chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It has gone from bad to worse and she can't work; Dizzy off and on; Weak off and on; She has been sleeping 12-13 hours per night which is not normal for her; He shoulder got worse to the point of throwing up; After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work; Arm hurt; She was sick; Feeling very bad the day after; Fever; Headache; achy all over for 3 days - arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on) and ASTHENIA (Weak off and on) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt). On 23-Jun-2021, the patient experienced PAIN (He shoulder got worse to the point of throwing up) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on) and SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 23-Jun-2021, PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt) had resolved. At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on), SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included muscle relaxers and applying dry heat and cold.  Patient took second dose on 20-JUL-2021 (040C21A)   This case was linked to MOD-2021-278689 (Patient Link).
Burning  sensation as vaccine entered injection site. Excruciating pain radiating down entire arm several hours later, and unable to move arm.  Nausea and vomiting 16 hours later which lasted 24 hours. One week later developed muscle pain in left leg.
I have had an incredibly itchy, raised rash all over my legs, arms and torso since the day after the administration of the 2nd dose. It is seemingly getting worse, not better as of today (9 days post vaccine).
AFTER RECEIVED VACCINE, TOOK 5 HR. NAP. WHEN HE AWOKE, MOM NOTICED HIS FACE WAS SWOLLEN, 8-9 HRS. AFTER RECEIVING VACCINE. NEXT MORNING SHE NOTICED HE STILL WAS SWOLLEN. SHE GAVE BENADRYL. NURSE SPOKE WITH MOM ON 2/6/08. SHE STATES SWELLING IS GONE AND PATIENT IS ACTING FINE.
pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves; some redness in a circular pattern a few inches below the injection site; pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves; malaise; low grade fever 99.2 degrees; Initial information received on 16-Aug-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involved a 65 years old female patient who had pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves (sciatica) (pain in extremity), some redness in a circular pattern a few inches below the injection site (erythema), malaise and low grade fever 99.2 degrees (pyrexia), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past vaccinations included pneumonia (pneumococcal vaccine), shingles vaccine (varicella zoster) and flu vaccine (influenza vaccine) previously and had experienced cramping in her calf.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided   On 10-Aug-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 10-Aug-2021, the patient developed a non-serious malaise and low grade fever 99.2 degrees (pyrexia), on the same day following the administration of the vaccine.  On an unknown date, the patient developed a non-serious pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves (sciatica) (pain in extremity), some redness in a circular pattern a few inches below the injection site (erythema), (unknown latency) following the administration of the vaccine.  It was reported that "she has no physician information as she received her vaccine at pharmacy."  Other relevant laboratory test results were not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for all the reported event.  There will be no information on the batch number for this case.
Wide spread itching starting around the site of injection less than 24 hours after injection and has continued. Itching is present on thorax, upper and lower extremities. Negative for visible rash. Erythema and palpable nodule only present around site of injection on left deltoid. Accompanied by tenderness of palpable lump from injection site. Only unexpected outcome was wide spread pruritis
inadvertently got some of the product in her eye; inadvertently got some of the product in her eye; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number 52LX4, expiry date 23rd April 2023) for prophylaxis.   On 19th January 2022, the patient received Shingrix. On 19th January 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter mentioned that, while she was preparing a Shingrix vaccine for injection, inadvertently got some of the product in her eye, which led to occupational exposure while preparing product for administration and exposure via eye contact. The reporter consented to follow up.
This patient broke out in a rash and bumps all over her body on 02/20/01, itching a lot. Diagnosed 02/21/01 with chicken pox. Treatment: Atarax syrup, Zovirax liquid.
Knot at injection size (golf gall size); heat and redness 4-6 inches; itching.
This case was reported by a healthcare professional (nurse) and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with influenza vaccine (manufacturer unspecified). On an unspecified date the subject received a dose of influenza vaccine (unknown details). At an unspecified time after vaccination with influenza vaccine, the subject experienced allergic reaction. No additional details were available at the time of reporting. At the time of reporting the outcome of the event was unspecified. After the next vaccination with influenza vaccine the event recurred. See case A1007735A for details.
chest pain intermittent for 2 days, EKG no acute changes, high sensitivity troponin 2217 (ref range <45).
Severe flu-like sx, sore throat, aches, sinus congestion, didn't check temp, did have chills; Seen by MD no treatment; Had a high blood sugar; was dizzy;
I thought I had a sinus infection, I had a stuffy nose and then I had jaw pain, I thought I had a sinus infection. My daughter was visiting tested positive, So I went to get tested. My doctor gave me amoxicillin and I felt great within 24 hours.
given to a patient under 18 years of age with no reported adverse event; Initial information was received on 21-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old female patient who had given to a patient under 18 years of age with no reported adverse event after receiving influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Egg allergy.   On 19-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (unknown formulation) (Frequency: once) (with lot: UJ909AA, expiry date: 30-Jun-2023) (strength was unknown) via intramuscular route in left deltoid site for Immunization.  On 19-Nov-2022 the patient had a non-serious event given to a patient under 18 years of age with no reported adverse event (Product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved in 2022 for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
she was given 2 doses same day . No reaction . Facility  has 4 buildings. in every building , consents were filled and facility checking temp, billed then given to residents and staff for pharmacists and  nurses to go through  the consents and administer. for the memory care building since patients were cognitive, team was reassured by director to keep consents and nurses at facility took patients temp  and to go based on facility master copy that Nurse accompanied by another nurse took CVS team to memory care , they were asking our immunizers to go to room number .... and immunize Mrs ...., immunizer will verify name on bracelet and immunize,.
LEG PAIN; FEVER; EXTREMELY TIRED; HEADACHE; FELT AWFUL; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced felt awful. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced extremely tired. On 08-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced leg pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative, and Platelet count (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, extremely tired, headache, felt awful and leg pain was not reported. This report was non-serious.
Information has been received from a certified medical assistant concerning a pt who was vaccinated with a dose of varicella virus vaccine live (lot 632037/1355J). The CMA reported that shortly after receiving Varivax the pt was seen in the doctor's office with shingles. At the time of this report the pt's outcome was unk and there was no product quality complaint. Additional information has been requested.
8/13/21: Patient arrived at the ER due to shortness of breath since 1 week ago. Associated symptoms include dry cough and dizziness.  Intubated in the ER. Diagnosed with: acute hypoxic resp failure, COVID-19 pneumonia, septic shock, oliguric AKI requiring CRRT, partial proximal IVC thrombosis, emboli in the lingula Note: patient previously vaccinated with J&J COVID-19 vaccine on 4/27/21. 8/30/21: patient died this morning.
20JUL97 sudden onset arms 2xnl size, red, purple, hot-went to ER said not vaccine rx;did ultrasound & sent home;21JUL pt to MD adm to hosp had hugh blood clot that had to be dissolved-surgery;f/u 6wk remove rib;MD felt rxn not r/t vax;
The patient received the 2nd Covid vaccine on Thursday, March 18th at 10 am.  Six days later on March 24th in the morning, the patient experienced pain in the lower left leg when bending the leg at the knee.  Three days after that on March 27th the patient noticed the pain had subsided, but the leg had swelled up.  The patient saw her PCP two days later on Monday, March 29th.  Suspecting a blood clot, the patient was sent to the hospital for an ultrasound of the left leg that confirmed a blood clot.  The patient was given an Rx for Eliquis.  Revisit to the PCP three days later confirmed the blood clot was going away.  However, the patient was told to stay on the Eliquis for 6 months and repeat the D-dimer lab test to check on the status of cloting in the patient.  This patient has never ever had any previous blood clots in her lifetime.
Patient reported: hoarse, right foot was numb, and lightheaded. Observation Pulse 68, no shortness of breath, no dyspnea. Advised to continue to wait for observation, but patient left. Advised to take Benadryl and cold liquids and go to ED if symptoms worsen.  The vaccine was 2nd Pfizer dose Lot ER8732.
Hives-severe & prolonged requiring several trips to MD for antihistamine tx.The hives are described as generalized and persistant.
Vomiting, Diarrhea, Fever Lasted for about 8 hours. Weak for next 24 hours, then full recovery.  Note: this happened while we were traveling: approx 48 hours after vaccination. We thought it might be food poisoning, or a virus.  48 hours after reaction, patient's spouse came down with a very very mild version of the illness.  She also had vaccination, though she had the opposite versions of the nasal / injection for H1N1 and seasonal.  Full recovery after 24 hours.
Cold Sweats; Chills; getting frustrated; This is a spontaneous report from a contactable consumer (patient). male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 14Apr2021 (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 (Lot: ER2616) on 24Mar2021 for covid-19 immunisation. The patient got the second shot and he had cold sweats in the middle of the day (15Apr2021) and chills on and off, patient was getting frustrated with all of these questions. None treatment was received. The outcome of cold sweats, chills was not recovered, getting frustrated was unknown.  No follow-up attempts are needed. No further information is expected.
1. Pressure and pain in left arm, sudden onset 3 days after second dose, ongoing intermittent. 2. Numbness and tingling "funny-bone" sensation from left forearm through left index finger. 3. "Pins and needles" tingling, numbness and pain in both feet and sometimes lower legs, four days after second dose. Ongoing intermittent. May subside for many hours or a few days, then flare up again. Symptoms worse in left foot. 4. Aching pain in bottoms of both feet when walking. 5. Sometimes "pins and needles" sensation will fire randomly at various locations over the body. 6. Fluctuating resting HR and BP. * Contacted my PCP 15 days after second dose and 11 days into symptoms. Teleconference with PCP prompted concerns over the possibility of Guillaine Barre Syndrome and immediate referral to neurologist at Hospital. Complete and thorough exam by both healthcare provider and attending Neurologist found no signs of muscle weakness, paralysis or muscle weakness. Was given additional signs and symptoms of GBS to watch for and instructed to report to Emergency if any signs of facial drooping or foot/leg weakness paralysis occurred. Advised to discontinue Zinc supplementation to see if that reduces "pins and needles" sensation and left arm/foot numbness and pain. Almost no symptoms during bed rest/sleep.
Patient reports pain and tingling down to hand. Redness and swelling around the injection site and above elbow
Information has been received from a registered nurse concerning a 12 year old female patient with no pertinent medical history who on an unknown date was vaccinated with her first dose of GARDASIL. About 6 hours after receiving her first dose of GARDASIL, the patient developed shortness of breath. She went to the Emergency Room but was not admitted to the hospital. No specific treatment was given. The patient had gone to two different doctors and was still experiencing symptoms. The reporting registered nurse considered "shortness of breath" to be an other important medical event due to visit to the Emergency Room. No further information is available.
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUL-2014, the patient was treated by a physician at an eye center for a blistering vesicular outbreak, which was diagnosed as herpes zoster iridocyclitis. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Upon internal review, herpes zoster iridocyclitis was considered to be medically significant. Additional information has been requested.
SWOLLEN  & SORE LYMPH NODE UNDER LEFT ARM PIT, NOTICED ON FRIDAY 1/8/21 THOUGH 1/10/21 AM. SWELLING STARTED TO DECREASE BY SUNDAY AFTERNOON 1/8/21, SWELLING DOWN BY SUNDAY NIGHT 1/8/21
Localized erythema reaction to right upper arm. 3/17/2015 3 1/2 inches x 3 1/2 inches. 3/18/2015 3 1/2 inches x 7 inches.
Information has been received from a female who on 7/25/05 was vaccinated in the left deltoid with a second dose of Pneumococcal 23v polysaccharide vaccine. On 7/25/05, the patient developed soreness at the injection site. The pt subsequently developed swelling and erythema 7cm by 3cm on the inner aspect of the left bicep. The pt did not seek medical attention for the experience. At the time of this report, the patients soreness at the injection site and swelling and erythema on the inner aspect of the left bicep persisted. Additional information is not expected.
red lump; Vaccination site erythema; A spontaneous report was received from a healthcare professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red lump.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the eventred lump.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported. .   The outcome of event, red lump was unknown.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 01-FEB-2016 the patient was vaccinated with first dose of improperly stored GARDASIL (lot # K004205, expiry date 12-JAN-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the GARDASIL experienced a temperature of 32.1 Fahrenheit (F) for a 10 hours time frame. it was also reported that there was no previous temperature excursion, it was also reported that the nurse called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a pharmacist technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On January 2017 (reported as " a couple hours ago), the patient who was on therapy with ixekizumab (TALTZ) 80 mg (lot number, expiration date, strength, frequency, route of administration were not reported) an immunosuppressant injection, was administered a dose of ZOSTAVAX 19400 PFU lot # M033910, expiration date: 17-OCT-2017 (dose, strength, frequency and route of administration were not reported) for prophylaxis. No untoward effects noted. Additional information has been requested.
? 1st Pfizer dose on 04/24/21, 2nd on 05/15/21. Patient turned 16 on  between doses. Patient was under 16 at the time of the first dose.   No adverse affects to report. Just underage at the time.
Rash leukopenia and elevated LFT's (Give (5) days post vaccine while on Bactrim, felt to be allergic RXN to Bactrim rather than vaccine rxn.
The client is at school (college) and her mother called to cancel her appointment for her next series of vaccines and she related the following. On 12/14/2007 she received three vaccines. Adacel, Gardasil and Hep B. The next day she felt achy in the joints and then her hands swelled to the point she could not use them. She went to the local ER and was given some steroids and the symptoms improved but 3 or 4 days later the hand swelling and joint pain returned and she was sent to see a rheumatologist who did blood tests for arthritis. The tests came back negative, but he told her her immune system must have been weak and three vaccines at one time was too much for her (even though as a child she received multiple vaccines). He gave her a Medrol dose pak and had her take Aleve and her symptoms abated but it took several weeks until she was able to use her hands enough to draw.