chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.     This case was linked to US-MODERNATX, INC.-MOD-2021-092175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092175:wife case
As of this morning- 5 days after receiving my second dose. My left arm was tender and red about 2 inches below the injection site. The red and warm area measured about 1.5 inches high by about 4 inches around my arm. I also have slight chills.   About 18 hours after receiving the shot I got a headache up the back of my head. Tylenol was taken and it took care of the problem.
pt recv vax; 28jul95 inc induration in lt arm, firm, warm & reddened; c/o pain in lt axilla;
Patient felt lightheaded/dizzy after receiving second dose pediatric Pfizer, applied ice pack to forehead, patient felt better after 10 minutes
Fever; headache; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 25Feb2021 at 13:30 (at the age of 31-years-old) at unknown, single for COVID-19 immunisation. Medical history was reported as none. The patient had not known allergies. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were not reported. The patient experienced fever, tiredness and headache on 26Feb2021 at 04:00 AM. The events were reported as non-serious. No treatment was received for the events. The patient had recovered from the events in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
little nagging headache; a little tiredness; This is a spontaneous report from a Pfizer sponsored program  via a contactable consumer. This consumer (patient) reported that the female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunization. The patient experienced little nagging headache on an unspecified date with outcome of unknown, a little tiredness on an unspecified date with outcome of unknown. Consumer asking if she can take her Fluticasone. Consumer asking if she can take her Allegra. Consumer has a diagnosis of COPD. Consumer was advised by HCP to not take Prednisone at this time. Consumer curious as to why she shouldn't take the Prednisone. Consumer did voice during conversation of other concerns that she tolerated the Pfizer Covid 19 Vaccine well. She stated "I only experienced a little nagging headache enough to know it was there and a little tiredness". She has COPD and is taking predisone. her doctor told her not to take if getting the Covid vaccine. She has had both doses of the vaccine and wants to know how long she should wait to take her predizone again.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IPF" (unspecified if ongoing), notes: Other medical history: IPF. Concomitant medication(s) included: CRESTOR, start date: Jan2003, stop date: 11Jul2022; OFEV, start date: Jan2020, stop date: 11Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (14Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (Jul2022) strong red line, notes: antigen tests show a strong red line; (15Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (16Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (17Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days; (18Jul2022) very faint line, notes: After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received other medication in 2weeks. product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 11Jul2022, Treatment stop date: 15Jul2022, Indication: Treatment of COVID-19. After 3 days of paxlovid fever and symptoms ceased had a very faint line in antigen test which remained faint for another 4 days and then antigen tests show a strong red line I do not fever nor major symptoms (only a bit of fatigue).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12-01-2022 (day after) woke up with red splotches on arms and legs 12-02-2022 woke up with large painful blisters around both ankles, called pharmacy and told flu shot was probably the cause 12-03-2022 went to hospital Emergency, was given steroid shot and prescription, also Mupirocin ointment  12-05-2022 blisters were extremely painful, went to family practice doctor, received antibiotic shot 12-06-2022 to current, blisters continue to be painful and are treated with ointment
Mother observed her son sitting and crying on 10-14-15, and noticed a rash on his (R) anterior thigh area, which she pointed to today. Father states on 10/23/15 he noticed his son having problems walking, and his (R) foot was turned in, and then two days ago they felt his head and he was hot like a fever, TYLENOL given.
A non-serious spontaneous report of flu symptoms has been received from a consumer concerning a child subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 08-Oct-2010. On 11-Oct-2010, the child presented with flu symptoms. No medical attention or other symptoms were reported. The outcome of the event are unknown.
Notes: After vaccinations, patient became dizzy and pale. He had some tensing of arms and was directed to lay down. Glucose was 76. He was given a juice box and some water. At 5 minutes, BP was normal. At 15 minutes, BP was also normal and dizziness had resolved. He did complain of intense pain extending from upper arm to hand on right side where he received the HPV.
approx 3yrs p/vax pt exp mild case of chickenpox rash w/less than 50 lesions. addl it was noted pt did have vesicles & fever.
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. On or about 18-DEC-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance 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 29-JUL-2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and prednisone for management of his painful symptoms and chronic pain. 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. Causality assessment was related. Additional information has been requested.
The morning after I received the vaccine my lower back starting aching and then progressively throughout the day, my body started to ache. At the same time, my left arm that received the injection was sore and getting more difficult to use as the day progressed. By late afternoon/early evening, I started a low grade temperature from 99.3 - 100.1 all evening. The low-grade fever continued throughout the night and into the early morning hours with very little sleep. I took 2 extra-strength Tylenol at 3 different times from 12pm on 3/5 to 6am on 3/6. It didn't really seem to give me  much relief or reduce the fever/pain. I went back to sleep at 7am for 2 hours and when I woke up at 9am, I felt so much better. No fever. I took a shower and felt even better and the fever was gone. Aches and pains were gone, but I still have the soreness in the arm and it is lessening every day. It was almost like a delayed reaction but it was a 24 hour reaction definitely.
Dtap and MMR where given on 06/29/09 in right thigh. On 07/02/09 pt accompanied mother.Complained of red raised spot on right thigh 9cm x 8cm. Mother was told to ice area 20 min, Q/2hours and massage, return if symptoms become worse or do not improve.
Severe sore throat with visible erythema in posterior pharynx.  No fever, no lymphadenopathy.  So severe I couldn't swallow my own secretions for a few days!  I took a day off work and went to Urgent care on 1/19, swabbed negative for strep and for covid.  I went to work the rest of the week and tested myself again twice that week for covid, both negative.  By Friday Jan 22, it was improved and mostly gone by jan 23rd. I had a telemedicine appt during the week (can't remember which day) with my PCP and her thought was maybe it was a vaccine reaction since I had no other symptoms and testing was negative.
Right thigh swollen-discolored and slightly warm to touch. -Rx: Cetirizine 3/4 tsp BID with cool compresses.
Starting nearly three months after my booster shot, I experienced persistent mild-to-moderate discomfort (soreness, pressure, occasional sharp pain) the left upper quadrant of my chest, extending from under the armpit down diagonally to the bottom of my rib cage
As part of the employer program, the employee received a Hep B vaccination under a standing order. Pt called the nurse with a complaint of hives.
Influenza vaccine administered HIGH in left deltoid. Arm/shoulder was typically sore for first several days; acetaminophen or ibuprofen was effective. Then more significant shoulder pain developed. By 3 weeks post-immunization, "rotator cuff" symptoms were evident and NSAIDS had no impact. Indomethacin, Naproxen, and Nabumetone were all used with no relief of shoulder pain.
This spontaneous prospective pregnancy report as received from a respiratory therapist refers to a female nurse of unknown age. The respiratory therapist reported that a pregnant nurse was administering VARIVAX (Merck) to a patient on 27-SEP-2013 and the patient moved while the dose of VARIVAX (Merck) was being administered. The patient only received a partial dose of the VARIVAX (Merck) and the pregnant nurse had VARIVAX (Merck) in her eye. The pregnant nurse washed her eyes and went to her OBGYN physician (name of OBGYN physician was unspecified). No adverse event reported. The nurse's pregnancy information was not reported. The last menstrual period (LMP) and estimated due date (EDD) were not known. The pregnancy outcome was pending. The nurse sought unspecified medical attention. The patient's event was captured in 1310USA002538. Additional information is not expected.
With anthrax vaccine (4), service member (SM) denies any unusual or prolonged local reactions. He experienced a migraine headache. He describes the headache pain being constant aching pain with occasional sharp pains located at the base of his head and was accompanied by nausea. He had no improvement with OTC headache remedies (Tylenol, ibuprofen, Goody's powder). He had no history of similar headaches. He also had sore joints and muscles with onset within 24 hours of vaccine receipt and resolving within 3 days. After AVA (5), SM denies any unusual or prolonged local reactions. He experienced a "terrible" headache with n/v. Also, his "whole body" was sore (muscle and joints ached all over). These symptoms lasted about 5 days. His headache came and went. In addition to nausea, he also vomited a couple of times. He spoke to an MD on the phone and was told his symptoms were 'normal reaction to AVA.' Had similar symptoms after his 6th anthrax vaccine 'only a little worse' and lasted about a week. He had the same reaction after his next anthrax vaccine (7), but the headache and body aches were 'the worst'. He wondered if that week would ever end. His unit released him from work x 2-3 days. He could not concentrate due to the nausea and pain. Since his last AVA vaccine, he has not experienced any muscle or joint pain, other than r/t overuse. He has had 1-2 headaches since then with one migraine in the fall of 2006. He has had other minor headaches, but not associated with nausea and aching. Other headaches have always gone away with OTC meds. Muscle and joint pain was constant dull aching pain rated as 4-5/10 using pain ascale of 0-10. Treated with OTC analgesics with no significant decrease pain. The only thing that helped was massaging muscle and that provided ltd relief. He had some morning stiffness that took 'awhile to loosen up'. No paresthesias. PAIN: Wrist symptoms, elbow symptoms, arm symptoms, back symptoms, knee symptoms, leg symptoms, ankle symptoms, muscle aches, and arthralgias. No localized joint swelling. Symptomms: Muscle Pain; Symptom: Joint Pain, multiple joints, Headache, Migraine; Nausea w/vomiting
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an approximately 59-year-old female patient (pt) who was 59 years old at the time of vaccination (calculated based on the suspect vaccine start date; age at vaccination reported as 56 years old, conflicting information). No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 21-JUL-2010, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a county health department for the long-term prevention of shingles and zoster-related conditions. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about 2010, including any and all of its sequelae (also reported as subsequently (date not provided), the pt was treated by a healthcare provider for shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX)). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences (also reported as had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). The pt had endured substantial pain and suffering. She had incurred significant expenses for medical care and treatment, and would continue to incur such expenses in the future. The pt had lost earnings and had suffered a loss of earning capacity. The pt had suffered and would continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
This case was reported by a nurse via sales rep and described the occurrence of pain in unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were unknown. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected as adult as per the vaccine indication. The nurse shared during meeting with the sales representative that two or three patients had called to let the office know that they had experienced pain and redness. The reporter did not agree to follow up.
Phone call from patient 6/16/10 states "the day after the vaccine I started having muscle weakness in my arms and legs for 1-2 weeks. I saw my primary Doctor that week. Since then I've had problems walking and swallowing. I am under the care of a neurologist and rheumatologist."
approx 7 days p/ vax pt devel varicella rash w/5-10 vesicles
This is a spontaneous report from two contactable consumers, a consumer and another consumer (Patient). A currently 68-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in 2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute bronchitis/bacterial pneumonia diagnosis on an unspecified date with outcome of unknown. The information on the lot number has been requested.
First symptoms in evening after the vaccination;  Chills with extreme shaking, headache. The next day in the morning symptoms:  extreme headache,  flank pain, feeling faint and light headed, low blood pressure. Then;  nausea, vomiting,  and sensation throughout body.   To emergency room;  treatment of medications Zoltan, Prednisone.
Pharmacist counseled patient on the adverse event with the imz. Physician prescribed antibiotics and prednisone. Pharmacy suggested taking Benadryl and that patient is allergic to a component of the immunization.
Developed subclinical rubeola approximately 12/23/04, now with protein in urine, increased blood pressure, joint pain and abdominal pain.
Patient admitted to the hospital for COVID 19. Reporting per Moderna COVID 19 EUA.
reduced ROM in left shoulder; Pain at injection site; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 24-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at 12:45 (at the age of 24 years), as DOSE 1, SINGLE for COVID-19 immunization. The patient also received apremilast (OTEZLA, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date, at 30 mg, BID for an unspecified indication. The patient medical history included Psoriasis. The patient concomitant medications were not reported. The patient did not take other vaccine in four weeks. Other medications taken in two weeks included Otezla 30mg PO BID. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. On 26Feb2021 at 13:00, the patient experienced reduced ROM in left shoulder and pain at injection site. The patient did not receive treatment for the events. The outcome of the events was not resolved at the time of this report.  No follow up attempts are needed. Information on lot/batch cannot be requested. No further information is expected.
warm spot below site of injection; red spot below site of the injection; fever; chills; flu-like symptoms; arm is still sore; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received in 21st September 2021, experienced a red, swollen arm, and cellulitis refer case US2021252050).   On 6th December 2021 11:00, the patient received the 2nd dose of Shingrix. On 7th December 2021, 1 days after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. In December 2021, the patient experienced fever, chills, influenza-like symptoms and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, influenza-like symptoms, pain in arm, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient received the 2nd dose of Shingrix in her right arm at around 11 am on Monday from the day of reporting. 14 hours after received Shingrix around 1 am on 7th December 2021, the patient developed a fever, chills, and flu-like symptoms that lasted a few hours and then resolved. The patient reported on the day of reporting that her arm was still sore and that there was a warm, red spot that appeared below the site of the injection (currently unresolved). She could not provide the lot or expiration date of either dose of Shingrix vaccine. The reporter consented to follow up by phone. The reporter gave consent to contact her HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252050:Same reporter
2" diameter rash (sore to the touch) developed around injection site on day 12 following vaccination