she had maybe a low grade fever. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Lap Right Colectomy on 11/15/21 11/18/21:10:28 received Covid 19 booster 11/18/21: 8 pm, moaning and discomfort-given tylenol and ultram at 9:45 pm 11/19/21: 2 am, tossing and turning 11/19/21: 7 am, vomited, doctor contacted for ondansetron 11/19/21:7:15 am, patient expired
Redness, swelling, itching, heat and slight pain at injection site. Baseball size.
Fever (99-105 degrees) intermittently for 3 days after vaccine. Temp unsure as parent has an unreliable device. However, T max on the parents device was 105 rectally. Child also fussy.
2 days after receiving shots RT leg, sore, red, warm and swollen about the size of mom's palm of hand. Went to see Dr on 2/10. Told was an allergic reaction. Gave BENADRYL and IBP about 4 days. Leg better since 2/12. Still a little bruised.
Information has been received from a nurse concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who on 23-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine. There was no concomitant medication. "3 days later," on 26-JUN-2008 the patient called the office to report she was dizzy. At the time of the report, the patient was recovering from being dizzy. The patient sought medical attention by calling the office. No further information is available.
Pt. states that after receiving the 2nd dose of Moderna 03/12/2021, started experiencing symptoms that evening of chest pressure, shortness of breath, and confusion. 2 days later felt feverish, chest pressure, and confusion lasting 1 week.  03/19/2021 HVR diagnosed still with shortness of breath and chest pressure. Urgent Care visit 03/24/2021 150/?, recommendation for ER for observation. A-Fib, Inflammation and Pericarditus. Stress Test preformed, heart rhythm monitor, Sleep Study. Cardiac Meds prescribed.
Pt had a profuse bruise on the left arm that covers most of the upper arm and parts below the elbow. Bruising started the evening after the flu shot and continued to look worse. When patient came in there were parts of the bruise that were looking like it was healing.
first dose 02JAN2021 and second dose on 27FEB2021; first dose 02JAN2021 and second dose on 27FEB2021; loss of hearing as confirmed by hearing test given by audiologist; Dizziness; This is a spontaneous report from a contactable consumer, other health care professional via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). This consumer (patient) reported for herself that:  A 56-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. Medical history included none. The patient concomitant medications were not reported. Patient received other medications within 2 weeks of vaccination. Patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took bnt162b2 (Batch/Lot Number: EL3246), via an unspecified route of administration, administered in Arm Left on 02Jan2021 15:00 (at the age of 56-year-old) as dose 1, single for covid-19 immunisation. On an unknown date in 2021, the patient experienced loss of hearing as confirmed by hearing test given by audiologist, dizziness and first dose 02JAN2021 and second dose on 27FEB2021 (off label use and inappropriate schedule of vaccine administered) on 27Feb2021. The patient underwent lab tests and procedures which included acoustic stimulation tests: loss of hearing on an unknown date in 2021. The events resulted in physician office visit. No treatment was taken as a result of events loss of hearing as confirmed by hearing test given by audiologist, dizziness. The outcome of the events loss of hearing as confirmed by hearing test given by audiologist, dizziness were recovered with sequel (with lasting effects, as reported) on an unknown date in 2021, for other events was unknown.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events Deafness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Woke up at 3AM on 9/2/09 & felt very weak then developed fever up to 101.5, bad headache, vomiting, light sensitivity, 4-5 hours later. R arm pain at injection site on 9/2/09 also.
Patient reports low fever, and allergic symptoms including itching, hives, and a possible rash, all begining 7/24/22 (the day after their vaccination). Patient advised on care, and recommended to begin treatment with benadryl.
other people had situations that required treatment; 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 VACCINATION COMPLICATION (other people had situations that required treatment) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (other people had situations that required treatment). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (other people had situations that required treatment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-355659.
Psoriasis; The skin in and around my ears began in flacking & pealing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Mar2021 15:00 (Lot number: EN6208) at the age of 65 years as dose 2, single, intramuscular, administered in arm right, administration date 27Feb2021 15:00 (Lot number: EN6198) as dose 1, single and intramuscular, administration date 21Oct2021 (Lot number: FH8027) as dose 3, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PSORIASIS (non-serious) with onset 2021, outcome "unknown", described as "Psoriasis"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "The skin in and around my ears began in flacking & pealing". Therapeutic measures were taken as a result of skin exfoliation. No follow-up attempts are possible. No further information is expected.  Follow-up (21Dec2021): This is a spontaneous follow-up report received from a same contactable consumer. This Consumer (patient) reported in response to Non-HCP letter sent which included that:  Updated Information: Primary Reporters/patient phone number, middle initial added, age, vaccination facility added.
Arm  soreness; Loss of appetite; Shortness of breath; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm  soreness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery, High cholesterol and Diabetes. Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced TENDERNESS (Arm  soreness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Shortness of breath) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDERNESS (Arm  soreness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pyrexia: he also had fever He also had fever. In January 2021, X-ray: normal (normal) Took xrays and said lungs were clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
WAS IN TEARS; JOINT PAIN; This spontaneous report received from a consumer via a representative concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced was in tears, and joint pain. The action taken with covid-19 vaccine was not applicable. The outcome of the joint pain and was in tears was not reported. This report was non-serious.
Headache started after 26hr of vaccination and a low grade fever started with chills after 30hrsof 2nd dose.; chills followed by low grade fever; chills followed by low grade fever; This is a spontaneous report from a contactable consumer (reported on herself).  This 49-year-old female patient received second dose of BNT162B2 (COVID vaccine, solution for injection, lot number EL3247 expiry date: unknown) via an unspecified route of administration on in Left arm as a single dose on 09Feb2021 09:45 AM, for Covid-19 immunization. Medical history included asthma. She was allergic to Aspirin. Concomitant medications (within two weeks of vac-cine) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (Advair), MONTELUKAST SODIUM (Singulair) and ESOMEPRAZOLE SODIUM (Nexium). She received first dose of BNT162B2 (COVID vaccine, solution for injection, lot number EL3247expiry date: unknown) via an unspecified route of administration on in Left arm as a single dose on 19Jan2021 10:00 AM, for Covid-19 immunization. She did not receive any other vaccine in four weeks of Covid-19 vaccine. On 10Feb2021 around 12: 45pm, in the afternoon, she experienced headache, but she did not think that this was related to vaccine and she continued with her routine on remaining of the day. After 6pm on 10Feb2021, she experienced chills followed by low grade fever. The patient did not receive any treatment for the events. The outcome of the events of headache and chills followed by low grade fever was recovering. The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination.   No further information was available.
This spontaneous report as received from a female consumer of unknown age refers to herself. The patient is allergic to medication in the mycin family and also has thyroid issues. The patient's medical history included recent unspecified surgery. On 03-OCT-2014 (reported as 3 weeks ago) the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency unknown) (Lot # and expiry date not provided) dose 1. Concomitant therapies included SYNTHROID, sulfamethoxazole, BACTRIM and KEFLEX. On 03-OCT-2014 (reported as within 12 hours of receiving the vaccine, the patient experienced swelling, redness and pain to the touch at the injection site after receiving PNEUMOVAX 23. Reporter also stated that this reaction was worse compared to other vaccine injection site reactions she experienced however the reporter could not specify which vaccines. Reporter also stated that Erythromycin (manufacturer unknown) made her throat swollen shut and that she is allergic to medications in the Mycin family. The outcome of pain to touch at injection site, redness at the injection site and swelling at the injection site was reported as recovered/resolved on 8-OCT-2014 (reported as 5 days following AE onset date). Causality of the events with PNEUMOVAX 23 was unspecified by the reporter. Additional information has been requested.
8 cm circular well-circumscribed area of mild edema and erythema around the influenza vaccination site. It is not tender. He moves his shoulder well but has some mildly increased discomfort with movement. There is no streaking anywhere. There is no fluctuance. He has full sensation throughout the left upper extremity. Differential diagnosis includes moderate local reaction to influenza vaccine versus cellulitis. He likely had a similar toxic local reaction last year that was more severe than his current. Should the pain increase or he develop any fevers or of any questions or concerns that this may be more of an infectious scenario that he should return for reevaluation. For now, recommended symptomatic management with ice and rest and observation.
My period started 10 days earlier then usual and is still going on, today is 11th day already. Also, I'm on birth control.
The red first appeared in my left eye and the white part was bloody red so I called my eye doctor and he said to get LUMIFY and it would only help for a half a day and the red would come back so when that didn't really help I went to see the doctor who said it was not an infection but an inflammation and he prescribed a steroid which I took for three weeks but the whites in my eyes were not bloody red but still red, he told me I would always probably have the red tint in my eyes due to the swollen capillaries due to the swelling and the way they stay until today.
No soreness at injection site. Experiencing some tiredness, but not the same as in previous days.
16apr90 pt vax hepta B. w/i hrs pt became dizzy for 4 days.  21may90 pt vax 2nd hepta B.  sx reoccured. at time of report pt mentioned episodes of dizziness for 1 min. or 2 usually followed by a change of body position. see worm
pt recvd vax & did not develop a titer p/8 wks;MD reported approx 14 patients;pts assigned WAES95081597 & 95081815 through 95081827;
Instant black and blue bruise and swelling at injection site that increased in size over 10 min. Pain and soreness radiating up arm throughout shoulder and neck within minutes as well as pain radiating down left leg, described as "muscle soreness and aches". I asked patient to wait in the store for about 40 min following vaccine, checking up every 10 min. Called her primary care physician that she was supposed to see that day for a flu shot but decided to come to pharmacy instead. Spoke w nurse/MD who advised me that patient was ok to go home and should just be aware if symptoms don't subside. Counseled patient that she should see her MD if the pain/aches did not get better or got worse throughout the night. Checked up on patient at home 1.5 hours after vaccine and she seemed to be feeling okay, leg was still achy but arm and neck getting better. Advised her to ice arm to decrease swelling.